[{"id": "FDA-2007-P-0415", "agency": "FDA", "title": "Enact Stricter Guidelines in Prescribing Methadone for any Reason (CLOSED)", "update_date": "2021-09-01", "update_time": "01:01:09", "purpose": "Nonrulemaking", "keywords": ["Victims", "METHADONE", "Enact", "stricter guidelines ", "CDER"], "comments": [{"text": "HELLO, DUE TO THE RELAXED LAWS IN REGARD TO METHADONE DISTRIBUTION, MY SISTER WAS ALLOWED ACCESS TO THE DRUG OFF THE STREET AS A WAY TO HELP HER SLEEP BETTER. SHE OVERDOSED ON METHADONE ON JAN. 1ST 2007. I AM ASKING ON HER BEHALF,( AND ON THE BEHALF OF ANY POTENTIAL FUTURE VICTIMS OF THIS DRUG ) THAT METHADONE NOT BE GIVEN TO ADDICTS IN DOSES EXCEEDING THEIR DAILY AMOUNT, THUS NOT ALLOWING FOR ITS EASY ACCESS ON THE STREET. MAY YOU LET YOUR CONSCIENCE GUIDE YOU IN ANY DECISION MAKING PROCESS REGARDING THE EASE OF AVAILABILITY OF THIS DEADLY/DANGEROUS DRUG. BEST REGARDS, DUSTIN RHODES", "comment_id": "FDA-2007-P-0415-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2007-P-0415-0004", "comment_date": "2008-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 635}, {"text": "I Lost my husband due to methadone Overdose In December 2007, I was left with 3 children to raise. I am a resisdent of the Eastern KY,  West Virginia area One of the biggest areas in the comtry for methadone distribution. Here ANYONE as long as you are 18 and have cash can go into 1 of any number of methadone clinics and walk out with a cocktail of  things. Methadone syrup, wafers, pills and in some cases if you have enough money all of it and in large quantities (up to 240 pills). I dont think its right that these people just walk in there and get it sell it that night and keep claiming lives and go on like they did nothing. Its just the families of the deceased that has to deal with the loss because I assure you the person who sold my husband methadone is still selling and still causing deaths. He dont care that he befriended my husband and contributed to his death. He tried to sell to my 13 year old child after her father was buried. But its not just one its 1 of hundreds or thousands of people who go to these doctors and they arent monitered or anything. They are given their weapons (120 to 240)and they go kill with it. They kill our friends and our family and Not one soul, not one of you can say it hasnt touched in your family because if it hasnt it will, Its hitting everyone. Everyone thinks it wont until you face the day you have to put someone you love underground forever. Please help stop the sensless distribution of Methadone before it claims your husband ,wife,child or parent. Whatever the case may be its not safe to be given to people not under close watch. Knowing alot of people really need it, it can still be a good idea to give it inpatient and if its not an inpatient case there is other methods other less dangerous drugs to use without sending this deadly stuff out on the streets for our loved ones to get, killing and forever throwing grief upon the innocent families of those it kills. I know i am one voice but i hope and pray to GOD I am a loud voice because someone needs to get us help to get this off the street, off the pharmacy shelf  and in hospitals only.   Thank you and GOD BLESS", "comment_id": "FDA-2007-P-0415-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2007-P-0415-0009", "comment_date": "2008-11-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2269}, {"text": "Methadone has left many families without their loved ones.  The clinics that dispense this drug must be under scrutiny by the Federal Government.  My grand daughters father died from a so-called overdose given by a clinic for painand I do not want anyone to lose their father  like she did.", "comment_id": "FDA-2007-P-0415-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2007-P-0415-0006", "comment_date": "2008-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 305}, {"text": "Methadone is killing our children.  It is in our communities, school systems and in the home.  Much of it is obtained by doctors or clinics who are out to make money and worse than drug dealers.  A former student has died recently because of obtaining Methadone from the EAST INDIANA TREATMENT CENTER.  A doctor by the name of Dr. Nabil Babar is prescribing Methadone to many individuals here in the Maysville, Ky. area.  This doctor should by stripped of his occupation and these clinics should be closely monitored.  I have reported this particular clinic to to DEA and have spoken to our congressmen.PLEASE SAVE OUR CHILDREN!!!!Julie FernSt. Patrick SchoolMaysville, Ky.  41056", "comment_id": "FDA-2007-P-0415-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2007-P-0415-0008", "comment_date": "2008-08-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 750}, {"text": "Please consider the strictest possible regulations for the drug methadone. Personally, I feel this drug should be taken off the market. It is much too dangerous and unstable to be given for any reason. My son died after being given this drug to help him recover from a prescription drug addiction. His life was never the same once he was in the methadone program. He had numerous car accidents, physical problems, and depression and anxiety. These all occured after entering the methadone clinic. Another problem is doctors continue to treat these patients , in methadone clinics, with painkillers, muscle relaxants. The combination is deadly. It compromises the respiratory system and many times results in death while sleeping. I told my sons doctor he was a drug addict on methadone and he still walked out of his office that day with large prescriptions for painkillers and muscle relaxants. Something must be done, either take it off the market or start educating doctors on how to prescribe such a dangerous drug.Thank You,Linda Tyler", "comment_id": "FDA-2007-P-0415-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2007-P-0415-0005", "comment_date": "2008-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1200}]}, {"id": "FDA-2018-N-1621", "agency": "FDA", "title": "Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments ", "update_date": "2018-10-10", "update_time": "15:22:16", "purpose": "Nonrulemaking", "keywords": ["Patient-Focused Drug Development on Chronic Pain", "Notice of public meeting", "request for comments", "Meghana Chalasani", "Chronic Pain", "CDER", "OPEN", "2018-247"], "comments": [{"text": "My mother had severe restless leg syndrome (RLS.) After years seeking help for her overwhelming need to move her legs at night and dealing with dismissive and nearly abusive physicians, we found an M.D. who said that he would not have believed her symptoms had he not had RLS himself!  Her husband, of 50 years, had to move to a separate bedroom because of her constant need to move.  Mother was finally treated with drugs that allowed her to sleep for longer periods without walking about.  Those drugs, first Sinemet and then various dopamine agonists, worked for a few years, but with major side effects that led to severe augmentation.  Her RLS then started earlier in the day and prevented going to a movie, listening to a lecture or traveling despite her determination to live her life fully.  She was exhausted all day and would sometimes just fall asleep in the middle of a conversation because of the impact of the medical regimen.  When she was dying, she was in agony with RLS because she could not get up and move about.  Moving while lying in bed did not alleviate the symptoms or did so only while she continued movement.  When her RLS medications no longer worked, her neurologists had nothing to offer.  Fortunately, once she was in hospice, people actually cared about her comfort and she was provided with opioid pain control which, more importantly to her, helped control her RLS.  It was so sad that mother had to be dying to receive appropriate care.  Fortunately, more physicians now understand that RLS is actually not in ones head, but is a real, not manufactured condition to gain attention. ", "comment_id": "FDA-2018-N-1621-1507", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1507", "comment_date": "2018-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1617}, {"text": ".  .  25 .  21..    ... ", "comment_id": "FDA-2018-N-1621-1311", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1311", "comment_date": "2018-07-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 184}, {"text": "Multiple sclerosis, EDS, mcad..I cant have injections bc of EDS. Professionals should know that. My last resort is going to be learning to buy and do heroin.", "comment_id": "FDA-2018-N-1621-0663", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0663", "comment_date": "2018-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 162}, {"text": "I have been frustrated by having to even go to pain management to get my pain pills. First I received dilaudid from my eye surgeon that removed my blind eye. Then he no longer wanted to prescribe the 8-10 pills I used monthly and said I had to instead use the time , energy and money to go to a pain clinic for these pills for my blind ennucleated eye neuropathy. Im allergic to codeine and need dilaudid for relief. First the pain clinic said I could come every 3 months and get these pills, then they said CDC guidelines indicated that if they gave me any opiates I had to be seen monthly.  This is costly and I have to drive or be driven ( I have lots of vision issues in the other eye) to a clinic an hour away because the one here in town shut down. This is a racket that is inconveniencing and punishing legitimate patients need for pain control. Also over the past year and a half Ive been to the ER with kidney stones twice. In past years before this opioid epidemic kidney stone patients were regularly sent home with opiates as trying to pass a kidney stone is excruciating. Now they will not give you anything to help. This is cruel! Full disclosure- I never had kidney stones before 16 months ago but my brother had suffered with them off and on for 20 years and was always given pain meds. Anyway, my point continues to be that this crackdown on doctors and pharmacists is causing financial stress, treatment stress and travel stress on patients and is causing Doctors and Pharmacists to be reluctant to provide needed interventions to control pain. If I didnt have the medication for my neuropathy Id be bedridden for 2-5 days a month. The pain is like a knife stabbing me through my eye and into my brain.  With this pain control Im only having to spend 1-2 days per month in the bed and nonfunctional to my family. I do use an ice pack during flares and I use OTC analgesics to manage pain as much as possible. ", "comment_id": "FDA-2018-N-1621-0671", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0671", "comment_date": "2018-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1937}, {"text": "Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to Patients1. How would you describe your chronic pain? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)muscular, skeletal, neurological; both diffuse and highly localized. I have a condition called Ehlers-Danlos Syndrome.2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)Tens of joint dislocations daily, muscle spasms, restricted range of motion, chronic fatigue, mobility problems, inability to lift over a few pounds.3. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your chronic pain? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)Sleeping, feeding self, washing self, recreational outings, working fulltime, sex.4. How has your chronic pain changed over time? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)Started when I was around 23. I am now 29. Its all day every day but highly variant.Topic 2: Patients Perspectives on Current Approaches to Treatment of Chronic Pain1. What are you currently doing to help treat your chronic pain? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)Topicals, heat, PT, trigger point injections, nerve blocks, exercise as much as possible, non-opioids, opioids, mindfulness, therapy.a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)Ive gone through virtually every option offered by any doctor Ive encountered except for prolotherapy (insurance wont pay) and steroid injections (contraindicated for my condition).b. What factors do you take into account when making decisions about selecting a course of treatment?I read the existing literature and also am constrained by provider willingness.2. How well does your current treatment regimen manage your chronic pain? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)I would say its moderately controlled due to opioids.3. What are the most significant downsides to your current treatments, and how do they affect your daily life?Biggest issue is things not working well enough and fatigue and stigma from medication.4. What challenges or barriers to accessing or using medical treatments for chronic pain have you or do you encounter?This war on opioids is out of control. Its a terrifying climate. I have intractable pain according to my state laws, but it is still extremely intimidating to even admit I am seeking pain mgmt unless the provider is trusted. I have been diagnosed and in treatment for years, but the strongest thing I have ever gotten prescribed is Tramadol despite the failure of invasive procedures. I went from being a research mathematician with an active social life to fully disabled and no longer active in my field.5. What specific things would you look for in an ideal treatment for your chronic pain?OPIOID ACCESSIBILITY.", "comment_id": "FDA-2018-N-1621-0674", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0674", "comment_date": "2018-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3700}, {"text": "At the age of 71 and being a retied public official  I find my government jumping the gun on these decanoin rules recommending and justifying an opioid crisis. For years heroin and fentanyl have been corrupting our society from Mexican drug gangs and their local distributors. This is a known fact that has been by panic and misinformation by our own government that has fueled the so called opioid crisis. My story is a 6 year battle with spinal stenosis, degenerative disc disease and spinal cord damage, six major surgeries including a spinal fusion, spinal cord stimulator that has been removed do to no relief and a pain pump that offers very little help. Now for the facts the only medication and I have been prescribed everything known to man opiates offer the best pain relief when managed properly. Yes we have those who have no control over their addictions who need the proper treatment for which lacking, so they are mixed in with us the legitimate people who need their pain medication on a routine basis and we have a so called crisis and the FDA, CDC and DEA swing into action with swiping us all and our doctors off the map. This whole political witch hunt needs to stop and be thought through and just maybe a common sense approach may come of it. To finish my story I am looking at another major surgery to decompress my spinal cord and fuse L-2 and L-3 vertebraes to relief some of the severe pain I deal with, not to mention my pain meds have been cut back by almost half and my pain doctor gave up and quit pain management. Will someone please listen to us and give our God given right to proper medical care and keep political witch hunts out of our medical care. ", "comment_id": "FDA-2018-N-1621-1414", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1414", "comment_date": "2018-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1696}, {"text": "Hello,When i heard i am being given the opportunity to speak on this matter it gave me pause, I want to speak up however, the complete demonization of chronic pain sufferers and their quest to get some relief to have a semi normal life made me fear coming forward. After reading some of the comments i decided i have to speak. When did it become acceptable to punish all for the crimes or weakness of others? Example of the women who took 35 Vicodin a day! How is that my fault and why should i pay personally for her addiction ? I have been on pain meds for many years, i even took myself off them for awhile to see how i felt and could i cope without. I was off of pain meds for 9 months and i can tell you it was not fun. I tried ibuprofen, it doesnt work and made my stomach ulcers worse, i tried stretching, exercise, diet change, hot baths, ice, aspirin,12 aday! antidepressants. i gave it my all. Finally after days in bed i made an appointment to see my doctor and was immediately put back on my pain meds.I take 2 or 3 a day just enough to take the edge off my pain and be able to be a productive citizen and live a semi normal life.I have spinal and cervical stenosis, I have had one full knee replacement and one that needs replaced, due to arthritis i was also diagnosed with fibromyalgia.Now you want to limit my pain relief because their are people who have addiction problems ? You want me and others to suffer for the weakness of others ? I have even had some doctors try to get me to take Marijuana so they do not have to wright a pain med prescription. ??  Now i am old enough to remember when Marijuana was evil and against the law, now it is like going to the 7/11 store here in Oregon, there is a pot shop on every corner! the world is upside down for me. I have been passed around by my own doctors, who disagree strongly with these new RULES but are in fear, and i can only hope my new doctor stands by me. by the way what ever happen to the medical oath Do No Harm because the doctors are in fear due to the new Rules, in turn harming chronic pain sufferers to avoid reprecission from the FDA.I understand that there are people with drug problems, i understand everyone is different and some cannot help themselves when it comes to misuse of drugs, They will find other drugs as they always have. You will not solve the drug problem in america by restricting those who truly need relief! you will force many to become Illegal users, Suicides will increase and pain suffers will have their quality of life dissolve.Please find another way, please dont take it out on true chronic pain sufferers.Peoples lives are at stake!! not just the over users and abusers but the real chronic pain sufferers who go by the book and are responsible.Thank You ", "comment_id": "FDA-2018-N-1621-1409", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1409", "comment_date": "2018-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2905}, {"text": "Thank you for the opportunity to give input on the current state of medical care for people with chronic intractable pain.  One issue I would like to call to your attention is the difficulty of just obtaining, or picking up, medication from the pharmacy.  Chronic pain patients often have several other medical conditions in addition to whatever diagnosis (es) are causing their pain.  Some of these are treated with medications that may also be controlled substances that are not either opioids or benzodiazepines.  In fact, the vast majority of these medications have little to no risk for abuse and certainly no value for diversion or other illicit use.  As an example, I am diagnosed with lupus, Sjogrens syndrome, intractable seizures, rheumatoid arthritis, mixed connective tissue disease, peripheral neuropathy / permanent nerve damage secondary to Guillian Barre Syndrome, narcolepsy with cataplexy, generalized anxiety disorder, hypertension, GERD, chronic fever, insomnia, vitamins B-12 and D deficiency, Raynauds phenomenon, begin positional vertigo and severe osteoporosis secondary to long term steroid treatment.  A long list, to be sure, and I take 11 different different medication per month. Of these medications, one is a low dose opioid on which I have been stable for 12 years at the same dose, one is a benzodiazepine prescribed for seizure control, one is a antidepressant used for dual purposes of sleep and anxiety,  one is a eugeroic used to combat narcolepsy, three are anti-convulsants for seizure control, two are for hypertension and two are for vitamin deficiencies.  Of these 11 medications I get each month, 7 are controlled substances.  One is Schedule 2 and the remaining 6 are on Schedules 4 and 5.  All of these require careful attention and planning in terms of refill schedule, physician appointments required, and in arranging transportation to and from both the pharmacy and the physicians as I cannot legally drive due to intractable seizures.This may sound easy - like just run to the pharmacy a couple times a month and all is well.  For me, it isnt.  I live in an extremely rural area and the closet pharmacy is 15 miles away.  Leaving the house is quite difficult due to my existing medical conditions.  All of the pharmacies close to me have a strict policy that they will not refill controlled substances until you are completely out - on the 30th day.  Because of my seizure disorder, I have to plan my life carefully around those 30-day refill dates because missing a dose can be life-threatening. And of course they are all on different days of the month. And of course because of the seizures I cannot drive there myself so that means finding transportation for that long round trip ride. Then there are my other meds so even more different refill dates and trips to the pharmacy to manage.  I expend most of my available trips away from home energy on pharmacy visits - my husband nor friends can drop off or pick up controlled substance prescriptions as they require you to show a valid State ID matching the prescription each time.  Because of this, weve been unable to visit family that live a few states away for years because of my meds. I often say that my best friends are my pharm techs because I see them more than anyone else in my life. I understand the need to address medication diversion and I hate to hear about people overdosing on illicitly obtained meds. I hope that the FDA and the CDC decide to focus their efforts on those who are illegally obtaining Schedule 1 and 2 medications and/ or diverting these for illicit use, and those overdosing on illegal drugs such as heroin and illicit fentanyl.   However, most chronic pain patients are not diverting nor overdosing. Nor using heroin or illicit fentanyl.  We need our medications too badly to divert them.  However, the Federal, State, local, and arbitrary pharmacy rules impact my life so greatly that the pharmacy is the only place I get to go.  I would to be able to visit my mother or my sisters more so I could call them my best friends, not the pharmacy techs.  Respectfully submitted,Sharon E.", "comment_id": "FDA-2018-N-1621-1410", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1410", "comment_date": "2018-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4179}, {"text": "To whom it may concern, in 2015 with no Rhyme or Reason I woke up and was unable to walk properly, bend over twist or left. I went to the doctor told them what I did the day before you thought maybe a back sprain it was too intense I had an MRI mild disc bulge didnt explain the nerve pain didnt explain the amount of pain I was in or the weakness I was explaining in my left leg the pain was excruciating. I have two children forward 2018 here now still battling to find out what is causing the extreme nerve pain the extreme pain in my neck and lower back the paralysis in my foot and why my left side is not working what I can tell you is that the without my nerves suppressants and my pain management medication I do not know how I would be able to care for my children or myself suffering from migraines constant back pain neck pain and nerve pain is debilitating I have never been flagged I have followed all my doctors orders I have tried stretching I have tried doctor order exercises and Im still trying to do and accomplish those exercises. acupuncture Ive never called in early for a perscription Ive never lost a prescription even when my Dr have wrote me too many prescriptions I have brought back those prescriptions and said I already had a prescription for this month and you wrote me an extra one there are plenty of good patients out there that do not need to be treated as drug Seekers who do not need to be in pain management clinics or severe contract where theyre scared every single time that theyre going to lose their medication. you were taking the right of the doctor away to treat his patient and assess his patient because they become too nervous that the federal government is going to come down on them for writing too many pills too many prescriptions theyre only allotted this many perscriptions of this type of drug how can you put that type of pressure on the people who are supposed to be caring for our health and well-being theyre supposed to treat us as humans and as their patients not worried about upsetting the government over pill counts you want too stop addictions I get that but taking away peoples medication is not going to do do that youre going to drive people to the street you arent going to help them be anyting going to do is cause harm suffering and make people look for something some where they be I not trust the the doctors they should be trusting and talking to.", "comment_id": "FDA-2018-N-1621-1402", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1402", "comment_date": "2018-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2498}, {"text": "I have refractory RLS (severe Restless Leg Syndrome) and although it is not considered a chronic pain condition, we are still being caught up in the opiod crisis and the overreaction with regulations that can penalize those in real need.  RLS is a movement disorder -- you cannot sit still or sleep because of an awful sensation in your legs or arms (like crawling insects) that is relieved only by walking around or otherwise moving your legs.  When it hits, mostly at night, you cannot sleep. And for those like me, with severe RLS, it hits every single day.  I have had it so bad I couldnt ride in a car, would stand to eat dinner, couldnt work on a computer because I couldnt hold my arms still, couldnt sit down to read a book or take a nap, would pound my legs so hard they would bruise, and at one point was throwing things and ripping magazines at 3 am from frustration and total lack of sleep.  It is not curable.    I have had RLS since I was 13.  I am now 66.  I went through virtually every treatment regimen for RLS, until as a last resort, my doctor put me on a low dose of methadone.  It literally changed my life when my RLS attacks went from every day to none at all.  It is the only drug that has totally worked for me.  This opiod is known to benefit severe RLS patients, yet the  repurcussions from this opiod crisis are causing doctors to decrease or stop dosages; insurance companies to put in place  incentives to NOT prescribe these drugs; and now the feds to try and control things without knowing the unintended consequences.  This is just not right.   I have total sympathy for CPP, and I support them.  Just know that there are other very legitimate reasons for patients to need opiods.   We are not addicts.  We are only trying to live normal lives.   Regulations on opiods need to allow their legitimate use not only for CPP, but for other conditions like RLS as well.   Doctors and patients know best.", "comment_id": "FDA-2018-N-1621-1405", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1405", "comment_date": "2018-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2024}]}, {"id": "FDA-2018-P-0673", "agency": "FDA", "title": "Requests that the FDA produce a study on control of alprazolam products in relation to the overall effect on the Opioid crisis in the USA.", "update_date": "2021-02-17", "update_time": "17:40:12", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Justice for Jake", "produce a study on control of", "alprazolam products in relation to the overall", "effect on the Opioid crisis in the USA", "OPEN"], "comments": [{"text": "If someone is poisoned by lacing punch, gummie bears or whatever, it is not the drugs fault, it is the person delberately tampering with the food, beverage committing murder. Does the date rape drug take the rap when someone puts it in another persons drink? Is it guilty of the crime?Despite what ignorant individuals are stating, the only people suffering from the opioid crisis are the people that need the medication to live. The lives of people with horrible medical conditions have been destroyed. The lives of the elderly have been destroyed. The correct od stats are 17k. People do not take the time to fact check the current fad.  Govt quietly corrects data while continuing to disseminate erroneous data, MILLIONS OF PEOPLE WITH ILLNESSES WHO PREVIOUSLY WERE ABLE TO FUNCTION, CONTRIBUTE TO SOCIETY ARE NOW INCAPACITARED AND IN EXRUCIATING PAIN. YOU HAVE DESTROYED THEIR LIVES AND THEIR FAMILIES AND WE BY FAR OUTNUMBER THE POOR LITTLE ADDICTS WHO COULD CARE LESS ABOUT ANYTHING OTHER THAN GETTING THEIR ILLEGAL FIX ON THE STREET.THE SICK ARE NOW COMMITTING SUICIDE DUE TO NONSTOP PAIN.STOP PICKING ON PEOPLE WITH ILLNESSES OF ANY KIND.THERE SHOULD NOT BE A SIGN IN A CANCER DOCTORS OFFICE STATING THEY CANNOT GIVE YOU THE MEDICATION YOU NEED FOLLOWING CHEMO AND RADIATION.THE DEA LIES ABOUT DRUG SHORTAGES FOR THE SICK, WHILE THE FDA WEBSITE LISTS THEM AS SHORT.IGNORANT AMERICANS YET TO BE AFFECTED BY THE FACT THAT PAIN KILLS CONTINUE TO PREACH WITHOUT KNOWING THE CORRECT STATS OR THE TRUTH.PERSECUTION OF PEOPLE IN PAIN OR ANY ILLNESS NEEDS TO STOP.MAKING IT HARDER FOR SOMEONE THAT MEDICALLY NEEDS OPIOIDS OR XANAX IS IRRESPONSIBLE.Figures Lie and Liars Figure  Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard  Lawhern, National Pain Report, 11/17/17http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.htmlCDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, JEFFREY A. SINGER, 3/22/18https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-highAre Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.https://www.ncbi.nlm.nih.gov/pubmed/28402482B.C. doctors cant limit opioids or discriminate against pain patientsCAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/The Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935The truth about the US opioid crisis  prescriptions arent the problemMarc Lewis is a neuroscientist/author on addiction, The Guardianhttps://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptionsFentanyl  Heroin Deaths Lead Soaring Overdose Rate, 12/21/17, PNNhttps://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-medsWhy Untreated Chronic Pain is a Medical Emergency1/28/18 by Pharmaciststeve http://www.pharmaciststeve.com/?p=23988Untreated Chronic Pain can Kill!  6/20/17 Suzanne Stewart, NPRhttp://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.htmlCDC Report Ignores Suicides of Pain Patients, June 07, 2018, Pat Anson, PNNhttps://www.painnewsnetwork.org/stories/2018/6/7/cdc-report-ignores-suicides-by-pain-patientsJeffrey M Geurin, Staff Sergeant, United States Air Force 1997-2008https://www.regulations.gov/document?D=FDA-2018-N-1621-1264Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227Response to: FDA-2017-N-5608 by: Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MDU Alabama at Birmingham School of Medicine  Yale School of Medicine https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938attachmentNumber=1contentType=pdfTime:  Report: Chronic, Undertreated Pain Affects 116 Million AmericansBy Maia Szalavitz 6/29/11http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/10 Myths About the Opioid Crisis, Pnn https://www.painnewsnetwork.org/stories/2017/12/24/10-myths-about-the-opioid-crisisThe other opioid crisis: hospitals are running short of powerful painkillersPAULINE BARTOLONE, KAISER HEALTH NEWShttp://www.latimes.com/business/la-fi-opioid-painkiller-hospitals-20180316-story.html#In the midst of a massive opioid crisis, hospitals are experiencing an opioid shortageAaron Schachter, 5/14/18https://www.marketplace.org/2018/05/14/health-care/midst-massive-opioid-crisis-hospitals-are-experiencing-opioid-shortage", "comment_id": "FDA-2018-P-0673-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0007", "comment_date": "2018-08-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5323}, {"text": "We highly object. Making it difficult for people who legitimately need medication is not the way to stop overdoses from illegal street drugs which are many times laced with heroin. The majority of deaths are due to ILLEGAL drugs bought on the street.  By restricting opioids and in this case xanax, you are only driving up the black market for these illicit drugs. People who actually need these medications are being denied access and in some cases are probably now desperate enough to try impure illegal drugs in order to manage medical conditions. Who benefits? The drug cartels which now have even more people to sell to as  restricting access has now driven up demand.  Since the crackdown on opioids began, we now have even more ER overdose cases.  Guess what, they arent from legitimate prescriptions, but street laced copies especially fentanyl.  And for the record, someone could just as easily kill them-self with alcohol (a central nervous system depressant) tobacco, tylenol, aspirin, antihistamines...To combat illegal drugs, you should be looking to the DEA to crack down on drug cartels, pill mills and hey how about looking into those drug and alcohol Rave parties. Children and teens need to be properly educated by their parents. It is time for people to start taking responsibility for themselves and to stop blaming drugs. This is like blaming steak knives for every stabbing death and banning them. What about butter knives?  They can kill as well. And knives dont just get up off the table and stab someone, just like drugs dont just jump out of their bottle into peoples mouths or up their noses. There will always be something illegal on the street that entices some people to get high. Targeting legitimate prescriptions only creates additional suffering and hardship for those that need the medication, while those abusing it still have access to their illegal supply.", "comment_id": "FDA-2018-P-0673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0004", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1926}, {"text": "In order to ensure that Alprazolam (Trade Name Xanax) be more strongly controlled in distribution and use I support moving it from Schedule 4 to Schedule 2.In the United States the drug continues to show up in overdose cases implicating it as a contributor to overdose situations which lead to hospital visits, temporary or permanent debilitation and death. I find this petition to be in good order becamse Alprazolam has an actual and growing potential for abuse not only of the drug by itself but in combination with other drugs such as both the natural and synthetic opioids.Scientific evidence of its pharmacological effect continues to indicate it is a serious mood, mind and body altering drug which must be distributed in only rare cases.The state of current scientific knowledge regarding the drugs interactions with other drugs, such and natural and synthetic opioids as well as the psychiatric states it can trigger have been recorded in studies that the manufacturers continue to marginalize.Over the course of its (relatively) brief history a pattern of abuse has arisen for the drug itself and it is now being used in combination with other drugs to create specific life endangering effects.The scope, duration, and significance of abuse is increasing at a high rate over time.  The control of the current supply has clearly been lost.The risk there is to the public health continues to be loss of mental ability, physical ability and life.  The debilitating effects of the drug lead to the curtailing of economic activities by family members which damage growing children, other family members and the entire community in which these tragedies occur.  Death is also expensive.The psychic and physiological dependence liability is clear and warned about.  It is hard to manage with an individual of general intelligence and strength let alone someone suffering from the very symptoms this drug is supposed to alleviate.", "comment_id": "FDA-2018-P-0673-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0005", "comment_date": "2018-07-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2027}, {"text": "I am a 55 year old female and disabled since MVA in 2005. I am a RN and worked as a nurse for 35 yrs. I have had multiple surgeries due to the accident and also was diagnosed with Hep C that was contracted in the late 80s from a blood transfusion. I was infected for more than 20 years before being aware and it quietly destroyed my liver. I was blessed to bedcover a perfect match at the very last moment and I have been cured of the Hepc now. However I continue with severe chronic pain and my new liver has complicated my options for pain relief. My doctors had found the best medication for me wS Fentanyl patch. It worked well for me for many years. My life and activities were greatly improved. My liver health had been great for 5 years. Since the opioid rules I have lost two of my PCP because they could not prescribe to me. My liver enzymes have been spiking since they took the patch away. My BP has been extremely high at times. I have allergies to a few pain medications and many I simply cant have for reason of causing harm to my liver. Now being sent your in paon management clinics that insist on painful injections that I was told by my doctors I could not have. I pay huge copays and family must run me to appointments that last for hours. They never put hands involved me nor read my piles of records. They send me for repeated Scans MRIs and such for proof that I already have in my records. I am now on oxycodone pills that they previously took me off due to allergy. I continue to have pinching in my liver and my daily pain is 9-10. I never sleep through the night due to constant pain. I need more oregano surgeries but due to my health now I worry about the risks. My life now is very difficult I am depressed and tearful most days. I have 5 sons and 4 grandchildren and fur to my pain I rarely can participate with them and depression again.Before all of this Opioid crisis my quality of life was good. Pain was minimal and I enjoyed my family had normal relations with my husband. I even thought I could possibly work a few hours a week sitting at a desk. I very much miss my job as a nurse. Even if u could not go back to work at least I felt a timed I could be purposeful. Its no longer the case.all I can do now is happily retire and spend days enjoying life and my grandchildren Burbank thats option is gone. I have to have pain control and the proper medication that does not harm me. Like it or not Fentanyl worked well and I had  complications. I seem to put that small percentage that. Policy and lawmakers has not considered. I refuse to have my life taken away after all I have been through. I want my PCP back and not be told he will risk losing his license to care for medical ", "comment_id": "FDA-2018-P-0673-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0006", "comment_date": "2018-07-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2717}, {"text": "I am a 41 year old disabled women. This is ridiculous on how Congress want to restrict the people who really need pain meds even more. I had to get 3 spinal surgeries and still have pain, muscle spasms, permanent nerve damage and pain. It is hard doing everyday activities. In my spine I have 15 titanium rods, 4 cages and 2 spacers. My back is permanently damaged. I have depression and anxiety disorder. It is a hassle to see the doctor and they consumed with the fear of prescribing pain meds. What are the people with real pain going to do? You guys are going at this wrong. Us economically disproportionate patients will suffer. The people with money will have access. I am tired of the lack of care. The state of Florida medical is worse. I am always compliant,  get drug tested and go to my appointments. Why do I have to suffer?", "comment_id": "FDA-2018-P-0673-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0008", "comment_date": "2018-08-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 836}, {"text": "I object to this matter. I have been on alprazolam for 4 years. Obtaining this medication was not simple. I had multiple breathing attacks during the day, Ive had my left side go numb, and multiple physical symptoms due to severe anxiety. The stigma already surrounding mental health is a hindrance to individuals who seek care. Why make this more complicated thus increasing the likelihood of self medicating a mental issue? This issue would been seen heavier on other sides such as alcohol as patients self treat anxiety in ways not helpful. Stop hindering the accessibility to mental health, and medications used appropriately are far less likely to be abused, because when someone needs it, they dont feel it. I dont feel Xanax. I begin to have a normal heart rate and other symptoms gone. Yes counseling helped give me tools to help, but xanax is also a necessary tool. We deserve a quality of life. We did not choose this. ", "comment_id": "FDA-2018-P-0673-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0010", "comment_date": "2018-08-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 966}]}, {"id": "DOE-HQ-2021-0017", "agency": "DOE", "title": "Workplace Substance Abuse Programs at Department of Energy Sites", "update_date": "2022-09-15", "update_time": "10:50:29", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "To Whom It May Concern:The Department of Energys proposed rule Workplace Substance Abuse Programs at Department of Energy Sites, Code of Federal Regulations Citation 10 CFR Part 707 is a worthy attempt to better our surroundings. Department of Energy employees and contractors who have security clearances undoubtedly handle sensitive and important information that necessitates discretion and delicate handling. I believe that the inclusion of contractors to the list of individuals that would fall under this proposed rule is a well-intentioned understanding that although they may be employed by the government, and The Department of Energy more specifically, on an as need basis, their importance and handling of information may be the same as any regular employee. The Workplace Substance Abuse Programs proposed rule is significant for the sole fact that the employees and contractors here have the ability to affect the environment, public health and safety, or national security; testing these individuals to make sure that they are not in any way distracted or under another influence is imperative to continue The Department of Energys mission running unimpeded. Because of the importance laid out here, I believe that the agency should take additional measures to reinforce the idea that there is a zero-tolerance policy for substance abuse and that the work being conducted should not be conducted by individuals that cannot abide by the rules. One such additional measure that I believe could benefit The Department of Energy is increasing the size of the annual sample rate from 30 percent. The current proposed rulemaking lists those individuals in testing designated positions be tested at an annual sample rate of 30 percent, which I believe is not at a percentage high enough to ensure the departments continued safety nor the safety of everything that the department affects. At what percentage would safety concerns be duly covered I am not sure of, but at a higher rate from which it currently stands is needed. Moreover, as to 707.14(e), the department must add additional stipulations to the return of a contractor who was removed from the site for the use of illegal drugs. At the moment, the only requirement is that such individual who was removed from duty for such use of illegal drugs needs to notify The Department of Energy of their intent to return to a testing designated position and that The Department of Energy approve their return to such a position. I believe that because such individuals in these positions have already proven to show they interact with illegal substances, stipulations be added return to their post. Their approval to return to testing designated positions (which necessitate security clearances) should be conditioned on increased testing on their return. This would increase the likelihood that if such person decides to use illegal drugs again then the increased testing would increase the possibility of the department knowing about their refusal to comply with the departments policies. The people that are in these testing designated positions are individuals who make important decisions. They are protective force personnel, people involved in the construction/maintenance/operation of nuclear reactors, and personnel that deal with hazardous materials. The decisions these people make, and the mistakes they make as well, impact the public at large. Should they use illegal drugs the chances that mistakes, issues, and a host of other unfortunate situations arise undoubtedly increases. That is why The Department of Energy needs to increase annual sample rate as well as add conditions to the return of offenders of the policy. Thank you. Christian Ruano", "comment_id": "DOE-HQ-2021-0017-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOE-HQ-2021-0017-0002", "comment_date": "2021-11-04", "comment_time": "04:00:00", "commenter_fname": "Christian", "commenter_lname": "Ruano", "comment_length": 3827}, {"text": "Implementing substance abuse programs at the Department of Energy Sites is a good idea. Monitoring employees through drug tests will keep the sites clean and prevent accidents from happening. I believe some drugs shouldnt be included in the test since some people use them for beneficial reasons. ", "comment_id": "DOE-HQ-2021-0017-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOE-HQ-2021-0017-0003", "comment_date": "2021-11-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 302}]}, {"id": "DEA-2011-0006", "agency": "DEA", "title": "Establishment of a New Drug Code for Marihuana Extract", "update_date": "2021-12-02", "update_time": "01:00:47", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I oppose the DEAs continued criminalization and regulation of Marihuana (Marijuana) and implore the agency to cease its regulatory efforts which are opposed by a majority of Americans.", "comment_id": "DEA-2011-0006-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0006-0002", "comment_date": "2011-07-08", "comment_time": "04:00:00", "commenter_fname": "Benjamin", "commenter_lname": "Kerensa", "comment_length": 189}, {"text": "Re:Docket No. DEA-342GW would like to correct the drug code for marihuana  extracts referenced in paragraph nine of its previous remarks. The drug code should have been noted as 7350, rather than 9350.", "comment_id": "DEA-2011-0006-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0006-0008", "comment_date": "2011-09-07", "comment_time": "04:00:00", "commenter_fname": "Alice", "commenter_lname": "Mead", "comment_length": 206}, {"text": "The Holy Oil  illegal to manufacture because it contains 6 pounds of cannabis as described in Exodus 30:23!!!  We kicked the King of England out for freedom of religion now it is time to get rid of the DEA  ", "comment_id": "DEA-2011-0006-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0006-0004", "comment_date": "2011-07-11", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Byrnes", "comment_length": 212}, {"text": "I would like to tell you in this case how wrong you guys are. I need CBD for my pain.I have dealt w/Cancer since i was 17 almost the last 18 yrs of my life.It was never cured until March.I started on a CBD formula and I can tell you it is not a narcotic drug at all.You never feel high or any side effects from this part of the plant.Only relief of pain, you get and oxygen feeling in your body because it replaces it in your cells.You can feel tiny little bubbles in your body, which helped my arthritis greatly, and started helping the cancer and of course THC knocked the cancer all the way out.But you can process all THC out of the medication too.The DEA really needs to talk to the people who can make a formula like this.You are really screwing with my life.I can get sick again just waiting on you guys to get your info correct.I never write in on things, I just let you boys do your job.But in this case you have never been so wrong.You can not flunk a drug test off CBD.it is on of the least harmless things you can put in your body.Heck water is more dangerous than CBD.Really a schedule 1?Please rethink this...My Life demands on it.Blessings.Keep up the good work.", "comment_id": "DEA-2011-0006-0003", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0006-0003", "comment_date": "2011-07-08", "comment_time": "04:00:00", "commenter_fname": "Tonya", "commenter_lname": "Myers", "comment_length": 1177}, {"text": "Will this new code be applied to Cannabidiol if it is not combined with any other cannabinols?Specifically, here is the quote that applies to the new code: Marihuana Extract meaning extracts that have been derived from any plant of the genus cannabis and which contain cannabinols and cannabidiols.This quote clearly states that the new code will apply to combined cannabinols and cannabidiols.But what about 100% pure Cannabidiol by itself with nothing else?  It is currently exempt as a schedule 1 drug and no DEA license is required to purchase it.Will 100% pure Cannabidiol have this new code?Thank you,Sherrie", "comment_id": "DEA-2011-0006-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0006-0005", "comment_date": "2011-08-22", "comment_time": "04:00:00", "commenter_fname": "Sherrie", "commenter_lname": "Berry", "comment_length": 656}]}, {"id": "FDA-2019-N-1482", "agency": "FDA", "title": "Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments", "update_date": "2023-06-01", "update_time": "12:22:54", "purpose": "Nonrulemaking", "keywords": ["2019-262", "OC", "Notice", "Scientific Data and Information", "Products Containing Cannabis", "or Cannabis-Derived Compounds", "Request for Comments", "Open", "CBD Oil"], "comments": [{"text": "There needs to be regulations put in place IMMEDIATELY regarding any company manufacturing and/or selling any CBD product. I know of 1 company in particular,Le-Vel Brands LLC, who refuses to provide the ingredients list on their labels or provide it to consumers regarding their new CBD skincare. When asked, they inform the questioning person that Le-Vel doesnt have to provide that information because its a proprietary formula. They are marketing it as CBD skincare and they dont even list if CBD is actually in it. ", "comment_id": "FDA-2019-N-1482-0540", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-0540", "comment_date": "2019-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 534}, {"text": "I struggle with bipolar depression and severe anxiety. Going into public was near impossible before I found CBD. Please dont restrict this product. It is the safest and most inexpensive fix for a crippling condition. ", "comment_id": "FDA-2019-N-1482-3089", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3089", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 222}, {"text": "Good day to you. It is intellectually dishonest to deny research, while simultaneously ignoring the vast amount of information available. Cannabis heals. It has the ability to stick finincial gamps in families, it can help heal our land mass ,by providining a true Alternative source of fuel/fiber,The approach the government has taken towards medicinal plants has fractured at the fabric of our society, as evidenced by the disproportionate amount of people serving time for cannabis related offenses.There is no need to perpetuate, and hinder the economic potential of many Americans , who simply want to build a future for themselves, whether that be by making choices for their health, or their businesses.I have found relief in these plants. I have personally suffered from treatment-resistant mental illness, the Ive suffered for my adult life,  not responding to traditional medications.  Now, with the help of CBD, hemp, et el I have found relief.My mental illness impacted my psychosocial life terribly.  It was difficult for me to hold on a job, or finish school, however, for the first time I am providing a means of living, and a means to better mental health through this  plant.An  establish a standard,  without the governing power entangling themselves within the industry, would be lovely. Theres enough for everyone. Let us build our wealth,  and our health...Thank you for your time. ", "comment_id": "FDA-2019-N-1482-3118", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3118", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1503}, {"text": "I struggled with migraines for the past 40 years and I tried many remedies but none have helped me until I tried a product with CBD and no THC.  I dont drink alcohol or caffeine.  I reduced stress, exercise, used bio-feedback, massage and even had a subdermal neurostimulater planted in my body.  I lost a lot of time from work.  It has cost me thousands with trips to the emergency department.  With CBD I have been migraine free.  I cant even begin to explain my quality of life now.", "comment_id": "FDA-2019-N-1482-3124", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3124", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 495}, {"text": "Hello and thank you for the opportunity to share my thoughts hopefully this is helpful Heres the full list of studies:Cannabis kills tumor cellshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1576089http://www.ncbi.nlm.nih.gov/pubmed/20090845http://www.ncbi.nlm.nih.gov/pubmed/616322http://www.ncbi.nlm.nih.gov/pubmed/14640910http://www.ncbi.nlm.nih.gov/pubmed/19480992http://www.ncbi.nlm.nih.gov/pubmed/15275820http://www.ncbi.nlm.nih.gov/pubmed/15638794http://www.ncbi.nlm.nih.gov/pubmed/16818650http://www.ncbi.nlm.nih.gov/pubmed/17952650http://www.ncbi.nlm.nih.gov/pubmed/20307616http://www.ncbi.nlm.nih.gov/pubmed/16616335http://www.ncbi.nlm.nih.gov/pubmed/16624285http://www.ncbi.nlm.nih.gov/pubmed/10700234http://www.ncbi.nlm.nih.gov/pubmed/17675107http://www.ncbi.nlm.nih.gov/pubmed/14617682http://www.ncbi.nlm.nih.gov/pubmed/17342320http://www.ncbi.nlm.nih.gov/pubmed/16893424http://www.ncbi.nlm.nih.gov/pubmed/15026328Uterine, testicular, and pancreatic cancershttp://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page4http://www.ncbi.nlm.nih.gov/pubmed/20925645Brain cancerhttp://www.ncbi.nlm.nih.gov/pubmed/11479216Mouth and throat cancerhttp://www.ncbi.nlm.nih.gov/pubmed/20516734Breast cancerhttp://www.ncbi.nlm.nih.gov/pubmed/18454173http://www.ncbi.nlm.nih.gov/pubmed/16728591http://www.ncbi.nlm.nih.gov/pubmed/9653194http://www.ncbi.nlm.nih.gov/pubmed/25069049http://www.ncbi.nlm.nih.gov/pubmed/22198381?dopt=Abstracthttp://www.ncbi.nlm.nih.gov/pubmed/21097714?dopt=Abstracthttp://www.ncbi.nlm.nih.gov/pubmed/12746841?dopt=Abstracthttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3339795/?tool=pubmedhttp://www.ncbi.nlm.nih.gov/pubmed/22594963http://www.ncbi.nlm.nih.gov/pubmed/15753356http://www.ncbi.nlm.nih.gov/pubmed/10570948http://www.ncbi.nlm.nih.gov/pubmed/19690545http://www.ncbi.nlm.nih.gov/pubmed/12091357http://www.ncbi.nlm.nih.gov/pubmed/16908594http://www.ncbi.nlm.nih.gov/pubmed/12511587http://www.ncbi.nlm.nih.gov/pubmed/19608284http://www.ncbi.nlm.nih.gov/pubmed/21475304http://www.ncbi.nlm.nih.gov/pubmed/12514108http://www.ncbi.nlm.nih.gov/pubmed/15313899http://www.ncbi.nlm.nih.gov/pubmed/20053780http://www.ncbi.nlm.nih.gov/pubmed/18199524http://www.ncbi.nlm.nih.gov/pubmed/19589225http://www.ncbi.nlm.nih.gov/pubmed/12182964http://www.ncbi.nlm.nih.gov/pubmed/19442435http://www.ncbi.nlm.nih.gov/pubmed/12723496http://www.ncbi.nlm.nih.gov/pubmed/16250836http://www.ncbi.nlm.nih.gov/pubmed/17237277http://ww.ncbi.nlm.nih.gov/pmc/articles/PMC2277494http://ww.ncbi.nlm.nih.gov/pubmed/19916793http://www.ncbi.nlm.nih.gov/pubmed/21115947http://www.ncbi.nlm.nih.gov/pubmed/15454482http://www.ncbi.nlm.nih.gov/pubmed/16139274http://www.ncbi.nlm.nih.gov/pubmed/12130702http://www.ncbi.nlm.nih.gov/pubmed/19457575http://www.ncbi.nlm.nih.gov/pubmed/18615640http://www.ncbi.nlm.nih.gov/pubmed/17931597http://www.ncbi.nlm.nih.gov/pubmed/18438336http://www.ncbi.nlm.nih.gov/pubmed/19916793http://www.ncbi.nlm.nih.gov/pubmed/18387516http://www.ncbi.nlm.nih.gov/pubmed/15453094http://www.ncbi.nlm.nih.gov/pubmed/19229996http://www.ncbi.nlm.nih.gov/pubmed/9771884http://www.ncbi.nlm.nih.gov/pubmed/18339876http://www.ncbi.nlm.nih.gov/pubmed/12133838http://www.ncbi.nlm.nih.gov/pubmed/16596790http://www.ncbi.nlm.nih.gov/pubmed/11269508http://www.ncbi.nlm.nih.gov/pubmed/15958274http://www.ncbi.nlm.nih.gov/pubmed/19425170http://www.ncbi.nlm.nih.gov/pubmed/17202146http://www.ncbi.nlm.nih.gov/pubmed/11903061http://www.ncbi.nlm.nih.gov/pubmed/15451022http://www.ncbi.nlm.nih.gov/pubmed/20336665http://www.ncbi.nlm.nih.gov/pubmed/19394652http://www.ncbi.nlm.nih.gov/pubmed/11106791http://www.ncbi.nlm.nih.gov/pubmed/19189659http://www.ncbi.nlm.nih.gov/pubmed/16500647http://www.ncbi.nlm.nih.gov/pubmed/19539619http://www.ncbi.nlm.nih.gov/pubmed/19059457http://www.ncbi.nlm.nih.gov/pubmed/16909207http://www.ncbi.nlm.nih.gov/pubmed/18088200http://www.ncbi.nlm.nih.gov/pubmed/10913156http://www.ncbi.nlm.nih.gov/pubmed/18354058http://www.ncbi.nlm.nih.gov/pubmed/19189054http://www.ncbi.nlm.nih.gov/pubmed/17934890http://www.ncbi.nlm.nih.gov/pubmed/16571653http://www.ncbi.nlm.nih.gov/pubmed/19889794http://www.ncbi.nlm.nih.gov/pubmed/15361550http://www.ncbi.nlm.nih.gov/pubmed/19509271http://www.ncbi.nlm.nih.gov/pubmed/18546271http://www.ncbi.nlm.nih.gov/pubmed/16936228http://www.ncbi.nlm.nih.gov/pubmed/16337199http://www.ncbi.nlm.nih.gov/pubmed/19609004http://www.ncbi.nlm.nih.gov/pubmed/16818634http://www.ncbi.nlm.nih.gov/pubmed/12648025http://www.ncbi.nlm.nih.gov/pubmed/17952650http://www.ncbi.nlm.nih.gov/pubmed/16835997http://www.ncbi.nlm.nih.gov/pubmed/17065222http://www.ncbi.nlm.nih.gov/pubmed/18197164http://www.ncbi.nlm.nih.gov/pubmed/18938775http://www.ncbi.nlm.nih.gov/pubmed/19047095http://www.ncbi.nlm.nih.gov/pubmed/19442536http://www.ncbi.nlm.nih.gov/pubmed/18286801http://www.ncbi.nlm.nih.gov/pubmed/19914218", "comment_id": "FDA-2019-N-1482-3132", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3132", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5531}, {"text": "I take CBD going on 2 years now. It has helped me with my stress and anxiety. I would recommend CBD to anyone who deals with this problem.", "comment_id": "FDA-2019-N-1482-3133", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3133", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 138}, {"text": "I have used medical marijuana in the past and it worked for my depression. I lost my job because of this and am no longer using medical marijuana because of federal law. This is absolutely wrong!! Medical marijuana is a life saver and not dangerous! I no longer trust the FDA or the federal government due to the lies being told. Medical marijuana was legal in California in 1996 almost 24 years ago and had been studied more than any other drug that I know of! Why are there legal drugs that may cause death that are FDA approved and marijuana is not even though there are no deaths? This has got to end.", "comment_id": "FDA-2019-N-1482-3136", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3136", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 617}, {"text": "CBD oil has helped me in ways that other medicines couldnt. It helps me with both sleep and inflammation. It has also provided careers for thousands including some of my closest friends.  ", "comment_id": "FDA-2019-N-1482-3112", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3112", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 193}, {"text": "Dear FDAIm a citizen of the United States of America. Im also someone who suffers from sever Agoraphobia, Fibromyalgia, as well as other health issues. I just have one simple question. Ive been aware of hemp based edible products that have been on the market for many many years(hemp burgers) as well as hearing about hemp being in the diet of American Indians. Im also aware of the epidiolex situation. My question is, how can anyone be protected from others using a product thats been publicly known and used for many years before? For example, if I figure out that olive oil helps my dry skin due thyroid disease, am I able to stop anyone from using it in a recipe for resale once I have a study done and file the necessary IP protection? Thank you for your time", "comment_id": "FDA-2019-N-1482-3125", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3125", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 840}, {"text": "1) We ask that Hemp and CBD be covered under the 7 U.S.C. 499 et. Seq. The Perishable Agricultural Commodities Act, to protect growers, producers, suppliers, and distributors.  It will also make available the Blue Book for Credit Verification.2) Secured transport of Hemp, biomass and CBD isolate and products regulations that will make interstate and international commerce easier to control3) Guidelines and Regulations for laboratories and testing facilities to make them licensed by the USDA, FDA or EPA that will make all laboratories and testing facilities on the same standard that is overseen by a Federal Agency so, that the customer is assured of the quality of the product.We will also need to ask the Industry for suggestions on the following prior to any new regulations:We would also like to ask for assistance in the banking and finance realm now that hemp is legal under the Farm Bill.And the industry needs the ability to get crop insurance at a reasonable cost.", "comment_id": "FDA-2019-N-1482-3171", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1482-3171", "comment_date": "2019-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1009}]}, {"id": "FDA-2019-P-0538", "agency": "FDA", "title": "Request that FDA refuse to accept any submissions by Lannett Inc. in furtherance of its application submitted under the 21 U.S.C. \u00a7 355(b)(2) approval pathway (a \u201c505(b)(2)\u201d) for cocaine hydrochloride, 4% and 10%. Any such submissions by Lannett are barred by the new chemical entity exclusivity arising from FDA\u2019s approval of Genus\u2019s NDA 209963 under Section 505(c)(3)(E)(ii) of the FDCA.", "update_date": "2019-08-28", "update_time": "14:30:42", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "Genus Lifesciences, Inc. (\u201cGenus\u201d),", "Lannett Company, Inc. (\u201cLannett\u201d) in", "K&L GATES LLP", "CDER", "cocaine hydrochloride, 4% and 10%.", "new drug application (\u201cNDA\u201d) 209963 under", "Section 505(c)(3)(E)(ii) of the FDCA", "for cocaine hydrochloride nasal solution", "new chemical entity (\u201cNCE\u201d)", "exclusivity under 21 U.S.C. \u00a7 355(c)(3)(E)(ii),"], "comments": [{"text": "Genus Reply Comment to Citizen Petition", "comment_id": "FDA-2019-P-0538-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-0538-0025", "comment_date": "2019-05-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}]}, {"id": "FDA-2010-P-0091", "agency": "FDA", "title": "Requesting Changes in Benzodiazepine Labeling", "update_date": "2022-01-05", "update_time": "01:04:01", "purpose": "Nonrulemaking", "keywords": ["CDER", "Benzodiazepine Labeling", "closed"], "comments": [{"text": "This person Jenelle commented I understand that people have addiction problems to these meds but because these meds are looked at as being so addictive I have not been able to get the help I need for my anxiety which makes my lupus even worse all they prescribe me is serequel. ***It sounds like she is confusing addiction/abuse with physical dependency and withdrawal. Serequel also has many side effect, anxiety being one.She said Id rather be addicted to benzos than not be able to work, go out, or even look at people in there eyes without having an anxiety attack.***If Jennelle gets addicted/physically dependent on Benzes not looking people in their eyes will be a walk in the park compared to the incapacitating withdrawal symptoms that have made people have to leave their jobs do to intense life altering withdrawal symptoms which are both physical and mental in nature and can last months and years in some cases, some people are never the same do the changes the drug causes once physical dependency has occurred. I would be hell dealing with benzodiazepine withdrawal on top of Lupus, what nightmare.", "comment_id": "FDA-2010-P-0091-0060", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0060", "comment_date": "2010-08-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1209}, {"text": "Concerning benzodiazepine drugs:My story:  I have been on Xanax for years, so many that I cannot remember when I started.  My doctor never told me about physical addiction all those years.  My current Nurse Praticioner gave me only meger information on how to withdraw from this drug.  She did not mention anything about phyical addiction, and so now I am in the withdrawal phase.  I have gone through the worst part of the withdrawal, and now I am in a protracted stage, and I do not know when the withdrawal will be finalized.  And I was on only 0.5mg per day, a rather low dosage, but having taken this Xanax drug for years, I have become physically addicted to it and now am in withdrawal.  This Citizen Petition should be taken seriously by the FDA, and not put aside.  It was the FDA that approved the drug Xanax, and the FDA needs to alter that approval with guidelines on its use and the use of other benzodiazepine drugs.  The FDA has a responsibility to the citizens of the United States of America to insure that the citizenry has full knowledge of these drugs as to their use together with warnings about addiction.  ", "comment_id": "FDA-2010-P-0091-0112", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0112", "comment_date": "2013-04-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1159}, {"text": "Please consider this petition carefully.  Your attention to this matter could reduce much preventable suffering, as well as substantially reduce health care costs caused by unnecessary prescriptions and the ineffective treatment of prescription-caused problems as though they were an independent problem.", "comment_id": "FDA-2010-P-0091-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0040", "comment_date": "2010-05-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 304}, {"text": "I have been on Klonopin 12 years-was never told it was addicting by any of the 4 doctors I have seen. I should have been given an informed consent to sign.", "comment_id": "FDA-2010-P-0091-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0006", "comment_date": "2010-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 155}, {"text": "Im a French citizen, member of the Yahoo benzo group, the French Yahoo benzo group, and the Yahoo benzo protracted group.Benzodiazepines have completely destroyed my life. They were first prescribed to me as a sleeping aid while I was trying to give up smoking  I suffered very bad psychological adverse effects while on them and my life started to fall apart but that was nothing compared to what I was about to go through.All hell broke lose when I tried to get off them (after 2 and a half years of use). Ive experienced more than a hundred symptoms, both psychological and physical, and a dramatic cognitive deterioration. Because of these drugs, the lively young woman I was became a homebound invalid. I was 26 years old when first prescribed benzodiazepines and had my whole life ahead of me. At 32 years old and 31 months off benzodiazepines, I cant get out of bed (or sit up in bed) 90% of the time. I suffer from excruciating joint pain day in and day out, debilitating fatigue, gastrointestinal issues, and a vast array of neurological symptoms. I cant work, cant drive, cant read, cant take care of my home, or even of myself. Everyday I wake up to that agonizing state, wondering how such a dangerous drug can have been be prescribed so lightly for decades.Besides I get little to no help from my doctors whom I have to educate on the issue. What I suffer from  benzodiazepine protracted withdrawal syndrome  isnt known by the French medical authorities. The French usually wait for an FDA ruling to start changing their own prescription habits. I implore the FDA to take action on the matter  those benzodiazepines can cause absolute mental and physical torture and we must shield the generations to come from this terrifying plight.", "comment_id": "FDA-2010-P-0091-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0028", "comment_date": "2010-04-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1881}, {"text": "I am in support of this petition.  I was prescribed klonopin for insomnia in 2005.  After 3 months I tried to wean off.  It took me several years.  I have been off of the medication for almost 18 months and still have some severe neurological issues that were not present before the administration of this medication.", "comment_id": "FDA-2010-P-0091-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0034", "comment_date": "2010-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 317}, {"text": "Please support the changes to the labelling on benzodiazapines.  They are very diffiult to withdraw from and can cause permanent damage.  Unfortunately, most people are not adequately informed of the risks.", "comment_id": "FDA-2010-P-0091-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0038", "comment_date": "2010-05-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 206}, {"text": "I am a elementary school principal who was misdiagnosed with a brain aneurism last year.  I was given ativan, a benzo, to handle the stress and was addicted and having side effects after one week.  I suffered through three months of withdrawal.  This was the worst experience in my life. I was given ativan with no information that for some people it was highly addictive.  I was treated poorly by health professional who didnt read literature and only knew what pharma sales people told them.  These drugs should be outlawed.", "comment_id": "FDA-2010-P-0091-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0043", "comment_date": "2010-05-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 531}, {"text": "I am a mental health professional and a former consumer of benzodiazepines (bz). I have spent the past 4 years moderating an online bz withdrawal (wd) and recovery support group with members hailing from all corners of the world and whose lives have been negatively affected the bzs. One thing we all share in common is that our Drs never informed us about how addicting these drugs were, even within as little as 7 days use, nor were we alerted to the effect these drugs could have on our overall health and well-being. Four yrs ago and after 16 yrs of daily use as prescribed I was instructed by a Dr to discontinue 10mgs of Klonopin (equiv to 200 mgs Valium) cold turkey. I never abused this drug. For the next 4 months, I was incapacitated by the wd this produced. But that was hardly the end of it. While I am happy to report that I am mostly well at 4 yrs off, I still experience a grocery list of symptoms characteristic of bz wd. And while this event proved to be a defining moment in my life, it was, and remains, the most violent and traumatic thing I have ever experienced in all my 53 yrs. This drug robbed me of 16 vital yrs right out of the center of my life, yrs which I now have very little memory of due to the effect of the drug. The disturbing part to me is that during that time, I could not see what was happening to me nor could I see the deterioration occurring in my health, this from the effect the drug was having on my brain. Moreover, this unnecessary and devastating loss could have easily been avoided had I simply been informed about the inherent risks and dangers that come with taking this class of drugs. PLEASE, hear our voices. Inform Drs and consumers by distributing educational material, posting warnings and appropriate, clear prescribing/withdrawing guidelines. The personal, social, economic and spiritual ruin this class of drugs is bringing to the lives of consumers and to that of their loved ones is pervasive and, again, wholly avoidable. Thank you.", "comment_id": "FDA-2010-P-0091-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0008", "comment_date": "2010-03-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1996}, {"text": "My physician prescribed 10mg valium for a short trip for motion sickness prevention and jet lag.  He did not warn me to taper off it slowly nor that after three weeks of taking valium that I could develop a dependence.  Three weeks after my trip and abruptly stopping valium, I ended up with severe anxiety, vertigo and palpitations that brought me to the Emergency Room of a local hosptal.   The ER physician did not understand that valium takes three weeks to process out the body unlike shorter acting more in benzos like ativan or xanax.  Finally found an otoneurologist who understood the problem.  He informed met that 2mg would have been the correct dose rather than 10mg and that they always advise patients to taper even 2mg slowly.  Could have saved thousands of dollars in medical tests and emergency room costs.  Within five days of putting me back on low dose valium, the vertigo subsided (whereas several friends who had vertigo in recent years took a month or longer for the dizziness to subside from vertigo).  Next doctor tried to tell me I could go on lexapro and three weeks later stop the valium cold turkey.  Again, another misinformed but well meaning doctor.  I tried to cut several milligrams from the valium as suggested but did not take the lexapro.  High anxiety and I was concerned about vertigo returning.  Only after I found a  benzo support forum based in the United Kingdom (benzobuddies.org) did I get proper information on how to slow taper off the valium.  FDA needs to get involved here to instruct doctors and patients about dangers of many classes of benzodiazepenes and stop throwing antidepressants and other meds to add when what is needed is education about how to taper slowly off the benzodiazepenes.  Also, friends of mine have been handed out xanax and klonopin like candy without any warnings.  they were horrified to read about it on the internet.  Psychiatry is doing a disservice when it comes to this wanton behavior regarding benzodiazepenes.", "comment_id": "FDA-2010-P-0091-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0016", "comment_date": "2010-03-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2006}]}, {"id": "EPA-HQ-OAR-2011-0817", "agency": "EPA", "title": "Reconsideration of Portland Cement NESHAP and NSPS", "update_date": "2022-04-26", "update_time": "14:36:32", "purpose": "Rulemaking", "keywords": ["Portland Cement", "mercury", "SO2", "NOx", "VOC", "HAP", "HCL", "THC", "NESHAP", "clinker", "wet scrubber", "dry scrubber", "monovent", "PM", "dioxin", "fabric filter", "thermal oxidizer", "hazardous waste", "reconsideration", "kiln", "raw mill", "clinker piles"], "comments": [{"text": "Comment", "comment_id": "EPA-HQ-OAR-2011-0817-0483", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2011-0817-0483", "comment_date": "2012-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 7}, {"text": "This comment and attachment refers to docket number EPA-HQ-OAR-2011-0817Per a request from one of the EPA panelists in Arlington Texas at our 8/16/2012 public hearing,  I am submitting information about a Cooks Childrens hospital study describing the abnormally high incidence (and personal/educational costs) of air pollution in the Dallas/Fort Worth area.  This asthma study was done several years ago so the situation could even be worse at this time.  Allowing cement plants to delay pollution reduction programs will only harm the health of all our citizens.  PLEASE DO NOT ALLOW THE DEADLINE TO BE EXTENDEDThank you John Rath1537 Country forest Ct.Grapevine, TX 76051817 442-8418", "comment_id": "EPA-HQ-OAR-2011-0817-0502", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2011-0817-0502", "comment_date": "2012-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 725}]}, {"id": "FDA-2010-N-0449", "agency": "FDA", "title": "Risks and Benefits of Lon-Term Use of Nicotine Replacement Therapy Produts; Public Workshowp; Request for Comments", "update_date": "2021-09-01", "update_time": "18:07:19", "purpose": "Nonrulemaking", "keywords": ["cder2010128", "CDER"], "comments": [{"text": "The idea of the FDA to ban the sale of electronic cigarettes while at the same time allowing the sale of cigarettes is so idiotic that it makes my blood boil. It is a fact that cigarettes are more harmful than electronic cigarettes, that fact cannot be disputed. So logic would say that if you are going to ban electronic cigarettes you should ban regular cigarettes. I have no idea who is running the FDA, but that individual should be FIRED. I would personally love to testify before ANY government commitee in regards to the stupidity of this subject and IF the tobacco industry is greasing someones palms at the FDA that individual should be FIRED also. I am sick and tired of special interests ruling this country and I am sick and tired of common sense being thrown out the window !!!!! So get some common sense and do the right thing !!!!!", "comment_id": "FDA-2010-N-0449-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0449-0002", "comment_date": "2010-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 846}, {"text": "I think that the new warning labels on the cigarette packs are a great idea. I would like to see something a bit more slap in the face for the second hand smoke label. The ones that are available make it look more like its just an annoyance than potentially harmful or even fatal. With 3,000 people dying every year from lung cancer caused by second hand smoke, I think people should be a little better informed. I also think that a label should be made that makes parents consider the likelihood that if they smoke then their children will also smoke because that is the example they see. I am torn between two of the pics for the addicting label. The guy smoking through his throat, and the puppet. I think the smoking through the throat guy is very intense, but something about the puppet gets to me personally. One of the reasons I dont smoke or drink alcohol or coffee is because I dont like feeling like Im not in control of myself. If I cant look at something and say no, I feel like Im not really calling the shots anymore. I dont know how many people share that feeling, but I think the image is more thought provoking.I am afraid we kinda dropped the ball on the smoking can harm your children label. None of the children look harmed except maybe the last one. Screaming kids and illustrations arent going to cut it with people who put addiction before child care. Let them see the irreversible damage they can cause. When we are talking about kids we cant afford to pull any punches, or sugar coat things.Fatal lung cancer, the deceased with a toe tag. I like it. Its very final and to the point. The picture looks colorless and cold which is a great way to portray it on a cigarette label. I also like the lung comparison, its a good visual to put in their minds right before they suck down some of that sweet tar.The guy hooked to the bag is probably my favored one for the heart disease label. Everyone thinks about lung cancer when they think about the adverse side effects of smoking, but they dont consider the heart disease and stroke as much. Lung cancer seems more gradual and fightable, but strokes and heart attacks are sudden and often fatal and can come without much warning. That makes them scary.For smoking during pregnancy I think the baby illustration should be an actual photo, and maybe we should take the pacifier off the table and put it in a small casket or on a tombstone. Again, with babies who dont have a choice, we really need to hit hard.I think the corpse with the stitched up chest cavity is the kicker for the smoking can kill you label. Its a more memorable image than the guy in the suite or the coffin illustration. Its a nice cold hard dose of reality. If you dont care about dying, then the picture wont bother you and you can smoke merrily along.I suppose the lady crying would be my pick for the second hand smoke label. A lady in obvious distress usually invokes some kind of sympathy or concern. It might be enough to plant the seed of change.Something about the lady blowing the bubble gets my attention for the quit smoking label. I think it must be contrast between blowing a nice clean bubble and exhaling gray nasty smoke out your mouth. It makes smoking seem dirty by comparison. I think the t-shirt guy is just going to invite ridicule.", "comment_id": "FDA-2010-N-0449-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0449-0007", "comment_date": "2010-12-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3468}, {"text": "I would like to see electronic cigarettes get the green light as a nicotine replacement therapy option. It is working extremely well for me. I must say i was actually suprised by this as i was a smoker for 27 years. I believe there are already tests done in the 40s on the inhalation of propelyne glycol. O a;sp fee; we cam assume that harm around inhalation of vegetable is minimal (if any), as we have thousands of cooks in this country who use this product daily. I strongly suggest e-cigs be regulated as a tobacco product, rather than as a drug delivery device. Thanks.", "comment_id": "FDA-2010-N-0449-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0449-0006", "comment_date": "2010-11-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 584}]}, {"id": "EPA-HQ-ORD-2010-0396", "agency": "EPA", "title": "Toxicological Review of Formaldehyde Inhalation Toxicity", "update_date": "2022-10-07", "update_time": "09:19:02", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Dear EPA,I am grateful the EPA has finally recognized the toxic hazards of formaldehyde.  It seems as though a number of chemical companies are aggressively trying to get the EPA to remove the mention of leukemia as a possible risk.  I urge the EPA to leave it in.  Whenever industry fights against recognized issues with their chemicals, it is most often due to the associated profit impact of the industry that will have.  The chemical industry serves only one purpose, maintain profit margins from the chemistry industry.  They dont serve the public, they sell to the public many times misinformation about chemicals in order to assuage the public into continuing to buy and use their products.  I hope EPA continues to monitor formaldehyde toxicity and starts forcing all natural gas facility to report all emissions of formaldehyde consistently across the entire natural gas supply chain.", "comment_id": "EPA-HQ-ORD-2010-0396-0033", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0033", "comment_date": "2022-04-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 903}, {"text": "Comments submitted by American Chemistry Councils Formaldehyde TSCA Risk Evaluation Consortium", "comment_id": "EPA-HQ-ORD-2010-0396-0100", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0100", "comment_date": "2022-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 99}, {"text": "ACC Formaldehyde Panel comments containing past EPA engagements and communications. Due to the limitation in the number of attachments per submission, this submission is 1 out of 2 submissions.", "comment_id": "EPA-HQ-ORD-2010-0396-0101", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0101", "comment_date": "2022-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 193}, {"text": "Comments on Sensory Irritation of Formaldehyde", "comment_id": "EPA-HQ-ORD-2010-0396-0086", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0086", "comment_date": "2022-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 46}, {"text": "Technical Comments on Portions of the Environmental Protection Agencys (EPAs) Draft IRIS Toxicological Review of Formaldehyde (Inhalation)", "comment_id": "EPA-HQ-ORD-2010-0396-0087", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0087", "comment_date": "2022-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 157}, {"text": "Technical Comments on Certain Elements of the Environmental Protection Agencys (EPAs) Draft IRIS Toxicological Review of Formaldehyde (Inhalation) Pertaining to the Bottom-Up Approach to Bounding Low-Dose Cancer Risks ", "comment_id": "EPA-HQ-ORD-2010-0396-0084", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0084", "comment_date": "2022-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 246}, {"text": "Comments by Robert Golden (Owner, ToxLogic, LLC) and Stewart Holm (Chief Scientist, AFPA  AWC) on the IRIS Draft Assessment of Asthma and Sensory Irritation Risk of Formaldehyde", "comment_id": "EPA-HQ-ORD-2010-0396-0073", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2010-0396-0073", "comment_date": "2022-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 187}]}, {"id": "DOD-2011-HA-0085", "agency": "DOD", "title": "TRICARE; Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries", "update_date": "2020-10-22", "update_time": "01:28:06", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Dear Sir/Maam,Please note my strong support FOR the proposed rule change.  The exclusion of maintenance therapies for addiction treatment because they are addictive ignores best practices in the medical treatment of substance use disorders, ties the hands of service providers, and makes recovery from chemical dependence harder for patients to achieve.The proposed rule change would increase the effectiveness of treatment for this life-threatening and widespread illness.Thank you, William AprillLCSW-BACS, LAC, CCGC", "comment_id": "DOD-2011-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0002", "comment_date": "2012-01-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 565}, {"text": "Patients enrolled in a methadone clinic accept a high level of supervision and demonstrate a commitment to their recovery.", "comment_id": "DOD-2011-HA-0085-0017", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0017", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 122}, {"text": "I have submitted the comment below on letterhead using the file upload function.  Here is the text.As a researcher and clinician in the addiction field, I am writing to express my strong support for the proposed inclusion in TRICARE of coverage for methadone and buprenorphine maintenance for drug dependent individuals.   Extensive research  much of it conducted with former military personnel receiving care in the Veterans Health Administration  indicates that opiate substitution therapies sharply reduce illicit drug use and risk of fatal overdose.  These therapies have also been proven highly cost-effective.At a time when a growing number of U.S. military personnel are reporting problems with prescription and non-prescription opioids, the addition of this benefit to TRICARE is critically important.  For the regulatory change to be maximally beneficial to the health of our military personnel and their families, it should be coupled with extensive outreach to TRICARE providers to make them aware of the new insurance benefit.Thank you for proposing this major step forward for the TRICARE program.", "comment_id": "DOD-2011-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0003", "comment_date": "2012-01-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1284}, {"text": "The use of opioid maintenance therapy on a long term basis has not been proven to improve functionality or reduce mortality or relapse. Most tests of the efficacy of opioid treatment therapy have been conducted on a short term basis. Research has shown that on a short term basis, those given methadone or buprenorphine reduce their use of other opioids, but only for as long as they are on the drugs. Many continue to use other substances such as alcohol, and continue to be at risk of overdose. Methadone overdoses have increased 400% from 2004-2008. Harm reduction philosophy (upon which use of an addictive substance is sanctioned to treat dependence on another substance) is an enabling philosophy that continues addiction, rather than treat it. As long as the person remains dependent on an abusable substance, he or she can never realize his/her potential as a whole, infinite spiritual being. It is a disrespectful and demeaning approach to the plight of the addict and keeps him/her shackled to the progression of this dangerous mental disorder and foreshortens his/her life. The use of chronic opioid therapy for chronic noncancer pain has created this epidemic of opioid dependent persons and yet so little is being done to stop the production of opioid dependent persons and much is being propagated about the evidence-based need for the use of more opioids to treat the problem. This is insane!", "comment_id": "DOD-2011-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0004", "comment_date": "2012-01-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1419}, {"text": "The proposed change reflects the best evidence-based practice in the treatment of opioid dependence.  I fully support this change in the applicable regulation.I speak from the experience of prescribing buprenorphine (Suboxone/Subutex) since 2004 in the treatment of opioid dependence in the context of a comprehensive treatment program by our agency of which I am the medical director.  I also support Opioid Treatment Programs that prescribe methadone in the treatment of opioid dependence along with counseling.I am Board-certified in Internal Medicine and Addiction Medicine and have been working in the field of addiction medicine since 1989.", "comment_id": "DOD-2011-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0007", "comment_date": "2012-01-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 666}, {"text": "Dear Sir or Madam,On behalf of the Ohio Department of Alcohol and Drug Addiction Services (ODADAS) Clinical Roundtable Committee, I am pleased to submit the following comments on the proposed rule related to TRICARE benefits, Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (Document ID DOD-2011-HA-0085-0001).The Clinical Roundtable -- comprised of six senior clinicians and supervisors with established expertise in the clinical treatment of addictive disorders, drawn from ODADAS-certified treatment agencies from across the state -- strongly supports extending the benefit so that maintenance regimens of Medicated-Assisted Treatment (MAT) will be covered by TriCare. Scientific literature supports provision of MAT on an ongoing basis as being far more efficacious than alternative approaches, including detoxification-only or short-term utilization of MAT. Furthermore, several Roundtable members are familiar with the use of opioid replacement therapies (MAT) on an ongoing basis in their own agencies and have found it to be effective and practical.The Clinical Roundtable also recommends addressing barriers that limit access to other clinical services (counseling, case management) within the TRICARE system. MAT is considerably more likely to be effective when combined with counseling and case management services; however, community agencies with the highest level of expertise in providing such services have found that they cannot receive reimbursement through TRICARE. While the Clinical Roundtable fully supports and recommends immediate action on the MAT proposal, there is a strong consensus that further access to addiction-related services needs to be addressed as well.Thank you for this opportunity to provide comment. Please do not hesitate to call or email if I can be of additional assistance.Sincerely,Orman Hall, DirectorODADAS", "comment_id": "DOD-2011-HA-0085-0026", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0026", "comment_date": "2012-02-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2019}, {"text": "On behalf of NAADAC, the Association for Addiction Professionals, which represents the professional interests of more than 75,000 addiction counselors, educators and other addiction-focused health care professionals in the United States, Canada and abroad, we thank you for this opportunity to submit comments to the Department of Defense regarding the TRICARE:   Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (RIN 0720AB54).  NAADAC applauds the proposed change in TRICARE policy regarding the use of therapeutic drugs in maintenance treatments for substance dependence.  There is a wealth of medical evidence available that supports the belief that medication-assisted treatments are safe and highly effective.  The extension of benefits to include these treatments increases the quality of treatment options available to TRICARE beneficiaries.  The use of medication-assisted treatments is not for everyone.  Thus, we would recommend that included in the rule is a requirement that all individuals undergo an assessment prior to starting any medication-assisted treatment to ensure that they are receiving the appropriate care.  We also recommend that there be a requirement that anyone receiving medication-assisted treatments also take part in a comprehensive psychosocial treatment program to be administered concurrently.  We believe these added components will serve to prevent further dependence by assisting counselors in obtaining an ongoing assessment of the treatment.While NAADAC does not have an official written statement outlining support for medicated assisted treatment for individuals with addiction problems, since 2005 we have been active in the development of training experiences surrounding this topic for addiction treatment professionals.  Through a training program entitled NAADACs Life Long Learning Series five different training experiences have been developed and trained to ", "comment_id": "DOD-2011-HA-0085-0015", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0015", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2048}, {"text": "As an addiction psychiatrist working with active duty servicemembers, I support the rule change in its proposed form as it allows lower echelon agencies the ability to refine its policies congruent with the needs of the service and servicemember alike.  The rule change also takes quite a bit of anxiety off the clinician as well, in clarifying and supporting the role of buprenorphine in the treatment of opioid dependence for the active duty population.  Thank you very much for ensuring federal regulations keep up with advances in addiction treatment.", "comment_id": "DOD-2011-HA-0085-0019", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0019", "comment_date": "2012-02-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 555}, {"text": "Sirs/Madam, My issue is the stopping of prescription for Methadone from legal Pain Management Offices owned and run by MDs. I have been takeing Methadone for about 8 or 9 years for sever lower back pain and withot it I would problably not be able to get out of bed in the morings. I take no other durg and have never taken any, I am 66 years old and from what I hear and have investegated on the internet the withdrawal symthoms are not very plesant and take a long time. I live alone and have Enfezema and I and on oxegen 24 hours 7 days a week, with a heart condition high blood pressure and it is very hard for me to get around. Also any other drug that can replace Methedone is also taken off the list, is there no special consideration for older people such as myself? Thank You John W. Rosmini", "comment_id": "DOD-2011-HA-0085-0011", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0011", "comment_date": "2012-01-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 809}, {"text": "February 24, 2012Submitted via http://www.regulations.gov Department of Defense 1160 Defense Pentagon OSD Mailroom 3C843 Washington, DC 20301-1160Re: Support for proposed rule: TRICARE; Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries, RIN 0720-AB54To Whom It May Concern:The McDermott Center (dba Haymarket Center) welcomes the opportunity to express our support for the proposal to remove the prohibition against use of medications in the treatment of substance dependence for TRICARE beneficiaries.  For over 30 years, Haymarket Center has served as the Chicago Metropolitan Areas largest nonprofit substance abuse treatment provider. While treating over 22,000 clients annually, on any given day Haymarket has 400 patients in residential treatment, detoxification, outpatient treatment or recovery homes.  Haymarkets substance abuse treatment efforts include services for pregnant and post-partum women, as well as programming for families and fathers. Buprenorphine, methadone, and suboxone have been shown through multiple clinical studies to be effective medications when used for detoxification, short- and long-term maintenance treatment.  While these drugs are themselves addictive, when administered in an appropriately controlled manner they are safe and effective methods of opioid treatment.  By removing the prohibition on addictive medications, returning veterans with substance-abuse disorders and TRICARE recipients will receive a higher quality of care, with a decreased likelihood of an addictions relapse. Haymarket Center strongly urges the Department of Defense to remove the prohibition on addictive medications for TRICARE patients.  Should you have questions, please contact Dr. Dan Lustig Psy.D. CADC MISA II, Vice President of Clinical Services, by phone at: (312) 226-7984 ext. 488.Sincerely,Ray Soucek PresidentHaymarket Center", "comment_id": "DOD-2011-HA-0085-0023", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0023", "comment_date": "2012-02-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2084}]}, {"id": "FDA-2011-N-0583", "agency": "FDA", "title": "Orphan Drug Regulations", "update_date": "2023-01-24", "update_time": "12:14:45", "purpose": "Nonrulemaking", "keywords": ["oc2011179", "OC", "Orphan Drug", "0910-AG72"], "comments": [{"text": "The proposed rule that I am choosing to comment on is one that is being filed by the FDA that is suggesting changes to be made to the Orphan Drug Regulations that were passed in 1992.  The changes being made are, more or less, being used to clarify almost two decades old language that, if updated, will benefit persons in the U.S. suffering from a rare disease that affects roughly about 200,000 people, such as cystic fibrosis.After careful study of the proposed amendments to what was originally the Orphan Drug Act of 1983, I believe that this was the right move to be made by the FDA.  As technology continues to grow and develop, so should acts such as this, especially if they involve anything within the medical spectrum.  The advances that have been made in medicine since 1983 are vast and when there are regulations in place that deal with specific rare conditions and diseases the only logical step to take would be to review the issues, and amend them as such.  According to the Federal Register, since the Orphan Drug Regulation was published in 92, there have been over 3,350 different requests for orphan-drug designations for these rare diseases and conditions.  I believe that is too high a number of requests to not have put any sort of amendments in place before now, but that is neither here nor there.  The proposed changes will serve well to aid the requests of the individuals who are in need of these exclusive orphan-drugs.", "comment_id": "FDA-2011-N-0583-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0583-0002", "comment_date": "2011-11-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1511}, {"text": "Shire comments to the FDA proposed amendment to the orphan drug regulations", "comment_id": "FDA-2011-N-0583-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0583-0012", "comment_date": "2012-02-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 75}]}, {"id": "TTB-2009-0001", "agency": "TTB", "title": "Increase in Tax Rates on Tobacco Products and Cigarette Papers and Tubes; Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes; and Changes to Basis for Denial, Suspension, or Revocation of Permits", "update_date": "2014-12-01", "update_time": "13:32:34", "purpose": "Rulemaking", "keywords": ["tobacco", "cigarettes", "cigars", "pipe tobacco", "chewing tobacco", "snuff", "roll your own", "excise taxes", "exports", "imports", "recordkeeping", "tobacco products", "floor stocks tax", "permits", "health insurance", "CHIPRA"], "comments": [{"text": "how come certain people end up paying for for this schip program and others dont pay one cent. this schip program is a way to stuff the states pockets with cash.what did the states do with all that tobacco settelment which was in the billons of dollars besides buying paintings and landscaping the state capital and a host of other bullshit. you need to have agi pay the this outrageous tax with the so called bailout.because thats what they did.bailed out and left the country.but obama will find away to tax something to pay for that to.trillon dollars going to bailingout the auto ind. then end up filing bankrupcy. what a bunch of idiots.  ", "comment_id": "TTB-2009-0001-0006", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0006", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Keith", "commenter_lname": "Anderson", "comment_length": 679}, {"text": "This rule proposes to tax cigarette rolling papers. How does this tax impact people who purchase cigarette rolling papers for marijuana use? It seems this would be taxing marijuana use and not tobacco use? Cigarette rolling papers are not commonly referred to as a cause of cancer.Please clarify what is a cigarette tube?Why are pipes, water pipes, hukahs, evaporators, and other smoking devices not taxed as well? It does not seem to be good policy to only target one delivery system and not all systems.", "comment_id": "TTB-2009-0001-0003", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0003", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Patrick", "commenter_lname": "Shipp", "comment_length": 540}, {"text": "Comments ;    Their needs to be a seperate line for all cigar tobaccos , filler ,binder and cigar wrapps  WRAPPER  Blunt Wraps . This is cigar tobacco not cigarette tobacco. You have put this into RYO but it needs its own line item.  All the information collected to April 1 2009 , is just cigarette tobacco this information must be kept clean. It is used for the Dept of Ag. , MSA , and TTB.  On TTB form5220.6 (07/2007) on the right margen their is enough space to put an extra line. Have them mark it RYO Cigar Wrap  and keep it clean. Also in the future it would be good to review with the industry befor the final rules are completed. THANK YOUGeoffrey H. RanckPS  call me.", "comment_id": "TTB-2009-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0007", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Geoffrey", "commenter_lname": "Ranck", "comment_length": 810}, {"text": "I strenuously object to the OBAMA tax on tobacco and cigarettes. During difficult times when people are so short on money in the first place, you very significantly target a select group of people and tell me what is good for me. I dont have insurance on myself and your decision is to make me pay for insurance on a child that is not even mine to support. And you give me no choice in the matter. You pass a bill that demands that I pay a tax on a product that is legal citing all matter of literature about the health aspects of smoking cessation. When will you pass a bill on the obese. You want to generate income, thats your target demographic. There is the revenue you need to support the uninsured children of the United States Obseity is the leading cause of disease in the United States. Smokers have been under attack for a long time. Its time to cease the madness.", "comment_id": "TTB-2009-0001-0005", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0005", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Linda", "commenter_lname": "Tesch", "comment_length": 940}, {"text": "American Legacy Foundation1724 Massachusetts Avenue, NWWashington, D.C. 20036 Comments Submitted on May 29, 200927 CFR Parts 40, 41, 44, 46, and 71Docket No. TTB-2009-0001Notice No. 93RE: T.D. TTB-75To the Director, Regulations and Rulings DivisionAlcohol and Tobacco Tax and Trade Bureau1310 G Street, NW, Suite 200-#Washington, DC 20005The American Legacy Foundation (Legacy) is pleased to submit these comments in support of the proposed regulations by the Alcohol and Tobacco Tax and Trade Bureau (TTB) regarding the increase in tax rates on tobacco products and cigarette papers and tubes; floor stocks tax on certain tobacco products; cigarette papers and cigarette tubes; and changes to the basis for denial suspension or revocation of permits.  Legacy is a national, independent public health foundation created in 1998 out of the landmark Master Settlement Agreement (MSA) between the tobacco industry, 46 state governments and five U.S. territories. Our mission is to build a world where young people reject tobacco and anyone can quit.  Legacy does not lobby or take positions on specific legislation.  Our programs include:  truth - A national youth smoking prevention media campaign responsible for preventing approximately 450,000 youth from beginning to smoke in its first four years(1)EX - An innovative smoking cessation public education campaign designed to help smokers re-learn life without cigarettes. Research Initiatives  Examining the various causes and effects of tobacco use in the United States.   Outreach to Priority Populations  Priority Populations Initiatives and grants provide critical interventions using methods that are culturally competent and tailored for the specific needs of communities disproportionately affected by the toll of tobacco. Legacy applauds TTB for promptly publishing for public comment proposed regulations to carry out the Childrens Health Insurance Program Reauthorization Act (CHIPRA) and increase the excise taxes on tobacco products.  Legacy has long supported increases in excise taxes on tobacco products, as well as tax parity between cigarettes and cigar products, as part of a comprehensive tobacco control program.  Excise tax increases can serve to both increase revenues for prevention and cessation services as well as decrease tobacco consumption.  Increasing taxes on tobacco is one of the most effective ways to reduce tobacco use.(2,3,4)  Increased taxes on cigarettes and other tobacco products make them more expensive, and as a result, youth are discouraged from smoking(5) and adult smokers are more likely to quit.(6)  TTBs effort to devise these regulations is commendable.  We believe that the proposal would properly implement the CHIPRA amendments and should be adopted as the final regulation. However, more needs to be done. We encourage the Bureau to: 1. pursue tax parity between cigarettes and all cigar products; and 2. create a standard definition of cigarillos and improve the reporting of information to the public regarding the sales of different types of large cigar products. First, there should be tax parity between all cigar products and cigarettes.  CHIPRA, and the regulations that TTB has proposed, do create federal tax parity between cigarettes and small cigars, which mimic cigarettes except that they are wrapped in tobacco leaf instead of paper, taxing them both at approximately $1.01 per pack.  However, all other cigar products, including traditional large cigars and cigarillos, are taxed as a percentage of their manufacturers price. (Cigarillos are also called cheroots or blunts.  We will refer to these products collectively as cigarillos.)  Some large cigars and cigarillos, particularly those that are more expensive, are taxed at significantly lower rates than cigarettes and small cigars, because the tax is capped at $0.40. There is also concern that, at the low end of the scale, tobacco companies may be able to reduce the impact of the new, higher taxes by manipulating the weight of their cigar products. Consider, for example, a little cigar product with a manufacturers price of $0.75 per 20 little cigars.  Under the new rules the tax per pack would be $1.0l.  However, the manufacturer could lower that tax to $0.39 per pack simply by slightly increasing the size of their little cigars so that they would be classified as large cigars.  It appears this has occurred: On the same day that CHIPRA went into effect (April 1, 2009), the brands Santa Fe, King Edward, and Blackstone changed their products from little cigars to cigars. (7)  While this may not be illegal, the manufacturers are clearly gaming the system to receive the most preferential tax treatment and keep the prices of their products low.These differential rates fly in the face of sound policy. All cigars, just like cigarettes, cause lung, oral, laryngeal, and esophageal cancers, and chronic obstructive pulmonary disease (COPD).(8)   The disproportionately low tax on some cigars and cigarillos maintains their price advantage, which could increase their rate of consumption(9,10) and, in particular, make them more appealing to youth.   Indeed, these products are increasing in popularity.   Consumption of little cigars has increased by 240% while cigarillo consumption increased by almost 150% between 1997 and 2007. At the same time, typical large cigar consumption decreased by 6%.(9) Second, the Bureaus reporting of information regarding sales of large cigars does not differentiate between typical large cigars, or stogies and cigarillos.  This makes it difficult to definitively track the consumption rate of cigarillos although available data suggests that it is rising. The problem is compounded by the fact that there is no standard definition of cigarillos, making it difficult to accurately compare the data and reports that do exist.   More refined information would make a valuable contribution to both tax and public health policy. We encourage TTB to define cigarillos, perhaps by reference to its previous definition of cigarillos as large cigars weighing 3  10 pound per thousand,(11) and collect and publish data based on its definition. We would note that the United States Department of Agriculture uses this definition although it does not provide reports regarding consumption. We would also note that TTB already tracks and provides information on two different price categories of large cigars (Class A-G, and Class H).(12)  In closing, Legacy is pleased that these taxes on tobacco products were raised by CHIPRA and that TTB has taken appropriate and timely steps to assure that they are collected.  We look forward to working with TTB on the additional issues we have raised.  If you have any questions or need further information, please contact Stephenie Foster, Senior Vice President of Government Affairs, at 202-454-5559 or sfoster@americanlegacy.org.Endnotes: (1) Farrelly MC, Nonnemaker J, Davis KC, Hussin A. The Influence of the National truth Campaign on Smoking Initiation. American Journal of Preventive Medicine, 2009; 36(5): 379-384.(2) IOM (Institute of Medicine). Ending the Tobacco Problem: a Blueprint for the Nation. Washington, DC: The National Academies Press.  2007.(3) U.S. Department of Health and Human Services. Reducing Tobacco Use: A Report of the Surgeon General. Atlanta, Georgia: U.S.Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2000.  (4) The World Bank. Curbing the Epidemic:Governments and the Economics of Tobacco Control. 1999; Washington, DC. Chapter 4: Measures to Reduce the Demand for Tobacco. (5) Carpenter C, Cook PJ. Cigarette taxes and youth smoking: New evidence from national, state, and local Youth Risk Behavior Surveys. Journal of Health Economics, 2008; 27:287-299. (6) Levy DT, Romano E, Mumford E. The relationship of smoking cessation to sociodemographic characteristics, smoking intensity, and tobacco control policies. Nicotine and Tobacco Research, 2005; 7(3): 387-396. (7) Per phone conversation with Swisher International representative on May 28, 2009(8) National Cancer Institute. Smoking and Tobacco Control Monograph 9: Cigars: Health Effects and Trends. National Institutes of Health, 1998. (9)  Maxwell JC. The Maxwell Report: Cigar Industry in 2007. Richmond, VA: John C. Maxwell, Jr. 2008. Original concept in Kozlowski LT, Dollar KM, Giovino GA. Cigar/cigarillo surveillance: limitations of the U.S. Department of Agriculture system. American Journal of Preventive Medicine, 2008; 34(5); 424-6.(10) Ringel J, Wasserman J, Andreyeva T. Effects of public policy on adolescents cigar use: evidence from the National Youth Tobacco Survey.  American Journal of Public Health, 2005; 95: 995-998; Delnevo C, Hrywna M, Foulds J, Steinberg M. Cigar use before and after a cigarette excise tax increase in New Jersey. Addictive Behavior. 2004; 29: 1799-1807; Delnevo C, Foulds J, Hrywna M. Trading tobacco: are youths choosing cigars over cigarettes? American Journal of Public Health, 2005; 95: 2123.(11) TTB Industry Circular Number: 69-11, Reconstituted Tobacco As Wrapper for Rolls of Tobacco, April 3, 1969.  Found at: http://www.ttb.gov/industry_circulars/archives/1969/69-11.html.  Accessed on May 27, 2009.(12) 27 CFR Parts 40 and 275", "comment_id": "TTB-2009-0001-0008", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0008", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Cheryl", "commenter_lname": "Healton", "comment_length": 10358}, {"text": "OK.  I know Im not going to get honesty here, (if I get anything at all, other than an investigation) but Ill ask the question anyway:Whats the real reason for this increase?According to your Industry Circular (http://www.ttb.gov/industry_circulars/archives/2009/ic2009_01.html) for Roll-Your-Own Tobacco2 (which is what I smoke) the tax has gone from $1.0969 per pound to $24.78 per pound.  As you state that is a $23.6831 per pound increase.  I ask again: What is the real reason for a 2,259.09 percent increase in these taxes?I see that the increase for pipe tobacco went from the same $1.0969 per pound as my Roll-Your-Own, to $2.8311 per pound, a mere 258.1 percent increase.  I guess you consider pipe smokers to be of a higher class than us Roll-Your-Own smokers.  Something is not right in whats going on here.I do not believe this has anything to do with the Childrens Health Insurance Program Reauthorization Act of 2009 (the Act, Pub. L. 111-3).  That is merely the vehicle you decided to use for your other actual reasons.  I do not believe this has anything to do with childrens health.  I believe something else is going on and I am sure it has much more to do with you stealing my money.  It is plain and simple theft.This is just another large pile of manure I am seeing more and more from my government.  However, in this particular case, it is a 2,259.09 percent increase in the amount of manure I am use to and thus is the reason for this comment on this latest attack on the ever more tax paying citizens of this country.", "comment_id": "TTB-2009-0001-0004", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0001-0004", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Kevin", "commenter_lname": "Reynolds", "comment_length": 1771}]}, {"id": "FDA-2012-P-0260", "agency": "FDA", "title": "Request that the (\"Commissioner\") investigate actions taken by the Center for Devices and Radiological Health (\"CDRH\") related to the August 8, 2011 proposed rule", "update_date": "2019-12-20", "update_time": "12:32:25", "purpose": "Nonrulemaking", "keywords": ["cdrh", "cranial electrotherapy stimolator", "August 8, 2011", "76 FR 48062", "CES", "February 10, 2012", "insomnia", "chronic pain", "open"], "comments": [{"text": "As a PhD psychotherapist who supervised clinicians in a WTC mental health program for five years, I experienced a severe case of PTSD after leaving the program, with accompanying depression.  That lasted for almost two years.  When the Fisher Wallace stimulator was recommended to me, I had never heard of it, but obtained the device within a week.  Using it for 20 minutes per day on the lowest level level I had no side effects from it, and my symptoms were almost totally alleviated within 10 days.  For myself, I need to use the machine at least three days per week to remain symptom free.  The machine is not expensive, I can use it while drinking my morning coffee and reading the paper, and it has been easier than playing around with psychotropic medications to try to find one that would work, and it has nine of the side effects of meds!!!", "comment_id": "FDA-2012-P-0260-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0014", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 849}, {"text": "The Fisher Wallace device is excellent. I have recieved much praise from my patients who have used for pain, anxiety and depression. I highly recommend it.", "comment_id": "FDA-2012-P-0260-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0015", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 155}, {"text": "I am a board certified psychiatrist in practice for 34 years.  I have founded several mutispecialty centers and maintain a private practice.  I served as Assistant Clinical Professor of Psychiatry at UCLA from 1979--2001.  I am author of Contagious Emotions:  Staying Well When Your Loved One is Depressed, a Simon and Schuster hardcover and trade paperback.I have direct clinical experience using the FW Cranial Stimulator on patients with insomnia, GAD, Major Depressive Disorder and Bipolar Disorder, Depressed.  I have prescribed the FW device to approximately 30 patients.  The device has been well tolerated by every patient and not one patient has ever returned their device within the 60 days period that is given for refunds.  I most commonly use the device in combination with other therapies but have used it as a stand alone device for insomnia.The device should be classified no higher than Class Two.  It has less adverse events than patients I have sent for rTMS therapy--in fact every patient has complained about some adverse effects from TMS.  Its efficacy has been greater and it is a far less invasive treatment in terms of delivery.  I have no financial interest in the Fisherwallace company nor do I receive remuneration from the company.  I am voluntarily contributing this information to correct a mistake that does a disservice to patients.  ", "comment_id": "FDA-2012-P-0260-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0012", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1397}, {"text": "I have used a version of the Fischer Wallace Stimulator on both myself and patients for more then 20 years.  More recently I have specifically used the Fischer Wallace Stimulator, also on patients as well as myself.  Indications I have used it for include pain and menopausal symptoms including fatigue due to poor sleep at night.  I have NEVER had a serious side effect from the unit. Once in a while a patient may complain of feeling slightly dizzy after using the unit but nothing else.  It works well on orthopedic type pain such as low back or cervical pain.  It works great for calming headaches.  I strongly endorse the use of this unit. Bonnie OConnell, Physical Therapist", "comment_id": "FDA-2012-P-0260-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0011", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 680}, {"text": "Cranial electrostimulation (CES) is a safe, effective, economic treatment for the symptoms of anxiety, depression, and sleep disturbance that commonly occur in soldiers and veterans suffering with posttraumatic stress. The device and therapy offer another option in addition to psychotropic medications and verbal therapy for the treatment of these conditions. In the past 10 years, over 2.5 million men and women have served in the combat theaters of Iraq and Afghanistan. Estimates of those suffering with posttraumatic stress range from 20 to 40%, or 500,000 to 1,000,000. CES devices offer significant, clinically meaningful advantages over existing approved alternative treatments, especially over those anti-depressant medications that are ineffective in treating soldiers with PTSD. Cranial Electrotherapy Stimulation devices, including the Fisher Wallace Stimulator, are intended to treat life-threatening or irreversibly debilitating psychiatric conditions in soldiers suffering from depression, anxiety and insomnia in association with Post Traumatic Stress and substance abuse.The availability of the device is in the best interest of patients  especially our soldiers.  With the return of hundreds of thousands of soldiers from Iraq and Afghanistan, subjecting CES manufacturers to the PMA process will interfere with the availability of these devices precisely when access to them is most needed.  ", "comment_id": "FDA-2012-P-0260-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0004", "comment_date": "2012-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1443}, {"text": "Because I have chronic pain and most nights cannot sleep through the night, I decided to try the CES unit to see if it would help me sleep and might relieve some of my fibromyalgia and arthritis pain. I was amazed at the first nights relief. By the end of the week I was sleeping without break for the entire night.  I was  in absolute disbelief. Awaking pain-free with the ability to move and walk was truly wonderful. I have recommended the CES unit to my military clients and I am appalled that this valuable noninvasive technology is in peril of not being available.", "comment_id": "FDA-2012-P-0260-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0019", "comment_date": "2013-05-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 575}, {"text": "The Fisher-Wallace device has been extremely effective with many patients with whom I have used it to improve depression, anxiety, and sleep issues.  I am finding it more effective than other similar devices.", "comment_id": "FDA-2012-P-0260-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0010", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 208}, {"text": "I am a mind/body psychotherapist and dance/movement therapist, in private practice and teaching here and in Europe, in and out of academic settings.I have had several severe repetitive impact injuries resulting from working with seriously psychotic patients with dance/movement therapy in hospital and clinic settings for over 30 years. I have had 3 major surgeries as a result of these injuries: one for a large calcified  tumor in my right metatarsil, a 3 level lamenectomy and micro-discectomy on my lumbar spine, and a shoulder surgery with 12 elements, including repairing a full rotator cuff tear, and repositioning my biceps tendon.Because I also have severe cervical stenosis, as well as lumbar stenosis,  and have been having severe radiculating pain down my right arm, I was told I likely would need neck surgery in the future to address this problem.The pain made it difficult for me to sleep and lack of sleep made the pain worse. My osteopath suggested the Fisher Wallace Stimulator to deal with the pain and associated difficulty sleeping. I have been using it for several months and find it extremely helpful. I find it also helps with the emotional side of dealing with severe pain. My pain is more manageable, my sleep better in general, and I feel more resilient in dealing with it. I have also recommended this device for two of my psychotherapy clients; one dealing with the severe pain of RA, and related insomnia, anxiety and depression,  and one with PTSD with associated bio-emotional symptoms.I highly recommend this device and its FDA approval.", "comment_id": "FDA-2012-P-0260-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0013", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1620}, {"text": "It is another expansive scam.  Product does not do any thing", "comment_id": "FDA-2012-P-0260-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0007", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 60}, {"text": "The Fisher wallace device is no different than any other depression treatment. it works for a while, then stops. This suggests to me it is a placebo effect - a very expensive one since insurance doesnt cover it and it costs $700. Worse are the sponges that the company charges a ridiculous amount for.Frankly, I think its an overpriced rip off that should not be approved.", "comment_id": "FDA-2012-P-0260-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0008", "comment_date": "2013-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 392}]}, {"id": "FDA-2009-N-0025", "agency": "FDA", "title": "Animal Food Labeling; Declaration of Certifiable Color Additives", "update_date": "2022-01-05", "update_time": "01:03:35", "purpose": "Rulemaking", "keywords": ["animal food labeling", "declaration of certifiable color additives", "Center for Veterinary Medicine", "2015-247", "OMB Control Number 0910-0721", "2015-784"], "comments": [{"text": "The information collection is essential to the FDAs performance and the information may become important down the line.  The collection of information regarding the burden to manufacturers of pet food that are required to include the presence of color additives on their animal food product labels is necessary if the FDA ever wanted to re-write the rule after another notice and comment period. The information would be informative and beneficial to those who might want to comment on a proposed regulation to change the current requirement. However, as someone who purchases pet food, I find the regulation of the requirement of the informative labels to be important. Therefore, I find this particular collection of information to be trivial. I did review the numbers that the FDA estimated and the total burden to the manufacturers and I think that the burden to them is considerable low compared to the importance of the informative food labelsI assume that the FDAs estimations are correct based on the method they used to get to their final number. The only thing that I suggest would be that the information be a little less vague in that it explains a little more in depth how the FDA estimated the number of manufacturers with sales greater than zero to be 25,874 and how they estimated the flow of new products to be 10 percent, etc. A more precise estimation may be of greater help in the future. ", "comment_id": "FDA-2009-N-0025-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0012", "comment_date": "2018-03-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1554}, {"text": "I think it is more valuable to know the quality of ingredients in pet foods-to be assured the food is not made from diseased, degrading animals than to worry about dyes at this point. When that is taken care of then dyes can be dealt with. Very disappointed in the way pet foods have become a dumping ground for unusable animals.", "comment_id": "FDA-2009-N-0025-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0024", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Adele", "commenter_lname": "Gaskin", "comment_length": 334}, {"text": "After some research into this topic, I have come to my personal opinion that this amendment should be approved for the following reasons: 1)Child food dye allergies  Children have been diagnosed with more and more food allergies in the past decade or so. Children may be exposed to the foods given to their pets and should be warned of the risk involved in handling or being exposed to the product. One may not know what their level of allergy is until it is too late. For some, a rash or perhaps respiratory problems, and death have even been the result in some cases. 2) The right to know  In general, consumers have the right to know what is in the products they are buying and consuming, whether it be for themselves, for their children, or for their pets. And for some people, pets are their children. The FDA would not deny a mothers right to know what is in her childs breakfast, so why would a pet lover not have the right to know what is in their pets meal? 3) Animals are not necessarily tested for allergies or intolerances as humans are. Basically they are just given food that their owner thinks is (or will be) good for them. An owner may make an educated decision to stay away from an ingredient that holds a higher risk to a reaction based public notification or outbreaks from certain products. In conclusion, the bottom line is that animals have rights and they should be treat like humans. The have the right to a nutrients meal and the owners have the right to know what is in  their animals food. I am not that fun of animals, but I believe that we owe it to them to feed them as best we can base on the knowledge we obtain through the manufacturers and governments that regulate.", "comment_id": "FDA-2009-N-0025-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0004", "comment_date": "2010-01-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1757}, {"text": "After some research into this topic, I have come to my personal opinion that this amendment should be approved for the following reasons: 1)Child food dye allergies  Children have been diagnosed with more and more food allergies in the past decade or so.  Children may be exposed to the foods given to their pets and should be warned of the risk involved in handling or being exposed to the product.  One may not know what their level of allergy is until it is too late.  For some, a rash or perhaps respiratory problems, and death has even been the result in some cases. 2)The vegan community is ever-growing.  Some pet owners only want the best for their animals, including the knowledge of what exactly is in their pets diet.  Some foods are tinted with the dye that is extracted from carmine, which a pigment is obtained from insects.  Vegans would not be happy knowing that they gave their animals contaminated products.  3)The right to know  In general, consumers have the right to know what is in the products they are buying and consuming, whether it be for themselves, for their children, or for their pets.  And for some people, pets are their children.  The FDA would not deny a mothers right to know what is in her childs breakfast, so why would a pet lover not have the right to know what is in their pets meal? 4)Animals are not necessarily tested for allergies or intolerances as humans are.  Basically they are just given food that their owner thinks is (or will be) good for them.  An owner may make an educated decision to stay away from an ingredient that holds a higher risk to a reaction based public notification or outbreaks from certain products. In conclusion, the bottom line is that animals have rights. As a fan of animals, I believe that we owe it to them to feed them as best we can based on the knowledge we obtain through the manufacturers and governments that regulate.", "comment_id": "FDA-2009-N-0025-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0003", "comment_date": "2009-12-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1986}, {"text": "Susan THIXTON has once again hit the nail on the head! Im not as concerned about the dyes as I am about the diseased  dying animal carcasses used in our pets food is rediculous! For the FDA to say they see nothing wrong in using this is asinine!", "comment_id": "FDA-2009-N-0025-0026", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0026", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Ronald", "commenter_lname": "Krikorian", "comment_length": 257}, {"text": "I seriously disagree with the stance the FDA is taking regarding ingredients in pet foods. If it is helpful for a consumer to be knowledgeable about dyes and additives as they shop for their pets, then why wouldnt it be helpful for owners to know if ingredients sourced from diseased animals, condemned animals or animals that have died other than by slaughter are included in the pet food. The stance of the FDA not to disclose illegal waste ingredients to the pet consumer makes NO sense whatsoever. Pet owners pay for this food and deserve to know what they are feeding their pets. Along the line of full transparency, please, FDA, step up and do the job you are supposed to be doing.", "comment_id": "FDA-2009-N-0025-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0019", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 709}, {"text": "I want to know what is in my pets food!We ask FDA to consider  if color additives help pet owners to comparison shop and avoid substances they dont want their pet to consume, why wouldnt the disclosure of ingredients sourced from diseased animals or animals that died otherwise than by slaughter provide consumers the same benefit? To refuse to require pet food labels to disclose this vital information to pet owners is unjust (at the very least).", "comment_id": "FDA-2009-N-0025-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0025", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "P", "commenter_lname": "Ianniello", "comment_length": 479}, {"text": "I agree with FDAs belief that pet owners will benefit from pet food label disclosures of color additives. However, I am dismayed that FDA Center for Veterinary Medicine does not require disclosure on pet food labels of illegal ingredients specifically allowed by FDA enforcement discretion.Dr. Steven Solomon stated in response to Citizen Petition FDA-2016-P-3578 we do not believe that the use of diseased animals or animals that died otherwise than by slaughter to make animal food poses a safety concern and we intend to exercise enforcement discretion.I ask FDA to consider  if color additives help pet owners to comparison shop and avoid substances I dont want my pet to consume, why wouldnt the disclosure of ingredients sourced from diseased animals or animals that died otherwise than by slaughter provide me, the consumer, the same benefit? To refuse to require pet food labels to disclose this vital information to pet owners is unjust (at the very least).", "comment_id": "FDA-2009-N-0025-0029", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0029", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Arian", "commenter_lname": "Heald", "comment_length": 1028}, {"text": "We ask FDA to consider  if color additives help pet owners to comparison shop and avoid substances they dont want their pet to consume, why wouldnt the disclosure of ingredients sourced from diseased animals or animals that died otherwise than by slaughter provide consumers the same benefit? To refuse to require pet food labels to disclose this vital information to pet owners is unjust (at the very least).", "comment_id": "FDA-2009-N-0025-0032", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0032", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Angela", "commenter_lname": "Bertucci", "comment_length": 430}, {"text": "Greetings, while I agree that pet owners deserve to know if their pets food contains color additives I also strongly urge the FDA to clearly state when ingredients are sourced from diseased animals, condemned animals or animals that have died other than by slaughter. We deserve to know. ", "comment_id": "FDA-2009-N-0025-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0025-0034", "comment_date": "2021-03-08", "comment_time": "05:00:00", "commenter_fname": "Seth", "commenter_lname": "Levinson", "comment_length": 295}]}, {"id": "HHS-OS-2019-0003", "agency": "HHS", "title": "Pain Management Task Force Meeting - May 9-10, 2019", "update_date": "2024-03-11", "update_time": "10:35:05", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Families for Intractable Pain Relief (FIPR) recommends adding a section to 2.7 to address the overlooked condition of constant severe intractable pain.  Individuals who have such pain do not experience remissions  frequent relapses.  The pain level is extremely severe  it is constant with no remissions.  Many of these patients have been treated for long periods of time with opioid pain medications at high doses  have experienced great harm since 2016 due to reduction or cessation of their opioid medications.2.7.9  Constant Severe Intractable Pain Constant severe intractable pain is defined as an excruciating, constant pain state without remissions that is not curable by any known means, causes adverse biologic effects on the bodys cardiovascular, hormone,  neurological systems, and leads to a bed- or house-bound state  early death if not adequately treated.  This category of pain differs from chronic relapsing pain (addressed in 2.7.5) in that there are no remissions at all; the pain is both very severe  constant.  Constant severe intractable pain can be caused by rare illnesses including adhesive arachnoiditis, some autoimmune diseases, Reflex Sympathetic Dystrophy (RSD) (also called Complex Regional Pain Syndrome (CRPS)),  genetic connective tissue disorders such as Ehlers-Danlos Syndrome  Marfan Syndrome.  Gaps and RecommendationsGap 1:  The existence of such pain is not widely accepted, which contributes significantly to its under-treatment.  Lack of awareness often makes these patients the victims of stigma  disbelief on the part of physicians.  These patients require comprehensive, compassionate palliative care which will likely require opioid pain medications, often at high doses, in addition to adjuvant treatments and therapies.  The goal of treatment is to provide life-long pain relief sufficient to normalize physiologic and mental function and enable the patient to independently carry out activities of daily living to the maximum extent possible.  Patients with constant severe intractable pain are often met with great hostility and resistance because they are, by definition, incurably disabled and will have to take opioids for a long period, probably for the rest of their lives.  In the absence of clarifying guidance about what to do with these seriously ill patients who have already tried and failed standard treatments, pain practitioners accepting such patients for care will be likely to tell them they must lower their opioid doses and essentially start over, requiring them to jump through hoops already tried and failed.  Recommendations:1a:  Educate physicians, pharmacists, law enforcement, and regulatory agencies at all levels to the fact that pain of this nature exists, is totally debilitating, and leads to early death if not adequately treated.  Endorse the long-term use of immediate or extended release opioid medications at whatever dose is required to manage the pain, when all efforts at standard care have failed.  Practitioners should continue successful treatment protocols for long-term stable legacy patients who have demonstrated that benefits exceed risks.  Practitioners should avoid mandating changes to treatment regimens that are succeeding, as changes in medication protocols, once a patient is stable, are frequently destabilizing and very harmful to these complex, often frail patients.1b:  Emphasize the following in educational efforts to combat stigma against these patients:oPatients who request a specific opioid medication almost certainly know what works best to manage their pain.  Such requests should not be construed as drug-seeking behavior.  Also, physicians should believe patients who report that a medication isnt working or intolerable side effects are being experienced.oSuccessful pain care of these patients is best measured by 3 outcome metrics:  1) pain control, 2) functional capability, and 3) quality of life as reported by the patient with confirmation by a family member.  A focus on MME is inappropriate as many of these high-dose outlier patients are limited in their ability to metabolize medications due to genetic variance, gastrointestinal malabsorption from diseases and surgeries, or dysfunctional receptors.oFor successful patients, months or years of effort have likely gone into developing the personalized treatment protocol that works.  In these cases, the best practice is to keep doing what works.  For these patients, the current protocol represents the pinnacle of individualized, patient-centered care.  Forced tapering or forced change in regimen brings about unnecessary suffering, disruption of life, and loss of quality time for patients who have already suffered greatly before finding their successful regimens.  Such forced change not only disrupts the lives of these patients during the transition, but may never result in outcomes as good as those produced by the regimen from which the patient is being forced to change. ", "comment_id": "HHS-OS-2019-0003-0388", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0388", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Kristen", "commenter_lname": "Ogden", "comment_length": 5266}, {"text": "May 5, 2019Re:  HHS-OS-2019-0003Subject:  Public Comment for the Pain Management Best Practices Inter-Agency Task Force  Thanks you for this final opportunity to comment on the Task Force draft report.  Dr. Singh, I read somewhere that you were encouraging patient and advocate input regarding patients lived experiences.  Our lived experience as a couple living with long-term debilitating illness was overall very good for many years.  However, unless something changes to remedy our current situation, our lived experience in the future will be unsatisfactory and quite bleak.  When my husband, Louis Ogden, and I wrote to the Task Force on April 1, we were about 6 weeks into the unfortunate and ill-advised process of trying to transition from his former regimen of high-dose OxyContin to an opioid regimen using injectable hydromorphone.  Now, at 11 weeks, we are both very dissatisfied, and we feel angry that this change has been forced on him.  The hydromorphone does not relieve his pain nearly as well as OxyContin, and the constant experience of pain up, pain down, pain up, pain down, all day every day is destroying his quality of life.  For 8  years, he enjoyed remarkably consistent pain relief 24/7 with no dose escalation.  This medication protocol, while considered extreme by some, gave him excellent pain relief with no significant side effects, greatly improved function, and a hugely improved quality of life.  We were able to travel (with accommodations, of course), he was able to do chores around home, and for the last few years he spent a lot of timing playing music and improving his skill playing guitar and electronic keyboard.  At this point, his ability to do almost anything enjoyable is greatly reduced.  He spends most of his waking hours sitting on the couch in a reclined position with his head propped on a pillow to try to minimize his head and neck pain.  Traveling even a short distance has become much more difficult and more painful for him.  He isnt really able to participate in chores or light yard work any longer.  While he used to enjoy playing his guitar or keyboard for 2 or 3 hours in a day, he can now only play for a few minutes at a time.  The personal satisfaction he gained from playing music, from being able to learn and progress in this creative outlet surely isnt important to the DEA or the Virginia regulatory agencies that have prevented us from being able to fill prescriptions for pain medications here in our home state.   He had found an extremely effective care regimen with the help of Dr. Forest Tennant, had accepted the limitations associated with his illness, and found music and other activities that made his life good despite the illness.  For now, at least, those days are over.Many among the current generation of pain care practitioners do not know nearly as much about treating severe intractable pain as the elder generation, and those older, experienced doctors are now being dismissed as out-of-date purveyors of improper care  because the well-funded anti-opioid groups, the CDC, the DEA, and state legislators say soeven though prescriptions written and treatments provided were totally legal and the results were very successful in the opinion of the patients and families affected.  It is a sad state of affairs when truly gifted physicians are deliberately discredited by the DoJ and DEA in attempts to reduce their influence.  We, and many other families in our situation, need your help!  Please adopt the proposed section 2.7.9 submitted by Families for Intractable Pain Relief that addresses constant severe intractable pain.  The failure of your draft to address such pain will mean that these patients will continue to lack credibility and will continue to suffer from inadequate care or reversal of their prior highly effective pain care regimens. You will have failed to thoroughly address gaps and inconsistencies in pain care policies and best practices, because you will have failed to acknowledge the existence of those who suffer the worst pain of all.  My husbands future quality of life will largely depend on the output of this Task Force and the actions Congress will take to implement the recommendations.  Please dont allow our lives to be ruined by failure to acknowledge constant severe intractable pain.  My husband and I, as well as thousands of other families, deserve better!Sincerely,Kristen D. OgdenCo-Founder/Co-Leader, Families for Intractable Pain Relief (FIPR)", "comment_id": "HHS-OS-2019-0003-0387", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0387", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Kristen", "commenter_lname": "Ogden", "comment_length": 4581}, {"text": "There is an astounding amount of misinformation, disinformation,  flat out lies going around about the so-called opioid crisis. The actual numbers are lower than what frequently appear in headlines; and for all the hysteria  hype, ALL drug deaths combined kill fewer than medical errors, influenza,  far, far fewer (orders of magnitude) than heart disease, cancer, tobacco, hypertension, and many other conditions (CDCs own data). Prescription opiate pain meds do not, and have not, caused the crisis; the number of prescriptions have plummeted since 2011, but the number of opioid deaths has gone up considerably. This is because the overwhelming majority of ODs are due to illegal drugs, NOT prescriptions. And unlike alcohol  tobacco, pain meds play a vital part in allowing millions of pain patients to work, function, and live decent lives. The primary actors in creating the hysteria were the members of PROP; their lying PROPaganda campaign has led to the destruction of millions of lives, caused post-surgical  injured patients to be literally tortured, and millions to die in unnecessary agony. They created this hysteria because they have earned vast amounts of money --and power-- from it. I have multiple chronic pain conditions,* one extending back to the 70s. I was first advised to apply for disability by my long-term neurologist in 1988; I was able to continue working until 2011 with responsibly prescribed pain meds. I have never abused them, sold them, or done anything nefarious with them. I now have ZERO pain meds; my doctor cut me off because of the opioid hysteria, not because of anything I did wrong or any negative impacts I had from the pain meds. I now am nearly completely unable to function or care for myself. Merely changing the sheets can put in me bed for days. I worked in basic medical research for many years: I can read and evaluate medical and scientific journal articles and facts. And the facts are, there is no scientific, medical, or simply sane reason for this witch hunt of pain patients. There is no opioid epidemic outside of the minds of hysterics and PR-hungry, greedy liars, like Andrew Kolodny, Jane Ballentyne  their ilk. The CDC has been silent for far too long about the impact of the supposedly voluntary guidelines. The guidelines have become weaponized. The DEA is attacking  closing down the few remaining clinics and doctors who are still willing to treat pain patients, probably because its a great deal easier to look up a doctors office in the phone book than it is to track down illegal drug dealers. Plus the doctors have all that money sitting in easy-to-access banks, again unlike the drug dealers. This has become an Age of Institutionalized Sadism. Millions have been forced into unspeakable, unnecessary agony. This trend MUST be stopped. This illegal, immoral, and cruel national crusade to torture this countrys own innocent citizens will go down as one of the most shameful periods in our history. I hope it will be history soon, because thousands of pain patients are killing themselves because their doctors have abandoned them. Also, the suicide rate among veterans is appalling, at least partially due to them losing their pain medications --again, FOR NO REASON other than GREED.My mother was forced to die in unspeakable, untreated agony when she died of leukemia. No doctor would give her any pain relief even though there was absolutely no question she was dying. Her monstrously hideous death did not save one single recreational drug user from using a drug, or from ODing, or from anything else. This story is being repeated daily. Please, stop this madness and reverse the diabolical trend of the torture of innocent civilians  veterans; because it IS pure torture. *intractable migraines, CRPS (post-surgical), SI joint deterioration, upper back injury, severe carpal tunnel, congenital leg deformity, fibro, severe GI attacks. ", "comment_id": "HHS-OS-2019-0003-0071", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0071", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Kelly", "commenter_lname": "Howard", "comment_length": 4092}, {"text": "I benefited  greatly from the Opioid medication my Nurse Practitioner Primary Care Provider prescribed me. I chose Tylenol/Codeine instead  of Hydrocodone due to abdominal sensitivity, voluntarily.  For the short time I was approved  a prescription.  She withdrew the prescription from me.  Due to the pain contract rules.  The pharmacy did not fill the complete amount of  pills to cover the months supply. Having run out of medicine and in agonizing  pain.  I used a an old prescription of Hydrocodone. I was given at the Hospital Emergency Room prior to the new pain Prescription..  When given the random U A at my clinic.  although I informed the technician.  Due to this my pain contract was terminated. This happened nearly three years ago.  Although i appealed it I was denied.  I had to endure at the time seven months of agony with screaming pain.  While my right hip deteriorated into mush.  I was at the verge of suicide.  Believing in a greater power that i was what kept me alive.  And i made it through a total hip replacement.  even though I endured the torture I had to go through.  I am still to this day living the torture of no relief for my double form of chronic pain. Arthritis on every joint the cause of hip joint disintegration.   and Fibromyalgia the cause of chronic pain on every fiber nerve and muscle of my being.  I am a self sustaining person.  i cant help but think.  How much longer can I hold on?  How much longer will i be able to continue earning my own living?  Managing my Chronic pain with no help  means bearing with it for me!  How much longer can i live with pain before I totally brake?  Speaking for my self and the millions of people through out our nation suffering chronic pain.  In some cases, the only thing that allows us to experience a somewhat normal life is Opioids. Let our doctors treat our pain without fear of retaliation by the DEA! CDC Guidelines should be just that...Guidelines! Not the law... so dont treat them as such! Establish clear guidelines for Chronic Pain Patients that allow us to be treated by out Pain Management Physician and not by the government!  Please take away patient restrictions such as contracts which treat us like we have commited crimes and are on probation or parole.We are not ADDICTS! Our doctors are not DEALERS! ", "comment_id": "HHS-OS-2019-0003-0080", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0080", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Iris", "commenter_lname": "Ayala", "comment_length": 2342}, {"text": "I have had two failed back surgeries,  had breast cancer and chemo, the chemo has played havoc on the nerves in my legs.  Without pain medication I would be in a wheelchair.  I have also been getting injections in my back and neck for the last 12 years, along with the pain meds I can walk.  Some days are still worse then others.  Basically  I feel the government is getting involved where they shouldnt.   They should not be able to make a decision on my medical care or the medication that I take.  That is between me and my doctor.  Period.  I am not addicted,  I use my medication to get me through my life and I dont feel that is unreasonable, I do not feel anyone besides my doctor should have a say so on my care.  We pain patients should not have to suffer because you guys cant get control of the illegal drugs coming from other countries.  We should not be treated with disrespect either because of our medication.   You are treating us very unfairly and its not right. ", "comment_id": "HHS-OS-2019-0003-0078", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0078", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Christy", "commenter_lname": "Ashford", "comment_length": 1001}, {"text": "Im a 39 year old female with Ehlers Danlos Syndrome. Im currently fighting for my life because I have intractable pain thats  under-treated. I was barely able to do normal day to day activities before I began opioid therapy 10 yrs ago. I have both c and l spine disk herniations with nerve compression in 2 areas. I systematically tried every non opioid medication and alternative therapy before deciding to take long-acting oxycodone. It literally saved my life and I began to actually function like a normal person! I did some substitute teaching, was able to finally be active with my family, made and sold my artwork, etc. For Joint-type EDS,   PT strengthing exercises are the main treatment and I am proud to say I did so well with these during opioid therapy, I was asked by 2 ppl if I was a trainer! A year and a half ago, my trusted pcp was told to refer me to a pain specialist b/c of the cdc guideline. Once in pain mgmt, I was force-tapered down to 1/5 of my therapeutic dose, again, due to the cdc guidelines. I am down to 95 lbs and have been struggling to do basic housework and self care. My joints are dislocating more frequently due to destabilization as I cant do my pt strengthing exercises due to pain. My specialist can not safely do injections as the nerve compression is in the thoracic area, making it a high risk for lung puncture.  My life felt full of potential and hope, now I actually wonder if Ill be able to continue. I have little energy left after continually dealing with relentless pain.", "comment_id": "HHS-OS-2019-0003-0327", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0327", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Carrie", "commenter_lname": "J", "comment_length": 1523}, {"text": "I am a 58 year old divorced mother of 4 adult children and 7 grandchildren. I will never be able to come even close to performing, functioning or have the mindset I once did prior to the implementation of the 2016 CDC guidelines! Im experiencing abandonment of care! I no longer have access to the instrumental tools, medications that I need for functionality and any semblance of quality to my life! I have called well over fifty different pain management clinics and cannot get into one!This has been horribly debilitating painful illness not being able to have access to the medications that wants help me function  and  engage in life the pain causes me extreme depression, frustration, sadness among a gambit of other issues!I suffer and endure incurable deep-rooted, ceaseless, recurrent, obstinate,  ever-present, incessant, continual, lasting persistent, deep-seated  AGONIZING, pain, miser, torture, torment,  tormenting, hurtful stiffness, soreness, burning, agony, throbbing, piercing, Sharp severe caustic extreme intractable/chronic pain due to arachnoiditis, stiff person syndrome, fibromyalgia, lupus, Parkinsons disease, arthritis, anxiety, depression, insomnia...This journey this path is incomprehensible for individuals who do not have intractable/chronic pain, 24/7,  365 days a year to understand!My life and standards of living are incredibly compromised!In addition, the collateral damage that occurs due to our inability to function, perform, engage in normal tasks/functions  that a parent, grandparent or employee should  functioning member of society would do our children our grandchildren our workplace do not get the quality and quantity of care and attention that they should!The individual I once was no longer exist the person that was able to go to work, engage with family, friends, interact with life and sustain a sense of normalcy is goneI suffer with cognitive difficulties or fibro fog, headaches, sensory sensitivity, exhaustion, muscle tightness, digestive issues, and disabling pain, anxiety and depression I never feel good, lack of control, grief and worry, immune dysfunction, chest pain, inflammation, insomnia, memory loss, my body is now overly sensitive to, well, pretty much everything! Its not that I am emotionally over-sensitive its a psychological thingSince the implementation of the 2016 CDC guidelines my life has literally declined 98%. In all respects financially, health related, depression and biggest loss is the quality and quantity of time I was able to spend with family is all but gone!I no longer can work, engage outside my home in any capacity! My standard of living is well beneath the poverty standard now and Im in the process of potentially losing my home of 32 years! All of this because I am not able to have access to the essential tools/medications that I need for functionality and any semblance of quality to my life!The pain is so bad I isolate in my room as not scare my family to the horrible struggles I am going through! This is not living its barely just existing! In such a short amount of time my life went from being engaged and happy in life, and being a functional member of society giving to thy fellow man advocating for individuals with autism... to barely existing and living in a painful tortuous hellthis is not living!I would in a hot second absolutely waive any liability in any way shape or form to receive my lifesaving, life-enhancing and life enriching tools/medications back! It is worth any kind of side effects or consequence to my health! Not having my tools/medications is a death sentence! My organs are starting to shut down, being in constant, continual pain leads to depression and premature death! When drug addicts use/take drugs their lives declinespiral out of controlWhen a intractable pain patient uses their tools/medicationsTheir functionality and semblance of quality returns to their lives!Huge difference!Can not compare the two!Intractable pain definition, Intractable pain, also known as Intractable Pain Disease or IP, is a severe, constant pain that is not curable by any known means and which causes a bed or house-bound state and early death if not adequately treated, usually with opioids and/or interventional procedures.Intractable pain - Wikipedia, 2017I currently have a list of suicides due to pain of 300 + more in the realm of 400 these individuals took their lives because of the Insidious, constant, never ending, tortuous pain they felt 24 7, 365 days a year every minute of every day! Data from the CDC itself reveals that there is no relationship between rates of opioid prescribing and rates of opioid overdose-related mortality... and there never has been.  Yet the CDC is refusing to analyze its own data or to conduct an outcomes study for the horrendous results of their deeply flawed and biased 2016 guidelines. ", "comment_id": "HHS-OS-2019-0003-0245", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0245", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Cathy", "commenter_lname": "Kean", "comment_length": 5055}, {"text": "Pain is relentless Pain is cruel It doesnt discriminate It can happen to you!Everyone is just one car accident, surgery, illness away from living the rest of their lives in torturous, stabbing, burning, caustic, incessant intractable pain!Believe me this is a Journey you do not want it is literally hell on earth!In memory of those in the intractable pain Community who could not handle their pain anymore due to the 2016 CDC guidelines! Please give us back our tools, medications that give us functionality and any semblance equality to our lives! Without are medications it is a death sentence and torture!Suicide due to pain videos I have 7 more plus I have to make so many morehttps://youtu.be/CSkxF1DMQwshttps://youtu.be/0ACgV0aLIAkhttps://youtu.be/hRGECrgVPskhttps://My story published in pain News Network describes my journey!www.painnewsnetwork.org/stories/2018/7/13/living-with-a-beast", "comment_id": "HHS-OS-2019-0003-0149", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0149", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 986}, {"text": "This is my story of how the opiate hysteria has effected my life.My story is twofold. I lost my husband to suicide 5 years ago due to untreated pain. Every day of my life and others who loved him have been affected. I couldnt save him. I hate myself for not doing something to somehow help him but I went through every legal avenue I had before me.During the time following his death, I have had such a difficult time finding a doctor who would prescribe my anxiety/seizure medicine, I was in the ER with seizures and have had increased psychiatric issues. I developed PTSD after witnessing my husbands suicide. Then further traumatized by lack of treatment over the last 5 years.I have an autoimmune disease, peripheral neuropathy, Fibromyalgia, Pernicious anemia, Hashimotos, among other conditions. Long qt, (but still given medicine that is dangerous with this condition)The straw that broke the camels back for me and beginning to standing up for pain patients started a few months ago.I suffered 2nd  3rd degree burns over 5% of my body. I was taken by ambulance from my local hospital to a special burn unit. I was treated by having it scrubbed without adequate pain relief, given some Bactitracin and bandages and told how to care for it.I didnt realize I was released without pain meds until half way through the 2 hour ride home. I began to have pain again after the meager relief I had in the hospital. I looked at my paperwork and saw take Ibuprofen for pain.I immediately sent a message to my concierge doctor whom my family paid an extra 175$ a month for specialized treatment. She already knew about my accident and  I was going to be driving past her office.She refused to see me or prescribe anything besides Ibuprofen. No advocacy at all. I felt abandoned.I got home and cried almost non-stop. I contemplated suicide.I didnt sleep more than 5 minutes at a time.I have never experienced this level of pain. I have nightmares about it.After a week of this my fiance called the burn unit and was irate. The nurse who he spoke with was apologetic for releasing me without pain medicine. She told us to come back and she would personally advocate for me. I sat in the ER for 2 hours but was admitted to the special burn unit.I couldnt walk on that leg. I hopped to the bathroom for week.I was apologized to and treated well by the nurses at the hospital. I was released with a weeks worth of pain meds.I went back a week later to be lectured by the doctor that I couldnt be in that much pain and if I was still taking pain meds it was in my head. To be clear I had only had opiates a few times in my Iife. After my C-sections and a few times over the years for a kidney infections. I never went back. I fired my doctor and on top of it all, I was charged for another month of concierge medicine !I dont leave my house, I am pain most of the time over a 7 and rarely get below a 6. I cant walk very far. I gave up my drivers license. My agoraphobia which had been getting better since my husbands suicide is worse than it ever has been.And I still dont have a family doctor.The photo is a day after the burn injury. My buttocks, thighs and pernium were also burned.", "comment_id": "HHS-OS-2019-0003-0400", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0400", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3421}, {"text": "I have to say 1st how miserable my life has become. Jan 2019 started out to be the best year. It was supposed to be my year to get back to work. Started off after getting 2major health concerns dealt with. Then onto Going back to work. I left the work force in 2018to care for a parent after a full health crisis in 2017 where my attention was focused on my mom and 1of my children. 2018was spent developing a care system for parent and getting back on top of my health. Even after 2016 guidelines were in place, my doctor working with me agreed to a treatment plan. One which included pain medication. I had always been active and daily did every aspect of physical therapy I was taught. Had previously tried every aspect of alternative treatment. Not helpful , at least not without also using pain meds in conjunction. I have spent more money out of pocket for failed treatments,braces,and devices. I was stable on meds. Then February came and new insurance. From day 1of this new insurance, BCBS, its been hell to continue my prior treatment. But worse has been the sudden shift in treatment by my doctor. Not once had I actually been told why my treatment was changing. For3 months I have suffered and been lied too. This opiod hysteria caused good doctors to now become liars. And good forbid 1shred of honesty come out. My doctor and I had a plan, was completely fine, then 1,pill a day was gone. Then 2pills a day are gone. My quality of life now so low. Ive not been able to keep up with housework, let alone go back to work. Open communication with my doctor is gone. Cdcs recommendation of making sure patient is stable during pill reductions, a joke. My doctor now does not care. Not even when I called daily for 2 weeks worried about my blood pressure. Only after reaching out to a different Dr. Did I get attention from my doc. Even STIll she take my concerns seriously and hastly choose a BP med that I cant take. The only sane and rational help has been from my pharmacist! Meanwhile my life and health decline do to under treatment and everything is passing me by. And my doctor doesnt care, because its easier to not deal with BCBS. Oh but our pain MGMT doc who abandoned pain PTs will now treat SUD, and my doc will manage with MMJ, both of which will be cash only. Insurance needs to be charged endangerment of patients. And doctor needs to be told to give me back some quality! I Need To Go Back To Work!  I still cannot believe this was allowed to happen, since when does insurance company have the right to tell a doctor how to or not to treat. Please, hear me. Please Help.", "comment_id": "HHS-OS-2019-0003-0087", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0087", "comment_date": "2019-05-15", "comment_time": "04:00:00", "commenter_fname": "Natalie", "commenter_lname": "B", "comment_length": 2653}]}, {"id": "FDA-2017-N-1094", "agency": "FDA", "title": "Training for Opioid Analgesic Prescribers--Exploring the Path Forward", "update_date": "2017-08-25", "update_time": "16:17:17", "purpose": "Nonrulemaking", "keywords": ["2017-76", "Training for Opioid Analgesic Prescribers"], "comments": [{"text": "Dear Dr. Throckmorton,Lets go back in time for a minute and recognize that FDAs ineffective warning, regarding the dangers of corticosteroids used to treat back pain, continues to result in unsustainable numbers of catastrophic injuries throughout the country - and the legitimate need for opioids for adhesive arachnoiditis patients (including misdiagnosed cases of Fibromyalgia).  As we both know, the topic of pain is complex (and not what it appears) as underlying profit motives have skewed accurate statistics.    On the National debate: Federal OWCP is willing to authorize reimbursement for repeated, high risk epidural steroid injections.  Ron Angel was offered ESI treatment indefinitely for his low back pain (approx. $2000 per injection).   Ron also suffered an OTJ cervical spine injury, now a retired wildland fire fighter: https://www.painnewsnetwork.org/stories/2015/10/21/jumping-from-fire-into-federal-work-comp-nightmare For the record (again), the most commonly used corticosteroid used for back pain is Pfizers Depo-medrol.  Below is the link to Pfizer/New Zealand Depo-medrol datasheet:  http://www.medsafe.govt.nz/Profs/Datasheet/d/Depomedrolinj.pdf Please note top of page 7:  Depo-Medrol may be used by any of the following routes: intramuscular, intra-articular, periarticular, intrabursal, intralesional and into the tendon sheath. It MUST NOT be used by the intrathecal, epidural or intravenous routes (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE EFFECTS). And bottom of page 18:  ADVERSE EFFECTSAdministration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, headache, functional gastrointestinal disorder/bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site. FDAs warning has not changed the harmful standard of care for back pain, or the problem of injured worker coercion to undergo high risk, high cost injections:  https://www.fda.gov/Drugs/DrugSafety/ucm394280.htm We have reason to believe that FDA sold out to the interests of professional medical societies and large corporations (Pfizer).  Arachnoiditis is grossly misdiagnosed for fear of legal liability;  adverse events are under-reported/not reported to FDA for same reason.  Check out the comment written by Dr. Laxmaiah Manchikanti,  Chairman of the American Society of Interventional Pain Physicians in Pain News Network blog:  https://www.painnewsnetwork.org/stories/2015/8/19/experts-say-epidural-injections-overused Laxmaiah Manchikanti, MD 2 years ago Pending Awaiting Moderation  1 likeThis is a very interesting perspective; however, there appears to be significant misinformation. All in all arachnoiditis is a significant problem which has been missed by multiple governmental agencies as well as physician organizations. It will not go away by ignoring it. All parties have responsibility. It can be avoided by utilizing alternate techniques, alternate drugs, and finally patients must also share responsibility. In the United States, no one can force anyone to have a procedure. Further, each and every patient should be educated about and understand the risks and benefits of any and all procedures and physicians should explain to them that steroids are an off-label use. When you add up the error rates and multiply the estimated numbers of ESIs administered annually, you start to realize the magnitude of the problem.  This cumulative trauma impacting the American public is not sustainable  -- and little is being done to address medical malpractice taking place across the country.  Both FDA and CDC are disregarding this public health crisis. Lets face it:  these agencies are run by politically appointed administrators.  Dr. Tennant should be leading discussions on long term intractable pain conditions at FDA.  Instead, the view is lop-sided, thanks to the likes of PROP, Ballantyne, and Sullivan:    https://www.painnewsnetwork.org/stories/2015/12/10/controversy-grows-over-journal-article-on-pain-treatment  On the Montana Front - please familiarize yourself with these egregious cases: https://www.painnewsnetwork.org/stories/2017/5/26/patient-suicide-blamed-on-montana-pain-clinic https://www.painnewsnetwork.org/stories/2017/5/18/patients-allege-mistreatment-at-montana-pain-clinic https://www.painnewsnetwork.org/stories/2017/5/19/montana-urine-tests-sent-to-bankrupt-drug-lab http://mtpr.org/post/pain-helped-him-pull-trigger Unsuspecting back pain patients are pushed into harmful procedures then end up with permanent injuries and chronic pain for the remainder of their lives.  Corporate decision makers deny these injuries and abandon them in their time of need.  Weve been here done this. Submitted on behalf of Arachnoiditis Awareness and Prevention A.S.A.P. ", "comment_id": "FDA-2017-N-1094-0251", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0251", "comment_date": "2017-07-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5323}, {"text": "Please start over with appropriate CDC guidelines. Doctors need reassurance that it is safe to help chronic pain patients,Preventing suicides in opiate refugees. We must help patients who have become dependent on opiates over the last two decades. Some cannot wean off opiates. In my home state of Montana, there is a hostile regulatory environment for doctors who help pain patients.  ", "comment_id": "FDA-2017-N-1094-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0018", "comment_date": "2017-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 411}, {"text": "This is crony capitalism!  Why are we attacking law abiding citizens using narcotic pain killers with government intervention?  If the pain patients dont get their treatment from a doctor they will get it from a dealer.  Heroin use will go up if we restrict pain medication for patients.  Great for big government jobs for all the law enforcement involved in the war on drugs but terrible for the patient.  This is just like gun control where overzealous idiots try to take guns from law abiding citizens to reduce gun ownership by criminals and it NEVER WORKS!  Get big government out of the doctors office; these people went to school for YEARS and they know better than government agencies what their patients need.  If you support restrictions on patients pain medications I hope you die a slow and painful death yourself so that you become a victim of your own legislature.  Doctors and patients dont need the government counting their pills.", "comment_id": "FDA-2017-N-1094-0050", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0050", "comment_date": "2017-05-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 957}, {"text": "Hi again.  The past few months I have been slowly buying things to make artisan soaps.  I have been on SSI for years with my autistic daughter.  I want to DO THINGS!  BE PRODUCTIVE and give back!   If I have to sit in a chair and cry all the time, how could I possibly live?  No human wants to do nothing and be in constant pain.  This kind of pain never goes away.  No, I would never kill anyone, but this kind of pain is relentless.Brodericks neighbors told the Review Journal that he was a husband and father of two, who mostly kept to himself but had a friendly wave. One neighbor called Broderick a really nice gentleman who complained of back pain.He used to talk about taking pain pills, said Welborn Williams. He couldnt get any sleep at night.Brodericks Facebook page reveals a man who loved fishing and was a gun enthusiast. Ironically, in 2012 Broderick recommended without comment on his page a story about an employee at a Las Vegas medical clinic who was shot during an armed robbery.The Review Journal reported that Broderick had a concealed weapons permit and five firearms. Williams said Broderick had offered to teach him about firearms.I hate to see anyone in pain like that, Williams said. But there should have been another way for him.https://www.painnewsnetwork.org/stories/2017/6/30/patient-shoots-two-at-las-vegas-pain-clinichttp://www.pharmaciststeve.com/An email received this week from a chronic pain activist: We just lost another intractable member of our support group two nights ago. She committed suicide because her medications were taken away for interstitial cystitis (a horribly painful bladder condition) and pudendal neuralgia, both of which she had battled for years. The nerve pain is equivalent to end-stage cancer pain, but the CDC and doctors in Colorado were merciless. She just couldnt hang on any longer without hope. She was just 30 years old.http://globalnews.ca/news/3571142/commentary-a-deeply-disturbing-email-begins-to-tell-the-opioid-story-for-chronic-pain-patients/Theres a difference between the people (who) need them and the people who are abusing them, Kain said.The CDCin 2016 released new guidelines that discourage primary care doctors from prescribing opioids for chronic pain. The guidelines were meant to curb the rampant over-prescribing practices of the past but may have also created unintended consequences. I dont walk with a cane. I dont have an open wound. Im not in a wheelchair, Kain said, adding that looks can be deceiving. Most of the time, shes stuck in her Pleasant Hill home trying to get through the day with excruciating back pain.http://www.kcci.com/article/has-opioid-epidemic-vilified-chronic-pain-patients/9970531", "comment_id": "FDA-2017-N-1094-0183", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0183", "comment_date": "2017-07-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2910}, {"text": "I am a chronic pain patient and it took over 8 months to officially diagnosis me.  I agree with training those prescribing pain medication both on pain and addiction signs.  I also agree with go slow and low but not making it LAW because think about my situation I have Complex Regional Pain Syndrome CRPS and if you make limits on pain medication a law by state I have to go every week to the doctor to get a new prescription, pay co pays every week, go to the pharmacy every week until officially diagnosed with chronic pain. This puts burdens on the doctors time and the patients time and money.  Most chronic pain patients take medication responsibly to ease the pain.  We arent taking it to feel good. There must be some subjectivity when dealing with pain.  The 30 day to now 3-7 days has been rectified, urine screens happen monthly, we go every month to the doctor as implemented.  The focus needs to be on illicit drugs on the street. Evidence has proved that prescriptions have declined while overdoses have increased.  Some insurances dont cover investigational treatments so your options are limited by insurance.  You cant put real pain patients into one box and you cant scare doctors so much they abandon patients because of too much oversight.  They are trained and if they arent get them to take an online course and if a patient needs to be in pain management get them to a specialist.  We must find a way to stop hurting real pain patients because we deserve care just like someone with cancer does and we also need to find a place for those suffering side effects of taking pain medication and get them help.  Stop hurting and start helping.  Id love for CDC and politicians making black and white rules to live just one day in my shoes.  Talk to the different chronic pain support groups, rare disease groups.  You must hear both sides and bring the pendulum back that has swung way to far in err of hurting pain patients.  ", "comment_id": "FDA-2017-N-1094-0086", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0086", "comment_date": "2017-05-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1987}, {"text": "Note I have RA, OA, fibromyalgia, degenerative  herniated disk (lumbar  cevical). Been on opioid 20 yrs this yr. I want to increase my meds from 4 to 5 a day. Instead I was given a stronger med 4 sa day. Stronger is not as effective as the one I was taking. Ive protested but Drs say cant prescribe more than 4 a day, so I suffer in silence. Afraid to upset the apple cart.", "comment_id": "FDA-2017-N-1094-0095", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0095", "comment_date": "2017-05-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 408}, {"text": "Sirs, I have been in pain management since 2003.  I have Osteoporosis which has caused scoliosis of my spine.  I also have spinal stenosis and herniated discs along with other spinal diagnoses.  Last year the doctor cut back on my fentanyl and the year before they cut my oxycodone for break through pain.  Now they want to cut my medication again because government knows better than my doctor.  Without my medication, I will be bed ridden.  In my lower back, my spine at L1 has completely disappeared. For those who dont know, your spine holds up your entire body.  With medication I can at least dress myself and do a few activities such as walking my dog.  Without it, I can do nothing.  I have never abused my meds nor given any away.  They are too precious to me.  I have always passed my drug tests.  I pray that none of you have to suffer the pain I have experienced but if you do, you better hope someone is there to help you.  Because well people abuse drugs, you are going to punish those who are helped by them.  This is so unfair.  Im afraid you will see suicide rates go up and you will probably see another epidemic of older people soliciting black market drugs to alleviate their pain.  I would much rather be healthy and drug free but since Im not I am so grateful for the doctors who understand my chronic pain and can help.  I ask you to reconsider the people like me who need these drugs to have some semblance of life.  One size doesnt fit all and the government isnt all knowing.", "comment_id": "FDA-2017-N-1094-0099", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0099", "comment_date": "2017-05-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1526}, {"text": "I have been suffering from degenerative joint disorder from the age of 23- I am now 47.  I have had 4 separate corrective surgeries on my spine- one repeat.  I have had three corrective knee operations.  I have Carpal Tunnel syndrome, bursitis in four joints, and OA in many.  I have neuropathy in my limbs and torso.  I have pinched nerves in or near my S/I joint.  As my pain increases, the dose and frequency of my pain meds decrease because my doctor is terrified of losing his license.  my teeth are worn down from gritting my teeth.  I get migraines that make me vomit.  I spend days and weeks in bed in too much pain to chew food.  but the doses and frequency continue to go down for fear of prosecution.  I have the scans of a woman twice my age, and still my doses go down.  They want to remove me from all opiates now.  I am on 10 mg of methadone a day (2 doses of 5 mg).  I have planned my suicide.  I have scheduled 6 surgeries this year.  if they do not remove all pain (they cannot, as half of it is from spinal trauma) I will follow through.  I plan on dying on your lawn.  It is time to stop this.  pain management is necessary for much more than just cancer and hospice.  I am traumatized.  I am not depressed.  I am merely incapable of continuing an existence no one would allow a dog to live.  I scream myself awake every night for months on end.  they cannot give me enough sleep medications to keep me out during the spasms.  please stop torturing me and people like me.  it is enough.", "comment_id": "FDA-2017-N-1094-0100", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0100", "comment_date": "2017-05-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1506}, {"text": "The FDAs draft curriculum is a step in the right direction and away from the corrupt and biased recommendations from the CDC. Their guidelines, they prefer to say, call for more cautious prescribing, but are having the effect of creating tremendous fear and panic in pain management practices and in patients, for no good reason. Legitimate and stable patients are being forced off their life-saving medications, and many are being fired from the practices for no other reason other than fear of the CDC guidelines.  Many practices are laboring under the belief that the CDCs recommendations apply across the board and have become the new standard of care. This is not even the stated intention, however,  it has become adopted across the country with draconian measures.  The FDA should reject everything PROP recommends. PROP is a commission, wholly-funded by the Steve Rummel Foundation, which is a completely anti-opioid group. Its leader, Andrew Kolodny, is well-known for his business relationships with Reckitt Benkiser, and their US corporation, Indivior, who is the manufacturer of Suboxone, Subutex, and Bupenorphine.  All of these into relationships show the financial benefit to these corporations and the rehabilitation industry of the CDC guidelines, and suggest such bias and collusion that the FDA must repeal the CDC recommendations and start over with a brand-new, qualified, and unbiased panel. It is well-known that of the three Core Experts, two of whom were epidemiologists and not physicians. Their field of expertise ranged from seat belt safety laws to preventing childhood obesity. Only one physician was considered a Core Expert, and while at least a practicing physician, had no experience in pain management. Their attempts to keep the core panel anonymous, their attempts to avoid open comments, the fact that they were ordered to redo the first set of guidelines and return with a different set of recommendations entirely - but essentially returned the same document - shows that there was a bias and an agenda from the beginning.  Many of their date it was flooded from the beginning as well. When all of the CDCs actions to avoid accountability, their questionable business relationships, and their unqualified experts are all taken into account, they create great suspicion.The entire CDC recommendations on opioid prescribing are tainted by the presence of so many who will benefit from moving patients (who are stable on opioids) onto anti-addiction medications  -  including the entire rehabilitation industry, of which Andrew Kolodny is a major player. This, combined with his relationships with the manufacturers of anti-opioid medications, demonstrates that each of the CDCs recommendation is fruit from a poisoned tree.  The WHOs ladder of pain management has worked in every country in which it has  been adopted.  Conversely, countries such as India, that banned the use of opioids, are now pleading for morphine, as their citizens are suffering  - while Portugal, who has removed all limitations on drugs, has one of the lowest overdose rates in the world. It is well-known by now that our overdose problem is not caused by those who use opioids for chronic conditions. Even the CDC itself admitted in March 2016 that, We dont have an opioid problem. We have a heroin problem. We also have new evidence that the rate of opioid prescriptions have decreased, but overdoses are rising. It doesnt take a panel to see that there is no correlation between legitimate opioid users and illegal drug abuse. This heroin/fentanyl epidemic, caused by the illegal importation of these dangerous drugs across American borders  is the true source of the increasing rate of overdoses. The CDC limited its studies to those studying the use of opioids for three months or shorter, ignoring the body of evidence that supports long-term opioid use for chronic pain.  They then said there was no evidence that supported the use of long-term opioids. This is disingenuous at best.  We are encouraged that the FDA has greater foresight and is planning to look at all the evidence, and not limit their own investigation to those studies that support their already-determined outcome.   Even the data itself is unreliable. From county to county, there are no consistent measures for determining a cause of death. We dont even have the same standards for medical examiners versus coronets. If we want to determine the cause of death, we have to start at the beginning with standardized requirements for suspected overdoses. Only when the original data is reliable can conclusions  be drawn. We urge the FDA to start there and work forwards, instead of allowing secretive panels to create income for special interests.  Also, please examine how the manufacturers of these anti-opioid drugs have engaged in illegal trade practices in the UK  United States, where they are being sued by 35 states for deceptive trade practices. ", "comment_id": "FDA-2017-N-1094-0197", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0197", "comment_date": "2017-07-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5117}, {"text": "I am a chronic pain patient and I am 77 Yeats old and have severe adhesive arachnoiditis, I have a pacemakerI have tried everything known to man in the last 30 years. Before starting opiates , they do help keep the pain down to a livable manner. I do depend on a higher level than the CDC has wrote we who have this disease should be put in the cancer pain level. As the pain is noted to be equal to bone cancer", "comment_id": "FDA-2017-N-1094-0209", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0209", "comment_date": "2017-07-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 416}]}, {"id": "FRA-2019-0071", "agency": "FRA", "title": "Drug and Alcohol Testing of Mechanical Employees\n\n\n", "update_date": "2022-07-20", "update_time": "14:05:26", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The control of alcohol and drug use should be enforced in every workplace and for every type of employee regardless of the type of occupation. There are many jobs in society that should require the responsibility and control of alcohol and druge use. Especially when it comes to mechanical employees or those dealing with more serious responsibilites on the job on as daily basis. In agreement, employees who are testing or inspecting railroad rolling equipment should be covered when it comes to the scope of alcohol and drug regulation. Regulated employees should definitely include any MECH employees in order to make sure that they are covered. If this issue is proposed it would help when it comes to accidents as well as fatal accidents to prevent or keep them from continuing to happen as often and if any do happen, these specific employees would be covered and included. This rule would also not affect environmental resources or increased emissions both directly or indirectly so there should be no reason these employees shouldnt be covered. ", "comment_id": "FRA-2019-0071-0013", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0013", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Alexandra", "commenter_lname": "Canaveral", "comment_length": 1053}, {"text": "I think this rule is necessary in order to make sure the use of ALcohol and drug is legal and will be regulated in any situation. The Mechanical employees and their rights to the previous acts have t be specified in this follow-up rule in order to make sure their rights of alcohol and drug use are legal and working correctly. This rule is giving clarification to many things involved in the previous acts published.", "comment_id": "FRA-2019-0071-0005", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0005", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Guangshi(stone)", "commenter_lname": "Chen", "comment_length": 417}, {"text": "I support this proposed rule. The opioid epidemic has become larger than we couldve ever predicted and its a sickness that needs attention and availability. This proposition to expand coverage and redefine regulation is a step in the right direction to addressing the issue directly and transparently.", "comment_id": "FRA-2019-0071-0010", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0010", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Joshua", "commenter_lname": "Cruzado", "comment_length": 311}, {"text": "This proposed rule follows basic common sense on this issue. The rule protects railway workers, engineers, and others as well as the general public. According to the rule, it also saves millions of dollars per year through its deterrence effects. This is a logical step to take to expand the FRAs Congressionally mandated program. It is important for those who are inspected rolling equipment to be in the most sober state of mind they can be while performing their duties, lest they risk not only their own lives, which is commented on in the proposed rule, but the lives of those in the general public if they fail to adequately perofrm their testing/inspection duties due to a substance abuse disorder. ", "comment_id": "FRA-2019-0071-0011", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0011", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 711}, {"text": "The work that the people do benefit the country so making it to where the people working the trains and insure that it works properly is beneficial so that they can do the work correctly so that commerce and public transport keep on flowing so the country keeps up with the demand of products needed.", "comment_id": "FRA-2019-0071-0009", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0009", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Ashtyn", "commenter_lname": "Bombala", "comment_length": 300}, {"text": "Comments related to Docket No. FRA-2019-0071 Safety-sensitive jobs in relation to Medicinal cannabis use has been a hot topic in legislation. I was recently asked how it made me feel to be an advocate and so open about my medical cannabis treatment?  How has it affected my life? I chose to become a nurse because I love to take care of people. Its my passion and gives me purpose, to care for others and uphold the oath that I took. I have been left with this hollow feeling inside accompanied by waves of mourning and frustration. I  continue to advocate for those like myself who either cant Medicate or suffer the repercussions of it. When the topic comes up hows it affected my life and others seek to help me find solutions to my problem my response is usually to this effect:I couldnt continue to contribute to the decline of the quality of life of Oklahomans at the hands of Oklahoma healthcare in order to obtain a paycheck all the while being scrutinized for my methods of medicating which is much safer and effective when properly maintained and managed. One mistake and a positive drug test for metabolites would immediately flag me for drug abuse and treatment and have to go before the board of nursing in order to gain back licensure. I was passive-aggressively threatened by an employer whenever I brought up cannabis use for the patients that I was caring for and that we should be supporting them and educating them.  I mentioned that theres a degree of liability here as well. The response I was given was nurses who medicate are the only liability so I nodded my head and  turned in my resignation letter 3 days later due to extenuating personal circumstances as well. There are other workforce concerns that go greatly unaddressed while medicinal cannabis remains a negative focal point burn out, lack of adequate sleep, pharmaceuticals etc which completely overlooked.  Stress and each individuals tolerance in managing has a great impact on their work and safety of them and those their work affects. Programs like Predictive Safety mentioned  in the article below should be utilized by employers to monitor changes in ability to perform safely. https://tulsaworld.com/opinion/columnists/lawrence-pasternack-medical-marijuana-and-workplace-safety/article_a55493d6-fed6-522e-b743-191002d46d71.htmlConsider the following about stress and as an example the effects of working under safety sensitive conditions. According to The American Institute of Stress:About 33 percent of people report feeling extreme stress77 percent of people experience stress that affects their physical health73 percent of people have stress that impacts their mental health48 percent of people have trouble sleeping because of stressThose in safety sensitive positions should be able to medicate freely on their own time without fear of judgement or retaliation. Cannabis and all of its metabolites should be removed from workplace drug testing as it is an out dated resource and only contributes to stigma. Our bodies hold onto THC in fat cells while other drugs that cannabis is often compared to metabolize within a few days. The reason our bodies hold onto cannabinoids is simple and inarguable. Our bodies want it, need it even. The presence of metabolize does not indicate that there is an active impairment. The people who fall under this category are in some of the most mentally and physically taxing jobs because they are safety sensitive and would greatly benefit from medicinal cannabis after a long stressful day at work. According to the report, 15.6% of all nurses reported feelings of burnout, with the percentage rising to 41% of unengaged nurses. Whats really interesting as well, is that 50% of nurses who reported feeling burned out also reported that they had no plans to leave their organizationpointing to the importance of supporting and meeting nurses where they are at in the workforce.PTSD is an occupational hazard for nursing. It is estimated that up to 14 percent of the overall general nursing population experience symptoms that meet the criteria to be diagnosed with PTSD, which is 4 times higher than the general adult population.  The  stigmatic bias and disregard for the many medicinal qualities of cannabis by many of our leaders is the root of the problem. I am a nurse and patient and have seen and heard hundreds of testimonies from people some would consider to not be using medicinally.The fact is that medicinal cannabis is the most safe and effecive treatment option for most of the people who medicate. These people have tried traditional methods of treating their problems only to end up with more complications both short term and long term. As a medical professional it is of utmost importance that I hold tight to my oath to cause no harm and continue to advocate for medicinal cannabis use where it is applicable and reasonable. ", "comment_id": "FRA-2019-0071-0008", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0008", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Kara", "commenter_lname": "Mccurry", "comment_length": 5113}, {"text": "Given that railroads have such an impact on our nation and communities via general transportation and supporting our economic system. It is obvious that the FRA should expand its scope of alcohol and drug regulation to cover mechanical (MECH) employees who test or inspect railroad rolling equipment. Also, the fact that two MECH employees have passed due to related events furthers the argument that something needs to be done. ", "comment_id": "FRA-2019-0071-0016", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0016", "comment_date": "2021-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 434}, {"text": " DOCKET NO. FRA-2019-0071 Posted by the Federal Railroad Administration (FRA)Control of Alcohol and Drug Use: Coverage of Mechanical Employees and Miscellaneous AmendmentsSection:  II Mechanical Employees, Contractors, and SubcontractorsDear FRA,I am writing regarding the proposed rule revisions to FRA Regulations (49 CFR, Part 219). This rule will require random alcohol and drug testing to expand to contractors and subtractors working in the Maintenance of Way (MOW).  Before June 12, 2017, only the regulated mechanical employees required pre-employment, post-accident, and random drug and alcohol testing.  I support the revisions because these contractors are equally responsible for inspecting the railroad equipment and tracking their signal and communication systems.  Train accidents are happening every 3 hours in our country.  This data covers railroad employees, distracted drivers, and lack of proper warning signals for pedestrians and drivers. When an employee becomes involved in a railroad accident, they must provide a specimen within 4 hours unless immediate medical treatment is required.  If the worker is delayed based on injuries, an on-duty supervisor must provide documentation to the administration explaining such.  The different agencies can go to the FRA website to view the mandated requirements for stand-alone or random drug and alcohol testing. These random screenings are performed quarterly on their roadway workers.  The testing is divided into two separate categories, 50% involves testing for drugs and the other 25% involves testing for alcohol usage for annual records. In closing, my position remains to support the proposed rule that alcohol and drug screening be expanded to all roadway workers.  Hopefully, this will eliminate some percentage of tragic accidents that we often hear about regarding individuals losing their lives or life-threatening injuries, trying to outrun a train when approaching the railroad tracks.  The clients in my treatment program are placed on a daily call-in for random drug and alcohol screening.  The outcome of relapsing seems to decrease in numbers because of accountability.   Therefore, the duties of a railroad worker who repairs our bridges, tracks, and roadways should be accountable for the safety of keeping themselves, our citizens, and co-workers unharmed if preventable.  ", "comment_id": "FRA-2019-0071-0018", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0018", "comment_date": "2021-04-13", "comment_time": "04:00:00", "commenter_fname": "Helen", "commenter_lname": "King", "comment_length": 2457}, {"text": "I am for this proposed rule since it provides a safer work environment for mechanical employees.  If I was an employer, I wouldnt want my employees to the intoxicated or under the influence while dealing with machinery or equipment. It can lead to accidents especially if the equipment was dealt with improperly. Under executive summary, It explains incidents that led up to the revision of alcohol and drug regulation. These incidents either caused an injury or death for mechanical employees. If frequent drug tests became a necessary precaution, it will help prevent these kinds of incidents from increasing.  ", "comment_id": "FRA-2019-0071-0015", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0015", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Nadia", "commenter_lname": "Legorreta", "comment_length": 618}, {"text": "I think the clarifying of the Support act is a move that is necessary in order to cover more or fewer people. This explanation and clarification on mechanical employees is necessary and must be addressed in certain situations. I would encourage this proposed rule in order to create better environment for the control of Alcohol and Drug use, make it clear and specific to everyone.", "comment_id": "FRA-2019-0071-0004", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0004", "comment_date": "2021-03-10", "comment_time": "05:00:00", "commenter_fname": "Guangshi(stone)", "commenter_lname": "Chen", "comment_length": 382}]}, {"id": "FDA-2010-D-0350", "agency": "FDA", "title": "Tobacco Retailers on Tobacco Retailer Training Programs", "update_date": "2023-05-04", "update_time": "09:45:01", "purpose": "Nonrulemaking", "keywords": ["ctp", "tobacco retailers", "tobacco training programs", "2017-344", "0910-0745"], "comments": [{"text": "A Smoke Free Paso del Norte is an initiative funded by the Paso del Norte Health Foundation established in 1999 with a goal to eliminate smoking in the three state, two country region. Since 2006 The University of Texas at El Paso has served as the backbone organization for the smoke-free initiative. ", "comment_id": "FDA-2010-D-0350-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0019", "comment_date": "2016-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 302}, {"text": "Please dont take our flavors away!  6 people n my family habe quit smoking by vaping.  We all breathe better, no respiratory infections, bronchitis or COPD n the past 3 years. Doctors r happy we r n better health because of VAPING.  Please keep legitimate vape shops open so we live longer and enjoy our lives without having lung/breathing issues.", "comment_id": "FDA-2010-D-0350-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0030", "comment_date": "2019-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 352}, {"text": "I agree with beginning with this guidance for tobacco retailers on tobacco training programs. It is a small step in improving public health and the guidance for tobacco retailers is a great start. Monitoring and educating children, and adults alike, that choose to vape, smoke, or chew tobacco make them high risks of developing minor and major health deficits in latter years. Educating employees to educate the consumer on e-cigs, nicotine use, and health could positively impact the over-all health of people who smoke, dont smoke, and want to quit. The FDA currently features Lung Illness Associated with the Use of Vaping Products. Because vaping has become a popular fad with children and young adults, targeting the working population of the industry could benefit the consumer to make an educated judgement on purchasing these products.Thank you for your time.", "comment_id": "FDA-2010-D-0350-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0028", "comment_date": "2019-12-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 893}, {"text": "In the second paragraph of the background portion of this article, when it states: (3) written company policies against sales to minors and other restrictions on the access to, and the advertising and promotion of, tobacco products;, I believe that this said training that is going to be taking place is something that could be very good for minors who are getting addicted to tobacco. Due to the fact that there have been multiple companies targeting minors with the use of fruity flavors in their tobacco products, I strongly believe that we should use any means necessary to train/guide tobacco retailers in the way of putting them through training and giving the employees a written test before they are allowed to sell tobacco products.", "comment_id": "FDA-2010-D-0350-0029", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0029", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 741}, {"text": "We support FDAs goal of addressing education among tobacco retailers about compliance and enforcement of The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We recommend that: 1) As planned, encourage all tobacco retailers have a basic program that meets FDA proposed educational standards. Currently no requirement exists for retailers to implement education among their employees about compliance or enforcement of the Tobacco Control Act. An incentive to do so exists only if retailers have a documented violation of the Tobacco Control Act and want to avoid resulting fines.  2) FDA could consider additional methods to provide an in-person educational training to tobacco retailers that receive citations for violating provisions of the Tobacco Control Act. We believe that if the FDA developed and implemented an in-person retailer education training program for those that have received citations, it may increase retailer compliance with provisions of the Tobacco Control Act. This is particularly true for retailers who may not allocate sufficient resources to their own retailer educational programs. Also, rather than relying on retailers to learn about the details of the Tobacco Control Act themselves, FDA may be ideally positioned to provide education to retailers. This is particularly true for lesser-known provisions of the Tobacco Control Act. For instance, while most retailers may be aware of the minimum age of sale, other provisions of the Tobacco Control Act (e.g., existence of self-service displays and vending machines) may be less obvious and therefore less likely to have compliance at the retail level. Evidence of this is found in publicly available warning letters, where the majority of warning letters from advertising and labeling inspections are for self-service displays [1]. In-person education to tobacco retailers that receive citations could help retailers better understand the role that the FDA plays regulating the marketing, advertising and sale of tobacco products, the rules of the Tobacco Control Act, and repercussions of violating the rules. FDA could consider ways of leveraging the already-existing FDA retailer inspections program, which sends adult FDA inspectors into tobacco retailers, for such in-person retailer training.3) FDA could consider convening an in-person meeting of state and national experts and stakeholders on educational programs that may increase tobacco retailer compliance with the Tobacco Control Act. Evidence from a 2000 systematic review by Stead and colleagues [2] shows that retailer education alone may not be sufficient to maximize retailer compliance with federal tobacco sale regulations. Interventions which only supplied retailer education (often via a mailed informational packet) did not produce statistically significant decreases in sales of tobacco products to minors [3-5]. However, more intensive interventions that included in-person visits to retailers, community education and engagement, and media coverage had greater effects in terms of compliance with tobacco sale laws [6, 7]. An in-person meeting on educational programs to increase retailer compliance with the Tobacco Control Act may provide the opportunity for state and national experts and stakeholders to discuss innovative ways to complement retailer education with more intensive interventions and engagement. We believe these efforts to increase education of retailers could allow greater compliance with the Tobacco Control Act  and one of its goals of improving rates of compliance with tobacco regulations among retailers. Hannah M. Baker, MPHAntonio Powers, BSBALeah M. Ranney, PhDAdam O. Goldstein, MD, MPHDepartment of Family MedicineUniversity of North Carolina at Chapel HillReferences1. US Food and Drug Administration. Compliance Check Inspections of Tobacco Product Retailers. 2016 [cited 2016 April 13]; Available from: www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm.2. Stead, L.F. and T. Lancaster, A systematic review of interventions for preventing tobacco sales to minors. Tobacco Control, 2000. 9(2): p. 169-176.3. Skretny, M., et al., An intervention to reduce the sale of cigarettes to minors. New York State Journal of Medicine, 1990. 90(2): p. 54-55.4. Gemson, D.H., et al., Laying down the law: reducing illegal tobacco sales to minors in central Harlem. American Journal of Public Health, 1998. 88(6): p. 936-939.5. Schofield, M.J., R.W. Sanson-Fisher, and S. Gulliver, Interventions with retailers to reduce cigarette sales to minors: a randomised controlled trial. Australian and New Zealand journal of public health, 1997. 21(6): p. 590-596.6. Keay, D., et al., Effect of a retailer intervention on cigarette sales to minors in San Diego County, California. Tobacco Control, 1993. 2(2): p. 145.7. Biglan, A., et al., Mobilising positive reinforcement to reduce youth access to tobacco. Tobacco Control, 1995. 4(1): p. 42.", "comment_id": "FDA-2010-D-0350-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0018", "comment_date": "2016-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5098}, {"text": "there is no reason in the world that retailers need a training program. this divisoin can simply send out a notificatoin to the retailers on what is relevant and advise them if they want to check on anyting to go to the internet site and that is enough. there is no reason at all to spendmoney in retailer trainnig other than that.no retailer needs these fat cat bureaucrats to come in and lecture about somethign they may forget five minutes after hearing it. put the information on line and in a written document to each of them and that is it. that is all the taxpayers of this country believe this agency shoudl do. this agency is about employees who want jobs to last for eternity. these employees at this aencyu dont want to do anythint to fimply life. they want to set up  huge bureaucracy so they always  have jobs. there is no area in the country that needs downsizng more than this self perpetuating fat cat buraecuracy. this commetn is for the public record.", "comment_id": "FDA-2010-D-0350-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0023", "comment_date": "2019-07-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 969}, {"text": "Under the  Tobacco Control Act the regulation contains provisions to limit young peoples access to cigarettes and smokeless tobacco products, as well as restrictions on advertising and promotion of such products, to minors.Youth tobacco use in New York State is still a big problem.*Each year, 10,600 kids under 18 become new daily smokers in New York.  Thats 29 kids who will become smokerstoday..*The Surgeon General of the United States calls tobacco use a pediatric epidemic, with 3.6 million youth currently smoking cigarettes.  *Youth exposure to tobacco marketing in New York State remains high.*The New York Youth Tobacco Survey indicate 85% of high school students were aware of tobacco-related ads in convenience stores, supermarkets, gas stations or pharmacies in 2014. *Awareness of pro-tobacco marketing via the internet was reported by 79% of high school students in 2014.*Over 92% of high school students were exposed to tobacco marketing in 2014, via the internet or in a retail environment. Tobacco industry marketing causes youth smoking, according to the U.S. Surgeon General.2012*Nearly 9 out of 10 cigarette smokers first tried smoking by the age of 18. *The tobacco industry spends $235 million a year marketing to New York youth$9.6 billion nationwideNew York needs to protect our youth from the direct and manipulative  marketing tactics of Big Tobacco companies", "comment_id": "FDA-2010-D-0350-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0020", "comment_date": "2016-12-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1911}, {"text": "Underage tobacco usage is an epidemic that is having a profound effect on Americas youth. High rates of tobacco usage have resulted in more tobacco related diseases, which are responsible for over 440,000 deaths a year in the United States (The Columbia Daily Tribune). With over 12,000 warnings being issued to tobacco retailers in several states, it is apparent that retailers of tobacco products need to do a better job of educating their employees on the effects of tobacco products; as well as the penalties for violating the policies in regards to selling products to minors. While programs such as the we card initiative have helped reduce the number of tobacco sales to the youth, more needs to be done. Tobacco companies/retailers spend millions in legal fees concerning tort law, where many of them are found to be liable for the ill effects that using tobacco products have on the human body. In the case of Lukacs v. Phillip Morris, Inc, it was ruled that Phillip Morris Inc., was responsible for the plaintiff losing his tongue to a disease that was directly caused by using tobacco products; thus resulting in a 37.5 million dollar settlement (Public Health Advocacy Institute). While using tobacco products is a choice that is left up to the individual, tobacco companies must bare some of the burden associated with the health risk involved with using such products. With that said, tobacco usage is something that will not go away and as a society we must continue to educate our youth, adults and retailers on the negative effects of using tobacco products. It is because of this that I am in support of the Food and Drug Administration docket No. FDA-2010-D-0350, Draft Guidance for Tobacco Retailers on Tobacco Retailer Trainer Programs.References:http://www.columbiatribune.com/news/2011/nov/10/fda-eyes-tobacco-retailers/http://www.tobacco.neu.edu/litigation/resources/victories.htm", "comment_id": "FDA-2010-D-0350-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0010", "comment_date": "2012-01-11", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1962}, {"text": "Docket ID FDA 2010-D-0350", "comment_id": "FDA-2010-D-0350-0027", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0350-0027", "comment_date": "2019-11-16", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 25}]}, {"id": "EPA-R03-OAR-2022-0790", "agency": "EPA", "title": "Removal of Stage II Gasoline Vapor Recovery Program Requirements", "update_date": "2024-02-09", "update_time": "12:17:02", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I do not agree with the proposal to remove requirements for VRS in DC. Washington DC is a city, and cities have already been proven to cause increased exposure to pollutants. Relaxing the restrictions on air quality cannot possibly be in the best interest of public health, and this proposal leads me to believe that economic and technological factors were considered as well. Even if it truly has been proven not to affect attainment, this proposal will definitely negatively affect the air quality in D.C.According to A Method for Determining In-Use Efficiency of Stage II Vapor Recovery Systems, the research found that the estimated efficiency of these systems was between 81% and 93%, when compared to other conventional methods. With efficiency this high, it seems that this is not a factor driving their removal.   In the Final Rule Determining Widespread Use of Onboard Refueling Vapor Recovery and Waiver of Stage II Requirements, the EPA states that Removing Stage II control equipment will also eliminate expenses associated with operating Stage II systems. This makes it clear that they are not prioritizing public health and welfare when considering the proposal. Washington D.C. is currently in nonattainment for 8-hour Ozone. It reached nonattainment in 2018, and has been in it since. With the removal of Stage II Vapor Recovery Systems, the air quality can only continue to get worse. The proposal states that this removal of requirements is necessary due to conflicts with other systems, but did not explicitly explain how these other systems will be regulated to make up for it. Sources:Environmental Protection Agency. (2015). Final Rule Determining Widespread Use of Onboard Refueling Vapor Recovery and Waiver of Stage II Requirements [Fact Sheet]. https://www.epa.gov/sites/default/files/2015-09/documents/stage_2_vapor_factsheet.pdfMacIntosh, D. L., Hull, D. A., Brightman, H. S., Yanagisawa, Y.,  Ryan, P. B. (2003, July 1). A method for determining in-use efficiency of Stage II Vapor Recovery Systems. Environment International, 20 (2), 201-207.  https://www.sciencedirect.com/science/article/pii/0160412094901376#:~:text=The%20estimated%20efficiency%20per%20refueling,between%2081%25%20and%2093%25", "comment_id": "EPA-R03-OAR-2022-0790-0009", "comment_url": "https://api.regulations.gov/v4/comments/EPA-R03-OAR-2022-0790-0009", "comment_date": "2024-02-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2307}, {"text": "I do not agree with the Environmental Protection Agencys (EPA) plan to remove the requirement of Stage II Vapor Recovery System (VCR) in cars of the District of Columbia (DC). Stage II Vapor recovery systems were required in DC since 1993 because the city was labeled as, Serious nonattainment for the 1-hour 1979 ozone NAAQS in the Federal Register at 56 FR 56694 (November 6, 1991).I think continuing the mandate of Onboard Refueling Vapor Recovery (ORVR) is not enough to ensure better air quality for the residents of DC and anyone affected by the citys air pollution. The EPA states, Given the widespread use of ORVR, Stage II control systems now provide increasingly less air pollution reduction beyond what is provided by ORVR and therefore are increasing less cost-effective (EPA). Although it may be more cost effective to remove the mandate of Stage II VCR, it is not worth or comparable to the health of the people affected by this. I dont believe this mandate should be lifted, because I think the continued use of Stage II VCRs can only help to improve DCs air quality. If we remove this mandate we are setting up the city to be classified as a serious nonattainment for the 1 hour ozone NAAQs.CitationsFact Sheet. FACT SHEET FINAL RULE DETERMINING WIDESPREAD USE OF ONBOARD REFUELING VAPOR RECOVERY AND WAIVER OF STAGE II REQUIREMENTS, Environmental Protection Agency, www.epa.gov/sites/default/files/2015-09/documents/stage_2_vapor_factsheet.pdf. Accessed 8 Feb. 2024. The Federal Register. Federal Register\u202f:: Request Access, 16 May 2012, www.federalregister.gov/documents/2012/05/16/2012-11846/air-quality-widespread-use-for-onboard-refueling-vapor-recovery-and-stage-ii-waiver. ", "comment_id": "EPA-R03-OAR-2022-0790-0010", "comment_url": "https://api.regulations.gov/v4/comments/EPA-R03-OAR-2022-0790-0010", "comment_date": "2024-02-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1820}]}, {"id": "HHS-OS-2018-0009", "agency": "HHS", "title": "Meeting of the Pain Management Best  Practices Inter-Agency Task Force ", "update_date": "2019-01-11", "update_time": "01:03:34", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I am a chronic pain person.  I have for last 5 yrs taking 2 ophiod medication a day.  This is the only medication that works.  I have done over the counter pills, therapy, injections , chiropractor, surgeries, ect to no relief of my pain. I have had four shoulder surgeries for torn rotator cuff and now have a calisfied shoulder.  CDC now says 90 mm is my limit.  My doctor has tried about every medication to try but did not help.  Herion is what is causing deaths and now doctors are being arrested for writing ophiod prescriptions and this is wrong.  The data includes all ophiod related death.  Why is there a break down of herion only death data?  This is a witch hunt and attack on the innocent for chronic pain and their doctors.  What we need is for law enforcement to do their job and stop the illegal herion,fentanyl from being sold in this country.  These laws on ophiod criss has no barring  herion use but harming chronic pain patients and their doctors.  You are now forcing doctors to turn away the chronic patients to commit sucide because they have no way for quality of life from severe pain that none of you have ever experienced.  It should be up to doctors not government to determine how to treat chronic pain.  We have all been put on a list, tested,  pill counts, ect which a conviced person is not made to do but yet more death have gone up from herion.  Anytime government gets involved  it does more harm than good.  Please listen to the chronic pain patients and doctors and quit harming all of us as your laws and guidelines are harming us and not helping herion addictions.  I now if go to hospital,  I have to bring my medication or no help for pain from surgeries as hospitals will not give you medication ordered by surgereons.  Putting doctors in jail is wrong and making decissions on how to treat is the doctors decision and not to be prosciuttoed for treating patients.  DEA should not be arresting private pain management offices and making doctors to turn away patients for treatment.  Why dont you pass laws on herion addicts for their use?  These laws and forced guidelines have done more harm to the innocent chronic pain patients than the herion addict.  PLEASE wake up and get data on death you have caused now on innocent people who did not have any addictions but to have a quality of life to have some relief of their pain.  It has been documented that chronic pain patients do not develop addictions but only relief of pain.  Limiting surgery patients for pain medication is wrong and should not be lumped into one group as every surgery, person have different levels of pain than government telling you your pain level should be.  Please I beg your to stop passing laws and guidelines you have no business in.  Only the health insurance companies are benefiting as they now will not pay for it.  You need to stop and help turn back the guildelines that were in affect in 2012.  Chronic pain patients are now being treated as criminal for suffering from diseases, bad surgeries, ect and now suffer from pain and ophiod prescriptions are only pain relief for a quality of life you have now taken away from them and  prison doctors and clinics for trying to help chronic pain patients.  So wrong and I can only hope you read this and do the right decisions and stop making bad laws and guidelines that have not stop herion addictions and herion from being sold in this country. Also CDC have admitted data are not correct.", "comment_id": "HHS-OS-2018-0009-2014", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-2014", "comment_date": "2018-06-18", "comment_time": "04:00:00", "commenter_fname": "Kathleen", "commenter_lname": "Queen", "comment_length": 3479}, {"text": "I am judged on my appearance, I have tattoos, but I have never failed a drug test, not ever. If a doctor is going to judge on appearance then they need to acknowledge  LACK of signs of addiction, I dont slur my words, I dont lack hygiene, I dress appropriately for the weather, I dont ask for early refills, Im not impoverished, or living outside my means.I am 54, started paying into social security when I was ELEVEN years old,  on disability for an inoperable back since the late 90s (approved in 10 days time FROM APPLICATION-FACT) , I have vertebra L4 shattered in 4 pieces.I have been on Norcos since the 90s, never failed a drug test, never asked for early refills. I lost my pain doctor, I was abandoned actually, and now I am treated as a drug addict teenager. I am sick of being categorized alongside the dregs of society. All Ive ever done is help people, and Im tired of being treated like Im one of the problems with society. I informed my PCP that I had witnessed drug sales IN THEIR LOBBY, to which they didnt even respond, but when I needed medications from that office I was shunned and lied to, and treated like I was a criminal.Doctors need better guidance from you, as they seem too scared to act outside of what they PERCEIVE to be the parameters (what I interpret as lack of own self confidence).They too often discontinue meds, or refuse to continue meds,  absent fact or finding of fault on the part of the patient . The denial of appropriate care is a violation of a basic human right, ESPECIALLY in a country that legislates healthcare !!! I suspect my own PCP of illicit or abusive drug use, perhaps doctors should submit to testing as well, and be allowed to express that they are openly clean as well, and not addicted to any substances.How many doctors are actually hiding their own addictions, while cutting legit pain patients off their meds ?Doctors need to be reminded to FIRST DO NO HARM , not all people prescribed pain meds are drug abusers.Even addicts need to be treated with compassion, not judgment , ostricisation ,  and lack of care.Doctors need to acknowledge individuality in their patients, and not group all pain patients into one nefarious category,THAT is medical negligence. If we are not supposed to take other patients meds, then we should not be looked at in the same negative category as any other patients.It isnt fair to my family, or anyone around me ,for me to be hurting and compromised , and be grumpy , because some doctor is on a power trip, so busy knowing it all, that they fail to acknowledge any facts.Its hard to trust any doctor after being treated this way. I have been abandoned by four doctors in a row, I have had medical records LOST by doctors.The only thing Im guilty of is wrecking my body (once worked 9 days with a broken back, got harder by the day), working to take care of my family and pay my taxes like a real american , I didnt ask to be put on disability and I sure didnt ask to be put in the position I am in now, denied proper medical care because of someone elses actions. How can I have any quality of life if it is taken away from me ?I am attaching a copy of parameters that was not compiled by me, but by my wife, and I wholeheartedly agree with all the points outlined in it. (I also use my wifes email address, please do not disregard my comments  due to a shared email address.) ", "comment_id": "HHS-OS-2018-0009-1949", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-1949", "comment_date": "2018-06-18", "comment_time": "04:00:00", "commenter_fname": "Lawrence", "commenter_lname": "Garner", "comment_length": 3511}, {"text": "To whom it may concern,  I am a 40yr old chronic pain patient, Im legally disabled and have been treated by a pain management Dr for over 5yrs. When the CDC guidelines came out, nearly every Dr/specialist/dentist/etc..began taking meds from every patient, terminal, chronic, and acute pain patients alike - all because of incorrect data and overreaction. Now millions of people, including myself, have been left suffering in pain, and what is that going to accomplish? Nothing!!! Chronic pain patients are seeking a life with less pain, while addicts are seeking a high, taking anything they can find, which is more often than not, a drug thats been smuggled in or made by an at home chemist, whos putting Lord knows what into them  - Fentanyl, as we all know, is used very often. When research into the actual cause of listed opioid deaths is completed, 99% of the cases involved Fentanyl, Oxycontin, Morphine or Heroin, occasionally Xanax or Valium was also present. Nearly all were known drug addicts, taking too much while chasing a high, while pain mgmt patients take the same amount every day, and dont take more than prescribed! For me, with my overactive thyroid, any medication I take to work only half as long as its supposed too, from the very first dose, and now because of the CDC guidelines, my Dr cut my medicine amounts in half without warning or cause, purely based on the CDC 90 MME number, which does not take into account metabolism and genetics affecting the efficacy of meds for each persons body and metabolism. I agree that Dentists and primary care Drs treating acute pain patients should not be prescribing the strongest, more addictive meds, without at least consulting a specialist. I lost my younger brother to a heroin overdose in 2011, he switched after becoming addicted to Oxycontin, which his dentist gave him oxy for a toothache!!! It wasnt abscessed or severe, yet the dentist gave him one of the most abused/strongest meds on the market. He was an addict, stealing to support his habit, only wanting to get high, and after numerous times going through rehab, and even overdosing once already, nothing scared him enough to want to stop using. I believe hed still be alive if that dentist hadnt prescribed it.   Treating every person as if were addicts, and all built the same, absolutely will not work, and it will do nothing to stop the number of overdose deaths, if anything, theyll increase, as chronic pain patients either commit suicide because they cant live with the pain anymore, or, they themselves turn to buying illegal drugs on the streets, just trying to get some relief, and die from some nasty concoction that isnt what they expected. The 2 meds I take, are not listed one single time as cause of death, and yet theyre affected because theyre categorized the same as the ones people are actually dying on. We need individualized health care, built to each persons body, genetics and metabolism  - were not one size fits all! Stop punishing millions of innocent people, keep in mind that if we cant walk, stand, sit, etc...we wont be able to vote either! Go after the true source of the problem, illegally manufactured and smuggled drugs  - not chronic pain patients just trying to live a semi-normal life with less pain. Thank you for your time, Jennifer V ", "comment_id": "HHS-OS-2018-0009-0004", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0004", "comment_date": "2018-05-24", "comment_time": "04:00:00", "commenter_fname": "Jennifer", "commenter_lname": "Vinnard", "comment_length": 3470}, {"text": "I am 62 year old disabled woman. I have osteoporosis and I have suffered two major BURST fractures and have lost count of how many compression fracture I have suffered. I suffed at least 2 compression fractures that were between 25%-50%. I have suffered a dislocated fracture of my R wrist an external device was used to set that fracture. I have broken of my feet at least twice. I suffered 3 compression fractures at my neck when I was knocked out by a 40 lb block of ice that fell off an M1Tank while I was working at APG, MD. I have at least 2 buldging discs and a pinched nerve at my T12 vertebra. I have Fibromyalgia, arthritis thru out my back, DDD and migraines. In an effort to deal with my chronic pain issues I have spent, out of pocket, over $10,000 on epidurals, acupuncture, Thi chi classes, maggage, chair yoga classes, vitamins, essential oils, herb and PT. I currently walk 3 miles almost every day and eat a healthy diet. While these things help me deal with my chronic pain I still can not function without my opioid pain medication. I have been on them for 20 years. About 10 years ago I came off of my pain medication for approximately 2 years because I wanted to see how my body felt. During that year my life went down hill. I barely made it too work because I was in so much pain, I was not able to do any chores around the house, I never had sex with my husband, I was unable to exercise and I had no social life at all. The pain was so severe that I could not be around my grandchildren. Then in March of 2011 I was in an accident that resulted in a 60% burst fracture. Since the accident I have remained on pain medication Oxycontin. I experienced an unusually long recovery time because of the osteoporosis. I was not a candidate for cement fill because the vertebra was shattered and the cement would have leaked though the veterbra which would have caused me to be paralyzed. This was confirmed by two orthopedic surgeon. I also want to mention that I had both my knees replaced in 2016 and 2017. Knee replacements do not make you 100% pain free.  After my burst fracture in 2011 I was put back on Oxycontin. I built tolerance to the Oxycontin because my recovery time was so long and because I was in a great deal of knee pain. My orthopedic surgeon wanted me to wait until I was 60 before he would replaced my knees I would not turn 60 until 2016. During the time with my PCP I felt that my pain was adequately managed. I held a job, was able to have limited visits with friends and family and exercise 3 times per week. In 2014 my Primary Care Physician (PCP) told me that things were changing...that due to opioid overdoses the CDC was writing guidelines for opioid prescribing and he felt I would be better served going to a Pain Management Doctor (PMD). The first thing the PMD did was cut my Oxycontin in half. His reasons were that the drugs were no longer working for me. This was devastating for me and my life completely changed over night. I was no longer able to work, exercise or socialize. During the next 4 weeks he lowered my meds 2 more times. I suffer terribly but despite excruciating pain I try really hard to do the things I HAVE to do to try and help my pain and stop my osteoporosis from getting worse. Now my doctor says he does not know how much longer he can continue to prescribe my opioid pain medication. I can not take even more pain. Please do not prevent doctors from prescribing pain medication to chronic pain patients. Please do not take away my pain medication I would lose the ability to function. There has got to be a way to handle this opioid (heroin) crisis without making pain patients suffer. It is inhumane, torture and cruel. We are suffering we are losing hope and some of us are contemplating sucide. I am begging you dont take our meds away. Sincerely Kathy Dominick", "comment_id": "HHS-OS-2018-0009-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0006", "comment_date": "2018-05-24", "comment_time": "04:00:00", "commenter_fname": "Katherine", "commenter_lname": "Dominick", "comment_length": 3899}, {"text": "Any coordinated federal policy on pain management must start with the role of government. Government has a compelling public interest in prosecuting pill mills and shutting down the illicit drug trade. Government should have no role in regulating what dosages physicians prescribe to legitimate patients.Patients in pain management need two things from the federal government: 1) The CDC must immediately revise opioid prescribing guidelines to clarify that benchmark dosages do not apply in cases where pain is intractable, the painful condition is expected to last a lifetime, and other treatments have been ineffective or do not yet exist. Patients with a lifelong diagnosis of intractable pain should get the same exceptions from dosage limitations that cancer patients get - at the doctors office, at the pharmacy, and for every insurance plan covering prescription medication.2) The DEA and state medical boards must never target physicians for disciplinary review based solely on number and dosage of opioid prescriptions, absent other evidence of criminal activity. Doctors who specialize in treating intractable pain will prescribe more pain medicine at higher dosages. Treating this as a warning sign in itself is, in effect, federal discrimination against patients with disabilities.For the last twenty years Ive been in pain management for a lifelong condition called IC/BPS. There is no cure, and the cause is unknown; the most likely theory is that its autoimmune.To give you an idea what that is, imagine your body is mis-programmed to punch bloody holes in your bladder 24/7. Imagine urine dripping in from your kidneys feels exactly like salt on a hundred razor cuts, and the only (partial) relief is peeing.Unfortunately I am one of the 5% with my diagnosis for whom all known treatments (diet, non-opioid medication, electrical stimulation, weeks in a multidisciplinary pain clinic, physical therapy, meditation/hypnosis/mindfulness, alternative medicine, pouring various medications into my own bladder through a catheter multiple times daily, and all other treatments currently known to science) have no effect. Barring a research miracle, this will continue for the 40+ years I have left to live.Combined with other coping strategies, pain medication gives me a productive, near-normal life. Pain medication has allowed me to earn a doctorate, teach college, and raise a healthy, happy son with my loving husband.With my current treatment, managed by a pain specialist, I can be away from a toilet for up to an hour. I can teach class, fly on a plane, and walk in the park with my child. In twenty years, I have never achieved that level of functionality with any other treatment. At or below dosages recommended by the CDC, I get approximately ten minutes between bathroom visits. Needless to say, this is not consistent with working, parenting, or any semblance of a normal life. Consider an analogy: Suppose you are visually impaired, and need a cane to get around. Suppose theres a national epidemic of people beating each other with canes. Would the solution be to make canes illegal? Clearly not - this would deny millions of Americans with disabilities a legal accommodation they need to participate in society.My lifelong disability requires pain medication as an accommodation for me to participate in society, just as a person who uses a wheelchair requires a ramp.Please reject the false and insidious narrative that opioid medication is only for cancer and end-of-life care. I am living proof, there is such a thing as palliative care - care for a disease with no known treatments remaining - that is not also end-of-life care.As your task force meets, you may hear stories of chronic pain patients started on long-term medication too soon, before non-opioid treatments had been fully exhausted. Please also remember, your policy must serve patients for whom that is not remotely the case.When you hear the claim that quality of life is always better without opioids, I urge you to please remember me.", "comment_id": "HHS-OS-2018-0009-0005", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0005", "comment_date": "2018-05-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4207}, {"text": "I am a long term chronic pain patient who uses opiates to have any quality of life at all. I have RA, Sjogrens Syndrome, Fibromyalgia, Osteoarthritis, ulcerative colitis, intercystial cystitis I have had pain since I was a child. We were too poor at the time to have it doctored so I was given aspirins. Then I took ibuprofen until I developed ulcers of the esophagus and even developed Barrents esophagus. Opiates are the only thing I can take safely now. Have you ever felt so ill that you couldnt get up to go to the doctor? As a pain patient, my life is now knowing I have to go over to my doctors office every month to get a script to fill. It doesnt matter how exhausted I am or how much pain I am in, it has to go like that now. A blizzard could be on its way and you still cant get them filled any sooner than the exact date. I would think that electronic scripts would be way more crime proof than this way. I dont have an issue getting my blood pressure meds, stomach meds or any other filled. I get to the pharmacy counter where I have to prove myself to get a drug that is prescribed by a doctor. A doctor who knows and has already assessed my need for it. Meanwhile, I see people buying carts of alcohol and carton of cigarettes. No issue. No explaining. Every month I live in fear of being cut off or tapered down. If the DEA is going into the addiction prevention business, they should include alcohol and tobacco as they are drugs. I have been working for a drug prevention coalition in my area for 15 years. I understand addiction and drug trends. The opiate/heroin issue is fading replaced by meth for adults and vaping for youth. The outcries to fix the opiate issue will lessen because the suburbs will feel safe again. Meth is considered a redneck drug and there will be no outcry to fix that ...Meanwhile, pain patients will be the true victims of this war. I urge you to stop trying to baby proof the world. It doesnt work.", "comment_id": "HHS-OS-2018-0009-0057", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0057", "comment_date": "2018-05-24", "comment_time": "04:00:00", "commenter_fname": "Donna", "commenter_lname": "Thacker", "comment_length": 1946}, {"text": "Too many chronic pain patients are going to be suffering even more because their doctors are afraid to prescribe pain medications now. You need to figure out where the people who are dying from opiates are getting them from. The people that I have heard of that have died bought them from someone not knowing that they were laced with fentanyl. I think you are targeting the wrong audience. You dont know how despairing it is when your doctor tells you that they will not treat your pain anymore.", "comment_id": "HHS-OS-2018-0009-0099", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0099", "comment_date": "2018-05-26", "comment_time": "04:00:00", "commenter_fname": "Traci", "commenter_lname": "Morgan", "comment_length": 501}, {"text": "Ive been dealing with Pain Management for several years now, its always the same band aid fixes used by different doctors that have short lived results.  Im 51 years old, I have Osteoarthritis, degenerate joint disorder, spinal stenosis, Fibromyalgia, and compilations from hip replacement.  Theses are the major issues I have that have also caused smaller issues that have become quite painful in just dealing with daily living.  Ive been given oral medications, topical medications, spinal injections, and physical therapy.  Ive had several operations that have led to more complications,  total hip replacement led to infections and multiple surgeries.  Shoulder surgery led to muscle wasting and limited use of my left arm, and finally neck surgery where fixtures backed out and now my neck wants to go forward. Now im on the verge to start yet again more issues that came from complications, the roto cuffs in both my arms have been effected. Along with the trap muscles in my shoulders are in constant spasm due to both my neck and shoulder issues.  I know how the proces works, you go see your family physician who in turn will send me to see a Orthopedic surgeion.  I will undergo MRIs, Xrays, and maybe changes in my medications, I am now at the point where it may involve some type of surgery again.  But I know that no matter what is done to me I will be in chronic pain for the rest of my life.I used to work for a major health insurance company I fully understand benefits and the changes that have been made concerning opid medications.  Now we have alternative medications and services that are out there but are non covered by the Health insurance companies and guidelines.  Through several of the persons who have preformed physical thereapy on my person have advised me things and then would say but its none covered.  I want to address this now.Acupuncture:  Per my health insurance which is Medicare they will purchase or rent a muscle stimulator or Tens unit but not cover Acupuncture.  As a person who is looking for releif how am I to know what will and will not work if Im given a band aid of a Tens unit that after a period of time I keep turning it up to dull the nerves in my body to the point it doesnt work any more?  Can I try Acupuncture?  No its a none covered benfit under my health insurance, As a widow living on social security disability this will not fit in my budget.  So I can not tell you if this will work for me to help control pain.Physical massage therapy:  I can have as a covered benefit if my Doctor prescribes physical therapy part of this therapy can be Physical massage but its limited to moduals of time and never extends past that.  As I have a person preforming physical therapy on my body in the form of the modual of physical massage I am always being told I would benefit from more massage.  But due to the limitations in benefits and services this is a Non covered Benefit by pretty much every single health insurance company.Medical marijuana:  Yes I carry a Medical marijuana card but lets look at this please.  One obtaining a card is not covered by Health insurance.  The fee was $200 for a doctor to approve and confirm I meet one or more of the conditions.  Next its either $50 dollars for the card that is full price on the website or $25 dollars if your on assistance programs.  Then you will have follow up appointments with the physician that is $100 each.  Then finally the products weather its oils, foods, vaps and so on all of that is out of my pocket.  As a person living on assistance and social security disability plus a recent widow, this all is a huge hit on my pocket.So in the years that Ive required Pain management so much has changed that I feel I have no quality of life anymore.  Since Im a recent widow things have gotten worse on my end in just normal home management.  Yes you have a Opid problem in the united states but this has caused us the people who are suffering already limited on what we can and can not do to give us just a moment rest, a good nights sleep, or maybe some quality in life.Ive given up on what anyone can do to help me, being a chronic pain sufferer I now have medical issues Ive never thought I would have to deal with besides Pain. High blood pressure, Diabietes type II, Insomia, Depression, Anexity, Concentration issues, forgetfulness, liver monitoring due to medications. And the Physicians will have a pill for everyone of them issues but the one thing that is making my life a total hell. PAIN", "comment_id": "HHS-OS-2018-0009-0104", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0104", "comment_date": "2018-05-26", "comment_time": "04:00:00", "commenter_fname": "Sharon", "commenter_lname": "Williams", "comment_length": 4674}, {"text": "My mother was continually cut down on her pain medication by her doctor. She has had Hepatitis C since her early 20s and has tried interferon treatments several times and it didnt work. This last time almost killed her.  This disease has caused many issues for her and pain. She has never abused her medication. , never llost them, never dropped them in the toilet, never had them stolen or any other reason that actual addicts claim when trying to seek more. To lump everyone together is absurd! Each patient should be treated differently. If a patient gives any of the above excuses yes cut them off! But for Gods Sake dont punish the people who are not a problem and need help with their pain! I hope a solution is found soon so people suffering can find some relief and not by the way of suicide which I believe a lot of people will choose if they feel they cannot live with the immense pain they are in. ", "comment_id": "HHS-OS-2018-0009-0088", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0088", "comment_date": "2018-05-26", "comment_time": "04:00:00", "commenter_fname": "Josie", "commenter_lname": "Mannor", "comment_length": 909}, {"text": "I am sure that these all sound very similar since we are all left out  in the cold with no help. I personally  was cold turkeyed off my pain meds and it was awful. I am not a criminal I am sick with incurable diseases. Shame on every single person who is allowing needless suffering by MILLIONS!!!!  How sad and pathetic a world we live in when we are forced to suffer all day everyday because of nonsense and numbers that are incorrect. None of us did anything wrong or asked for this to happen and Im sure if whomever makes decisions spent time in our bodies they would think and feel alot different. We forgot along the way about putting ourselves in others shoes. We also have forgotten compassion and empathy. Someone NEEDS to make this right. Thanks for reading, Haley S from Montana ", "comment_id": "HHS-OS-2018-0009-0091", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0009-0091", "comment_date": "2018-05-26", "comment_time": "04:00:00", "commenter_fname": "Haley", "commenter_lname": "Starkel", "comment_length": 815}]}, {"id": "FDA-2018-N-1072", "agency": "FDA", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis plant and resin; Extracts and tinctures of cannabis; Delta -9-Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request for Comments", "update_date": "2018-05-02", "update_time": "16:14:10", "purpose": "Nonrulemaking", "keywords": ["Notice", "CDER", "2018-186", "International Drug Scheduling", "Convention on Psychotropic Substances", "Single Convention on Narcotic Drugs", "Cannabis plant and resin", "Extracts and tinctures of cannabis", "Delta -9-Tetrahydrocannabinol (THC)", "Stereoisomers of THC", "Cannabidiol", "Request for Comments", "OPEN"], "comments": [{"text": "Abuse potential is a retained drug ability that makes an individual dependent on the drug. The ability depends on drug administration, as well as the speed at which the drug enters an individuals bloodstream and nervous system to enhance production of a high sensation. Drugs that enter the body system fast are easily addicted compared to those with a slower rate. Most drugs are harmful to health, because of abuse, and have a potential of bringing dependency, for instance, cannabis. Cannabis contains multiple cannabinoids and psychoactive chemicals THC. Cannabinoids have activities at cannabinoid 1, and 2 (CB1 and CB2) and CB1 are most abused due to its effects on memory processing, inflammation, and pain. Researchers have conducted on the effects of abuse potential of cannabis with an aim of getting information on its harmful and legitimate use, national controls status and the potential effect of international control of the drug.Actual abuse occurs when individuals consume drugs in harmful amounts or methods. Actual abuse results in psychological, social and physical harm. Cannabis, being the commonly abused drug has led to a review concerning it by the World Health Organization (WHO).Cannabis can be categorized into the cannabis resin and plant, cannabis tinctures, extracts, and delta -9-tetrahydrocannabinol. Actual abuse of cannabis mainly occurs when it is used in excess for medical purpose and due to the emergence of pharmaceutical preparations that are related to cannabis, and useful in therapies.Cannabis, also known as marijuana, is extracted from a hemp plant, known as cannabis sativa that is also used for medical purposes. It can be taken in the form of a capsule, pill, mouth spray, and smoke, or maybe baked and then eaten. It is used to relieve and control symptoms such as nausea, pain, insomnia, tremors, and numbness caused by damaged nerves. In the administration of cannabis, considerations must be put on the amount, because it varies in strength and quality. There are however restrictions on marijuana administration, that is: certain individuals are not allowed to consume it, for instance, pregnant or breastfeeding mothers and mental health patients. The most used illegal drug in the United States is cannabis and synthetic THC, also known as dronabinol, which is an approved drug ingredient that is derived from marijuana and is used to make MARINOL capsules (generic), as well as SYNDROS oral solution. MARINOL and SYNDROS are useful in anorexia treatment, which is related to a loss of weight of acquired immunodeficiency syndrome (AIDS) patients, as well as vomiting and nausea by cancer chemotherapy patients who are faced with difficulties during treatment.Trafficking drugs is an illegal trade comprising cultivation, manufacture, distribution, and sale of products that are prohibited by laws on drugs. Despite the medical use of cannabis, FDA does not approve products from or containing marijuana. FDA refers to schedule I under the CSA, which controls marijuana and its substances, hence, they consider trafficking illegal. MARINOL and SYNDROS, which are authorized for various medical purposes, are also controlled, but in different schedules that are MARINOL, control is in schedule III, while SYNDROS is in schedule II under the CSA.The 1961 convention that contains schedule II puts together cannabis resin, cannabis, extracts, and cannabis tinctures, while schedule of 4 of the same years convention contains the cannabis resin and cannabis plant. There is, however, change in 1971s convention whereby the schedule I and II contains synthetic and natural cannabinoids. The impact gained from scheduling changes is an increase in the medical use of cannabis and its components, for instance, in therapeutic use. The impacts obtained from scheduling can be considered a preliminary analysis, and they are not useful in determining whether to change the control status of a substance.", "comment_id": "FDA-2018-N-1072-6217", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6217", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3995}, {"text": "Abuse potential is a retained drug ability that makes an individual dependent on the drug. The ability depends on drug administration, as well as the speed at which the drug enters an individuals bloodstream and nervous system to enhance production of a high sensation. Drugs that enter the body system fast are easily addicted compared to those with a slower rate. Most drugs are harmful to health, because of abuse, and have a potential of bringing dependency, for instance, cannabis. Cannabis contains multiple cannabinoids and psychoactive chemicals THC. Cannabinoids have activities at cannabinoid 1, and 2 (CB1 and CB2) and CB1 are most abused due to its effects on memory processing, inflammation, and pain. Researchers have conducted on the effects of abuse potential of cannabis with an aim of getting information on its harmful and legitimate use, national controls status and the potential effect of international control of the drug.Actual abuse occurs when individuals consume drugs in harmful amounts or methods. Actual abuse results in psychological, social and physical harm. Cannabis, being the commonly abused drug has led to a review concerning it by the World Health Organization (WHO).Cannabis can be categorized into the cannabis resin and plant, cannabis tinctures, extracts, and delta -9-tetrahydrocannabinol. Actual abuse of cannabis mainly occurs when it is used in excess for medical purpose and due to the emergence of pharmaceutical preparations that are related to cannabis, and useful in therapies.Cannabis, also known as marijuana, is extracted from a hemp plant, known as cannabis sativa that is also used for medical purposes. It can be taken in the form of a capsule, pill, mouth spray, and smoke, or maybe baked and then eaten. It is used to relieve and control symptoms such as nausea, pain, insomnia, tremors, and numbness caused by damaged nerves. In the administration of cannabis, considerations must be put on the amount, because it varies in strength and quality. There are however restrictions on marijuana administration, that is: certain individuals are not allowed to consume it, for instance, pregnant or breastfeeding mothers and mental health patients. The most used illegal drug in the United States is cannabis and synthetic THC, also known as dronabinol, which is an approved drug ingredient that is derived from marijuana and is used to make MARINOL capsules (generic), as well as SYNDROS oral solution. MARINOL and SYNDROS are useful in anorexia treatment, which is related to a loss of weight of acquired immunodeficiency syndrome (AIDS) patients, as well as vomiting and nausea by cancer chemotherapy patients who are faced with difficulties during treatment.Trafficking drugs is an illegal trade comprising cultivation, manufacture, distribution, and sale of products that are prohibited by laws on drugs. Despite the medical use of cannabis, FDA does not approve products from or containing marijuana. FDA refers to schedule I under the CSA, which controls marijuana and its substances, hence, they consider trafficking illegal. MARINOL and SYNDROS, which are authorized for various medical purposes, are also controlled, but in different schedules that are MARINOL, control is in schedule III, while SYNDROS is in schedule II under the CSA.The 1961 convention that contains schedule II puts together cannabis resin, cannabis, extracts, and cannabis tinctures, while schedule of 4 of the same years convention contains the cannabis resin and cannabis plant. There is, however, change in 1971s convention whereby the schedule I and II contains synthetic and natural cannabinoids. The impact gained from scheduling changes is an increase in the medical use of cannabis and its components, for instance, in therapeutic use. The impacts obtained from scheduling can be considered a preliminary analysis, and they are not useful in determining whether to change the control status of a substance.", "comment_id": "FDA-2018-N-1072-6215", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6215", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3995}, {"text": "CANNABIS KILLS CANCERREF:   http://freecannabiscancerbook.com. Cannabis for Treatment of Cancer by Justin Kander and Dennis Hill.Cannabis Kills Cancer by multiple mechanisms including Apoptosis and Reactive Oxidative State. This is described in the eBook available online Cannabis for Treatment of Cancer by Justin Kander, Cannabis Researcher, and Dennis Hill, Biochemist formerly of MD Anderson Cancer Center in Houston Texas.  The Anderson Cancer Center in Houston is the number one rated cancer center in the United States. Dennis Hill started his own hash oil extract treatment after being diagnosed with aggressive Prostate Cancer.  He started his treatment as an alternative to conventional chemotherapy, radiation, and surgery.  Dennis started his treatment on July 8, 2010, and was still alive in good health as of October 2017.  Dennis Hill has Videos on YouTube where he discusses the mechanisms of cannabis extracts killing cancer.  Its worth noting that CBD, another Cannabis extract is known to be active against cancer as well.  The hash oil treatment as popularized by Rick Simpson and is known as Phoenix Tears or Rick Simpson Hash Oil.I know of a Liver Cancer patient diagnosed July 14, 2014, with an advanced stage primary liver cancer with a tumor size of 4 x 5 inches.  The tumor marker AFP was 133651.  Traditional treatment at the City of Hope Cancer in Duarte California reduced the size of the tumor, and the AFP was in the 20,000 to 25,000 level by January 2015. Patients last Chemo treatment was in April of 2015.  The last Oxycodone prescription was in mid-year 2015.  Tumor marker AFP continued to improve gradually declining to 44.5 on September 28 October 2015. Patients hair grew back, gained weight and condition continued to improve.  Patients condition continues to be in good health as of 4/21/2018. There is no advanced stage cancer present.  All of patients friends remark on how good conditions appear to be.  The patient is treated by Aunt Zeldas dispensary located in Bodega Bay California. Patient treatment is by THC and CBD Hash Oils.Aunt Zeldas dispensary is featured in documentary to be released shortly about Pediatric Cancer Treatment by CBD and THC Hash Oils.", "comment_id": "FDA-2018-N-1072-6398", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6398", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2368}, {"text": "   Patients in the state of Utah are trying to be heard with a ballot initiative for medical cannabis for the 2018 ballot.  My personal story is I have facial nerve pain,  fibromyalgia, degenerative disk disease, facet disease, stenosis foraminal meaning the narrowing of the neurological chamber around my spine, and bone spurs.  I visited my dying auntin the legal cannabis state of Washington where she gave me what was left of her cannabis oil to see if it would help. Just a drop the size of a grain of rice of full cannabis oil was all it took and I wouldnt have to take muscle relaxants, sleep pills, antI-nflammatories, anxiety medication, pain pills and if I was there long enough I could of probably of gone off the seizure medication as well. Most have heard about how well it effects the part of the brain in controlling seizures.Seizure medication is what they give me to numb down my central nervous system that misfires. The problem is you cannot numb down one nerve you numb them all down so my vision has become impaired, my hearing has decreased, I have problems with memory and coming up with words. I have neuralgia, where I cannot feel in extremities, so for a moment consider all those pills and their debilitating side effects from each one of them. The thought of taking what our own government, in their patent on cannabis, called a neurolprotectant as opposed to something that causes neurological decline is a no brainer. People, like myself, just want to have a better quality of life without all the pills.So it definitely made a believer and an activist out of me. Once you open the doors to all the information that is out there and hear peoples stories you just cannot go back. I will continue to to use the voice my aunt no longer has of how well this works and how it would have helped her so much more if she would have had it available sooner because she lived here in Utah and only moved in her last 3 months of life.I enclosed a lot of good investigative information with reliable links for your review.Knowledge is power, it should not be illegal to take care of ourselves and our illnesses we defiantly should not have to leave our familys and our homes to have a better quality of life.Thanks for your time and attention in this matter. ", "comment_id": "FDA-2018-N-1072-6632", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6632", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2335}, {"text": "Hemp is the most renewable and versatile crop that God has given us!! Its a fuel, a medicine, a textile and we are Fools for falling into the ploy of Big business and Big Pharma!! It Is Not, Has Not nor Ever Will be a gateway drug. If you need an industry to ban for the good of the people/public safety, it should be alcohol!!", "comment_id": "FDA-2018-N-1072-6859", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6859", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 332}, {"text": "   Several individuals have used the same words to describe their feelings to keep the regulations on marijuana and the cannabinoids, and they have used the words supporter of scientific research as a reason to do so.  When one looks at the research, however, these individuals have no concept of the scientific research on marijuana and the cannabinoids.  Here are some SCIENTIFIC REALITIES to consider  1. Scientists from the National Institutes of Health (NIH) have written a 61-page review (Pharmacol Rev. 2006, 58 (3): 389-462; article in attachments) entitled THE ENDOCANNABINOID SYSTEM AS AN EMERGING TARGET OF PHARMACOTHERAPY with 67 pages of references.  A few quotes from the abstract are shown below:a. In the past decade, the endocannabinoid system has been implicated in a growing number of physiological functions, both in the central and peripheral nervous systems and in peripheral organs.b. More importantly, modulating the activity of the endocannabinoid system turned out to hold therapeutic promise in a wide range of disparate diseases and pathological conditions, ranging from mood and anxiety disorders, movement disorders such as Parkinsons and Huntingtons disease, neuropathic pain, multiple sclerosis and spinal cord injury, to cancer, atherosclerosis, myocardial infarction, stroke, hypertension, glaucoma, obesity/metabolic syndrome, and osteoporosis, to name just a few.c. The growing number of preclinical studies and clinical trials with compounds that modulate the endocannabinoid system will probably result in novel therapeutic approaches in a number of diseases for which current treatments do not fully address the patients need.  2. Patent US 6,630,507 B1 issued 10/7/2003 to the assignee THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.  The patent is entitled CANNABINOIDS AS ANTIOXIDANTS AND NEUROPROTECTANTS.  The summary of the patent states:a. Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism.  This new-found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. b. The Cannabinoids are found to have application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimers disease, Parkinsons disease and HIV dementia.  3. InMed Pharmaceuticals have demonstrated positive results with cannabinoids treating glaucoma. (inmedpharma.com).  4. GW Pharmaceuticals has a pending FDA application with CBDa. An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma. (ReutersAnother comment by those individuals using the same worded anti-marijuana statement was:     Todays high-potency dispensary marijuana has a high potential for abuse, a high incidence of actual abuse, has not been proven to be safe or effective for the treatment of any medical condition, and is heavily trafficked in illicit markets.The people that make this comment offer no references to a high incidence of actual abuse to support their cause and clearly are unaware, or ignoring, all the data that shows THC and CBD to have medicinal benefits. One can also list folks, who have previously been against marijuana, move to have it legalized once they had seen the positive effects that THC and CBD can have.   1. Government officials, such as the previous Speaker of the House, John Boehner and former governor of MA, William Weld, have realized that marijuana and the cannabinoids have medicinal value to people.    2. RAMP, Republicans Against Marijuana Prohibition, was started by a mother who personally experienced the positive benefits of cannabinoids for her son.  3. On a personal note, I have experienced the pain-relieving properties of CBD for my arthritic hand.In summary, I strongly support a decision to deregulate cannabis, THC and CBD and the other cannabinoids in the cannabis and hemp plants so that the true potential of these chemicals can be fully realized.  It seems unconscionable to keep these therapeutic agents out of the hands of people in need.", "comment_id": "FDA-2018-N-1072-6865", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6865", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4770}, {"text": "Comments on International Cannabis SchedulingTo Whom It May Concern, The Ohio Rights Group (ORG) is responding to request by the U.S. Food and Drug Administration for comments concerning the International Drug Scheduling for five substances: Cannabis plant and cannabis resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers of THC. The ORG is 501(c)(4) non-partisan, organization that advocates for the rights of Ohioans to make medical, therapeutic and industrial use of the Cannabis plant and supports the growing number of individuals, organizations and industries facilitating those uses. Our comments are: The plant. Cannabis is complex. The plant is comprised of 450 chemicals, including 78 largely un-researched, but arguably therapeutic cannabinoids, in addition to delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The FDA tends to view medicinal value through the limited lens of a single chemical entity, failing so far to approve any product derived from a botanical. Well, it should. Cannabinoids work synergistically together to create an entourage effect in which the whole is greater than the sum of its parts. The endocannabinoid system. Both THC and CBD were newborn discoveries when the 1971 Convention on Psychotropic Substances was codified. Then, neither scientists nor politicians understood the human bodys close relationship with the cannabis plant. During the 1990s, researchers uncovered internal cannabinoid receptors and cannabinoids such as Anandamide. They called this configuration the endocannabinoid system, essentially cannabis within. What is its purpose? The stability, harmony and homeostasis of the body. This is why cannabinoids, whether internal or external, modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects. What happens in the absence of cannabinoids? An endocannabinoid deficiency syndrome develops. Research. The HHS is charged with undertaking a scientific and medical evaluation of the five substances. Dare we say, finally? Marijuanas placement in the CSAs most restrictive Schedule I obstructed cannabis research in the United States for almost 50 years. Most of the major advancements have, by necessity, occurred elsewhere. Science has only scratched the surface of the treasure trove that embodies the medicinal benefits of cannabis and cannabinoids. In 2004, a search of cannabinoid in Pubmed.gov from the National Library of Medicine produced 5,900 citations; in 2010, that number was 12,000.  Now, that same search finds 23,365 results. Cannabinoid medicine is clearly a science whose time has come. Public policy. The CSA uses three criteria to determine classification under Schedule I: high potential for abuse, no currently accepted medical value in the U.S. and lack of accepted safety under medical supervision. When drafted, cannabis placement in the CSA was deemed provisional by HHS pending a review, which was completed with the 1972 Shafer Commission report. Not surprisingly, the Nixon administration ignored the report because it favored decriminalization. That sinister move had devastating consequences. Over the following 45 years, arrest and incarceration rates in the U.S. exploded. More than 20 million Americans have been arrested for some type of marijuana violation, particularly people of color who comprise almost 60% of those incarcerated for drug offenses. Americas prison population now tops 2.1 million, the largest in the world, and spending to prosecute the drug war exceeds $50 billion. Clearly, HHS considerations go far beyond scientific and medical evaluations. But strictly concerning Schedule 1. High potential for abuse, no. An estimated 35 million Americans use cannabis monthly. Considering the endocannabinoid system and its deficiency syndrome, perhaps otherwise law abiding citizens are augmenting their systems and mediating a deficiency, instead of abusing CB1 receptors. The lexicon of the FDA, HHS and WHO must change. No accepted medical value, incorrect. Because of federal intransience, 45 states have legalized medical marijuana, whether whole plant or CBD only. Each of these laws is predicated on medical expertise. Lack of safety, no. In 1988, DEA Administrative Law Judge, Francis Young ruled, Marijuana in its natural form is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within the supervised routine of medical care. Enough said. The FDA, HHS and WHO have a critical and unique opportunity to make right a 45-year old wrong. To end the revolving door of mass arrest and incarceration. To unleash a new wave of honest research to uncover the truth about this medicinal plant. And most importantly, to ease human suffering, which may in turn heal the planet.Respectfully submitted, Mary Jane BordenTreasurer, Ohio Rights Group ", "comment_id": "FDA-2018-N-1072-6922", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6922", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5158}, {"text": "To whom it may apply,I hope this rescheduling takes place soon, and allows patients to access a medicine that they need.", "comment_id": "FDA-2018-N-1072-6890", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6890", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 130}, {"text": "I work in the Cannabis industry as a graphic designer for one of the top producing edibles and concentrates manufacturers in the country. We offer edibles, wellness products and concentrate products for recreational use, and also for medical patients. However, what were most proud to offer is high THC:CBD oil for patients with seizure disorders.One of our patients, Super Nova, perhaps the sweetest 5 year old you will meet, is also tasked with rare neurological disorder-Schizencephaly. She was having 100 seizures a day until she started treatment with our oil. The severity of her condition led to stalled physical and mental development. She is currently 6 months seizure free. At five years old, she just sat up on her own power. At five years old - she just told her mother she loved her for the first time.This is powerful medicine, but it is also extremely helpful for those of us with muscle pain, back spasms, PTSD, anxiety and numerous other issues. However, the recreational side of it should not be ignored - Its a much safer substance than alcohol or cigarettes, which are currently both available to the public. I have dealt with alcoholics my whole life, and have had my life upended because of them. Ive never had a person high on marijuana kick in my front door, wreck my car or threaten me. I have had an alcoholic do all of those things to me, though.Please free this plant. ", "comment_id": "FDA-2018-N-1072-4762", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-1072-4762", "comment_date": "2018-04-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1462}]}, {"id": "FDA-2015-P-3991", "agency": "FDA", "title": "Petitioner requests the FDA Commissioner to issue a Federal Regulation to augment FDA Citizen Petition  for Public Hearings to establish standards for \"medical\" and recreational marijuana's harms to mental and physical health that might be caused by cannabis in any of the forms currently being marketed to the general public.", "update_date": "2017-09-06", "update_time": "15:31:30", "purpose": "Nonrulemaking", "keywords": ["Cannabis", "2015-6894", "OPEN", "Citizen Petition for Public Hearings", "medical and recreational marijuana", "The Take Back America Campaign", "Roger Morgan", "Frederick Mayer", "Bishop Dr. Ron Allen", "Scott Chipman", "Federal Regulation"], "comments": [{"text": "Sir or Madam: I urge you to ignore the misrepresentations and falsehoods provided to you by The Take Back America Campaign. Please rely on reputable sources when making determinations about marijuana and cannabidiol. ", "comment_id": "FDA-2015-P-3991-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-P-3991-0014", "comment_date": "2017-09-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 227}, {"text": "The unnecessary and irrelevant regulation and burden that this petition brings to discussion is 100% ridiculous to anyone who is actually involved in the current industry or benefits from it. There will be unnecessary regulatory costs and burden placed upon the manufacturer of products which will be then be passed along to the consumers in both the recreational and medical markets. In the end this piece of legislation does nothing to progress its own agenda  and is obviously written by a group who does not understand the industry or the challenges that people in and out of it face.", "comment_id": "FDA-2015-P-3991-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-P-3991-0012", "comment_date": "2016-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 588}, {"text": "I am asking for the research on Marijuana, especially Medical Marijuana. I have researched history over and over again concerning why Marijuana is still in need of more research. Why Marijuanais listed by the Federal Government as a non medical use drug, classified in the Schedule 1 controlled Substance Act?My History research has lead me to believe that Marijuana was suppose to have been researched as to why Marijuana isa MIRACLE drug (herb is actually what it is) and has actually helped more people then not. According to the Marijuana Tax Act of 1937 and President Nixon Shafer Commission, we the citizensof THE UNITED STATES OF AMERICA and not THE DIVIDED STATES OF AMERICA should be able to understandwhy Marijuana isnt being researched for the pros instead of research of Marijuana being researched for the cons.As History repeats itself usually then realistically Marijuana will always stay at the Federal Governments Schedule 1 controlled Substance Act. I as well as other citizens feel like this is so unjust.I used THE UNITED STATES OF AMERICA versus THE DIVIDED STATES OF AMERICA as an example because of each State being allowed to vote for making Marijuana legal or not. This is VERY UNFAIR, why? I would love to respond bysaying that since each State can decide for itself, then why not my State?  I also can answer by saying that whomeveris in office such as the Governor of the State amongst legislatures, etc. being the people that can make this decisionand not the people who happen to live in that particular State. I am on disability for a variety of health issues. Since the DEA has yet once again interfered with Professional Skilled PainSpecialist deciding on what is best for there patients concerning therapy, injections, Medications, etc. being used by theProfessional Skilled Pain Specialist then this really brings up a HUGE PROBLEM FOR PEOPLE WHOM HAVE HEALTH ISSUES..We the citizens even though we may be disabled for many, many reasons as to how we became disabled still should havethe right to live our life to the best way we can without being in pain 24/7,Depression, Nausea, etc.The WAR ON DRUGS has failed for so many years now, why not do the research of the pros of using Marijuana andallow anyone that has MAJOR health problems ( Yet again brings up the question of weather the DEA is qualified to determinehow badly the MAJOR health problems are with each individual) to be able to have the choice of what to use (within reason)to help control the Pain, Depression, Anxiety, Lack of Sleep, Nausea, PTSD that unfortunately people suffer from.Just imagine how much the Federal Government would save on overcrowding of prisons and the up keep of each prisonerthat has been arrested or still serving time  ( since Marijuana is so harmful to people causing peopleto commit violence, theft, harder drugs, murder, resisting arrest, etc. that some people belong in prison if they are trafficking Marijuana. (Not really, BUT FOR THE SAKE OF TOTAL EMBARRASSMENT ON THE LAW OFFICIALS THAT HAVE ARRESTED THESE INDIVIDUALS.) and also making it almost impossible to get a job with a felony hanging over your headeven after serving the time in jail or prison.Yes, I was being a little sarcastic about Marijuana causing people to commit violence, rape, murder, etc. with the exception ofMarijuana being laced with something off the streets. That my friend is just another point I feel should be made. No onethat has a medical card receiving Medical Marijuana from a Marijuana dispensary should not worry at all that the Marijuanahas been laced or has anything in it that possibly could put someone in danger.To make ABSOLUTELY POSITIVE that the Marijuana being dispensed is not tampered with in any way then thats anotherreason for the Federal Govt to legalize Marijuana or at least de classify Marijuana until further research can be doneas it should have been since the Marijuana Tax Act of 1937 and President Nixon Shafer Commission.One last thought, people have said that younger children could possibly get ahold of Marijuana causing death, well unfortunatelyyounger children can get ahold of Guns, Tylenol lying around on a dresser, alcohol, etc. it all depends on the safety thatyou provide for any younger child. I would much rather prefer should any child (God Forbid) get into something dangerousthat it would be Marijuana versus these other examples given.Thank you for taking the time to read just SOME examples that hopefully can be used or at least thought of when itactually comes down to ending the failing WAR ON DRUGS and realizing that Marijuana is a NATURAL HERB  that Godeven saw fit to grow on this earth that we live in to help people.", "comment_id": "FDA-2015-P-3991-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-P-3991-0011", "comment_date": "2016-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5016}]}, {"id": "FDA-2010-N-0136", "agency": "FDA", "title": "Implementation of the Family Smoking Prevention and Tobacco Control Act Request for Comments (Advance Notice of Proposed Rulemaking)", "update_date": "2022-01-05", "update_time": "01:04:08", "purpose": "Rulemaking", "keywords": ["ctp20103", "family smoking", "tobacco", "CTP"], "comments": [{"text": "I do not think that the outdoor advertising of cigarettes and smokeless tobacco should be regulated. Although I am a non-smoker and do not support the tobacco industry, I am highly against censorship and feel that this form of censorship is inappropriate. It would only set the precedence for other such censorship actions if approved. This is not the answer to controlling the tobacco use.In the background information the FDA cites that this consideration is being made in an effort to protect children and adolescents from the harms caused by tobacco use and, if they are, whether the restrictions under consideration would be justified, lawful, and appropriate.  I believe that any new regulations that implement the proposed steps will only be overturned by a judge anyway. On March 18, 2010, the Food and Drug Administration announced rules that restricted the way the tobacco industry can advertise and sell cigarettes and smokeless tobacco products (Layton, 2010). Among those rules was a requirement for tobacco advertisements to be limited to black text with no graphics except in adult magazines or retail establishments only open to adults (Layton, 2010). Tobacco producer R.J. Reynolds Tobacco and Lorillard challenged the rule on the basis that it violated their first amendment rights. A federal judge later ruled in favor of the argument stating that the company could use imagery and colors to communicate what the product is and who makes it (Layton, 2010). Protecting children and adolescents from the harms of tobacco use should be the parents responsibility, not the governments. One of this countries founding principles is the right to free speech. We violate this by approving the proposed actions and will only set the precedence for such future actions. What is next? The censorship of junk food, fast food, and alcohol?References:Layton, L. (2010). New FDA rules will greatly restrict tobacco advertising and sales. Washington  Post. Retrieved from: http://www.washingtonpost.com/wp-dyn/content/article/2010/03/18/AR2010031803004.html", "comment_id": "FDA-2010-N-0136-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0136-0019", "comment_date": "2010-05-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2110}, {"text": "The FDA is doing the United States a great public service by pursuing the regulation of outdoor advertising ofcigarettes and smokeless tobacco. The youth of America must be protected from advertisement strategies which draw future voters into the dilemma of developing a widely known fatal habit. As developed by Marc C. Willemsen, Dutch Foundation on Smoking and Health we must look to study the relationship between tobacco consumption and tobacco advertising through 1.econometric research on the link between expenditure on advertising and tobacco consumption2.research comparing tobacco consumption within a country before and after an ad ban3.international comparison of trends in tobacco consumption and anti-tobacco measures   A recent meta-analysis of 48 econometric studies found that tobacco advertising significantly increased tobacco sales ([2]). Recent reviews by the United States Institute of Medicine ([3]), the United States Department of Health and Human Services ([4]) and the World Health Organization ([5]) reached the same conclusionIn order to ensure the regulation will not violate the First Amendment because it is not adequately tailored to achieve the substantial state interest of protecting children and adolescents from tobacco products, the FDA must pursue the total ban of outdoor advertisement since it is statistically shown to reduce tobacco consumption by up to 9%.(http://www.globalink.org/en/advertising.shtml)Since it seems the tobacco companies will somehow throw enough money around in court in order to avoid such a crippling business regulation, it would be in the best interest of the United States government to empower cities to deal locally with violations of outdoor ad regulations. Legislation may be needed to force advertisers to honor their pledge to protect children from alcohol and tobacco ads. http://linkinghub.elsevier.com/retrieve/pii/S07493797080050", "comment_id": "FDA-2010-N-0136-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0136-0009", "comment_date": "2010-04-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2085}, {"text": "I agree that restrictions should be placed on tobacco advertisements. According to the CDC, Centers for Disease Control and Prevention, (2000) regulating advertising and promotion, particularly which directed at young people, is very likely to reduce both the prevalence and initiation of smoking. I am for the current age restrictions to purchase tobacco products. However, further restrictions can possibly lower the number of tobacco users.  Advertisements for tobacco products persuade consumers to purchase products that can potentially be life threatening. On average, during 20002004 smoking accounted for an estimated 3.1 million years of potential life lost for males and 2 million years of potential life lost for females annually, excluding deaths from residential fires and adult deaths from secondhand smoke, (Centers for Disease Control and Prevention, CDC, 2009). Tobacco doesnt only affect those people that use the product; it can affect those that are around the product as well. Second hand smoke is very dangerous. Laws forbidding smoking in restaurants is a great regulation and should be carried out nationwide. It is on a person to decide for themselves whether or not they would like to use tobacco. However, it is not up to them to decide for other and that is why those regulations, and this proposal, are very important. References Centers for Disease Control and Prevention. (2000). Smoking and tobacco use: tobacco advertising and promotion. Retrieved April 14, 2010, from http://www.cdc.gov/tobacco/data_statistics/sgr/2000/highlights/advertising/index.htm Centers for Disease Control and Prevention. (2009). Smoking and tobacco use: Smoking-attributable mortality, years of potential life lost, and productivity lossesUnited States, 2000-2004. Retrieved April 14, 2010, from http://www.cdc.gov/tobacco/data_statistics/mmwrs/byyear/2008/mm5745a3/highlights.htm", "comment_id": "FDA-2010-N-0136-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0136-0004", "comment_date": "2010-04-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1969}, {"text": "Another sad day to be an American. The regulations are crippling business and consumers alike. The more I learn the more I realize that honesty, integrity, and morality have left our leaders in every avenue. I still have faith though please reconsider the nicotine requirements on electronic cigarettes. Its sad were not worried about GMOs in our food. Please start helping us and not the special interests. Stand up for whats right.", "comment_id": "FDA-2010-N-0136-0036", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0136-0036", "comment_date": "2013-01-23", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 443}, {"text": "The Family Smoking Prevention and Tobacco Control ActThe Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) is a great start on a problem that should have corrected long ago. Just by the fact that the U.S. continues to allow the smoking industry to operate the way that it does is an insult to all taxpayers. I recently knew a man who passed away from lung cancer as a result of 20+ years of smoking. While he was a friend of mine I was infuriated that he had absolutely no insurance thus the hospital had to pick up the bill and from there the taxpayers in my city had to pay for. Not to mention the passing of the new healthcare reform bill. Personally I feel that advertising for tobacco industries should be severed from public view, on top of that smokers should be limited to where they can smoke to prevent people like myself or an adolescent from inhaling the toxic fumes. Why should the non-smokers have to pay for advertising for tobacco industries or worse their medical bills? I say that the FDA should cross the road less traveled and cease the sales of tobacco products and outlaw them and treat them as any other drug (or poison) that people put into their bodies.", "comment_id": "FDA-2010-N-0136-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0136-0003", "comment_date": "2010-03-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1205}]}, {"id": "FDA-2011-P-0869", "agency": "FDA", "title": "Refuse to File Any New Drug Application (NDA) for Buprenorphine/naloxone Drug Product Unless Such NDA References Suboxone\u00ae, the Sublingual Film Formulation of This Product-CLOSED", "update_date": "2013-11-22", "update_time": "13:02:08", "purpose": "Nonrulemaking", "keywords": ["Film Formulation ", "Sublingual Film Formulation", "Suboxone\u00ae", "NDA ", "Buprenorphine/naloxone ", "Refuse to File ", "cder", "closed"], "comments": [{"text": "na", "comment_id": "FDA-2011-P-0869-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-P-0869-0007", "comment_date": "2013-11-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}]}, {"id": "FDA-2023-D-0466", "agency": "FDA", "title": "Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "update_date": "2023-10-24", "update_time": "12:29:19", "purpose": "Nonrulemaking", "keywords": ["2019-576", "CDRH", "Clinical Considerations for Studies of", "Devices Intended to Treat Opioid Use Disorder", "Draft Guidance for Industry and", "Food and Drug Administration Staff", "Availability", "OPEN"], "comments": [{"text": "Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder", "comment_id": "FDA-2023-D-0466-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0011", "comment_date": "2023-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 84}, {"text": "The FDA has been actively addressing the opioid overdose crisis by taking measures to reduce unnecessary opioid exposure and support OUD treatment so im going to comment related deficiency  the things which not include in scope of this guidance.1.The CDRH is committed to contributing to the efforts to combat this national crisis and offers recommendations to ensure the safety and effectiveness of devices intended to treat OUD in the clinical study design process.2.Some products such as, diagnostic tests for opioid use and devices intended for pain treatment are not falling in this guidance.3.By which pathway Devices Intended to Treat Opioid Use Disorder should be approved is not given.4.Guidance should also report what kind subjects used for clinical study additional provide the information about clinical study plan for devices intended to treat Opioid Use Disorder OSD.", "comment_id": "FDA-2023-D-0466-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0004", "comment_date": "2023-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1107}, {"text": "Comment on Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder", "comment_id": "FDA-2023-D-0466-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0010", "comment_date": "2023-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 95}, {"text": "Non-pharmacological preventative measures to address OUDDetermining cost savings in preventing OUD vs. treating after the fact such as opioid clinics and treatment centers. Determine percentage of patients with unintended OUD at onset of first prescription Determine the financial, battle readiness and phycological impact of OUD in active-duty military and veterans. Ensure any approach is an interdepartmental, interagency process that combined allows a potential solution to move forward unabated allowing it to arrive at a scientific determination of effectiveness. Explore FDA cleared/FDA approved Class II and Class III technologies already in place to provide a non-pharmacological solution to preventing opioid addiction. Protocols applied to known technologies, the evidence shows a lower first dose and subsequent reduction of dosages preventing the need to prescribe a second dose. This suggestion based on direct experience presenting this Opioid Preventive solution to HHS in October 2016 by invitation of Secretary Tom Price. Design a preventative treatment flowchart showing Opioid Preventative oDrug Manufactured and available by prescriptionoPrescribers such as Hospitals, Private Practice, Active Military and VAoPatient who has a injury or diagnosed with acute, subacute or chronic pain. Include post-surgery therapy and treatment of pain. oInsert technology and protocols that demonstrate technologys ability to mitigate the patient issue with pain the number on objective to no more than 30 days oIncludes treatment protocol, treatment frequency, treatment time over a 2-week to 4-week period. Achieved preventing a need to re-prescribe. Protocol that patient feedback adds to measure effectiveness of treatment.oPost treatment assessment showing patient adherence to protocol schedule, initial opioid dosage, reduced dosage over treatment period and overall patient outcome. \uf0a7Estimate impact on US population with an effective preventive solution in place. Some of the areas of focus might be:Reduced costs in managing addition, overdose and suicideMilitary battle readiness and reduction of VA costsLess liability for the physicianLess burden on HHS and its departmentsA Model of leadership that may be followed across the globeAnd the individual quality of life due to preventing vs. treatingSuggest primary focus on prevention readily available, science based and backed by clinical studies, while maintaining the treatment of addiction until the scales of prevention and treatment balance equally until prevention becomes primary and addiction treatment secondary. ", "comment_id": "FDA-2023-D-0466-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0015", "comment_date": "2023-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3632}, {"text": "The FDA has been actively addressing the opioid overdose crisis by taking measures to reduce unnecessary opioid exposure and support OUD treatment so im going to comment related deficiency  the things which not include in scope of this guidance.1.The CDRH is committed to contributing to the efforts to combat this national crisis and offers recommendations to ensure the safety and effectiveness of devices intended to treat OUD in the clinical study design process.2.Some products such as, diagnostic tests for opioid use and devices intended for pain treatment are not falling in this guidance.3.By which pathway Devices Intended to Treat Opioid Use Disorder should be approved is not given.4.Guidance should also report what kind subjects used for clinical study additional provide the information about clinical study plan for devices intended to treat Opioid Use Disorder OSD.", "comment_id": "FDA-2023-D-0466-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0003", "comment_date": "2023-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1107}]}, {"id": "CMS-2019-0111", "agency": "CMS", "title": "Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2020 (CMS-1715-P)", "update_date": "2020-10-16", "update_time": "21:14:52", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Sept 12, 2019Centers for Medicare amp; Medicaid ServicesDepartment of Health and Human ServicesAttention: CMS1715PP.O. Box 8016Baltimore, MD 212448016RE: Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule andOther Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; MedicaidPromoting Interoperability Program Requirements for Eligible Professionals; Establishment of anAmbulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment ofOpioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning ImproperPrescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory OpinionRegulations [CMS-1715-P]Dear Administrator Verma:I am writing in response to the request for comments on the Centers for Medicare and Medicaid Services(CMS) Calendar Year (CY) 2020 Revisions to Payment Policies under the Physician Fee Schedule (PFS)and Other Revisions to Medicare Part B proposed rule.I am a physical therapist assistant and am concerned about this potential regulation change.  Physical therapy and occupational therapy services are critically important for improving patient function in order to return home or maintain their highest level of independence and quality of life.I appreciate the opportunity to provide feedback to CMS on the proposed rule. Specifically, I am writingin response to CMS proposed application of the CQ/CO modifier when outpatient physical therapy andoccupational therapy services are furnished in whole or in part by a physical therapist assistant (PTA) oroccupational therapy assistant (OTA).I understand that Section 53107 of the Bipartisan Budget Act of 2018 (BBA), enacted on February 9,2018, included the assistant adjustment as a pay-for provision related to the repeal of the Medicare Part Bpayment cap for therapy services. However, if finalized as proposed, this policy will negatively affectMedicare beneficiary access and add administrative burden. Further, if the application of the modifiers isfinalized as proposed, the access to and safety of vital outpatient physical and occupational therapyservices for the most vulnerable physically impaired beneficiaries will be compromised.I ask the Secretary to not finalize these policies as proposed. Instead, I am requesting that CMS, infinalizing the therapy assistant adjustment provisions of Section 1834 of the BBA, implement thefollowing policy:1. When a therapist and assistant are jointly furnishing services to a patient at the same time as ateam, and the therapist is fully engaged in the service during that time, the service during thattime period should be identified as a therapists services and be allocated to the therapist.2. That CMS define in whole or in part to mean skilled therapy service furnished by a PTA or anOTA that is furnished under the supervision of a therapist, but independent of any time thetherapist is furnishing the service.3. That only those units of services provided in whole or in part by the assistant should be subjectto the 10% de minimis standard, the CQ/CO modifier, and subsequently the 15% paymentadjustment, not all units of the entire therapy service.4. That no new burdensome documentation requirements be added. At a maximum, sub regulatoryguidance could revised to include a statement such as The provider should have a mechanism inplace to provide evidence whether a specific service was furnished independently by a therapistor an assistant, or was furnished in part by an assistant in sufficient detail to permit thedetermination of whether the de minimis threshold was met.Thank you for the opportunity to comment on the CY 2020 Medicare Physician Fee Schedule andproposed rule.Sincerely,Alvin FallPTA", "comment_id": "CMS-2019-0111-6442", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6442", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4096}, {"text": "I am writing in strong support of CMS efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as other members of the medical team, which may lead to unnecessary confusion. Rather than stating that the documentation of students can be verified, the term medical, PA, and NP students should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6412", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6412", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1988}, {"text": "I am writing in strong support of CMS efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as other members of the medical team, which may lead to unnecessary confusion. Rather than stating that the documentation of students can be verified, the term medical, PA, and NP students should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6590", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6590", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1972}, {"text": "Thank you for recognizing and addressing the disparity between student documentation requirements for teaching physicians and their students and those for advanced practice nurses (APRNs) and physician assistants (PAs) preceptors and their students. Currently, CMS allows teaching physicians to review and verify any student documentation of the components of E/M services in the medical record, rather than re-document the work. However, this burden reduction policy was not applied to APRN/PA preceptors and their students. Excluding APRN/PA preceptors and their students from this policy had the unintended effect of heightening the challenge of securing preceptors for APRN/PA students when teaching clinicians are in short supply. The revision contained in the Medicare Physician Fee Schedule proposed rule will authorize all APRNs /PAs and physicians to review and verify rather than re-document work for all E/M services by all members of the medical care team (including APRN/PA students). This will remove the disparity and lead to parity among providers and burden reduction for all clinicians. Therefore, we support the inclusion of APRN/PAs in the proposed rule.For additional information, please contact the AANP Government Affairs Office at 703/740-2529 or governmentaffairs@aanp.org.", "comment_id": "CMS-2019-0111-6713", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6713", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1348}, {"text": "As a physical therapist and employer of 5 Physical Therapists assistants, I urge the payment policy be reviewed and deemed not beneficial for patient care.  The use of physical therapists assistants in the healthcare world is vital for efficiency and quality.  The proposed decrease in reimbursement will negatively impact employment and likely lead to additional shortages of rehab professionals through the country.  I fully understand the need for cost containment however strongly disagree with this methodology. I urge your committee or group to reconsider the payment reduction.Sincerely, Joe Walters PTOwner, Physical Therapy OnePortage, MI 49024   ", "comment_id": "CMS-2019-0111-6706", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6706", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 671}, {"text": "I am writing in strong support of CMS efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as other members of the medical team, which may lead to unnecessary confusion. Rather than stating that the documentation of students can be verified, the term medical, PA, and NP students should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6705", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6705", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1972}, {"text": "CMS, I strongly disagree with the CY 2020 Medicare Physician Fee Schedule Proposed Rule update to certain CPT codes for cardiac PET Imaging (CPT codes 78491, 78492, 78x31, 78x32).  I disagree with this policy as it is based off of incorrect data and observation. It appears that inaccurate overhead data, a lack of thorough survey inputs and non-real world assumptions have caused Medicare and the RUC to recommend changes to the work inputs associated with Direct Expense and Practice Expense values, that combined with an inaccurate utilization rate resulted in a proposed reimbursement decline that is significant enough to make it impossible for facilities to continue to offer cardiac PET services after January 1, 2020.The RUC and Medicare relied on market survey data to provide inputs for calculating the technical component (TC) reimbursement. These flawed surveys provided incorrect data or incomplete data regarding equipment direct expense, utilization rate, and practice expense inputs.  In addition, the surveys failed to assess the true cost of starting, operating, and maintaining a cardiac PET lab, omitting input allowances for numerous high cost requirements.  Therefore, based on this flawed survey data, both the RUC and Medicare recommended a reimbursement value well below what is necessary for the technical operation of a cardiac PET laboratory.  I request that CMS NOT commence with the proposed reimbursement in 2020 and instead allow reimbursement to continue at current levels.", "comment_id": "CMS-2019-0111-6759", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6759", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1543}, {"text": "Dear Administrator Verma,RE: CMS-2019-0111-0092I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC). This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA. This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing the patients anesthesia professional to have familiarity with the patients health characteristics and medical history.  In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.  Thank you for taking the time to review these comments.Sincerely,Pamela Thurman726 Marina Village DrGrand Rivers, KY 42045-9010  ", "comment_id": "CMS-2019-0111-6644", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6644", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1838}, {"text": "Dear Administrator Verma,RE: CMS-2019-0111-0092I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC). This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA. This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing the patients anesthesia professional to have familiarity with the patients health characteristics and medical history.  In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.Sincerely,Ursula Waller128 Marshall RdBuckhead, GA 30625-2906  ", "comment_id": "CMS-2019-0111-6631", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6631", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1770}, {"text": "Dear Administrator Verma,RE: CMS-2019-0111-0092I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC). This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA. This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing the patients anesthesia professional to have familiarity with the patients health characteristics and medical history.  In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.Sincerely,Jaclyn Taylor108 S Elmhurst AveMount Prospect, IL 60056-3125  ", "comment_id": "CMS-2019-0111-6629", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6629", "comment_date": "2019-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1779}]}, {"id": "FDA-2018-D-1334", "agency": "FDA", "title": "Opioid Dependence:  Developing Depot Buprenorphine Products for Treatment", "update_date": "2019-02-07", "update_time": "10:53:56", "purpose": "Nonrulemaking", "keywords": ["Opioid Use Disorder", "Developing Depot Buprenorphine", "Products for Treatment", "open", "cder", "2017-1067", "2018-1008", "Opioid Use Disorder", "Developing Depot Buprenorphine", "Products for Treatment", "open", "cder"], "comments": [{"text": "With our rapidly changing society and health care system, opioid addiction has become a major problem all over the United States. The use of depot buprenorphine is one solution to help in decreasing opioid dependence. With the trial being a controlled, blinded study testing the doses seemed to prove to help. The patients that were tested with different characteristics such as new participants to treatment, the already stable patients like if the patient has a relapse, and patients that are not very like to prove effectiveness. Patients that are being seen at least weekly help to keep the studies current and allow for adjusting the dosages to better help to decrease the dependence on opioids. Since they are being checked weekly, it helps to build rapport with the patients making them more willing to come forward with what opioids they may have taken. The endpoints for patients help to better determine the studies effectiveness. With the reduction of cravings, improvement in sleep or mood, or other reported outcomes better helps to demonstrate the benefit of the depot buprenorphine. With the information about cravings, sleep, and mood this could lead to more products like buprenorphine being approved. One study done that was randomized with 428 participants. Forty-eight participants had a reaction at the injection site. With the buprenorphine 17.4% had a good response and 14.4% had a good response with the placebo. (Lofwall  et. el, 2018) If this only helps a few people with opioid dependence it would be worth it. Plus with more studies done it can help even more.Lofwall  et el. (2018). Weekly and monthly subcutaneous buprenorphine depot formations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: a randomized clinical trial. JAMA Inter Med. 1;178(6):764-73. doi: 10.1001/jamainternmed.2018.1052.", "comment_id": "FDA-2018-D-1334-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1334-0005", "comment_date": "2018-07-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1880}]}, {"id": "CDC-2015-0045", "agency": "CDC", "title": "Medical Examination of Aliens-Revisions to Medical Screening Process", "update_date": "2015-08-24", "update_time": "10:30:17", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Additionally, HIV prevention strategies such as male circumcision may be playing a role, although definitive studies of this effect are still pending.The practice of surgery on functioning and vital organ of a male infant who is too young to consent is barbaric. Mass genital mutilation to prevent the spread of HIV is a solution worse than its problem. In the former case, you have an innocent child robbed of sexual pleasure, possibly deformed, exposed to the risks of an unnecessary surgery, all for an unproven benefit. In the latter case, a grown adult has had opportunity for education about HIV, can reduce risk with barrier methods, and in the end can choose to have sex with only a few safe partners instead of wanton promiscuity. HIV is an insignificant problem for intelligent adults who take responsibility for their own actions and is a sham justification for an outdated and unethical religious practice.  ", "comment_id": "CDC-2015-0045-0006", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0045-0006", "comment_date": "2015-08-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Md", "comment_length": 942}, {"text": "every single exclusion should stand as not being allowed in thos this country. in addtiohn, ebola and lassa and investigation of other horrific diseases also need to be added. I am shockedat the lazy, inept, stupid way this list was formed so that all kinds of disease are brought into this country so that taxpayrs can bears the brunt of payingfor the medical treatment of all these sneaking leaching lawbreaking aliens. none of them have any health documents and this agency seems to be saying welcome and well let American taxpaeyrs pay all your expenses. what a horrible idea for American taxpayers/citizens. we are being pauperized by ththe stupidity and ineptness of this agency. hiv should not be let into this country so they can become a public ward. let their own countries pay for their problems. we dont want hem here. they didnt get it here so lket them have it treated in their own country where they got this disease. why let in diseased people?  taxpayers in America are being gouged over and overand over again for these sick and diseased foreigners. we simply cannot pay for the entire world. these diseased people are a real threat to America and the American people. why would you let in unvaccinated childrenunder ten to bring disease in to our kids, who are pretty healthy. no way should American taxpayers be paying the medi cal bills of all thjese potential immigrans. they need to pay their own medical bills before they gethere to show fitness to come here. these freed rides need to stop. American citizens dont get them. we are gouged for every sinof medical care we get. we dont get freebies. we pay and pay and pay. cdc  has been proven and is notorious for being politcail hacks with no real concern for medicine.  they want ot let alien immigrants have a free pass and yet own the bodies of all American citizens. the problem is withthe health of the immigrants, not here. this ount of control leaching by aliens is outrageous. it is also time to shut down diverswity imigrants entirely. we have more than enough diversity in the usa with people here from every country on earth. we dont need any more diversity. in fact its hard to fina fellow American anymore. letting in Chinese from yulin for example means we have to worry about whether our cats and dogs are being served as food. we need to select foreigners who we want to let in , not jjuust let in any old culture with bad habits. the tps people have been here 20 years fro Honduras and theirdisaster evaporated ten years ago and yet political chicnanery still has them here. 20 years is not tempoirary. add ebols and lass to the list and start examining what other diseases need to be added to this list. there was no public comment when you took hiv off the list and it is time for this issue to be decided again. I see no reason for making American taxpayers into saps for the diseases of those who caused themselves to be sick with hiv from insane sex practices. keep out the hivs. cdc pulled a fast one on the American public on changing the hiv status and prevented public comment on this. also to say a disease isnt reported does not mean it is not present. us doctorsare notorioiusly deficient in sending reports of diseases. they dont send in anything. your information collection from them is notoriuosjy insufficient. all kids under ten from foreign countries who seek to come here need to be fully vaccinated. they bring diseases ijnto places lke Disney world and land to cause diseases in aemrican kids. cdc is fully political and not rtruly health wise at all. you are more lax with foreigners.  cdc cuases muchfinancial harm to American taxpayers. your chart in this proposal is vacuous, inept and meaningless. I am shocked at how inept and inaccurate this proposal is. your staff needs to befired and you need more accuracy in what you do at the cdc. this agency is so busy hiding out from the American public and answering no questions that it  has affected the insane thinking at this edivision. ", "comment_id": "CDC-2015-0045-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0045-0002", "comment_date": "2015-06-29", "comment_time": "04:00:00", "commenter_fname": "Jean", "commenter_lname": "Publi", "comment_length": 4115}, {"text": "The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is amending its regulations that govern medical examinations that aliens must undergo before they may be admitted to the United States. While I agree with most of the newly proposed rule, there are parts that are troublesome to me. One particular part is The HHS/CDC is amending the definition of communicable disease of public health significance. They are actually removing some of the diseases they have been testing for off the list. I would protest this intensely. The HHS/CDC is also amending the provisions that describe the scope of the medical examination for aliens by incorporating a more flexible, risk-based approach, based on medical and epidemiologic factors. I also would disagree with this section of the rule also.In this day and age, removing known communicable diseases from the CDC short list could be potentially dangerous. With the threat of easily spread disease like EBOLA, Bird and Swine Flu, and many, many, others the time to even more vigilant could not be more imperative. Be easing restrictions on disease testing and shortening the list, you run the potential disaster or outbreak scenario happening. Aliens must tested stringently, including extensive medical examinations to prevent these nightmare scenarios. Its time tighten these policies, not loosen them. While most of the proposed Rule is sound, these two items are the most troubling in my opinion.", "comment_id": "CDC-2015-0045-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0045-0003", "comment_date": "2015-06-29", "comment_time": "04:00:00", "commenter_fname": "Jason", "commenter_lname": "Priest", "comment_length": 1521}, {"text": "While I understand the need to adjust the health regulations for aliens of the United States, it seems this rule takes it a bit too far. As we all should know, scientific knowledge has improved, and will continue to improve drastically overtime. Thus, medical advances have been made possible, and many diseases are not nearly as contagious and deadly as they used to be. However, by revoking such diseases as syphilis, leprosy, and gonorrhea of communicable disease status, that may lead to a lessening of preventative measures taken in order to prevent such diseases as may have been previously used. These diseases are still going to have public health significance, especially if they are thought of as diseases that will not cause any danger. For example, if one individual thinks nothing of his/her STD and assumes his/her sexual partner will not catch the STD or that if they do, it will taper off on its own, that individual will likely spare themselves the embarrassment and carry on without notifying the partner. Then, if the partner catches it, never realizes, or does realize it and doesnt think much of it, this entire process carries on. It is too risky to the public good to downgrade the urgency of these types of preventable diseases. As an American-born citizen, I can say with the utmost confidence that I would appreciate aliens going through extensive health screenings before entering the nation or coming in contact with fellow Americans. In history, there are countless occurrences of plagues taking over nations and killing off much of the populations. Whilst I know medical technologies have drastically advanced since these days, I also believe that there are many diseases that have not even been introduced yet and it is important to continue the current procedure in order to ensure nothing new plagues the nation. As far as foreign vaccinations go, I would suggest that all foreign aliens be required to receive all the same required vaccinations that Americans receive if they want to be a part of this nation. This goes back to the same reasoning of not wanting a new, foreign disease to somehow be introduced to the American people, most if not all of whom would not be immune to such. I would assert that a proof of vaccination from their home country is unnecessary because I would suggest giving them vaccinations anyways, as you cannot always trust they would present legitimate certificates or that the doctors operated in professional, sterile environments. With all these new regulations and requirements being proposed, I would personally assert these standards to all immigrants: 1) if their intentions for coming into the US is for work and opportunity, they should at least be near the American health average. Treat them as American citizens are treated. Hold everyone to the same standard. 2) if their intentions for immigrating to the US is for better healthcare and a doctor who holds the skill set to potentially save their life (which is certainly a valid possibility) from a disease for which their native doctors have little to no treatment/cure, make sure they are properly insured in their country so as not to cost American taxpayers money for services which will not benefit them. ", "comment_id": "CDC-2015-0045-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0045-0004", "comment_date": "2015-07-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3268}]}, {"id": "TTB-2016-0004", "agency": "TTB", "title": "Amendments to Streamline Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes and Facilitate Use of the International Trade Data System ", "update_date": "2016-12-22", "update_time": "10:21:49", "purpose": "Rulemaking", "keywords": ["alcohol", "distilled spirits", "wine", "beer", "malt beverages", "tobacco", "cigarettes", "imports", "recordkeeping", "tobacco products", "processed tobacco", "International Trade Data System", "ITDS", "Customs and Border Protection", "CBP", "Customs", "importation"], "comments": [{"text": "If we have to enter TTB approval number for each line on the entry, it will be too much time required for our broker to clear our shipment.  Or they will charge a lot more money to do so, and this shouldnt happen.Please remove the requirement for the brokers to have to enter the TTB for each line on the entry as part of the PGA message set.", "comment_id": "TTB-2016-0004-0005", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0004-0005", "comment_date": "2016-08-15", "comment_time": "04:00:00", "commenter_fname": "Carey", "commenter_lname": "Weiss", "comment_length": 367}]}, {"id": "FDA-2017-N-6529", "agency": "FDA", "title": "FDA\u2019s Approach to Evaluating Nicotine Replacement Therapies; Public Hearing; Request for Comments", "update_date": "2018-03-05", "update_time": "14:28:15", "purpose": "Nonrulemaking", "keywords": ["CTP", "2017-1029", "Nicotine Replacement Therapies"], "comments": [{"text": "Comments on IQOS. Existing Cigarettes Cause Death and Cancer. IQOS has a lot less risk than normal cigarettes.It is Nicotine! I am for the Philip Morris IQOS.  It doesnt have all the nasty cigarette stuff in it.  Also if you think you are going to lower nicotine amounts incigarettes good luck, when that happens the Mexican Sinaloa Drug Cartel will smuggle in Nicotine in the USA just as theydo Meth, Cocaine, Ecstasy, and Marijuana and other Drugs. The Culiacn  Mexican Drug cartel will smuggle it in the USAwhen you lower the amount of nicotine in cigarettes you will create a black market.  Did you know the Sinaloa Drug cartel gets 25% of their profits from Marijuana that they smuggle into the USA???  Interesting huh.  I learned all of this on Netflix check it out sometime.I dont think the government wants to enrich the Mexican Drug with the ban or lowering the level of Nicotine in Cigarettes.If you do lower it, its not rocket science you will create a black market and the Sinaloa Drug Cartel will bring in the nicotine.Well see what happens.....By the way...I dont do any drugs never have and never will...I am just smarter than the average person in America!", "comment_id": "FDA-2017-N-6529-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0015", "comment_date": "2018-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1252}, {"text": "After reading a small portion (plus a synopsis) of the 590 page study released last week from the National Academies on Public Health Consequences of E-Cigarettes [ http://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes ] I am convinced the Royal College of Physicians was correct and our CDC was not thinking in the best interest of all Americans. Yes the report suggests there may be some potential risks associated with e-cigarettes, but they found sufficient research to suggest that, compared with combustible tobacco cigarettes, e-cigarettes contain fewer toxicants; can deliver nicotine in a manner similar to combustible tobacco cigarettes; show significantly less biological activity in a number of in vitro, animal, and human systems; and might be useful as a cessation aid in smokers who use e-cigarettes exclusively. I think the potential risks from flavorings with any diacetyl, acetoin or acetyl propiony components need further evaluation. Is 0.05% mortally harmful or 5.0%? What are the acceptable ppm that we might inhale here and explain it in comparison to walking down a crowded street in New York City where I live. I dont want to only hear about the AWFUL DANGERS, I WANT TO KNOW HOW THAT COMPARES IN RELATIONSHIP TO THE MANY OTHER RISKS WHICH ARE NOT SCRUTINIZED TO THIS LEVEL.  Should the vaping industry only offer, as some companies who focus on ejuice flavorings never include these trace elements (Purilum, Flavor Revolution are two, Loranns does not. Within The Flavor Apprentice, a person must look at each product to find out, or simply look at the FLAVOR BLACKLIST on DIY EJUICE RECIPE WEBSITES )  I do believe that vapers can live without the potential risk of a cinnamon, as it is made as a flavoring today, just to give you one example. But should you restrict such simple flavors as Flavorahs Apricot, Banana or Brie Cheese? NO. Which also makes me remind you that potassium supplements bout OTC and not evaluated by the FDA are not Bananas, yet the 3% (?) of the tobacco leaf that is Nicotine is Tobacco????  The true addition of cigarettes stems from a multitude of ingredients, one addictive portion, adding another layer to the next. If Nicotine is the 3%, what is that next component called with is know as the 4th  5th % which many people trying to quit add to ejuice because they need that chemical too? WTDs or something like that. I believe that is a more addictive component both physically and psychologically. Nic Salts are another consideration. Regardless, Vaping is not smoking as the CLEAN INDOOR AIRr ACT OF NYS HAS NOT DELINEATED. I personally started my journey as a vaper using the Juul device a friend thought I would benefit and it truly did work... but a year into it, I noticed I needed 1 more box of 4 pods a month. I switched to a simple Innokin mod and Naked100s Amazing Mango at 6mg. Today, I might vape anywhere from ZERO to 6 mg/ml strength ejuice and never more than 90ML a week. Im at the point 30 months into vaping, I could stop... I dont chose to and my physician of 26 years, an Assoc Prof at NYU is pleased with my decision. I do not believe we should restrict the flavors for any other reason until they have independently documented and confirmed by a second un-related source harm. VAPING IS MORE SUCCESSFUL THAN ANY NRT AVAILABLE TODAY AT GETTING CURRENT SMOKERS TO STOP LIGHTING UP AND REMAIN COMBUSTION FREE BEYOND 6 MONTHS, BEYOND 1 YEAR... None of the approved NRTs have a success rate that is significantly higher than a persons choice to go Cold Turkey. One reason vaping has been so successful, is the variety of choice to match each individuals personal taste bud. If you return to the range of Regular Tobacco Flavors or depth of Menthol as a flavoring thinking, you will be opening the door for a new Cartel as opposed to the many Small Businesses, the back-bone of American inspiration and dedication, who keep this marketplace competitive. I WAS VERY PLEASED TO FINALLY HEAR AN AMERICAN VOICE, BESIDES HARVARDS TOBACCO HARM REDUCTION SUPPORTERS, SAY THIS:Thus, among adult populations, the Report states, to the extent that e-cigarette use promotes either reduction or complete abstinence from combustible tobacco smoking, e-cigarettes may help to reduce health risks. E-cigarettes could similarly reduce risks to youth who take up e-cigarettes instead of combustible tobacco cigarettes.So, in summary, please back off the vaping industry with all your stigmatized prejudice and start taking action to save more lives.", "comment_id": "FDA-2017-N-6529-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0019", "comment_date": "2018-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4713}, {"text": "Furthermore, giving individual buproprion with the nicotine patch is a good idea because the nicotine patch alone abstinence rate is 32%; whereas, wellbutrin combined with a nicotine patch increases abstinence rates to 50%. However, since wellbutrin is only prescribed by physicians including physicians in the FDA new NRT policy is essential.", "comment_id": "FDA-2017-N-6529-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0021", "comment_date": "2018-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 343}, {"text": "As a mental health provider, I have seen first hand the harrowing effects of nicotine on health as well as anxiety and mood.  Most of my patients desire to quit, they just dont know how or need NRT to assist them in being successful. I have seen great benefit from the patch combined with lozenges and gum on smoking cessation.  Unfortunately, many insurance companies will not cover the cost of these modalities and in the underserved and marginalized population that I serve, they  simply cannot financially manage the cost of NRT out of pocket.  This is a community health concern, and the negative effects of smoking are utilizing  significant tax dollars in managing the medical co-morbidities that come as an after effect of nicotine use.  ", "comment_id": "FDA-2017-N-6529-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0022", "comment_date": "2018-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 751}, {"text": "Has the FDA been in talks with 22nd Century Group, Inc. about their very low nicotine combustible cigarettes? Would the FDA sponsor these products in effort to promote smokers the ability to quit?", "comment_id": "FDA-2017-N-6529-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0014", "comment_date": "2018-01-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 196}, {"text": "Representing ATTUDs comments on Nicotine Replacement Therapies", "comment_id": "FDA-2017-N-6529-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0040", "comment_date": "2018-02-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 67}, {"text": "It seems that there is continuing research that shows that switching smokers to cigarettes with very low nicotine levels may be the most effective way of alleviating the addiction to cigarettes.  Can you share the results of the FDAs study into Very Low Nicotine cigarettes and give us an update on the status of regulating nicotine levels in cigarettes to non-addictive levels?  Also, will you be regulating the nicotine levels in smokeless tobacco as well, as this is a market with an addiction problem as well.  I thank you for your time.  ", "comment_id": "FDA-2017-N-6529-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0009", "comment_date": "2018-01-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 548}, {"text": "Good Evening,I want to applaud your efforts, time and resources to allow a low nicotine cigarettes to become available to everyone who are trying to quit but still have the need to have a cigarette in their hand. My grandma used a patch and tried the gum and it was unsuccessful for her. She enjoyed having that cigarette  in her hand and I know if she was alive today I truly think the spectrum cigarette would have been a successful path for her quitting smoking for good but unfortunately she passed from cancer due to her past habit:(22nd century has what society needs and that is the lowest nicotine cigarette. The science has proven this is capable its in your hands to make it become available to the people that want and need to stop.Thank you Kami", "comment_id": "FDA-2017-N-6529-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0006", "comment_date": "2017-12-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 789}, {"text": "Provide a clear statement of whether you support or oppose the proposed rule or guidance.LEAVE OUR CIGARETTE TOBACCO ALONE......STOP WASTING TAXPAYERS MONEY ON DESTROYING AMERICANS FREEDOM OF CHOICE.......THE ALTERNATIVES ARE .....NOT.....WHAT....WE.....WANT......Include any of the following that support your position:    data= ANY TIME THE GOVT IS INVOLVED IN OUR FREEDOM OF CHOICE, PER THE CONSTITUTION.....THERE IS ALWAYS A SEVERE PROBLEM.........    research......OUR CHOICE, NOT YOURS........    analysis....SUPPOSED HELPING THE CHILDREN......GREAT COMMUNIST TALKING POINTS......THE MORE YOU STIR THE POT, THE MORE IT STINKS........HUMAN NATURE, WHEN YOU MAKE A BIG DEAL OUT OF SOMETHING, CHILDREN WILL .....ALWAYS.....MIGRATE TOWARDS IT.   IF YOU (GOVERNMENT) WOULD GET OUT OF THE AMERICAN PEOPLES PERSONAL BUSINESS, THERE WOULD BE NO NEED FOR PROGRAMS SUCH AS: WAR ON DRUGS, AND 1,000 OTHER GOVT WASTEFUL PROGRAMS........", "comment_id": "FDA-2017-N-6529-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0013", "comment_date": "2018-01-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1034}, {"text": "To have an addiction to smoking is an issue that is very common and an issue that is rapidly growing and affecting younger ages. Statistics even show that the average age for a new smoker is 13 (Illinois Dept. of Public Health). Millions are affected by smoking, more and 16 million Americans alone are suffering from diseases caused by smoking (CDC, 2017). Taking the initiative to reach out to the public to bring an idea together to tackle this issue is a great idea. As said, the first plan of action by the FDA is to look into reducing nicotine levels in cigarettes to a minimal and non-addictive amount. This is a great start and I believe that the first action should be a major one in order to actually make an impact on the publics health and those who need this change. The plan to increase access to replacements for nicotine and access to therapy is also a major step that will help in the process to impact the public in a positive and major way. Much of the public is not exposed to opportunities to reach out for therapy, and its possible much of the public is not educated on what replacements there are in order to help. But most importantly, there are communities that arent even aware of how important it is to seek a replacement and/or therapy. Many people are ignorant to the consequences of smoking and this is something that should be emphasized when advertising any therapy programs", "comment_id": "FDA-2017-N-6529-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0007", "comment_date": "2017-12-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1416}]}, {"id": "EPA-HQ-OPP-2021-0409", "agency": "EPA", "title": "Petition to Cancel Seresto Registration; Notice of Availability", "update_date": "2023-07-13", "update_time": "14:44:28", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I lost 2 of my dogs within 2 months of using this product both to organ failure and they were healthy prior so it came as a complete surprise. This is terrible and I feel very upset that the government would allow unsafe products ", "comment_id": "EPA-HQ-OPP-2021-0409-0024", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0024", "comment_date": "2021-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 230}, {"text": "my name is jerry kurtz,i had a beautiful male presa canario named baron.he was a perfectly healthy dog.when he was a year old,i put a seresto collar on him,12 hours later he had a massive seizure.i took him that morning to my vet,he said he had a seizure.i questioned him,how come my dog had a seizure after putting on this collar.he put him on an animal seizure pill.they kept getting worse.i took him to the best animal hospital in akron ohio.he spent the night.the vet told me he he had epilepsy,they put him on a human drug.he kepy getting worse.he was on on 2 animal seizure drugs,and a human seizure drug.his seizures kept getting worse.he had 14 back to back seizures on 10-29-2019,he was born on 4-28-2017.he was 2 and a half years old.i loaded my best friend into my pickup truck having a massive seizure,he was 135 pounds,and took him to my vet,and had him put down,he was 2 and a half years old.isnt it kinda strange,i had a perfectly healthy dog,12 hours later after putting the seresto collar on him,he had a massive seizure.i had over 8 thousand dollars worth of vet bills and pills,that doesnt include having him creamated,or the 2 thousand dollars i paid for him.please take these collars off of the shelves,so no one else has to go through what i did.thank you,jerry kurtz.", "comment_id": "EPA-HQ-OPP-2021-0409-0036", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0036", "comment_date": "2021-07-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1290}, {"text": "Hello, this comment is to support the withdrawal of Seresto (and similar products) from the market. My family lives in rural coastal CA. This is about our 11 year old Pesto. Bad fleas this year. Typically we havent treated him in the past and he mostly just scratched. About 4-5 years ago we had Seresto for the first time and he only wore it about a week and then we thought his bad skin area above the tail was getting worse so we took it off. In June 2021 we needed to help him and us as we were all getting bit more than normal So on Tuesday June 22, 2021 evening I put his new and not counterfeit Seresto collar on him per instructions. I was looking forward to the end of our flea misery. Instead on Thursday afternoon he began limping a little and by the evening, 48hr after Seresto, he could not walk all of a sudden. (Video 1) I am so glad I put it together and googled. Immediately alarmed by the reports, I took it off and wiped him with wet towel, offered water which he didnt want. I let him rest, about 15 min without collar he got up and drank water. About 2 hrs later he moved better. Next morning he walked almost normally! I washed him and 24 hrs after collar was taken off, he even chased a tennis ball happily. This is a clear confirmation of the immediate negative and positive response of his body to the pesticides in the collar when used and when taken off. I am mad that this is allowed to happen, and any warnings are mentioned just as minor skin irritation. Underneath the animal skin, their body is being poisoned The product should be taken off the market, and not just for the sake of the animals, but us humans too. We have small kids, everyone touches his coat, there is no way to avoid touching the collar, having the powder spread on household couch/bed fabrics etc.Thanks for your effort to prevent more animal deaths from use of the dangerous pesticides.Jana Zucchi", "comment_id": "EPA-HQ-OPP-2021-0409-0032", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0032", "comment_date": "2021-07-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1965}, {"text": "Einstein was a 4.2lb, 2 yr old lively and healthy Maltese. Around May 2018, his prior vet put him on Bravecto (Merck)  Interceptor (Elanco) when he was 5 months and weighed less than 3.5lbs. A new vet in July 2019, told me Einstein didnt meet the weight requirement and recommended Seresto collar for small dogs. Seresto collar for small dogs is up to 18lbs. I dont believe that a 4lb dog metabolizes medication the way a 18lb dog does. How does a licensed vet not know that Einstein who weighed under 4lbs at the time should not take Bravecto?! We dont give the same flu shot dosage to a 5 yr old and a 30 yr old. Around April 2019, Einstein wore the Seresto collar. May 2019, Einstein developed skin issues. These appeared to be one-offs so I didnt make the connection and neither did the vets. June 2019, he began to circle often during his walks and at times, lose balance when he attempted to relieve himself. His circling, energy level, decrease in appetite, nausea and loss of balance continued to increase to warrant a vet visit on July 11, 2019. On July 16, 2019, I reported to the vet Einstein slept with his head against the wall.By mid-to-late July 2019, Einstein would fall trying to urinate because of his frequent circling. Other symptoms included coughing, shivers/tremors, not eating, and physical weakness. Physical exams were done, medications added with no relief. July 29, 2019, we were referred to a neurologist for possible Shaker syndrome. At this point, Einstein at 3lbs, could barely walk.On August 1, 2019, Einstein went to a neurologist to have a MRI/CSF. MRI/CSF results showed obvious brain inflammation/damage to include partial vision loss. Einstein was monitored overnight at the hospital and by next afternoon, he was able to balance enough that he could walk. Einstein had to take daily medications - immunosuppressive and chemotherapy drugs: Prednisolone and Cyclosporine twice/day and every 3-4 weeks, Cytosar.November 25, 2019, Einstein had his second MRI that revealed brain atrophy and enlargement of the right lateral ventricle, essentially a slight improvement from his initial MRI but persistent inflammation still there. Because I wanted to protect Einstein and do my best to keep him healthy and the vet and the neurologist said it was ok, I put a Seresto collar on him in approximately December 29, 2019. By early January 2020 Einstein again lost his balance, started circling and developed a severe head tilt. I took off his collar as soon as I could as I suspected it was Seresto.His symptoms were deemed to be progressing. Einstein wasnt improving much after his treatment and subsequently added another medication, Leflunomide in February 2020. Einstein lost the use of his hind legs and I rushed him to the neurologist on February 7, 2020, where the neurologist determined that multifocal was worse on his left brainstem and MUE continued to progress. Our follow up visit on February 10, 2020 was mostly observation of Einstein and to discuss other treatments, medications and potential outcome. A consultation included an oncologist for potential radiation therapy but determined the success rate would be low. The neurologist gave Einstein less than 25% survival and predicted that seizures would appear soon and ultimately kill him. Like Johnson  Johnson and Purdue Pharma, Bayer/Elanco need to be fined for their negligence and lack of accountability, transparency and ethics/. Studies have shown that the collar is also harmful to humans. If Seresto collars were meant for kids, it would be off the market and class action lawsuits, wrongful death claims would already be filed. All of us consider our dogs to be family, not like family. I have lost a family member, akin to a child. I know without a doubt that if I did not put his collar on, he would be alive AND healthy. Seresto, Bayer, Elanco et al are negligent. They knowingly knew or shouldve known the harmful chemicals used for the collar induced negative side effects in dogs and humans to a degree that it shouldve been deemed adverse to the point that in good conscience for the safety of the public, should not have been available. But they ignored this and put the product into market, misleading consumers to believing the product passed rigorous tests and therefore, safe. The lack of integrity caused emotional and physical distress and death of a living being. So, please, I ask...I demand...I need Seresto off the market for good. ", "comment_id": "EPA-HQ-OPP-2021-0409-0031", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0031", "comment_date": "2021-07-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4626}, {"text": "I have 2 dogs, ages 9 and 5. They have both been perfectly healthy up until last month when I put new serresto collars on them both ( purchased from Chewy.com). Within a few days, our older smaller dog started presenting very strange paranoid behaviors which are still occurring. ( I just took collars off them both today).She randomly runs away with her tail underneath her and hides which is extremely abnormal for our normally happy and affectionate little love. Both dogs have been on and off throwing up, with our younger guy coughing and hacking a lot. Serresto works for keeping fleas and ticks at bay, but it certainly is not worth the life of my pets.", "comment_id": "EPA-HQ-OPP-2021-0409-0035", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0035", "comment_date": "2021-07-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 660}, {"text": "This is just another avenue of science deniers plying the public with misinformation to cause fear over another flea medicine. The issue is with counterfeit products and that is where the focus should be. ", "comment_id": "EPA-HQ-OPP-2021-0409-0073", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0073", "comment_date": "2021-08-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 205}, {"text": "I hope they take this product off the Market. My dog was so sick with vomiting. We took the coller off and in a couple of hours he was better. Worse stuff ever. And I handle my dogs and I was felling ill.", "comment_id": "EPA-HQ-OPP-2021-0409-0229", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0229", "comment_date": "2021-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 204}, {"text": "This is such a danger to animal well being.Ive seen many dogs with reactions as I own a pet care service and handle many different pets. ", "comment_id": "EPA-HQ-OPP-2021-0409-0176", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0176", "comment_date": "2021-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 149}, {"text": "The EPA has historically failed pets.  I hope that you will do the right thing cancel the Seresto registration before more pets die or become ill.  It is senseless and inexcusable that approx. 1700 beloved pets have died due to this product.  How many class action lawsuits and complaints need to be filed before you take action?  The chemicals in these collars are dangerous.  The company is about profit and is clearly not going to do the right thing.  You need to act now.", "comment_id": "EPA-HQ-OPP-2021-0409-0177", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0177", "comment_date": "2021-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 475}, {"text": "please discontinue use of seresto collars.  These chemicals are dangerous and not beneficial to the environment we live in.", "comment_id": "EPA-HQ-OPP-2021-0409-0179", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2021-0409-0179", "comment_date": "2021-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 123}]}, {"id": "FDA-2017-D-2497", "agency": "FDA", "title": "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids", "update_date": "2018-01-29", "update_time": "14:06:44", "purpose": "Nonrulemaking", "keywords": ["2017-313"], "comments": [{"text": "HiDear Sir and MadomI am a acupuncturist work in Virginia. acupuncture is works. I help many patient out pain or chronic pain with acupuncture. They wrote the story for me before. I put it in attachment as follow, may help you make the decision", "comment_id": "FDA-2017-D-2497-0293", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0293", "comment_date": "2017-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 264}, {"text": "Please see uploaded file with comments", "comment_id": "FDA-2017-D-2497-0445", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0445", "comment_date": "2017-07-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 38}, {"text": "A recent clinical trial comparing acupuncture to IV morphine in the Emergency Department* showed acupuncture providing comparable pain relief, with a faster onset time and fewer minor adverse events (4 versus 85).  A large meta-analysis** definitively established acupunctures efficacy over and above placebo for chronic pain -- while also showing that even the sham acupuncture (placebo) procedures used for these trials themselves had a clinical effect size of 0.33, comparable to that of NSAIDS but without their side effects (which kill over 10,000 patients per year in the United States).  Many well-meaning and otherwise expert physicians are simply not aware that acupuncture is a highly effective nonpharmaceutical alternative to opioids for acute as well as chronic pain, with an excellent safety profile.*Grissa, M. H., Baccouche, H., Boubaker, H., Beltaief, K., Bzeouich, N., Fredj, N., ...  Nouira, S. (2016). Acupuncture vs intravenous morphine in the management of acute pain in the ED. The American journal of emergency medicine, 34(11), 2112-2116.**Vickers, A. J., Cronin, A. M., Maschino, A. C., Lewith, G., MacPherson, H., Foster, N. E., ...  Acupuncture Trialists Collaboration. (2012). Acupuncture for chronic pain: individual patient data meta-analysis. Archives of internal medicine, 172(19), 1444-1453.", "comment_id": "FDA-2017-D-2497-0672", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0672", "comment_date": "2017-07-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1385}, {"text": "I respectfully request that you keep the revisions or even reduce the pressure on doctors, patients, and pharmacies. Chronic pain patients have been suffering for far too long and need relief from the FDA, CDC, and DEA. Since 2010, prescriptions for opioid medications have decreased substantially. In 2015-2016 the CDC issued Opioid Prescribing Guidelines with the intention of helping doctors who have chronic pain patients, on dosing amounts. However since then they are being used as a de facto law by the DEA and other state and federal agencies. The DEA is putting pressure on doctors and pharmacies to reduce or eliminate patients from getting the opioid medications we desperately need. What this is doing is creating more pain since there are no good alternatives or when there are, insurance companies are not paying for them. Please help to ease the burden on us chronic pain patients and doctors. ", "comment_id": "FDA-2017-D-2497-0364", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0364", "comment_date": "2017-07-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 933}, {"text": "With the growing opioid crisis it is imperative that prescribers are familiar with referring to alternative therapists for their patients. Acupuncture has long been used to manage pain and offers a safe, effective, addiction free alternative to opioids. ", "comment_id": "FDA-2017-D-2497-0256", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0256", "comment_date": "2017-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 254}, {"text": "I have a concern regarding the draft revisions to the Food and Drug Administration Blueprint for Prescriber Education for ER/LA Opioids. In the draft, acupuncture is referenced as a complementary therapy for managing acute and chronic pain, however, there is no strong evidence that acupuncture is effective in treating pain. Acupuncture has proved to be no more effective than placebo in the well-controlled and large randomized clinical trials to date.The FDA must continue to protect American consumers from dangerous and/or inefficacious medical interventions. While the opioid epidemic is unfortunately negatively impacting many citizens of our country and abroad, it is important that fraudulent medical practices which claim to treat pain are not allowed to flourish. There are science-based non-pharmacological interventions that are capable of reducing pain in certain patient populations.  Physical therapy and exercise have been shown through large trials to be effective in alleviating many forms of lower back pain, and science- and evidence-based physicians and practitioners are already using and should continue to be encouraged to recommend these interventions and others which have a strong and unbiased evidence base. Researchers, physicians, health practitioners, and patients must work together in order to find and implement more strategies to treat pain. This must occur concomitantly with the removal of interventions which have been shown to be ineffective, such as acupuncture. More studies are not needed for acupuncture because the existing literature and trials focusing on acupuncture have shown the intervention to be no more than placebo.Research must be done on the interventions which show promise in treating pain. This research should be science-based and designed rigorously in order to show clinical utility and benefit above that of placebos. ", "comment_id": "FDA-2017-D-2497-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0025", "comment_date": "2017-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1914}, {"text": "The FDA cannot condone, let alone encourage, unproven modalities such as chiropractic and acupuncture. Especially in the latter case where it has been shown over and over not to work for anything. Its a pre-scientific superstition, not medicine.It is unethical and immoral for a medical care professional to even offer these quack services. The FDA would be doing a tremendous disservice by encouraging that doctors learn about using them.All doctors need to know is that these are worthless and potentially dangerous shams.Mountains of evidence about this are available at the following links:https://sciencebasedmedicine.org/category/acupuncture/https://sciencebasedmedicine.org/category/chiropractic/", "comment_id": "FDA-2017-D-2497-0026", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0026", "comment_date": "2017-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 758}, {"text": "I received acupuncture treatment throuout my pregnancy. It helped managr the nausea, stress and fatigue I was experiencing. This allowed me to work comfortably and longer into my pregnancy. Otgereise I would have had to take more sick days.", "comment_id": "FDA-2017-D-2497-0051", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0051", "comment_date": "2017-05-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 240}, {"text": "As a mental health health professional, I oppose this draft vehemently.  There is NO scientific evidence to support chiropractic and acupuncture interventions for chronic pain.", "comment_id": "FDA-2017-D-2497-0052", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0052", "comment_date": "2017-05-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 176}, {"text": "This seems a step backwards. Now more than ever, we have evidence that there is no indication for opioids for pain beyond 3 months. Use without upper limits on dose in non-malignant pain is also missing. The curriculum doesnt mention the inappropriateness of using opioids for fiber-myalgia, non-specific musculoskeletal pain, and chronic headaches. Just stick to the CDC guidelines. Why would you not stick to the CDC guidelines, especially for the upper limits. PROP gave you good advice. Please change this.", "comment_id": "FDA-2017-D-2497-0291", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0291", "comment_date": "2017-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 520}]}, {"id": "FDA-2016-P-2072", "agency": "FDA", "title": "Requests that the FDA guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in All Settings (Including Non-Medical Settings) by Individuals (Including Non-Medically Trained Individuals)", "update_date": "2016-12-14", "update_time": "11:46:08", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "2016-4203", "Adapt Pharma", "Pacific Link Consulting", "FDA Guidelines for the Optimal Dose", "and Pharmacokinetics for any Naloxone", "Containing Product", "Intended for the Emergency", "Treatment of Suspected Opioid", "Overdose in All Settings", "(Including Non-Medical Settings)", "by Individuals", "(Including Non-Medically Trained Individuals)", "OPEN"], "comments": [{"text": "I support the cause of the petition. Opiate overdoses are a huge issue, and if doctors and pharmaceutical companies are going to enable people by prescribing opiates, there needs to be a better way to prevent deaths when there is an overdose.", "comment_id": "FDA-2016-P-2072-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-2072-0003", "comment_date": "2016-10-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 242}, {"text": "I support Adapt Pharmaceuticals petition.  As opioid use rises, and pharmaceutical opiates like Fentanyl are becoming prescribed more regularly, first responders need a faster acting, higher strength medication.  According to the Center for Disease Control (CDC), naloxone has been responsible for saving over 10,000 lives between 1996 and 2010.  The lives saved will only increase with the intranasal Narcan becoming more readily available.  A higher dose being available can assist when a person overdoses on a more potent opioid such as Fentanyl.  According to the National Institute on Drug Abuse, by 2014 overdose deaths from prescription opiates had tripled in the last 20 years, with there being nearly 207million opiate prescriptions written in the United States in 2013.Studying the way the product Narcan is delivered is a great idea.  Having a package that is easily opened, then delivered, in its entirety, will ensure that people are getting their full dose quickly. Also, having the package labeling instructions easily understood by teenagers and by illiterate adults just makes sense. These easy to comprehend package instructions will ensure that almost anyone who has a Narcan kit can effectively deliver a dose in a life-saving moment. As the CDC explains, over 165,000 people have died from opioid overdose in the US from 1999 to 2014, today over half of these deaths each year are from prescription opioids. Please process Adapt Pharmaceuticals request, and get started on approval of other forms of Narcan. The more opiates are prescribed, the more the US needs a medication like this available to first responders, and other potential witnesses of a likely opiate overdose. Thank you.Jeremy G.", "comment_id": "FDA-2016-P-2072-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-2072-0004", "comment_date": "2016-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1746}]}, {"id": "FDA-2021-N-0951", "agency": "FDA", "title": "Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis; Public Workshop; Request for Comments", "update_date": "2021-12-06", "update_time": "16:00:15", "purpose": "Nonrulemaking", "keywords": ["OPEN", "Request for Comments", "Public Workshop", "in an Evolving Opioid Crisis", "Evaluation and Mitigation Strategy (REMS)", "Prescriber Education Through a Risk", "Reconsidering Mandatory Opioid", "CDER"], "comments": [{"text": "1-Mandatory education improves appropriate opioid prescribing by teaching the prescriber indications and contraindications for specific opioids. This also leads the prescriber to do their own research on the opioid to ensure they are putting these drugs in the right hands. It would also encourage the prescriber to ask more questions to the patient, to identify risk of misuse prior to dispensing the drug. For pain management and treatment of opioid use disorder, it would provide alternative methods than just prescribing a drug. While these methods might be more intense and could possibly involve therapy or collaboration with other health care professionals, it ensures the patient is getting the best quality care in the long term and not just prescribing a drug because it is easier. Mandatory education would no doubt make education more consistent, efficient, and effective. It would also allow for more innovation surrounding management of opioid use disorder and pain management. With more eyes and variety of knowledge backgrounds, research and development of opioids would improve drastically because the drug manufacturer would be under pressure to create a drug that is the next best thing. In addition to more research being done, the process would be more efficient because gold standard practices would come out of this education. Lastly, it would hold prescribers accountable, if you have standards and the prescriber is not abiding by them, it is easier to pick out the bad apples and create a network of ethical prescribers. We know overprescribing happens too often with prescription and nonprescription drugs. Education would specifically help opioid prescribing by making the prescriber more aware of the consequences of even prescribing just 1 more pill than needed. The hill to climb is that more burden is put on the prescriber to collaborate with other healthcare professionals or entities. The reality is that by overprescribing, it puts these drugs on the streets and into hands that were never meant to have it. Even with a post-op patient that is given 5 pills, if they only use 3, it takes 1 person to know the drug can be sold on the street for a lot of money. The most important point to come out of mandatory education would be the innovation of alternative treatments. When you are faced with prescribing a drug that is known to have high rate of misuse versus another drug or management plan with low rate of misuse, in most cases the latter would be chosen. Education should not only surround the opioids but also those alternative treatments such as physical therapy, trigger point injections, bioelectric therapy, etc. 2-Core competencies and knowledge gaps that should be addressed are indications/contraindications, implications of drug, side effects, and long term versus short term use. Some clinical challenges are patient compliance, cost, immediate relief, and time constrictions with patient. More intensive screening needs to be mandatory by talking to the patient about their past prescription drug and substance use. This can be used to determine if prescribing a non-opioid can provide favorable results instead of opioids, determining medical history to rule out possible adverse effects, and consider the psychological state of the patient. Spending more time with the patient to get a full picture rather than just a diagnosis will help with overall treatment plans.3-Goals should include understanding basic ethical obligations to the public and reviewing the oath they took as prescribers, consideration of innovative implementation, and understanding each drug they are prescribing. In ways of measuring the understanding of a drug, a test can be administered and if they do not pass a specific drug/section, they are unable to prescribe that drug. Systems like these seem harsh, but it will provide incentive to the prescriber to be better. 4-Many challenges will arise, but initial challenges include cost of program, personnel to run the program, and how the system will be delivered- online or in person. In cases of counting for continued education, having a system in place to determine how many credits or hours are needed to satisfy requirements. We can learn that without education programs, no standard of practice will be implemented. The same patient could go to different clinics and receive completely different care. We also will learn that patient compliance and trust would increase because they will know that it doesnt matter where they go, they will receive the best care. 5-Technology platforms can be unreliable at times but for the most part, if the platform is user friendly and keeps the prescriber in mind, I dont foresee any severe issues that couldnt be mitigated through technology support. However, with any remote work, you run the risk of dishonesty among the prescriber, but there are ways to ensure when taking knowledge assessments there cannot be any cheating. ", "comment_id": "FDA-2021-N-0951-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0023", "comment_date": "2021-11-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5037}, {"text": "Please find enclosed input from the American Society of Addiction Medicine (ASAM).", "comment_id": "FDA-2021-N-0951-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0038", "comment_date": "2021-12-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 82}, {"text": "Federal Register CommentDocket No. FDA-2021-N-0951In Response to the Food and Drug Administrations Request for Comment and Public Workshop on Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid CrisisBoston University School of Medicine Continuing Medical/Continuing Nursing Education Office (BUSM CME/CNE) has been offering educational activities on safer opioid prescribing since 2010.  Our current opioid REMS program, entitled Safer/Competent Opioid Prescribing Education:  SCOPE of Pain, launched in March 2013 and has been operating continually since then.  To date, we have educated over 225,000 individuals  including healthcare providers (both prescribers and non-prescribers), affiliated health professionals, public health professionals, and students.We are grateful for the opportunity to provide a comment on the FDAs consideration of mandatory prescriber education.In 2017, we observed the effects of a newly enacted NY state mandate on opioid prescribing education.  We partnered with the New York Chapter of the American College of Physicians to offer our SCOPE of Pain program to satisfy the New York requirement.  Within three months, over 60,000 New York-licensed clinicians had completed our program. We compared clinicians who completed SCOPE of Pain under the New York state mandate with those who had completed it voluntarily in other states, controlling for profession and specialty.  We found that clinicians in the mandated group were less likely to report intention to improve their practice as a result of the education.  While trying to put our findings into perspective we found a lack of peer-reviewed published evidence supporting the efficacy of mandated continuing education on any topic.  We are also concerned that mandated training could decrease access to appropriate opioid therapy for patients with severe pain. This concern is based on the experience of mandated training required to prescribe buprenorphine for the treatment opioid use disorder in the Drug Addiction Treatment Act (DATA) 2000 and the Comprehensive Addiction and Recovery Act (CARA) 2016. Since the enactment of these laws, the vast majority of prescribers, including those in primary care, have chosen not to complete the required training and thus not offer the life-saving treatment for patients suffering from OUD. We fear that similarly most prescribers will opt out of an opioid prescribing education mandate and thus not be able to prescribe opioids to patients in need. This decrease in access to appropriate opioid therapy will further increase existing disparities in pain care, and will further marginalize an already highly stigmatized and marginalized patient population.Finally, if the goal of mandated education is to improve patient care, we suggest that rather than mandating a short-term educational program for everyone, consideration should be given to a mandate for demonstration of competency in safer prescribing of all controlled substances in order to maintain a DEA registration number. This competency requirement would allow those already expert to test out and for those needing education to demonstrate competency after completing the education. By including all controlled substances, it will be less likely that prescribers will opt out as maintaining a DEA registration is essential for clinical practice. ", "comment_id": "FDA-2021-N-0951-0054", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0054", "comment_date": "2021-12-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3510}, {"text": "I wish to provide insight to your proposed mandatory opioid prescriber education program. Despite the noted decline in opioid prescriptions per 100 individuals, there has been an alarming increase in fatalities stemming from drug abuse. According to CDC data, 2020 witnessed a 29.4% increase in overdose deaths. This data reveals that the decrease in opioid prescriptions has not necessarily translated to fewer overdose fatalities. The proposed uniform, nationwide educational program for prescribers will prove to be a pivotal step towards addressing and reducing opioid addiction.In addition to substance abuse treatment options, the prescriber educational program should include goals for healthcare providers to initiate conversations on risks of opioid addiction with patients. For example, a patient preparing for surgery should be clearly informed of the potential side effects and risks associated with opioid prescriptions during their pre-operative appointments. They should additionally be equipped with knowledge on how to differentiate between normal, expected postoperative symptoms (including pain) and postoperative discomfort/restlessness (which can stem from either surgery or frequent, continued use of opioids). If the patient were to have difficulty in differentiating between the two, they should feel comfortable to discuss their symptoms with their healthcare provider. The program should also discuss strategies to monitor patient opioid use. Healthcare providers should always have answers to the following questions in regards to their patients: How many opioid prescriptions were given to this patient over time?How large of a prescription has been given to this patient at one time?How long has it been since this patient has been in chronic pain? What are other non-medicated strategies that can effectively manage this patients pain?Monitoring patients through frequent, routine follow-up visits to counsel and gradually reduce dependence on opioid prescriptions will be extremely beneficial towards reducing overdoses.While the consistency of such a program can be challenging, healthcare has largely evolved towards virtual platforms in just the last year; many patients and healthcare staff can now access patient information from the comfort of their homes or offices. Therefore, implementing this programs educational materials through an online platform will reach a significantly large number of healthcare providers, whilst enabling them to review the information at a time convenient for them.Given the severity of our opioid crisis, I believe the proposed plan to increase prescriber education surrounding opioid use is of utmost importance and should remain a top priority for FDA. Thank you for your time.", "comment_id": "FDA-2021-N-0951-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0021", "comment_date": "2021-10-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2838}, {"text": "Prescription opioid medications have contributed to positive experiences for individuals needing pain management; however, physicians over prescription of opioids to patients for decades has caused one of the most pressing issues the nation is facing today. There is no question that the push from big pharmaceutical companies to prescribe opioids for non-cancer related pain in the late 90s contributed to massive amounts of consumers addicted to prescription pain medications. Free samples were often given to individuals seeking pain relief, leading to addiction in these individuals, some of which were unable to afford the medications turning them to obtain these drugs illegally. This created an epidemic in our country that has been addressed since it was identified but continues to remain a burden on our health system. According to the HHS, more than 760,000 people have died since 1999 from a drug overdose, and appropriate prescribing of opioids is an essential way to protect the health and safety of US citizens.Education is always an effective and low-cost method of program implementation. It is only logical that prescribers be required to educate themselves on the best practices of prescribing controlled substances, especially those with high abuse potential such as opioid analgesics. If the FDA was previously concerned about implementing mandatory prescriber education programs due to placement of an undue burden on the healthcare delivery system, it should be apparent that the absence of mandatory prescriber education has prolonged an ever-concerning national crisis. The current pandemic has shown us that we are able to provide many services to individuals from the convenience of their own homes. Employment of a mandatory prescriber education program would be highly beneficial and easily conducted virtually to reach as many stakeholders as possible. To outline a few appropriate goals of a mandatory prescriber education program, we should begin creating a list of topics that should be covered. A good place to start is looking at the blueprint that has been developed by the FDA for prescriber education for ER/LA opioid analgesics. Pulling from those, some necessary topics to be included are:Federal requirements for prescribing controlled substances Assessment of the patient needs for the medicationProper patient counseling on safe use of medicationsPrevention, screening, and signs of addictionAlternative options for pain managementSpecific drug information regarding opioid analgesicsThis program should aim to educate all prescribers on these topics and ensure complete comprehension prior to completion of the program. In order to measure the effectiveness of this program, participants should be assessed on the skills they have developed. This can be accomplished through monitored breakout discussions among the participants. The proctors of the discussions can develop questions they believe incorporate the topics that the program set out to inform prescribers on and evaluate the discussion among the participants to determine what skills were learned. The program can also include a segment after educating prescribers in which they complete a self-assessment providing examples of what they learned from each topic that was covered. Another method to measure the impact of the program is one that would take place over a longer period after the program ended. This would be to monitor the prescribing behavior in the program participants and compare changes from before educating to those afterwards. This is already a common practice in some states that have established prescription drug monitoring programs, making this method of evaluation the most feasible. Common program evaluation methods can be used to determine the effectiveness of a mandatory prescriber opioid education program, and surveillance data on the numbers of opioid prescriptions given can, over time, reinforce the programs effectiveness. We can look at the success rates of private and state entities that have implemented educational programs for opioid prescribers and determine that a nationwide standard should be enforced. Unfortunately, the burden the opioid crisis is putting on the nation is of far more concern than the burden the FDA was previously concerned about with requiring prescribers to participate in this educational program. The evidence is clear that we will benefit from applying more efforts towards combating the opioid crisis, one of which is to more extensively educate prescribers of best practices when handling these highly addictive substances. ", "comment_id": "FDA-2021-N-0951-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0031", "comment_date": "2021-12-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5114}, {"text": "It is interesting to me that this is an FDA workshop that I had never heard of; as an MPH student and someone that had worked in the healthcare field before, I thought it would be something that would be mentioned in class or a professional setting. I do have to say that since 2012 from 84 prescriptions per 100 residents to 67 prescriptions per 100 residents in 2016, and 52 prescriptions per 100 residents in 2018, the rate dropped to 43 prescriptions per 100 U.S. residents in 2020 the implementation of REMS has had quite a successful run, but not as successful as it could be. The issue is that the epidemic isnt over; the numbers have only been rising. Provisional data from CDCs National Center for Health Statistics indicate an estimated 100,306 drug overdose deaths in the United States during the 12 months ending in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before. Also, In 2019, an estimated 10.1 million people aged 12 or older misused opioids in the past year. Specifically, 9.7 million people misused prescription pain relievers, and 745,000 people used heroin. (https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm). This goes into the fact that cocaine, heroin, methamphetamine, and benzodiazepines have also become a major indicator of the rise of opioid misuse. That is due to the lack of educational spread and prevention, which is clearly shown in this article and the above numbers. The purpose of the workshop is to make REMS mandatory through risk evaluation and mitigation strategies for healthcare workers that prescribe opioids. The workshop can be attended by anyone who works in healthcare but is specifically targeted to prescribers. The issues start early on with the implementation of the workshop. First, it shouldve been mandatory for any healthcare provider that even remotely works with opioids, not just prescribers. There are too many cooks in the kitchen when it comes to prescribing medication; the pharmacist, any medical provider that the patient sees other than the prescriber, mental health providers, or anyone that the patient sees that helps them with their health. Therefore, REMS should be mandatory for everyone because not every patient is the same, but the goal of healthcare is the same: to do no harm. If only a certain number of healthcare providers are getting this continuing education opportunity, why cant everyone? The other thing that couldve been mentioned here is who gets notified about the workshop. Is it well-known hospitals in well-known areas where the people can afford treatment if they become addicted, or does the notification of the workshop not discriminate? To be even a spark of equality in the healthcare system, there needs to be an accessible and affordable way to educate all. Thats where I would love to see that analytical makeup of attendance and where the statistical data presented below is kept. If someone came to the workshop, where do they work, what is their line of profession, what is the population they see compared to others. I think this information is essential to all present to the stakeholders attending the workshop because it shows the pros and cons of not only making it mandatory but also if the FDA keeps it in general care. The final thing that sparked my interest is that the blueprints currently do not include principles for managing opioid use disorder, including treatment with buprenorphine. My curiosity lies in why treatment was not part of the workshop. Its a very crucial part of lowering the number of patients that go into overdose and die. Substance use disorders can be best treated on an outpatient therapy basis or in an inpatient program dedicated to treating people with addiction. Many of these programs use medications to help patients transition from physical dependence on opioids. The medicine buprenorphine also relieves opioid cravings without giving the same high as other opioid drugs. Prescribed by many physicians from office settings, this is typically a daily dose placed under the tongue and can be delivered as a once-a-month injection or through thin tubes inserted under the skin and last six months (https://www.hopkinsmedicine.org/opioids/treating-opioid-addiction.html). Different addiction treatments should be added to the blueprints because if the healthcare provider cant prevent the addiction, they most certainly can treat it. Nevertheless, I thought this approach was fascinating, and I hope through the decisions made in October, a real change can be made in 2022.  ", "comment_id": "FDA-2021-N-0951-0027", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0027", "comment_date": "2021-11-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4651}, {"text": "Over-prescribing of opioid drugs in the United States has fueled the opioid overdose epidemic, contributing to 200,000 overdose deaths from 1999 to 2017 (Mathis, 2020). It is necessary for all health care providers to do their part in reducing the possibility for opioid abuse in their patients and those that their patients may influence. A mandatory REMS educational program could address the over prescribing of opioids for acute pain through teaching prescribers screening questionnaires, recognizing warning signs of drug abuse, limiting opioid prescriptions, encouraging patients to utilize non-addictive pain management strategies, and recognizing the potential consequences for over prescribing. In a REMS program, prescribers should be required to learn ways to accurately assess and detect a patients levels of pain prior to making the decision of whether to prescribe opioids.  A REMS program can address which types of acute pain may require prescription of opioid drugs, and which may not. Most surgeries and invasive procedures may generally cause more acute pain than acute injuries. Another screening tool, which is required in Massachusetts by law, that can be used is The National Institute on Drug Abuse Quick Screen (Keith, 2020). This is a quick questionnaire that can be used to assess frequency of drug use and risk for potential abuse. Surveys like this should be taught to prescribers in a mandatory program to reduce the chance of prescribing opioids to people prone to abuse. Early warning signs of prescription drug abuse can be easily detected if prescribers are properly educated on what to look for. Patient and provider communication is key to detecting these early warning signs (Mathis, 2020). Providers should be taught to look for how many providers the patient has seen in the past and if those previous providers were prescribing opioid drugs. Doctor shopping, when a patient tries to obtain multiple prescriptions from multiple prescribers at the same time, is a common sign that a patient has been abusing opioid drugs (Keith, 2020). They should note if the patient immediately asks if they can be prescribed opioids and if they frequently ask for refills or misplace their medications regularly. Additionally, prescribers should base their decision to prescribe on evaluative measures such as special physical and diagnostic tests for pain rather than relying solely on patient reports. The ability to clinically rule out if someone is over-exaggerating or faking their pain through evidence-based measures makes the prescribers decision process easier. These strategies should all be covered in a mandatory REMS program.Education on prescribing fewer opioids in one singular prescription for acute pain rather than prescribing in excess would be beneficial to include in a REMS program. Healthcare professionals can always prescribe more pain medications if needed. For example, if prescribers are going to prescribe opioids to patients for acute pain, they should only prescribe two to three days worth of medication and then encourage use of NSAIDS or acetaminophen to manage pain. If the patient reports that they are still having unbearable pain not manageable through over-the-counter medications, prescribers should then consider an additional prescription of another two to three days of medications.There are many potential consequences that prescribers may not immediately consider when prescribing opioids to patients. Not only are patients at a higher risk for developing an addiction to the opioid themselves, but one factor that is often overlooked is the possibility of the patient abusing their excess prescription to sell and supply opioids to others. Even if a patient is not abusing their excess prescription themselves, it can still be used to harm others. Not only is selling excess opioids a possible issue, but if drugs are leftover and end up in a medicine cabinet, young adults or children in the household are more likely to abuse these drugs.It would be extremely beneficial to require a mandatory REMS education program for prescribers to reduce over-prescribing opioid drugs to patients. The simple implementation of this program will help reduce patient drug abuse, the likelihood of other family members to abuse these drugs, and repercussions for doctors if these unfortunate events do occur. Keith, D. A.,  Hernndez-Nuo de la Rosa, M. F. (2020). Special Screening Resources: Strategies to Identify Substance Use Disorders, Including Opioid Misuse and Abuse. Dental clinics of North America, 64(3), 513524. https://doi-org.proxygw.wrlc.org/10.1016/j.cden.2020.03.002Mathis, S. M., Hagaman, A., Hagemeier, N., Baker, K.,  Pack, R. P. (2020). Provider-patient communication about prescription drug abuse: A qualitative analysis of the perspective of prescribers. Substance abuse, 41(1), 121131. https://doi-org.proxygw.wrlc.org/10.1080/08897077.2019.1635956", "comment_id": "FDA-2021-N-0951-0029", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0029", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5097}, {"text": "Since the 1990s, pharmaceutical companies marketed synthetic and semi-synthetic opioids to medical providers, assuring the fact that they were nonaddictive or were less addictive than other opioid options at the time, such as morphine. The lobbying, sponsorships, and heavy marketing tactics employed by pharmaceutical companies catalyzed the increase in opioid prescriptions which has stemmed into whats now known as the opioid epidemic: the misuse and abuse of opioid drugs, leading to negative health outcomes or deaths due to overdose. The health impact of this issue is nothing less than substantial. In 2019, approximately 10.1 million Americans reported opioid misuse, 1.6 million had an opioid-use disorder related to prescription medication, and there were an estimated 70,000 opioid-related deaths in the United States that year. In addition to these health outcomes, we also see an associated economic burden of $78.5 billion each year related to this opioid epidemic. Taking a deeper look into this issue, we can see that approximately 25% of individuals who were prescribed opioids have misused them, with an average of 10% developing an opioid use disorder. The 2012 Risk Evaluation and Mitigation Strategy (REMS) was developed by the Food and Drug Administration (FDA) with the purpose of providing training to medical professionals for prescribing medications with specific risks and concerns. This program includes training on Extended Release and Long-Acting (ER/LA) opioid medications which educates healthcare professionals on appropriate opioid prescriptions and prevention of opioid misuse or abuse in patients. Ultimately, the goal was to reduce the frequency and severity of opioid-related adverse health outcomes such as addiction or overdose through an upstream, educational program for medical care providers. However, due to concerns about the burdens of this extra program, the FDA decided not to make the REMS mandatory. Instead, this program was made widely available to healthcare providers. As mentioned in the document, there were approximately 350,000 individuals who completed the REMS training program since 2013. With an estimated 1 million opioid-prescribing healthcare providers in the United States, this means that only one-third have completed this training. Although the number of prescribed opioids has decreased over the years, presumably due to the efforts of this program alongside other alternative educational interventions, studies continue to show that opioid medications are prescribed in excess following medical procedures, where up to 70% of opioid tablets were unused. These results indicate an unnecessary over-prescription of opioids. Now that the conversation of REMS training is back on the table, it is important to consider making this program mandatory so that all opioid-prescribing healthcare professionals can be equipped with the necessary knowledge and training to reduce opioid abuse and overdose.In public health, it goes without saying that prevention is always better than the cure. It is worth investing time and resources into addressing the upstream issue of opioid abuse and overdose, starting at the source. Though implementing a mandatory program may increase the burden on healthcare workers, the downstream effects of reducing opioid-related misuse and reducing opioid abuse and death is substantial and will outweigh the costs. Patients trust their providers to prescribe them with the appropriate type and necessary amount of medication to help them with their health issue. This is based on patient-provider trust and the position that healthcare providers are in to treat health conditions with the necessary resources. Thus, doctors, physician assistants, and nurses, have the due diligence to be aware of the ramifications of opioid over-prescription as well as inform their patients of the risks associated with any opioid analgesic they may be prescribed. The REMS program will ensure that physicians are equipped with this knowledge and skillsets to empower their patients to prevent drug abuse and overdose, while maintaining accessibility to these controlled substances. It is time for the federal government to step in and make this a mandatory training, ensuring that medical providers have a standardized knowledge and practice across the country to combat the opioid epidemic. ", "comment_id": "FDA-2021-N-0951-0035", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0035", "comment_date": "2021-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4455}, {"text": "According to the National Institute of Health (NIH), Americas medical research agency, prescription opioids are often a springboard into addiction.  The National Institute on Drug Abuse (NIDA, under the NIH) reports that  75% of opioid abusers started with medically prescribed opioids, and nearly 80 percent of heroin users reported using prescribed opioids prior to beginning their heroin use .There can be little argument that a poorly considered prescription, even for an understandable reason, can derail a persons life. Countless testimonials showcase the reality of how a life can be horribly altered for the worst because of innocent and valid opioid prescriptions.  Obviously, patient pain is a horrible thing, and should be limited where possible. However, broad and unconsidered opioid prescriptions can lead to killing a demon today, and facing the devil tomorrow. In these situations the few days of pain that may have been avoided by opioid use are surpassed by a lifetime of suffering, loss, and self-harm. Yet early marketing for drugs such as OxyContin made explicit promises that their drug was non-addictive, leading to mass-misinformation in patients and doctors alike. Although this misinformation regarding the addictiveness of opioids is being re-dressed, the epidemic continues and some doctors may still struggle to see how an understandable prescription to ease a patients very real pain can result in such a painful an addiction.It is true that, particularly during this Pandemic, our healthcare system is highly burdened, and healthcare practitioners should devote their time to saving lives. However, education will help save lives in the long run by stopping addiction before it starts. Furthermore, doctors are already required to continue their education. Most States require Continuing Medical Education Credits (CME) to maintain ones medical license because medicine is an ever-evolving field and great harm can come to patients if doctors do not keep up to date with new findings and methods. Requiring a class on the risks of opioids is a low burden, particularly when the statistics come to light. Since 1999, 760,000 people have died of a drug overdose. In 2018, two thirds of all drug overdoses involved opioids. Given the majority of opioid addictions begin with a prescription, can we really afford not to educate doctors? Not only should the FDA require education, the education should include alternative treatments that should be considered before opioid pain killers where possible, better steps to address post-prescription care, weening schedules, and care/check in protocols for when the prescription ends.Opioids have a place in society, and can be of enormous benefit to suffering people, but opioids should be a last resort, not a first option. With better education, perhaps the early marketing false information can be eliminated from the medical conscious and replaced with a deeper understanding of how to balance pain management with a happy addiction-free life.Thank you for taking the time to read my comment. ", "comment_id": "FDA-2021-N-0951-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0002", "comment_date": "2021-09-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3192}, {"text": "THe 3 stooges would better serve our Nation, in regulating opioids, then the administrative epistocratic narcissists who believe their statistical positivism and quick and dirty simple minded evidentialism is beyond good and evil and any and every moral consideration that the public and private citizens have. It is as Aristotle indicated- educating the mind and not educating the heart- is no education at all. Clearly FDA staff and their thick as theive rubberchickendinnered friends in academia lack moral engagement on pain care and they believe that all use of opioids are unwarranted. It is a terrible thing to see and have no vision. THE FDA anf their immoral friends in academia clearly have no vision to improve pain care or cure pain. It wasnt any of them who called for curing pain in the NPS- it was yours truly. Since you dont have a heart to care and have no clue that happiness id the aim of government as Jefferson indicated- go work slinging burgers at mcdonalds- your simple minded machine robopathic machine logic is unfit for serving humans and your unfit to serve in government. Your carelessness cannot be squared with any theory of government, management or morality. You are clueless about the care ethics of Tronto, Nussbaum, Sen, Sandel, Gilligan, Watson, Butler- to name a few. YOur heartless robopathic narcissists who care nothing for people in pain. You can debate me anytime in public- your vast darkness will be unobscured.And your immorality is legion- belongs in dystopian novels or theater of cruelty. Your claim to expertise are as thin as your cartoon thin morality.Kindly put an egg in your shoes and beat it.", "comment_id": "FDA-2021-N-0951-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0020", "comment_date": "2021-10-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1648}]}, {"id": "FDA-2010-P-0095", "agency": "FDA", "title": "Reclassify Nicotine Vaporizers (E-cigarettes) from \"Drug-Device Combination\" to \"Tobacco Product\"", "update_date": "2022-02-17", "update_time": "21:08:46", "purpose": "Nonrulemaking", "keywords": ["drug-device", "tobacco product", "e-cigarettes", "CTP"], "comments": [{"text": "I watched my grandmother get pumped with morphine for 5 days and die because of cigarettes! EVERY alternative out there besides E cigarettes dont work for most people. Hand mouth fixation is a huge part in trying to quit smoking. Vaping has saved my life and countless of others. I dont see the real logic in banning vaping products! ", "comment_id": "FDA-2010-P-0095-0108", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0108", "comment_date": "2017-06-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 334}, {"text": "I would like to urge the FDA to support the Petition submitted by the American Association of Public Health Physicians (AAPHP) requesting the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products (instead of trying to ban the products by classifying them as drugs or devices).", "comment_id": "FDA-2010-P-0095-0087", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0087", "comment_date": "2010-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 317}, {"text": "PLEASE, PLEASE, PLEASE dont ban e-cigs or all nicotine and flavored vape juice.Five years ago I switched from a 50-year, on again, off again, 1 pack of cigs a day habit to vaping and dont want go go back. Ive also been able to reduce the nicotine content I vape from 16% to 4 or 0%.My husband of 30 years still smokes over 1 pack of cigs a day and I know he wont quit his 65-year habit. Hes tried every quit method available but still eventually goes back to cigs.I know if I dont have access to vaping I could easily go back to smoking. I DONT want that but its EXTREMELY hard to live with a smoker without smoking myself.History has proven prohibition doesnt work, especially with kids. People will always find a way to get their fix be it alcohol, drugs or tobacco.The government does not regulate vitamins and supplements which have also harmed people over the years. Consumers have no idea whats in those products and you let those stay on the market. Why not? I guess that lobby is too powerful and persuasive.I very much wish the US government WOULD regulate vape juice AND vitamins and supplements. I would feel better knowing just what these products contain and that they were manufactured under sanitary conditions. Right now, its a crap shoot as to what we are consuming in these completely legal, for now, products.So, again. PLEASE do not BAN all flavored or all vape products. I dont want to go go back to smoking but its practically inevitable if I cant vape. I see vaping as the lesser evil. Banning all flavored vape juice, even to adults, is overkill.According to news reports it seems the majority of illnesses and deaths are linked to black market, doctored and illegal product.PLEASE FIND OUT WHAT IS CAUSING THESE EVENTS FIRST. DONT JUMP THE GUN!! Your decision should be based on SCIENTIFIC EVIDENCE, NOT EMOTION OR SPECULATION - OR POLITICS.Im all for controlling whats in vape juice and prohibiting sales to minors who will, however, continue to purchase such products on the black market, just like they do other only for adults products.Unfortunately human nature is such that bans actually make banned items MORE desirable, especially to kids! Im sure you know that!So, please, make sensible rules. Let those of us who got hooked on nicotine 50+ years ago when we didnt know cigarettes were harmful, continue to have access to some flavored vape juice, I like caramel. If you ban all flavors you can be sure people will doctor juice themselves.BTW, there are hundreds of recipies for home made vape juice online and the ingredients are legal and available everywhere.If you dont regulate the manufacture of vape juice to assure its sanitary, were sure to see a spike in illness from poisoning as a result of home made juices.Ever hear of bathtub gin? People died or went blind during prohibition because of home cooked brews. Prohibition not only failed spectacularly it gave rise to a much worse evil: organized crime.So, take a bit more time to come up with a reasonable, rational plan.", "comment_id": "FDA-2010-P-0095-0113", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0113", "comment_date": "2019-09-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3306}, {"text": "This is requesting that the FDA support the Petition submitted by the AAPHP instead of trying to ban ecigarettes.", "comment_id": "FDA-2010-P-0095-0085", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0085", "comment_date": "2010-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 113}, {"text": "This comment supports allowing continued access to e-cigarettes by informed adults who are unable or unwilling to become tobacco-free. Fact:   Most of the lethality of traditional cigarettes is from the smoke not nicotine.Fact:   Nicotine addiction is difficult to overcome because of physical changes to the brain.Fact:  Current smoking cessation medications and techniques dont help everyone.Tobacco free is friction to those individuals who cant or wont break their addiction.  Some of these individuals have found e-cigarettes and in the process have decreased or eliminated their exposure to deadly smoke even if all risks are not eliminated with certainty.  As a society built upon the principles of individual rights to life, liberty, the pursuit of happiness (when others are not harmed) and equal protection under the law, we should not eliminate access  by informed adults to alternatives to  frequently lethal smoke from traditional cigarettes. Where uncertainty and /or disagreements exist, the informed adult should decide provided no one else is harmed. Regulation of e-cigarettes as a tobacco product can prevent harm to others such as children and the non-addicted.  Access to e-cigarettes is the compassionate thing to do for addicted individuals whose lives and happiness in some cases literally depends upon them", "comment_id": "FDA-2010-P-0095-0081", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0081", "comment_date": "2010-07-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1368}, {"text": "We have many examples of folks that have successfully stopped smoking analog cigarettes and are now using e-cigarettes exclusively, all with great health benefits.  I can show blind studies, friends of mine with COPD that went to see their physician and without the doctors awareness, the patient had quit smoking cigarettes and now only use electronic cigarettes.  The patients health was SO much better the doctor was alarmed and wanted to know more.  They asked that I bring in literature so that (the doctor) might give this information to other smokers.  By the way, my friend improved so dramatically that she no longer meets the requirements for oxygen under her health insurance plan, her numbers are too good.Wouldnt you want this to be the wave of the future, especially when we, the people, are now going to cover health care costs for anywhere from 32 to 40 million more people?  Isnt this a step in the right direction?On the street, the FDA and Big Tobacco and Big Pharmacy are getting a bad name.  It would appear you would not pass anything that doesnt put money in those pockets, including yours via sin taxes.  Is it really the public health you have at heart?", "comment_id": "FDA-2010-P-0095-0068", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0068", "comment_date": "2010-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1237}, {"text": "I think this is ridiculous! E-cigarettes have helped me quit smoking cigarettes in about 3 days! I see no reason why they should be classified as a tobacco product. They do not have tobacco in them! Only flavorings and nicotine. I can go on and on about this but, Ill leave that up to the experts who have ACTUALLY USED A E-CIGARETTE!!!!!Thanks,Lance Seme", "comment_id": "FDA-2010-P-0095-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0005", "comment_date": "2010-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 375}, {"text": "I feel e-cigarettes should be classified as a tobacco product.  They are used in place of traditional cigarettes to deliver nicotine to the user without combustion.", "comment_id": "FDA-2010-P-0095-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0006", "comment_date": "2010-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 164}, {"text": "Classify e cigarettes as a tobacco product", "comment_id": "FDA-2010-P-0095-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0007", "comment_date": "2010-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 42}, {"text": "Signed. Please reclassify as Tobacco product.", "comment_id": "FDA-2010-P-0095-0053", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0095-0053", "comment_date": "2010-03-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 45}]}, {"id": "NHTSA-2002-13680", "agency": "NHTSA", "title": "Operation of Motor Vehicles by Intoxicated Persons", "update_date": "2021-02-10", "update_time": "01:07:19", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "SO, CAN THE COUNTY HANDLE ANTIVIRUS TELEPHONE CALL BUD?", "comment_id": "NHTSA-2002-13680-0017", "comment_url": "https://api.regulations.gov/v4/comments/NHTSA-2002-13680-0017", "comment_date": "2020-05-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 55}, {"text": "I want to take this opportunity to comment on the proposed rule regarding BAC and withholding Federal-aid highway funds from states that fail to enact a 0.08 BAC legislation.  After reading the proposed rules, and the supplemental information I am in favor of this rule.  Having the great fortune of personally being unaffected by alcohol related tragedies, I am able to render an unbiased opinion in regards to the BAC proposal.  I believe it is in the best interest of the citizens of the USA to have BAC 0.08 legislation in place.  In fact, I would offer that 0.08 is still rather conservative after reading the laboratory results comparing BAC and impairment to operate a motor vehicle.  I deduce that to drastically affect alcohol related accidents the BAC standard should actually be around 0.05.  I understand that it is better to approach such issues in stages, as BACs nationwide have been as high as 0.10 or higher and transitioning to a BAC of 0.08 is quite a step.  If the idea here is to decrease alcohol related accidents and deaths, I would pose the question of why legislative legitimacy of alcohol checkpoints has not been addressed?The only criticism that I have of the proposed rule is that the penalty of failing to comply is actually reasonably lax.  I understand the massive amounts of money that we are talking about, but in the grand scheme of things 2% of a states Federal-aid budget is not all that much percentage wise to open the eyes of state legislators.  Beyond that, the penalty is capped at 8%, which is still potentially a large sum of money, but percentage wise is still a manageable number.  I wonder if the idea was not to actually force the states to comply by using large percentage penalties, but rather to make the penalty just enough of an irritant to a state that eventually it would conform in order to stop the irritation?  A state might view the 2-8% penalty as an acceptable cost in order to not pass the 0.08 BAC legislation hurting the people of that state by potentially having more alcohol related accidents than the national mean, and also hurting the people of that state by causing a burden upon them to either accept worsening road conditions, or a state tax hike in order to offset the 2-8% penalty.I appreciate the opportunity to offer my opinion on this important rule, and hope to see the direct decline in alcohol related traffic accidents as is predicted.Sincerely,James R Earp", "comment_id": "NHTSA-2002-13680-0005", "comment_url": "https://api.regulations.gov/v4/comments/NHTSA-2002-13680-0005", "comment_date": "2003-03-26", "comment_time": "05:00:00", "commenter_fname": "James", "commenter_lname": "Earp", "comment_length": 2498}, {"text": "As a concerned driver, I do not drink and do not condone driving while impaired. I have been turned in dozens of impaired drivers over the last thirty years. I have also seen how alcohol impairs judgement in friends and acquaintances. This is a bad program. First of all, it is unconstitutional. The Federal government lacks jurisdiction on this matter. As an end-run around constitutional law, the program uses an enforcement technique that is onerous, at best - the withholding of funds. Second, its ineffective. The current laws are more than adequate. Lowering the permitted BAC pacifies the justifiably upset members of MADD while doing absolutely nothing to remove drunk drivers from the road. Legal impairment does not always equal physical impairment. I implore you to do the right thing and abandon this ill-advised program.This is an illegal and ineffective program. It should be abandoned immediately.", "comment_id": "NHTSA-2002-13680-0003", "comment_url": "https://api.regulations.gov/v4/comments/NHTSA-2002-13680-0003", "comment_date": "2003-03-19", "comment_time": "05:00:00", "commenter_fname": "David", "commenter_lname": "Barnes", "comment_length": 937}]}, {"id": "FDA-2020-D-2016", "agency": "FDA", "title": "Temporary Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol During the Public Health Emergency", "update_date": "2023-11-22", "update_time": "11:13:23", "purpose": "Nonrulemaking", "keywords": ["CDER"], "comments": [{"text": "Referring to Policy of Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, CDER Guidance for Industry, Dated October-2023, Section-III [Policy of Testing Methanol] A, Drug Products, to perform the specific identity test that includes a limit test for methanol, on each container within each shipment of each lot of pharmaceutical alcohol before the component is used in the manufacture or preparation of drug products.As stated under citation # 27  28 in the guideline, based on the knowledge of shipping controls, we the drug product manufacturer interpret, representative sample from each lot shall be used for Methanol testing to confirm its identity. ", "comment_id": "FDA-2020-D-2016-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-2016-0007", "comment_date": "2023-11-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 711}]}, {"id": "HHS-OS-2018-0027", "agency": "HHS", "title": "Pain Management Task Force Draft Report", "update_date": "2019-04-02", "update_time": "01:29:04", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Chiropractic needs to be included rather than dismissed as a modality as this report indicates", "comment_id": "HHS-OS-2018-0027-0415", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-0415", "comment_date": "2019-02-01", "comment_time": "05:00:00", "commenter_fname": "Norri", "commenter_lname": "Collier", "comment_length": 94}, {"text": "I have chronic pain due to nerves damaged in a surgery for 5 years now.  I tried every conceivable alternative treatment, yoga, meditation, acupuncture, CBD, and THC, and on and on.  They did not work    Then I tried Tylenol and after 3 days it  made me sick.  Then I tried Ibuprofen, which helped a bit but it injured my stomach and I had to stop taking it.  I tried some other NSAIDs, but they did not help much. Finally I was prescribed hydrocodone.  7.5 mgs twice a day and it works.  Nothing else does.  I have had 3 surgeries trying to fix the nerve, nothing is fixed yet and thank God for hydrocodone. I read where some study found tylenol and or advil was found to work as well as opioids for post operative pain.  I have never heard anything so ridiculous in my life.You should know, my brothers Doctor is scared to death to prescribe any type of opioid. He thinks the guidelines are the law. I am sure by now you have gotten enough data to see the guidelines have not reduced opioid deaths but just increased fentanyl deaths.This lady in our community due to the guidelines had her pain pills discontinued.  She killed herself...https://www.pressdemocrat.com/news/8639079-181/charge-dismissed-against-petaluma-man.I dont know how you can fix this mess you have made, but it has caused way too much suffering.", "comment_id": "HHS-OS-2018-0027-0357", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-0357", "comment_date": "2019-01-24", "comment_time": "05:00:00", "commenter_fname": "Timothy", "commenter_lname": "Fitzpatrick", "comment_length": 1390}, {"text": "I am a 64 year old female chronic pain patient suffering from Spondylolisthesis (having  had a failed back surgery), Fibromyalgia and Osteoarthritis. I was forced to leave my lucrative professional career and go on SS Disability about 10 years ago.My initial pain management physician,  treated me with many epidural steroid shots and pain medication until I was suddenly unable to reach him and his staff after countless calls for an appointment and to renew my medication. I was forced to go to the ER because of my intolerable pain, after which I went to his office in person. He burst out of his office and screamed out loud to a packed waiting room that I was a desperate drug addict seeking drugs. I was stunned and mortified.I found another pain management specialist under which I endured more epidural steroids. As a type 1 diabetic these raised my blood sugar levels to extremely high levels and had me in danger of hyperglycemic coma. They also caused severe epidural headaches.  He then had me try innumerable medications including Gabapentin, muscle relaxers, low dose Naltrexone, and others. These provided zero pain relief or gave me intolerable side effects to include severe dizziness. He then coerced me in to having a spinal cord stimulator implanted in my body. This failed to relieve my pain and it was removed.  I then had a stimulator from another manufacturer implanted. This did help with my pain but did not eliminate the need for further relief in order to function, so he continued to provide some pain medication.He then tapered my pain medication to half of what it had been. He told me it was because the government was cracking down on Doctors, and that several of his colleagues had lost their licenses. He was afraid to prescribe. His pain management group now became a spine care center. He suggested I get a second spinal cord stimulator implanted in another area of my back.He now tells me the practice no longer prescribes pain medication - even for cancer patients.I now receive a fraction of the pain medication which allowed me to live a tolerable life. I can no longer do any housework. The time I can spend on my feet or walking is very limited. I cannot have a normal social life or participate in many activities.My life has been forever altered by pain which could easily be controlled by a safe, inexpensive pain medication solution that I am now being denied. The opioid deaths in this country are happening to drug addicts deciding to take illegal, deadly street drugs - not patients like myself in a controlled physician environment. The millions like me in this country, have been thrust in to a life of severe suffering. Some so bad,  that suicides from intolerable pain are skyrocketing.We ask that legitimate pain patients not be punished for the actions of drug addicts, and that our Doctors be allowed, without fear, to treat us.Thank you for your attention to this urgent human crisis.", "comment_id": "HHS-OS-2018-0027-0312", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-0312", "comment_date": "2019-01-23", "comment_time": "05:00:00", "commenter_fname": "Stephanie", "commenter_lname": "Lobignat", "comment_length": 3037}, {"text": "Incurable Chronic Pain Condition. Treated over many years, started with medication therapies, invasive procedures, Brain Surgery, Gamma- knife Radiation and eventual disability 10 years before retirement age.I worked through all the complications of every medicine, every procedure, surgery, but the Gamma-knife was my Achilles heel.I have tried everything recommended and suggested in the Trigeminal Neuralgia treatment handbooks for patients which are acknowledged by the leading specialists in the field. Patient Advocacy included.Its been long, hard and painful.I just want to be able to have some kind of life which even with OPIOIDS is limited.My latest attempt is a small portable ultrasound device I had to petition my doctor for over two years to be able to try. Oh! Yes! And on my own dime as any alternative therapy I tried was out of pocket as well.This is the shame of it all. Pain medications work to alleviate pain. All the alternative treatments cost exorbitant amounts of money that have no coverage.Until the Insurance Industry opens its pockets and that includes Medicaid and Medicare Im afraid alternative medicine will remain out of reach for most Chronic Pain Patients.I even read in these comments a plug for massage therapy? Whos kidding who? Massage therapy may assist some pain patients but many of us cant get out of our house to get there....... Or have the assistance we need to participate in the recommended alternative therapies. What I see happening is now the one item OPIOIDS is now being trashed or being set up as a non-viable payment reimbursement classification.I myself just changed my insurance provider and it created nothing but problems for my doctor, pharmacy and especially me!I left one pharmacy I tried due to the insurance company I had, yes Atena and CVS.Aetna was sold and CVS bought. CVS pharmacy in Chicago made up their own rules as to how they would dole out prescription narcotics outside of the law. I called and emailed the CVS corporate in Rhode Island. I did receive a call back from a corporate pharmacist telling me the CVS pharmacy was not following the law. I couldnt run away fast enough!My doctor who I respect who I discuss my interactions with has shared that pharmacists are totally ignoring prescriptions.I myself had a pharmacist of course from the same CVS write a belligerent note on my prescription bottle highlighted with bright pink highlighter. I thought the note was from my doctor, after speaking with her and her office, found out it was placed on my script bottle from the pharmacist?Who does that? Get in the middle of a 20 year relationship with a patient and a doctor?Its important you know I want to be out of pain, Ive had enough, I didnt ask for it and Ive tried everything experts have recommended and had to save up money for the privilege of doing it.So after you tackle laws on OPIOIDS. You could tackle payment reimbursement parameters for payment related to alternative treatment.All I see happening is the government does not want to pay for legal prescription therapy that is reimbursed.How about the study committee for ethical insurance reimbursement for all the marvelous alternative treatments that we are supposed to take advantage of and have access to use?If they work as well why arent they paid at 80/20 long term with no time limits applied?All you are doing is setting up a stampede to the nations emergency rooms for people in pain.Or the black market for lethal doses of drugs to stop the pain.Do you not understand most of us live on the edge as it is!", "comment_id": "HHS-OS-2018-0027-0313", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-0313", "comment_date": "2019-01-23", "comment_time": "05:00:00", "commenter_fname": "Christine", "commenter_lname": "M", "comment_length": 3731}, {"text": "Acupuncture is an effective and safe on the pain management. Hopefully it will be covered by Medicare.", "comment_id": "HHS-OS-2018-0027-0321", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-0321", "comment_date": "2019-01-23", "comment_time": "05:00:00", "commenter_fname": "Ling", "commenter_lname": "Zheng", "comment_length": 102}, {"text": "Dear Dr. Singh,RE: Docket ID# HHS-OS-2018-0027As a Certified Registered Nurse Anesthetist (CRNA), Im writing today to express my concerns with the Department of Health and Human Services Pain Management Best Practices Inter-Agency Task force draft report titled Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations. I am supportive of recommendation 1c under section 3.3.3 (Workforce), which recommends expanding the availability of non-physician pain specialists. However, this recommendation is contradicted by another recommendation in the report for credentialing and training requirements that limit the pathways available for non-physician practitioners, such as CRNAs, to be able to provide interventional pain procedures. CRNAs are qualified pain practitioners who have the training and experience to provide high-quality treatments to patients suffering from a wide range of acute and chronic pain conditions, in a variety of practice settings. CRNAs who provide pain management do so in accordance with our professional scope of practice, federal and state law, and facility policy.As part of our educational preparation, CRNAs are required to learn and demonstrate competence in the management of pain. And, the standards issued by the Council on Accreditation mandate that nurse anesthesia programs provide content in, but not limited to, anatomy, physiology, pathophysiology, pharmacology, and acute and chronic pain management. These standards also require that student nurse anesthetists obtain clinical experiences in regional anesthetic techniques (i.e., spinal, epidural, and peripheral nerve blocks). As such, CRNAs possess the necessary knowledge and skills to employ therapeutic, physiological, pharmacological, interventional, and psychological modalities in the management and treatment of acute and chronic pain. Additionally, the Centers for Medicare and Medicaid Services (CMS) recognizes the ability of CRNAs to perform and bill for acute and chronic pain management services. The U.S. House of Representatives also recognizes the ability of CRNAs to perform pain management services and urged the Department of Defense to make funds available for CRNAs to pursue existing pain management fellowships. CRNAs and other non-physician providers play an integral role in providing these services, which positively impact several areas, including patient safety, reducing prescription drug abuse, and cost savings; and should be recognized in the report.I strongly urge HHS and the Task Force not to adopt these recommendations as drafted and request that the credentialing and training requirements be amended to be inclusive of all types of practitioners and their educational pathways. Sincerely,Jennifer Andrews1240 Golf Crest CtSpringfield, IL 62707-7601  ", "comment_id": "HHS-OS-2018-0027-1725", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-1725", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "Jennifer", "commenter_lname": "Andrews", "comment_length": 2981}, {"text": "Dear Dr. Singh,RE: Docket ID# HHS-OS-2018-0027As a Certified Registered Nurse Anesthetist (CRNA), Im writing today to express my concerns with the Department of Health and Human Services Pain Management Best Practices Inter-Agency Task force draft report titled Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations. I am supportive of recommendation 1c under section 3.3.3 (Workforce), which recommends expanding the availability of non-physician pain specialists. However, this recommendation is contradicted by another recommendation in the report for credentialing and training requirements that limit the pathways available for non-physician practitioners, such as CRNAs, to be able to provide interventional pain procedures. CRNAs are qualified pain practitioners who have the training and experience to provide high-quality treatments to patients suffering from a wide range of acute and chronic pain conditions, in a variety of practice settings. CRNAs who provide pain management do so in accordance with our professional scope of practice, federal and state law, and facility policy.As part of our educational preparation, CRNAs are required to learn and demonstrate competence in the management of pain. And, the standards issued by the Council on Accreditation mandate that nurse anesthesia programs provide content in, but not limited to, anatomy, physiology, pathophysiology, pharmacology, and acute and chronic pain management. These standards also require that student nurse anesthetists obtain clinical experiences in regional anesthetic techniques (i.e., spinal, epidural, and peripheral nerve blocks). As such, CRNAs possess the necessary knowledge and skills to employ therapeutic, physiological, pharmacological, interventional, and psychological modalities in the management and treatment of acute and chronic pain. Additionally, the Centers for Medicare and Medicaid Services (CMS) recognizes the ability of CRNAs to perform and bill for acute and chronic pain management services. The U.S. House of Representatives also recognizes the ability of CRNAs to perform pain management services and urged the Department of Defense to make funds available for CRNAs to pursue existing pain management fellowships. CRNAs and other non-physician providers play an integral role in providing these services, which positively impact several areas, including patient safety, reducing prescription drug abuse, and cost savings; and should be recognized in the report.I strongly urge HHS and the Task Force not to adopt these recommendations as drafted and request that the credentialing and training requirements be amended to be inclusive of all types of practitioners and their educational pathways. Sincerely,R Haynes1919 Dunraven RdBloomington, IL 61704-9705  ", "comment_id": "HHS-OS-2018-0027-1738", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-1738", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "R", "commenter_lname": "Haynes", "comment_length": 2966}, {"text": "Hi- I am a psychologist, and I have RLS, and I work in substance use treatment and fully understand the importance of addressing the opioid crisis. I nightly take Requip and Gabapentin which make me too drowsy to function, even at a low dose, during the day. I am embarrassed that I occasionally need to take Tramadol for long afternoon meetings. I probably take two pills a month, or less, yet it is important that I be able to continue to do. It is the only medication that does not make me drowsy and yet helps me to sit and function at work during meetings. It is important that legislation not be too strict that it overrides medically necessary treatment.thank you!", "comment_id": "HHS-OS-2018-0027-1751", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-1751", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "Sue", "commenter_lname": "Nelson", "comment_length": 676}, {"text": "I have had hip dysplasia, spinal deterioration, 3 left hip replacements,  two right knee revisions, RSD/CRPS, pineal brain  tumor and seizures from a year old until today (age 541/2.. ) Ive been forced to taper off benzodiazepines (after 23 years) which has caused deafening tinnitus. My pain medication was cut from oxycodone 15mg TID (7 years without incident or abuse)  to 10mg Hydrocodone. My pain management doctor refuses to increase medication to help with my excruciating pain. I have only left my bed, in 8 months, to go to multiple specialists that are a 3 hr rpund trip from my home. The doctors have taken away my quality of life. I have broken no laws EVER, dont use alcohol/marijuana or illegal drugs, jumped through every hoop but I am still treated like a drug addict!! I havent been able to be the wife, to my husband of 32 years, that he deserves and Ive missed almost a year of being able to visit my four children and 5 grandchildren ( and another grandbaby is due late May 2019). I have been treated horribly by pharmacists every time I have to pick up my low dose medications. Im afraid of being completely cut off of all opioids due to false narrative of opioid crisis, doctors fears and pharmacists/insurance company refusing to fill doctors orders! The guidelines were never meant to effect current pain patients but were the ones being effected the most while illicit drug use increases. My disability,  constitutional and human rights are being violated. Please stop this before more chronic pain patients commit suicide after being forced to stop all opioids! Lawmakers should never get between a patient and their doctor! ", "comment_id": "HHS-OS-2018-0027-1693", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-1693", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1705}, {"text": "End the Drug War.In a decriminalized environment absolutely none of this draft report would be necessary. Government created a problem, now government is pretending to want a solution, but in fact until the Drug War is completely and permanently ended no solution will ever be anything other than substantially sub-optimal. In a decriminalized environment opioid addiction is 100% benign, except for those individuals who knowingly and intentionally pursue risky behavior. These people are already pursuing their risky behavior choices in the current Drug War environment, so there will be absolutely no negative impact of decriminalizing opioids, and the elimination of negative Drug War externalities will be overwhelmingly positive for society.Providers need to quit being paranoid about opiates.Government needs to grow up.", "comment_id": "HHS-OS-2018-0027-1699", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2018-0027-1699", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "Richard", "commenter_lname": "Stewart", "comment_length": 867}]}, {"id": "DOS-2020-0005", "agency": "DOS", "title": "Notice of Public Meeting Concerning the Use of Digital Sequence Information of Generic Resources", "update_date": "2021-02-19", "update_time": "01:08:54", "purpose": "Nonrulemaking", "keywords": ["Digital Sequence", "Meeting", "comments", "CBD", "Water conservation"], "comments": [{"text": "Digital images and DNA sequence data on the worlds biodiversity are currently tracked by the traditional methods of scientific literature. In almost all academic research there is no direct monetary gain (in fact, most researchers pay to have their work published) and benefit sharing is implicit in the generally available distribution platforms. Any additional regulatory requirements for tracking and benefit sharing would discourage and impede biodiversity research. International collaborations would falter, conservation efforts would lose followers and momentum. I study insect diversity throughout the Neotropics. My work has been welcome to collaborators in over a dozen countries, improving knowledge of their biodiversity and helping to identify regions of high endemism. Additional administrative requirements of tracking and benefit sharing would either make this kind of work too difficult to contemplate, or at least greatly reduce the amount of work that could be done. The goals of tracking and benefit sharing are laudable when it comes to prominent commercial products, but regulators should be aware of the impacts on the extensive community of biodiversity scientists. These scientists have dedicated their lives to a vision of global biodiversity knowledge, and with on-going planetary change there is an urgency to their work. Any process that hinders the rapid description of the worlds biota will do more harm than good.", "comment_id": "DOS-2020-0005-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOS-2020-0005-0004", "comment_date": "2020-03-05", "comment_time": "05:00:00", "commenter_fname": "John", "commenter_lname": "Longino", "comment_length": 1455}, {"text": "As a biologist generating and analyzing genetic sequence information, I encounter two main threats to free sharing of digital sequence information.  One is the possibility of companies deciding to claim the information as proprietary; the other is for governments to decide that it is proprietary to a country.  However, most of the data that I work with is not marketable.  Instead, it helps give a better picture of the biological diversity and the relationships among organisms.  In turn, these data enable better stewardship of natural resources and may point the way towards finding commercial applications, but the data themselves are not directly of commercial value.   Therefore, I would support promoting free exchange of data and programs to decrease bureaucratic barriers to scientific research, while recognizing the importance of rules to promote sharing any eventual profits with native communities and restrictions on data about potential biological weapons.  ", "comment_id": "DOS-2020-0005-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOS-2020-0005-0002", "comment_date": "2020-03-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 975}]}, {"id": "FDA-2015-D-4561", "agency": "FDA", "title": "Head Lice Infestation:  Developing Drugs for Topical Treatment", "update_date": "2016-10-25", "update_time": "16:10:29", "purpose": "Nonrulemaking", "keywords": ["2015-19", "Head Lice Infestation", "Developing Drugs for Topical Treatment", "CDER", "development program", "clinical trial designs"], "comments": [{"text": "I am a practicing physician and hold active licenses in 3 states. This particular guidance caught my attention because there already exists a nearly 100% safe and effective treatment for head lice utilizing an FDA-cleared medical device called the AirAlle (formerly Lousebuster). It received FDA-clearance in May of 2010. I am the medical director of Pediatric Hair Solutions which is a regional company dedicated solely to the treatment of head lice utilizing the AirAlle medical device. Pediatric Hair Solutions has 10 clinics across 4 states. We have now successfully treated more than 15,000 cases over the past 5 and 1/2 years. Rather than encouraging pharmaceutical companies to develop new potentially toxic topical treatments for head lice I would encourage the FDA to review the published data on the AirAlle medical device. The AirAlle uses heated air to desiccate live bugs as well as the eggs or nits. Researchers strongly believe that lice will not be able to develop resistance to this treatment method because the mechanism of action is water deprivation. The AirAlle kills not only live bugs but is also extremely ovicidal (it kills 99.2%) The cost of treatment is also significantly less than the cost of the popular prescription medication Sklice. Sklice is also only 70-74% effective as documented in the package insert. I would urge the FDA to review the studies referenced below and perhaps reconsider this recent guidance.1. An Effective Non-chemical Treatment for Head Lice: A Lot of Hot Air. Pediatrics November, 2006 Volume 118    Issue 5 2. Efficacy of the Lousebuster, a New Medical Device for Treating Head Lice (anoplura Pediculae) Journal of Medical     Entomology 48 (1) 67-72. 20113. A New Treatment Approach to Pediculosis Utilizing the Lousebuster TM Device and Safe Nontoxic Treatment Solutions    St. Jude Pediatric Infectious Disease Conference February 2012 Abstract #201221", "comment_id": "FDA-2015-D-4561-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-4561-0006", "comment_date": "2016-10-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1987}]}, {"id": "FDA-2011-N-0802", "agency": "FDA", "title": "Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments", "update_date": "2015-09-11", "update_time": "10:39:47", "purpose": "Nonrulemaking", "keywords": ["cder2011177", "CDER", "Naloxone", "Public Meeting", "Request for Comments", "2015-376", "open", "Exploring", "Uptake and Use"], "comments": [{"text": "I stongly support the increase availability of Naloxone in the prevention of Opioid Overdose. Making naloxone availalble saves lives! I work as a nurse on a adult detox center at the University of Minnesota, Fairivew and we have noticed an alarming upward trend of 18 y o to 28 y o heroin addicts. Most started with abuse of narcotics then switched to heroin. Many are motivated to come to treatment because a friend overdosed and died. Recently I cared for a young male who came in because he himself nearly  died of an overdose but a friend did rescue breathing and got him to an ER. Unfortunetly this friend overdosed the next day and died. We just had a high school student overdose on heroin and alcohol and died. As a mother and a nurse I request you make naloxone and needles available to the public. One idea would be to have public health and/ or pharmacys distribute the medication/syringes after a person views an informational adminstartion/safety  video on an i-pad. As a community in the Twin Cities we organized a  multi -agencyOpioid coaltion to fight this horrific trend of young opioid abusers. Availability of Naxolone is one layer of a solution to this problem. Additonal prevention and public education measures are urgently needed for this nation wide epidemic. Thank you,Mary Kay Borgstrom RNOpioid Coalition  Prevention Leaderwww.opioidcoalition.org", "comment_id": "FDA-2011-N-0802-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0006", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1403}, {"text": "Working in Massachusetts on the opioid overdose prevention initiative has been one of the most fulfilling times of my professional life.  Teaching a parent or loved one of an opioid addict, who is consumed with the fear of losing their loved one to overdose, how to reverse an overdose with nasal naloxone is unparalleled.  Most people are amazed at how easy it is to save someones life with this medication.  There is so much misinformation around naloxone that it is crucial to educate the public on its use and importance in our society.  None of us can change the fact that presently we are literally fighting for peoples lives when we talk about opioid abuse, but we can save people from dying from an overdose.  An overdose often opens the door for people to reevaluate their situation and look at treatment as a viable option.  I did a focus group a few weeks ago and this came from a participant: I dont use drugs, but I have been here a lot, Im an alcoholic.  I have had alcohol poisoning and I was lucky to survive. So when I took your class I thought it was important to get Narcan, because you never know.  I left here and went to a sober house.  My first day in the house, a young kid overdosed on heroin.  I used that Narcan and saved his life. I called 911, they came, they took him to the hospital, no issues. I need to get more Narcan.  Its important that alcoholics know that it does apply to them, it applies to everyone if you can save someones life. ", "comment_id": "FDA-2011-N-0802-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0004", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1521}, {"text": "Hello,The United States is a leader in preventing overdose deaths with the use of naloxone.People from all over the world utilize the resources that have been produced in the US about naloxone. The US has the experience, research,  and expertise to respond to this preventable  epidemic; leading the way for so many other places. Having naloxone empowers all parties to engage in meaningful and educational dialogue about the risks associated with substances. ", "comment_id": "FDA-2011-N-0802-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0016", "comment_date": "2012-06-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 500}, {"text": "Naloxone use by VA Police in a first responder role outside the VA Hospital on VA grounds or City property requiresregulations to outline clear authority for use.The Minneapolis VA has extended the naloxone rescue kits to providers  to prescribe to patients, in addition, seek to enable our VA police officers to be trained and have clear authority to administer a potential life saving medication foropioid overdose.I have been unable to establish authority for VA Police to administer naloxone (prescription medicine)  under a standing order  because a standing order for naloxone  is for an unknown patient.  I have asked our VA Legal counsel but no information is available. The VA Police Chief here in Minneapolis wants naloxone rescue kits available in the medical kits used by the VA officers.Clinical staff want this as well.  VA Police officers are  first responders to off-site areas(not in the hospital) that include apartments on this campus and must call 911  for city ambulance response if needed. Naloxone could be useful.  Past history does include a drug overdose at VA run apartments, sadly naloxone would not have helped in that case.  The Chief anticipates need.  Pharmacy Service will commit to training the officers in opioid overdose avoidance, recognitionand response.", "comment_id": "FDA-2011-N-0802-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0040", "comment_date": "2015-09-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1372}, {"text": "Accidental drug overdose is the fourth leading cause of premature death among adults in NYC . Between 2005 and 2010, an average of 684 New Yorkers died annually of an accidental drug overdose, with 70% attributable to opioids.  Since 2006, when NYS passed legislation legalizing the administration of naloxone by trained laypersons, DOHMH and NYS Department of Health have distributed more than 20,000 naloxone kits to non-medically trained New Yorkers.  As a direct result of these programs, 523 overdose reversals have been reported in NYS by trained laypersons administering naloxone in the community, while many more reversals have occurred but not been reported. In NYS, naloxone can only be prescribed and dispensed by a medical doctor, nurse practitioner or physician assistant; however, the majority of certified programs dispensing naloxone have limited clinical staff on-site. An over the counter designation would diminish the need for on-site clinical staff and increase the accessibility of naloxone for those who would benefit.  DOHMH recognizes that such an important step must be accompanied by a significant increase in the availability of opioid overdose prevention education, including information on risk factors for overdose, recognizing overdose symptoms, administering naloxone and stressing the urgency of calling 911.Expanding access to naloxone beyond conventional medical settings is a safe and effective way to prevent unnecessary overdose deaths.  DOHMH strongly urges the FDA to build upon NYCs experience and expand access to naloxone by making it available over the counter and increasing the availability of intranasal naloxone by approving it as an on-label use.", "comment_id": "FDA-2011-N-0802-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0034", "comment_date": "2012-06-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1713}, {"text": "As a front line activist in the field of overdose prevention, I have recorded many firsthand accounts from bystanders responding to Opioid overdoses. The majority of these overdoses involved heroin and Oxycontin. Many of the bystanders responding were parents who had received  Narcan from our fixed pilot site in Cambridge Mass, which allows the distribution of nasal Narcan under standing order from a physician an d does not require a doctor or nurse practitioner to be present on site at time of training and distribution to the public. In all cases of Narcan being administered, not once was it reported to have negative effects on the person overdosing, nor was it considered hard to administer via the nasal. Every case recorded reported the successful reversal of a potentially fatal overdose. Had Narcan not been present at the time of many of the reported overdoses, the rate of death may have been notably higher due to the publics fear to call 911 for fear of negative consequence, such as loss of housing arrest etc. i believe Massachusetts has a model program for the safe and effective overdose prevention training and distribution of Narcan. It would beneficial for other states to base such programs on the groundwork laid down by such pilot programs in order to save lives. The idealism behind a standing order for Narcan is simple in itself, as it removes the cost of having a Doctor on site at all times to oversee the distribution of the medication. Not only is this costly, but also is not a reality for many underfunded programs. By allowing Narcan to be distributed in the manner that Massachusetts does, the medication is getting into the hands of a marginalized community that greatly needs it. In the end, the measure is saving so many lives.", "comment_id": "FDA-2011-N-0802-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0019", "comment_date": "2012-06-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1779}, {"text": "In collaboration with other medical and public health professionals throughout the U.S., I am currently developing NIH funded online curricula for overdose prevention with naloxone for peers, family members and trainers, and for police, firefighters and EMTs. As a researcher and curriculum developer, who has worked with injection and non-injection drug users for decades, I fully support the dissemination of overdose prevention education with naloxone to reduce fatal overdoses and encourage drug users to seek effective drug treatment. I support making the process as simple as possible with ready access to naloxone and with Good Samaritan laws to protect lay people from arrest or fear of arrest. I also believe overdose prevention education should be readily available through face to face classes and online for easy dissemination of this life-saving medication. In addition, prevention education should be tailored to meet the needs of various populations and be available in a wide array of venues (doctors offices, hospitals, harm reduction  drug treatment centers, detoxification units, schools). Research on best practices and the best ways to effectively disseminate this life-saving overdose prevention education and medication is also needed.", "comment_id": "FDA-2011-N-0802-0032", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0032", "comment_date": "2012-06-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1280}, {"text": "The Baltimore City Health Department (BCHD) is pleased to comment on the potential value of making Naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities.BCHDs Staying Alive Overdose Prevention Program is currently the only overdose prevention program in Maryland.  BCHD launched Staying Alive in 2004 in response to a rising number of overdose deaths in the city, a number that surpassed the homicide rate.  In 2002, there were a record 343 overdose deaths involving alcohol or at least one drug of abuse, which included opioids, heroin or methadone.  In 2009, there were 229 overdose deaths.We believe that the Staying Alive program played a significant role in the drop in overdose deaths.  Among participants who have been dispensed Naloxone, there have been at least 240 reported overdose reversals. Additionally, through the Staying Alive program:4,000 vials of Naloxone have been dispensed1,200 providers have been trained at various facilitiesMore than 10,000 clients have been trained through the Staying Alive program.  Maryland, like many other states, is in the midst of an overdose epidemic.  While the Staying Alive program focuses its efforts on needle exchange clients and heroin drug users, there is a growing prescription drug abuse problem in Maryland such that 55% of all intoxication deaths involved a prescription opioid in 2010. This demonstrates an overwhelming need to expand the reach of overdose prevention programs and Naloxone distribution to populations beyond the traditional heroin user.  To address the overdose epidemic in Maryland, Naloxone needs to be easily accessible and made available to those who need it.  This includes making it available over-the-counter as well as including it in drug formularies for public and private health insurance programs.", "comment_id": "FDA-2011-N-0802-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0017", "comment_date": "2012-06-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2082}, {"text": "The ready availability of naloxone to reverse intended or unintended overdose of opioids is to be encouraged. It is likely to save many lives and isnt likely to present a risk to the public. I urge its acceptance by the FDA", "comment_id": "FDA-2011-N-0802-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0002", "comment_date": "2012-02-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 233}, {"text": "The availability of nalaxone makes the difference between life and death for many opioid users. Through increasing its availability the FDA will not only be saving lives but sending the message that all people, including those who use drugs are valuable and worth caring for. ", "comment_id": "FDA-2011-N-0802-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0010", "comment_date": "2012-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 276}]}, {"id": "DOD-2015-HA-0062", "agency": "DOD", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\nTRICARE:  Refills of Maintenance Medications Through Military Treatment Facility Pharmacies or Nation Mail Order Pharmacy Program", "update_date": "2020-10-22", "update_time": "01:30:45", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "These people who have worked so hard to ensure our freedom should not have to worry about their medications.  This rule is intended to save a few bucks but at what expense?  If our retired military are on maintenance medications they cant afford to miss a day of medications due to any sort of delays ie. snail mail.  ", "comment_id": "DOD-2015-HA-0062-0008", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0008", "comment_date": "2015-10-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 323}, {"text": "Recommend adding the following paragraph under paragraph 5 of Part 199.21 as sub paragraph viii.  All medications not provably known to be chemically stable at temperatures above 150 degrees Fahrenheit will be shipped in climate controlled containers during the months of May through September.  All medications not provably known to be chemically stable below the freezing point of water will be shipped in climate controlled containers during the months of November through March.  Climate control for these medications will be maintained until in the hands of the customer.The FDA only certifies medications to be chemically stable between the temperatures of 59 degrees Fahrenheit and 86 degrees Fahrenheit.  While some pharmaceutical manufacturers have tested their medications and found the climate control is absolutely necessary, many others have not.  UPS trucks and other delivery vehicles in the Southeast U.S. often have on-truck temperatures near the brown sides of their trucks that exceed the boiling point of water.  In the winter, particularly in the North, temperatures well below zero are similarly found in these vehicles.  Medications exposed to these temperatures can change chemical composition and pose grave risk to the consumer, to include the risk of death.  Anecdotal information on mail order pharmacy use in central Alabama has resulted in emergency room visits having been required for some patients as a result of these chemical changes in the heat of summer.  The FDA has the necessary reports on file.  If mail-order pharmacy use is to be directed, precautions should be taken to ensure the medicines shipped in this matter are kept in proper storage from the door of Express Scripts to the door of the customer.Those who have served our military and receive these benefits deserve to know their medications are safe.  Safeguards should be in place to ensure that all medications are kept within or near the FDA recommended temperature range of 59-86 degrees, unless it is absolutely proven that a particular medication can withstand a greater temperature range.  Best Commercial Practices do not do this.  Best Commercial Practices maximize profits, not safety.  Those who have served this country deserve to have their safety put first.  As such, I recommend that the proposed insertion of a sub-paragraph viii (8) with the verbiage above, be inserted into the proposed change to the regulations.  ", "comment_id": "DOD-2015-HA-0062-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0002", "comment_date": "2015-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2505}, {"text": "I have concerns that this change while offering some savings to Tricare is only targeting retirees. why arent active duty being targeted as well? This question has to be asked. Just as there is discussion of hardship waivers, why not blanket waivers for say remote duty stations that have no or limited pharmacy access. Active duty has more readily access the the military pharmacies than most retirees as a good portion of active duty reside on the same military installations the pharmacies. Also will additional staffing be provided at the military pharmacies to accommodate the influx of retirees who will be forced to use the base pharmacy because of this rule? i dont see anything posted about this issue.", "comment_id": "DOD-2015-HA-0062-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0005", "comment_date": "2015-10-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 721}, {"text": "I have concerns that this change while offering some savings to Tricare is only targeting retirees. The question has to be asked why arent active duty being targeted as well? Just as there is discussion of hardship waivers, why not blanket waivers for say remote duty stations that have no or limited pharmacy access. Active duty has more readily access the the military pharmacies than most retirees as a good portion of active duty reside on the same military installations the pharmacies. Also will additional staffing be provided at the military pharmacies to accommodate the influx of retirees who will be forced to use the base pharmacy because of this rule? I see nothing posted about augmenting staffing for the certain influx of retirees.", "comment_id": "DOD-2015-HA-0062-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0003", "comment_date": "2015-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 752}, {"text": "I would like to make the following comments to the interim final rule revisions paragraph (r) to 32 CFR 199.21:(2) Medications covered(iii) It will be cost effective to dispense the medication from the mail order pharmacy.A concerted effort on the part of the mail order pharmacy shall be made to refill all prescriptions, for a patient, at the same time.  All the filled prescriptions shall be combined and shipped in a single container .  I take 10 prescribed meds by mouth each day; Express Scripts cannot seem to fill all orders at the same time, rather they ship each med on a staggered basis (even when all scripts are submitted at the same time) thereby charging TRICARE more for shipping and handling.  My local pharmacy has no trouble filling all the scripts in a single visit for pick up.(5) Procedures.(ii) An effective communication plan that includes efforts to educate beneficiaries in order to optimize participation and satisfaction will be implemented.There must be an administrative channel for feedback as to the service received.  My mail order pharmacy issues many conflicting communications to me and there is no one person to talk to.  One representative says  something that is conflicted by the follow up representative; notification of shipment status is nearly always wrong in that the med does not get shipped as promised and is weeks behind.  I do not know that until I call, then I am informed they have not shipped it yet due to some lame excuse.  My satisfaction and health therefore suffer.  Prior approvals for brand name meds seem to disappear from the system.  My doctors spend a great deal of time writing justification of brand name meds and it appears they are routinely denied.   Denials of prescription medically necessary medications are not signed by a medical doctor or anyone, there must be personal accountability!  Personally, my experience with the mail order pharmacy is that they basically Deceive, Delay, and Deny prescribed meds for military retirees.", "comment_id": "DOD-2015-HA-0062-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0004", "comment_date": "2015-09-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2085}]}, {"id": "EPA-HQ-OGC-2022-0447", "agency": "EPA", "title": "Proposed Consent Decree in Center for Biological Diversity, et al. v. Regan, No. 4:22-cv-02285  (N.D. Cal.)", "update_date": "2022-08-09", "update_time": "16:34:15", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Air pollution is contributing to climate change. It makes it harder to breathe and it pollutes our waterways. These contaminants can cause cancer and other major health issues. Any regulation to help control or stop these contaminants from reaching the air is a win for our citizens, future generations, and our planet. Im all for cleaning up our environment. ", "comment_id": "EPA-HQ-OGC-2022-0447-0003", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OGC-2022-0447-0003", "comment_date": "2022-08-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 365}]}, {"id": "TTB-2010-0004", "agency": "TTB", "title": "Standards for Pipe Tobacco and Roll-Your-Own Tobacco", "update_date": "2021-06-11", "update_time": "12:05:29", "purpose": "Rulemaking", "keywords": ["tobacco", "pipe tobacco", "excise taxes", "tobacco products", "roll-your-own"], "comments": [{"text": "I feel that the tobacco should not be taxed again. There is a difference between roll your own tobacco and pipe tobacco. Pipe tobacco is there for those to enjoy a smoke every once and a while from their pipe for the aroma and flavor. Not for the rush of nicotine. The pipe tobacco has a different cut and length on it which makes it so it cannot be used in that fashion.", "comment_id": "TTB-2010-0004-0007", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0007", "comment_date": "2010-08-31", "comment_time": "04:00:00", "commenter_fname": "Dominique", "commenter_lname": "Ribarich", "comment_length": 371}, {"text": "Ive smoked only the pipe for 47 years.  I would never put RYO in a pipe.  RYO tobacco  is much too small a cut for the pipe bowl and would smoke very hot.  Pipe tobaccos larger cut would also not be suitable for RYO because it is cut too large to roll into a wrapper.  It is unfortunate that the RYO industry has tried to fool the government with labels.  The fact is you are on the proper track by distinguishing between the two types.  I suggest you base your analysis by examining reputable tobacco manufacturers and interviewing users of both types.  Pipe tobacco is not meant to be directly inhaled unlike RYO products.  I sincerely hope you will be successful in your endeavor to separate the two types.   I generally agree with the comments put forth thus far.  If you have pipe smokers on your staff, they will surely be able to help you distinguish the difference in cut, character and content of the product.  I wish to preserve the pipe smoking hobby and appreciate the opportunity to comment.  I know it is a difficult situation.", "comment_id": "TTB-2010-0004-0006", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0006", "comment_date": "2010-08-31", "comment_time": "04:00:00", "commenter_fname": "Robert", "commenter_lname": "Coffey", "comment_length": 1061}, {"text": "PTC Comments", "comment_id": "TTB-2010-0004-0166", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0166", "comment_date": "2011-10-25", "comment_time": "04:00:00", "commenter_fname": "Craig", "commenter_lname": "Williamson", "comment_length": 12}, {"text": "Pipe tobacco is often larger strands of tobacco, as in not finely cut as roll your own tobacco is.  Pipe tobacco can be aromatic and can contain Cavendish.  You will not find this among roll your own tobacco.  Due to the nature of pipe tobaccos cut, it doesnt smoke well when wrapped in the rolling paper for cigarettes.  Pipe tobacco is generally stronger and not recommended for inhalation, at least compared to roll your own tobacco.", "comment_id": "TTB-2010-0004-0004", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0004", "comment_date": "2010-08-31", "comment_time": "04:00:00", "commenter_fname": "Joseph", "commenter_lname": "Donofry", "comment_length": 446}, {"text": "I am apposed to the reclassification of Pipe Tobacco and Roll Your Own Tobacco.I do not believe that a discriminatory tax practice on some products but not all products is a fair or practice...I am not sure what reasoning you may be using for this reclassification so I am assuming that it must be due to the fact that it may be considered to be an unsafe product and that this is yet another attempt to discourage the use of Tobacco products.If this is the case then why do you single out tobacco as apposed to lets say prescription drugs and or all other unsafe products that are on the market.More people die from using prescription drugs than nation wide than those that use tobacco.If you truly believe that a product is so unsafe for consumption that you must penalize them for the use of it by means of an unfair tax then perhaps you should remove it from the market along with all other products that can be considered harmful,,,,Stop the discriminatory practices now.We are being over taxed as it is...leave well enough alone.  ", "comment_id": "TTB-2010-0004-0161", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0161", "comment_date": "2011-10-25", "comment_time": "04:00:00", "commenter_fname": "Larry", "commenter_lname": "Parsons", "comment_length": 1037}, {"text": "Please do not reclassify pipe tobacco! Some of are poor and retired . We cannot afford to pay higher prices for something we have done for years. Everything else is going up except our S.S. benefits. It is a struggle enough for us elderly to survive under the current laws. We ederly people are forced to live in sin because we cannot afford to get married without losing our S.S. Benefits, just because we have lost a spouse and found someone else. You have decided that gay people can be domestic partners with all the benefits but, deny us elderly to have the same rights without severe finacial penalties. As a veteran I am ashamed that our country is constantly trying to uindercut those of us who have less.", "comment_id": "TTB-2010-0004-0162", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0162", "comment_date": "2011-10-25", "comment_time": "04:00:00", "commenter_fname": "Calvin", "commenter_lname": "Chamberlain", "comment_length": 713}, {"text": "Proposed tests based on water, humectants and flavorings can be circumvented. Shred size adds a step that will deter many cigarette users. ", "comment_id": "TTB-2010-0004-0028", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0028", "comment_date": "2011-08-31", "comment_time": "04:00:00", "commenter_fname": "Robert", "commenter_lname": "Wagner", "comment_length": 139}, {"text": "DONT RAISE TAXES!!YOURE COSTING PEOPLE THEIR JOBS!!AGAIN GOVERMENT.. JUST LOOKING OUT FOR THE BIG COOPERATE CIGARETTE ROLLERS!!PUT THE LITTLE GUY OUT OF BUSINESS!!", "comment_id": "TTB-2010-0004-0103", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0103", "comment_date": "2011-10-24", "comment_time": "04:00:00", "commenter_fname": "Keith", "commenter_lname": "Sager", "comment_length": 188}, {"text": "The reclassifying of pipe tobacco should NOT happen, please, we the people are taxed and taxed and taxed on everything we do!Please leave this alone, between a horrific economy and the elimination of the middle class, never mind the political retoric , enough of our freedoms are already taken. NO RECLASSIFYING of pipe tobacco, please!!!", "comment_id": "TTB-2010-0004-0109", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0109", "comment_date": "2011-10-24", "comment_time": "04:00:00", "commenter_fname": "Renate", "commenter_lname": "Stone", "comment_length": 343}, {"text": "I think  the government has taxed us enough! We pay way too much in taxes the way it is it seems no matter what we do Uncle Sam has to take taxes on it I* say Enough is Enough!!!!!", "comment_id": "TTB-2010-0004-0111", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2010-0004-0111", "comment_date": "2011-10-24", "comment_time": "04:00:00", "commenter_fname": "Deborah", "commenter_lname": "Larrimore", "comment_length": 180}]}, {"id": "FDA-2003-D-0202", "agency": "FDA", "title": "Compounding of Drugs for Use in Animals Compliance Policy Guide", "update_date": "2021-09-01", "update_time": "01:03:00", "purpose": "Nonrulemaking", "keywords": ["Veterinary Drugs", "7125.40", "DRUGS", "ANIMALS", "COMPOUNDING", "COMPLIANCE POLICY GUIDE", "close"], "comments": [{"text": "I have a dog with a neurological condition. Luckily I am able to afford her neurological meds through a compounding pharmacy.  If these changes go into effect, I will no longer be able to afford these life-saving medications for her.  The direct result of this proposed change would be the euthanasia of my dog. Medicine is expensive enough, please do not make it more expensive with unnecessary regulations.  Having access to medicines to extend the lives of our pets is a simple pleasure.  The costs of these medicines should be reduced, not increased.  This will directly cause forced euthanasia to thousands of pets who currently receiving medical treatment.", "comment_id": "FDA-2003-D-0202-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2003-D-0202-0010", "comment_date": "2020-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 662}]}, {"id": "FDA-2019-N-5959", "agency": "FDA", "title": "Medication Guides:  Patient Medication Information; Proposed Rule", "update_date": "2024-03-13", "update_time": "15:48:47", "purpose": "Rulemaking", "keywords": ["2012-117", "Proposed Rule", "Medication Guides", "Patient Medication Information", "CDER", "OPEN"], "comments": [{"text": "I support the proposed rule, Medication Guides: Patient Medication Information, as a new type of medication guide to help patients use prescription drugs safely and effectively. The current medication guide does not provide a clear, concise, accessible, and sufficiently useful guide for patients. There is evidence that prescription drug product information may help patients use their prescription drugs safely and effectively, reducing preventable adverse drug events and improving health outcomes. As a nurse practitioner, I treat patients with diabetes, and medication errors can be life threatening, and could cause severe hypoglycemia or hyperglycemia. My patients have a wide range of literacy levels, and the clearer the labeling, the less room there is for error. An important element of the proposed rule is the requirement that patient mediation information be scientifically accurate and based on and consistent with the prescription drug to prevent misleading information. The changes to the new medication guide will provide patients with easy-to-read and concise information regarding their drugs, a clear understanding of the drug, and possible adverse reactions, and the ability to recognize when to call the doctor.", "comment_id": "FDA-2019-N-5959-0103", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0103", "comment_date": "2023-06-23", "comment_time": "04:00:00", "commenter_fname": "Amanda", "commenter_lname": "Colandro", "comment_length": 1249}, {"text": "For a majority of patients I talk to, the information they currently get is more than they are willing to read and is not laid out well. Information is not clearly labeled and is not always easy to find. I sometimes highlight certain areas that are of importance to the patient. Some patients ask that we do not give them the information at all since at our location we provide the information on separate sheets and sometimes they receive 5 pages of information.The drug package inserts should be done away with entirely as a part of this new patient information rule. The package insert is written in technical terms, and we usually pull the package insert off the bottle when they arrive and discard it. That is a lot of waste of paper when all that information is available online through multiple sources such as Facts and Comparisons, Clinical Pharmacology, DailyMed, etc. I believe patients would be more likely to read a shorter, more concise information sheet.", "comment_id": "FDA-2019-N-5959-0092", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0092", "comment_date": "2023-06-08", "comment_time": "04:00:00", "commenter_fname": "D", "commenter_lname": "Porter", "comment_length": 994}, {"text": "The iPledge REMS program continue to widen health disparities. Much of this could have been prevented by involving dermatologists in the pre-testing. There are still technical issues including lack of privacy as designees in any practice can be seen by all users.The following are the top priorities to address:test proposed changes to REMS system prior to implementation with physicians, patients, and pharmacists; allow for ample time for stakeholders to transition to a new platform including beta-testing; improve support services for prescribers when there is REMS System failure; and facilitate greater transparency between drug sponsors, REMS administrators, and stakeholders, including a named point of contact for key stakeholders.", "comment_id": "FDA-2019-N-5959-0124", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0124", "comment_date": "2023-07-24", "comment_time": "04:00:00", "commenter_fname": "Bruce", "commenter_lname": "Brod", "comment_length": 959}, {"text": "nker", "comment_id": "FDA-2019-N-5959-0110", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0110", "comment_date": "2023-07-03", "comment_time": "04:00:00", "commenter_fname": "Barbara", "commenter_lname": "Dunker", "comment_length": 4}, {"text": "The proposed rule to change the regulations for prescription drug products to simplify and highlight essential information can have a substantial positive effect on patient health literacy and education. Most people do not read the current patient package insert provided because it pertains too much information and is not direct, to-the-point information. The proposed Patient Medical Information (PMI) insert gives patients access to essential information on one page and lists need-to-know information in a standardized format. The PMI would include the product name, important safety information, common side effects, and a concise summary of indications and uses. As you can see, this provides critical information in a simplified and more effective manner. Multiple studies have shown that the current information provided with prescription drugs can be confusing, conflicting, and incomplete (Califf, 2023). When people are not provided with the proper prescription education, this can lead to the cessation of medication or improper use. Rightfully, one of the FDAs top priorities is to reduce misinformation and disinformation. When an individual has direct and easy-to-understand information in a consistent format, this can reduce both accidental and purposeful misinterpretations (Califf, 2023). I have been a registered nurse for over ten years and have worked most of that time in emergency rooms around the United States. I can attest that most patients do not know the side effects, precautions, or indications for their daily medications. The most often response I would hear when a patient is asked why they take a particular medicine is, My doctor told me to take it. This is not health literacy and does create informed patients. I firmly believe that simplifying and reducing the information provided with medication prescriptions will increase patient education and willingness to engage in health literacy and reduce misuse and misinformation. I appreciate your consideration.References:Califf, R. (2023, May 30). Fda proposes new, easy-to-read medication guide for patients, patient medication information. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-proposes-new-easy-read-medication-guide-patients-patient-medication-information", "comment_id": "FDA-2019-N-5959-0105", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0105", "comment_date": "2023-06-26", "comment_time": "04:00:00", "commenter_fname": "Steven", "commenter_lname": "Burdzy", "comment_length": 2398}, {"text": "After reading this proposed rule, I agree that there should be a standardized way that medication information is presented to patients. Given the limited time patients have with their practitioners to discuss the complexity of medications, patients rely on information they receive from other sources. Being that not all sources are reliable, reputable or accurate, it is essential for medication information be available in a clear, concise, and easy to understand format. Providing this information can help reduce confusion, medication noncompliance, and give patients more control and autonomy over their medication treatments. It prioritizes patient-centered care and medication prescribing. Patients heavily rely on literature that is accurate and clear to make healthcare decisions especially between choosing to take a medication or not. Pharmacists in one study by Alefishat et al. (2021) reported that Internet-based data can be beneficial but could actually be detrimental due to the fear and misinformation that can be found through Internet sources for medication information. This highlights the need for standardized medication information that is readily available to patients when needed.", "comment_id": "FDA-2019-N-5959-0114", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0114", "comment_date": "2023-07-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1205}, {"text": "Hello,I wanted to inquire on regulations of  medication guides and PMI. With regards to printed handouts, is there a way that we can have med guides/PMI default to QR code (electronic) instead of paper. Patients that decline the electronic delivery or QR code can have drug information printed off. Also, is there guidance on existing med guides provided via QR code. We are looking to incorporate software (MedsOnCue) into our facility but wanted to make sure it is in line with FDA guidelines.", "comment_id": "FDA-2019-N-5959-0129", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0129", "comment_date": "2023-08-16", "comment_time": "04:00:00", "commenter_fname": "Supriya", "commenter_lname": "Ziska", "comment_length": 500}, {"text": "As a professional in pharmaceutical sciences and accounting who has worked with non-profits and university research programs on both financial and health literacy, I support the FDAs proposed rule for the development of PMIs which can benefit patients and healthcare providers.  Promoting stronger health literacy within the population can improve adherence to the drug regimen and the patients health outcomes.  Standardization of a PMI template and simplifying access through electronic means would further facilitate health communications between the patient and their healthcare providers during the patient care process.  The implementation of the PMI would also contribute to a more independent and informed decision-making process for patients navigating outpatient procedures such as the blood transfusion services discussed in the proposed rule.  While there will be increased costs because of the development of the PMI, the benefits that it will provide to patients and providers would include better care management and reducing risks pertaining to drugs and outpatient services.  This can also reduce healthcare associated costs in the long term due to better compliance. From my work with my mentors in cancer education, individuals who were provided with clear instructions for self-exams and benefits for early screenings per guidelines from the American Cancer Society such as for breast or colon cancers, found information relevant to their personal needs helpful. The proposed rule for the PMI would positively help improve patient health literacy and guide those involved with developing and disseminating PMIs to provide resources which can mitigate risks for drugs and services in an outpatient setting.  On the other hand, I do understand that costs may be a factor, especially the increased resources which would be needed to ensure that the PMI development process move accordingly per the proposed rules.  For dispensers and other individuals who may have limited resources or will accrue additional expenses as a result of PMI distribution, the FDA should work with ensuring that implementation of PMIs would be as smooth as possible so that benefits can be realized.", "comment_id": "FDA-2019-N-5959-0127", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0127", "comment_date": "2023-07-31", "comment_time": "04:00:00", "commenter_fname": "Kevin", "commenter_lname": "Chevalier", "comment_length": 2218}, {"text": "I concur with the proposed rule Medication Guides: Patient Medication Information. My rationale for support is that the rule will help patients use their prescription medicine products safely and effectively, we must give patients written information about them that is clear, succinct, accessible, and helpful. This information must be presented in a way that is consistent and simple to understand. Further, the information paly a significant role because without this information, patients are unable to determine which medication is best for them as well as even if they do, how to take it. Finalizing the rulemaking help on the gathering, application, and management of knowledge regarding the use of drugs. The range of information about drugs includes identification, price, pharmacokinetics, dose, and side effects.in addition, it will help to monitor medication. It is crucial to routinely evaluate all prescription medications, over-the-counter medications, and supplements because all medications can have side effects that can result in new symptoms or exacerbate current symptoms. Its also critical to consider potential interactions.", "comment_id": "FDA-2019-N-5959-0126", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0126", "comment_date": "2023-07-28", "comment_time": "04:00:00", "commenter_fname": "Muaz", "commenter_lname": "Chaudhry", "comment_length": 1157}, {"text": "To Whom It May Concern, I am writing because I am concerned about your proposed rule regarding printed prescription drug information for patients. I appreciate that the FDA recognizes the importance of printed drug information for patients, but I believe the proposed rule lacks important patient protections. I dont believe the drafted rule achieves the FDAs stated goal of improving health because it does not require clear and useful printed prescription drug product information provided in the right manner. Like most Americans, my family and I take prescription medication, and we struggle to understand the printed medication information that accompanies our medications. We need to improve our understanding of the drugs we are taking and need improved printed copy to help us.I need clear, always accessible and useful written prescription drug product information.  Patients need a standardized layout researched to improve patient understanding and retention of information. Standardization principles should include use of color, consistent headings and MINIMUM FONT SIZES to increase understanding. Patient understanding and retention of information should be rigorously tested with REAL patient populations taking REAL prescription medication before adoption. Why would the FDA consider a change in prescription information for patients without first researching a format that improves patient understanding? I also believe the FDA should require standards for high quality printing and inspection so that ALL required information is present. The FDA rule, as it currently stands, could force the elderly and other patients to access life-saving information by only electronic means. This goes against common sense and can put Americans lives at risk. People deserve full access to their prescription drug information at all times, no matter their age, income, or geographic location. I urge you to revise your proposed rule for patient medication information in two ways:1.Require a standardized printed format that has been scientifically researched and proven to improve patient understanding.2.Require the drug manufacturer to supply the printed information and have it accompany the drug product and not printed in a retail pharmacy.Doing so will help save lives and improve medication outcomes. Thank you for your time and consideration.", "comment_id": "FDA-2019-N-5959-0146", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5959-0146", "comment_date": "2023-09-12", "comment_time": "04:00:00", "commenter_fname": "Russell", "commenter_lname": "Haraf", "comment_length": 2543}]}, {"id": "DEA-2009-0008", "agency": "DEA", "title": "Schedules of Controlled Substances:\r\nPlacement of 5-Methoxy-N,NDimethyltryptamine\r\nInto Schedule I of\r\nthe Controlled Substances Act", "update_date": "2021-12-02", "update_time": "01:00:54", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Please do not add 5-Methoxy-N,NDimethyltryptamine , or 5-MeO-DMT (5-methoxy-dimethyltryptamine) into Schedule I ofthe Controlled Substances Act.Thank you.Aneitra Batteast", "comment_id": "DEA-2009-0008-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0008-0005", "comment_date": "2009-09-10", "comment_time": "04:00:00", "commenter_fname": "Aneitra", "commenter_lname": "Batteast", "comment_length": 190}, {"text": "File ", "comment_id": "DEA-2009-0008-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0008-0007", "comment_date": "2009-09-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5}]}, {"id": "FDA-2005-P-0120", "agency": "FDA", "title": "Establish Therapeutic Equivalence Requirements for Any Generic or Following- on Drug Product Referencing Adderall XR MASP-CLOSED", "update_date": "2021-09-01", "update_time": "01:01:15", "purpose": "Nonrulemaking", "keywords": ["concentration-time", "curve", "xr", "masp", "disorder", "hyperactivity", "5mg", "10mg", "15mg", "20mg", "25mg", "30mg", "amphetamine", "single-entity", "salt", "ADDERALL", "ANDA", "application", "abbreviated", "drug", "new", "CDER-CLOSED"], "comments": [{"text": "na", "comment_id": "FDA-2005-P-0120-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0023", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}, {"text": "na", "comment_id": "FDA-2005-P-0120-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0021", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}, {"text": "na", "comment_id": "FDA-2005-P-0120-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0020", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}, {"text": "na", "comment_id": "FDA-2005-P-0120-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0022", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}]}, {"id": "DEA-2019-0007", "agency": "DEA", "title": "Schedules of Controlled Substances: Removal of 6-beta-Naltrexol from Control", "update_date": "2021-12-02", "update_time": "01:01:29", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Naltrexone is an opioid receptor antagonists and is commonly used in the treatment of opioid addiction and overdose, without the harmful addictive side effects of the drugs it treats.  Currently 6-Naltrexol is a schedule II controlled substance.  This proposed rule would allow more patients access to this life saving drug by removing the schedule II rating.  We agree with the action as it will save more lives and positively affect individuals and their families who struggle with drugs and alcohol addiction.Naltrexone is not a narcotic yet is used to help narcotic dependents who have stopped taking narcotics to stay drug-free. It is also used to help alcoholics stay alcohol-free. The medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by a health care provider. It will not produce any narcotic-like effects or cause mental or physical dependence however it may block the craving of wanting more. Naltrexone is prescribed for moderate-to-severe alcohol dependence, such as a patient that consumes five or more drink per day on a regular basis and has alcohol related problems. This medication is appropriate for patients that have tried to quit by abstaining from alcohol for several days before starting the medication. Naltrexone treatment is usually a minimum of 3 to 4 months. The goal is for the patient to be able to abstain from alcohol during this time, if so then treatment can be stopped. If on the other hand the patient continues to consume alcohol then the daily dose can be increased from 50 mg to 100 mg. There is also a monthly injection that is 380 mg and is given intramuscularly. Naltrexone is a drug that saves lives without the fear of addiction, and by removing this schedule II classification, it will become more available to a greater number of patients in need.", "comment_id": "DEA-2019-0007-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0007-0004", "comment_date": "2019-09-23", "comment_time": "04:00:00", "commenter_fname": "Karan", "commenter_lname": "Kortlander", "comment_length": 1943}, {"text": "6 Beta Naltrexol, which is an opioid antagonist, meaning, it blocks the bodies receptors preventing the body from responding to endorphins and opioid. This drug should not be listed as a scheduled II substance as science has shown there are no known potentials for abuse in contrast to other schedule II drugs such as, morphine. On the other hand,  6 Beta Naltrexol has shown to work similarly to Naltrexone which was removed from all schedules effective in 1975 because of the lack of evidence to show the risk for abuse potential.  While, 6 Beta Naltrexol works like naltrexone it does differ in some aspects, for instance, it has a lower potency, a significantly long half life, and with higher plasma concentrations making it as effective as naltrexone when given by mouth. With the current number of deaths by overdose being 399,000 people from 1999-2017 involving opioids including prescription and illicit. It is imperative that new preventions including medications like 6 Beta Naltrexol be made available for treatment and provided to those at risk for overdose without the constraints of schedule II drugs. Centers for Disease Control  and Prevention. (2019). Drug overdose. Retrieved from https://www.cdc.gov/drugoverdose/data/statedeaths.html", "comment_id": "DEA-2019-0007-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0007-0005", "comment_date": "2019-09-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1264}, {"text": "Its nuts that the majority of States have legalized the use of cannabis for recreational and medical use and the other States will make you a criminal and throw you in jail for years. Federal and States cannot accurately track tax revenues from cannabis sales because it is cash only transactions. And every day we get of cannabis is curing and helping people with their ailments from migraines and arthritis to pancreatic cancer (report from Harvard research: https://www.yahoo.com/lifestyle/study-on-cannabis-chemical-as-a-treatment-for-pancreatic-cancer-may-have-major-impact-harvard-researcher-says-165116708.html).Big Pharma has controlled the narrative with millions of dollars in political donations every year. Removing cannabis from being Schedule 1 drug is long over due and it is time to do whats best for America.Sincerely,Fil Lalau", "comment_id": "DEA-2019-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0007-0006", "comment_date": "2019-09-23", "comment_time": "04:00:00", "commenter_fname": "Fil", "commenter_lname": "Lalau", "comment_length": 896}, {"text": "I just wanted to make sure that I understood this rule completely. My understanding of the proposed rule is that the DEA wants to declassify a drug that is only available in research labs, not available to the general public or to most physicians for prescription to patients, has no addictive properties, is not being used to for any purpose what so ever, and there is no history of any abuse of the drug, etc. I assume that there are plenty of other classified drugs that fall into the same category as this one. Why not spend more time worrying and combating drugs that are readily available to citizens or that are highly prescribed by physicians rather than wasting time on drugs that no one outside of a lab will ever see or ingest? For the record, I am for stronger drug laws in this country!!!", "comment_id": "DEA-2019-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0007-0007", "comment_date": "2019-09-23", "comment_time": "04:00:00", "commenter_fname": "Phil", "commenter_lname": "Hanzlik", "comment_length": 801}]}, {"id": "DEA-2012-0008", "agency": "DEA", "title": "Disposal of Controlled Substances", "update_date": "2021-12-02", "update_time": "01:00:56", "purpose": "Rulemaking", "keywords": ["Disposal"], "comments": [{"text": "Drug Enforcement Agency:Since 2007, the Rock County Health Department in Wisconsin, in collaboration with many, many community partners, has collected 13,279 pounds of unwanted prescription and nonprescription medication through our drug collection program. This is 13,279 pounds of drugs that have been kept out of our groundwater and out of the hands of our children. We are proud of the collaboration that has successfully and safely collected and disposed of such a large amount of medication.  If these new regulations are put in place, it will very likely result in the end of this successful program due to the additional costs and logistical challenges.  In Rock County, law enforcement retains the controlled substances and the Health Department stores non-controlled substances in a secure facility. Local pharmacists separate the controlled medications from the non-controlled medications, but this will not be allowed under the new regulations.  Last year, the Health Department stored approximately 3600 pounds of non-controlled medications.  Some law enforcement offices do not have the capacity to store this quantity of medications.  The medication that is going to be destroyed is removed from the packaging; the medication is stored in containers and the packaging is discarded. Requiring medications to be stored in the packaging, in which it was received, will result in 7 to 10 times the number of containers needed to be destroyed. This is going to add a significant cost for disposal.Our local law enforcement agencies are already stretched due to budget cuts and placing this additional cost and responsibility on them will mostly like end our successful drug collection program.  Please reconsider these changes so we can continue to get these medications out of our community.", "comment_id": "DEA-2012-0008-0137", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0137", "comment_date": "2013-02-28", "comment_time": "05:00:00", "commenter_fname": "Chris", "commenter_lname": "Ramos", "comment_length": 1832}, {"text": "I own an independent pharmacy and it never made sense to me that we were trusted to dispense controlled medications to patients but not dispose of them if needed.  Prescription drug abuse is a huge problem and I hope this helps!", "comment_id": "DEA-2012-0008-0024", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0024", "comment_date": "2013-01-31", "comment_time": "05:00:00", "commenter_fname": "Elizabeth", "commenter_lname": "Thrush", "comment_length": 228}, {"text": "It is unfair to restrict medications to cancer patients only.  Myalgic Encephalomyelitis (ME) is an extremely painful condition which has been rated to have more serious and more severe pain than that suffered by a cancer patient.  ME also can result in death.  Currently the condition is known in the states as fibromyalgia/CFS.Please do not restrict pain medication to those only with cancer when there are far worse conditions.  I beg you.  I have been disabled with this condition for years and it is not painful when undergoing treatment, but always painful, 24x7x365xLIFE.If you start restricting one medication, others will also follow suit and it will not be possible for many to tolerate their conditions.  Assisted physician suicide is not an option to patients that believe in God.", "comment_id": "DEA-2012-0008-0030", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0030", "comment_date": "2013-02-04", "comment_time": "05:00:00", "commenter_fname": "Stephanie", "commenter_lname": "Mcgrath", "comment_length": 812}, {"text": "Hospitals have many challenges in todays changing healthcare environment.  Disposing of waste should not be one of them.The DEA should be providing guidance and support with controlled substance disposal.  We need to have guidlines.  The DEA tells us that flushing a controlled substance, putting it into kitty liter, and putting it into hazardous waste containers for haulers to remove is not making the CS non-retrievable, therefore is unacceptable disposal.  Since all of those are not correct the DEA should be providing us an answer.I think we can agree that hospitals want to do the right thing.  They do not want to see controlled substances leave a negative effect on our environment and certainly do not want to see them abused.  Its time that our government agencies (DEA, EPA) work together and provide us with the tools we need to get a very important job accomplished.", "comment_id": "DEA-2012-0008-0060", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0060", "comment_date": "2013-02-15", "comment_time": "05:00:00", "commenter_fname": "Mary", "commenter_lname": "Reissman", "comment_length": 911}, {"text": "I am the Founding Dean of the School of Pharmacy at Husson University.  I am writing this letter in strong opposition to one of the stipulations of the proposed rule:the substances contained in the inner liners and mail-back packages may not be individually handled, counted, inventoried, or otherwise discerned.For the past few years I have been volunteering to assist the University of Maines Center on Aging in their Safe Medicine Disposal for ME Program.  The data collected in this mail back program was one of a kind, since it was the only mail back program that could legally accept controlled substances.  Much important information was gathered through the project.  Knowing which medications are being wasted allows for targeted educational programs to medication prescribers and/or patients.  It also helps payers get a handle on the huge amount of waste in the system and may incentivize them to implement programs to help reduce it.  By preventing the cataloging of what is being collected throughout the country is a tremendous waste of extremely valuable information resources regarding our societys medication-taking behavior.  Patient non-adherence to prescribers direction is a significant health care problem that costs our society billions.  Besides the cost of the unused medication, other related expenditures include the extra health care costs for treating patients who become sicker from a lack of appropriate therapy, subsequent lost days of work, and the loss of other contributions to society.  More importantly there is much pain, suffering and early deaths that could be prevented.   The information gathered in take-back programs could help greatly in alleviating this problem.I urge the DEA to reconsider this portion of the rule.  A very simple solution to the DEAs concern for security is to have any cataloging or counting be conducted under the supervision of law enforcement agents.", "comment_id": "DEA-2012-0008-0067", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0067", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Rodney", "commenter_lname": "Larson", "comment_length": 2033}, {"text": "Thank you for the opportunity to comment on Docket No. DEA - 316.   The proposed rules are a common sense solution to the management of unwanted drugs.  It is critical that these drugs are diverted from disposal in landfills and wastewater treatment plants. The following suggestions would lower the cost to manage this waste while at the same time provide the necessary level of security when dealing with controlled substances.  1. There are requirements for 2 authorized employees to witness the removal of the inner liner ((1317.50).  Some small retail pharmacies may not have 2 employees working at the same time.   It is important to have 2 people witness the removal, but one of the two could be the reverse distributor employee.   The way to insure that there are 2 witnesses is to have a drop box that the user places the drugs into.   The box could have 2 separate locks that would require both the pharmacist and the reverse distriibutor to  be present when the box is unlocked.   2.  There is a requirement that the waste be destroyed within 14 calendar days.  (1317.15)   Currently the San Luis Obispo County Integrated Waste Management Authority, through our hazardous waste contractor, collects sharps from 45 local pharmacies.   The collected sharps are stored at our household hazardous waste facility.  To reduce costs we have our medical waste contractor pick up the sharps from the household hazardous waste facility on a monthly basis.   If we offer a similar service for the collection of drugs, we would also like to hold the drugs for a monthly pickup.    An alternative could be that the waste be destroyed within 30 days or when more than 200 pounds are stored, whichever occurs first. ", "comment_id": "DEA-2012-0008-0095", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0095", "comment_date": "2013-02-27", "comment_time": "05:00:00", "commenter_fname": "William", "commenter_lname": "Worrell", "comment_length": 1757}, {"text": "The City of Fort Collins would like to thank the DEA for publishing these proposed rules for safe medication disposal.  Overall, we are supportive of these rules and understand that DEAs primary concern is preventing illegal diversion of controlled substances.  The proposed regulatory language reads:Controlled substances collected by collectors may not be individually counted or inventoried.  The meaning of this rule is not clear.   The use of the word may leaves it open to interpretation.   If what was meant is, Controlled substances collected by collectors do not have to be individually counted or inventoried. we are very supportive.Suggestion:  Clarify the wording.  ", "comment_id": "DEA-2012-0008-0098", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0098", "comment_date": "2013-02-27", "comment_time": "05:00:00", "commenter_fname": "Errin", "commenter_lname": "Henggeler", "comment_length": 798}, {"text": "I am a PharmD student at the University of Arizona College of Pharmacy. The spirit of this rule would improve the public health of this nation. Throughout my educational career and my internships I have participated in many organized events where patients would bring in a brown bag of old and current medications where as student-pharmacists, we would counsel them on the safe and effective use of their medications. Many times patients brought in old controlled substance prescriptions that they or a recently passed away loved one no longer uses. Patients would frequently ask how to dispose of them because they did not want to flush them down the toliet nor simply throw them away and continued to hold on to them. I feel that retail pharmacies and pharmacists are in the best position to maintain a collection box and organize take back events. The major limitation in the past has been trying to have a law enforcement officer at the time when patients are able to bring in the unused scheduled drugs. Please allow pharmacists and pharmacies in good standing a simple way to be authorized and have autonomy to facilitate taking-back and mailing in the unused controlled substances. Any foreseeable negative is overwhelmingly overcome by the benefit the public health receives by reducing the number of unwanted, unused scheduled drugs from circulation.-RGPpharmacy studentUniversity of Arizona - College of Pharmacy", "comment_id": "DEA-2012-0008-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0005", "comment_date": "2013-01-08", "comment_time": "05:00:00", "commenter_fname": "R", "commenter_lname": "P", "comment_length": 1476}, {"text": "As co-chair of the WI Pharmaceutical Waste working group and manager of the Get the Meds Out mail back program, I would like to offer the following comments:[1317.02(a)] - Allowing only full-time government employees to accept controlled substances at take-back events or mail-back services is too restrictive. Allow civilian law enforcement employees who meet the same requirements as authorized employees of other collectors, such as retail pharmacies, to handle returned materials following the agencies secure protocols. 75785 of FR 77 (246) - Our law enforcement personnel have expressed concern over new logistical challenges and cost increases; allow registered pharmacists to pre-screen controlled substances from non-controlled substances prior to placing the drugs in a collection receptacle under law enforcement oversight at take-back events.75785 of FR 77 (246)- Allowing for only law enforcement agencies or collectors with on-site destruction capabilities to operate mail-back programs will increase costs. Allow all reverse distributors to accept and temporarily store mail-back packages.75785 of FR 77 (246)- states that controlled substances collected by collectors may not be individually counted or inventoried. Allowing for research entities in collaboration with law enforcement to carry out studies to characterize and quantify the medicines returned through take-back programs.75785 of FR 77 (246)- add provision that allows authorized individuals to dispose of an incapacitated ultimate user meds.  [1317.05(a)(2), 1317.05(b)(2), 1317.05(c)(2)(iii) and 1317.05(c)(2)(iv)] - Reference the Department of Transportation or other definition being used.75802 of FR 77(246)- Allow reasonable destruction time that fits with standard practices at reverse distributors and hazardous waste incinerators, and look to those businesses to best comment on this issue.   Allow visual pre-screening for noncompliant items at take-back events and collection receptacles. ", "comment_id": "DEA-2012-0008-0068", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0068", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Steven", "commenter_lname": "Brachman", "comment_length": 2032}, {"text": "To Whom it may concern;The DEA has proposed a rule for the Disposal of Controlled Substances that includes controlled substances held in Long-Term Care Facilities.  The definition of LTCF in the proposed rule combines facilities with extremely different levels of staffing and accountability.   This proposal recommends controlled substances that remain; either after a medication is discontinued or after the resident (ultimate user) has expired, be held in approved disposal receptacles until they can be returned to an authorized registrant for disposal, without regard for a facilitys professional staffing requirements.Whereas Skilled Nursing Facility and Nursing Facility are well defined categories of LTCF with specific professional staffing requirements, but have been included in a group of LTCF, that do not, by regulation, provide full time (24 hour) licensed personnelWhereas SNFs and NFs employ professional, licensed nursing practitioners as defined in 21 CFR U.S. C. section 802, that receive, store  and administer controlled substances for the ultimate user, Whereas controlled substances are never in the possession of the ultimate user, but are received and stored on their behalf as part of an prescribed treatment plan, while residing in a SNF of NF and are not accessible to children, teenagers or the elderly for misuse, abuse or accidental ingestion,Whereas dispensing practices are changing for SNF and NF, to allow for short dispensing cycles that limit the quantities of controlled substances that are received and stored in the facilities,Whereas these controlled substances may remain due to a change in the treatment plan for the ultimate user or through the death of the ultimate user,Whereas SNF and NF are regularly inspected for compliance with federal  and state regulationsTherefore, let it be proposed that SNF and NF licensed, administrative nursing practitioners be designated as authorized agents for the ultimate user in re", "comment_id": "DEA-2012-0008-0073", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0008-0073", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Scott", "commenter_lname": "Wheeldon", "comment_length": 2330}]}, {"id": "DEA-2012-0001", "agency": "DEA", "title": "Schedules of Controlled Substances: Placement of Five Synthetic Cannabinoids Into Schedule I", "update_date": "2021-12-02", "update_time": "01:00:56", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "You cannot regulate the people that you claim to represent! enough is enough! when are you going to understand that freedom is not conditional, you cannot have freedom while arresting people for doing what they choose. we will never have peace unless the government ends this power trip and let the people rule themselves.", "comment_id": "DEA-2012-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0001-0014", "comment_date": "2012-04-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 322}, {"text": "I am a Neuroscientist from MITs Department of Brain and Cognitive Science, and work in the USAs largest neuroscience research facility. I have a deep understanding of pharmacology, and am familiar with exactly how it is that pharmaceutical drugs work, helping save American lives and livelihoods.I suggest that the parties involved with this case DO NOT schedule these cannabinoids as schedule 1 drugs. It has been repeatedly shown in experiments that cannabinoids provide substantial beneficial effects to people who have Parkinsons Disease. This research was further expanded upon in 2010 with additional evidence that cannabinoid receptor agonists (the class of pharmaceutical which these chemicals fall under) can temporarily CURE Parkinsons disease. (Citation: CNS  Neurological Disorders - Drug Targets, 2009, 8, 432-439)I understand that drug abuse is a concern which needs to be addressed. But the very definition of a Schedule 1 drug (no accepted medical use) should be rejected for these compounds, due to the indisputable evidence that these drugs are known to bind to this class of receptor, which has in turn been PROVEN to improve the lives of Americans who are unfortunate enough to be affected by this terrible disorder.Ask yourself, if you or a loved one was unfortunate enough to develop Parkinsons disease, how would you feel knowing that you helped restrict neuroscientists access to these compounds, and blocked research on some of the most promising pharmaceuticals currently under investigation.Other than strongly discouraging research labs to research these chemicals, the additional hundreds of potential pharmaceuticals which are closely chemically related to these ones would NEVER be able to be researched, as scientists will be restricted by analog laws, and will not jump through government hoops for each and every possible unresearched chemical.New cures improve American lives. Listen to the science. Please, do not schedule these compounds.", "comment_id": "DEA-2012-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0001-0011", "comment_date": "2012-04-10", "comment_time": "04:00:00", "commenter_fname": "Elisha", "commenter_lname": "Gray", "comment_length": 2082}, {"text": "I would respectfully request that this measure be used as a time to re-evaluate the classification of Tetrahydrocannibinol (THC) because this proposal is strictly based upon matching the classification of that substance as a Schedule I drug.  Though I do agree that how these substances were presented and distributed was unethical, It does not mean that the substances should be immediately discounted as having no medical use or highly addictive without reviewing the evidence that determines the parent drugs, THC, classification.", "comment_id": "DEA-2012-0001-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0001-0008", "comment_date": "2012-03-12", "comment_time": "04:00:00", "commenter_fname": "Ray", "commenter_lname": "Stout", "comment_length": 540}, {"text": "The placement of JWH-018, JWH-200, JWH-073, CP-47,497 and cannabicyclohexanol as a Schedule I drugs under the CSA is a good policy choice for public safety, and to prevent abuse. However, I find it useful to further identify whether only these specific combinations or blends  are Schedule I drugs under the CSA, or if each separate component alone is also a Schedule I drug under the CSA. I believe to propose permanently placing these five synthetic cannabinoids as Schedule I drugs under the CSA will only create more work and a need to edit the rule in the future. As technology and science continue to improve, there is always possibility of discovering some medical use for these synthetic cannabinoids and/or their salts and isomers. To classify any drug as a Schedule I drug under the CSA permanently would only create more work for the DEA in the future when new technology may provide the discovery of medical uses.  A good alternative may be to classify these five synthetic cannabinoids and their salts and isomers as Schedule I drugs under the CSA subject to discovery of any and all medical uses by further and future medical and scientific studies and research.    Thank You", "comment_id": "DEA-2012-0001-0013", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0001-0013", "comment_date": "2012-04-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1189}, {"text": "proposed rule Docket No. DEA-5 should be enacted.we should also stipulate that smoking this chemically treated herb, laughingly sold as incense, is illegal.  ", "comment_id": "DEA-2012-0001-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2012-0001-0010", "comment_date": "2012-03-26", "comment_time": "04:00:00", "commenter_fname": "Gaspare", "commenter_lname": "Giarraputo", "comment_length": 175}]}, {"id": "FDA-2017-D-5912", "agency": "FDA", "title": "Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment", "update_date": "2017-12-18", "update_time": "14:20:11", "purpose": "Nonrulemaking", "keywords": ["2016-1012"], "comments": [{"text": "Gastroesophageal reflux (GERD) occurs in infants, children and adults. According to a large community-based study of children in the United States, the prevalence of various symptoms suggestive of gastroesophageal reflux was 1.8 to 8.2 percent (Winter, 2016). The presence of GERD in children is on the rise, possibly due to the increase in childhood obesity. Higher rates of GERD can be seen among children with developmental and neuromuscular disorders. Children need an adequate treatment plan for GERD. Although, developing drug treatment in the pediatric population can be complicated it is necessary. As for excluding infants in a clinical trial, it is a disservice to the infant population. The diagnosis of GERD in infants can be complicated due to other possible diagnoses. Regurgitation is present in 50 to 70 percent of all infants which peaks at age four to six months, and typically resolves by one year (Winter, 2016). Infants can develop other symptoms related to untreated GERD. A small minority of infants with GERD develop other symptoms suggestive of GERD, including irritability, feeding refusal, hematemesis, anemia, respiratory symptoms, and failure to thrive (Winter, 2016). It is necessary to evaluate drug treatment for GERD in the infant population. ReferencesWinter (2016). Clinical manifestations and diagnosis of gastroesophageal reflux disease in children and adolescents. UpToDate. Winter (2017). Gastroesophageal reflux in infants. UpToDate.", "comment_id": "FDA-2017-D-5912-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-5912-0003", "comment_date": "2017-12-18", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1493}]}, {"id": "FDA-2021-N-0275", "agency": "FDA", "title": "Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments", "update_date": "2021-09-02", "update_time": "12:14:28", "purpose": "Nonrulemaking", "keywords": ["2020-846", "CDER", "Notice", "Morphine Milligram Equivalents:", "Current Applications and Knowledge Gaps,", "Research Opportunities, and Future Directions;", "Public Workshop;", "Request for Comments", "Open"], "comments": [{"text": "Please remove MMEs.  Its based on flawed information.  Everyone metabolizes medicines differently.  Everyone also does better or worse on different medicines.  Pain is NOT the same for everyone.  There are SO many different types/kinds of pain.  As there are many different levels of pain for different people.  Expecting everyone to do well on the same medicine or same amount of medicine is insane.  The government should NOT be putting restriction on doctors(so then it harms us American people in pain).  The doctor knows his patients the best.  And we(the people) know our bodies  pain the best.( what works best for us).  The opioid epidemic is 90 some percent because of illegal street drugs.  NOT safe  effective prescription pain medicines.  Please STOP harming us(the American people in pain) more then were already hurting.  Its insane that we are now forced to live in excruciating pain  cant get out of bed or out of our homes because of being in SO much pain because of being cut off or cut SO low from the medicines that once gave us quality of life.  Which means now we cant work or take care of our families.  No wonder there are more  more committing suicides.  Or just as bad, turning to illegal street drugs.  Since the 2016 CDC guidelines  mme caps were made, over doses  deaths from illegal street drugs have shot up drastically(way way more then even before 2016).  Because the govt is just pushing more  more right to illegal street drugs since they cant get quality or care or treated humanely because they cant get their pain treated accurately any more.  This HAS to STOP!!!  PLEASE!  Millions of us people in pain are begging you!  PLEASE!!!   Thank you!Prescription pain medicines(opioids) are not harming or killing us.  You have it ALL wrong  are harming us more  even killing us!!!  Its illegal street drugs(opioids) that are causing the over doses  deaths.  Please, Please, PLEASE stop the torture on people in pain who are trying to get their pain treated accurately, legally  humanely.   hopefully with a little compassion.  Which youve taken away, since the doctors are SO restricted now.The opium plant was given to us since the beginning of time to help us with our pain.  Problems didnt start to occur until illegal street drugs came into the picture.  Because illegal street drugs arent controlled  you never know what they will contain or how much.  Plus then people use other drugs or alcohol  thats what causes them to overdose or die.  Speaking of alcohol, people die of alcohol thousands of times more then prescription pain medicines( illegal street drugs) but yet alcohol is legal???  Go figure!!!  Please stop torturing people in pain who just want to get relief(legally)  be able to live a half normal life.  Please get rid of mmes and the cap on prescription medicines.  One day you might find yourself in constant, ongoing pain, day after day, that nothing else helps but prescription pain medicines.  But then YOU wont be able to get relief then either.  How would you like to live your life like that?  Im sure you wouldnt.  Well, we dont want to either.  Prescription pain medicines are approved to help pain.   they work for many many people(who take them responsibly).  We the people should have the freedom to be able to get medicines that help us so we can move around(work, take care of family, etc.).  We should NOT be restricted  pain medicines should NOT be held from us when they greatly help us  give us a much better quality of life.  We should have a say in what our medical care consists of.  We should NOT be restricted.  Nor should things that help us be held back from us.  Nor should we be forced into something were not comfortable with(or that isnt approved like injections).Please help stop the torture people in pain are having to go through now.  Please stop mmes  caps on them.Thank you very much!", "comment_id": "FDA-2021-N-0275-0127", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0127", "comment_date": "2021-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4137}, {"text": "Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dosage your body has become dependent on. Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with Ochronosis/Alkaptonuria (AKU) to prevent chronic joint pain and inflammation.AKU is known as Black Bone Disease because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in Egyptian mummies! After being diagnosed with AKU, I was placed on a very high dosage of morphine to stop my body from producing Homogentisic Acid (HGA).  People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA. At high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them. My former physician of 32 years identified morphine as a pain medication that helped without causing  side effects. I was able to function again and live a decent life, in spite of having a debilitating disease. But in 2017, the CDC opioid guideline was adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a doctor to replace him. They all see my need for morphine, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me! Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also spread to my upper cervical spine, my lower cervical spine, along with my liver and kidneys. I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids.Only when I was forced on a lower dosage did AKU start to spread. I have had four failed surgeries on a non-operative disease, and no doctor wants to put their livelihood on the line to help keep this disease from hurting me more! I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive.Please help me obtain the help I need before this disease spreads even more than it has. I am totally bedridden and need help to regain my quality of life.I pray that a revision of CDC guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity. Legitimate pain patients who had never abused drugs are getting treated like addicts, demonized for taking prescribed medicines from licensed doctors.Please watch this video if you have any questions about my disease: https://www.youtube.com/watch?v=7PpQU3wrdlMt=30sGigi Brandford lives in Hawaii.\u2028", "comment_id": "FDA-2021-N-0275-0132", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0132", "comment_date": "2021-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3469}, {"text": "As with the entirety of the CDC guidelines and their implementation and cross reference allegedly unintended amongst agencies, private and public, medical facilities, practices, and other clinical locations and policies, the MME standards are not backed by high quality science of the 3,4 or even 2nd level.This is significant because while people who are clinically addicted as indicated by medical manuals have access to MAT including various buprenorphine products which has no defined MME equivalent and is very dangerous when considering the abuse and overdose context, medications more frequently used from chronic pain in the four decades ending through 2010 (many of which are used today but overall opioid prescribing(s) have dived off a cliff declining by roughly 70% since 2011) it makes no sense that narcotics such as hydrocodone, oxycodone, meperidine, hydromorphone, etc have become considered more dangerous and in the context of addiction and overdose, no more than 1% experience these adverse events (refer to BMJ); further, as a chronic pain patient, I can tell you doctors know what they are doing usually and are disgusted with the extreme interference by DOJ (including state DOJs) DEA, BOPs, Med Boards, etc as they seek to cast the addiction spell on all patients experiencing chronic pain from varying sources and diseases (endometriosis, sickle cell, myalgic encephalitis/chronic fatigue syndrome, CANCER) Most doctors already understand the pain medication hierarchy (for example: oxycodone is orally stronger than codeine mg for mg)Most doctors try everything else before narcotics, and most patients are literally scared to death of narcotics. The MME, based on little to zero science, has done nothing but to limit doctors in their individualized treatment. MME use in clinical settings has caused doctors of all shapes, types, and sizes to become scared of these millennia old opium medications and their century plus old derivatives (for example: hydrocodone  oxycodone synthesized around 1918 most likely for war vets which btw whose suicide rates have doubled in the middle of the cutting off of their decades old utilized narcotic  pain meds) To conclude, MMEs are not useful, do not make sense, do not prevent the patient that wants to down a bottle of ANY AVAILABLE pills for suicide(s), and are NOT scientifically backed by any source that has zero COI. Oxycodone is stronger than hydrocodone but as a result of MME use and CDC guidelines, myself as a patient who experiences better analgesia and less side effects with hydrocodone, am unable to get an effective dose of a hydrocodone product (60-90 mg/mme/day) and instead I am left to deal with 45 mg of oxycodone per day because according to MME/CDC guidelines, this equals 67.5 MME (yes, chronic pain patients have careers, can do math, and are also intelligent humans). So in effect, MME has forced me to be on a medicine that I dont feel is as effective. I should not have to feel that I am lucky to get treated at all as I have been made to feel based on all government policy. One more thing: doctors and pharmacists are scared of the number of pills as well as the dosage: Vicodin HP 1 every 4 hours or 180/mo makes sense based on my pain level and represents no increase for five to seven years in my clinical treatment but because of MME, 180 tablets per month is considered too many even though it equals in MME what I receive in oxycodone. I hope this reaches someone sane, intelligent, and not bought off by big pharma like Vanila Singh. Ms Singh will go down in history as the worst USA CMO because she now has a board position at BioDelivery Sciences, Inc and makes a wonderful $450,000 per annum for promoting buprenorphine products as the sole opioid to be used for chronic pain. My final note is that before the 2016 CDC guidelines became implemented into various laws, forced into clinical practice, etc., I was very stable as a patient 62 170 6-10% body fat, exercised 1-2 hours a day 3-4 days a week, could withstand 12 hour work days  my pain was effectively managed because with some diseases SYMPTOM MANAGEMENT IS ALL YOU CAN DO. Preventive measures like food cannot fix genetics, and we are not nazis practicing eugenics. I appreciate my heritage with blonde hair and blue eyes BUT EUGENICS is NOT what America is about.I wish the worst on anyone who doesnt get it, doesnt understand ultra metabolizers, and doesnt have a friend/family member experiencing a disease with pain as a symptom. Based on stats tens of millions of people experience debilitating chronic pain to the point they are disabled. Thats not cool, fun, funny, exciting, or interesting to deal with. Best wishes-", "comment_id": "FDA-2021-N-0275-0138", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0138", "comment_date": "2021-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4879}, {"text": "You cannot set a limit for opioids or any other medications.  Everyone is different  processes medication differently, just as they do different medications.  We are not robots that can all take the same medicine at the same doses  have the same outcomes.  We as people, our bodies are different  dont work like that.Between the 2016 CDC guidelines  the mmes, people in pain are being tortured. The government is playing doctor  knows nothing about our bodies  our pain(nor does it know our tolerances  how our bodies process pain meds or at what doses helps our pain).  Everyones pain is different  should not be treated the same.  Some people do well with lower doses.  But some people need higher doses  do very well with them.The government needs to quit playing All mighty or All knowing  stop restricting our doctors which in turn stops people in pain from receiving compassionate care  held from medicines that can greatly help them.Restricting doctors from prescribing prescription pain medicines are torturing people in pain  are just forcing then to go to the streets for illegal street drugs(which is the main culprit of the opioid epidemic) or they are committing suicide.Since doctors were forced to cut or drop peoples prescription pain medicines, over doses  deaths( also suicides) have sky rocketed.  Again, its just pushing more  more right to the cause(illegal street drugs).Most people want to do the right thing(legally)  go to a doctor to have their pain treated so they can live a half decent life.  So they can continue to work  take care of their families, etc.  But since the falsified  misleading 2016 CDC guidelines  mmes, its just pushing more  more to illegal street drugs  therefore more  more over doses  deaths, as well as suicides(since we just cant live every day in SO much pain).You have to burn the CDC guidelines  quit using them as law to prosecute our doctors(who are just trying to help us).  Do not make any more guidelines since theyll just be used as law again.   rescind the mmes too.Most of us know our bodies best  what helps us or works best for us.  We should be able to be a part of what our medical care consists of.  We should have a say in what we feel would help us(not forced into or away from something).I thought this was America???  Then why do we not have a choice in our own medical care/prescription care  why are medicines that greatly help us being taken away from us(when weve taken them as prescribed  stored correctly  when they have helped us for many many years)?Stop punishing  torturing people in pain because of illegal street drugs!!!That is not fair at all!!!  People in pain who take prescription pain medicines are being majorly tortured.  We are looked down on  treated like a druggie.  When were nothing like that.  We are given a hard time to get our prescriptions filled(if we can even get a prescription any more).  Our doctors are SO restricted that they dont know what to do so they make things up  make it seem like we are drug seeking or called other things, when its been proven time  time again, how well prescription pain medicines work.  But because the doctors hands are tied, they push us away  cant help us now.  Or are to afraid to.This has to STOP NOW!!!!  It should have never started.The CDC nor PROP(who where the ones who created the guidelines) do NOT have the expertise to be making rules or laws.   again we(American people) know our bodies best  should have a say in our medical treatment.  Not be pushed away or sent for another surgery or injection when those were proven before not to work.Stop this insanity!!!   give us back the meds that once gave us a quality of life!PLEASE!!!  Millions  millions of us are begging you!!!  Stop the insanity on safe  effective prescription pain medicines!  stop ruining our lives  torturing us!!!", "comment_id": "FDA-2021-N-0275-0140", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0140", "comment_date": "2021-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4237}, {"text": "Docket No. FDA-2021-N-0275 for Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments. The workshop had many informative presenters but I wanted to highly endorse Jeffrey Fudin, PharmD  Nabarun Dasgupta, MPH, PhD. As well as Toska Cooper, Liz Jonia-Grant  others in his study. Both Fudin  Dasgupta both stressed NO MME limits  pointed out the numerous flaws in the calculations/conversions themselves. The recommendations must remove current MME limits whether in the guidelines or state laws. It seems daily new federal/ state legislation is proposed to limit prescribing  its literally killing pain patients  Veterans. We have a critical patient care crisis that requires emergent actions. We need help now. Misinformation is rampant  being spread by a group of addiction experts w/o pain mgt experience. For one theyre highlighting common pain/disease signs  symptoms to pain med side effects  calling for forced tapering. This is unacceptable. Many are part of the disease process  are present whether on meds or not. This Propaganda/ opioidhysteria is hurting more people than its saving. Take a look at the current tapering recommendations/scenarios- Patient not functioning by atleast 30% - Taper. (Not every disabled person can reach this goal. Plus ALS, quadriplegics  other compromised pts are being forced tapered. It should NOT matter if they can get out of bed. Patient functioning well- TaperPt NOT functioning well - TaperPain adequately controlled- TaperPain NOT well controlled - TaperPt expresses pain mgt working very well - consider OUD, taper.Pt expresses need for higher pain medication - consider OUD , taper. No pt can succeed with these types of parameters designed to taper in just about every situation. Brain fog/confusion - TaperInsomnia - TaperConstipation- Taper. Look how many other med cause constipation, insomnia, brain fog  they dont call for immediate discontinuation. Plus many of these signs/symptoms continue after discontinuation of meds. Its their disaese/pain causing them. I have these with or without medication but they are extremely worse without adequate pain control. Suicidal ideations are common in both untreated  undertreated pain. A Misconception is pain pts want to end their life. No, we want the unbearable pain 24/7 to lesson- huge difference. Once our pain levels are controlled - the majority stop having these thoughts. Its really that simple. Its about STOPPING THE PAIN. Listed as a potential for harm - 65yo, anxiety/depression or 50MME. BUT Above 65yo is the lowest population of overdoses. Anxiety/depression is often a requirement for SSI/SSDI Disability approval because it is an expected outcome of disability. Chronic pain can be very depressing especially when its uncontrolled. I personally ( many others) didnt develop anxiety until the CDC guidelines were developed. This living in constant fear of losing ones meds returning to that agony is very disconcerting  real. But there are addiction experts now trying to add a new diagnosis that would make this fear similar to OUD. For a condition that they themselves created. Diabetics fear not having enough insulin- no difference. This is literally insane!I am bedbound w/o higher doses of pain medications along with associated meds. I am non functioning  dependent. At 90MME I am stable with much improvec function ability  my quality of life is much much mproved. No suicidal thoughts. I could still benefit from an even higher dose but that is no longer an option with the CDC GL  false narrative that pain meds are causing the opioid crisis. In 2019, per the CDC, out of the 70,000 OD deaths- 12,000 were from pain meds. Unfortunately they dont track how many were from suicides due to forced tapering. Liz Jonia-Grant wrote- It is disheartening, but unfortunately not surprising. Far too often we are the victims of good intentions of those wanting to do something About the opioid overdose epidemic but the something that is done over simplifies the problem  pushes cookbook medicine upon those of us with complicated medical conditions. And while everyone debates whether the MNE limit was the right thing to do,we are forced to live by it, because Medical personnel  others treat guidelines as mandates. So we wait. And we suffer. And we hope it will all get sorted so we can get the care we need. We need individualized care. NO MME limits  help pain pts access to opioid pain medications. In 2019 the 70,000 were mostly illicit made Fentanyl  heroin- street drugs. Yet pain pts  their doctors are the target. This isnt helping. Illegal drug deaths have exploded - thats the problem. Protect the patient. Thank you for your time", "comment_id": "FDA-2021-N-0275-0142", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0142", "comment_date": "2021-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5276}, {"text": "Placing chronic pain patients on the same dosage of opiate pain medication is not scientifically proven effective. Individual aspects have been ignored. People who have been stable and functional on higher doses are now disabled and suffering. The pendulum has gone too far in the wrong direction. Just because they are an easier population to target than illegal drug traders does not make it right. Government needs to remove itself from the physician/patient relationship and let doctors be doctors again.", "comment_id": "FDA-2021-N-0275-0108", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0108", "comment_date": "2021-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 508}, {"text": "Stop The Insanity. Remember that commercial? Well here we are. As a nurse (RN, BSN, DON) of over 37 years, havent we learned anything? You are punishing people in chronic, severe pain. We need the 90 MME lifted entirely. Physicians are trained to determine the best dosage, and closely monitor patients. This dosage doesnt even cover daily opioid therapy for most people on one medication, and now theyve been told they can only have one. The cuts have been extreme for chronic patients and they are getting sicker, avoiding hospitals and surgeries, and dying either to their illness or suicide. Some have resorted to street drugs with fatal consequences. Its gone as far as to limit dying hospice patients pain relief! We need this workshop to influence the CDC and actually save us all. NOW. My grandmother died in the 70s, screaming in pain. The doctor refused to give her any more morphine because shell become addicted. She died two days later. True story. You must LEARN and stop this ignorant cycle of patient abuse. Opioids ARE effective in long term, chronic pain. Doctors prescribe any and everything before using them. Let them do the job they are trained and educated to do. Study after study has shown that prescribed opioids are not the culprit with drug overdoses. Wake up and stop this cruel interference now.", "comment_id": "FDA-2021-N-0275-0112", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0112", "comment_date": "2021-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1391}, {"text": "These CDC Guidelines have become de facto law across the country  they have NO basis in science. It makes no sense that a pain patient might die if given 1mg over, but an addict *starts* MAT at 13 TIMES the MME amount. The guidelines do not take into account personal pharmacology, allergies, nor any other concerns. Its a one-size-fits-none sham of a guide. Also it doesnt matter if the guidelines say exceptions can be made! if the DEA/medical boards are using it as a hard-and-fast rule by which doctors lives are destroyed. Additionally, LTOT has proven to be safe and effective, not creating addiction at all, whereas the addiction reaction is known to happen with the first exposure. Plus, diversion among chronic pain patients is rare, and we know the opioid epidemic is actually an opioid overdose death epidemic, fueled by illicit fentanyl and fentalogues coming from the illegal drug trade, not prescriptions. The under-treatment and non-treatment of pain has led to countless suicides (as noted by the VA) and with post-COVID pain creating even more pain patients, this needs to be fixed RAPIDLY. The Guidelines have even created an international crisis, with one woman in Ontario asking to be euthanized rather than live with her untreated chronic pain. This is a genocide. It has to stop.  ", "comment_id": "FDA-2021-N-0275-0120", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0120", "comment_date": "2021-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1364}, {"text": "I definitely dont believe that using the MME conversion to help stop opioid abuse or OUD is based on any concrete research. Its as if someone just picked those numbers out of thin air. I am a chronic/intractable pain patient and have suffered for over 20 years. After trying almost every alternative I was finally prescribed proper opioid therapy and received monthly trigger point injections and chiropractic manipulations. When the pain flared I iced and used a TENS unit. Due to severe side effects I could not take a long acting medication and was finally prescribed 2 short acting medications. Between the two I was at a very high MME. I was able to work part time, care for my family and play my flute as a gig musician. I attended church weekly and was the music minister. This all came to an end in 2017 when I lost my Dr and the new one cut me off the main medication and left me with just the breakthrough one. In 15 days I was dropped to 40 MME. I became almost incapacitated. The pain was excruciating and left me bedridden. Two years later my Dr finally upped my dose to 60MME. Life is slightly better but I can no longer work nor play my flute. I suffer with flares that can sometimes last weeks. My husband has begged me numerous times to go to the ER. I always refuse. Chronic/intractable pain patients must be treated with individualized patient centered care and our pain is unique to each person. Its past time to repeal the CDC guidelines and put a stop to the MME conversions of opiate pain medication.", "comment_id": "FDA-2021-N-0275-0109", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0109", "comment_date": "2021-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1548}, {"text": "Chronic intractable pain patients are victims of what has been going on for the war on drugs. Our constitutional right has been taken away from us we are killing ourselves because we cannot stand the pain and I know that that will save money for people who are collecting disability but it is cruel for this country to be doing so. I have been a chronic pain patient for 20 years, have raised three children on my own who went to college my last is just finishing up college. It was very hard and if I had not had my fentanyl patches I would never have been able to do so at all. Im not going to say it was easy but it was doable and I raised those three children not to be drug addicts but to be healthy productive members of society. Now much of my pain medication has been taken away from me and I spend most of my time laying down in bed because my pain is from the neck down. The past year someone in the State of Florida did their job and deemed me disabled by the state because I cannot collect disability I was raising three young children when I became disabled and our system only goes back so many years in determining who is allowed to collect disability. Finally I was given Medicaid and I have had two ablations cervically and two lumbar ablations. My medications have been more than halved and I am suffering every day. I dont have family around who can take care of me I have to be able to function I have to be able to cook for myself I have very little money I do not collect disability I just get child support which will be taken away soon and alimony a very small amount. I need to be able to function I need to be able to drive and all this is slowly being taken away from me. Chronic pain patients are the most responsible people when it comes to their medications we need to be allowed to be given the amount of medications that we need in order to be able to function and not want to kill ourselves because we cannot stand the pain anymore. Most of us because of our pain cannot go and picket the governments in our states and we dont have money for lawyers to get to the supreme Court to make the changes needed. Most of us did nothing wrong but we are in a prison that we will never get out of until death. This does not mean we do not have the right to live please make the changes that are needed youre taking away your civil rights and our right to live.", "comment_id": "FDA-2021-N-0275-0118", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0118", "comment_date": "2021-06-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2409}]}, {"id": "CDC-2020-0029", "agency": "CDC", "title": "Management of Acute and Chronic Pain: Request for Comment", "update_date": "2020-10-16", "update_time": "11:48:19", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "You absolutely cannot let legitimate pain suffers just continue to suffer in pain.  As long as they are not abusing their medicines, they should be allowed to continue pain management for chronic medical condition such as peripheral diabetic neuropathy and other things that are incurable.", "comment_id": "CDC-2020-0029-1966", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-1966", "comment_date": "2020-05-12", "comment_time": "04:00:00", "commenter_fname": "S", "commenter_lname": "W", "comment_length": 289}, {"text": "Re: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)Docket No. CDC-2020-0029Salutations,As a practicing pharmacist in the independent community setting, Ive watched the countrys opioid epidemic spawn and evolve over the last 10+ years. My state has learned to be very diligent about the documentation and cross-referencing of CII opioid prescriptions; no longer is it common to see patients looking to fill scripts for unusually-large monthly supplies of opioids from a prescriber practicing on the other side of the state. Rather, now the common occurrence is a significant number patients who are asked to jump through hoops in order to treat legitimate pain. This sudden shift has proved detrimental for both patients dealing with chronic pain and patients dealing with addiction. Fentanyl has ravaged my state under the guise of heroin and its extremely troubling to see the aftermath entailed. Prescribers shouldnt have to deny care to patients because of a fear about what could happen to their license. The de-prescribing measures taken over the last few years are very effective and should remain in place to curb access of these drugs to individuals for whom theyre not intended. However, a concerted effort must be made to ensure those who need them arent suffering the collateral damage. Me must ensure that patients with qualifying past medical histories have access to these drugs and affordable addiction rehabilitation must be available for those who need it or would otherwise end up looking for street alternatives in the form of heroin. Lastly, we need to spearhead robust research into potential alternatives for chronic pain management as well as that for treating those with opioid use disorders. Substances with well-known anecdotal evidence suggesting potential use for the treatment of patients with OUD, such as mitragyine or kratom, must be studied and understood. Prohibition has rarely proved to itself as an effective solution; addressing the lack of access to adequate mental healthcare should be a top priority in addition to providing healthcare professionals with the resources and the approval in order to provide their highest level of patient care. ", "comment_id": "CDC-2020-0029-1967", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-1967", "comment_date": "2020-05-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2312}, {"text": "As a natural healthcare doctor (chiropractor) I see many people with long term chronic pain issues. And, though my patients get significant relief with chiropractic care they need safe alternatives to turn to when pain strikes and chiropractic is not enough. One of those safe alternatives is Kratom. A plant based medicine that has been used for hundreds, possibly thousands of years. Considering millions of people have taken this medicine for many years with little to no bad side effects is a testament to its safety and effectiveness. Of course, the pharmaceutical industry would like to eliminate this safe alternative to deadly opiates because of the profit motive. People are more important than drug companies making profit at the expense of human lives. Do the right thing and consider the centuries of safe use of Kratom for pain relief. ", "comment_id": "CDC-2020-0029-1973", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-1973", "comment_date": "2020-05-12", "comment_time": "04:00:00", "commenter_fname": "Bruce", "commenter_lname": "King", "comment_length": 849}, {"text": "    I am a retired 65 year old male. Due to several muscular/skeletal birth defects and long term wear I developed disabling spine and joint pain about 8 years ago. To date I have had 6 orthopedic surgeries. During these years I have used oxycodone acetaminophen for pain control. Oxycodone dosage has been up and down during these years. I have definitely felt the negative side effects of opiates such as irritability, increased tolerance, insomnia, and constipation. Until I retired 5 years ago, oxycodone was my only pain control medicine. After I retired, I was free from random drug testing by my employer and I started using marijuana in conjunction with oxycodone, eventually with my doctors knowledge. Upon having daily regular doses of marijuana I was able to substantially reduce the oxycodone dosage. There was a period were I stopped using oxycodone completely. Now, I use marijuana daily in conjunction with low 2.5mg doses (20mg/day) oxycodone. I realized the pain control was due to the combination of marijuana and opiate as soon as I began using marijuana regularly. Scientific publications have shown this effect. One in particular duplicated my 2.5mg oxycodone dose (1).    I am now a strong advocate for marijuana legalization and participate in state, local, and federal lobbying efforts. We need changes to federal marijuana laws and removal of marijuana from the Federal Controlled Substances List so that people like me can have access to safe, regulated,  high quality marijuana to reduce or stop their opiate use.(1) Cooper, Z.D., Bedi, G., Ramesh, D. et al. Impact of co-administration of oxycodone and smoked cannabis on analgesia and abuse liability. Neuropsychopharmacol 43, 2046-2055 (2018). https://doi.org/10.1038/s41386-018-0011-2", "comment_id": "CDC-2020-0029-1976", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-1976", "comment_date": "2020-05-12", "comment_time": "04:00:00", "commenter_fname": "Roger", "commenter_lname": "Sillmon", "comment_length": 1780}, {"text": "Today again Im thinking about whats to come in heath care involving chronic pain control At 70 years old my bodys is becoming more crippled. Changes are needed, I fear that at my age I already cannot control pain levels, sleep is becoming a huge issue. I pray that these rules involving treatment will change very soon.My doctors are clearly not willing to treat this issue  even knowing I need there help.In past years they have prescribed narcotic pain medicines for flares or injurys from my condition. I cannot submit to any more back surgery, clearly theres nothing  to be gained anymore. I do try everything else like a gym membership which I am using less now. Change is to slow in coming if at all to help me. Now with nerve pain setting into my feet its becoming hard to even walk. Im confined to my bedroom most of the time,the less active I am the more disabled I become.", "comment_id": "CDC-2020-0029-1975", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-1975", "comment_date": "2020-05-12", "comment_time": "04:00:00", "commenter_fname": "Roger", "commenter_lname": "Holland", "comment_length": 927}, {"text": "As a firefighter and EMT for over 20 years Ive seen the worst of this epidemic. I have also seen a lot of people that are good people have to suffer due to regulations and blanket approaches. There are a lot of people that have died due to over prescribing and abuse of narcotics. The flip side is there are a lot of people dying due to suicide because they dont want to live with the chronic pain. There are also a lot of people dealing with injuries who are too afraid to see out surgery knowing the pain meds prescribed wont cope with the pain post operation. Please realize you dont have to blanket approach this. There are solutions to stop the epidemic but also allow those that need these meds to have access to them. Thank you", "comment_id": "CDC-2020-0029-2029", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-2029", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 744}, {"text": "Most of my pain,depression, and stress comes from Military service. While managed with medication, and consultation most frustrations comes from discrimination, and poor management. These factors increase suicidal thoughts and low interest in achieving daily tasks.Its frustrating that mental health is not being addressed to a more legal and constitutional basis ", "comment_id": "CDC-2020-0029-2628", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-2628", "comment_date": "2020-06-02", "comment_time": "04:00:00", "commenter_fname": "Pablo", "commenter_lname": "Sanchez", "comment_length": 379}, {"text": "I have had diabetic neuropathy for over 13 years, to the point of tears. It is very uncomfortable to have a normal daily life. I was prescribed Cymbalta, when my symptoms were mild. Later another doctor prescribed Hydrocodone 5s, as my pain worsened. I was moved up to higher mg doses(10, 15,to 30. I was finally tested by a neurologist, and we decided methadone 10mg were the best option for me, because they ease my pain throughout the day. I feel like my life can have some sense of normalcy. Currently, I do not want surgery to kill the nerves, in my feet,so I am satisfied with taking medication. I wish I did not have to rely on these pills, but I do. I take them, as prescribed, proven by my tests each visit. I do not like people thinking everyone taking narcotic pain medication, is an addict, because I am not addicted", "comment_id": "CDC-2020-0029-2581", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-2581", "comment_date": "2020-06-02", "comment_time": "04:00:00", "commenter_fname": "Lester", "commenter_lname": "Wilson", "comment_length": 833}, {"text": "TO: CDCI suffer from bad knees.  I know this is not unusual as many have this problem.  My situation is different as I have Multiple Myeloma which is bone marrow cancer.  Surgery to correct my problem is very iffy as bone surgery and bone marrow cancer are incompatible and if done the bones take an extremely long time to heal if they heal at all.  I have tried Pain Management (PM) three times with no success.  The FIRST time I tried PM they said they could not help.  The SECOND time I tried PM they did a nerve block with no success.  Since the block failed, I was told nothing else could be done.  The THIRD time I tried PM, I was told they do not treat knee problems.  I believe PM is only for a select few.  They cannot treat pain if it is a bone on bone, but they do not inform you of this. I took an Opioid based drug for a year. I could not take 3 a day as recommended as it would make me itch all over.  I took only one in the morning to take the edge off my pain when I got out of bed.  From what I can determine all narcotic drugs make me itch.  However, while in rehab for orthoscopic surgery on my knee they would give patients 4 mg of Hydromorphone prior to physical therapy.  This is when I realized I could take it if I limited it to one a day and occasionally two if necessary.My Doctor claimed he could no longer give me a months supply.  A months supply was 3 per day for 30 days.  A month supply would last three months since I took only one per day.  I do not know if a Maryland State law was passed or if Priva Health (a physician health management program) is the problem.  I know Priva Health kicks back money to the Doctor, but Im not sure under what circumstances.  I imagine the less he provides, the more money he makes.At any rate, I have to take over the counter pain medication that will destroy my kidneys and they are slowly failing.  One of the problems with my particular cancer, it too destroys kidneys.  The combination of the two will accelerate their demise. RLR", "comment_id": "CDC-2020-0029-2588", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-2588", "comment_date": "2020-06-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2069}, {"text": "Ive been dealing with chronic pain for over nine years with multiple congenital spine issues that led to a neurological pain disorder called, central pain syndrome, leaving me in 24/7 moderate to severe pain. It took me 2 1/2 years of pushing for help, seven specialists to get a dx and appropriate treatment. I wanted to go back to my career! I had to put up with abuse by healthcare workers being blown off, ignored, belittled, demeaned, actually physically abused by behaviors such as of pulling a tray table away when my arms are resting on them, yes but why I was still wearing a neck brace, (my surgeon prescribed it for 12 weeks). I was being told how I feel and not being listened to, being yelled at when I asked, after 2.5 years Of doing exactly as I was told to for something stronger because i was suffering in pain all the time, which often involved being curled up in a ball, Teeth chattering and having a hard time to breathe. Miss treatment also included seeing a pain psychologist who mocked me because I said it was too hard getting into his anti gravity recliner because it required putting all my weight into both arms to do so. He told me, nobody else has ever complained about it, among other demeaning comments. I had 2 cervical spine surgeries That led to cervical spine and nerve damage as well as later found damage to my spinal cord. Ever since the CDC recommendations I have petrified of having my medications taken away yes I was told that is now what is recommended. It didnt matter all I went through to get the help I needed to be able to do basic things such as not being curled up in bed, breathing, being able to eat, stand, carry on a conversation, etc because of pain. If you were into Chronic pain groups on social media you would see the suffering. There are not many comments on this that you were asking for because chronic pain people are a group of people who struggle  With no just Pain, we struggle with just doing simple daily activities and having to write something, if one even hears about it, is very hard to do. So I dont just listen to those that have taken the time to write, go look in these pain groups and read about the suffering theres thousands and thousands of them. I still put up with attitudes from medical assistance and nurses at my doctors office. I have them documented. Im afraid to say anything because Im afraid to lose my compassionate doctor. And if I lost him what I find another who would be willing to prescribe me what is now a 10th of what I was taking that was recommended by the University of Michigan for my diagnoses. I cant write anymore now central nervous system becomes overstimulated and I get nauseous when I try to do too much.", "comment_id": "CDC-2020-0029-2592", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0029-2592", "comment_date": "2020-06-02", "comment_time": "04:00:00", "commenter_fname": "Sheri", "commenter_lname": "Kay", "comment_length": 2778}]}, {"id": "FDA-2013-P-1288", "agency": "FDA", "title": "Refrain From Implementing Neonatal Opioid Withdrawal Syndrome (NOWS)- Related Labeling Changes", "update_date": "2016-05-17", "update_time": "06:42:54", "purpose": "Nonrulemaking", "keywords": ["cder", "2013-8430", "citizen petition", "NAPW", "neonatal opioid withdrawal syndrome", "NOWS"], "comments": [{"text": "Petitioners comments are well-received and should be closely reviewed by the FDA. Pregnant women are particularly vulnerable and have suffered greatly when policy has been built on scientific evidence that was insufficiently scrutinized (e.g. pregnant women have been arrested and incarcerated for testing positive for illicit substances during medical care in many parts of the United States, generally based on concerns of the harms of that substance use on the developing fetus without a strong scientific consensus). The petitioners raise very serious concerns about the language used in the planned labeling changes as they relate to NOWS, including the use of the term lifethreatening and language that could easily be used by providers, policymakers, and law enforcement and judicial agencies to restrict access to opioid agonist maintenance treatment or to punish patients receiving such therapy. At this stage, we rely on agonist maintenance therapy as the gold standard for treatment of opioid use disorders, particularly among pregnant women. It is critical that the labeling changes account for this by:1) emphasizing the essential role of agonist maintenance treatment among pregnant women and2) adopting more limited and evidence-based language regarding the nature and risks of NOWS.I am a board-certified internist and infectious disease specialist as well as a buprenorphine provider. I am an NIH-funded substance use investigator directing clinical trials into pharmacologic and behavioral therapies for substance use as well as studies of programmatic and structural changes to clinical care to minimize the medical sequelae of substance use (including efforts to improve opioid stewardship and minimize opioid-related mortality).", "comment_id": "FDA-2013-P-1288-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-1288-0005", "comment_date": "2014-02-11", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1791}, {"text": "The American College of Obstetricians and Gynecologists strongly opposes the black box warning on opioid medications directed toward pregnant women.  Opioid medications are the safest choice for use by pregnant women who experience moderate to severe pain.  In addition, women who are pregnant and dependent on opioid medications put their fetus in great danger if withdrawn from these medications during their pregnancy.  Neonatal Abstinence Syndrome, which may result from maternal opioid use, is a fully treatable condition without subsequent patho-physiology.  The warning proposed by the FDA concerning infant death has not been substantiated.  Thank you.", "comment_id": "FDA-2013-P-1288-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-1288-0004", "comment_date": "2014-02-11", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 665}]}, {"id": "MSHA-2008-0014", "agency": "MSHA", "title": "Alcohol-and Drug-Free Mines: Policy, Prohibitions, Testing, Training, and Assistance", "update_date": "2019-09-04", "update_time": "01:00:59", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "We currently have a Zero Tolorence drug/alcohol policy.  This potential newrule would open the doors for employees to have reason to do narcotics,alcohol while on the job because they would have a out when caught.  This putsthe Company at a no win situation.   ", "comment_id": "MSHA-2008-0014-0023", "comment_url": "https://api.regulations.gov/v4/comments/MSHA-2008-0014-0023", "comment_date": "2008-10-06", "comment_time": "04:00:00", "commenter_fname": "Jr", "commenter_lname": "Payne", "comment_length": 300}, {"text": "About the alcohol and drug free workplace proposed rule.The proposed rule as written will do nothing to prevent the use of either alcohol or drugs in the workplace. If there are no adverse consequences for not only an unsafe act but an illegal act where is the deterrent?  A true alcohol and drug free workplace must be a zero tolerance workplace.If an employee has a problem and truly wants help, and ask for it most companies will assist in getting them the help needed. But if they ask as they are going in for a random test or after an accident it should be and is to late at that point.If a serious accident occurs due to an employee using alcohol or drugs and MSHA investigates who will be held responsible? The companies whose hand you have tied in trying to prevent that very situation. I have no idea where this proposed rule came from and dont really care, but if MSHA truly cares about miners safety this rule must be changed.If it is not then MSHA is an out dated organization concerned only with special interest lobbying groups, for this proposed rule could only have come from such a group.I hope you truly have the best interest of ALL miners at heart and change this proposed rule to a true alcohol and drug free workplace law.", "comment_id": "MSHA-2008-0014-0010", "comment_url": "https://api.regulations.gov/v4/comments/MSHA-2008-0014-0010", "comment_date": "2008-10-01", "comment_time": "04:00:00", "commenter_fname": "Gary", "commenter_lname": "Woods", "comment_length": 1343}]}, {"id": "FDA-2020-D-1079", "agency": "FDA", "title": "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability ", "update_date": "2023-01-26", "update_time": "11:36:27", "purpose": "Nonrulemaking", "keywords": ["2019-965", "CDER", "Guidance for Industry", "Cannabis and Cannabis-Derived", "Compounds", "Quality Considerations for Clinical Research", "OPEN"], "comments": [{"text": "Cannabis Varieties and Sources", "comment_id": "FDA-2020-D-1079-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0046", "comment_date": "2020-09-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 30}, {"text": "Hemp or Cannabis Sativa has been used for generations to provide relief for a variety of reasons. The cannabinoids found in the plant are now available for more research with the prohibition lifted. Many natural products have been found to be beneficial. Cannabis in particular has never been found to be harmful to consume. Where the trouble comes is with additives. The big vape problem was caused by the cheap vitamin E oil being used. We do need fair and reasonable regulation for the production and sale of cannabis products to keep consumers safe. What we dont need is the misinformation and false statements that lead people to believe that cannabis can be harmful.Please treat cannabis as you would any natural plant.This is a great resource for fiber, food, and relief. The uncertainty and fear is limiting the growth of this emerging industry.Lets get on with it and provide clear guidance for the health and safety of our consumers and the economy!", "comment_id": "FDA-2020-D-1079-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0008", "comment_date": "2020-07-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 994}, {"text": "https://patents.google.com/patent/US6630507B1/enHHS shall keep that patent ownership, and license the right (so long as the products are compliant) to make the claims of those specific benefits.The plant itself (in my opinion) needs to remain schedule 1 and ONLY the Products developed from shall be approved for therapies/supplements.But cannabis products are the best first step towards transitioning into Botanical Medicine. Next Catha Edulis Psilocybin ", "comment_id": "FDA-2020-D-1079-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0007", "comment_date": "2020-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 477}, {"text": "As stated, calculating the amount of a substance in a botanical raw material by dry weight is a standard procedure. However, the calculation of dry weight for an extract or solid oral dosage form is less familiar to many stakeholders than the standard calculation for botanical raw materials. Therefore, the draft guidance recommends calculating delta-9 THC by dry weight in intermediates and drug products by removing the water content, including water contained in excipients. We invite comment from the public on this recommended approach. In addition, FDA invites public comment on the appropriate manufacturing controls over materials that cross under the 0.3 percent delta-9 THC by dry weight threshold during the production of a drug that contains cannabis or cannabis derived compounds.  With respect to the manufacturing controls being contemplated, are contingencies being considered should the federal classification of these substances change?", "comment_id": "FDA-2020-D-1079-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0013", "comment_date": "2020-07-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 965}, {"text": "Just one more way for the government to say gotcha. One more reason to arrest and murder people over a damn plant. ", "comment_id": "FDA-2020-D-1079-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0022", "comment_date": "2020-08-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 115}, {"text": "I agree with DEAs ruling that CBD Production Process needs to be regulated. Most of the CBD hemp Extraction Processes generate a crude extract which may contain as high as 5% THC. Some of the producers conduct a molecular distillation followed by crystallization/precipitation to make CBD Isolate. Then they are left with a mother liquor which has as much 10-15% THC. Currently these products are instead of being destroyed are being sold in the market under the label Legal Hemp Extract. This should not happen and DEA should not let it happen. There are existing technologies which isolate THC from hemp extracts at an early stage and destroy the THC or make it unusable. ...similar to making alcohol denatured. DEA and the entire Hemp Industry should seriously consider implementing these technologies across the hemp landscape in USA. This will obviate the need to monitor regulatory compliance. It will be built into teh process.If DEA wants more information please reach out to me. I have worked in the chemical processing industry for over 40 years. and have around 100 Patents on various innovative processs. Thanks and Kind Regards....Anil Oroskar", "comment_id": "FDA-2020-D-1079-0061", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0061", "comment_date": "2020-10-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1188}, {"text": "I am an American cannabis researcher contributing to cannabis education, and it would truly be a dream to be able to start taking American cannabis research seriously. As of now, I have to look to other countries for reliable cannabis information.Without proper cannabis samples, how are current American scientists expected to produce quality studies, much less medicine to help anyone? Does the US ever want to contribute to cannabis medicine and help its people, or just sit on the sidelines while other countries reap all the benefits?We are already very far behind, and it is time to start catching up.", "comment_id": "FDA-2020-D-1079-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0034", "comment_date": "2020-09-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 632}, {"text": "Just deschedule it. CBD  THC have been life saving medicines that has allowed me to work full time  regain my independence without having to live off welfare even tho I totally qualify.", "comment_id": "FDA-2020-D-1079-0065", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0065", "comment_date": "2023-01-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 195}, {"text": "Why dont you guys spend time cracking down on fentanyl and pharmaceutical companies? Leave hemp and CBD alone you buttholes. You are trash and wasting tax payer money on bullshit.", "comment_id": "FDA-2020-D-1079-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0020", "comment_date": "2020-08-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 179}, {"text": "Before the FDA rules on this matter, the FDA should redefine how patients obtain medical marijuana prescriptions.  At present, it is easy for any adult to obtain the papers necessary to allow them to buy marijuana for medicinal purposes.  The patients should be required to have a written prescription from a physician with a brick-and-mortar office address, and the prescription should contain the physicians name, office address, and his medical license number.  Additionally, the prescription should say what condition the marijuana is treating.  The prescription should have an end date by which the patient would need a new prescription.  The FDA may wish to limit the types of conditions that can be treated with marijuana.  Otherwise, many adults who do not have a medical need for marijuana will be able to buy it, as they currently are able to do.  Not only is this situation skirting the law, but it is also denying tax revenue to the cities and counties that have legalized marijuana for added revenue, since there is no sales tax collected from sales of medical marijuana.", "comment_id": "FDA-2020-D-1079-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0009", "comment_date": "2020-07-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1089}]}, {"id": "FDA-2016-P-3912", "agency": "FDA", "title": "Requests FDA to (i) require proposed generic versions of Intranasal (IN) naloxone products to provide specific pharmacokinetic (PK), device, stability and Chemistry, Manufacturing and Controls (CMC) data, as set-out herein, within the ANDA, to support the interchangeability of generic IN naloxone and the IN naloxone Reference Listed Drug (RLD); (ii) not to approve any generic", "update_date": "2017-05-15", "update_time": "10:25:14", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "OPEN", "2016-6743", "Adapt Pharms Operations Ltd", "Intranasal (IN) naloxone products", "pharmacokinetic (PK)", "device, stability and Chemistry", "Manufacturing and Controls (CMC) data", "interchangeability of generic IN naloxone", "Reference Listed Drug (RLD)", "generic application"], "comments": [{"text": "Please keep in mind that there are legit chronic pain patients whom have tried everything with no success. The only relief for somepatients is being on Narcotic medication. Not everyone that takes medications are so called druggies.  There are plenty of patients thatsuffer 24/7 and without the medications that they take there life is worthless. some chronic pain patients cannot get out of beddue to them hurting until they take there medications and feel better. No one wants to be in pain and why should the FDA or theDEA make them suffer when there are medications that help?  This makes NO sense at all. We live in the U.S. and we are suppose tolive in a free Country, however, each day it seems like we are loosing our rights.", "comment_id": "FDA-2016-P-3912-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-3912-0005", "comment_date": "2017-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 770}, {"text": "FDA-2017-N-1847.Subject: Please preserve compounding substances.Pharmacy Compounding Advisory Committee,I urge the FDAs PCAC to preserve consumer access to important compounded ingredients. The substances being considered at the May meeting have been used for a long time and have demonstrated safety records. There may be commercial formulations of these substances, but the role of compounding pharmacies is to provide patients with special needs the medicines they require. Some people have environmental sensitivities and cannot have preservatives in their medicines; some have gluten intolerance and cannot have gluten in a pill; others, such as elderly patients and autistic patients, have difficulty swallowing pills. Compounding pharmacies can make special preparations for these patients. Heres whats at stake: Artemisinin is a compound found in sweet wormwood, an herb that has been used in traditional Chinese medicine for centuries. It is most notably used to treat malaria, but it may also be helpful for tuberculosis and a host of other conditions. Considering the rise of drug-resistant TB, which is virtually untreatable and is sending conventional doctors into a panic, it would be lunacy to restrict access to this herb. Ubiquinol is by far the most effective, bioavailable form of CoQ10. Some people may not be able to convert the ubiquinone form of CoQ10 into ubiquinol, which means access to ubiquinol products is extremely important. CoQ10 / ubiquinol has many benefitsit is used for energy production by every cell in the body. It is especially useful for patients on statins since these drugs deplete the body of CoQ10. Nettle has a number of salutary effects. It was used by Roman soldiers to withstand the cold by stimulating blood circulation. It helps the body detoxify itself, alleviates allergic reactions, and promotes healthy blood circulation. Vanadyl sulfate is an insulin mimic and a natural therapy for diabetes and insulin resistance. It is a form of a trace mineral found in mushrooms and shellfish.  Nicotinamide adenine dinucleotide (NAD) is a vital compound involved in mitochondrial health and energy metabolism. As NAD levels decline later in life, mitochondrial function is impaired, resulting in various symptoms of aging. NAD is also an essential cofactor of certain key enzymes that are responsible for longevity. Every year we are learning more about how critical NAD is, including for cancer control. Please do not further restrict the medicines that compounding pharmacies can make for their customers. The ability of compounding pharmacies to function, thrive, and produce these crucial supplements plays a crucial role in peoples lives.Ron Rattner1998 Broadway Apt 1204San Francisco, CA 94109", "comment_id": "FDA-2016-P-3912-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-3912-0004", "comment_date": "2017-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2789}]}, {"id": "NRC-2009-0225", "agency": "NRC", "title": "Fitness-for-Duty Drug Testing Program Requirements", "update_date": "2022-11-22", "update_time": "09:18:03", "purpose": "Rulemaking", "keywords": ["Fitness for duty", "HHS"], "comments": [{"text": "26.119 determines the standards for conditions of Shy Bladder.  This section of code has presented with unique challenges for Program Managers and donors alike.  The code stipulates a 5 business day standard for donors to consult with a physician when unable to produce a specimen.  Many of the donor participants are transient workers who do not carry insurance or regularly maintain a personal physician.    Workers who are traveling and away from their residence must now (when unable to produce a specimen)  attempt to travel home and find a physician who will immediately schedule an appointment and see them.  Finding a physician in the immediate area of the plant presents with challenges and appointments are difficult in a short time frame.  In this frequent scenario, the worker is unable to meet the 5 day standard, which invariably results in a permanent denial.  Another issue is that of the alternative process.  It would seem reasonable to immediately proceed to an acceptable alternative testing process such as oral fluid.  Established guidelines recently published should provide MROs and program managers with the needed tools and guidance to address this issue.  Recommendation: Provide for a more reasonable and realistic time frame for review of medical information when an individual cannot provide a specimen under shy bladder conditions.  Ten days seems reasonable since a review under positive conditions may be considered within days (see below).  Providing for a minimum time frame of ten days, and perhaps providing for a extension (not to exceed 30 days) under approved conditions of the MRO or program manager seems reasonable.  Additionally, adopt and clearly outline the conditions for alternative testing.  Oral fluid is less evasive than blood extraction and easily implemented.  Also consider providing program managers with the option to use oral fluid testing in any testing condition at any time.    This provides for flexibility within the program and strengthens the integrity and viability of the program when donors cannot predict the method of testing.    26.119FFD program personnel shall direct the donor to obtain, within 5 business days, an evaluation from a licensed physician who is acceptable to the MRO and has expertise in the medical issues raised by the donors failure to provide a sufficient specimen. If the MRO determines that the medical condition is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, then the MRO shall authorize an alternative evaluation process, tailored to the individual case, for drug testing.Time to complete MRO review. The MRO shall complete his or her review of positive, adulterated, substituted, and invalid test results and, in instances when the MRO determines that there is no legitimate medical explanation for the test result(s), notify the licensees or other entitys designated representative within 10 business days of an initial positive, adulterated, substituted, or invalid test result. The MRO shall notify the licensee or other entity of the results of his or her review in writing and in a manner designed to ensure the confidentiality of the information.", "comment_id": "NRC-2009-0225-0041", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0041", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 3315}, {"text": "26.187 outlines the credentials of the Substance Abuse Expert.  All industry SAEs are required to hold the credentials noted below.  However, the SAEs providing services to the industry are not practicing field treating addiction personnel, nor do they have the expertise to do so.    Instead, SAEs serving the nuclear industry are assessing, evaluating, and reporting recommendations to FFD program managers for referrals, but are not providing treatment.Conversely, a Masters level addictions professional who has completed a six year addictions program including focused training in assessment, but does not hold a license because they are not providing treatment does not meet the standard as noted below.  Individuals who have completed an addictions program have completed more focused training in substance abuse/addictions than the professionals currently listed.  Recommendation: Consider incorporating language that allows for the completion of an advanced degree in addictions (Masters) as a credential standard for performing as an SAE.  Credentials. An SAE shall have at least one of the following credentials:(1) A licensed physician;(2) A licensed or certified social worker;(3) A licensed or certified psychologist;(4) A licensed or certified employee assistance professional; or", "comment_id": "NRC-2009-0225-0042", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0042", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 1420}, {"text": "Determination of Fitness (DOF) is conducted in the event an individual has violated the FFD program, or is otherwise impaired on a level that compromises their ability to work safely and competently.  Often the DOF is initiated based on observed behavior.  However, code currently does not define what manner of observed behavior constitutes an evaluation.  Logic would dictate that the behavior that requires a DOF would be predicated on a failure of the FFD program or impairment that compromises safe competent operation.  However, utilities are conflicted and are initiating DOFs for any behavior due to an observed report.   As an example, some utilities are launching DOFs for such innocuous behavior as looking at another worker in an odd manner.  A preliminary assessment that collects relevant facts and information can determine if impairment may exist and identify any program violations, so that personnel are not being subjected to unnecessary evaluations.   Recommendation: Consider language that clarifies the role of the FFD program management in conducting relevant information that will contribute to a formal referral for DOF.  A preliminary assessment that clarifies FFD managements responsibility for conducting interviews, ruling out the possibility that drugs may have played a role in the behavior by conducting FFD collection and testing, reviewing past behavior observation reports, reviewing past self reports.  This information is akin to the information gathered by Reviewing Officials.  Conducting relevant information and subsequently providing that information to the SAE, MRO, or Psychologist is absolutely necessary and is in fact occurring at many utilities, while others, out of an abundance of caution, conduct a DOF for any observed behavior.  A determination of fitness must be made in at least the following circumstances:(1) When there is an acceptable medical explanation for a positive, adulterated, substituted, or invalid test result, but there is a basis for believing that the individual could be impaired while on duty;(2) Before making return-to-duty recommendations after an individuals authorization has been terminated unfavorably or denied under a licensees or other entitys FFD policy;(3) Before an individual is granted authorization when potentially disqualifying FFD information is identified that has not previously been evaluated by another licensee or entity who is subject to this subpart; and(4) When potentially disqualifying FFD information is otherwise identified and the licensees or other entitys reviewing official concludes that a determination of fitness is warranted under  26.69.(c) A determination of fitness that is conducted for cause (i.e., because of observed behavior or a physical condition) must be conducted through face-to-face interaction between the subject individual and the professional making the determination. Electronic means of communication may not be used.", "comment_id": "NRC-2009-0225-0043", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0043", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 3060}, {"text": "26.31 denotes the conditions for collection.  Administration of post event collection specific to the 4 hour reference has cause some confusion in the industry.  Very often a safety event is still under investigation after four hours leaving the OSHA recordable question unanswered.  It may be that the recordable question is not answered for 24 hours or more.  Personnel who are injured and transported for medical treatment may not return to duty days or weeks later without FFD testing.  The rule is clear that medical assistance cannot be delayed for FFD testing consideration.  However, when minor injuries occur, and the subject individual returns to duty the 8-10 hours later, the question of recordability is not yet answered, program personnel are often seeking guidance about whether FFD collections make sense under this standard.   Language that clarifies this frequent scenario would be most beneficial.  Additionally, the term substantial degradation to the level of safety has been frequently debated.  The question is often asked, What constitutes substantial  degradation?  Licensees are generally attempting to define what is meant by substantial.  It seems more prudent to state that degradations of plant safety that generally may compromise general safety and security may be more appropriate.  Post-event. As soon as practical after an event involving a human error that was committed by an individual who is subject to this subpart, where the human error may have caused or contributed to the event. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in(i) A significant illness or personal injury to the individual to be tested or another individual, which within 4 hours after the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, General Recording Criteria, and subsequent amendments thereto, and results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness;(ii) A radiation exposure or release of radioactivity in excess of regulatory limits; or(iii) Actual or potential substantial degradations of the level of safety of the plant;", "comment_id": "NRC-2009-0225-0036", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0036", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 2779}, {"text": "We as a nation need to continue to push the legalization of marijuana and keep it in schedule. Marijuana has been proven to be extremely beneficial to the human body Cannabidiol has the ability to stop cancer by turning off a gene called Id-1. This along with many other amazing things such as preventing Alzheimer are why we need to continue to push these regulations through congress. This needs to be doe for the people.", "comment_id": "NRC-2009-0225-0028", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0028", "comment_date": "2019-11-05", "comment_time": "05:00:00", "commenter_fname": "Braeden", "commenter_lname": "Clark", "comment_length": 423}, {"text": "Drug  Alcohol Testing Industry Association (DATIA) Comments", "comment_id": "NRC-2009-0225-0046", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0046", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Laura", "commenter_lname": "Shelton", "comment_length": 64}, {"text": "26.33 denotes the standard for the behavior observation program as noted below.  Behavior Observation is the cornerstone of the FFD program and has contributed to crucial observations that have protected the safety and security of licensee personnel.  Behavior observation has been extremely effective when implemented properly, but disastrous when not executed in the manner prescribed by code.  Over the years there have been note worthy examples of personnel who had expressed knowledge of FFD issues, but chose to ignore or down play observations for fear of becoming involved or implicated in actions that could impact an individuals  that could employment.   Additionally, the current language stipulates, detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty.  This language specifically addresses use, sale or possession of illegal drugs or alcohol, but does not address the abuse of legal drugs or other substances that have the propensity of impair and endanger safety.   Recommendation: Consider additional language that emphasizes the vital importance of the FFD Behavior Observation program and the potential consequences of purposely ignoring the mandate to report behavior observation concerns.  In two recent cases I was involved with, two supervisors observed serious behavior observation issues that were attributed to severe mental illness in each case.   In these cases, the observations were overt and abundantly apparent but were ignored.  Language should address willful noncompliance.  Additionally, recommend language that addresses detecting behaviors that may indicate possible sale or possession of abused legal or illegal drugs, alcohol, or any substance used for the expressed purpose of impairing an individuals ability to work safely and competently.  This would include inhalants or other household substances that have been used to alter or impair consciousness.  Licensees and other entities shall ensure that the individuals who are subject to this subpart are subject to behavioral observation. Behavioral observation must be performed by individuals who are trained under  26.29 to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security. Individuals who are subject to this subpart shall report any FFD concerns about other individuals to the personnel designated in the FFD policy.", "comment_id": "NRC-2009-0225-0032", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0032", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 2697}, {"text": "The conditions detailing remote collections (collections remote from the licensee) are not clearly denoted in the present code verbiage.  26.4 h,2, featured below seems to suggest that licensees may conduct remote collections via personnel who are asked to provide collections for the licensees.  There are sections of the code that allow for remote collections at hospitals for example, as a contingency when emergency conditions dictate.  Some licensees have established remote collection sites to manage personnel who are remote from the licensees collection facilities.  Examples include Information Technology, Engineering and other personnel who may reside in other states hundreds of miles from the licensee and provide services to the licensee remotely.  This section of code (26.4 h, 2) is confusing and does not clearly provide sufficient guidance on managing the issue of remote collections.  IF remote collections are permissible; under what conditions may they be managed?  Concerns have been raised regarding how such collection facilities should or should not be audited if they are providing infrequent services to the licensee, and are not involved the daily operations of the FFD program.  Should licensees depend on other licensee collection facilities to manage this unique population of workers?  If so, what guidance dictate the methods for managing the process?  What should occur if the donor tests positive at licensee who is collecting a specimen for another licensee? Clearly, licensees collecting specimens for each other is a far better option than relying on unvetted remote collection facilities.  However, there are scenarios that create the possibly that remote collections could not be completed by another licensee due to distance.  Recommend guidance that provides for clear direction concerning this unique issue.  Licensee companys increasingly are placing demands on FFD program personnel to accommodate remote collection conditions that would allow the licensee to meet the definition of critical group, thereby requiring placement in the FFD program.   Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to  26.31(c)(1), 26.35(b), 26.37, 26.39, and the applicable requirements of subparts C, and E through H of this part.(i) The following individuals are not subject to an FFD program under this part:(1) Individuals who are not employed by a licensee or other entity in this part, who do not routinely provide FFD program services to a licensee or other entity in this part, and whose normal workplace is not at the licensees or other entitys facility, but who may be called on to provide an FFD program service, including, but not limited to, collecting specimens for drug and alcohol testing, performing behavioral observation, or providing input to a determination of fitness. Such individuals may include, but are not limited to, hospital, employee assistance program (EAP) or substance abuse treatment facility personnel, or other medical professionals;", "comment_id": "NRC-2009-0225-0034", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0034", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 3188}, {"text": "The current rule stipulates personnel who are considered a part of the FFD program.  26.4 g, featured below states that personnel who are involved in the day to day operations of the program are considered FFD personnel, yet there are licensee employees who are called upon to perform infrequent duties, (For Cause, Post Event, back shift random testing) who are not involved in day to day operations.  A typical example would include Security personnel.  Security personnel, if not given access to random lists, are certainly notifying personnel and conducting collections.  This wording has caused confusion among licensees.  Recommend this section be clarified to clearly denote personnel who are considered FFD program personnel.    All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in  26.3(a) through (c), and, as applicable, (d), and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part, and, at the licensees or other entitys discretion, subpart C of this part:(1) All persons who can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to the MRO;(2) All persons who make determinations of fitness;(3) All persons who make authorization decisions;(4) All persons involved in selecting or notifying individuals for testing; and(5) All persons involved in the collection or onsite testing of specimens.", "comment_id": "NRC-2009-0225-0033", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0033", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 1732}, {"text": "10 CFR 26.75 provides for sanctions on any individual who violates the FFD program.  As noted below, the sanction for possession of illegal drugs, consumption of alcohol within a protected area, or while performing duties shall result in a minimum 5 year denial. This section does not address use of other intoxicating agents such as solvents, computer cleaners, glue, etc that have a equal to or greater impairing effect.  Additionally, the abuse of prescription drugs with the sole intent of impairing  or producing a high is also not discussed in this section.  Clearly the focus of this section is to address any individual who would willfully abuse substances with the sole intent of producing a high to alter consciousness, thus jeopardizing safety and security.    There have been cases noted with licensees involving the use of inhalants and/or prescription drug abuse where other entities have argued that the language of the code did not support sanctions in these specific cases.  Recommendation: Consider language that addresses substance abuse in all forms within the protected area or during performance of any tour of duty.    Any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, within a transporters facility or vehicle, or while performing the duties that require the individual to be subject to this subpart shall immediately have his or her authorization unfavorably terminated and denied for a minimum of 5 years from the date of the unfavorable termination of authorization.", "comment_id": "NRC-2009-0225-0039", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2009-0225-0039", "comment_date": "2019-12-05", "comment_time": "05:00:00", "commenter_fname": "Johnny", "commenter_lname": "Rogers", "comment_length": 1735}]}, {"id": "FDA-2016-D-1662", "agency": "FDA", "title": "Candidiasis: Developing Drugs for Treatment", "update_date": "2019-08-01", "update_time": "10:17:35", "purpose": "Nonrulemaking", "keywords": ["2015-566", "Vulvovaginal Candidiasis: Developing Drugs", "Treatment", "Draft Guidance for Industry"], "comments": [{"text": "September 8, 2016Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Room 1061Rockville, MD  20852RE:Docket No. FDA-2016-D-1662Comments on FDAs Draft Guidance for Industry: Vulvovaginal Candidiasis: Developing Drugs for TreatmentDear Sir / Madam:On behalf of SCYNEXIS, Inc., we respectfully submit comments on FDAs Draft Guidance for Industry Vulvovaginal Candidiasis: Developing Drugs for Treatment. SCYNEXIS, Inc. is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. Our lead product candidate, SCY-078, is a novel class, broad spectrum IV and oral antifungal that is a semi-synthetic triterpene derivative of the natural product enfumafungin for the treatment of serious and life-threatening invasive fungal infections, such as invasive candidiasis and invasive aspergillosis, including multidrug-resistant pathogens.  SCY-078 is also in development for Vulvovaginal Candidiasis (VVC) and recurrent VVC. Within Section II, B, 3. (line 105) of the proposed guidance, normal vaginal pH is described as: greater than or equal to 4.5.  SCYNEXIS, Inc. respectfully recommends replacing the proposed text as follows:replace greater than or equal to 4.5 with lesser than or equal to 4.5 Reference is made to Sobel et al, Lancet 2007; 369: 1961-71 (enclosed). We thank you for the opportunity to comment. Please contact me by telephone at 201-884-5471 or by email at david.angulo@scynexis.com if you have any questions concerning these comments.Sincerely,David Angulo, MDChief Medical Officer, SCYNEXIS, Inc.Enclosure: Sobel et al. 2007", "comment_id": "FDA-2016-D-1662-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-1662-0004", "comment_date": "2016-09-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1943}, {"text": "September 29, 2016Division of Dockets ManagementFood and Drug Administration5630 Fishers LaneRoom 1061, HFA-305Rockville, MD 20852Re:Draft Guidance for Industry - Vulvovaginal Candidiasis: Developing Drugs for Treatment Docket ID: FDA-2016-D-1662To Whom It May Concern:Cidara Therapeutics Inc. (Cidara) is pleased to submit comments in response to the Food and Drug Administrations new draft guidance titled: Vulvovaginal Candidiasis: Developing Drugs for Treatment (July 2016), Docket ID: FDA-2016-D-1662. Cidara thanks the FDAs Division for Anti-Infective Drug Products for providing sponsors developing therapies for the treatment of Vulvovaginal Candidiasis (VVC) with a revised guidance replacing the previously withdrawn guidance from 1998 (Draft Guidance for Industry - Vulvovaginal Candidiasis: Developing Antimicrobial Drugs for Treatment, July 1998).Cidara is a clinical stage biotechnology company developing novel anti-infectives including immunotherapies for the treatment of serious and life-threatening infections. Cidara is developing a treatment for medically significant Vulvovaginal Candidiasis (VVC) infections. Accordingly, Cidara has a unique stake in regulatory guidance pertaining generally to womens health and specifically to drug development for the treatment of VVC. We are providing 3 comments to the draft guidance for your consideration.1. The stated focus of the draft guidance is for developing antifungal drugs for the treatment of uncomplicated VVC (I. Introduction). Although important clarifications and definitions are provided in this guidance to assist sponsors developing drugs for the treatment of women suffering from uncomplicated infections, the definitions for uncomplicated and complicated VVC remain unclear.  This guidance represents an important first step.  An important next step is the provision of a draft guidance for developing therapies for the treatment of women suffering from complicated VVC.  Cidara urges the FDA to issue guidance as soon as possible to address this important medical need. 2. The guidance states that ...the primary efficacy endpoint should be clinical cure, defined as the absence of all signs and symptoms of VVC (II.B.8 Efficacy Endpoints). In the previous guidance from 1998, Clinical Cure was defined in the context of severity of disease.  For subjects with mild infections (any sign or symptom with a score of 1 or 2 at entry) scores of 0 were recommended at the Test-of-Cure visit.  For subjects with moderate to severe infections (any sign or symptom of 3 or more at entry) scores of 0 or 1 were recommended at the Test-of-Cure visit.  Cidara believes that it is reasonable to consider reinstituting the previous scoring system for a couple of reasons.  First, many normal, healthy women have baseline symptoms of itching, burning, or irritation.  Using an absence of all symptoms and signs to define clinical cure results in an inability for clinical cure to be achieved in these subjects even if the subjects clinical status returns to her baseline.  Second, residual symptoms from more severe infections may take longer to resolve, which is even more impactful given the earlier Test-of-Cure timepoint at Day 7-14.  Utilizing scores of 0 or 1 at the Test-of-Cure visit would allow for instances where mycological eradication has been demonstrated but where residual symptoms may take a little longer to resolve  The primary concern in both these scenarios is misclassification of outcome - marking a subject as a clinical failure when the subject should be a cure.  Under the current guidance, a change from 12 to 1 in one subject on Day 7 would be the same as a change from a 12 to 11 in another subject - both would be clinical failures.  We are concerned that this resulting misclassification of the outcome would make demonstrating superiority more difficult, even where there are clearly differences in how a patients feels and functions between the two study arms. Therefore, Cidara recommends keeping the previous recommendation for clinical cure as provided for in the 1998 guidance.3. The new guidance provides for the addition of safety information into the overall safety database from patients treated with the same therapy for other infectious disease indications (II.A.3 Safety Considerations).  The guidance also recommends for drugs administered topically that the focus should be on both local and systemic toxicity. Cidara agrees that for topical products where systemic exposures are low, the inclusion of safety data into the overall safety database from systemic exposure studies is valuable in providing an overall assessment of safety. Sincerely,Carmen M. Betancourt-Riche, MBA,  Senior Vice President, Regulatory and Quality AssuranceTaylor Sandison, MD MPH, Chief Medical Officer (Acting), Vice President, Clinical DevelopmentCidara Therapeutics, Inc., 6310 Nancy Ridge Drive, Suite 101, San Diego, CA 92121", "comment_id": "FDA-2016-D-1662-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-1662-0006", "comment_date": "2016-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5146}]}, {"id": "NHTSA-2016-0099", "agency": "NHTSA", "title": "Regulatory Update of Transfer and Sanction Programs", "update_date": "2019-02-08", "update_time": "11:33:20", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I own a new hatchback with glove compartment and console that I cannot lock a removable cover for my hatch.  I drive around without the cover on my hatch because my dog is back there most of the time.  I would like this interim final rule to provide more information about the exceptions to locations of an open container within the vehicle.  Particularly about those vehicles without the typical trunk that have no cover for the hatch in the back.  I ask for this because it could possibly be accessible to a determined passenger and potentially lead me to severe penalties. ", "comment_id": "NHTSA-2016-0099-0002", "comment_url": "https://api.regulations.gov/v4/comments/NHTSA-2016-0099-0002", "comment_date": "2016-11-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 576}]}, {"id": "DEA-2014-0005", "agency": "DEA", "title": "Schedules of Controlled Substances:  Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II", "update_date": "2022-03-22", "update_time": "11:18:07", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The proposed rescheduling of hydrocodone will place a large time-consuming burden on physicians and will result in a larger number of pills available for diversion.   I am a  Plastic,Reconstructive,  Hand surgeon in Lufkin, a small city in rural Deep East Texas.   I am very  busy, working at least 70 hours each week.   Burns and hand  arm surgery particularly, with crush injuries from the heavy steel manufacturing and logging industry, are associated with signficant pain.   It is my general policy to initially prescribe a small number of pain pills (30) following surgery.   It is also my belief that one doesnt get any extra points for suffering, so if a patient has pain then I certainly wish to alleviate his suffering. I am presently president of the medical staff at Woodland Heights Hospital,  recent president of the County Medical Society, former president of the medical staff at Memorial Medical Center, and I sit on the bylaws committees of both hospitals.  I have been a delegate to the Texas Medical Association twenty times in my 25 year career in this same location.  That is mentioned only to emphasize that I am not a crack-pot, I am a well respected member of the medical community.    If a patient requires a refill, I can currently pick up the phone and speak to the pharmacists I know by name and quickly provide a refill.   If hydrocodone is made schedule II, then I must instead write a prescription, make it accessible to the patient to pick up and carry to the pharmacist, or I must carry it to the pharmacy and drop it off.   Forty percent of my patients live farther away from Lufkin than forty miles.   Given the increased difficulty for me to refill the prescriptions I promise you that I will make my initial prescription in all cases at least 60 tablets.   Not all of them need a re-fill, I assure you of that;   but,  a significant number do, and it would be such a hassle trying to get patients from Jasper, Newton, Onalaska, Cleveland, Shepherd, Livingston, Crockett, Grapeland, etc their prescription refills, therefore  I promise you I will provide larger numbers up front.   Unused pills sitting around are likely to be diverted.   Please do not make my life more complicated, my patients truly in pain suffer more, and especially do not create your unintended consequence of MORE pills being diverted.   Houston is not the same as Lufkin, and Washington DC is not the same as Williston, North Dakota.   Please, while sitting in your ivory tower in Washington, DC,  try to imagine how it is in rural areas of East and West Texas, Wyoming, or Western North Dakota.    Enclosed is a photo of a map in my office.  I have had at least one patient come from each dot on the map.  Some of them have come for elective surgery, many in East Texas and Louisiana because they were injured.  How in the world do you expect me to get their schedule II scripts to them at 8:00 pm at night?   ", "comment_id": "DEA-2014-0005-0102", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0102", "comment_date": "2014-03-13", "comment_time": "04:00:00", "commenter_fname": "William", "commenter_lname": "Strinden md", "comment_length": 2937}, {"text": "On first thought, I support changing to schedule 11 as hydrocodone by itself is schedule 11.  However does this also apply to the cough syrups that have a small quantity of hydrocodone?  Just which combinations would be involved?", "comment_id": "DEA-2014-0005-0019", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0019", "comment_date": "2014-02-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 229}, {"text": "Re:  Docket No. DEA-389I am asking you to reconsider making hydrocodone a CII drug.  I have arthritis in my cervical spine and this medication offers some relief from the terrible pain.  I have been taking this drug for 2 years and dont believe that I am a public or personal threat to myself or to others.  I am prescribed 90 tables per month, but typically dont take them all.  I take them only as needed.  I feel that me and other patients like myself who are not abusing hydrocodone and are taking it as prescribed, are being singled out and punished just because others are abusing this drug.  People will abuse any drug, if they are so inclined.  If you make this drug a CII, I will have to get a new prescription each time, meaning that I will have to see my doctor each time and pay for an office visit each time.  I am have very limited income and a high insurance deductible, so this will very difficult for me to do.  Please, consider the patients that truly need this drug and who are not abusing or diverting it to others before making this decision that will impact my medical bills.  Thank you. ", "comment_id": "DEA-2014-0005-0043", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0043", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Jennifer", "commenter_lname": "Williams", "comment_length": 1150}, {"text": "I believe that hydrocodone products should be moved to C2 medications because too many people are abusing it because it is more available ,also it has big potential for abuse", "comment_id": "DEA-2014-0005-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0039", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 174}, {"text": "As a community pharmacist for 16 years and now a faculty member in a college of pharmacy teaching pharmacy law, I see several unintended consequences of moving hydrocodone combination products from CIII to CII status.  These include the following: 1.  Drug of choice prescribed will change from hydrocodone combination products to some other CIII medications like codeine codeine combination products, Suboxone and Subutex (which have off-label uses for pain) and other CIII pain medications. This really isnt solving the abuse problem -- it is just shifting the problem to another drug. 2.  This change will put increased hurdles on patients and pharmacists for those with legitimate pain and have a legitimate reason for using the medication. 3.  There are already drug shortages for other CII medications because of stop orders that wholesalers are putting on community pharmacies that are impeding those pharmacies and pharmacists abilities to take care of patients with legitimate needs.  Moving hydrocodone combination products to CII status will make this situation worse if there is no corresponding changes to this process.  4.  We are already seeing an increase in heroin and other CI substance abuse as a result of the decreased availability of oxycontin and other oxycodone containing products.  Not sure which is the lesser of the two evils.  I realize that the DEA is an enforcement agency -- I would like to know when the legitimate patient was lost in the big picture.  Instead of having health care providers and pharmacists taking care of patients as our primary roles, it seems that the DEA would rather health care providers and pharmacists have our primary role be the drug police.  That is not what I went to pharmacy school for nor do I believe this is what most health care providers went to school for. In conclusion, I realize why the DEA and FDA think that rescheduling hydrocodone combination products is a good idea.  I believe the unintended consequences of the move would actually make the situation worse.  Therefore, I respectfully ask that the DEA not reschedule hydrocodone combination products to CII.  Sincerely,Mary Gurney", "comment_id": "DEA-2014-0005-0038", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0038", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Mary", "commenter_lname": "Gurney", "comment_length": 2257}, {"text": "I am a nurse practitioner in a state that does NOT allow us to write class II narcotics.  For many patients we are their only healthcare provider.  This change will severely affect our patients ability to obtain their pain medications.  Our practice is in a very rural area where the nearest pain management provider is approximately 1 hour away making it unobtainable for many patients.    Many patients cannot make the drive due to cost of gas, cars in poor shape, or lack of family support to take them.  We also have a problem with the pain management providers not accepting all insurances, especially the Medicaid patients. I do not want to see this rule changed.  It will impact the poor, underserved patients the most.", "comment_id": "DEA-2014-0005-0018", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0018", "comment_date": "2014-02-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 768}, {"text": "My name is Deborah. I am 42 years old and live in Alabama. I have a lower spinal birth defect, DDD, spinal stenosis  other painful health issues. For the past 6 years I have been under the care of a neurologist. In order to function I rely on Norco 10/325s, 2 pills per dose, 4 doses per day. I have been on this amount for 3 years  have worked hard to not increase this dosage.  I am uninsured.  Alabama is a state that refused the medicaid expansion funding allowed via the new National Healthcare Law. What this means to me is that I am in the gap, not enough income to buy a health plan but too much income to qualify for help through my state. I had a hearing to determine if I will be allowed my SSDI benefits 12/18/13 and am still waiting for the decision, If approved there will still be a large gap between approval  when Medicare will cover my medical expenses. I woke this morning to find that the rescheduling of my pain medicine is one step closer to becoming a reality. The impact this will have in my life is enormous so I am writing to give you a glimpse into how this will affect my family.  My doctor of 6 years, due to a sanction placed by the state medical board cannot currently write any prescriptions stronger than a schedule lll. At this point I see my doctor 4x a year for appointments. Beginning last December the visits were reduced to $100 but until that point I had paid $175/visit for 3 years and then $250/visit from that point until the recent reduction. The $250 price range is the norm for visits to comparable doctors in my area. I have also done disc decompression that I raised 3/4 of the funding for via a fundraiser. I am making payments on the balance  will be for quite some time. I also pay out of pocket for all of my medications at the cost of $200/month. If this rescheduling goes into effect I will either have to stop treatments completely or switch my care to a new doctor  pay even more for my care. New patient doctor visits cost about $300  follow up visits are in the $200-250 range. I am aware that the cost involved with obtaining a new prescription each month could run $75 for a urine screen or pick up fee to full visit cost every month. There is no way I can possibly absorb these costs  it may not even be an option to continue my care. When I first heard of these potential new regulations I made a few calls to doctors in my area and each time I mentioned that I am uninsured  require narcotics to maintain my quality of life the roadblock came up. Doctors do not want to take on an uninsured patient, apparently we are a risk whether it be fear of our diverting our medications or the potential that we may need therapy or care that we are unable to afford. I beg of you to consider the impact this rescheduling will have on myself  my family. Being unable to work I rely on family to help with these expenses and it has created a circle where they break their backs only to keep us barely above water. My children will have to watch mom suffer in agonizing pain. Now I am able to walk for short distances  leave the wheelchair for times that the walking is just more than my back  hips can tolerate. As a chronic pain patient I am very aware that some misuse this type of medication. Narcotics were not my first choice nor one I wanted but the only other medication that somewhat helped is a medication called Ultram. I tried it but it made me drunken, loopy  unable to function, I fell several times while taking it. I am at risk for having seizures if I ever take it again. I take my medication as directed  humbly give urine screens  pill counts when asked, I keep my medication under lock  key  dont even let people know I am on this medicine for fear of my safety if those who are addicted find out I am prescribed this. I cant even rally the troops so to speak via social media to encourage others to speak out for fear of those addicted knowing I have access to this narcotic  additionally, my pain contract forbids my sharing that I take this medication. It may be hard to imagine having no health insurance, if you are reading this letter you probably have it; but please try to imagine how drastically this will impact my life if it does go into effect. PLEASE, I beg of you, dont take my quality of life away. I have so much to offer to my family and children and society but I cant if I am in such pain that I cant function. My pain without intervention is so bad that I am unable to even think coherently  become severely depressed. I have cried buckets wondering how I can help myself maintain what little quality of life I have. PLEASE dont punish me and my family for actions of those who acquire these drugs illicitly  harm themselves. Ive done everything required to show I do not misuse/divert my medicine. Abusers dont care about the law  will just find another substance to abuse. I have my pride, I have never begged for anything but I BEG you. If not for me, please, for my children.", "comment_id": "DEA-2014-0005-0022", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0022", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Deborah", "commenter_lname": "Anonymous", "comment_length": 5126}, {"text": "I think this is a great idea.  I work with addicted adults and teenagers, and think this move will help put these drugs more out of their reach.  You will always get people who are addicted to any opioids, but the harder you make it to get them, the better.", "comment_id": "DEA-2014-0005-0033", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0033", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 257}, {"text": "As a practicing physician, pain medications are a powerful (yet potentially dangerous) tool to assist my patients. Unfortunately those choosing to divert medications to unintended uses dilute my ability to provide safe and effective treatment to patients.I am IN FAVOR of moving hydrocodone-containing medications into Schedule II drug category to: 1) allow me to continue providing safe and effective therapy where appropriate; 2) improve surveillance on appropriate prescribing, dispensing, and utilization of these medications; 3) improve law enforcement and judiciary support to licensed prescribing physicians; 4) providing law enforcement and judiciary with enhanced mechanisms to stiffle illegal prescribing, use, and diversion of hydrocodone-containing substances.Hydrocodone medications have been Schedule III drugs and despite that level of oversight, drug diversion has demonstrably and consistently increased. Drug diversion is a HUGE public safety issue and the Federal Government is tasked with provision of measures to protect US citizens; albeit sometimes from their own misadventures.In dispatching its Public Safety mandate, the US DEA must move hydrocodone into Schedule II.", "comment_id": "DEA-2014-0005-0028", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0028", "comment_date": "2014-03-04", "comment_time": "05:00:00", "commenter_fname": "Michael", "commenter_lname": "Elston", "comment_length": 1228}, {"text": "As a practicing community Pharmacist for 35 years, I cannot express strongly enough the negative impacts of this proposal upon the delivery of pain controlling medication to the public.Doctors will no longer be able to quickly and efficiently call in or fax in prescriptions or refills for the mostly widely used pain medications.I practice in a rural area.  Patients often have difficulty in physically picking up handwritten Schedule-II prescriptions from their physicians.Also bear in mind that the main alternative will become Tylenol with Codeine, the age-old standard.  However, researchers tell us that approximately 30% of the population are unable to efficiently convert the inactive drug Codeine into its active metabolite Hydrocodone, in the body.  This explains why many people tell us that Codeine doesnt work for me.Although this proposal may seem warranted to stem the tide of Hydrocodone abuse, it is far too drastic.  Such a draconian measure would be akin to restricting tire sales in order to decrease automobile traffic deaths.  It makes no sense.Please err on the side of practicality and necessity.  People need fast access to powerful pain medication when necessary.  Not red tape.  Consider that your own families will most certainly be affected by this.Regards,-Doug Wells, Registered Pharmacist", "comment_id": "DEA-2014-0005-0047", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0047", "comment_date": "2014-03-05", "comment_time": "05:00:00", "commenter_fname": "Doug", "commenter_lname": "Wells", "comment_length": 1422}]}, {"id": "CDC-2018-0085", "agency": "CDC", "title": "Partnership Opportunity to Identify Products for Fentanyl Exposure in Personal Protective Equipment Information Database", "update_date": "2019-04-01", "update_time": "10:19:41", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "For this partnership to be most successful, we need manufacturers who are willing to participate and commit to helping end users find appropriate personal protective products that align with current guidance around fentanyl exposure. The current guidance is unclear, and a small working group of manufactures and stakeholders should convene to provide clarity, especially around dermal protection (gowns and coveralls). The CDC has provided guidance around PPE, however in areas such as respiratory, dermal (gowns and coveralls) and eye/face protection, it is not clear as to which PPE would be most effective related to relevant identified PPE standards. I have heard input from manufactures indicating that there is confusion around risk layering (e.g., multiple layers of risk for each identified user group) and that it would be difficult to translate into a guidance tool. More work needs to be done to simplify the PPE selection and risk identification guidance process.  ", "comment_id": "CDC-2018-0085-0012", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0012", "comment_date": "2019-02-27", "comment_time": "05:00:00", "commenter_fname": "Jonathan", "commenter_lname": "Bihl", "comment_length": 978}, {"text": "Blauer Manufacturing Co. is interested in participating in this partnership opportunity.  Blauer is a producer of PPE certified to the NFPA 1994 standard for Classes 3, 3R, and 4.  Consistent with the Interagency Boards (IAB) guidance on fentanyl response, our suits are used by drug interdiction teams that target fentanyl production and milling operations.", "comment_id": "CDC-2018-0085-0019", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0019", "comment_date": "2019-03-28", "comment_time": "04:00:00", "commenter_fname": "Tom", "commenter_lname": "Ames", "comment_length": 363}, {"text": "RPB Safety would be happy to participate from a respiratory protection perspective.", "comment_id": "CDC-2018-0085-0016", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0016", "comment_date": "2019-03-28", "comment_time": "04:00:00", "commenter_fname": "Christopher", "commenter_lname": "Hughes", "comment_length": 83}, {"text": "CDC-2018-0085; NIOSH-319SAS Safety Corp. is willing to participate", "comment_id": "CDC-2018-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0002", "comment_date": "2018-10-19", "comment_time": "04:00:00", "commenter_fname": "Todd", "commenter_lname": "Zuella", "comment_length": 76}, {"text": "Hello,I am submitting on behalf of Draeger as we would like to participate.Regards,Jimmy Vo", "comment_id": "CDC-2018-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0004", "comment_date": "2018-11-09", "comment_time": "05:00:00", "commenter_fname": "Jimmy", "commenter_lname": "Vo", "comment_length": 121}, {"text": "3M Personal Safety Division would like to participate.", "comment_id": "CDC-2018-0085-0021", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0021", "comment_date": "2019-04-01", "comment_time": "04:00:00", "commenter_fname": "Donald", "commenter_lname": "Rust", "comment_length": 54}, {"text": "CDC-2018-0085; NIOSH-319    National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention Bolle Safety is willing to participate in this program for PPE for Fentanyl Exposure.  ", "comment_id": "CDC-2018-0085-0005", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0005", "comment_date": "2018-11-14", "comment_time": "05:00:00", "commenter_fname": "Bill", "commenter_lname": "Godfrey", "comment_length": 224}, {"text": "this certainly brings about corruption. if fentanyl is that dangerous, why is it allowed to be used in america. why isnt it simply banned. i think this invites corruption when govt allows private industry to make money off references set for those using fentanyl. better to just ban this pollution toxic chemicals from any use at any time in america. this is an invitation to corruption.shut it down.", "comment_id": "CDC-2018-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0003", "comment_date": "2018-10-19", "comment_time": "04:00:00", "commenter_fname": "Jean", "commenter_lname": "Ublieee", "comment_length": 415}, {"text": "DuPont, as a PPE supplier, is interested in participating with this partnership and continues to be committed to helping end users find appropriate PPE for protection from the hazards of fentanyl exposure.The currently posted CDC guidance for Fentanyl PPE is not clear.  It is suggested that a small working group of manufacturers and other stakeholders should convene to develop further clarity. This is specifically true for standards that reference dermal protection (gowns and coveralls) and eye/face protection.The current CDC guidance for Fentanyl PPE, especially the PPE grid, needs significant clarification. Directing use of NFPA 1999 and NFPA 1994 certified ensembles is not appropriate for the specific Fentanyl hazards to be addressed.  It is suggested that further work should focus on simplifying the PPE selection and risk identification guidance process.", "comment_id": "CDC-2018-0085-0013", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0013", "comment_date": "2019-03-21", "comment_time": "04:00:00", "commenter_fname": "Susan", "commenter_lname": "Lovasic", "comment_length": 920}, {"text": "Diane Redden, LION First Responders PPE Inc. Lion is very interested in participating in this conversation. LION believes that it is imperative that a responder wear an appropriate level of an NFPA certified garment for any opioid response. A third party tested ensemble serves to protect the responders in an ever changing threat.  ", "comment_id": "CDC-2018-0085-0017", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0017", "comment_date": "2019-03-28", "comment_time": "04:00:00", "commenter_fname": "Diane", "commenter_lname": "Redden", "comment_length": 343}]}, {"id": "CDC-2015-0112", "agency": "CDC", "title": "Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain", "update_date": "2016-03-23", "update_time": "08:54:58", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "My son died of a heroin overdose in 2014 that started with legitimate prescription use after an accident. He had a history of abusing drugs, yet the doctor was more than willing to prescribe him oxy until he was addicted, and then cut him off by yelling at him in the hallway of his offices that he was done with him. We are losing a huge part of a generation to this disease, and steps HAVE to be taken to stop the over prescription and careless prescription of these very dangerous drugs. This is a start. Please enact these very sensible guidelines. Thank you.", "comment_id": "CDC-2015-0112-0586", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0586", "comment_date": "2015-12-23", "comment_time": "05:00:00", "commenter_fname": "Jeri", "commenter_lname": "Paull", "comment_length": 563}, {"text": "My son Luke was polite, popular, multi-sport, all-star athlete. He was raised in a typical middle class home, we were very involved in our kids lives.  As a freshman catcher on his high school baseball team he was being scouted by colleges.  He had a wide network of friends, good morals and values, and  a great sense of humor. People would meet him and tell us what an exceptional youngman he was.  Then at 16, he suffered a serious sports injury, which required a meniscal transplant  and was prescribed painkillers. Seemingly overnight, he became one of the hundreds of thousands of teens in our country addicted to prescription (Rx) painkillers. His life CHANGED  SO DID OUR FAMILIES.  He went from being the person I described above to a stranger, the addiction devoured him and our family. It has been heartbreaking . He is 28 years old and now sits in a prison cell with a 17 year sentence ( as a non violent , never had a weapon or hurt anyone but himself) all related to his addiction to the pain killers which then became heroin. Our son is a smart, kind person he should not be in prison, along with so many other addicts. It all started with the pain pills and how freely the RX was written over and over again . I have included a picture of my son, because I want to remind you these are real people with real families  So many people are addicted to prescription painkillers that drug overdoses are now the leading cause of accidental death in America, surpassing car crashes. And Rx painkiller abuse has led to an increased use of an even more deadly, accessible, and cheaper opiate: heroin. Please do not allow the special interest groups to interfere with progress and saving lives.  I beg you to listen and do the right thingRespectfullyStacy Y WatsonMore folks effected by this epidemic  can be contacted at http://addictsmom.com/", "comment_id": "CDC-2015-0112-1247", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-1247", "comment_date": "2015-12-29", "comment_time": "05:00:00", "commenter_fname": "Stacy", "commenter_lname": "Watson", "comment_length": 1900}, {"text": "Dear Maam or Sir,My name is Katerina Showalter and I am writing in response to Docket No. CDC-2015-0112 to ask for a change in the guidelines for how doctors can treat people in pain who need access to treatments including opioids.I need your help. I need you to listen to pain patients. I need you to include language in the guidelines that recognize patients as individuals who need access to effective pain management options, including opioids, sometimes for long periods of time or at high doses. I have a life-limiting progressive disease called mitochondrial disease. It causes severe pain, getting worse as more and more organs and muscles are affected. Since the rapid progression of my disease, I have tried many pain management options and even go to pain Cognitive behavioral therapy, but I was only able to leave my house regularly once I started opiod therapy. This semester was my first time going to school in 2 years. I am finally able to live out my life outside my bed. I understand that many less severe chronic conditions dont benifit from opiod therapy, but when you write these regulations you are also hurting my life as well. I want to participate in the community and be out of my bed. In fact on opiod therapy ive been able to do intensive Physical therapy and improve my autonomic function. Im now standing for the first time in years. Please dont send patients like me back to our beds. Our diseases are killing us, we dont need one more obstacle to enjoying our lives outside of the hospital.  Our care is only supportive, please dont take away one of our only supports. Thank you for your interest in my well being. Included are pictures of me in the hospital on TPN and 2 months later with opiod therapy out visiting a lake. Sincerely,Katerina Showalter", "comment_id": "CDC-2015-0112-0282", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0282", "comment_date": "2015-12-17", "comment_time": "05:00:00", "commenter_fname": "Katerina", "commenter_lname": "Showalter", "comment_length": 1845}, {"text": "Society is really trained to deal with things that have a beginning and an end,Either you get better or you are supposed to die. You are not supposed to have something that goes on and on, like chronic pain.Patients report that their doctors often dismiss their pain and send them away without providing any other options.Pain is experienced individually and is more than just a physical symptom and is not always resolved by curing the underlying disease. A third of the nation experiences chronic pain. ... Its more than we pay as a nation on cardiovascular disease and cancer.An estimated 116 million adults experience chronic pain, much of it preventable.The nations health care system has largely failed Americans in pain and calls for a cultural transformation of the way in which the United States approaches and manages patients with pain. Chronic pain also is the most common cause of work loss and disability.Why Not Prevent Chronic Pain?While major efforts are underway to prevent heart disease and diabetes, preventing chronic pain remains an elusive goal.Serious, chronic pain affects at least 116 million Americans each year, many of whom are inadequately treated by the health-care system, according to a new report by the Institute of Medicine (IOM). Im shocked and surprised at the magnitude of [the problem].There is abuse that occurs when individuals are drug-seeking and abuse that occurs in that people who need pain medications may not have access because physicians wont prescribe or the state has regulatory barriers.Making matters worse is the media and political attention that has been devoted to painkiller abuse and addiction. Conversely, very little attention is given to chronic pain, which affects a far greater number of people. About 9.3% of the population has drug or alcohol problems serious enough to require treatment, while severe chronic pain affects at least one in three Americans. (And yet, two national institutes are devoted to the research of addiction: the National Institute on Alcoholism and Alcohol Abuse and the National Institute on Drug Abuse.Although prescribing of opioids has almost doubled  going from 3.2% of the population in 1988-94 to 5.7% in 2005-08  its not clear that this is out of line with the rise in pain in the population or that the drugs are going to the right people.Its extraordinary how many patients describe themselves as feeling like collateral damage in the war on drugs because of extraordinarily burdensome [requirements to get opioid medications].There Are Many patients who had been on a stable and effective low dose of medication for years were suddenly cut off by their doctors for no apparent reason.Many pain patients, in fact, are paying the price for a policy not designed for their benefit.Doctors said they prescribed less than they thought was appropriate because of fear that law enforcement was looking over their shoulder.The majority of people with pain use their prescription drugs properly, are not a source of misuse, and should not be stigmatized or denied access because of the misdeeds or carelessness of others.Ironically, while many people with pain have difficulty obtaining opioid medications, nonmedical users appear to obtain them far too easily.But the barriers to appropriate care go beyond the issue of painkiller misuse. There are only about 3,000 to 4,000 pain specialists in the entire U.S., which means that primary-care physicians, whose numbers are also dwindling and who are not educated specifically about pain, are left to treat most pain with little specific guidance about effective care. In medical school, students receive only a few hours at most of education on pain treatment.Meanwhile public and medical misperceptions are widespread about the nature of pain, its causes and the way it affects individual patients. Misinformation is fueled by the fact that comprehensive research is lacking, even on basic questions like how many people suffer from disabling chronic pain and how well existing drugs like opioids treat long-term pain.The most important message to get out is the concept of pain itself as a disease. The majority of primary care physicians do not agree with this even though there is overwhelming research in both humans and animals [showing that] pain causes damage to the nervous system. Its dangerous not to treat pain.People can Die from Chronic Pain. Therefore we must not take away the rights from People who suffer from Chronic Pain Daily to receive the Medications they need to Better Their Quality of Life!!! I Stand for All the People who live in Chronic Pain and have to be worried Day in and Day out weather theyll be able to get their Medications. This is a Travasty to those who suffer from Debilitating Chronic Pain! Keep us out of Pain! Its our right as People World Wide whom Suffer from Chronic Pain! Again dont take away our Right to Live a Quality Life or the Best We Can!Sincerely Yours,Fred Alegre", "comment_id": "CDC-2015-0112-0089", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0089", "comment_date": "2015-12-16", "comment_time": "05:00:00", "commenter_fname": "Fredric", "commenter_lname": "Alegre", "comment_length": 5097}, {"text": "Doctors and nurses and research scientists have no knowledge about what it is like to suffer from a chronic illness or to require opioid medication for chronic pain.  Do you think we actually like to take these medications, with all their side effects?  You want to limit the amounts our doctors can prescribe, and limit the amounts we can take because you worry we will become addicted and use the medications to get high.  But what you dont understand is that people with severe chronic pain never get high from these medications.  The pain-numbing effect of the medication gets all used up fighting the pain, and there is nothing left over to actually make us high.  I have fibromyalgia and chronic migraines, and I have taken hydrocodone for years, and never once have I experienced any kind of high from taking it.  A little drowsiness, yes.  A lot of constipation, yes.  But a drug induced euphoria?  Never.Please, reconsider these so-called guidelines.  Dont make it harder than it already is for doctors to treat their chronic pain patients.", "comment_id": "CDC-2015-0112-0199", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0199", "comment_date": "2015-12-16", "comment_time": "05:00:00", "commenter_fname": "Cyrynda", "commenter_lname": "Walker", "comment_length": 1105}, {"text": "I think it is absolutely ridiculous that the patients that actually need meds for chronic pain have to suffer because of all the drug addicts. I take tramadol and have already been made to drop down to half of my normal Rx. And I suffer everyday!!! I think Drs need to do their jobs and give us the meds that we need and actually monitor patients and do surprise drug tests and drug tests every time a patient has an appointment. And also do random pill counts. And if u r caught abusing even once then no more meds. Then it would be the patients fault that they have to suffer. I also really think that the increase in heroin deaths is because u guys are taking away pain meds from pts that need them. I think a pt that wouldnt normally ever do heroin is doing it because they need pain relief. Just my opinion. Please u cannot take all opiod pain meds away. I think if u do, then ur gonna have really bad results. I was in so much pain at one point and hadnt been put on pain meds yet and I tried to kill myself because I was in so much pain. Please dont make us all suffer because of all the addicts!!!!!", "comment_id": "CDC-2015-0112-0031", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0031", "comment_date": "2015-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1127}, {"text": "Im writing to comment on your proposed rules for prescribing opiates.  I would like you to know the experience my daughter had from age 18 to 25, when she was killed by a physician who performed an endoscopy without anesthetic, tore her throat and led her to aspirate on blood in her throat.My daughter had POTS and Ehlers Danlos Syndrome (EDS). The POTS made her vomit multiple times per day.  The EDS allowed her synovial joint in her chest to sublux resulting in excruciating and acute constant pain each time she vomited.  She also had other joints that subluxed at various times and unremitting migraines.  Because of this she had chronic and acute pain on an ongoing basis.  One particularly good summer after she had gone to London for treatment, she insisted on remaining opiate free the following fall.  She ended up remaining in bed from September through the end of December, undoing all of he therapy she had done in London.Prior to becoming ill my daughter was a straight A student, planning to attend college the next year, popular with both males and females her age.  She was known as a very happy young girl and teenager.  None of the above was typical of her until she became ill.  Without the help of a physician who knew her prior to becoming ill, and was willing to prescribe her opiates, she would not have functioned at all during what proved to be the last 8 years of her life.It would be one thing to remove opiates if you had something with which to replace them.  Something that would effectively manage pain.  But, you dont.  Even with opiates my daughter, and most EDS patients, utilize additional forms of pain management--meditation, cortisone shots,TENS units, heating pads, physical therapy, Tramadol, etc.  None of it really alleviates the pain from EDS, but the combination usually makes it bearable.  Bearable for many means able to live and sometimes participate in activities.  It often does not mean being able to hold down a job, even beloved jobs.  I choose to believe you really do not want to make people suffer that much.  By the way, never did the opiates make my daughter high and that is what I understand from other chronic pain sufferers.Yours truly,Elayne Baumgart, Ph.D.", "comment_id": "CDC-2015-0112-0203", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0203", "comment_date": "2015-12-16", "comment_time": "05:00:00", "commenter_fname": "Elayne", "commenter_lname": "Baumgart", "comment_length": 2293}, {"text": "I have to say that I have been in pain from Spinal Stenosis, sciatica and scoliosis for the last 14 years. I have been under an Orthopaedic Surgeons care along with a Pain Management doctor for most of that time. I have had four major back surgeries in the past two years to correct the issues with just my lower spine. I have never taken more medication than my doctor instructed. Im on Lyrica, Skelaxin  Percocet. I try every remedy before taking pain medication. Im told I will be on these meds for a long time because of the problems with my spine but my goal is to take a minimum of  any medication. Ive signed a contract with my primary care physician and receive my prescriptions just through her and receive them at one pharmacy. I dont feel the need to be policed. If there was something as effective as the Percocet I would happily change to it but for now it works best and I take very few of the minimum dose. I just dont want my choice taken away so that Im house bound. ", "comment_id": "CDC-2015-0112-0202", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0202", "comment_date": "2015-12-16", "comment_time": "05:00:00", "commenter_fname": "Patti", "commenter_lname": "Plante", "comment_length": 1019}, {"text": "I am 47 years old, I have health issues that cause me to use pain medications.  I have never had a problem with alcohol or any type of drugs in my life.  I have 4 children and a husband; a wonderful job and great friends.  I am on pain medication so that I can function.  I know that my life has changed and Ive come to the understanding that pain is my new normal so I dont expect to live without it.  I only hope to continue to have the opportunity to be able to have these medications available to me and help me when I cannot walk.  When I cannot stand, cannot go to the restroom, cannot shower myself, cannot sit down by myself and cannot take the pain.  No one expects that this to happen to their life; one day you are okay and the next you cannot move and you dont remember what it feels like to not be in pain.  Just like you the reader, I too have a family, a grandson Id love to carry.  School plays Id love to attend, vacations Id love to be on.  I dont want to take any medications.  I dont want to visit the doctor.  I dont want to be looked at as if I am a drug addict.  I dont want to deal with the harsh judgement  every time I walk into my pharmacy.  I dont want to be terrified that today I am able to work, but tomorrow what helps me work may be taken away.  How will I live and help support my family?  How will I do anything?  I dont have a record.  I follow rules.  I pay my bills.  I am a good person.  Must we really be treated this way because life has dealt us issues that have caused us to need pain medication?  Please stop and understand that all I want is to continue to be apart of life and amongst the living.  I dont want to just exist in my room being take care of.  I want to take care of me for as long as I possibly can.  Please know that I am a responsible person; I am human.  I am only asking that you allow my doctor to take care of me the way he sees fit.", "comment_id": "CDC-2015-0112-0032", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2015-0112-0032", "comment_date": "2015-12-15", "comment_time": "05:00:00", "commenter_fname": "K", "commenter_lname": "S", "comment_length": 1987}]}, {"id": "FDA-2018-N-0128", "agency": "FDA", "title": "Notice; Nicotine Steering Committee, establishment of public docket", "update_date": "2018-06-27", "update_time": "10:07:45", "purpose": "Nonrulemaking", "keywords": ["2017-1177"], "comments": [{"text": "I watched my sister die a miserable death due to smoking.  She was addicted as a teen and repeatedly tried to quit. She died at 49 years old.  Legal tobacco is nothing more than regulated murder.  The FDA can and should do everything in its power to provide every avenue to the citizens of this country to conquer their addiction to tobacco.  The only bar for a method of quitting should be whether the side effects of the method to quit are equally as bad as or worse than tobaccos effects, a very low bar, indeed.  ", "comment_id": "FDA-2018-N-0128-0027", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0027", "comment_date": "2018-02-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 532}, {"text": "It makes sense to me to require any tobacco product that is sold in the USA to have a non-addictive level of nicotine.  I realize the tobacco companies will not like this, but I think its time that we, as a nation, take the lead and take action to remove products that cause major health problems.  This will lead to a new generation of young people not smoking as much as prior generations, which will greatly lessen the burden on our health care system.  Maybe this cant be done all at once, but lets at least start with providing low nicotine products along side traditional products, then give the tobacco companies a deadline years out when all of their products must be low nicotine.  Also, it looks like the science backs using a low nicotine product to help cigarette smokers quit smoking.  Lets provide this as an option for people where other methods or drugs arent working.Its time we make history and take a stand on this very important issue!", "comment_id": "FDA-2018-N-0128-0054", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0054", "comment_date": "2018-03-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 995}, {"text": "Comments submitted by the Campaign for Tobacco-Free Kids.", "comment_id": "FDA-2018-N-0128-0313", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0313", "comment_date": "2018-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 57}, {"text": "Back in 1998 I had an embolism that completely filled one of my lungs. My doctor told me it was caused by smoking and that if I didnt quit the next time it would likely kill me. When I left the hospital I had a new companion, an oxygen tank that went with me everywhere I went, 24/7. I tried everything to quit, prescribed to home therapies, yet nothing worked so I continued to smoke knowing that some day I may not wake up. Then in 2009 my Dr removed my bad lung, and put me in a nursing home/rehab home, to recover and teach me How to live with only one lung. Problem was the home didnt allow smoking, so my Dr bought me an electronic cigarette to help me with my cravings, because he knew I had tried everything. It was the best thing that ever happened to me, I not only quit smoking cigarettes but before I left the nursing home they took me off of the oxygen too. My blood oxygen level went from 89% to 98% without oxygen. When people say vaping saved my life, I can say it and mean it completely. There is no doubt in my mind, if I had continued to smoke back then I would Be dead right now, instead of sharing this with you.", "comment_id": "FDA-2018-N-0128-0069", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0069", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1155}, {"text": "I started smoking around 14, neither of my parents smoked but I had an older sibling that was smoking and hiding it from them so I started doing the same. I had a few friends around my age who also smoked. By 16 I was smoking around a pack a day, buying them from legal aged individuals. I couldnt play sports or run anymore and by 19 I was smoking 2 packs a day and started having much more serious coughing and breathing issues. I ended up seeing my doctor who told me I had early onset COPD and that it was only going to get worse. I tried quitting multiple times between then and around 21 using gum and patches and pretty much anything else someone said would work, but none of those methods worked in the long term. I always ended up going back to smoking. I bought my first vape pen around 21 and decided Id give it a try since I had tried almost everything else and stuck with it for a few months, but my device was extremely fragile and first generation technology so inevitably, it broke. Once it did I went back to smoking for a few more months but I then had a friend of mine show me his new vape device and it outperformed my old device 10 fold. The next day I went and bought the exact same one and threw out my cigarettes. From that point forward I havent picked up a cigarette since. I started with the highest nicotine possible and worked my way down to the lowest available. During that time I actually picked up running again, doing quite a few races with my older brother. My cough is completely gone and at my last check up my doctor actually told me that I didnt show any signs of ever being a smoker or having any COPD related issues. I breathe better and so does my family. I recently had a son who I never would have been able to keep up with or spend as much time with without this experience, not to mention the issue of second hand smoke which wouldve probably kept me from trying to have him in the first place. My entire life is better and its due in large part to vaping and how it helped me quit smoking when all other options failed miserably. Its difficult for me to think about being in my late 20s now having COPD or, even worse, cancer, but those were the only two ends I saw to the path I was on. My hope is that this same option that changed my life for the better will be around and available to someone who has a similar story as I do. Someone who is desperate for a better solution after trying all the others should be afforded that right.", "comment_id": "FDA-2018-N-0128-0088", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0088", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2522}, {"text": "I started vaping 3 years ago when my 3 year old daughter begged me to quit smoking so I wouldnt die like her grandfather. so I said I would try to quit. I had a friend that Vaped and said I should try it so I bought a ego pen expecting it not to work I think I half hoped it wouldnt work because I didnt want to quit smoking but I gave it a shot the pen held off the cravings for  a while but when I got a open system device is when I really started enjoying vaping now I can breathe better taste my food the way its supposed to taste and just better life all because my child was smart enough to know that vaping had to be better than smoking so if I can quit with vaping anyone can", "comment_id": "FDA-2018-N-0128-0096", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0096", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 703}, {"text": "I have been vaping for a little over a year now. I started smoking when I was 11, and quitting smoking and vaping has saved me! I have saved a lot of money, and feel so much better! I can taste and smell better.  I can breathe and not get out of breath so quickly walking! I also recently got my sister to vape, although she still smokes a few cigarettes now and then, she can breathe so much easier! She has COPD, and emphyzema from smoking, and has noticed a big difference in her breathing! ", "comment_id": "FDA-2018-N-0128-0167", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0167", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 494}, {"text": "I started smoking at the age of 13. By the time I was bombed in Iraq and medically retired for injuries after 9 years of service I was smoking up to 5 packs a day of cigarettes. I started vaping to save my life and prolong my time with my wife and children. I have been vaping for 5 years now and havent touched a single cigarette since my first month starting. I know for a fact if I wasnt able to vape, Id be back to smoking cigs. Please reconsider your thoughts and actions towards this wonderful life saving ade. If I could do it then anyone can. Why should our nation be emphysemic and cancerous? Why should our children be forced to live under the roof of a heavy smoker as mine did, potentially causing internal damage to them over a ignorant action of adults? Theres no reason for this. The life saving ade is here now! Thousands upon thousands of people have discovered it and are now living active and healthier lifestyles. Why take that away from the millions still suffering? Please, please reconsider this.  ", "comment_id": "FDA-2018-N-0128-0267", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0267", "comment_date": "2018-04-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1041}, {"text": "My father died due to lung cancer from smoking for 40+ years. I started vaping due to smokers cough and within three weeks of vaping i no longer had the cough. I strongly beleive that vaping is saving my life. I have more energy now than I did with smoking and feel 100% better.", "comment_id": "FDA-2018-N-0128-0285", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0285", "comment_date": "2018-04-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 278}, {"text": "Hello my name is Robert Postlethwait.i started smoking at the age of 18. since i started smoking i found that i enjoyed it, like i loved to smoke cigarettes. when i turned 33 i found i was having trouble breathing, my side of my body hurt real bad, i was having uncontrolable coughing fits. i started snoring while sleeping. then i found vaping and i have been vaping for the last 2 years and my side quit hurting i dont have coughing fits anymore. i can breath so much better now. i am healthier today because of vaping. now i enjoy vaping. my doctors told me if i stayed on my current path that i would die a young man. after vaping for 2 years i have been given a clean bill of health. please dont take vaping away", "comment_id": "FDA-2018-N-0128-0086", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0128-0086", "comment_date": "2018-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 732}]}, {"id": "FDA-2019-P-0114", "agency": "FDA", "title": "Request that the FDA make a determination that  Ketamine Hydrochloride Injection, 200 mg/2mL (100 mg/mL) is suitable for submission as an ANDA", "update_date": "2019-02-08", "update_time": "10:42:55", "purpose": "Nonrulemaking", "keywords": ["Pfizer Innovative Health", "determination that  Ketamine Hydrochloride", "200 mg/2mL (100 mg/mL)", ") is suitable for submission as an ANDA", "OPEN", "OPEN", "CDER-OGD", "Hospira Inc.", "Pfizer Innovative Health", "determination that  Ketamine Hydrochloride", "200 mg/2mL (100 mg/mL)", ") is suitable for submission as an ANDA", "OPEN"], "comments": [{"text": "I listened to President Trump speech tonight on TV   Please congress fund the wall,   help our president protect America.  thank you for your service.", "comment_id": "FDA-2019-P-0114-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-0114-0003", "comment_date": "2019-02-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 170}]}, {"id": "HUD-2006-0169", "agency": "HUD", "title": "FR\u20134887\u2013A\u201301\r\nAccelerated Claim and Asset Disposition (ACD) Program; Advance Notice of Proposed Rulemaking ", "update_date": "2021-01-07", "update_time": "01:11:33", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Suggestions:1)  Do NOT utilize the standard HUD liquidation claim form.  Create a new claim form for the specific purpose of ACD;2)  Treat the process more like a service transfer from a servicers standpoint....require a P  I claim simultaneous with the service transfer and then a second claim for reimbursement of escrow and corporate advances and fees associated with the ACD claim within a 60 day time period.  This will avoid supplemental claims;3)  Change the order/timelines....for example:  preliminary approval with a claim  service transfer within 60 days, submit P  I claim with simultaneous service transfer, prepare the advances/reimbursement/2nd claim within the next 60 days.4) Far too many HUD contractors with conflicting opinions.  Reduce/eliminate to one or two contractors, especially for purposes of documentation breaches.  Eliminate the requirements to send multiple copies to multiple contractors, i.e., shipment of docs required multiple notifications to various contractors.5) Generally, speed the service transfer time so as to not make the servicer responsible for potential servicing errors during the holding period.  Under the current format, a loan may not be transferred for months after claim and claim payment, but during that period, taxes and insurance becomes due, thus requiring payment and supplemental claim(s).Comment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0002", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0002", "comment_date": "2006-07-05", "comment_time": "20:39:40", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1517}, {"text": "The ACD program proved to be ineffective for Bank of America as only 4 loans during the demonstration period feel into the criteria.  Althought submission of loans happened every month, the first loan was always denied for provisional approval.  We are also having issues with new servicer requesting reimbursement for the participation fee Bank of America made on these loans for participating.  I believe this program would be more succesful if the criteria was broadened. Comment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0004", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0004", "comment_date": "2006-07-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 538}, {"text": "Here is our response concerning HUD-2006-0169-0010Comment on FR Doc # E6-15285", "comment_id": "HUD-2006-0169-0012", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0012", "comment_date": "2006-10-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "Docket No FR-4887-A-01Response from Midland Mortgage CoComment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0007", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0007", "comment_date": "2006-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 103}, {"text": "I.  Vacant Properties ? Section II. 1. (1) States, ?Mortgagees that elect to file claims on certain defaulted mortgages (such as vacant homes) would be required to submit the mortgages for assignment and payment of a claim pursuant to the ACD program?.  Question ? If a loan in foreclosure is found to be vacant does it automatically get submitted into the ACD program? If the above mentioned defaulted mortgages are not submitted will it jeopardize the conveyance claim post foreclosure? II.  Specified Eligibility Criteria ? Section II. 1. (2) Discusses eligible mortgagees (such as Chase) would be permitted to submit other types of defaulted mortgages that meet specified eligibility criteria. Question ? Please define other.  Would existing eligibility criteria change?III.  Multiple Servicers ? Section II. 2.  This section discusses the possibility of offering transferred loans to multiple servicers.  Question ? This could lead to reporting problems.  Would whole batches still go to one servicer and change from batch to batch?  Would a batch of loans be divided amongst various servicers?IV.  Other Alternatives ? Section II. 3. States, ?Another alternative would be for HUD to transfer the servicing of the loan to a servicer who would be responsible for servicing, foreclosing, and selling the assets?. Question- Please expand on this comment. Would loans in foreclosure be required to be transferred simply for the completion of the foreclosure?  Would this be an open bidding process for all P-Servicers, could Chase acquire loans from other servicers just to perform the foreclosure?V.  Control population results.  Over the last four phases there has been a control population excluded from every batch.  The purpose was to compare the control population with loans in the program to see if they cured the default through traditional measures as opposed to being part of the ACD program.  Question - Are any results from this study available?VI.  Will there be contract periods and commitments by the Lenders similar to the current practices?VII.  What kind of penalties will be involved for nonparticipation or not meeting quotas?Comment on FR Doc # E6-08637General Comment:I.  Vacant Properties ? Section II. 1. (1) States, ?Mortgagees that elect to file claims on certain defaulted mortgages (such as vacant homes) would be required to submit the mortgages for assignment and payment of a claim pursuant to the ACD program?.  Question ? If a loan in foreclosure is found to be vacant does it automatically get submitted into the ACD program? If the above mentioned defaulted mortgages are not submitted will it jeopardize the conveyance claim post foreclosure? II.  Specified Eligibility Criteria ? Section II. 1. (2) Discusses eligible mortgagees (such as Chase) would be permitted to submit other types of defaulted mortgages that meet specified eligibility criteria. Question ? Please define other.  Would existing eligibility criteria change?III.  Multiple Servicers ? Section II. 2.  This section discusses the possibility of offering transferred loans to multiple servicers.  Question ? This could lead to reporting problems.  Would whole batches still go to one servicer and change from batch to batch?  Would a batch of loans be divided amongst various servicers?IV.  Other Alternatives ? Section II. 3. States, ?Another alternative would be for HUD to transfer the servicing of the loan to a servicer who would be responsible for servicing, foreclosing, and selling the assets?. Question- Please expand on this comment. Would loans in foreclosure be required to be transferred simply for the completion of the foreclosure?  Would this be an open bidding process for all P-Servicers, could Chase acquire loans from other servicers just to perform the foreclosure?V.  Control population results.  Over the last four phases there has been a control population excluded from every batch.  The purpose was to compare the control population with loans in the program to see if they cured the default through traditional measures as opposed to being part of the ACD program.  Question - Are any results from this study available?VI.  Will there be contract periods and commitments by the Lenders similar to the current practices?VII.  What kind of penalties will be involved for nonparticipation or not meeting quotas?", "comment_id": "HUD-2006-0169-0003", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0003", "comment_date": "2006-07-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4715}, {"text": "Docket No. FR?4887?N?02 and title, HUDS ACCELERATED CLAIM AND ASSET DISPOSITION (ACD) PROGRAM; REOPENING OF PUBLIC COMMENT PERIOD .Bank of America is opposed to this ruling as it didnt prove to be beneficial.  The criteria was so strict that we only had 4 loans that actually were accepted as the first item submitted was always thrown out. Comment on FR Doc # E6-15285", "comment_id": "HUD-2006-0169-0011", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0011", "comment_date": "2006-09-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 426}, {"text": "Make participation voluntary and increase the incentive to participate.The claim filing process is extremely complicated.  Consider reducing the logistal difficulites associated with claim fling by allowing claims to be filed through HUD Connection.  Remove the requirement to isolate and recover advances pre and post approval date.Comment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0005", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0005", "comment_date": "2006-08-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 396}, {"text": "Amended response from Midland Mortgage Co re: Accelerated Claim and Asset Disposition (ACD) Program; Advance Notice of Proposed Rulemaking; Propoposed RuleComment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0008", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0008", "comment_date": "2006-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 203}, {"text": "August 3, 2006 Regulations DivisionOffice of the General Counsel, Room 10276Department of Housing and Urban Development451 Seventh Street, SWWashington, DC 20410-0500RE:  24 CFR Parts 203 and 291, Docket No. FR 4887-A-01; HUD-2006-0007 Accelerated Claim and Disposition ProgramDear Regulations Division:Thank you for the opportunity to comment on the Department of Housing and Urban Development?s Accelerated Claim and Disposition (ACD) Program proposed rule.  The Georgia Housing and Finance Authority (GHFA) has enjoyed a long and rewarding relationship with HUD and FHA.  As a State Housing Finance Agency (HFA) we share a similar mission with HUD, as does every state HFA, in that we work to help low and moderate income families achieve the American Dream of affordable homeownership.  The state HFA?s thank FHA for working with us over the last two years by being available to us and by listening and responding to our concerns.  You have proven to be a wonderful partner as we work together to meet our shared mission.In the request for comment on the proposed rule, you ask for comments on specific topics relating to the ACD Demonstration program.  As such, you specifically ask for comments from program participants.  The questions you ask in the request and the issues raised in the ?Third Report, Evaluation of 601 Accelerated Claims Disposition Demonstration? document dated February 17, 2006 can certainly best be addressed by program participants.  Therefore, we will address more global issues that we feel would add value to the program and prove to be not only cost effective for FHA but also add value to the FHA program for HUD and program participants, specifically state HFA?s.Regulations DivisionPage TwoAugust 3, 2006First, we feel that the ACD program can do more for FHA then just provide a cost effective means of managing foreclosure costs.  Implementing the ACD program should provide a cost savings to those of us who service FHA insured loans.  It also simplifies an area of frustration for many small servicers.   This coupled with FHA?s initiatives in recent years to simplify your program, could assist in increasing FHA?s market share.In Georgia, we estimate that by participating in the ACD program, we would recognize a cost savings sufficient enough to pass on to our customers in the form of lower interest rates.  While we already provide below market interest rates to low and moderate income families purchasing a home, any opportunity we have to further reduce our costs will be passed on to our customers.  This is consistent with our mission as well as FHA?s mission.  State HFA?s feel that our customers are our partners for the life of their mortgage.  Consequently, we try to the best of our ability to keep people in their homes and only foreclose when we have exhausted all available loss mitigation options.  We help fund an extensive counseling network throughout the state.  We require pre-purchase counseling for people who receive down payment assistance from us.  We also fund these same agencies for post-purchase counseling as another means of helping people stay in their homes and avoiding foreclosure.  Therefore, it was with great interest that we read in the ?Third Report, Evaluation of 601 Accelerated Claims Disposition Demonstration document dated February 17, 2006, page 10, fifth paragraph? that ?The JV servicer has a broader range of loss mitigation options, including restructuring the loan amount below the original UPB.?  We feel this is an excellent tool for both FHA and the borrower.  Additional loss mitigation tools should afford more people an opportunity to stay in their homes who otherwise could become homeless.  The additional loss mitigation tools and the use of highly trained professionals who specialize in working with delinquent borrowers will not only help keep more people in their homes, it will also help reduce the number of foreclosures which will reduce FHA?s costs.  It should also allow for a more consistent application of FHA loss mitigation to a larger population of FHA insured loans.  State HFA?s are particularly excited about this part of the program as our customers tend to live pay check to pay check and our participation in the ACD program will afford residents of our states more opportunities to save their homes when they encounter financial hardships.  Regulations DivisionPage ThreeAugust 3, 2006Ideally, all state HFA?s will be afforded the opportunity to participate in the ACD program.  If however, FHA decides to further test the ACD program prior to implementing it nationwide, we feel that at least one state HFA should be a program participant.  Georgia Housing and Finance Authority would like to be the participant representing state HFA?s.  Our participation would allow a sample of HFA borrowers to be part of the population being analyzed to determine how best to implement the ACD program.  This is, in our opinion, critical as HFA borrowers tend to have lower incomes then the average FHA insured borrower and most are first time home buyers.We look forward to learning how FHA decides to proceed with implementing the ACD program.  This is an exciting program that we feel will provide significant cost savings to FHA and state HFA?s who service FHA insured loans.  We also feel the program will provide further opportunities for our borrower?s to overcome hardships and possibly retain their homes.Sincerely,Philip C. Cottone, DirectorOffice of HomeownershipComment on FR Doc # E6-08637", "comment_id": "HUD-2006-0169-0006", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2006-0169-0006", "comment_date": "2006-08-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 6715}]}, {"id": "TTB-2016-0010", "agency": "TTB", "title": "Wine Treating Materials and Related Regulations", "update_date": "2022-08-24", "update_time": "09:03:35", "purpose": "Rulemaking", "keywords": ["alcohol", "wine", "recordkeeping", "wine treating materials", "fruit juice", "additives"], "comments": [{"text": "John Skrip IV4/16/18After reading the proposed regulation amendments made by the TTB to change the classification of some wine additives I have a few comments and concerns.  The first of which being the use of spinning cone and ultrafiltration in conjunction with the reduction of alcohol concentration (page 83757 column 3 and page 83758 columns 12).  My first concern is that although it is stated that TTB also is proposing to place nanofiltration, ultrafiltration, and reverse osmosis under the umbrella term cross flow filtration.  Although this sounds all well and good My first question is on the clarification of whether or not a spinning cone used to reduce alcohol content will still require a distilled spirits premises.  Although this is merely a suggestion I would recommend clarification of the issue within the proposed changes.   I would recommend the possible addition of a clause that would allow for winemakers to use a spinning cone to reduce alcohol concentration within their winery without a distilled spirits premises.  This would require some regulation for the disposal/destruction of the high proof removed from the wine; however, I believe that If done properly It would allow for more people within the industry to have greater control over the final product that they ship out.  This could result in higher quality and continued growth of the industry.One of the other Items I would like to comment on is the use of Alcoholic Oak extract for use in Wine (page 86731 column 2-3).  Although I generally believe that using an extract such as this detracts from the individuals who take the time to age in barrels or with oak substitutes I believe that the use of Alcoholic Oak extract may be beneficial to smaller wineries who do not have the time or capital to age wine.  That being said I believe that some middle ground can be reached.  I believe that in order to help consumers differentiate between genuine oak aged products and those made with extract a statement on the label should be displayed.  If these new extracts are used there should be some form of Identifier such as made using alcoholic oak extract. In doing this the TTB could protect their consumers from false advertisement and give their producers a way to promote their product all at once.The last regulation change I feel the need to comment on is the practices involving accidental water additions (page 83759 coulmns1-3).  Although I do see how not requiring TTB authorization to salvage wine which has been accidently added to water would be quite beneficial to producers by speeding up production I see a major flaw.  The way in which the regulation is worded, Proposed  24.251 sets forth authority and standards to allow for removal of accidental additions of water of not more than 10 percent of the original volume of the wine without the need to first seek TTB approval,  seems as if it would be perfectly fine; however, I can see It being abused by winemakers to fortify wines.  By using the method of reverse osmosis to salvage wine anyone who felt like not playing by the rules could distill slightly past the original concentration.  With no record of this there would be no red flags at the regulatory agencies and customers would be none the wiser.  I truthfully believe that this would be a non-issue, but on the other hand I still think that there should still be a reporting to the TTB in a formal capacity to make sure that nobody takes advantage of this new regulation.In all I believe with some minor adjustments the proposed regulations would be generally beneficial to the industry as a whole.  The reclassification and addition so new additives will make commercial scale production much simpler without approval for use of these new additives by the TTB on a case by case basis.", "comment_id": "TTB-2016-0010-0036", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0036", "comment_date": "2018-04-17", "comment_time": "04:00:00", "commenter_fname": "John", "commenter_lname": "Skrip", "comment_length": 3919}, {"text": "In regard to:  Reverse Osmosis To Enhance the Phenol Flavor and Characteristics of Wine and To Reduce the Water Content of Standard Wine.I oppose this suggestion by Constellation Wines, the worlds largest wine producer. First, I will address the inaccurate and misleading statements that the Notice attributes to Constellation.1. as a product of the reverse osmosis process, it is considered to be standard wine but with reduced levels of alcohol and water.First, under current regulations, it is NOT considered a standard wine if it has been concentrated by RO. This is a mistake. Yes, standard wine processed by RO in certain ways (to reduce alcohol or VA for example) results in standard wine. But wine concentrated, which is prohibited, is, by definition, not standard wine.Second, it is simply inaccurate to state that RO concentration will result in reduced levels of alcohol and water. Think about the bit of physics-defying magic being claimed here! A 14% alcohol wine is ~1% solids, 14% alcohols, and 85% water. How can the retentate have less of both alcohol and water? It cannot. Reverse Osmosis (Along with NF) cannot reduce both. They pass water preferentially to alcohol and thus reduce water, while concentrating (increasing) alcohol in the wine. RO and UF membranes pass from 35% to 75% of the alcohol into the permeate. Therefore, the alcohol in the retentate, ie, wine is INCREASED. And it is increased considerably, up to several % by volume. These facts are well documented. You could further consult with the companies who are experts in RO and Wine and/or our fine faculty at Enology  Viticulture programs such as Roger Boulton at UC Davis. 2. the petitioner asserts that many foreign countries permit the use of reverse osmosis as an acceptable winemaking practice to concentrate phenols and flavors in wine and in grape must and The expanded use of reverse osmosis would provide winemakers with better ability to regulate the alcohol content of wines. Regulate the alcohol content of wines? How? Well, upwardly only. Concentrating by RO or NF can ONLY raise alcohol and cannot lower it. Also, it is simply incorrect to say that unnamed foreign countries allow it. Surely the TTBs international liaisons can easily dispel this. But in case one is uncertain, page 113 of Jamie Goodes The Science of Wine states it clearly. MUST may be concentrated in some jurisdictions, but wines may not. Not in the OIV. Not in any major wine producing country. The notice later claims that in cold and wet parts of the EU, low quality wine may be concentrated. This is not true. In cold and wet areas MUST may be concentrated and resulting wine labeled table wine. But wine may not be concentrated. Same in Australia, where it is prohibited to concentrate wine. 3. This regulation does not subject Constellation or anybody else to unfair competition. As it stand currently, wines concentrated by RO may not be sold in any major market, including the US. They may not be produced in any major market, including the US. This isnt unfair, its parity. So, why is this practice which Constellation wants permitted so universally reviled? Because it concentrates alcohol, acids and aromas. It does so in unpredictable manners and results in odd, unbalanced wines. NF does the same. In fact, only UF allows those things (alcohol, acids and aromas) to pass, concentrating only phenolics, color, and body. The current regulation allowing only UF and prohibiting RO and NF for wine concentration is sound and internationally recognized. IMHO, this rule change would should be denied.", "comment_id": "TTB-2016-0010-0014", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0014", "comment_date": "2017-01-25", "comment_time": "05:00:00", "commenter_fname": "Dr. robert", "commenter_lname": "Kreisher", "comment_length": 3834}, {"text": "Wine has been produced in our country since before the signing of the Declaration of the Independence. In 2017, the National Association of American Wineries estimated the national economic impact of the wine industry to be approximately $219 billion between purchases, supplying, tourism and secondary impact. As such a large business in the U.S., it is essential the policies put forth to regulate it allow for continued growth and promote production efficiency while also maintaining quality. In regards to proposed amendments on ultrafiltration, extending this practice to separate discolored white wine for blending would be acceptable in good commercial practice. While the nuances for treating and creating red and white wine can vary greatly, allowing for ultrafiltration to be used to separate white wine would give the producer a greater control over the wine they are producing, allowing for the possibility of more product variety in the market. The use of reverse osmosis to alter wine characteristics should be allowed under federal regulation for several of the reasons stated in the proposed rule amendments. First, reducing the water content of standard wine would allow for wine producers to use more grapes in the making of their product. Purchasing more grapes as a result of this use would benefit grape growers. Including less water in the production of wine would also inherently increase the flavor of wines other ingredients and characteristics. Secondly, while America is the fourth largest wine-producing country in the world, not allowing for reverse osmosis to be used for flavor enhancement and water content regulation does put U.S. winemakers at a disadvantage. While the EU allows for this practice in only some regions, it is still occurring. And although Australia, for example, does not officially recognize the practice, it is still authorized and used. Completely not allowing reverse osmosis to be used in these circumstances prevents U.S. wine from reaching its full potential. These two proposed amendments alone allow for winemakers to have a greater control of their product, while also increasing the U.S.s ability to produce the best wine possible on the national and global stages. ", "comment_id": "TTB-2016-0010-0029", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0029", "comment_date": "2018-04-05", "comment_time": "04:00:00", "commenter_fname": "Coleman", "commenter_lname": "Reardon", "comment_length": 2373}, {"text": "I ask your attention to highlight, Flower  Botanical Wines in an effort to preserve historical methodologies, and treatments in Winemaking, and a vision to establish a broader market and diversity of winemaking consistent with good commercial practice.Thank-you for your time  considerationThis Comment refers to Page 83753 of Docket No TTB-12016-0010Add: flowers or botanicals to the definition of EssencesAdd: Below other wine Line (2) to read: wine made by blending wines or CO-FERMENTING Flowers with Fruits, or Juice24.218   Other wine.(a) General. Other than standard wine not included in other sections in this subpart are considered other wine. Those wines considered to be other wine include:(1) Wine made with sugar, water, or sugar and water beyond the limitations prescribed for standard wine.(2) Wine made by blending wines produced from different kinds of fruit.(3) Wine made with sugar other than pure dry sugar, liquid pure sugar, and invert sugar syrup.(4) Wine made with materials not authorized for use in standard wine.", "comment_id": "TTB-2016-0010-0012", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0012", "comment_date": "2017-01-24", "comment_time": "05:00:00", "commenter_fname": "Samantha", "commenter_lname": "Hunter", "comment_length": 1190}, {"text": "1.Limits of use of L(+) tartaric acid:US notified regulatory amendments concerning the use of L(+)tartaric acid including levels of use not exceeding good manufacturing practices (GMP) on the ground that it is generally recognized as safe in food. On the other hand, the European Union (EU) and the International Organization of Vine and Wine (OIV) both authorize the use of L(+)tartaric acid with limits respectively of 2,5g/l and 4g/l. These limits are justified by the assessment made by JECFA fixing the acceptable daily intake (ADI) is between 0 and 30mg/kg of body weight. Adding an excess of L(+)tartaric may modify the natural and essential characteristics of the wine which may come in breach of the Article 80(3)(d) of Regulation No 1308/2013 stating that oenological practices shall allow the preservation of the natural and essential characteristics of the wine and not cause a substantial change in the composition of the product concerned.For these reasons EU is of the opinion that a simple reference to GMP does not guarantee to meet the standards on health and quality set in the relevant EU legislation for EU consumers.2. Accidental addition of water:US notified regulatory amendments concerning the limit of 10 percent of accidental addition of water triggering the need to first seek for TTB approval before its removal from wines using reverse osmosis or distillation.It is useful to recall that the EU-US agreement on wine foresees in its article 3 that the term wine shall cover beverages which contain no added water beyond technical necessity and that EU considers adding water intentionally to wine products as fraud. Furthermore, in EU, any addition of water for facilitating the solution or dispersion of oenological products must be reported in a register held by the producer.For these reasons EU is of the opinion that any accidental addition of water should be reported to the competent authority and duly recorded even if it is in the context of its subsequent removal. Still on the accidental addition of water, the blending of a watered wine with a non-watered wine is not considered by EU as an acceptable solution to reduce the proportion of added water within the limit of 1%, this limit being accepted only in the context of the addition of water for facilitating solution or dispersion of oenological products. EU would like to precise that contrarily to what is stated in the notice, concentration techniques including reverse osmosis are allowed in EU for the enrichment of musts used to produce any category of wine under the conditions referred to in Annex VIII(I)(B)(1)(b) to regulation (EU) No 1308/2017.", "comment_id": "TTB-2016-0010-0030", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0030", "comment_date": "2018-04-05", "comment_time": "04:00:00", "commenter_fname": "Jesus", "commenter_lname": "Zorrilla", "comment_length": 2758}, {"text": "In reference to Diammonium Phosphate (DAP) additions as a nutrient required by yeast to complete fermentation:  The current legal addition limit is 8lbs/1000gallons.  There are multiple studies that show that a minimum YAN of 250-350 ppm is required to finish fermentation.  Making wine in Washington and Oregon, it is a commonly known fact that many to most of the grapes that come into the winery yield yeast assimilable nitrogen (YAN) levels of 0-100 ppm.  DAP provides 22 ppm of YAN for every pound per thousand gallons added to the juice.  With a legal limit of 8#/1000 gallons, that only brings the YAN addition to maximum increase of 176 ppm, which for many areas of the country is not enough nutrient for fermentation to be completed.  Since TTB is currently evaluating changes and ammendments to the current additives, Id like to propose that the legal limits for Diammonium Phosphate (DAP) be reevaluated to consider an increase in the legal addition limit to 15#/1000 gallons (=330ppm YAN), or something in that ballpark, that enables winemakers to get nutrients into the appropriate level for healthy fermentations.", "comment_id": "TTB-2016-0010-0002", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0010-0002", "comment_date": "2016-11-29", "comment_time": "05:00:00", "commenter_fname": "Heather", "commenter_lname": "Nenow", "comment_length": 1152}]}, {"id": "FDA-2011-D-0771", "agency": "FDA", "title": "Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments", "update_date": "2017-12-12", "update_time": "10:34:17", "purpose": "Nonrulemaking", "keywords": ["cder2011165", "CDER", "Blueprint", "Opioid"], "comments": [{"text": "Quest Diagnostics Incorporated appreciates the opportunity to assist the U.S. Food and Drug Administration in developing the Blueprint for Prescriber Continuing Education Program. Quest Diagnostics is the worlds leading provider of diagnostic testing, information and services that patients and doctors utilize to make better health care decisions. With over 25 years of experience in toxicology testing, we perform over nine million urine drug tests (UDTs) annually across our network of four certified laboratories. UDT is well-established and recommended as an effective tool in pain management and prescription drug monitoring by numerous provider and patient organizations as well as the Federation of State Medical Boards and the Department of Veterans Affairs. We agree that prescribers should be knowledgeable about the need for UDT as a valuable tool to enhance patient safety, ensure appropriate patient access to prescribed drugs, and to help curb the prescription drug abuse and misuse epidemic. Taking into consideration the increasing rate of unintentional drug overdose and death due to prescription drugs, the Blueprint should incorporate UDT four times a year or more as appropriate.Please contact me to further discuss the issues raised in this letter with the goal of improving patient care: Faith Cristol, 202-263-6260, faith.a.cristol@questdiagnsotics.com. ", "comment_id": "FDA-2011-D-0771-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0030", "comment_date": "2011-12-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1400}, {"text": "I am a pharmacist in Fredericksburg, VA and in the past 2-3 years have seen an explosion in inappropriate prescribing of controlled substances.  I am wondering why this blueprint is focusing only on long acting narcotics and not all controlled substances? I was recently a witness for the Virginia Board of Medicine in a case where a doctors license was revoked for inappropriate prescribing. As I speak with doctors on the phone when I am verifying controlled prescriptions, I realize many offices have no real procedures in place to prevent addiction and illicit distribution. First off, a signed pain contract must be in place for each patient and if they deviate, the doctor has every right to discharge the patient. Previous medical records must be verified! It is not difficult today to falsify or use someone elses records.  Personally, I would only accept records from a previous physician directly after contacting them myself.   I would not accept records handed to me by the patient.  If records can not be attained for a valid reason, the prescriber must perform an exam and any testing needed to confirm a diagnosis. PMP reports are also essential and must be done on every office visit... but be aware... patients now know about PMP reporting and will do whatever necessary to make sure their report looks acceptable.  They will travel to different states because right now state PMP websites are not linked and you can only view one state at a time. Also, healthcare professionals must register separately for each state. Another way to deceive PMP reporting is to use multiple false names and dates of birth by obtaining false state identification cards. Finally, urine testing and bloodwork should be done to confirm substance use and also detect any illicit substance use. Please contact me if I can offer any additional information because I deal with this issue on a daily basis... wesandlorimilton@comcast.net", "comment_id": "FDA-2011-D-0771-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0003", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1980}, {"text": "REMS are the latest in a series of oh my God we have to do something  proposals that have no scientific evidence behind them that they work.  Just as just say No, and DARE to keep kids off of drugs were massive failures because no one did any research to see if they would work to solve the problem they were aimed at, we spent billions of dollars on failed ideas.  There is a general consensus that education on utilization of these medications would be helpful, however, the particular design and pervasive nature of REMS has no scientific basis whatsoever.  It makes more sense to do some preliminary studies to help determine what types of educational approaches will work and then proceed with implementation.  Add to the mix complexity in the approach by combining more than one medication into a specific REMS, and you may end up with something that does not work at all. We already have seen that Actiq, Fentora, Abstrall, (and one other drug I cannot recall) have been lumped into one REMS, without any study as to whether putting these drugs together will be helpful or not.  I am a strong supporter of education, however, it must be done in the right manner and with the right basis or we will end up with a bunch of very expensive, dust gathering documents with no help for solving the problem at hand.Richard G. Harris M.D.   Pain Management", "comment_id": "FDA-2011-D-0771-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0010", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1388}, {"text": "Docket No FDA-2011-D-0771As Deputy Medical Director for Addictions for the Stewart-Marchman-Act Behavioral Healthcare and the Director of the Vince Carter Sanctuary I am asking that you use the REMS process to tighten up the prescribing indications for the opioids instead of relying upon a voluntary education program by manufacturers", "comment_id": "FDA-2011-D-0771-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0011", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 350}, {"text": "I would like you to be aware that dentists who are Diplomates of the American Board of Orofacial Pain have had extensive training in managing patients with chronic orofacial pain.  One aspect of this training includes the basic knowledge and appropriate use of pharmacotherapeutics.  We are similarly very concerned, as is the Administration, with the epidemic of prescription drug abuse.", "comment_id": "FDA-2011-D-0771-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0018", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 388}, {"text": "On behalf of the American Board of Orofacial Pain (ABOP), I would like to offer our support for FDA efforts to ensure comptency in prescribing practice for opioid medications.  The ABOP is committed to assist in safeguarding the public by virtue of granting Diplomate status to those who have demonstrated proficiency in evaluation, diagnosis, and management of patients suffering with chronic orofacial pain.  Our rigorous examination process consists of both a written and oral examination, which mirrors the Core Curriculum in Orofacial Pain, (American Academy of Orofacial Pain, 2011), which has been accepted by all of the University based training programs in the United States.  All programs include, indeed emphasize, appropriate use of medication as therapy for the chronic orofacial pain patient.  Among those medications are anticonvulsants, NSAIDS, antidepressants, headache medications, various channel blockers, and opioids, among others.  The American Board of Orofacial Pain requires demonstrated proficiency in the prescription and monitoring of all of the medications used for our patients.  We would be happy and eager to assist the FDA in any way to help educate doctors on appropriate prescribing practice. Anthony H. Schwartz, DDSPresident, American Board of Orofacial Pain", "comment_id": "FDA-2011-D-0771-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0023", "comment_date": "2011-12-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1333}, {"text": "I think this is a commendable effort but as a pain management and addiction medicine physician, I doubt that it will do much to curb the current epidemic of prescription drug abuse. I do think that it will have a small favorable impact; however, the vast majority of prescription drug abusers that I see in my addiction practice do not obtain their drugs from licit sources. Certainly, some patients do develop drug addiction during treatment for chronic pain and detecting and treating these patients will be beneficial to society. Some patients doctor shop and scam doctors and increasing vigilance may improve detection of these patients. But it is extremely unlikely that REMS will have much impact on the pill mills and other illicit sources of prescription opioids. The criminals will not respond to REMS. It is not clear at all how much opioids are diverted from legitimate prescriptions to the street. As the vast majority of overdose deaths are in abusers, not patents, it is unclear if many lives will be saved with this effort. I am weighing in on this topic because I suspect millions of dollars will be spent on developing and implementing REMS for little actual return. I realize that everyone wants to do something to help stem the tide of opioid overdose deaths and education is always a good thing. But I would not get my hopes up with regard to this effort having a large impact as it is not targeting the source of the problem. ", "comment_id": "FDA-2011-D-0771-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0015", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1458}, {"text": "The use of long acting opioids does not preclude the use of short acting opioids therefore it is important to cover the aspect of breakthrough pain and the use short acting opioids and fast acting opioids.  It is not clear to me why the time to response is the factor driving in the REMS.  ", "comment_id": "FDA-2011-D-0771-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0013", "comment_date": "2011-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 290}, {"text": "On behalf of the American Board of Orofacial Pain (ABOP), I would like to offer our support for FDA efforts to ensure comptency in prescribing practice for opioid medications.  The ABOP is committed to assist in safeguarding the public by virtue of granting Diplomate status to those who have demonstrated proficiency in evaluation, diagnosis, and management of patients suffering with chronic orofacial pain.  Our rigorous examination process consists of both a written and oral examination, which mirrors the Core Curriculum in Orofacial Pain, (American Academy of Orofacial Pain, 2011), which has been accepted by all of the University based training programs in the United States.  All programs include, indeed emphasize, appropriate use of medication as therapy for the chronic orofacial pain patient.  Among those medications are anticonvulsants, NSAIDS, antidepressants, headache medications, various channel blockers, and opioids, among others.  The American Board of Orofacial Pain requires demonstrated proficiency in the prescription and monitoring of all of the medications used for our patients.  We would be happy and eager to assist the FDA in any way to help educate doctors on appropriate prescribing practice.Anthony H. Schwartz, DDSPresident, American Board of Orofacial Pain", "comment_id": "FDA-2011-D-0771-0042", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0042", "comment_date": "2011-12-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1342}]}, {"id": "BOP-2015-0005", "agency": "BOP", "title": "Drug Abuse Treatment Program", "update_date": "2022-06-23", "update_time": "01:01:14", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am writing in support of BOP-2015-0005, Changes to the Residential Drug Abuse Treatment Program (RDAP)PERSONAL IDENTIFYING INFORMATION:  Please do not publish online but redact my following personal information: Sharon E. Kestner, 217 Hill Drive, Bristol TN 37620, (423)878-6430, sektn@btes.tv. Matthew Allen Branch 14162-084. I am writing to urge the BOP to permit prisoners with detainers to take advantage of early release.Right now, prisoners with state or immigration detainers may not benefit from the one-year reduction because part of theRDAP is completed in community confinement and prisoners with detainers may not be incarcerated in halfway houses.Nothing in the federal law authorizing early release requires a period in community confinement and that is according to theAmerican Psychiatric Association. The RDAP program can be successfully completed without a community portion.This would enable prisoners with detainers to participate in the program and enable many more prisoners to benefit.I am writing specifically in regard to my nephew, Matthew Allen Branch 14162-084. He will complete his RDAPprogram at FCI Beaumont Medium, around October 26, 2015. He currently has a detainer in Bristol, VA due to VOP. If he is not allowed to benefit from the early release incentive, then he continues to be penalized for his past and thingsthat are now, beyond his control. At some point the snow ball has to stop. This is the first time he has ever receivedtreatment for addiction. Locking an addict up, is not the answer. The treatment he has received since enrolled in RDAP,has been wonderful and has given him the tools he needs to live a successful free life.  He should be given a opportunityto prove himself based on his positive changes he has made as an Federal inmate including, being a model prisoner, earning his GED, working, and soon to complete the 9 Month of RDAP. I am asking you to please consider an implement the proposal that will allow my nephew and other non-violent inmates with detainers, to be rewarded with the time off andnot be penalized again for their past. Sincere Thanks! Sharon E. Kestner, 217 Hill Drive, Bristol, TN 37620, (423)878-6430, sektn@btes.tv", "comment_id": "BOP-2015-0005-0087", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0087", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Sharon", "commenter_lname": "Kestner", "comment_length": 2328}, {"text": "I am in support of this proposal which would allow a 1 year deduction in a sentence for an inmate who would complete a 9 month Residential Drug and Alcohol Rehabilitation Program", "comment_id": "BOP-2015-0005-0038", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0038", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 178}, {"text": "I need my husband at home, 7 years is enough, i hope qualify to take this program. Everyone makes mistake in life, but that doesnt mean they have to pay for them the rest of their life. Sometimes good people make bad choices, it doesnt mean they are bad, It means they are human.. ", "comment_id": "BOP-2015-0005-0033", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0033", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Arlene", "commenter_lname": "Guerrero", "comment_length": 291}, {"text": "Hello, I am submitting this in favor for this law to be passed.I believe that this program could be very beneficial to many of the inmates locked up. This program could help them in many ways. Not only could they come home a year earlier but they have this year to reconnect with their family. Some of them have been or will be locked up for many years. I believe that if you do the crime you do the time,however, in the time that they are away many learn so many lessons. I also believe that a lot of them would not even be there if they never would have got on drugs in the first place. For some that are there they have lost more then words could explain. They have lost loved ones and could not say a proper good bye. They are missing out on their childrens lives. When they get out their children will be grown. I believe that there are some good people that let there self get in a bad sittuation. Yes, do the time. However, for the ones who can own up to their mistakes, do everything in their power to do right now deserve to have this program. So I ask on behalf of not only the inmates, but the families on the outside for this law to be passed. ", "comment_id": "BOP-2015-0005-0023", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0023", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "April", "commenter_lname": "Morrell", "comment_length": 1166}, {"text": "My name is Noreen Malanga and I support the proposed rule by the BOP, Docket ID: BOP-2015-0005 where the Bureau proposes to revise the Residential Drug Abuse Treatment Program (RDAP) for federal prisoners. (Redact PERSONAL IDENTIFYING INFORAMTION for Noreen Malanga) The purpose of this revision is to help support prisoners reduce their recidivism rates by assessing the inmates progress through clinical evaluation rather than a written assessment that is no longer in clinical use, remove rules that would expel prisoners if they should happen to use drugs and/or alcohol or commit acts of violence during treatment/incarceration, limit the time frame for review of certain offenses, and lessen the restrictions for early release eligibility. As the mother of a federal inmate being held on drug offenses and that supports clinical evaluation and treatment and the practice of drug rehabilitation during incarceration, the proposed rule would positively impact the 94,700 federal inmates that are currently in custody for drug related offenses. 1 My son, Daniel Malanga, Federal Inmate 20170-052, was sentenced in April 2014 for drug related offenses (redact PERSONAL IDENTIFYING INFORMATION for Daniel Malanga) and is currently in custody of the Berlin Federal Correctional Facility in Berlin New Hampshire. His participation in RDAP and an early release would lessen the cost burden on the United States Government and its tax payers to maintain Daniels prolonged incarceration for his drug offenses. To the cost of incarcerating drug offenders and the need for early release, as of August 20, 2015, 48.6% of Federal inmates are in custody for drug offenses; thats 94,700 inmates.1 The Federal Register of the Daily Journal of the United States Government states that the average annual cost of incarceration for a federal prisoner is $29, 291.25. 2 In order to maintain drug offenders for an entire year, the annual cost, based on these statistics, would amount to over 2.73 billion dollars.  According to Ann Carson, in September of 2014, of the US Department of Justice Bureau of Justice Statistics, Between 2001 and 2013, more than half of prisoners serving sentences of more than a year in federal facilities were convicted of drug offenses (table 15 and table 16). On September 30, 2013 (the end of the most recent fiscal year for which federal offense data were available), 98,200 inmates (51% of the federal prison population) were imprisoned for possession, trafficking, or other drug crimes. 3   With reduced sentencing and participation in the proposed revised Residential Drug Abuse Treatment Program, not only would federal inmates benefit from a reduced recidivism rate, but the Federal Governments cost (ultimately a burden on US tax payers) to maintain those convicted of drug offenses would lessen with early release. In conclusion, the cost benefit of early release would lessen the burden on the US Government and its taxpayers, as the cost to maintain a federal prisoner held in custody for drug offenses in exorbitant at over 2.73 billion dollars. Once again, I fully support the revision of the proposed rule by the BOP, Docket ID: BOP-2015-0005 where the Bureau proposes to revise the Residential Drug Abuse Treatment Program (RDAP) for federal prisoners. REFERENCES 1 Federal Bureau of Prisons. Statistics of Offenses. Updated August, 20, 2015. Web.http://www.bop.gov/about/statistics/statistics_inmate_offenses.jsp 2 Federal Register, Daily Journal of the United States Government. May 12, 2014. Department of Justice and Bureau of Prisons. Web. https://federalregister.gov/a/2014-10859 3 Carson, E. Ann. Prisoners In 2013. Washington, DC: US Dept of Justice Bureau of Justice Statistics, Sept. 2014, NCJ247282. Federal data: p. 16; state data: p. 15 http://www.drugwarfacts.org/cms/Prisons_and_Drugs#sthash.w2AtviUp.4B4TQLBI.dpuf", "comment_id": "BOP-2015-0005-0044", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0044", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Noreen", "commenter_lname": "Malanga", "comment_length": 3967}, {"text": "BOP-1168-PI want to voice my support for the proposed revisions for the RDAP program for federal inmates. I believe it to be a beneficial program and the statistics show that it has been helpful for recidivism. I believe some compensation of reduction in time should be awarded to as many inmates as possible that complete this program. It would offer encouragement and self worth which is important to everyone, imprisoned or not. ", "comment_id": "BOP-2015-0005-0020", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0020", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Rosalie", "commenter_lname": "Rockers", "comment_length": 447}, {"text": "It is a great second option for non violent offenders with so many charged with 2 point enhancement it stops them from having a chance to get involved and learning something to have a better chance for when they get released.", "comment_id": "BOP-2015-0005-0017", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0017", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Kiwana", "commenter_lname": "Fobb", "comment_length": 225}, {"text": "I have read the revisions the Bureau of Prisons is proposing in order to allow more inmate participation. I strongly support the RDAP program as I have seen its positive effects on enrollees. I have noticed improved communication skills and anger management coping mechanisms being applied based on classes taught at RDAP and feel that these skills will not only be greatly beneficial to inmates who have taken the courses and will renter society with these new skill sets, but I also feel that society will benefit as well since inmates are learning how to express themselves, control their anger and identify triggers and patterns that have not been favorable to their well-being in the past. I believe allowing more inmates to enter the program will benefit them and society. I hope the Bureau allows inmates even with violent records to partake in the classes, even if they are not allowed early release, as stated by the proposed revisions proposed in the RDAP document.I do have some questions that I did not see addressed in the document: What are the rewards for inmates partaking in the program on their own volition? Some, I understand are not afforded early release, but it would seem if they are taking this program to improve their odds of success in society and reduce their rates or recidivism and they are successful and actively participating in the program, then should they not be granted some sort of incentive as well? Particularly those with long sentences? I read in the proposed revisions that RDAP reduces recidivism by approximately 8 percent for males and approximately 5 percent for females. While any reduction of recidivism is laudable, what efforts has or is the Bureau planning to incorporate in RDAP to lower the rates further? Are there comparable programs globally the the Bureau has studied to incorporate strategies to lower recidivism rates and increase the odds of success for the incarcerated individual and their family, since prison affects the family as well as the individual? The document states that approximately 18,000 inmates in FY 2014 participated in the program and that additional resources will not be necessary to accommodate the increased number of individuals attending the program. How will this affect the quality of training and preparation for release? Is the success rate expected to increase or decrease based on this information?  I hope the Bureau successfully allows more inmate participation and early release for those successfully completing the program as this will not only benefit inmates, but their families, and the American public as well.", "comment_id": "BOP-2015-0005-0058", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0058", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "C", "commenter_lname": "Finney", "comment_length": 2664}, {"text": "It is my opinion that All Inmates in the RDAP Program should get all the benefits from the program, they go through a process to get into the program so if they make it then they should not be penalized by not getting all the benefits including the Time Off Credit.  So I hope that the rules are changed to allow All Inmates in the RDAP Program to get the time off credits for completion of the program!!One of my best friends husband is in this program  has successfully completed it  he has learned allot from the program, its not fair that due to his charge he is not getting the time off credits!!  He has bettered himself by also taking training classes for his CDL  also Animal Rescue.Like I said, hope you give all the inmates the time off credits for completion of RDAP no matter what their charge is!!", "comment_id": "BOP-2015-0005-0070", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0070", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Scott", "commenter_lname": "Fauth", "comment_length": 835}, {"text": "BOP-2015-0005.  I believe they should be granted the year off for completing the program. I believe that them completing the program shows that they are ready for all treatment and to be able to go home to their families. Family support is a big factor on their completion of these programs.  I believe they deserve a second chance on proving themselves to society and their families. I think they will do better at home getting the proper treatment and not being locked away from society. If they continue being locked away when they are released they will not know how to be a normal human being in society. They are proving themselves as they complete the program that they are ready for a successful future.. Lets give them a second chance! Thank you in advance for you assurance in this matter! ", "comment_id": "BOP-2015-0005-0090", "comment_url": "https://api.regulations.gov/v4/comments/BOP-2015-0005-0090", "comment_date": "2015-09-28", "comment_time": "04:00:00", "commenter_fname": "Jessenia", "commenter_lname": "Cantu", "comment_length": 820}]}, {"id": "FDA-2013-P-1289", "agency": "FDA", "title": "Stay of Action on the Implementation of Labeling Changes of Neonatal Opioid Withdrawal Syndrome (NOWS) Extended-Release and Long-Acting Opiod Analgesics.", "update_date": "2014-12-05", "update_time": "11:40:02", "purpose": "Nonrulemaking", "keywords": ["cder", "2013-8425", "citizen petition", "stay of action", "open", "neonatal opioid withdrawal syndrome", "NOWS", "extended-release", "long-acting"], "comments": [{"text": "The American College of Obstetricians and Gynecologists strongly opposes the black box warning on long-acting opioid medications directed toward pregnant women.Women who are pregnant and dependent on opioid medications should not be withdrawn from these medications during pregnancy whether they be prescribed or illegally obtained. Withdrawal from opioids during pregnancy is known to cause extreme fetal distress and fetal death.   Neonatal Abstinence Syndrome, which MAY result following maternal opioid use, is a fully treatable condition without subsequent patho-physiology for the child.  The warning proposed by the FDA concerning infant death has not been substantiated.  Moreover, opioid medications are the safest choice for use by pregnant women who experience moderate to severe pain.  They should not be denied adequate pain relief and untreated maternal pain further stresses the fetus.  Please reconsider this warning.   Thank you.", "comment_id": "FDA-2013-P-1289-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-1289-0004", "comment_date": "2014-02-11", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 956}]}, {"id": "CDC-2021-0031", "agency": "CDC", "title": "Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies", "update_date": "2021-06-08", "update_time": "10:14:00", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I strongly support development of this toolkit to help facilitate greater access to sterile syringes through pharmacies. Given 90% of Americans live within 5 miles of a pharmacy, they serve as critical access points for the distribution of syringes - which in turn, reduces the burden of costly conditions including HIV, hepatitis, endocarditis, etc. In NC, we are in the planning phase of developing a pharmacy-based syringe service program. This toolkit will help tremendously in the creation of that program and others. ", "comment_id": "CDC-2021-0031-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0003", "comment_date": "2021-04-26", "comment_time": "04:00:00", "commenter_fname": "Amanda", "commenter_lname": "Isac", "comment_length": 523}, {"text": "Docket No. CDC-2021-0031I am writing in reference to the above proposal for a harm reduction toolkit in community pharmacies. As a public health student, I am interested in impactful, easily implemented, and low-cost strategies to mitigate the opioid crisis in the United States and its associated morbidity and mortality.This initiative by the Centers for Disease Control and Prevention (CDC) is intended to support community pharmacists with education and training to build understanding and skills related to non-prescription drug sales (NPSS). Focusing on this sector of healthcare providers could ultimately facilitate increased access to sterile syringes resulting in a direct impact on reducing bloodborne pathogens, such as hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV) which are commonly associated with needle sharing among persons who inject drugs (PWID).Urban and rural areas alike are seeing spikes in HCV, HIV, and co-infection related to the opioid crisis. The incidence of HCV has increased four-fold in the last decade and most in adults aged 20-39 (CDC). The CDC estimates that co-infection of HCV and HIV occurs in 25% of PWID. Needle sharing occurs more commonly in young PWID (age 18-29), with nearly half of PWID reporting that they share needles (CDC). Community pharmacists contribute to harm reduction strategies as they are often the final healthcare provider contact for prescription opioids. Pharmacists already have increased responsibilities in harm reductions strategies as screeners for drug diversion and drug-seeking behavior. Increased participation by pharmacists in syringe service programs (SSPs) may depend on low resource, time-efficient training and education.Studies from other countries suggest that pharmacists are both willing and are empowered to play a larger role in needle exchange programs. The North America Syringe Exchange Network currently lists 360 (SSPs) across 43 states. SSPs have been associated with a 50% reduction in HIV and HCV incidence (CDC). Wider adoption of programs, however, can depend on state and local laws governing sales of syringes and pharmacist understanding of these rules. Assessing community pharmacists willingness to participate in a non-prescription syringe sales (NPSS) is essential to successful implementation of successful SPSS initiatives. A 2015 study of community pharmacists in Kentucky showed that, of the 1282 participants, 39.1% were not willing to provide clean needles/syringes yet 30.0% were very willing to do so (Goodin 2018). Of the community pharmacists who felt that a needle exchange program could have an impact on public health they were 3 times more willing to provide clean needles and, to a lesser degree, dispose of needles compared with chain/supermarket pharmacists.  A study of Indiana pharmacists showed that syringe sales were strongly associated with a supportive belief regarding syringe access for injection drug users and their comfort level in selling syringes (Meyerson 2018). However, pharmacists located in communities with high rates of overdose-related mortalities were 56% less likely to sell syringes. The barriers to selling syringes most often cited were not wanting to attract the wrong customer (55.4%) and personal disagreement with supplying injection drug users with syringes (46.3%).This pilot program seeks to further pharmacists understanding of, and skills with, the delivery of NPSS services. The program aims to correlate pre- and post-test responses with syringe sales during the six-week period. It would be interesting to see what the correlation would be over a longer period, perhaps 90 days, to see if there is a significant change in syringe sales overall and if the number of individual customers had increased and/or number of visits per customer to the pharmacy. A longer-term outcome of interest would be the incidence of new HIV and HCV diagnoses in communities served by participating pharmacies.It would also be interesting to see what the perceived barriers of NPSS for pharmacists are at baseline and if education and training can effectively overcome them. While increasing a pharmacists comfort level with selling syringes to PWID may be addressed through the pilot programs education component, overcoming personal beliefs regarding injection drug users may prove more challenging. The pharmacist can play a key role in harm reduction strategies for bloodborne pathogens associated with injection drug use. This proposed CDC program could demonstrate how a relatively low time commitment from participating pharmacists would result in expanded NPSS. This important initiative will provide insight into baseline skills and perception of NPSS and the effectiveness of training/education both by post-test surveys and change in NPSS as a result of the program. ", "comment_id": "CDC-2021-0031-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0004", "comment_date": "2021-06-02", "comment_time": "04:00:00", "commenter_fname": "Kelly", "commenter_lname": "Burns", "comment_length": 4981}, {"text": "Harm reduction toolkits are a significant step in the right direction for preventing the spread of infectious disease. Reducing the harm associated with drug use is an important factor that oftentimes is looked upon negatively or overlooked. However, research has shown increasing access to clean syringes does not increase injection frequency, drug use or disposing of syringes in an unsafe manner. This proposed project has the potential to positively impact communities around the country. However, there is one big question I had when reading this notice; how will this harm reduction toolkit address stigma surrounding the purchase and sale of syringes?  The over-the-counter sale of non-prescription syringes is already legal, yet this does not appear to have a big impact on decreasing needle sharing; why is that?Stigmatizing language has significantly impacted individuals ability to access clean syringes. Research has shown stigma against individuals who use drugs is a huge public health issue. Many communities have implemented policies surrounding this issue based off stigma. This can easily be seen through attempts to implement needle exchange programs. Many communities across the country have tried to implement needle exchange programs. However, false ideas that these programs lead to more substance use and needles being improperly discarded have led to shutting down these programs. Promoting over the counter needle sales may meet less pushback in communities than needle exchange programs have, but addressing community wide stigma is still going to be a big issue when trying to get individuals to utilize this program. It is important to create an atmosphere where individuals feel like human beings and feel valued and respected; this is before someone even steps foot inside a pharmacy. There is a lack of research available regarding individuals experiences purchasing sterile syringes over the counter in community pharmacies. However, the research that does exist brings to light stigma and rejection individuals have faced when trying to purchase over the counter syringes. A 2018 study in the Harm Reduction Journal (https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-019-0327-1 ) sought to understand the experience of retail pharmacy syringe purchases in Arizona. All participants in this study were refused when trying to purchase non-prescription syringes in community pharmacies. A 2015 study in California interviewed 46 individuals who repeatedly cited stigma regarding syringe access. Although legal to purchase, participants were often denied syringe purchases and felt stigmatized and embarrassed. This experience also discouraged participants from attempting to go to a different community pharmacy to buy a syringe. This is a pattern that is repeated in research done in states across the country. Although technically legal, many individuals who have attempted to buy syringes have been rejected. Many of these individuals have been rejected based off the individual beliefs and comfort levels of pharmacists. It can be difficult for someone to have the courage to go into a pharmacy to purchase a needle; being rejected once could potentially keep them from ever trying to purchase a syringe within a community pharmacy again. Therefore, the community pharmacy training is vital for the harm reduction toolkit for non-prescription syringe sales in community pharmacies to be successful.  I am glad the CDC is working to implement an in-field demonstration and evaluation of a training for pharmacy personnel. I wanted to emphasize the importance of addressing stigma in this training. Providing the tools to prevent needle sharing does not do anything unless the distribution process is set up in a way that makes consumers feel comfortable and confident. Overall, this training, as part of the harm reduction toolkit has the potential to do a lot of good, and I am looking forward to see the results of this project. ", "comment_id": "CDC-2021-0031-0008", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0008", "comment_date": "2021-06-02", "comment_time": "04:00:00", "commenter_fname": "Casey", "commenter_lname": "Richman", "comment_length": 4180}, {"text": "Harm reduction in conjunction with shame reduction are important and yet still underutilized approaches when tackling the opioid epidemic. Yes, it would be the ideal for those suffering from addiction to attain and maintain sobriety, but this is a challenge for many; a lifetime goal not so readily achieved. With this in mind it is important to foster safe habits for those consuming/misusing both prescription and non-prescription opioid drugs, in particular for persons who inject drugs (PWID). PWID tend to associate with others that consume opioid drugs, sharing both drugs and injection supplies such as syringes. This has led to an increase in Human immunodeficiency virus (HIV), Hepatitis C (HCV) and many other blood borne infections among PWID. With this in mind many cities across the United States have implemented or encouraged community organizations that manage exchange programs that allow individuals to trade used needles for clean ones. These programs are hugely beneficial to their communities, and provide wonderful data of the benefits that clean syringes provide. It seems sensible to utilize this information to expand access to clean syringes to every community in the United States. Further, with so many Americans living within accessible distance to local pharmacies, these pharmacy locations present as ideal hubs for non-prescription syringe sales (NPSS) and information on safe injection practices. Now it would seem rather small in scale to only feature 12 project pharmacies, for a short 6 week data collection period, in the in-field demonstration and evaluation, but perhaps this will serve as a jumping off point providing preliminary data that could be utilized to justify the expansion of such programs.  Of additional note, as important as this proposed data collection is to understanding how crucial NPSS truly is to public health it would seem to be only a starting point. The question remains what will be garnered from this information, and what further steps could be taken to protect those that suffer from addiction, and in particular PWID. Harm reduction tactics far exceed NPSS, including such avenues as opening Safe Injection Sites (SIS). While cities like Philadelphia, Pennsylvania battle with federal courts in their efforts to open a local SIS within their community, the United States loses approximately 128 people each day to the misuse of prescription and non-prescription drugs (National Institute on Drug Abuse, 2020). All while, according to the American Medical Association (who supports the utilization of SIS) 11 countries globally are home to 120 SIS that save lives every day (https://www.ama-assn.org/delivering-care/opioids/will-us-get-its-first-supervised-drug-consumption-sit). For decades such SIS have functioned internationally serving their respective communities. The goal of such SIS locations is to foster safe environments for PWID providing them with clean injection facilities, equipment and access to medical care in the event that an overdose does occur. The opening of such sites in the US would also allow the opportunity to provide PWID with educational materials on clean injection practices, addiction treatment options, primary care treatment options and other preventive services. They certainly could provide a large opportunity in addiction treatment and care within the United States.  In 2017, the Department of Health and Human Services (HHS) declared the opioid crisis a public health emergency, and committed to tackle the misuse of both prescription and non-prescription opioid drugs with their five-point strategy:  (1) better addiction treatment, and recovery services; (2) better date; (3) better pain management; (4) better targeting of overdosing reversing drugs; and (5) better research. Considering these commitments it is ideal that they actually invest accordingly. So, yes the CDC should move forward with harm reduction toolkits and data collection on such resources. Yet still, in the ideal they are also keeping in mind the vast many ways to implement harm reduction tactics. Hopefully this is merely a jumping off point, and that other approaches that embrace not just harm reduction, but also shame reduction approaches are fostered. ", "comment_id": "CDC-2021-0031-0007", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0007", "comment_date": "2021-06-02", "comment_time": "04:00:00", "commenter_fname": "Colleen malloy", "commenter_lname": "White", "comment_length": 4287}, {"text": "Dear Mr. Zirger,As a candidate pursuing Masters in Public Health (MPH) and Doctor of Medicine (MD) degrees, I would like to voice my support for the proposed demonstration project, the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies, which will evaluate pharmacist training materials, harm reduction kits, and publicly available online resources that seek to improve outcomes among persons who inject drugs (PWID). Based on data from the Centers for Disease Control and Preventions (CDC) National Vital Statistics System (NVSS) (https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm), drug overdose deaths have risen to the highest number ever recorded in the year since the outbreak of the COVID-19 pandemic  with over 90,000 lives lost during the 12-month period ending in October 2020. The steep rise in drug use-related morbidity and mortality makes all effort to implement effective harm reduction strategies both timely and necessary.  Syringe service programs (SSPs) that provide sterile injection equipment, testing for infectious diseases associated with injection drug use (e.g., HIV, hepatitis C virus), overdose education materials and naloxone kits, and/or referrals to general and addiction-related health care services, have been shown to significantly reduce many of the negative and potentially fatal health consequences experienced by PWIDs  without increasing drug use (Abbasi, 2017; Baker et al., 2020; Childs et al., 2021; Hawk, Vaca  DOnofrio, 2015). Indeed, the CDC has consistently called for improving nationwide access to SSPs that offer sterile needle and syringe exchange as critical to reducing the transmission of HIV (Abbasi, 2017). Despite the robust evidence base, SSPs have often been met with political opposition, particularly in non-urban areas disproportionately impacted by the burdens of drug use and dependence (Baker et al., 2020; Childs et al., 2021); however, resistance to strategies proven effective in reducing harm among PWIDs has been shown to stem predominately from stigma more than prior poor experience, meaning local engagement has and will continue to be essential to realizing approaches that meet individuals and communities where they are. Although medical offices and other health care facilities have not necessarily been preferred sources of sterile equipment exchange due to systems-wide stigmatization and criminalization of drug use, recent analysis of qualitative interviews with key informants from community-based organizations serving PWIDs has confirmed the importance of distinguishing local champions of harm reduction programs as a primary strategy in mitigating the challenges of SSP implementation (Childs et al., 2021). Indeed, the identification of implementing sites with wide population coverage is a necessary next step to addressing needs that have rapidly changed during the COVID-19 pandemic.Notably, polling in the United States reliably places pharmacists among the most trusted professions, where the majority of Americans (64%) rate the honesty and ethics of pharmacists as high or very high (Reinhart, 2020). Given likely routine interaction with many undiagnosed PWIDs, community pharmacists who have trusting relationships with consumers are in a unique position to screen and facilitate access to sterile injection equipment via non-prescription syringe sales (NPSS), which do not require authorization from another licensed prescriber. And as essential personnel, pharmacists are already positioned to reach individuals and communities with the highest need. The pre-test/post-test survey of pharmacy personnel NPSS knowledge, as well as the quantification of syringe sales and health care services referrals, will provide crucial feedback on the effectiveness of the project in increasing provision of harm reduction products to PWIDs. Because attitudes and beliefs regarding drug use and dependence have been shown to so significantly influence the experiences of individuals and communities with SSPs, the CDC Information Collection Review Office should consider incorporating a qualitative component into the evaluation, including targeted interviews or open-ended survey questions, in order to best understand the implementation and impact of the proposed project from the perspective of community pharmacists. Overall, SSP approaches like NPSS that provide safe injection equipment represent evidence-based strategies for reducing harm among PWIDs. The increasing morbidity and mortality associated with injection drug use during the COVID-19 pandemic absolutely necessitate the careful development, realization, and evaluation of expanded opportunities to meet individual and community need  such as that described by the proposed project. Sophia DemuynckThe George Washington University", "comment_id": "CDC-2021-0031-0010", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0010", "comment_date": "2021-06-04", "comment_time": "04:00:00", "commenter_fname": "Sophia", "commenter_lname": "Demuynck", "comment_length": 4965}, {"text": "I am very pleased to see the CDC working to create a harm reduction-oriented toolkit for non-prescription sales of syringes in community pharmacies. In NC, the Department of Health and Human Services promotes these types of sales, so this toolkit will be useful for this promotion. One of the NC Opioid Action Plans strategies is to train pharmacists to provide and refer people to harm reduction services. The NC Board of Pharmacy and the NC Association of Pharmacists have been very supportive of non-prescription sales as an evidence-based practice, and this toolkit will help their promotion of non-prescription sales of syringes. The following flyer was created by the NC Harm Reduction Coalition with assistance and support from the NC Board of Pharmacy, and it is housed on the Board of Pharmacys website. http://www.ncbop.org/faqs/FAQsNonPrescriptionSyringeSalesNC.pdf ", "comment_id": "CDC-2021-0031-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0002", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anna", "commenter_lname": "Stein", "comment_length": 899}, {"text": "I am in full support of the proposed CDC regulation on the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies. Increasing community access to sterile syringes would help to reduce the incidence of sharing needles among those using drugs. HIV and Hepatitis C virus (HCV) transmission can occur through shared syringe use. Among the population of people who inject drugs, a 2018 study found that syringe sharing is popular among all age groups, with younger people ages 18-24 reporting the highest incidence of sharing needles (48%), with findings concluding that 32% of the population shares syringes (Centers for Disease Control and Prevention, 2021). Thus, shared syringes during injection drug use are a major contributing factor to HIV transmission. According to the (CDC, 2021), In 2016, injection drug use (IDU) contributed to nearly 20 percent of recorded HIV cases among menmore than 150,000 patients. Among females, 21 percent (about 50,000) of HIV cases attributed to IDU. Additionally, women who become infected with a virus can pass it to their baby during pregnancy, regardless of their drug use. Thus, implementing the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies can indirectly positively impact mother-to-child HIV transmission rates.Risk reduction programs known as Syringe Service Programs (SSPs) aimed to increase syringe access have been implemented in urban, rural, and suburban communities throughout the United States. The programs have successfully presented a direct between increased access to sterile syringes and a reduction in HIV/AIDs cases. While these programs have shown to help reduce viral infections alone, they cannot adequately supply the number of sterile syringes needed to prevent outbreaks. The existence of an SSP in an area, however, will not necessarily prevent an outbreak of HIV or HCV infection; in addition to substance use prevention and treatment services, PWID needs access to an adequate number of sterile syringes. The Joint United Nations Programme on HIV/Acquired Immunodeficiency Syndrome (AIDS) (UNAIDS) recommends the provision of 200 sterile syringes per injector per year for a high level of coverage. Access to sterile syringes can be provided through SSPs and through pharmacy sales. (Des Jarlais, 2015). The Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies would help meet the need to adequately supply sterile needs for this population which is at increased risk for HIV/HCV infection.Allowing sterile syringes to be sold in community pharmacies would in access to many injection drug users. In rural communities, injection drug use has increased, creating an increased need for sterile syringe access. According to (Havens, Oser, and Leukefeld, 2011), nonmedical prescription opioid users reported the prevalence of IDU to be 44.3%; and the majority of these IDUs were injecting controlled-release oxycodone formulations rather than heroin and/or cocaine. This rapid escalation in the number of IDUs puts this population at increased risk for HIV and other blood borne infections. The Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies would benefit such communities as pharmacies are readily accessible, typically within 20 miles from residential homes (Casey, Klingner, and Moscovice, (2002). The availability of sterile syringes in community pharmacies will prove to be equitable. Approximately 90% of the population lives within 5 miles of a community pharmacy (Kelling, 2015). Therefore, injection drug users in all communities will have access to sterile syringes. Thus, decreasing the need to share needles and reducing the risk for HIV and HCV infection. Additionally, increasing access to sterile syringes via community pharmacies will decrease the burden HIV costs have on the healthcare system. The lifetime healthcare costs for a person infected with HIV at age 35 is approximately $326,500, with about 1.2 million people in the U.S living with HIV/AIDS (Ritchwood, Bishu, and Egede, 2017). Therefore, the proposed CDC regulation on the Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies will only prove beneficial to public health and the healthcare system.  ", "comment_id": "CDC-2021-0031-0005", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0031-0005", "comment_date": "2021-06-02", "comment_time": "04:00:00", "commenter_fname": "Ashley", "commenter_lname": "Darby", "comment_length": 4539}]}, {"id": "FDA-2022-N-2657", "agency": "FDA", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration\u2019s Study of Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages", "update_date": "2023-10-11", "update_time": "09:33:47", "purpose": "Nonrulemaking", "keywords": ["CTP", "2022-718", "Study of Assessing Physiological", "Neural and Self-Reported", "Response to Tobacco Education Messages", "Open"], "comments": [{"text": "California Ban on Menthol Cigarettes and flavored vapes: The FDA with the help of the State of California has just approved kids to die at an alarming rate. Removing Menthol Cigarettes, Flavored Vapes opens the doors for the black-market to open their doors, and they are now open. You still can purchase Menthol Cigarettes, Flavored Vapes at a huge savings since there is no tax, Im sure they are coming in from Mexico, and China. Im also sure they are loaded with very harmful chemicals worse than purchasing them from a licensed retail smoke shop. As a retired Trauma Surgeon banning the flavored Cigarettes will only allow kids to start reparenting more; here is a brief list of what can flavor a Cigarettes: Cough syrup, cough drops, mouthwash, toothpaste, candy, chewing gum, essential oils, furniture polish, household cleaners, solvents, liquid smoke. All of these are a death sentence if inhaled and i have seen under aged patients die within hours of experimenting from the list above. Kids as in underaged will experiment ER they will die in hours. The laws that were in place before the ban did not contribute to the death of kids, they were good laws. Many people are now growing their own Tabacco, flavoring it at harvest in backyards, patios, and inside homes in bad weather areas of the country. All or any regular cigarette can be flavored to menthol or to their liking. Probation has never worked in closing Im wondering how many children will die that is directly related to the Ban Wording (OUR KIDS WILL BE SAFE). Im tracking deaths of our youth in California to bring up at a later date. When the first death happens, I will post it and continue to post all underaged deaths in relation to the California Ban on Menthol Cigarettes and Flavored Vapes. ", "comment_id": "FDA-2022-N-2657-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2657-0002", "comment_date": "2023-01-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1810}]}, {"id": "DEA-2014-0008", "agency": "DEA", "title": "Controlled Substances:  Adjustment to the Established 2014 Aggregate Production Quota for Marijuana", "update_date": "2021-12-02", "update_time": "01:01:29", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I do appreciate the fact that President Obama decided to allow for there to be more testing for medical use of marijuana.  California which is part of the fifty states already has ICD-9 codification of diseases for the use of cannabis, maybe NYS can use these codes to get people treated for their chronic illness.  Now we have to watch for the unnecessary trafficking which has occurred for years with Mexico in the USA.  Fine way to start medical regulation leaving the door open for more legal issues.  ", "comment_id": "DEA-2014-0008-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0008-0002", "comment_date": "2014-05-27", "comment_time": "04:00:00", "commenter_fname": "Yolanda", "commenter_lname": "Rosado", "comment_length": 506}]}, {"id": "VA-2020-VHA-0023", "agency": "VA", "title": "AQ31-Proposed Rule-Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists", "update_date": "2021-12-13", "update_time": "15:35:34", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Opioid addiction is an ever-present threat to individuals living in the United States of American and around the world. According to the National Institute on Drug Abuse, 128 Americans die each day from a drug overdose. The problem of opioid addiction and overdose has been an increasingly important issue in the United States over the past couple of decades. Public health professionals and governmental organizations have been working together to create initiatives and rulings that favor preventative and treatment services for individuals that are addicted to drugs. The problem of opioid dependence is one that was, in part, caused by the drug manufacturers and physicians of the 1990s. Addiction and overdose are problems that need to be addressed. The United States Department of Veterans Affairs is working to improve the health outcomes of veterans who are at risk for addiction and overdose due to opioids.Many deaths related to opioid addiction are preventable with public health intervention. Drug addiction is a multifactorial health issue caused by a multitude of different situations. Individuals impacted by opioid addiction often lack sufficient social support systems, suffered previous serious injuries, and are victims of poor prescription practices. Without interventional activities, an addicted individual could end up dying from a drug overdose. There are currently several populations disproportionately impacted by opioid dependence and opioid overdose.Several populations are more vulnerable to struggling with drug addiction. A specific population at an increased risk within the United States are veterans. The Department of Veterans Affairs has an entire unit dedicated to overcoming drug abuse in veterans. The organization states that veterans experience Post-Traumatic Stress Disorder (PTSD) as a result of their service to their country. These individuals are more susceptible to drug use. This increased use could pose threats to their lives. Additionally, as a person is exposed to more stressors, the more that negatively impacts their health outcome.Opioids are powerful drugs. Many of them serve as integral aspects of pain-relieving treatment in the United States. However, there are drawbacks to these powerful compounds. According to the Centers for Disease Control and Prevention, in the 1990s, the number of prescriptions written out for opioids began to rise. A rise in prescriptive practices correlated with the increased mortality due to opioid overdose. Since the discovery of opioids as an effective treatment for pain management, there have been issues with abuse, addiction, and overdose. As a nation, the United States is currently trying to combat this public health crisis.A rule recently proposed by the Department of Veterans Affairs dealt with opioid addiction in the veteran population. As previously noted, these individuals are at an increased risk of addiction and overdose with opioids. The proposed rule would eliminate copay requirements for veterans seeking help for opioid addiction. Additionally, copayments would not be required for the obtainment of opioid antagonists. Common opioid antagonists are Naltrexone and Naloxone. Drugs like Naltrexone and Naloxone act in opposition to opioids. Opioid antagonists allow for the reversal of the negative impacts of opioids. If using extended-release versions of these drugs, they can cost hundreds to thousands of dollars. Veterans are typically older Americans who are already on restricted incomes. Adding this expense could push their budgets to the max. Eliminating the copay for Naltrexone and Naloxone could not only reduce the cost burden for veterans but also save their lives.The number one cause of opioid dependence is related to pain management. Veterans experience injuries that persist well after they return home. We must ensure they have access to all of the services that they need to live a happy and healthy life. These high-risk individuals should have adequate access to opioid antagonists. Veterans should also have access to counseling and educational information on the subject of opioid addiction. We must fight for those who fought for us!", "comment_id": "VA-2020-VHA-0023-0009", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0009", "comment_date": "2020-11-18", "comment_time": "05:00:00", "commenter_fname": "Kaitlyn", "commenter_lname": "Eckley", "comment_length": 4228}, {"text": "Opioid overdose death rates in the veteran population have increased over 65% since 20101 which is of particular concern after noting the already increased risk veterans are placed at for developing comorbid mental health conditions. The Department of Veteran Affairs has many initiatives in place for combatting this problem, but there remains the issue of opioid use specifically as research is continuing to show that current efforts (such as decreasing prescription provision) are not sufficient in reducing this phenomenon. This proposed rule would eliminate the copays needed for veterans covered under the VA to access potentially life-saving drugs such as naloxone, an opioid antagonist that could bring an individual out of an active overdose. While available without prescription, naloxone can cost individuals hundreds of dollars without insurance in some locations, and even with insurance can be costly. Previous research in the veteran population has shown that increased copays can decrease not only medication adherence, but medication seeking2. If the goal is to protect our veterans from the harm of prescription drug misuse, the answer shouldnt be making it more difficult to access ALL medications, but instead making those that are helpful and potentially life-saving more accessible. The military experience, as researchers have described it, puts veterans at a unique risk for developing mental health conditions that adversely affect their daily life and can drive other inhibiting factors such as homelessness or poverty3. The logical and data-based solution that exists to help prevent these factors from interfering with an individuals ability to access necessary healthcare is to eliminate copays when capable3,4. We see that the opioid epidemic is showing no signs of slowing down and we know that since 2017 there have been staggering trends in overdose fatalities even without considering veteran status. Adding this in, it seems only logical that this step, eliminating copays for opioid education resources and antagonist agents, be taken to protect those that spent their life protecting us. This proposed rule does, however, indicate that these waivers would be applicable to those indicated as high risk and does not have current definition about how those identifications would be made, which is where I think there should be further discussion. Previous research has discussed the different conditions that are unique to veterans regarding opioid use as well as how veterans are at a higher risk level than many for disabling conditions upon returning from service3. This prompts me to question the necessity of this inclusion for this proposed rule. Why must an already-established high-risk individual be re-classified into a second tier of high-risk to access resources that should be available to all? What separates risk level when you are involving an already high-risk group of people? Why do we need to sever the resources within this population? Arent all at a high enough risk to justify their deserving free resources to protect their health? This proposition also includes leverage about education. I think this is an extremely valuable consideration and am so glad to see that the VA is wanting to educate those at risk of opioid misuse on ways to prevent overdose as well as how to respond in the event that those efforts arent successful. That said, why are these services not currently being provided, and if they are to be in the future, why is a copay even necessary? What message does that send our veterans? This proposed rule about eliminating copay requirements for opioid antagonists and educational services about their use is extremely encouraging and a giant leap forward in my view. What I want to focus on moving forward is why we are still considering only providing this accessibility to some, and not to all. Is it necessary to classify at-risk individuals by who has the most risk, when in reality they all are in need of help? Is it really that much of a stretch to provide this service to all veterans? Can we not work together for all and not just for some?1.https://doi.org/10.1016/j.amepre.2019.01.0162.https://doi.org/10.1161/circulationaha.108.783944 3.https://doi.org/10.3109/10826084.2013.796991 4.https://doi.org/10.1161/circulationaha.108.829655", "comment_id": "VA-2020-VHA-0023-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0008", "comment_date": "2020-11-17", "comment_time": "05:00:00", "commenter_fname": "Kyle", "commenter_lname": "Caldwell", "comment_length": 4602}, {"text": "The Opioid Crisis in the United State is getting worse every day. Studies show that individuals with mental health illnesses have a higher chance of developing comorbid conditions like substance use disorders.  Risk factors for mental health illnesses consist of both stress and trauma (NIH Comorbidity: Substance Use Disorders and Other Mental Illnesses DrugFacts) that are commonly found in the Military experience. The 2014 JAMA Psychiatry study found the rate of PTSD to be 15 times higher than civilians. (NAMI Veterans and Active Duty)  Given this information, it is the duty of the Department of Veteran Affairs to eliminate copays for Opioid Antagonists and Education on Use of Opioid Antagonists free of cost", "comment_id": "VA-2020-VHA-0023-0006", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0006", "comment_date": "2020-11-12", "comment_time": "05:00:00", "commenter_fname": "Casey", "commenter_lname": "Capstick", "comment_length": 729}, {"text": "The elimination of copayment for opioid antagonist is critical for the progress in the United States. More specifically it is needed to prevent overdose among veterans and people affiliated with the Dept. of Veteran Affairs. Eliminating the copayment for opioid education will benefit people of all backgrounds but especially for people who may not have the funds to educate themselves on the dangers of opioid abuse. Proving the free education will prevent future overdoses and also spread awareness of the negative side effects of drug abuse. I would change the wording in the proposal from antagonist to something that is more relatable and not so demeaning to people who will interpret it the wrong way. Other than that, the proposed federal rule should be passed and will be very beneficial to society as a whole. ", "comment_id": "VA-2020-VHA-0023-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0003", "comment_date": "2020-11-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 819}, {"text": "Medical protocols that govern copayments to correspond with current legislative requirements. VA would be eradicating the copayment prerequisite for opioid antagonists equipped to veterans. These veterans who are at abnormal risk of overdose of a explicit medication or substance in order to setback the result of such an overdose. VA would also explain that no copayment would be mandatory for providing of learning on the use of opioid antagonists. The recommended rule would be a crucial part of VAs challenges to help veterans at an extreme risk of overdose.", "comment_id": "VA-2020-VHA-0023-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0004", "comment_date": "2020-11-09", "comment_time": "05:00:00", "commenter_fname": "Eugenia", "commenter_lname": "Cabrera", "comment_length": 567}, {"text": "While Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 already have eliminated co-payments for Veterans regarding Opioid antagonists, and the education of utilizing those lifesaving antagonists this rule would make the law clear in the VAs co-payment regulations, 38 CFR 17.108 and 17.110. This measure is critical in creating cross-governmental cohesion in the fight against the opioid crisis in our Veteran populace. According to the Veterans Administration, the use of Opioids by the VA has decreased sustainably in the past several years, which has led to a decline in Opioid use and addiction amongst our Veterans. The availability and education on the use of Opioid antagonists would only further this fight against addiction and potentially save the lives of those suffering from Substance Abuse Disorder.  The amendment to Section 17.110 paragraph (c)(12) adding a clear definition to whom is characterized by high risk is also an essential step in ensuring that any Veteran needing these measures will have the availability of lifesaving opioid antagonists afforded to them.This proposed rule to amend 38 CFR 17.108 and 17.110 only solidifies the message of a united front against the opioid crisis in our Veteran community, and it secures that the policies enacted by Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 remain intact. ", "comment_id": "VA-2020-VHA-0023-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0005", "comment_date": "2020-11-09", "comment_time": "05:00:00", "commenter_fname": "Suzanne", "commenter_lname": "Kleisch", "comment_length": 1400}, {"text": "The U.S. Department of Veterans Affairs (VA) proposal for this rule change is a great idea to remove the barriers to treatment faced by veterans. Removing copays and providing education are two strategies that could potentially improve the health outcomes of veterans battling opioid use disorder (OUD) which leads to opioid overdoses. We must combat the factors that may deter veterans from receiving treatment. This proposed rule to, provide education on the use of opioid antagonists and to exempt co-payments, showcases the VA understands the need for prevention intervention strategies to remove the burden on the veteran population and their families. According to the Pain Management Opioid Safety VA Educational Guide (2014), veterans are more likely to die from accidental overdose than non-veterans.1 Research shows that veterans are prescribed higher doses of opioids and receive prescriptions for sedatives concurrently when suffering from Posttraumatic Stress Disorder (PTSD).1 This combination increases the likelihood for an accidental overdose.1 The National Institute on Drug Abuse found that barriers to opioid antagonist include stigma, lack of education, and lack of patient interest.2 Other research found that logistics, treatment experiences and beliefs, and knowledge of OUD medications also contribute to the lack of opioid antagonist use by patients and providers.3 The stigmas associated with OUD and high out-of-pocket cost were the most common barriers for patients.3 A common drug to reverse the effects of opioid intoxication is naloxone, commonly known as Narcan. In 2013, the Substance Abuse and Mental Health Services Administration started to recommend providers prescribe this drug to patients taking opioids.4 The cost of Naloxone product have been increasing since 2009. Currently the version manufactured by Kaleo has increased from $690.00 USD in 2014 to $4,500 USD in 2016.4 This life saving drug can cost a veteran hundreds of dollars with insurance and be even more costly without it. The goal should be to improve the health outcomes of all veterans. Making sure they can afford their medications is one way to do this. Removing the co-payments from inpatient hospital care, outpatient medical care, and for medications will remove the barrier veterans face when trying to receive care. A large majority of veterans deal with homelessness and poverty after service. It is understandable that these veterans will not have insurance that will cover these treatments. The lack of knowledge about OUD medications contributes to the absence of opioid antagonist use by patients and providers. Research found that the lack of knowledge pertained to where/how to get treatment and negative views of OUD medications.3 Providing education will give veterans a sense of involvement and control over their treatment. Educating on the use of opioid antagonists to reverse the effects of overdoses of specific medications or substances will improve the health literacy of veterans. With the epidemic on opioid overdose continuing to rise it is important that we create legislation to combat it for the most at risk populations. Veterans volunteer their lives and time to protect the United States and it is our duty to protect them when they return home. Many veterans suffer from injuries, both physical and mental, while in service to this country, that lead to their prescription and addiction to opioids. They come back from war and suffer from stress, anxiety, pain, trauma, which tarnishes their mental health. The proposed rule by the VA to eliminate co- payments for inpatient hospital care, outpatient medical care, and for medications and providing education on opioid antagonists gives us the opportunity to do just this. As a daughter to two veterans and a family member to multiple veterans from varies branches of the military I believe this proposed rule will be impactful to veterans battling OUD.References1.Pain Management Opioid Safety VA Educational Guide . U.S. Department of Veteran Affairs ; 2014. 2.NIDA. Substance Use and Military Life DrugFacts. National Institute on Drug Abuse website. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life. October 23, 2019 Accessed November 18, 2020.3.Mackey K, Veazie S, Anderson J, Bourne D, Peterson K. Evidence Brief: Barriers and Facilitators to Use of Medications for Opioid Use Disorder. U.S. Department of Veterans Affairs ; 2019. 4.Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone  Risks to Efforts to Stem Overdose Deaths. New England Journal of Medicine. 2016;375(23):2213-2215. doi:10.1056/nejmp1609578 ", "comment_id": "VA-2020-VHA-0023-0013", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0013", "comment_date": "2020-11-18", "comment_time": "05:00:00", "commenter_fname": "Patricia", "commenter_lname": "Thomas", "comment_length": 4895}, {"text": "Comment on Government Agency Document with Request for Public CommentThe Department of Veteran Affairs (VA) proposes a rule amending medical regulations to eliminate the copayment requirement for opioid antagonists furnished to veterans at high risk of overdose. The purpose of this rule is to help veterans at high risk of overdose by eliminating barriers to this medication. High risk of overdose is defined by provider diagnosis of either current opioid dependence or treatment as well as a history of prescription drug or other substance misuse. Elimination of this copayment is an important step in protecting veteran patients with a risk of opioid overdose. Opioid overdose is a well known blight in our society. Opioid prescriptions have long played a role in long-term treatment of patients with chronic and severe pain. While more and more literature shows the downsides of this prescription practice and CDC guidelines work to stem opioid prescriptions, the healthcare system is nonetheless forced to attend to the amount of patients currently reliant of opioid prescriptions and their associated health risks. A multi-faceted approach attending to long-term pain management solutions and short-term patient safety concerns is necessary. One of the short-term needs for patient safety is protection against opioid overdose. According to the CDC, 47,600 people in the U.S. died as a result of drug overdoses involving opioids in 2017. While overdose-related deaths decreased 4% from 2017 to 2018 (CDC, 2018), the problem is not going away anytime soon. Naloxone is an over-dose reversing drug available by prescription for patients at high risk for opioid overdose. This medication is an acute response to a patient immediately after overdose and accessibility is indispensable. Essentially, this medication only works if it is readily available when an overdose occurs (CDC, 2019). Trends in naloxone prescription as studied by the CDC show that while prescription rates have increased from 2012 to 2018, there are significant differences in dispensing naloxone between states and counties despite consistent state and national laws. Studies show that nationwide, only one naloxone prescription is dispensed for every 70 high-dose opioid prescription (ie. High risk patients for opioid overdose). Also a significant amount (71%) of Naloxone Medicare prescriptions require a copay, compared with commercial insurance. From these studies, we can see the barriers to access that must be overcome in order to provide safety measures to patients at high-risk to opioid overdose. So how do veterans fit into this picture? Veterans are a high-risk population for both opioid use and abuse. According to the October 2018 statement from Robert Wilkie, Secretary of Veterans Affairs, veterans are 40% more likely to experience severe pain than non-veterans while nearly 50% of older veterans carry some form of chronic pain diagnosis. Moreover, veterans are twice as likely as non-veterans to die of opioid-related drug overdose. Pain recovery and risk of opioid addiction are complicated by co-occuring mental health disorders such as anxiety, depression, and post-traumatic stress disorder (Henson, 2020). These factors all set up a picture where veterans should have extra protection and access to safety measures such as Naloxone.Therefore, the Department of Veteran Affairs decision to eliminate the copay for opioid-reversal agents, such as Naloxone, is a hugely important step in supporting veterans at high-risk for opioid-related overdose. By eliminating the cost barrier to access, Naloxone is more readily available to be picked up by patients and it will be able to stand by in the medicine cabinet to do its job as needed. Moreover, this move is a statement by the VA of support of their at-risk patients that they value the availability of this life-saving medication and their patients lives over the cost of this drug. Next step is to incentivize increased Naloxone provider prescription levels!", "comment_id": "VA-2020-VHA-0023-0015", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0015", "comment_date": "2020-11-19", "comment_time": "05:00:00", "commenter_fname": "Evdokyia", "commenter_lname": "Hail", "comment_length": 4041}, {"text": "The U.S. Department of Veterans Affairs reported a 64% reduction in opioid use since 2012. This public information was released on July 30, 2020. The significant drop was a result of altering treatments for chronic pain. VA Secretary Robert Wilkie said, collectively, uncontrolled pain, distress, and functional impairments can reduce the quality of life of Veterans and their families, increasing the risk for overdose, substance use disorder, and suicide. The Opioid Safety Initiative also showed results of a decrease of 87% in opioid use. To prevent opioid overdose, Veterans have been given naloxone through the Opioid Overdose Education  Naloxone Distribution program. On June 30, 2020, the Drug Take Back Program reported over 193 tons of medications returned by Veterans. VA pharmacies have been conducting outreach visits and follow-ups with Veterans and staff on the effects of opioid overdose, safety when using the drug, and what and how to use naloxone. They have been working diligently to help reduce opioid use in this demographic. The Veteran Affairs Department has engaged in the opioid crisis for over 20 years. They have taken many measures to help assist Veterans who fall to opioid use. A key element is pain management and education. This area addresses self-care, improving skills, and support in pain management. The dept of Veteran Affairs provides complementary pain management treatments that discuss Whole Health and reduce pain through acupuncture, meditation, yoga, spirituality, tai chi, chiropractic care, and relaxation treatment. These therapies are put in place to improve mental health. By addressing mental and physical health simultaneously, there is hope that stress is alleviated, and there is an improvement in pain tolerance. The VA also encourages behavioral therapies to improve cognition, mindfulness-based stress, emotional awareness and expression, self-regulation, acceptance, and commitment. Behavioral interventions are expected to enhance the skills of mindfulness and understand where the pain is impacting the body. Guided Imagery is a mind-body technique that helps relieve pain and allows for visualization. Restorative therapies allow Veterans to treat pain through physical therapy, exercise, heating pads, and ice packs. Physical therapy and massages help relax muscles and joints to relieve stress and anxiety, improving mobility and strength. Veterans find relief through therapeutic exercises, aqua therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. There are many resources Veterans can use to help aid their mind and body back to good health without the use of opioids. For opioid risk mitigation, an option is the use of naloxone rescue treatments. Proper education on naloxone should be given with frequent observations and through medical records in EMR systems. Risk assessments for respiratory depression and risk reports should be done frequently with strict regulations. These individuals who are at a high risk of an overdose of a specific substance should be closely observed. Individual therapy and group therapy with like individuals can increase therapeutic benefits. Group therapy can help individuals overcome feeling alone and build camaraderie in battling addiction and refraining from overdoses. The importance of naloxone use is a priority. Veterans should understand what medication they are taking and why it is being used; strict follow-up care is necessary to avoid abuse and overuse of drugs. Eliminating the copayment will relieve a Veteran of the financial burden while under treatment. Veterans have sacrificed enough to protect the people of this country. It is our responsibility to provide proper healthcare and encourage healthy living. Eliminating the copayment will allow a Veteran to fight this battle with focus and determination. Treatment timeframe varies per situation, but when trying to heal the mind and body simultaneously, removing a stressor can increase the chances of a successful recovery. Veterans Affairs. Go to VA.gov, 3 Nov. 2017, www.va.gov/PAINMANAGEMENT/Veteran_Public/Complementary_Treatments.asp. ", "comment_id": "VA-2020-VHA-0023-0010", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0010", "comment_date": "2020-11-18", "comment_time": "05:00:00", "commenter_fname": "Fatima", "commenter_lname": "Akbar", "comment_length": 4229}, {"text": "The Supreme Court has generally recognized that Congress has broad constitutional authority to establish and shape the federal bureaucracy. Congress may use its Article I powers to create federal agencies and individual offices within those agencies, design agencies basic structures and operations, and prescribe, subject to certain constitutional limitations, how those holding agency offices are appointed and removed. Congress also may enumerate the powers, duties, and functions to be exercised by agencies, as well as directly counteract, through later legislation, certain agency actions implementing delegated authority. The most potent tools of congressional control over agencies, including those addressing the structuring, empowering, regulating, and funding of agencies, typically require enactment of legislation. Such legislation must comport with constitutional requirements related to bicameralism (i.e., it must be approved by both houses of Congress) and presentment (i.e., it must be presented to the President for signature). The constitutional process to enact effective legislation requires the support of the House, Senate, and the President. Even though the Department of Veterans Affairs is an executive agency, it is still subject to the same Congressional influences as a creature of statute under 5 U.S.C. 551. Under Public Laws 114-198 and 114-223, Congress properly enacted legislation that required the Department of Veterans Affairs to exempt copayments for: (1) opioid antagonizers for high-risk veterans;  and (2) educational opportunities on the use of opioid antagonizers. Thus, the VA was required to comply. The proposed rule ensures that Public Laws 114-198 and 114-223 will continue to be enforced. Furthermore, the  VA exercised its discretionary authority under 5 U.S.C 701 as an agency in explaining a definition of  high-risk veteran under the rules, as such a definition aids in the enforcement of the statutes. The VA, rather than Congress, is better equipped to devise such a definition as it is exposed to the difficulties veterans face. The judiciary has the ability to review this definition, if challenged, under 5 U.S.C. 706. However, any review would pass muster, as the definition is neither arbitrary nor capricious.  Thus, the VAs proposed rule is a fine example of an executive agency ensuring compliance with Congressional direction. ", "comment_id": "VA-2020-VHA-0023-0019", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0019", "comment_date": "2020-12-10", "comment_time": "05:00:00", "commenter_fname": "Cade", "commenter_lname": "Myers", "comment_length": 2408}]}, {"id": "DEA-2011-0015", "agency": "DEA", "title": "Classification of Two Steroids, Prostanozol and Methasterone, as Schedule III Anabolic Steroids Under the Controlled Substances Act", "update_date": "2021-12-02", "update_time": "01:00:55", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I find it very upsetting that you can just point a finger and do whatever you want. I dont do any illicet drugs or buy from black market sources. However, I do enjoy taking dietary supplements . When you can go to any store and buy alcohol and destroy your body, life and those around you it makes banning these supplements seem kind of silly. Basically you are forcing people like me who dont want to break any laws want to go to black market sources and buy things that are not regulated or safe. Why is it that women can buy hormonal products all day long which allows them to have sex unresponsibly but yet , a guy like me who is older cant help his body be healthy. Dont use teenagers as an excuse to help your ban. just regulate it and I.D. them. I shouldnt have my freedoms taken away because some people are ignorant and irresponsible with how they use certain products. Kids are getting high on nutmeg for gods sake and you can overdose on it and die. ...just saying. please consider the freedoms we the people love and hold dear before waving your big magic wand .Warmest Regards, A concerned Taxpayer", "comment_id": "DEA-2011-0015-0003", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0015-0003", "comment_date": "2011-12-02", "comment_time": "05:00:00", "commenter_fname": "J", "commenter_lname": "Sanders", "comment_length": 1156}, {"text": "I support the Drug Enforcement Administrations proposed rule that would classify two steroids, rostanozol and methasterone, as anabolic steroids under Schedule III of the Controlled Substances Act (CSA).  If these two drugs became classified as Schedule III controlled substances they would be added to the list of anabolic steroids that must have regulated provisions of control according to the CSA. Tests have been done to show that these two drugs fit the four criteria that classifies a steroid as an anabolic steroid as defined by the Anabolic Steroid Control Act of 2004.  Adding rostanozol and methasterone to this list would make these drugs illegal to use or possess for anyone who is not following the regulation provisions of the Controlled Substance Act.  This could prevent the use, sell, and trafficking of these drugs to people who are not using them correctly and do not really need them.  Anabolic steroids are very dangerous when not used correctly.  They cause both physical and emotional problems, such as severe mood swings.  They are also very addictive and if anything can be done to keep these drugs out of the hands of people who will be negatively affected by them, it should be done.  This regulation would provide that help.  Therefore, I support this rule. ", "comment_id": "DEA-2011-0015-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0015-0004", "comment_date": "2011-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1294}, {"text": "The classification of these two substances as Schedule III Anabolic Steroids Under the Controlled Substances Act should be a no brainer. No opposition should be in place or have any merit. The damage these two types of steroids can ,and have done while not under proper supervision is great. One person has already lost their live and I hope we dont lose anymore. The longtime affects of misusing steroids is clearly known, but with no harsh penalties in place people will continue to abuse them. The immediate removal of all supplements containing  these two drugs should become top priority once the law allows. I look forward to reading in the future about how this proposed rule has been passed.", "comment_id": "DEA-2011-0015-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0015-0005", "comment_date": "2012-01-19", "comment_time": "05:00:00", "commenter_fname": "Mike", "commenter_lname": "Beato", "comment_length": 704}]}, {"id": "DEA-2010-0010", "agency": "DEA", "title": "Electronic Prescriptions for Controlled Substances", "update_date": "2023-01-05", "update_time": "11:20:14", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "For comments or questions, please contact Beki Marshall.", "comment_id": "DEA-2010-0010-0057", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0057", "comment_date": "2010-06-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 56}, {"text": "RIN 1117-AA61/Docket No. DEA-218I", "comment_id": "DEA-2010-0010-0117", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0117", "comment_date": "2020-06-04", "comment_time": "04:00:00", "commenter_fname": "Naomi", "commenter_lname": "Turner", "comment_length": 38}, {"text": "1. The knowledge-based form of the two-factor test is an archaic method of security. For instance, in 2018 the Hawaii emergency agency responsible for a missile scare had their password leaked because it was written on a post-it note on the monitor, and a photo of the monitor circulated the internet. Passwords are a faulty method that invites human error too frequently. An alternative to this form is a call system, where a physician can log-in to the system by dialing a number and a receiver authorizes the first factor of the log-in. 2. Remotely identity proofing to ensure service to rural areas sacrifices security. A major argument for Electronic Prescriptions is efficiency. In rural areas, where the doctor to patient ratio is more manageable than urban areas, the need for efficiency is minuscule. 3. Viewing a drivers license via video for remote identity proofing is not a secure method. Video and photos can be manipulated far too easily with current technology. 4. The record of the changes in the internal audit trail should be compressed to save storage space. 5. A practitioners access must be revoked also if it is discovered the practitioner accesses the system irregularly, using an algorithm that flags irregular activity. 6. N/A7. External USB devices should not be used for the two-factor authentication because they can too easily be compromised, and access will be revoked too frequently.8. Iris scans are a very secure method of identity and the current technology allows for broad use of this technique. This technique should be adopted for authentication.9. N/A", "comment_id": "DEA-2010-0010-0122", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0122", "comment_date": "2020-06-10", "comment_time": "04:00:00", "commenter_fname": "Troy", "commenter_lname": "Sims", "comment_length": 1703}, {"text": "Just a couple comments from an interested party on the reopened DEA EPCS IFR Comment Period; RIN 1117-AA61/Docket No. DEA-218I . An open ended question 7 was asked What types of issues have registrants encountered during the adoption and implementation of EPCS into their workflow, particularly where a prescriber uses an electronic health record (electronic medical record)?  and I would like to make 2 comments for this question.  1)I fully concur with the National Council for Prescription Drug Programs ( NCPDP) comments  and add additional verbiage on  the  1311.300 Application provider requirements - Third-party audits or certifications. Third Party Audit requirement are costly and burdensome to both the e-prescribing system vendors and the pharmacy management system vendors.   Vendors rarely, if ever,  make substantive changes in the EPSC system software unless the underlying  message standard changes.  Until CMS mandated the SCRIPT V2017071 standard effective 01-01-2020, there hadnt been a standards change, i.e. a substantive change to the EPCS processing since 2013, nearly 7 years.  However during that time period, vendors may have had to conduct as many as 4 additional audits depending on the timing of their audits.   Its costly and burdensome, with limited if any value.    I respectively request that the DEA reconsider this requirement  and remove the every two years requirement.   I would recommend that the new language would state that  audits are only required when substantive changes are made to the electronic prescribing of controlled substances functionality. 2)EPCS Renewal Request Issue:    Years ago, pharmacies were put at risk when a penalty was accessed to a pharmacy  for faxing forms to prescribers which facilitated the ease of prescribers approving refill requests. Basically the pharmacy sent a form, that the prescriber had to sign and return. It was deemed that this form in its current state could be considered the pharmacy prepopulating the prescription information  and was prescribing. There has been concern in the industry that this same risk exists with electronic prescribing of controlled substances RxRenewalRequest and RxRenewalResponse transactions, and that this could again put pharmacies at risk.   This process when done electronically is a completely different workflow than a faxed refill request.   The pharmacy is sending an RxRenewalRequest with fields mandated by the NCPDP SCRIPT standard to the prescriber which contains  consistent, relevant information related to the patient and the prescription to enable better decision making on the part of the prescriber.   The prescriber cannot sign this and send it back to the pharmacy.    The response must be an  RxRenewalResponse and it is a completely different transaction/message that is constructed and digitally signed by the prescriber and transmitted by its EHR system to the pharmacy.   Therefore, I would also concur with NCPDPs request that the DEA confirm the RxRenewalRequest message does not constitute pre-population and the use of this message type supports the DEAs mission to limit prescribing of controlled substances to circumstances of true need while obviating the need to resort to less secure, more vulnerable prescription-writing processes.", "comment_id": "DEA-2010-0010-0146", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0146", "comment_date": "2020-06-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3484}, {"text": "RE:  reopened DEA EPCS IFR Comment Period; RIN 1117-AA61/Docket No. DEA-218I . An open ended question 7 was asked What types of issues have registrants encountered during the adoption and implementation of EPCS into their workflow, particularly where a prescriber uses an electronic health record (electronic medical record)?  and I would like to make a comment for this question.   I would like to make a comment on the transfer of unfilled on file controlled substance prescriptions. The  North Carolina Board of Pharmacy Newsletter made comments stating their concerns to this  in their July 2018 (link: https://nabp.pharmacy/wp-content/uploads/2016/06/North-Carolina-Newsletter-July-2018.pdf ).  This article was then reprinted by other state BOP newsletters stating their concerns.  They stated the issue much more eloquently than I, so Ill quote them below.In April 2017, word began swirling that Drug Enforcement Administration (DEA) viewed transfers of on file CS as not allowed. On July 7, 2017, Loren Miller, associate section chief, Liaison and Policy Section, Diversion Control Division, DEA, sent an email to Carmen Catizone, executive director of the National Association of Boards of Pharmacy, setting forth DEAs view on the matter.In that email (which can be found at www.ncbop.org/ PDF/LMillerDEAGuidanceTransferofOnFileCS Prescriptions.pdf), Mr Miller states the view that Title 21 Code of Federal Regulations (CFR) 1306.25 allows a pharmacy, once it has filled an original prescription for a controlled substance in Schedule III-V, to transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . Mr Miller further stated that an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.As the pharmacy  industry is hesitant to engage in this practice of forwarding unfilled or filled controlled substances prescriptions without additional guidance and clarification,  I  would respectfully request that the DEA clarify the position their position on this and state rules by which this can occur. Thank you for your thoughtful consideration of my comments. ", "comment_id": "DEA-2010-0010-0147", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0147", "comment_date": "2020-06-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2449}, {"text": "Dear Sir or Madam:Please find our uploaded comments and supporting addenda with respect to the Electronic Prescriptions forControlled Substances Interim Final Rule; Reopening of Comment Period; RIN 1117-AA61/Docket No. DEA-218I.Respectfully,Ken Whittemore, JrSurescripts, LLC", "comment_id": "DEA-2010-0010-0134", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0134", "comment_date": "2020-06-22", "comment_time": "04:00:00", "commenter_fname": "Ken", "commenter_lname": "Whittemore", "comment_length": 325}, {"text": "First, I would like to thank you for looking of ways to better the Electronic Prescriptions for Controlled Substances (EPCS) system. As a Nurse Practitioner Student, I have been able to see how the EPCS system is used at multiple different clinical sites and speak to multiple providers on their opinions of the system. The EPCS has first off brought increased convivence to the providers. I have worked with providers that have used the traditional paper system and the EPCS systems. The convivence and efficiency that EPCS brings to the provider is something that they applaud over the traditional paper system. They report that is takes less time to use the EPCS system than writing a paper prescription with all the required information. The use of EPCS also eliminated the possibility of the patient potentially losing the paper prescription. Which could potentially leave the provider in a dilemma to write another controlled prescription if the original prescription was reported lost. This implementation of EPCS is also very convenient for the patient. EPCS simplifies the process for the patient and allows the patient to not have to present to the clinic to pick up a paper prescription. The patient just has to present to their local pharmacy to pick up their controlled substance just like any other electronic prescriptions. This efficiency is also beneficial in events like the current COVID-19 pandemic because it limits the interaction needed by the patient and limits potential exposure in immunocompromised patients. The Two-Factor Authentication system is something that I believe should remain in effect at this time. Speaking with multiple health care providers they report that is doesnt add increased workflow that is burdensome to the healthcare provider.  They reported the most difficult portion was setting up the system but once up and running it did not add an unreasonable amount of time to autheticate. Two-Factor authentication also adds another layer of security to the system that could prevent people from potentially compromising the system. The diversity of different authentication types is beneficial because it gives options to the organizations on how they want to authenticate. I have seen a Windows operating system being used with All Meds Electronic Health Record and DrFirst Medication ordering as an EPCS interface. They used a Symantec Token OTP hard token and a login and password as authentication factors. This has worked effectively with no errors in submission. They also have never run into any stock issues with local pharmacies in southern California.In summary, The EPCS system has been beneficial for both providers and patients. The ease of the program and the efficacy is something that should be continued and the continued usage of a two-factor authentication allows an added layer of security to the system with little burden on the healthcare provider once set up. I hope this information helps you make any future decisions in regards to the EPCS system.  ", "comment_id": "DEA-2010-0010-0106", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0106", "comment_date": "2020-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3082}, {"text": "The security concerns regarding electronic prescriptions are valid and the 2010 rule requiring two-factor authentication process made sense back then, but there are better alternatives today.  The main concern addressed by the two-factor authentication is to ensure that the right patient is actually getting the prescription rather than someone who just hacked the patients account. However, the two-factor authentication, either biometrics, passwords, or computer key, can be challenging for the elderly population who rely on prescriptions.  These challenges are likely to make it impossible for them to use electronic prescriptions and will continue showing up to the doctors.  Especially in todays world we do not want elderly people leaving their houses and going to the doctors office to get their prescription because of the risk that they will be exposed to others who are ill.  So, in order to keep the agencys goal of ensuring that the patient is the actual person receiving the prescription without adding a burden onto the patient, the doctor could electronically send the prescription to the patients pharmacy rather than having the patient receive the prescription themself.  An alternative to the current process of electronic prescriptions for controlled substances (EPCS) is to have doctors who are registered to prescribed controlled substances send the prescription directly to the patients pharmacy rather than to the patient directly.  Sending the prescription directly to the pharmacy reduces the risk of pharmacists prescribing forged prescriptions to someone who was able to hack the software and have a prescription sent to their device.  When a patient shows up to the pharmacy they could simply scan their drivers license/ID, and the pharmacists computer system will be able to determine which prescription the person needs.  The two-factor identification process should still be required for the doctors. In light of the technology available in todays society the two-factor identification process should not be as difficult on doctors.  A doctors office could very easily obtain the technology for a biometric scan as one of the two factors, or they can simply use a hard token such as a USB. This could make EPCS even easier for patients to refill their prescriptions as well as improving security to avoid misuse or abuse.  This will also reduce the burden on the patients.  Patients will no longer need any fancy technology to receive their prescriptions.  Their doctors can simply send the prescription directly to the pharmacy when the patient needs it.  The patient can then simply go to the pharmacy, show their drivers license or other identification card, and pick up their prescription. This will reduce the security risk of someone other than the patient obtaining the prescription as well as reducing the burden on the patient to have the necessary technology. In conclusion, the two-factor authentication for the patient should be removed and be added to the pharmacy.  The doctor should have to use two-factor authentication to send a prescription directly to the pharmacy and the patient will be required to show personal identification.  ", "comment_id": "DEA-2010-0010-0105", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0105", "comment_date": "2020-04-27", "comment_time": "04:00:00", "commenter_fname": "Chris", "commenter_lname": "Turnbull-solis", "comment_length": 3379}, {"text": "The re-evaluation of electronic prescriptions for controlled substances (EPCS) is a critical component to tackling the opioid crisis. Acceptance of prescription opioids continues to grow in our nation and use persists despite all the evidence we have around addiction and lack of long-term effectiveness.1 Tackling this opioid epidemic needs to start with how it is being prescribed. EPCS is one intervention to prevent abuse and addiction and decrease overdose in our nation.Currently, physicians are required to provide patients with handwritten prescriptions for controlled substances. But in a practical workflow, these prescriptions are not always handwritten, sometimes printed from an electronic health system (EHR) and just hand signed. These paper methods of prescribing controlled substances have been victim of fraud for quite some time. Prescription pads get stolen, handwriting has been forged, signatures copied. The wrong paper prescription falling into the hands of the wrong patient is one way addiction begins. In 2016, more than 11.5 million Americans reported misusing prescription opioids in the past year.1 Better regulation is needed to provide more security in controlling such addictive drugs.Moving to a model of EPCS presents as another disadvantage for independent community providers. This regulation furthers the monopoly of large system run practices in our communities. But at some point, we need independent providers to sacrifice this for the greater good of our public health. Physicians should want this type of regulation. It not only makes writing for controlled substances safer, but also easier.Currently the workflow for physicians to have to leave their electronic system to write a paper prescription is cumbersome to their productivity and patient wait times. Additionally, printing a prescription to hand sign is worse. The process for a prescription to be printed requires multiple steps. Within the EHR system, the physician can prepare the prescription on the EHR system to be printed, and instead of clicking send and the process being done, they have to fetch the printed paper prescription off the printer (wherever that printer is located within the office), hand sign it (with a pen that they never have readily available), and reenter the exam room to deliver to the patient (hoping the patient hasnt already started walking towards check-out). This valuable time could be spent answering messages, reviewing laboratory results, or other tasks that could help eliminate pajama time. Allowing for electronic prescriptions to be sent to the pharmacy for controlled substances would allow for better time management.But what exactly would that workflow look like? What options are there for two-factor authentication? What about failed transmissions? Why are we trying to figure this out? EHR vendors should have this solution. And if they do not have this solution, they should be creating the solution. We have entrusted these companies to make systems that do not burden our medical providers. These systems were meant to protect our clinicians. The EHR systems should seamlessly integrate this technology without any extra cost or licensure. This technology should just exist.Simply enough, we all know patients who have lost a written prescription. These get misplaced, lost, and often stolen from friends and family members. Currently, we do not have a good process for replacing these prescriptions and we do not have a good confirmation with the pharmacy system to know if this was inappropriately filled. Until we have a process that monitors the prescription and distribution of controlled substances, we will continue to see rates of abuse and misuse increase.2Most importantly, EPCS can help provide more data around safe prescribing. According to the Centers for Disease Control and Prevention, there were 191 million opioid prescriptions filled in the United States in 2017.1 This data shows we are currently able to access data on what controlled substances are being prescribed and filled, but we are not able to access data on the prescriptions that are being prescribed but not filled. We could get a better idea of physicians who are over prescribing this way. We can implement educational opportunities to providers we deem as high risk. This electronic tracking of controlled substances will provide us with more information in tackling the opioid epidemic.Overall, EPCS will help improve the safety of prescribing controlled substances while increasing the satisfaction of our physicians, pharmacists, and patients. Please take these comments into consideration when making further decisions on this regulation. Thank you.References:1.https://www.cdc.gov/drugoverdose/opioids/prescribed.html2.https://www.ncbi.nlm.nih.gov/books/NBK537318/", "comment_id": "DEA-2010-0010-0107", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2010-0010-0107", "comment_date": "2020-05-04", "comment_time": "04:00:00", "commenter_fname": "Carissa", "commenter_lname": "Russo", "comment_length": 4998}]}, {"id": "FRA-2001-11068", "agency": "FRA", "title": "U.S. DOT/FRA - Notice of Proposed Rulemaking", "update_date": "2021-02-10", "update_time": "01:34:21", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Docket Management SystemU.S. Department of Transportation, Room PL-401400 7th Street, S.W.Washington, DC 20590-001COMMENT:  FRA Docket No. FRA 2001-11068, Notice No. 3The Substance Abuse Program Administrators Association (SAPAA) appreciates the opportunity to submit comments in reference to 49 CFR Part 219 Control of Alcohol and Drug Use: Notice Inviting Comment on July 2002 Canadian Human Rights Commission Policy on Alcohol and Drug Testing; Proposed Rule.SAPAA is a non-profit trade association whose members represent all of the alcohol and drug testing service agents including third party administrators (TPAs), in-house administrators, medical review officers (MROs), Substance Abuse Professionals (SAPs), and manufacturers of testing devices. Our membership includes representation from Canada in all the above professions. Therefore, on behalf of SAPAA members (who represent well over 200,000 employers and more than 3.5 million DOT regulated drug tests) and the drug testing industry as a whole will take this opportunity to provide comments on the above referenced FRA docket.SAPAA General CommentsWe support to amend the regulation to narrow the current exemptions of certain operations by foreign railroads and small railroads from full application of FRAs requirement. We concur with your language Under the NPRM, an employee of a foreign railroad (a railroad incorporated outside the United States) whose primary reporting point is outside the United States (a foreign railroad foreign-based or ``FRFB employee), who performs train or dispatching service in the United States covered by hours of service laws would no longer be exempt from the pre-employment drug testing, random alcohol and drug testing, and employee assistance program requirements of part 219.We endorse foreign-based railroad companies complying with all regulations that apply to U.S. railroad companies. This is consistent with other modes of foreign-based transportation entering into the United States.The fact that a worker is from a foreign railroad foreign-based or FRFB employee does not remove the worker from risk or potential safety hazards associated with the use of alcohol or drugs of abuse. This discrimination in coverage between workers performing the same functions, which affect the lives and safety of every person on U.S. soil, is not only inequitable but lacks common sense.  We are very much for a regulation that applies the same rules to every worker who performs a covered function.We appreciate the opportunity to provide these comments and feel that your effort to tighten loopholes in the regulation will reduce the potential for serious injury and/or property loss.Sincerely, Ira Jane Hurst-Romero, C-SAPA, C-SIPresident", "comment_id": "FRA-2001-11068-0023", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2001-11068-0023", "comment_date": "2002-12-18", "comment_time": "05:00:00", "commenter_fname": "Jeffrey", "commenter_lname": "Morrison", "comment_length": 2921}, {"text": "Comments formulated through input from DATIAs Legislative and Regulatory Committee and DATIAs Board of Directors.", "comment_id": "FRA-2001-11068-0007", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2001-11068-0007", "comment_date": "2002-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 123}, {"text": "Canadian Pacific requires an extension of time to file comments regarding this NPRM since the Regulatory Impact Statement has not been made available as indicated in the NPRM preamble.", "comment_id": "FRA-2001-11068-0003", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2001-11068-0003", "comment_date": "2002-01-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 194}]}, {"id": "FDA-2022-N-1128", "agency": "FDA", "title": "Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment", "update_date": "2022-12-14", "update_time": "09:42:10", "purpose": "Rulemaking", "keywords": ["CVM", "Defining Small Number of Animals for Minor", "Use Determination", "Periodic Reassessment", "OPEN"], "comments": [{"text": "The article discussed the study of testing a small number of animals. The small number was around 80,000 for animal testing. This is considering a small amount due to the amount of testing that has to be done. The world is consciously growing with different products, diseases and etc. It is not safe to conduct on actual people, so animals are being used. I agree with the article keeping the numbers low. However, we cannot determine what is low. We do have to use animal for testings over humans. As long as the numbers are not to extreme with testing, I see no issue on this motion, ", "comment_id": "FDA-2022-N-1128-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0013", "comment_date": "2022-10-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 592}, {"text": "The FDAs proposal Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment is an important rule that can incentivize the animal drug industry to seek FDA approval. I agree with a portion of section  D. Costs and Benefits that the proposed rule may help pet owners who need FDA-approved animal drugs for their pets with special needs. Drug development incentives help animal drug testing companies better regulate their medication. This regulation is imperative to the health of animals receiving medication. The clause mentioned for sponsors is extremely efficient in terms of allowing annual renewal and requiring substantial evidence. In response to ways in which the FDA could change the quality, utility and clarity of the information, the absolute definition of what the increased size of animals will be, must be reiterated throughout the proposal. Furthermore, the proposal could benefit from emphasizing this threshold of animals as an adjusted number to define who could qualify for minor drug use. The other comments, although reactionary, have mistaken the small number of animals as a pool to test. This misconception could be further clarified in the beginning of the proposal. Alongside clarification of what the upper-level threshold, there should be a continued effort to say veterinary drugs, thus people will not believe this testing is for human use. Another feature of this proposal that should be amended is the timeline of the reassessment for the threshold. The reassessment of the numbers was conducted in 2018 to 2019. This timeline is before the COVID-19 pandemic, which had an increase in pet adoption and household pets. There should be an exception to the reassessment rule of five years if a known historical spike in pet ownership exists. According to the American Pet Products Association, the number of household pets has increased over 60% since 2019. (APPA, Pet Industry Market Size, 2021). This oversight may lead to another increase in the upper threshold for pets. The Brakke report indicated as well is from 2018, which leaves a gray area to the number of disease incidence that have occured.The annual designation reports to FDA, and the costs of minor use determination requests are explained and executed properly, but there should be more information on the one-time cost to reading and understanding the rule. This one-time cost should be prevalent in the docket as a specified measure. I ask, if the cost will change based on the price of the drug, the means of production for creating a drug, and the profit of an animal drug company. An imperative factor of this proposal I applaud is understanding the cost pet owners are paying for animal medication. The method to allow drug companies to bypass conditional approval and instead roll out new drugs on the basis of substantial evidence will be cost-effective to both the FDA and specific companies. This extra step helps maintain that increasing the threshold and drug production will also be accessible to the consumer. However, if there are many incentives for drug companies to release minor-use drugs quickly, what measures are used to stop drug companies from overpricing their product? How will an animal drug company be monitored from overcharging medication in order to create a greater profit margin? Although I agree strongly with this federal proposal, I believe it is a necessary step to increase the rate of animal drugs that are needed for rare cases. The proposal, however, needs to provide more information and clarify small points for accessibility. The explanation of what a small number of cats and dogs mean could be reaffirmed as to not shock people. More information towards the pet owner and cost protection would be important to add. The references used could benefit from newer journals that reflect the spike in pet ownership since 2020. This proposal should be a part of the regulatory process in order to help thousands of animals. ", "comment_id": "FDA-2022-N-1128-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0014", "comment_date": "2022-10-21", "comment_time": "04:00:00", "commenter_fname": "Vishali", "commenter_lname": "Muthuvinayagam", "comment_length": 4117}, {"text": "proposal is for killing 80,000 dogs and l50,000 cats in labs under this proposal. and you have the audacity to call that a smallnumbers. i find that egregious and the actions of mad scientists. a small number is l00 dogs, l00 cats. the usa public wants all use of any animals to be stopped entirely since the fact is the results of using animnals for drugs for humans makes zero sense. so that uwe can use cells and real people to do lab tests for human drugs and once we find out they are safe for humans then we can transfer them carefully to animals. stop this massacre of aninmals now. we need to stop mad crazy scientisst= from using this method developed in l500 a.d.", "comment_id": "FDA-2022-N-1128-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0008", "comment_date": "2022-09-19", "comment_time": "04:00:00", "commenter_fname": "Jean", "commenter_lname": "Publiee", "comment_length": 685}, {"text": "Food and Drug Administration21 CFR Part 516 [Docket No. FDA2022N1128] RIN 0910AI46Defining Small Number of Animals for Minor Use Determination; PeriodicReassessment AGENCY: Food and Drug Administration HHS.ACTION: Proposed rule.I am a concerned citizen of the US. I came across this proposed rule while searching for what was going on with animals in regulatory actions. It is common knowledge that most drugs for Humans are tested on animals first including dogs and cats before they have any kind of human trials as stated on the FDA site. I know from personal experience that animals use many of the same drugs and medicines that Humans do, considering that most drugs are tested on animals first which is not surprising. Your proposed rule is to revise the small number of animals definition for dogs and cats in your existing regulation for new animal drugs for minor use or minor species. For the purpose to provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or minor uses in major animal species. You want to revise the small number of dogs included in the small number of animals definition from 70,000 to 80,000 and the small number of cats from 120,000 to 150,000. The reasoning behind this is to market drugs earlier, which in turn could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions.While I understand the need for some animal testing for both human and animal drugs, 70,000 dogs and 120,000 cats are not a small number. What you are proposing to raise it to does not seem like much, until you want to raise it again in the future.  If the purpose is to develop drugs for uncommon diseases in dogs and cats is not 70,000 and 120,000 not enough? I do not think raising the number would have much of an impact on drug development if it had not already been done so. While you do have the option to revisit this in the future, maybe we should think of ways of lowering the number not raising it. I do believe using that many animals which is not a small number will lead to an inhumane place.", "comment_id": "FDA-2022-N-1128-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0015", "comment_date": "2022-11-04", "comment_time": "04:00:00", "commenter_fname": "Margo", "commenter_lname": "M", "comment_length": 2255}, {"text": "This rule seems like this would further the support for minor animals which is beneficial for owners of minor animals so I will support this rule. ", "comment_id": "FDA-2022-N-1128-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0009", "comment_date": "2022-10-03", "comment_time": "04:00:00", "commenter_fname": "Ian", "commenter_lname": "Epperson", "comment_length": 147}]}, {"id": "FDA-2022-N-0165", "agency": "FDA", "title": "Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments", "update_date": "2022-06-30", "update_time": "13:57:24", "purpose": "Nonrulemaking", "keywords": ["OPEN", "Request for Comments", "Establishment of a Public Docket", "Dispensed in an Outpatient Setting", "on Safe Disposal With Opioid Analgesics", "Providing Mail-Back Envelopes and Education", "CDER", "2021-715"], "comments": [{"text": "Comment regarding: Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient SettingI think that regulation requiring a Mail-Back Envelope to be provided with every opioid analgesic will create a lot of waste and burden on the retail pharmacy.  I think regulation should look at making every retail pharmacy be able to take back unused narcotics for destruction.  Certainly having prepaid envelopes offered to each patient is fine but requiring them to be given even if not desired is wasteful.", "comment_id": "FDA-2022-N-0165-0045", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0045", "comment_date": "2022-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 557}, {"text": "Whether there are specific opioid analgesic drug products for which requiring mail-back envelopes is more important from a public health perspective and, if so, which products. Although some opioids are more abused than others, all opioids have the potential to be abused or misused. Having exceptions will add confusion and inefficiencies. A pharmacist can provide a first-time education which can include the general purpose of the envelope, general information about unsafe disposal, etc. If there are exceptions, patients will come asking for help to sort or select the appropriate medications to place in the envelope. Patients will not retain after 6 months such details. It will be simple to have pharmacies stick a label stating: Must be safely disposed of according to the law. It is a single step that can be easily introduced into a pharmacy workflow. Patients will respond to a general call of disposing of by mail if there is a continuous message, not a bi-annual campaign.  It is more likely that a well-developed program that provides clear communication of the multiple alternatives to dispose of unused opioid have an impact. Repetition and reach are key to any public health effort. How pharmacies could develop and implement algorithms to determine when to provide a mail-back envelope, including how feasible or practical it would be for pharmacies to do so.How pharmacies could identify those patients who are most likely to have unused opioids to optimize the provision of mail-back envelopes to these patients and potentially positively impact the share of mail-back envelopes that are utilized to safely dispose of opioid analgesics. It can be difficult for a pharmacy to identify patients who potentially will have unused medicine. Therefore, pharmacies can have the envelope available and can target, based on past prescriptions, patients with possible unused opioids. As a one-time effort is great but not as an ongoing effort. Pharmacists promote in a general manner to dispose of all unused medicine and individually when providing medication therapy management (MTM). But not all patients have the benefit of an MTM service.  Whether requiring the provision of mail-back envelopes under the OA REMS should also include a requirement for patient counseling and/or provision of take-home materials on safe disposal at the point of dispensing.Having an envelope is a novel approach that will add cost to the manufacturer and to the dispensing of an opioid prescription. A pharmacist can provide a first-time education which can include the general purpose of the envelope, general information about unsafe disposal, etc. We need to look further into what causes residues or unused medications. An additional first-step strategy is to minimize risk and the possibility of having home residuals is educating doctors to prescribe fewer quantities for post-surgeries. A patient with a tooth extraction does not need a 7-day supply of therapy. A patient with shoulder surgery will visit the surgeon in a week, why give the patient 21-days of therapy?  The burden always falls outside the doctors realm. What pharmacists need is the capability of deciding approaches to avoid getting into the hands and homes of patients an amount of drug that, to start, is suspected and probable of converting to unused.", "comment_id": "FDA-2022-N-0165-0053", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0053", "comment_date": "2022-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3421}, {"text": "While I appreciate the intent of this proposed program, I dont think the implementation would work. People may lose or misplace the envelope and many people may never use them. This creates a lot of waste and doesnt address the issue. Instead, I think that it makes more sense to have drop boxes for all unused medication in every pharmacy and those can be incinerated. For patients who are unable to get to a pharmacy, having an envelope as described available on request would help them.  ", "comment_id": "FDA-2022-N-0165-0042", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0042", "comment_date": "2022-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 511}, {"text": "Do you really think that it is easier to store an envolope until needed, find the envelope when it is needed, place the contents in the envelope, and take it to the post office/mail box than it is to flush a few tablets down the toilet?  It sounds like a gimmick to get more money for the post office.", "comment_id": "FDA-2022-N-0165-0057", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0057", "comment_date": "2022-04-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 301}, {"text": "What you have done to the most needy population is criminal, chronically Ill people need their pain relief and because others use street drugs I have to lay in bed and cry in pain. Im in pain 24/7 because you have interfered with with my doctors ability to treat my pain properly your proposal doesnt go far enough to help the chronically Ill. I have considered suicide and considered street drugs I just havent gotten to the point that Ive made those moves. I dont want to leave my wife and daughters but Im not sure I can handle this pain much longer but you people dont care . Fuck You", "comment_id": "FDA-2022-N-0165-0063", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0063", "comment_date": "2022-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 637}, {"text": "The idea of providing mail-back envelopes with opioid analgesics is a great idea to minimize opioid medications from lingering in our communities.  I would desire to see the mailers be recyclable to minimize waste and unintentional negative impact on the environment.  I also would recommend making acceptance of the mailer voluntary for the patient for similar reasons since the majority of chronic opioid prescriptions dispensed to individual patients will be consumed.", "comment_id": "FDA-2022-N-0165-0065", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0065", "comment_date": "2022-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 471}, {"text": "Most pharmacies have drop boxes for returning unused medications. Because of the CDC guidelines and concerted effort to avoid prescribing pain medication to patients, there is little opportunity for diversion but much greater harm to patients as prescription opioids are now being overly policed by the DEA. Micromanaging every single pill dispensed to patients is a wasteful diversion from the true threat to public health from the manufacturing and trafficking of illicit deadly drugs, and it also interferes with the practice of medicine. If a pharmacy doesnt have a drop box, then mail back envelopes can be available at the pharmacy if asked for. Does the DEA now plan to start tracking how many prescribed pills that a patient takes? Will that become a new red flag for prosecution or justification for the DEA to make dosing recommendations which become de facto law?", "comment_id": "FDA-2022-N-0165-0062", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0062", "comment_date": "2022-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 879}, {"text": "This is an absurd, unreasonable, and wasteful effort. People can obtain methods to destroy unwanted medications from their pharmacies. This is unnecessary, a huge strain on pharmacies, and provides dubious benefit. Studies show the majority of diverted medications are from health care facilities, not consumers. This is an unreasonable attempt to mitigate a problem that doesnt exist. ", "comment_id": "FDA-2022-N-0165-0064", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0064", "comment_date": "2022-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 428}, {"text": "This is absurd. If you must send something to the patient then is should be an envelope or container that automatically renders drug unusable once place in envelope. Putting opioids into the mail in an envelope just increases risk of diversion. ", "comment_id": "FDA-2022-N-0165-0066", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0066", "comment_date": "2022-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 245}, {"text": "Waste of money and pharmacist time as a valuable resource.  Also, this creates more opportunities for theft of opioids as they are circulated through the mail system with SO many chances for them to be taken.  NOT a good idea for SO many reasons.  We have safe disposal options already.", "comment_id": "FDA-2022-N-0165-0068", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-0165-0068", "comment_date": "2022-05-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 286}]}, {"id": "DEA-2018-0005", "agency": "DEA", "title": "Controlled Substances Quotas", "update_date": "2021-12-02", "update_time": "01:00:45", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "EDUCATION, NOT PROHIBITION!! I am one of those intractable (aka high impact) pain patients. with severe and complex conditions who are only kept stable by high doses of opioids. Yet lately, because of the random musings of others who begin their diatribes against opioids, as a rule, saying, Im not a Dr. but.... Then off the non-doctors go on ignorant rants about numbers of pills rather knowing one thing about what those numbers of pills are quelling when used properly as ACTUAL doctors who HAVE studied pain know. By focusing on prescription opioids you are not stopping addicts deaths  you are making legitimate pain patients collateral damage in a war that is fighting the wrong enemy.Even the CDC has said as of May of 2017 that PRESCRIPTION OPIOIDS ARE NO LONGER CAUSING THE OVERDOSE DEATHS!! Please hear those of us who are not addicts but are medically using our prescribed opioids properly. One of the things I KNOW is right  true is that doctors are not getting enough education (because no one is waiting for the NIH studies that ONLY started about 3-4 years ago) about pain as a disease rather than a symptom (as called for in the National Academies [formerly the Institute of Medicine] 2011 pain care study Relieving Pain in America:  [link: http://bit.ly/2uA2WtY ]. Because of this failing, we have seen millions being incorrectly prescribed opioids (or not prescribed opioids when needed). Opioids are a tool - thats it. Like guns, they can be used for good or bad. Which is why my motto is EDUCATION, NOT PROHIBITION. As near as March 2017, Dr. Debra Houry of the CDC testified before the Energy and Commerce Committee, Oversight and Investigations Subcommittee stating this: Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. article entitled CDC: Painkillers No Longer Driving Opioid Epidemic [link: http://bit.ly/2w8W9Gz]Bottom line: If this trajectory of blindly stopping opioid PRESCRIPTIONS from getting to the people who - like me - have severe and complex health histories involving devastating chronic, intractable pain. YOU will be directly responsible for the heart attack and stroke deaths of millions of INNOCENT patients in America who did nothing wrong (who broke no laws, who were not addicts, who followed e-v-e-r-y rule).You and your subordinates will be responsible for their slow and tortuous deaths due to the unnecessary and inhumane forced reduction of these pain patients opioid pain treatments. You can not assign arbitrary numbers pills or milligrams to individualized people with pain conditions anymore than every cookie-cutter treatment works for every diabetic. Or cancer patient. Or thyroid patient.  Please THINK before responding to trouble with a knee jerk response. Thank you.   ", "comment_id": "DEA-2018-0005-0097", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-0097", "comment_date": "2018-04-23", "comment_time": "04:00:00", "commenter_fname": "Radene", "commenter_lname": "Cook", "comment_length": 3085}, {"text": "Hello,I am attaching comments already made by Dr. Richard Lawhern, PhD urging the DEA to stand down on further restrictions on the production of opioid pain medications. I am writing as both an emergency preparedness professional and a chronic pain patient who is able to enjoy a reasonable quality of life because of stable doses of this type of medication. Dr. Lawherns comments make the case much better than I. However, I want to specifically ask the DEA several questions:1. What data is being used to justify further restrictions?2. What is the analytical methodology?3. Who performed the analysis to justify further restrictions?4. What are their qualifications?I am also attaching a study I completed on the number of prescriptions issued in Louisiana in 2015. The annual number of prescriptions is often presented as a shocking statistic by Louisiana government officials to justify further opioid prescription limits. Simply stated, this view is patently indefensible. My simple model has been reviewed as valid by a number of pain management professionals and medical school faculty. Bottom line: The DEA has already caused critical shortages of injectable opioids used in hospitals for pain management before and after surgery. Beyond the suffering caused to patients, it has directly contributed to patient deaths due to compounding errors by hospitals attempting to cobble together these important drug regimens. If that was the goal of the DEA restriction - good job.I am also attaching an article by Jeffrey Singer that debunks the basis of the DEA proposal. You are chasing the wrong problem. Perhaps I would suggest that the DEA focus on their intended mission - stopping illegal drugs. Stand down from torturing chronic pain patients, hospital patients, hospice patients, cancer patients, trauma victims, mothers, and other that absolutely need these medications.Thank you for the opportunity to comment.Henry Yennie312 Lovers LaneBaton Rouge, LA 70806", "comment_id": "DEA-2018-0005-0134", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-0134", "comment_date": "2018-04-23", "comment_time": "04:00:00", "commenter_fname": "Henry", "commenter_lname": "Yennie", "comment_length": 2093}, {"text": "Ive been on pain meds for 7 years..as a LAST resort...ive done EVERYTHING recommened by my dr.s and specialists...ive had 4 major spine surgeries...including a total neck replaced...i was in a headon car crash with a big truck..i was in a small car..toyota...no seatbelt..when i was 18...1983...ive NEVER taken pain meds and went to chiropractors 2..3..s a week...and worked 25 years....in 2004 i fell sideways off a high curb carrying my autistic st son...breaking my back...i had lumbat surgery...and discontinued opioid pain meds...i continued chiropractic care for my neck..My lumbar surgery totally failed and desperately needed another one...Which i had...a year later...2011...every disc in my neck came out...3 went into spinal cord 3mm...after i bumped my forehead.....an emergency total neck replacement done...i developed tumors/cysts on my sp.cord..and all over my spine in neck..thoracic..lumbar...my discs have deteriorated...bone spurs develpoed....excess swelling in spine...I discovered that BPM...by MEDTRONICS was used in my lumbar...my 1st surgery...which is poison in my spine...highly toxic....i have severe nerve..muscle damage...sevete stenosis..cysts on cord...whole spine arthiritic..fusing together....i am in so much pain....i dont want to live....i was tapered off meds..due to epidemic...This is not right...my doctor had tears in her eyes when she told me that everyone is being tapered off pain meds...by 2018...and ive tried Tramadol....it did NOT help....but hurt my kidneys...i take 20 to 30 ibeprofens a day..plus otc tylenol....i will die soon.....from either lidney failure or heartattack...as my pain is so bad..my BP is extremely high....ive raised 4 children...2 were my step sons...they both have autism..whom had to be placed in foster homes now...because of this...Please listen to us...Ive heard so many mothers whom lost their teens to prescription drugs...including a cousin of mine...where the teen will become addicted from an injury...or take them right from the cupboard at home...etc...HOW COME THESE PARENTS ARE NOT BEING CHARGED?...EVERY BOTTLE OF OPIOIDS SAY TO LOCK UP YOUR MEDS!!!!....etc....why do we..us chronic sufferers...have to pay for it now???....PLEASE LISTEN TO US CHRONIC PAIN SUFFERES....WE JUST WANT TO LIVE...AND NOT SUFFER...WE ARE RESPONSIBLE...AND NOT ADDICTS...Doctors just NEED to be trained better on reading mri s...xrays...medical reports...and trained on how to determine if the patient is in chronic pain.....instead of cutting us all off....i really do not know how much longer i can live like this...ive enclosed a photo of my neck replaced...which is extremely misaligned...causing severe NERVE damage...pain...and a pic.of me..bedridden..swollen neck...with cysts...or tumors...i was taken off my opioid pain meds in this condition...because of this epidemic....its inhumane...abuse...", "comment_id": "DEA-2018-0005-0577", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-0577", "comment_date": "2018-04-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2897}, {"text": "DEA has no reliable way to determine whether or how much any controlled substance is diverted to non-medical use.Hospitals are experiencing shortages of scheduled drugs and patients are being endangered because of past unjustified restrictions on production. The DEA is at fault. Restrictions on medical supply are ineffective and unjustified.Actively managed pain patients are almost never involved in opioid overdose-related deaths, and in the few cases where they are, it id plausibly as a consequence of under-treatment of pain and depression, forcing the patient to seek relief in street markets.  DEA has already damaged countless lives by creating a hostile regulatory environment, driving doctors out of pain practice and forcing the discharge or coerced tapering of patients in agony. Withdraw DEA proposed rule making.  It is counter-productive and inhumane.", "comment_id": "DEA-2018-0005-0645", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-0645", "comment_date": "2018-04-27", "comment_time": "04:00:00", "commenter_fname": "Mona", "commenter_lname": "Twocats-romero", "comment_length": 883}, {"text": "I am a CMT, 45 yr old and over 20 yrs sober. I am a chronic pain patient. I am submitting this comment not for myself but for others to have the right for proper pain mngt. I dont use pain meds any more due to the help of natural alternatives like kratom, skullcap, kava, magnolia bark and many other herbs but I do support patients who chose to take Rx for pain. I was on opioid meds since 1999 and 3 yrs ago I eased off all of them and onto herbal teas and supplements. I didnt experience any WD except from gabapentin. I never sold or bought opioid meds when I was on them and I do not believe I ever became addicted to them. The statements taking an opioid for longer than 3 days turns you into an addict is the far from the truth. I run a group Kratom United, we grew to 2,000 members in 2 yrs but in the past yr our members shot up to over 7,000. I have heard from CPP whove been abandoned by their Drs, fired, let go, cut off their Rx or tapered way down and seeking a safe alternative since the medical community have turned their backs on them. I was given the choice to switch to natural alternatives but many of my members were not granted that luxury. I have had so many members share stories of their Pain Warriors committing suicide in the past yr and I dont see it slowing down. I also have a veterans group Veterans Care Alliance Botanicals where we send care packages to veterans whove been tapered down or cut off their Rx pain meds AND benzos for PTSD. I am getting reports their BP is rising stroke or near stroke levels, vets are committing suicide. This is no way to treat someone that fought for our freedoms and to yank away their quality of life. Some even at the end of life. I have friends who are or family are going through chemo and radiation whove asked their oncologist, PCP or pain mngt doctors for help with pain associated with their cancer treatment and were denied! I honestly believe this is genocide of the sick and weak and this is NOT helping the opioid epidemic but its driving people in pain to the streets who are seeking pain relief NOT drugs. Driving people to seek relief on the black market is sending them to drug dealers selling fake pills laced with illicit fenyntal and heroin. If addicts steal pills or buy heroin laced with illicit fenyntal who are you saving and who are you punishing? The CDC reported opioid OD on the rise yet failed to report the number who died from illicit fenyntal. The CDC reported OD from prescription opioids but failed to report the number who died from their own prescription and how many died from stolen Rx. Hospitals are running out of opioids to treat patients who are coming out of surgery, they are running out of opioids to treat major trauma, patients are even postponing elective surgeries due to fear of NOT having adequate pain mngt after a surgery and to be honest I am one of them. I have a torn rotator cuff and need surgery but out of FEAR of not having proper treatment after surgery I have not had the surgery.  I work with people who are ready to get clean and rarely do I get someone who are addicted to their own prescription opioids. This whole restriction on opioids is punishing pain patients NOT saving addicts, and do you really think saving an addict over punishing a pain patient is the moral thing to do? when I was on opioids I was on 100 mmg fenyntal, 120 mg Oxycontin and 40 mg endocet. I was told because my metabolism is so fast, Rx exit my system at a higher rate than your normal person.   90 mg a day is NOT adequate pain mngt for chronic pain! Allow Americans in pain some dignity and the choice if they want opioid pain mngt or herbal pain mngt. Each time I get online I see another person committed suicide and what your doing by limiting legit pain patients safe access to opioid meds is contributing to deaths and the real opioid epidemic which is from illicit drugs like herion and fenyntal analogs not even manufactured in a US lab or from a US Dr prescription. My comment is not to protect my own access to pain meds, its to protect the rest of the American pain patients rights to pain mngt. Please stop this attack on pain patients and allow chronic pain and cancer patients some dignity most at end of life a some what quality of life. {please omit my name and files to the public}", "comment_id": "DEA-2018-0005-0791", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-0791", "comment_date": "2018-04-30", "comment_time": "04:00:00", "commenter_fname": "Kelly", "commenter_lname": "Devine", "comment_length": 4400}, {"text": "I am a chronic pain patient first of all. but prior to that I worked in healthcare since I was 18 years old. the DEA present course of actions if allowed to continue will make life even more unlivable than it already has for chronic pain patient. My Dr closed his practice last April for fear of DEA retribution. if the DEA had been doing it job all along things may not have gotten so out of proportions. it is however a fact of record that prescriptions peeked in 2012 and and have steadily declined every since.  Furthermore the death stats for 2016 were very clear that deaths were on the rise for illicit fentanyl and heroin. yet every news meeting keeps screaming government rhetoric that it is prescription opiods are the cause of death. Also it has been proven that less than 5% of the population becomes addicted to prescription pain medication.It is my understanding with the exception of Prince almost all of the high profile deaths involved alcohol that is legal. However there are as many studies that prove that people tend to develop drug seeking behavior when their pain medications needs are not met.The DEA allowed CVS and Walgreens pharmacies to run for years with hundred of thousands of missing controlled drugs. When you consider both companies are worth billions of dollars the fines they paid were miniscule . I have been in pain management clinic since 2010. Another pain Dr wasted almost 2 years of my life with repeated tapering every month. New pain Dr told me a DEA agent told one of my Dr that they did not care who suffered or who committed suicide that they ( the DEA ) were going to get the drugs off the street.I cannot take marijuana, I cannot drink. I only take what I must for pain. because of the DEA enforcing CDC guidelines that were intended ( so the public was told ) for general practitioners starting new opioid therapy have some how morphed into a bible to justify the DEA war against doctors and patients. this is not about prescription drugs anymore. this is about power. This is about the government not wanting to pay for medications necessary for some of us on Medicare.Somewhere along the way the government realized that disabled people are on medications.  This seems to be some form of government depopulation. Already hospital have to triage and restrict who gets pain medication due to insufficient supply- further reductions could result in patients having surgeries and being left to scream in agony simply because there is not medication available.I am drug tested monthly and my pills counted. the DEA has everyone convinced that responsible pain patients are diverting our medications. the CDC guidelines have made no provisions for the 100 million chronic pain patients, that 1.5 million are on greater than 200 MME. yet our government will spend a billion dollars dropping bombs in Syria over the death of 70 people who died heinously. I submit to chronic pain patient are suffering a slow, heinous death at the hand of DEA agents hopped up on righteousness and testosterone. The fact that there was only a 2 week public opening for comments aligns this move as more socialist than a democratic based government. Actually all the actions by the DEA in the past 5 years have followed a socialist agenda. The FDA and the DEA failed to intercede until the CDC was tasked with drawing up the guidelines. Canada drafted and and adopted opioid prescribing guidelines in 2010  were the DEA and FDA not aware of this.Furthermore my pain medication are subtherapeutic as of right now because of the DEA enforcing the CDC guidelines as law, stalking Drs about quantity, drug and drug combinations. I was forced to stop taking benzodiazepines because of the DEA enforcing guidelines as laws. the DEA agents have no medical training or a right to question what combinations are therapeutic. The DEA need to cease and desist in there actions on prescription medications. anymore effort should be direct at the illicet Fentanyl and heroin that is the true cause of deaths in the United stated. you cannot penalize the entire country for the misappropriation of prescription narcotic in 5 state. The world is watching the Democracy of the United states create guidelines and implement a socialist agenda for a desired outcome without accurate scientific support. it is time place moratorium from any other government actions until the death stat fro 2017 are released to the public. I read on a Johnson and Johnson site last night that was citing the stats so they must have been released preemptively which is why the DEA only allowed 2 weeks of open comment. The US that has always argued against cruelty in other countries is looking like a fool to those countries now.", "comment_id": "DEA-2018-0005-1325", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-1325", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Janice", "commenter_lname": "Anonymous", "comment_length": 4771}, {"text": "Dear DEA,I have had 29 left knee arthrotomies, 12-15 left knee arthroscopes, 6 right knee arthrotomies, 6 right knee arthroscopes, left finger trigger release, digits 3 and 4, back fusion, 2 nasal reconstructions and some other surgeries.  I had my left knee replaced in 1993 and need another left knee replacement, a right hip reconstruction, a left shoulder repair, bone spurs in my right and left foot, carpal tunnel in both right and left hands.  I have been on crutches since 8-13-1982 (Friday the 13, 1982 was the day I had surgery and have not been off crutches, which is 36 years of dragging myself around on crutches and damaging my elbows, shoulders, wrists, and hands and have the matching nerve damage to go with it).  I have Plantar Fasciitis on both the right and left foot as a result of back surgery which is common and I developed bone spurs.  I have tried the DTAP treatment.  The first 3 treatments helped my right foot which is the foot I can weight bear on and the last 2 treatments have not helped.  I might qualify for the Tenex procedure which is very expensive. I cannot have the hip reconstruction because I cannot weight bare on my left leg.  I cannot have the left shoulder repaired (which was damaged because of a doctor giving me a drug overdose after my 8 1/2 hour back reconstruction, in which I was opened from the front of me and the back).  The doctor never apologized for the drug overdose.  The doctor told my mom while I was on life support that he gave me the overdose, on the 4th and 5th day he began to lie about what he did to me.  I was given 2 other drug overdoses by doctor/nurse incompetency and those people didnt take responsibility for their mistakes.  As a result of the last drug overdose where my heart stopped and I did not get the oxygen to the brain I have the lovely side effects of having lost my extensive vocabulary, ability to be excellent with my grammar skills, remembering relatives names, places I have been, geography, movies I have seen, books I have read, and conversations I have had. I originally fell down a cliff at age 15 in 1978 when the guide took us off the trail and instead of getting me help he had me walk on my ripped up knee for 12 more days.  I was rebuilt and working as a waitress before college and the Holiday Inn had illegal flooring in the restaurant and I was one of the 10 plus workers that were injured. I had many falls as a result of the problems with my knees and the many knee surgeries.  I was on and off crutches since 1978, but have been on crutches since 8-13-1982.  I have nerve damage in both my left and right elbows and down towards my hands, along with the carpal tunnel as a result of the falls and the crutches.  I have nerve damage in my lower left leg.  I have nerve damage to some of the muscles in my left leg.  I have extreme weakness in my left leg and foot.  I have a ruptured patellar tendon and quadriceps because Dr. Robert Watanabe ruptured my quads and patellar tendon and hid the information from me.  When a quadriceps ruptures, one only has a few weeks to fix it because the quad retracts up the leg and one loses the ability to use the leg properly. I had the quad repaired.  I then had the quad rupture again because the allograft was not big enough and I was on the waiting list for a larger quadriceps patellar tendon prior to the rupture which the Texas Workers Comp had approved and when the donor allograft came up and was found to be disease free the Texas Work Comp broke the law and denied the allograft which I had waited over 1 and1/2 years for.The Tx Comp had to promise to pay the Red Cross prior to allowing me to go on their list.  Typical Tx Work Comp broke the law and I had my quadriceps retract up my thigh I had to sue the insurance company for bad faith.  It turns out the lawyer representing the Texas insurance company shared a dorm room with the judges husband.  How is that for justice being blind.  The Texas Courts for over 37 years did not punish the insurance company that had represented the Holiday Inn. Texas is pro-business and could care less about an injured worker.The workmans compensation turned over private documents that showed that they wanted to emotionally harm their most expensive injured patients that they were responsible for.  The Texas judicial system did not punish the company or the people who made these decisions hoping the patients would kill themselves which would ultimately save the company money. I was injured on 7-19-1981 at the Holiday Inn and never expected what I thought was a reputable company to be so crooked and have my life affected for 37 years plus.  I never expected to have so many doctors with so-called good educations give me drug overdoses that put me on life support or almost killed me from their negligence. I am in agony all the time, with joints hurting at different pain levels.I cant walk and suffer 24/7. I have never been high. Opiates medications help me. You are punishing me.", "comment_id": "DEA-2018-0005-1362", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-1362", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Dawn", "commenter_lname": "Anonymous", "comment_length": 5029}, {"text": "Announcement States:** The Missouri League for Nursing is in full support of the state of Missouris collaborative effort to ensure the safety of our residents and educate our prescribers in their role in leadership to address this number one health crisis in the United States, said Peggy Neale-Lewis, RN, CPHQ, President, Missouri League for Nursing. My Response:Where are the legislators, physicians and nurses who are willing to risk it to stand up for pain patient rights. What happen to those in healthcare who follow the Hippocratic oath of number one rule of First Due NO Harm. If we do not designate, train and equip our facilities, physicians and nurses how to treat pain and its underlining causes healthcare is headed in world of despair. As anyone should know we all grow old. The elderly is one situation I find disturbing in my 4 years of research, meeting patients, advocating and becoming a patient leader. The elderly generation were taught to trust physicians and are being taken advantage of. There is multitude of new doctors who have risen into the new age of practicing medicine. I dont debate the need for change. I do however debate the shift of the change in healthcare. Taking both parties into consideration, providing awareness, education and prevention is a must to move forward on both sides.Since the CDC Guideline was released, there are now tens of thousands of non-cancer pain patients on long term opioid prescription therapy who are being INVOLUNTARILY tapered down or off of their pain medications. Would you want to be the one wearing this shoe? This has resulted in patient abandonment, being un-treated/under treated and millions left to suffer with debilitating pain.  Some of these patients have had their opioid medications abruptly discontinued throwing them into withdrawal. I am 35 and would like to live to see my grandchildren while being close to pain free as possible. As life exists now without opioid medicine  therapy my pained life is flashing before my eyes and I am living NO where near a quality of life or minimal pain levels. I have missed out on multiple activities, ball games, archery and so much more! My children deserve their mom!  By following suggested materials from networked counsel I have managed to bring my daily pain level to a 50/50 scale. The education materials and skills do not change the fact my body an central nervous system are on sensory over load from my underling cause of pain Adhesive Arachnoiditis  Reflex Sympathetic Dystrophy Syndrome. Any activity I chose to participate in I have consequences of debilitating pain that takes days to recoup from. I have to choose to use my energy pennies wisely! I am in the fight for my life and without regaining access to opioid medication I do not know what my future will entail. I chose to focus on the I cans instead of the I cants while the rods wreak havoc on my internals.  Unfortunately the passenger of the 99 mva committed suicide on Easter. I do not know the circumstances of his situation for it had been quite a while since we had seen one another. What I do know is he hit his head in the wreak, refused medical treatment that day and never obtained access to care for injuries sustained in the accident. It is a sad situation in this Nation  for Missouri residents are facing life without someone to stand up and provide a voice to a silenced community. And just do whats right by legitimate pain patients! There now abounds significant anecdotal evidence and significant documented media reports, that these patients who have been involuntarily tapered down or off their opioid medications, are committing suicide due to the intense pain that has resulted.Thank you for time, open mind and ear! ", "comment_id": "DEA-2018-0005-1381", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-1381", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Lacy", "commenter_lname": "F.", "comment_length": 3830}, {"text": "Your job is to protect the innocent and prosecute the guilty not the other way around. I am 60 and suffering with uncontrolled Chronic pain I no longer care about life. This all has gotten so out of control that the line between right and wrong is so blurred that maybe its time that you take a step back and see we are not the enemy. Please someone has to step up and do what is right. Thank you", "comment_id": "DEA-2018-0005-1423", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-1423", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Denise", "commenter_lname": "Farmer", "comment_length": 396}, {"text": "I am embarresed and ashamed by what this country has become! Governments have an obligation to take measures to protect people under their jurisdiction from inhuman and degrading treatment. Failure of governments to take reasonable measures to ensure accessibility of pain treatment, which leaves millions of people to suffer needlessly from severe and often prolonged pain, raises questions whether they have adequately discharged this obligation.My cousin hung himself because he could not bare the suffering and daily torture of chronic, intractable pain. He was being treated with methadone. One of Dr. Forest Tennants patients just killed herself. Thanks to the witch hunt by the DEA. Her family stated that she was in such a state of despair and anxiety due to the forced retirement of this great man, and she knew she would never find a Dr. to treat her pain. Life was not worth living if you are being tortured every waking moment! She will not be the last pain patient to end their life. The DEA has blood on their hands! The DEA is directly responsible for this young womans death, and every person who takes their life due to untreated pain. Shame, shame, shame! Why are the abusers and addicts being treated like victims? Illegal drug abuse is a crime! They choose to be addicted! They have hope to be cured. Most do not want help. Myself on the other hand did not have a choice to have two rare spine diseases with no cure or effective treatment, in addition to a genetic disorder that causes pain, osteoarthritis from a lyme infection and a severely degenerated spine. There is no hope for a cure. I have diseases, addicts do not have a disease! Stop practicing medicine without a license. Thought that was a crime? I do not need any protection from myself or my personal physician in regard to my care! We got it. For the last three months, I have been profiled as a drug abuser at the pharmacy. There has been a shortage of my prescribed medication. This is a violation of my human rights. The Social Security Admin. determined that I am disabled since 2007. This was before the diagnosis of the two rare spine diseases I suffer from. I have to go out of stare to see the few experts in this country that have experience in my multiple rare conditions. Pain patients are not the majority of people overdosing! The DEA should be spending their time and resources on stopping the flow of heroin and illicit fenanyl from entering the country, not on this pathetic witch hunt on Drs. who have compassion to treat human beings from be tortured and giving them a level of functionality so maybe life can be worth living. The depth of ignorance about legitimate chronic pain is shocking! There are over one million chronic pain patients in this country. Alcohol causes more deaths and also takes the lives of innocents. Couldnt solve that problem. Cigarettes is the same. But those issues got swept under the rug while people are still dying. Since the government is now profitting from maijuana, it is no loner the gateway drug?Whats really behind this campaign that only punishes patients and their Drs. is money and power. Patients will be left with two options, seeking out street drugs or suicide. Thanks DEA.......Pray you or your loved ones dont need surgery or get a disease that causes chronic pain. Actually I hope you do...... ", "comment_id": "DEA-2018-0005-1428", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2018-0005-1428", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Jacqueline", "commenter_lname": "Schneider", "comment_length": 3457}]}, {"id": "FDA-2016-P-1090", "agency": "FDA", "title": "Requests that the FDA take action to implement two initiatives for the co-prescribing of naloxone as part of FDA\u2019s comprehensive action plan to respond to growing epidemic of opioid abuse, dependence, and overdose.", "update_date": "2020-07-23", "update_time": "17:18:03", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "OPEN", "2016-1889", "Lachman Consultant Services, Inc.", "naloxone", "epidemic", "opioid", "abuse", "dependence", "overdose", "implement two initiatives", "co-prescribing", "Medically Assisted Therapy (MAT)", "Risk Evaluation and Mitigation Strategies", "REMS", "Elements to Assure Safe Use", "ETASU", "high-dose", "benzodiazepine", "Adapt Pharma Ltd."], "comments": [{"text": "July 15, 2016Division of Dockets Management (HFA305)  Food and Drug Administration  Department of Health and Human Services  5630 Fishers Lane, Room 1061  Rockville, MD 20552    Dear Sir or Madam,   On behalf of the Partnership for Drug-Free Kids, a national non-profit organization that provides support and guidance to families struggling with their son or daughters substance use and advocates for greater understanding and more effective programs to treat the disease of addiction, I write to offer our position on the Citizens Petition requesting that the Food and Drug Administration (FDA) require naloxone co-prescribing with high dose opioid prescriptions, all products prescribed for medication assisted treatment of opioid disorders and simultaneous opioid and benzodiazepine prescriptions.  The Citizens Petition also asks the FDA to update specific Risk Evaluation and Mitigation Strategies (REMS). Currently there are 129 overdose deaths in the United States each day, most of which are caused by an opioid.  Co-prescribing naloxone to reverse potential opiate overdoses is a common-sense step to help address this crisis.  Despite the fact that the Centers for Disease Control and Prevention (CDC) has called on prescribers to consider co-prescribing in certain circumstances and the fact that three states (Maryland, Delaware and Massachusetts) have issued similar state-level recommendations, not enough physicians are acting.  IMS data shows that in the year that ended February 2015 there were 247 million opioid painkillers prescribed but only 40,000 prescriptions for naloxone. We need to make sure that physicians are getting naloxone in the hands of more patients and families.We urge the FDA to require naloxone co-prescribing under the conditions laid out in the Citizens Petition.  We also urge FDA to update the REMS to require that medication guides include information about opioid overdose and treatment and to update the Elements to Assure Safe use to require that naloxone be prescribed and distributed alongside all medicines to treat opioid use disorders, high-does opiates and opiates prescribed alongside benzodiazepines unless providers opt out on documented grounds.At the Partnership we work with far too many families who have lost a child to an overdose and countless more moms and dads who are terrified that their child will be the next overdose statistic.  Co-prescribing naloxone will dramatically increase access to this medication and will give families a fighting chance to save their loved ones life in the event of an overdose.I thank you for your attention to this important matter and look forward to continuing to work with the FDA to reduce opiate misuse and abuse in our country.Sincerely, Marcia Lee TaylorPresident and CEO", "comment_id": "FDA-2016-P-1090-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0012", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2913}, {"text": "I am a writing on behalf of the American Association for the Treatment of Opioid Dependence in support of the Adapt Pharma Citizens Petition. With best regards, Mark Parrino ", "comment_id": "FDA-2016-P-1090-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0019", "comment_date": "2016-09-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 199}, {"text": "Caregiver Action Network (CAN) supports the Citizen Petition submitted by Adapt Pharma. CAN is the nations leading non-profit organization advocating for the 90 million family caregivers across the country. We are aware and alarmed that the majority of opioid overuse and heroin deaths in the U.S. actually occur in the home. We believe, as do many experts, that co-prescribing naloxone, the opioid overdose antidote, is an effective way to combat the epidemic of opioid overuse deaths.Therefore, we support the recommendation that providers prescribe naloxone with all high-dose opioid products, all Medically Assisted Therapy (MAT) products, and all opioid drug products when combined with a benzodiazepine prescription. We further support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids, and all opioid dosages when combined with benzodiazepine, unless providers opt-out on documented grounds.We believe that these recommendations will help address the major implementation barriers to co-prescribing under the current guidance, including stigma and awareness and education levels. Requiring the offer of a prescription for naloxone as an ETASU within the REMS framework will raise the level of patient awareness and education both of naloxone and its use in an opioid overdose emergency. It will help create a more robust dialogue between a physician and patient around opioid risks, including the opportunity for physicians to discuss risk in the context of the benefit of naloxone as part of risk mitigation. ", "comment_id": "FDA-2016-P-1090-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0005", "comment_date": "2016-06-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1660}, {"text": "I have been a Family Physician for 30 years. I am now a federal government physician working in Baltimore, MD -- and we are one of the epicenters for the heroin epidemic. All of our patients prescribed narcotics, to include methadone, need to be offered intranasal naloxone. Period. They and their families need to also be educated on the correct use of the intranasal form of this drug. It is safe, it is effective, and it is saving lives. What is the down-side?", "comment_id": "FDA-2016-P-1090-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0021", "comment_date": "2016-10-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 463}, {"text": "August 5, 2016Comment on Docket ID: FDA - 2016-P-1090-0004Dear FDA reviewers,The US Pain Foundation supports the Citizens Petition submitted by Adapt Pharma. The mission of the US Pain Foundation is to educate, connect, inform and empower those living with pain while also advocating on behalf of the entire pain community. As a 501(c) ]3 non-profit dedicated to serving those who live with pain condition and their care providers, US Pain Foundation helps individuals find resources and inspiration. We are gravely concerned about the on-going opioid overdose epidemic in the United States, now resulting in an average 129 deaths daily according to Addiction Policy Forum. More than 75% of these take place outside medical settings, with the majority of these (54%) taking place in homes. The pain community is one of the most impacted by these unnecessary deaths. Not only are these loses unnecessary, there are enormous direct and indirect costs to families, healthcare systems, employers and society that may be greatly mitigated through existing channels. We acknowledge that co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Both the American Medical Association and the Centers for Disease Control and Prevention issued guidelines which call for physicians to offer naloxone when factors that increase risk for opioid overdose, such as a history of overdose, substance use disorder, high-dose opioids, or opioids prescribed concurrently with benzodiazepines, are present. However, in spite of a growing consensus to co-prescribe naloxone, IMS data shows little uptake of naloxone by prescription under the current opt-in approach. In the year ended February 2015 there were 247 million opioid painkiller prescriptions, but only 40,000 prescriptions for naloxone, which indicates that support for co-prescribing is not translating into every day practice.We therefore support the recommendation that providers prescribe naloxone with all high-dose opioid products, Medically Assisted Therapy (MAT) products and all opioid drug products when combined with benzodiazepine, unless providers opt-out on documented grounds. Moreover, we support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids and all opioid doses when combined with benzodiazepine, unless providers opt-out on documented grounds.These recommendations will help to systemize the existing broad support for co-prescribing. These will also drive greater awareness and education, and help to address stigma by enabling more discussion between physician and patient on opioid risks and the beneficial use of naloxone in emergency overdose situations. We support the Citizens Petition and encourage FDA to exercise its authority in order to help stem this crisis which is taking many of our best and brightest away from us.Paul GilenoPresidentUS Pain Foundation670 Newfield Street, Suite BMiddletown CT 06457www.uspainfoundation.org", "comment_id": "FDA-2016-P-1090-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0016", "comment_date": "2016-08-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3359}, {"text": "July 11, 2016Division of Dockets Management (HFA305)Food and Drug AdministrationDepartment of Health and Human Services5630 Fishers Lane, Room 1061Rockville, MD 20552Dear Sir or Madam,The Strengthening the Mid-Atlantic Region for Tomorrow (SMART) NFP supports the Citizens Petition submitted by Adapt Pharma. The SMART Congressional initiative is the integration of Regional Science and Technology activities, issues, events and projects that are shared among the 4 states (MD, DE, NJ and PA) to foster regional technical, economic development and education/workforce development.  SMART has 12 working groups comprised of industry and community leaders across the 4 states in healthcare, veterans issues, and workforce development.We are gravely concerned about the on-going opioid overdose epidemic in the United States, now resulting in an average 129 deaths daily according to Addiction Policy Forum. More than 75% of these take place outside medical settings, with the majority of these (54%) taking place in homes. Our 4 states are among the most impacted. Not only are these losses unnecessary, there are enormous direct and indirect costs to families, healthcare systems, employers and society that may be greatly mitigated through existing channels. We acknowledge that co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Both the American Medical Association and the Centers for Disease Control and Prevention issued guidelines which call for physicians to offer naloxone when factors that increase risk for opioid overdose, such as a history of overdose, substance use disorder, high-dose opioids, or opioids prescribed concurrently with benzodiazepines, are present. However, in spite of a growing consensus to co-prescribe naloxone, IMS data shows little uptake of naloxone by prescription under the current opt-in approach. In the year ended February 2015 there were 247 million opioid painkiller prescriptions, but only 40,000 prescriptions for naloxone, which indicates that support for co-prescribing is not translating into every day practice.  Each of the SMART states has been affected by this public health crisis.We therefore support the recommendation that providers prescribe naloxone with all high-dose opioid products, Medically Assisted Therapy (MAT) products and all opioid drug products when combined with benzodiazepine, unless providers opt-out on documented grounds. Moreover, we support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids and all opioid doses when combined with benzodiazepine, unless providers opt-out on documented grounds.These recommendations will help to systemize the existing broad support for co-prescribing. These will also drive greater awareness and education, and help to address stigma by enabling more discussion between physician and patient on opioid risks and the beneficial use of naloxone in emergency overdose situations. We support the Citizens Petition and encourage the FDA to exercise its authority in order to help stem this crisis which is not only ravaging the SMART states, but the entire country. Sincerely,Robert CarulloSMART Executive Director", "comment_id": "FDA-2016-P-1090-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0014", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3583}, {"text": "Dear Sir or Madam, Facing Addiction, a national non-profit organization dedicated to finding solutions to the addiction crisis by unifying the over 45 million Americans and their families directly impacted by addiction, understands that Adapt Pharma has submitted a Citizen Petition requesting the Food and Drug Administration (FDA) to require naloxone coprescribing with Centers for Disease Control and Prevention (CDC) defined high risk opioid prescriptions, such as high doses, simultaneous opioid and benzodiazepine prescriptions and all prescriptions for addiction medications for opioid use disorder. The petition also asks the FDA to require updates to specific opioid and addiction medicine Risk Evaluation and Mitigation Strategies (REMS). In light of the petition, Facing Addiction would like to support this needed requirement. The opioid overdose epidemic continues to ravage the United States, with 28,647 deaths from prescription drug and heroin deaths in 2014. 75% of these took place outside medical settings, with the majority of these (54%) taking place in homes. Co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Yet, there has been no sign of the meaningful growth in both naloxone prescribing and education of both prescribers and patients that is necessary to make a significant impact on the scale of this crisis. Facing Addiction supports coprescribing naloxone with highrisk opioid prescriptions, including highdose prescriptions and all prescriptions for medications to treat addiction involving opioid use. We thank you for your attention to this important matter and look forward to continuing working with the FDA to reduce the number of opioid overdose deaths and save lives. Sincerely, Greg Williams, Executive Vice President, Facing Addiction ", "comment_id": "FDA-2016-P-1090-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0015", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2048}, {"text": "Caregiver Action Network (CAN) supports the Citizen Petition submitted by Adapt Pharma. CAN is the nations leading non-profit organization advocating for the 90 million family caregivers across the country.We are aware and alarmed that the majority of opioid overuse and heroin deaths in the U.S. actually occur in the home. We believe, as do many experts, that co-prescribing naloxone, the opioid overdose antidote, is an effective way to combat the epidemic of opioid overuse deaths.Therefore, we support the recommendation that providers prescribe naloxone with all high-dose opioid products, all Medically Assisted Therapy (MAT) products, and all opioid drug products when combined with a benzodiazepine prescription. We further support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids, and all opioid dosages when combined with benzodiazepine, unless providers opt-out on documented grounds.We believe that these recommendations will help address the major implementation barriers to co-prescribing under the current guidance, including stigma and awareness and education levels. Requiring the offer of a prescription for naloxone as an ETASU within the REMS framework will raise the level of patient awareness and education both of naloxone and its use in an opioid overdose emergency. It will help create a more robust dialogue between a physician and patient around opioid risks, including the opportunity for physicians to discuss risk in the context of the benefit of naloxone as part of risk mitigation. ", "comment_id": "FDA-2016-P-1090-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0006", "comment_date": "2016-06-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1659}]}, {"id": "FDA-2019-N-2037", "agency": "FDA", "title": "Electronic Nicotine Delivery System (ENDS) Device and E-Liquid Manufacturer Site Tours Program", "update_date": "2019-07-25", "update_time": "08:41:35", "purpose": "Nonrulemaking", "keywords": ["Electronic Nicotine Delivery System (ENDS)", "Device and E-Liquid Manufacturer", "Site Tours Program", "CTP", "2019-256", "OPEN"], "comments": [{"text": "I highly support the regulation of ENDS and other e-liquids. Not only do I believe that industry needs to be regulated, I believe the U.S. Health and Human Services department should more heavily announce dangers and negative effects regarding several aspects such as health and environmental issues from using e-liquids/ENDS. I believe in todays climate, the U.S. should rely on Social Media platforms to reach the main consumers of ENDS and e-liquids. Although an official U.S. federal branch may be hesitant to utilize such an informal method, todays main ENDS users are highly concentrated on Social Media. Social Media has proven to gain much exposure and influence.", "comment_id": "FDA-2019-N-2037-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2037-0006", "comment_date": "2019-07-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 693}, {"text": "I have a complaint about Vape Shops. While is was visiting a vape shop in Dyersburg Tennessee i purchased some e-liquid  Full Spectrum CBD, well i got it home  come to find out they were both expired, the e-liquid was over a year old  the Full Spectrum CBD was 7 months old. Why arent vape shops monitored by the F.D.A. for selling out-dated e-liquids  Full Spectrum CBD liquids to be vaped, ingested or other wise ??? ... These are products that people are smoking or vaping or being eaten  the vape shops should be monitored by the F.D.A. because they are selling out-dated products to be vaped or smoked or consumed by ingestion by human beings!! ... please F.D.A. monitor  search or investigate vape shop owners...please ..it could be harmful to people smoking or vaping or consumed by people. SERIOUSLY !!  ty Vickie F. Schoeneberg", "comment_id": "FDA-2019-N-2037-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2037-0005", "comment_date": "2019-07-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 871}, {"text": "We request that you visit our facility at: 1600 Mall CirFort Worth, Tx.76116We feel seeing a retail/manufacturing operation will aid in giving FDA further understanding about the current burdens and willingness to comply with PMTA deadlines and procedures. Thank you.-Steamist Vape Supply", "comment_id": "FDA-2019-N-2037-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2037-0015", "comment_date": "2019-07-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 328}]}, {"id": "DEA-2015-0006", "agency": "DEA", "title": "Controlled Substances:  Proposed Adjustments to the Aggregate Production Quotas for Difenoxin, Diphenoxylate (for conversion), and Marijuana", "update_date": "2022-03-22", "update_time": "11:17:21", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Before increasing the amount of the drug that the DEA needs, I think we should consider having a long needed national debate about whether or not Marijuana should be in the Schedule 1 category.  If it is going to remain in this category, the government should not be growing it period.  Therefore I disagree.", "comment_id": "DEA-2015-0006-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0006-0007", "comment_date": "2015-05-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 308}, {"text": "In my humble opinion, the DEA should approve of an increase of Cannabis production to ten times the amount currently set for studies of its medical efficacy. It appears that this may not be enough as studies throughout history has already proven the medical efficacy of the Cannabis Plant. As far back as 1974, proof of the medical efficacy of the plant was established and promptly ignored by the DEA... http://www.alternet.org/story/9257/pot_shrinks_tumors%3B_government_knew_in_74. It seems that we really are dealing with the most beneficial plant on Gods Green Earth. Yet our Government unwisely chooses Prohibition. Perhaps we can investigate how an American DEA has chosen to ignore scientific fact, continued on a ruinous Cannabis Prohibition that has had our system of governance stepping far away from the established sciences, and that has completely and legally devastated the lives of so many Americans. This incompetence cannot stand. We are a Nation of Freedom and Liberty that works best wihtin the Natural Order. Judging by this failure to capitalize on knowledge we had as far back as 1974, Im not even sure that ten times the amount of Cannabis would be sufficient to provide the DEA with enough evidence to get it to finally accept  the fact that Cannabis is a beneficial plant.To take things further, I have learned that the Prohibition against Industrial Agricultural Hemp is based on Junk Science and Politics. The truth be told, it appears the real basis for this wretched Cannabis Prohibition is simply a machine called the Decorticator. This machine allowed a huge increase in the harvest of Hemp and this threatened the fortunes of a pulp wood baron. From that, it appears that this Prohibition was concocted by Robber Barons, Corrupt Bankers, and Corrupt Law Enforcement. The inventor of the Decorticator died penniless and many an Off Shore Drug Lord, Robber Baron, Corrupt Banker and Lawman have made fortunes. Over 24 Million Americans have gone to Prison for using the most beneficial plant on Gods Green Earth, enough to fill a Super Bowl Stadium 460 times. It also appears that this enforcement of the Cannabis Prohibition through a multitude of arrests and Marihuana Tax Stamps were merely being used to stampede the American Farmer out of the iHemp business. Mankind has used all forms of Cannabis for thousands of years. Our Founding Fathers grew it by the ton. They referred to Cannabis as a Gift of Divine Providence. What happened to our Common Sense?  Our American Cannabis Prohibition is nothing short of the worst public policy miscalculation in American History. Being a veteran, I find it odd that my fellow veterans and countrymen are free to grow and use cannabis, yet if I were to do so here in West Virginia, I would be imprisoned and my property would be confiscated. How American is that? I find it odd that many other Nations that we fought and died for, in an effort to insure their freedom, are now free to use all forms of Cannabis, and we Americans are not. America is now the only industrialized Nation in the world without an Industrial Hemp program. And the DEA dares to claim its all because of some horrid belief that getting high on marihuana poses a grave danger to our health. Rubbish! Youve known the truth since 1974 and yet today, youve ignored the science from all over the world.So please, with all due haste, continue on with your increase in production of marijuana so you can study it some more. I think its safe to say if the DEA were to objectively review the results on hand at this very moment, it could easily conclude that this Cannabis Prohibition has been nothing short of a dismal failure and this so called War on Drugs is nothing less than a War on the American People. We are a far better society than what weve been served by the DEA. Unfortunately, due to this revelation of the knowledge the DEA has possessed for decades now, any of your conclusions are instantly suspect. Lying is lying and liars have a way of deceiving anyone and everyone. We are Americans and we have been lied to by our very own Government over a very beneficial plant so as to insure the fortunes of nefarious men of design. We are not free as you claim. History will not treat this Cannabis Prohibition well. If I were to possess a magical power to undo this mess America has gotten itself into, I would. As it is, I would strongly urge the DEA and all other National entities that support the Cannabis Prohibition to reconsider your position. If you outlaw nature and its bounties, you are imprisoning Freedom and Liberty. An objective review of the bottom line results of your efforts prove the point. At this time you have failed the American ideals of our Revolution. America does not accept failure in its bureaucratic management teams. Your only way out is to cease this unwise Cannabis Prohibition immediately. Your mission is to insure the Quality and Certainty to the next American Cannabis Industry.", "comment_id": "DEA-2015-0006-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0006-0002", "comment_date": "2015-04-13", "comment_time": "04:00:00", "commenter_fname": "Don", "commenter_lname": "Smith ii", "comment_length": 5117}, {"text": "You need both THC and CBD to get high.  Marinol will not get you high.  Marinol is pure THC made by chromatography tube from another substance.  Please consider this.  Thank you.", "comment_id": "DEA-2015-0006-0003", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0006-0003", "comment_date": "2015-04-13", "comment_time": "04:00:00", "commenter_fname": "Jim", "commenter_lname": "Demaio jr.", "comment_length": 178}, {"text": "I support the DEAs request. Medical cannabis production for the use of determining its benefits and/or detriments must be allowed and the regulations for those studies suspended or revoked. The DEA should also, in the process of increasing its production of cannabis for this research, suspend restrictions on individuals who use cannabis for those medical purposes to allow for their research to include said individuals.Politics aside, the best interests of the people should be considered above all. The costliest and most ineffective war in history is the War on Drugs, especially when cannabis is the controlled substance most often vilified. As a substance that is unprocessed, unfermented, naturally produced and providing numerous beneficial uses, the restrictions of cannabis should be immediately repealed. Over $1 trillion tax dollars spent, with much of it wasted on cannabis related interdiction.As a man of GOD, I have never condoned the abuse of any drug, including those legalized drugs that have proven to be harmful to the physical body as well as detrimental to our society as it relates to my beliefs, (i.e. tobacco, alcohol and other drugs like cocaine, heroin, meth, LSD and other man-made/manufactured substances). However, this one substance that has no evidence of causing those aforementioned effects is still being touted as a villain. DUIs, DWIs  and other effects of consuming those substances cannot be attributed to cannabis use. And I do not use nor condone the use of cannabis, but only since it is illegal to do so and I am morally inclined to respect and uphold the law. Were it not so, I would probably be a responsible consumer of cannabis. For medicinal and possibly recreational purposes, as well.My mother, who recently passed, suffered from cancer, dementia, hypertension, arthritis and diabetes. There has been astounding research done prior to her death, (but not by the FDA or DEA), concluding that most of these serious conditions have been halted and/or reversed by the use of medicines derived from cannabis. CBD, CB1, CB2, and other medicines derived from the cannabinoids in this plant. While it cannot be proven that CBD could have helped my mother, that possiblity is ever present in my mind. Please, remove the stigma from this natural plant first by calling it by its taxonomic nomenclature, cannabis, verses its derogatory slang, marijuana and perform honest, transparent research.Sincerely.Rev Dana D Jones, SrPastorKoinonia Christian Fellowship", "comment_id": "DEA-2015-0006-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0006-0006", "comment_date": "2015-04-22", "comment_time": "04:00:00", "commenter_fname": "Rev dana d", "commenter_lname": "Jones sr", "comment_length": 2565}, {"text": "What if marijuana and its cannabinoid components worked to help prevent cancers, and The DEA removing them from our food (hemp) and medicine actually were the primary reason cancers were able to survive, thrive and kill their host. The DEA would be responsible for every preventable cancer related death much like big tobacco since the 1930s. Especially since we knew about marijuanas potential since the 1970s.Michelle Leonhart is allowing people to needlessly suffer unimaginable death while she rants about how bad drugs are. Well she is the devil herself while she denys people medicine based on the principals of marijuana prohibition. Its no longer about marijuanas affect on the degenerate races - (H. Anslinger), its about the truth and stopping the pain and suffering of so many.As someone who has experienced the pain of cancer first hand I can honestly say there are much worse things than marijuana that we can use for pain, and Im referring to opiate based pharmaceutical drugs my doctors offered me.", "comment_id": "DEA-2015-0006-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0006-0004", "comment_date": "2015-04-13", "comment_time": "04:00:00", "commenter_fname": "Ray", "commenter_lname": "Anonymous", "comment_length": 1080}]}, {"id": "FRA-2009-0039", "agency": "FRA", "title": "Alcohol and Controlled Substance Testing for Maintenance-of-Way Employees", "update_date": "2021-02-10", "update_time": "01:34:44", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am a licensed prof. counselor in my state. Would I be eligible to work with employees who have violated the rules of their positions? I have a masters degree in counseling and psychology and have performed non-DOT evaluations. I have extensive experience in substance abuse issues as well.", "comment_id": "FRA-2009-0039-0024", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0024", "comment_date": "2015-06-11", "comment_time": "04:00:00", "commenter_fname": "Marion", "commenter_lname": "Hecht", "comment_length": 291}, {"text": "Having worked 30 years in the alcohol and drug field EAP programs are great, but the counselors do no have that 24/7 contact with alcohol and drug clients.  Also many of them have little alcohol and drug background/experience (i.e there many qualified SAPs too that do not have the alcohol and drug background:social workers, doctors and other professionals) they are great professionals but lack the knowledge on dealing with this population.  Also many of them (EAP) are just too close to the companies.  Many of these Employers need to stop doing in-house alcohol and drug training themselves, and bring in experienced SAPs with a lot of alcohol and drug background. What happen in 2007,Massachusetts is the result of rare/little testing and poor supervisor alcohol and drug training/ EAP programs that have weak SAPs with little alcohol and drug background.", "comment_id": "FRA-2009-0039-0004", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0004", "comment_date": "2014-08-04", "comment_time": "04:00:00", "commenter_fname": "James", "commenter_lname": "Armstrong", "comment_length": 861}, {"text": "It is the opinion of the Semo Port Railroad that the small railroad exception in 49 CFR 219 needs to stay the way it is. If there was to be a change it could cause adverse impact on the small railroads in cost and time for the employees to take out of their day to go to the drug testing facility. We have 4 people in the Semo Port office and only 2 could be considered a maintenance of way worker, but their jobs do not revolve around the railroad solely. Three of the four people who work for Semo Port are drug and alcohol symptom certified to where they can determine whether someone was under the influence or not and we all see each other every day so we would know if something was wrong. We have 5 guys on our train crews that we use on a normal basis. Three of them have been here for going on 21 years and the other two have about 2-3 years of experience and there has never been an issue of someone being under the influence of drugs or alcohol. Semo Port Railroad also has an impeccable safety record. For the last 10 years we have received the ASLRRAs Jake Award for Railroad Safety which is no accidents/incidents in a calendar year. We strive to run a safe and effective railroad. I did some research and a local drug testing firm gave me a quote on what drug tests cost. A DOT drug test through them would be $47/test. If we would have to drug test 50% of our staff it would equate to an extra $376 in expenses and a 25% alcohol test would equate to $188 for a total of $564 in extra expenses per year that we could use elsewhere in the railroad.As far as the contractors go, if a contractor does work previously for a railroad that does not have the exception then they will have the drug and alcohol policy already in place. It should be up to the contractor to determine if one of their people is under the influence seeing how they should know their workers better than we do.  Again, the 49 CFR 219 small railroad exception should stay the way it is. ", "comment_id": "FRA-2009-0039-0015", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0015", "comment_date": "2014-11-24", "comment_time": "05:00:00", "commenter_fname": "Jacqueline", "commenter_lname": "Prater", "comment_length": 2007}, {"text": "Joint comments of the Rail Labor Organizations (ATDA, BLET, BMWED, BRS, IBEW, SMART-TD)", "comment_id": "FRA-2009-0039-0017", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0017", "comment_date": "2014-11-25", "comment_time": "05:00:00", "commenter_fname": "Freddie", "commenter_lname": "Simpson", "comment_length": 87}, {"text": "Attachment #1 - Joint Comments of the Rail Labor Organizations (ADTA, BLET, BMWED, BRS, IBEW, SMART-TD)", "comment_id": "FRA-2009-0039-0018", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0018", "comment_date": "2014-11-25", "comment_time": "05:00:00", "commenter_fname": "Freddie", "commenter_lname": "Simpson", "comment_length": 103}, {"text": "If drug and alcohol testing is to be considered for the employees of our Department of Transportation, it should mandated for every employee that works for the department, not just a solicited few covered employees.  This should also include volunteers as well as contractors and subcontractors.  It is imperative that the safety of our transportation system be given the utmost positive response by individuals and groups indicating the necessity of mandatory testing for illegal and legal substances of all kinds.    The costs of these proposed regulations will outweigh the consequences of not utilizing mandatory testing for all situations to include pre-employment, random, and post accidental testing of any employee with access to all Department of Transportation (DOT) and Federal Railroad Administrative (FRA) safety-sensitive functions.  The benefits of the amendment rule will be accrued primarily from the expected injury, fatality and property damage avoidance that would result from the expansion of the proposed rule covering Maintenance of Way (MOW) employees subcontracting for the railway and the Post Accident Toxicology (PAT) testing threshold increase.  It is vital employees of our transportation system, whatever the position, be under regulation for the testing of illegal substances.", "comment_id": "FRA-2009-0039-0003", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0003", "comment_date": "2014-08-04", "comment_time": "04:00:00", "commenter_fname": "Carol", "commenter_lname": "Hopkins", "comment_length": 1322}, {"text": ".I absolutely agree with Carol.  Every person who works for the Federal Government, no matter what their position, should be under this type of program.  Pre-employment, random, and post-incident testing is the only way to assure that your employees are not impaired.", "comment_id": "FRA-2009-0039-0010", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0010", "comment_date": "2014-10-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 267}, {"text": "Per FR Vol. 79, No. 144 (Page 43859, Section 219.207-Fatality), the FRA is proposing the removal of NRC phone number 1-800-424-8801 (as it\u0080\u0099s no longer correct) and leaving NRC phone number 1-800-424-8802 as the sole number for making FRA notifications through the NRC. I recommend removing both of the listed NRC phone numbers (1-800-424-8801 and 1-800-424-8802) from the 49 CFR 219 regulations and replace them with the phone number 1-800-424-0201. REASON: Though currently managed by the NRC, the toll-free phone number 1-800-424-0201 is owned by the FRA as a railroad accident reporting hotline and is referenced in FRA regulations 49 CFR 225.9, 229.17, 230.22 and 234.7, and NTSB regulation 49 CFR 840.3.  Because 1-800-424-0201 is owned by the FRA, the FRA can independently transfer this number to any call center, should the FRA ever choose to no longer use the NRC as its call center solution. This is something that cannot be done with the NRC owned 1-800-424-8802 number. Solely using 1-800-424-0201 in the FRA and NTSB railroad regulations provides more flexibility to the FRA, should they ever wish to change call centers, since their phone number would never have to change in the regulations. It also makes any transition of call centers nearly seamless for industry, as none of their notification procedures, policies or plans would have to change.  The FRA would lose the use of 1-800-424-8802 if they stopped using the NRC as their call center. This recommended change would impact 49 CFR 219.203, 219.207 and 219.209; though I recommend the change be made to all FRA railroad regulations that reference reporting requirements to the NRC.", "comment_id": "FRA-2009-0039-0005", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0005", "comment_date": "2014-08-25", "comment_time": "04:00:00", "commenter_fname": "Christopher", "commenter_lname": "Mattice", "comment_length": 1688}, {"text": "Docket No. FRA-2009-0039Regulatory Identification Number 2130-AC10The proposed amendments to expand the FRAs control of the use of alcohol and drugs by maintenance-of-way (MOW) activities are greatly needed and will go a long way in closing up an oversight that has contributed to avoidable deaths associated with railroad activities. (Boardman)  What must also be considered are the thousands of business operations across the country that control and operate rail yards and tracks adjacent to active rail lines, and that perform maintenance on those adjacent tracks with equipment that has the propensity to foul active tracks. (Federal Railroad Administration)  The businesses that use rail and the railroad for transportation of goods must inspect, repair, and perform maintenance on track that is used by railroad personnel to deliver, pick up, or switch railcars.  These operations are not required to employ an alcohol and drug testing policy but can easily interdict an error provocative environment (Chapanis) into the railroad operations with little to any regulatory control.  The general workforce has shown positive results from those tested that was more than twice that of the federally mandated safety sensitive workforce of which includes railroad workers. (Drugs Testing Book)  The fact that covered personnel are subject to drug testing at any time and place in accordance with the NTSB post-accident review and the positive test results are almost 20% for those tested who were involved with fatal accidents is a sad commentary on the effectiveness of the current efforts for controlling the use of drugs and alcohol within the railroad personnel. (Federal Railroad Administration 10)  Drug screenings, education, and responsible management practices must be implemented if we are to stem the tide of fatal accidents within the federal railroad operations.  The cost in human life far out-weighs the cost of an effective meaningful drug interdiction program.  Railroad employees whether federal employees, or employees that directly impact railroad operations and are employed by other business enterprises must be monitored for any alcohol or drug induced impairment.  The Federal Railroad Administration who is charged with ensuring the safe continuous operations of our nations railroad must be able to identify those individuals who would hinder that mandate.  BibliographyBoardman, Honorable Joseph H. National Transportation Safety Board. 10 April 2008. www.ntsb.gov. 23 November 2014 http://www.ntsb.gov/doclib/recletters/2008/R08_05_07.pdf.Chapanis, A. THE ERROR-PROVOCATIVE SITUATION: A CENTRAL MEASUREMENT PROBLEM IN HUMAN FACTORS ENGINEERING. 1980. Transportation Research Board. 23 November 2014 http://trid.trb.org/view.aspx?id=185046.Drugs Testing Book. Drugs Testing Book 2014. 2014. 23 November 2014 http://drugstestingbook.com/laboratory-accreditation-regulation/historical-overview-of-workplace-drug-testing-programs/.Federal Railroad Administration. AMENDMENTS EXPANDING AND UPDATING THE FEDERAL RAILROAD ADMINISTRATIONS CONTROL OF ALCOHOL AND DRUG USE REGULATIONS Notice of Proposed Rulemaking Regulatory Impact Analysis. Regulatory Impact Analysis. 2014.. Freight Rail Today. 1999. 23 November 2014 https://www.fra.dot.gov/Page/P0362.USC. 49 USC Chapter 211 Hours of Service. 2008. http://www.brs.org. 23 November 2014 http://www.brs.org/Regulatory/The%202008%20Law%2049USCChapter211.pdf.", "comment_id": "FRA-2009-0039-0016", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0016", "comment_date": "2014-11-24", "comment_time": "05:00:00", "commenter_fname": "Robert", "commenter_lname": "Knight", "comment_length": 3587}, {"text": "I worked until I retired..Now Im in fl", "comment_id": "FRA-2009-0039-0027", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2009-0039-0027", "comment_date": "2016-07-11", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Bice", "comment_length": 48}]}, {"id": "FDA-2021-P-0514", "agency": "FDA", "title": "Requests that the FDA declare that Naloxone HC1 Nasal Spray, 8 mg/Spray, is suitable for submission as an ANDA and to introduce a new 8 mg/Spray metered spray strength for prescription use", "update_date": "2022-04-25", "update_time": "11:42:15", "purpose": "Nonrulemaking", "keywords": ["Suitability Petition", "CDER", "HYMAN, PHELPS & MCNAMARA, P.C.", "for prescription use", "metered spray strength", "introduce a new 8 mg/Spray", "Approved Drug Products with", "Orange Book", "Therapeutic Equivalence Evaluations", "Reference Listed Drug (RLD)", "as an ANDA", "Abbreviated New Drug Application (ANDA)", "is suitable for submission", "8 mg/Spray", "declare that Naloxone HCl Nasal Spray", "OPEN"], "comments": [{"text": "On behalf of Hikma Pharmaceuticals USA, Inc. (Hikma), the undersigned submits the following comments pursuant to 21 C.F.R.  10.30(d) opposing the above-referenced suitability petition.", "comment_id": "FDA-2021-P-0514-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0006", "comment_date": "2021-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 204}]}, {"id": "FDA-2009-N-0582", "agency": "FDA", "title": "Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner", "update_date": "2024-01-05", "update_time": "08:40:52", "purpose": "Rulemaking", "keywords": ["cder", "cder20096", "television and radio", "conspicuous", "neutral manner", "dtc", "advertisements"], "comments": [{"text": "Nice idea but an utter waste.  Lawmakers must learn medication selection involves a complex assessment based on patients current health and medication use. Medicine is different from McDonalds in this way; you cannot accomplish such education concerning possible side effects or life threatening risks in a 30 second ad spot intended mainly  to sell you on the benefits. There is no way to give patients enough information to make an informed decision.  DTC ads merely encourage people to go ask for the latest drug (which  is often an over-priced me-too drug at that) because they saw it on TV. Caveat emptor, indeed.  The new rules are fine but will prove to be as ineffective as the previous ones.", "comment_id": "FDA-2009-N-0582-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0024", "comment_date": "2010-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 721}, {"text": "Due to the short length of most commercial advertisments for new and exisiting drugs, I do not feel like there can be enough control of advertising claims.  Consumers already deal with endless numbers of drug and device recalls.  Possible side effects and device malfunctions should be clearly stated.", "comment_id": "FDA-2009-N-0582-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0022", "comment_date": "2010-05-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 301}, {"text": "FDA looked to rules of other agencies, including the Federal Trade Commission, the Securities and Exchange Commission and others who had previously interpreted clear and conspicuous in a similar fashion. As to defining a neutral manner, the Agency noted it was unaware of similar regulatory precedent and determined that it would interpret neutral to mean unbiased. To achieve a neutral and unbiased presentation, it said the major statement must not be presented in competition with other elements if these elements would arrest the attention and distract consumers from the presentation of the risk information.Significantly, the Agency did not propose that the major statement be included in both audio and visual parts of the advertisement, even though it said it thought such a standard could enhance the clarity, conspicuousness and neutrality of the major statement. While to a great degree the Agency has already been utilizing similar criteria to determine whether a broadcast DTC advertisement is false and/or misleading, the new standards set forth in greater detail the approach FDA will utilize in reviewing broadcast DTC advertisement for prescription drugs. While it is not, as FDA says a set formula, it does provide a roadmap as to how advertisers can satisfy FDA that their advertisements effectively communicate the overall message of a major statement. I will have agree with the FDA in setting these additional standards with some additional clarifications to how this would be implemented, because Drug companies are using all means to attract the consumers to many dangerous drugs even though the doctor may not agree with however the consumer would insist on trying such drugs because of the way it was presented to him in such a believable manner.", "comment_id": "FDA-2009-N-0582-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0014", "comment_date": "2010-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1935}, {"text": "I am all for having clearer understanding in drug related commercials.  Too often the person describing the drug goes through the side effects so quickly you never hear what they say. I also believe the hide the side effects with images that take away from what the drug can do to you. The writing in magazine advertisements should be much larger, one should know what the drug can do to them without them being hidden. ", "comment_id": "FDA-2009-N-0582-0058", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0058", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Marty", "commenter_lname": "Pace", "comment_length": 420}, {"text": "I feel this rule would help in a lot of ways. It would force the pharmaceutical companies that advertise on television or the radio to clearly let people know of the risks and side effects of taking their prescription drug and not to distort any of the negative side effects. This would allow the consumers watching/listening to the drug ads to have a better understanding of the risks involved in taking the drug they are considering to try before they purchase the drug or to be left to find out firsthand the side effects by actually taking the prescription drug. By making the pharmaceutical companies state the side effects both verbally and visually more people are apt to hear/see the side effects. People will no longer miss the small print at the bottom of the screen while being more focused on the happy people enjoying their day because of the drug showing in the background or listening to the happy tune playing. I feel as though this rule would have a positive impact both on the consumers by keeping them well informed of the prescriptions drugs they are thinking of using and on the pharmaceutical companies actually advertising the drug because it will keep them honest and most likely get more people to try their drug. I know I would be more likely to try a prescription drug that would help me if I knew of all of the negative side effects that could happen before trying it than a prescription drug I knew almost nothing about. ", "comment_id": "FDA-2009-N-0582-0056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0056", "comment_date": "2012-03-27", "comment_time": "04:00:00", "commenter_fname": "Amanda", "commenter_lname": "Darnell", "comment_length": 1450}, {"text": "I would like to comment on this new regulation on Direct-to-consumer prescription drug advertisements. As many state that they believe that this is a waste of money as well as non-educational information to an audience who probably will not pay attention, I believe that this will help the general public gain more knowledge of what prescribed medications are available to them. Making sure that advertisements have a clear, conspicuous, and neutral manner will ensure viewers that they are getting the correct information. Seeing a commercial that is only interested in sky rocketing sales and misleading the public into believing their medication is the best for them when it truly is not occurs well too often than it should. It is very common to see people smiling and jumping for joy, moving to upbeat music while bright colors and an excited public audience show a beautiful, healthy world. This information is purely for selling and does not prove that any medication is proven to work accurately or be the best for any patient. Also, fine print and quick communication of negative side effects at the end of the commercial do not help the public to know all aspects of the prescription drug. This is purely unfair and misleading to the public. I believe that if money is going to be spent on a prescription drug advertisement, it should be spent knowing that the advertisement works at its best to the general publics advantage and is not misleading in any way, shape, or form. All advertisements should be educational when they are about something as serious as a prescription drug as patients need whats best for their well-being, not a turn around. I conclude my comment expressing my agreement with these regulations. I do believe this will work to our advantage and will be a great help to society.", "comment_id": "FDA-2009-N-0582-0057", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0057", "comment_date": "2012-04-12", "comment_time": "04:00:00", "commenter_fname": "Audrey", "commenter_lname": "Johnson", "comment_length": 1825}, {"text": "Food and Drug AdministrationFDA-2009-N-0582, and RIN 0910-AG27While I do feel that this rule could be beneficial to the general public, as possible consumers to these prescription drugs, I cannot make a set judgment on the overall effectiveness without first knowing the FDAs detailed standards for determining whether this regulation would be met.I certainly agree that advertisers often use distractive tactics to subdue the otherwise startling effects of the side effects being listed. However, the commercial is advertising the drug with the purpose of selling it.  While we can continually raise the standards of drug companies to fully explain the possible side effects in a 30 second blurb, it seems more reasonable to expect a certain level of responsibility on the consumer to request this information when they speak to their doctor.", "comment_id": "FDA-2009-N-0582-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0047", "comment_date": "2012-02-16", "comment_time": "05:00:00", "commenter_fname": "Lacey", "commenter_lname": "Mccauley", "comment_length": 880}]}, {"id": "DEA-2011-0007", "agency": "DEA", "title": "Controlled Substances and List I Chemical Registration and Reregistration Fees", "update_date": "2021-12-02", "update_time": "01:00:46", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think the fee increase is not a great idea. Most practices have encountered losses in the past 2 years due to Medicare and Medicaid reimbursement cuts. In the area in which I work, we have a 75% Medicaid/Medicare population and we take care of patients most practitioners wont due to the insurance issues. I think instead, every practice who cannot provide proof of a 15% medicaid and at least a 30% Medicare patient population (both), should have thier rates increased for the rest of us who provide care to those without private insurance.With gas, food and everything else increasing, and reimbursements dwindling; this is not a good time to increase fees  for somethin which is mandatory for practice.", "comment_id": "DEA-2011-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0007", "comment_date": "2011-08-02", "comment_time": "04:00:00", "commenter_fname": "Kathleen", "commenter_lname": "Glass", "comment_length": 732}, {"text": "I work as an NP in a non-profit, hospital based practice, covering three subacute rehab/LTC facilities.  I have received a cost-of-living increase or less increase annually because of the economy, not because of my performance.  The prescriptions I write are for long term care residents, patients at the end-of-life and post-op patients.  Neither I nor my practice have the financial where-withall to support increased DEA fees.  I think fees should be based on practice setting along with license to prescribe.  I do not make a six figure salary, nor do I anticipate making a six-figure salary in my lifetime.  I suggest the DEA review its licensing fees and adjust by practice and specialty.", "comment_id": "DEA-2011-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0006", "comment_date": "2011-08-02", "comment_time": "04:00:00", "commenter_fname": "Lee", "commenter_lname": "Holfelder", "comment_length": 694}, {"text": "I am opposed to raising the cost of DEA application fees. The cost is just another barrier to NP practice. It will keep some NPs from being able to provide patients with prescriptions for controlled substances. This will prevent patients from getting adequate relief of symptoms in many cases.", "comment_id": "DEA-2011-0007-0175", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0175", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Kerri", "commenter_lname": "Cook", "comment_length": 293}, {"text": "This proposal to raise fees for DEA number applications is a huge barrier to practice. I am a new NP and quite frankly cannot afford a $700 fee.Please reconsider raising the fee. ", "comment_id": "DEA-2011-0007-0179", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0179", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Marion", "commenter_lname": "Alston", "comment_length": 184}, {"text": "This fee is the most expensive that I am required to pay.  At present $550.00 every three years.  An increase in this rate will cause hardship on myself and other mid-level providers that must meet the requirement.  Please know that our salaries are not so large as to make this fee affordable.  Thank you for the consideration of what the fee increase will mean for us.", "comment_id": "DEA-2011-0007-0167", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0167", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Anna", "commenter_lname": "Bovee", "comment_length": 370}, {"text": "I propose that the DEA application fees DO NOT increase for Nurse Practitioners", "comment_id": "DEA-2011-0007-0174", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0174", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Colette", "commenter_lname": "Frena", "comment_length": 84}, {"text": "I dont agree that the application fee for a DEA number should be raised for midlevel providers", "comment_id": "DEA-2011-0007-0184", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0184", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Jeannine", "commenter_lname": "Hoshino", "comment_length": 99}, {"text": " I respectfully ask that you reconsider raising the rates for DEA licensure. To do so would place financial constraints and barriers to Nurse Practitioner practice. Nurse Practitioners fill vital gaps in underserved areas and populations. Many positions carry no provisions for reimbursement of necessary licensure and fees, leaving the Nurse Practitioners to absorb this cost on their own. Even if the cost were paid by a supervising physician, there might be a reluctance or inability to absorb the additional cost.Nurse Practitioners take their prescribing privileges very seriously. We are invested in our profession and the well being of our paitents. Please do not add unnecessary obstacles to providing care. This decision would have far-reaching implications.", "comment_id": "DEA-2011-0007-0162", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0162", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Kimberly", "commenter_lname": "Callahan", "comment_length": 787}, {"text": "I am a certified nurse midwife in Indianapolis.  In order to practice full-scope care to my clients, I maintain an active DEA.  I do not receive any reimbursement or funding from my hospital or employer for this registration.  I believe this large of a fee increase is truly prohibitive to practice in the current environment of healthcare budget restrictions.    ", "comment_id": "DEA-2011-0007-0160", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0160", "comment_date": "2011-09-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 364}, {"text": "Increases in the cost of maintaining a DEA number were inevitable, however this increase in light of a decreasing cost of administration with electronic registration and the proliferation of EMRs with improved potential for monitoring, is excessive and unwarranted. At a time when our incomes are being cut from every angle, from reimbursement to administrative costs, this would seem ill advised. Please consider that in addition, there is a tremendous amount of wasteful spending in the unnecessary and burdonsome costs associated with prescriptive limitations placed on NPs and PAs. Eliminating some of this waste would decrease expenses for the DEA thereby providing moneys from the cost savings. Please consider your support of this measure carefully. Thank you for seeking feedback on this issue.", "comment_id": "DEA-2011-0007-0149", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2011-0007-0149", "comment_date": "2011-08-29", "comment_time": "04:00:00", "commenter_fname": "Victoria", "commenter_lname": "Tyra", "comment_length": 802}]}, {"id": "NOAA-NMFS-2008-0020", "agency": "NOAA", "title": "Marine Mammal Protection Act Stranding Regulation Revisions", "update_date": "2014-11-05", "update_time": "13:42:37", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comments on draft regulations? 216.27 Paragraph (a)  The components of a health certificate should include:A veterinary certification statement that:The animal is fit to travel by whatever means of transportation are going to beutilized.That the animal is in sufficient body condition for release.That the clinical laboratory values do not preclude release.That any conditions set forth by NMFS with regard to release criteria have been met.The method of transport should be listed in the certificate.There should be a place to add a consignee if the animal has to travel somedistance to another organization/venue prior to release.? 216.27(b) The need to facilitate scientific research:Most scientific studies have been conducted with Tursiops at public displayvenues or at the few research venues equipped to house cetaceans. By comparison, there is virtually nothing known about the other 65 species oftoothed whales. With the intent to further knowledge on cetacean species, there should be a veryhigh preferential priority placed upon requests by research facilities to hold,either temporarily or for long term, stranded cetaceans which would otherwise bereleased, go into public display, or be euthanized.  Animals should be able to be preferentially diverted to such use by means of anon-releasable or postponed release determination.  ? 216.27(c) Standardized Method for Making Disposition DecisionsThese determinations should be able to be made in a short time frame, involvethe NMFS Office of Protected Resources Coordinators, and be able to circumventmost impediments to achieve a rapid determination.A suggestion is that special consideration be given to those researchers orfacilities holding a special research designation.  Such a special research designation would entail a new category of researchpermit which, once granted, would allow opportunistic research under theauspices of the research institution?s own IACUC without the usual requirementfor de-novo review by NMFS for each instance or opportunity afforded by astranding event.  Under the current system, a research permit would have to be written in advance predicting all the conceivable events and opportunities which might conceivablypresent themselves. In addition, under the current system, these strandedanimals would immediately become research animals even though they had recentlystranded.  These animals have a high risk health status for several months orlonger post stranding.  By comparison, in captive display, a newborn cetacean isnot even added to the national database until it is six months old because ofthe high cetacean neonatal mortality rate.  A research permit for these specialfacilities would have to recognize the nature of the health challenges thatstranded animals present.  By illustration, marine mammal stranding centerswhich treat stranded animals are not given ?take? numbers.  A cetaceanresearch/rehabilitation facility should be considered in the same light.In ? 216.27(c)(6), Does NMFS need to  further define or clarify what activities would qualify as intrusive research on  a marine mammal undergoing rehabilitation, based on the definition in  ? 216.3, or qualify the proceduresfor  making this determination for animals  undergoing rehabilitation? See comments immediately below concerning IACUCsIACUC oversight: Should NMFS require Institutional Animal Care and Use Committee(IACUC) review before intrusive research occurs on animals in rehabilitation?  An Institutional Animal Care and Use Committee (IACUC) is a USDA registered Committee charged with the institutional oversight of animals and animal carepersonnel. USDA veterinarians regularly  inspect registered facilities to assurecompliance with animal regulations. The purpose of IACUC is to certify theproper care and use of animals as guided by the Animal Welfare Act. Whendischarging its oversight mission, an IACUC will actively engage to ensure thatall institutional personnel are in compliance with permits, protocols andapplicable guidelines for the humane care of animals.USDA registration and a properly constituted IACUC insure the legitimacy andhumanness of research.  If a rehabilitation facility is USDA registered researchfacility, it should be allowed to make the determination within theinstitution?s IACUC whether a procedure is intrusive research or is simplymedically warranted.  In many cases the answer is ambiguous.  NMFS should relyupon the institution?s IACUC to make these determinations.At institutions which are not research registered with the USDA and have noIACUC, it is more complicated.   A facility with only an animal care committee,for instance, does not have the same legal liability as a USDA registeredfacility.  Registered facilities have strictly defined roles for IACUCmembership and administrative oversight culminating in the InstitutionalOfficial who is criminally liable for failure to comply with federalregulations.  NMFS desires to explore the requirement for IACUCs in the care ofanimals in rehabilitation.  The key to understanding the effectiveness of IACUCsis to realize that it is dependent upon the very real liability of anInstitutional Official who is him/herself able, by virtue of his/her position todiscipline, sanction, and/or halt any activity in question.  For institutionswhich are not registered as research facilities with the USDA, NMFS shouldexplore providing an optional proxy IACUC comprised of participants in the NMFSnational stranding network, which would report directly to the NMFS Office ofProtected Resources.  This proxy IACUC could provide service to strandingnetworks which do not have USDA research registration.  The InstitutionalOfficial would, in effect, be replaced by the Stranding Network Coordinator, whohas the power to move the agency towards revocation of a letter of agreement. This arrangement would provide consistency, affordability, and expertise in thedetermination of whether procedures are intrusive research or medicallywarranted.  IACUCs can perform very quickly utilizing a process of  ?DesignatedMember Review? that need not be explained in this text.? 216.27(c)(5), Should marine  mammals undergoing rehabilitation or  pendingdisposition determination be  subject to public viewing?It should be the decision of the institution whether animals underrehabilitation are available for public viewing.However, should the decision be made to allow public viewing, then the animalsmust be held to public display regulations.Any deviations from public display regulations must comply with 9 CFR:(Text from :9 CFR ?3.104) Space requirements:(a) General. Marine mammals must be housed in primary enclosures that complywith the minimum space requirements prescribed by this part. These enclosuresmust be constructed and maintained so that the animals contained within areprovided sufficient space, both horizontally and vertically, to be able to makenormal postural and social adjustments with adequate freedom of movement, in orout of the water. (An exception to these requirements is provided in ?3.110(b)for isolation or separation for medical treatment and/or medical training.)Enclosures smaller than required by the standards may be temporarily used fornonmedical training, breeding, holding, and transfer purposes. If maintenance insuch enclosures for nonmedical training, breeding, or holding is to last longerthan 2 weeks, such extension must be justified in writing by the attendingveterinarian on a weekly basis. If maintenance in such enclosures for transferis to last longer than 1 week, such extension must be justified in writing bythe attending veterinarian on a weekly basis. Any enclosure that does not meetthe minimum space requirement for primary enclosures (including, but not limitedto, medical pools or enclosures, holding pools or enclosures, and gated sidepools smaller than the minimum space requirements) may not be used for permanenthousing purposes. Rotating animals between enclosures that meet the minimumspace requirements and enclosures that do not is not an acceptable means ofcomplying with the minimum space requirements for primary enclosures.Thank you for the opportunity to comment.", "comment_id": "NOAA-NMFS-2008-0020-0007", "comment_url": "https://api.regulations.gov/v4/comments/NOAA-NMFS-2008-0020-0007", "comment_date": "2008-03-28", "comment_time": "04:00:00", "commenter_fname": "David", "commenter_lname": "Casper", "comment_length": 8856}, {"text": "Ive seen nothing in these provisions indicating federal funding for meeting these guidelines.  Consideration must be given to the financial responsibility of responding to marine strandings for species which are not endangered nor threatened. Funding availibility, beyond the meger Prescott grant program, is critical in order to comply with these regulations.", "comment_id": "NOAA-NMFS-2008-0020-0003", "comment_url": "https://api.regulations.gov/v4/comments/NOAA-NMFS-2008-0020-0003", "comment_date": "2008-03-04", "comment_time": "05:00:00", "commenter_fname": "Jason", "commenter_lname": "Adams", "comment_length": 400}, {"text": "This is a general public comment regarding RIN 0648-AW22", "comment_id": "NOAA-NMFS-2008-0020-0004", "comment_url": "https://api.regulations.gov/v4/comments/NOAA-NMFS-2008-0020-0004", "comment_date": "2008-03-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 61}]}, {"id": "DEA-2015-0017", "agency": "DEA", "title": "Schedules of Controlled Substances:  Table of Excluded Nonnarcotic Products: Vicks\u00ae VapoInhaler\u00ae", "update_date": "2021-12-02", "update_time": "01:00:51", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "We respectfully ask DEA to correct a typographical error in the spelling of The Procter  Gamble Company.  As publishedin the Federal Register (FR), Vol. 80, No. 207, pp 65635 - 65637 on October 27, 2015, the companys name is misspelledin four occurrences.  The correct spelling of Procter  Gamble contains an e in Procter, not an o (Proctor) as listed in theFR notice.", "comment_id": "DEA-2015-0017-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0017-0002", "comment_date": "2015-11-10", "comment_time": "05:00:00", "commenter_fname": "Todd", "commenter_lname": "Banks", "comment_length": 422}]}, {"id": "ED-2014-OSERS-0011", "agency": "ED", "title": "Proposed priority--National Institute on Disability and Rehabilitation Research\u2014Advanced Rehabilitation Research Training Program", "update_date": "2022-04-14", "update_time": "01:11:01", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Our group is pleased to see this priority.  We comment to express our concern that NIDRR is requiring a two year term for the policy fellows.  We agree that a two year fellowship is ideal, we also recognize that it is likely that fellows will come to the fellowship with significant variations in experience and training.  We recognize that for those fellows who complete the fellowship in DC, it is hard to imagine that they wouldnt require a full two years.  On the other hand, there may well be outstanding candidates who would only want one year.  We note that other policy fellowships are one year options.  We also note that in the past, our post-doctoral fellows have gotten outstanding academic job offers part way through their fellowships, or because the fellowship budget period is different than most academic schedules, may complete a year and a half in order to accept jobs that start in July.", "comment_id": "ED-2014-OSERS-0011-0003", "comment_url": "https://api.regulations.gov/v4/comments/ED-2014-OSERS-0011-0003", "comment_date": "2014-05-16", "comment_time": "04:00:00", "commenter_fname": "Kurt", "commenter_lname": "Johnson", "comment_length": 912}, {"text": "Docket ID ED---20140OSERS---0068Proposed PriorityRehabilitation Training:  Rehabilitation Long-Term Training ProgramRehabilitation Specialty AreasTO:  RoseAnn Ashby, U.S. Department of Education, RSA TrainingDear Ms. Ashby:I would like to express my appreciation to RSA for deciding to grant new awards in FY2014 to long-term training programs in select specialty areas.  I am particularly pleased that one specialty area is vocational evaluation, as I am a practicing certified and licensed vocational evaluator with the Virginia Department for Aging and Rehabilitative Services.  The occupation of vocational evaluator is a specialty, as the education and training as well as the occupation responsibilities differ from those of rehabilitation counselors and other rehabilitation professionals.  Vocational evaluators conduct assessments that include real or simulated work.  What better way is there to gauge preparedness for the goal of employment than to conduct assessment that is functional?  Vocational evaluators determine the aptitude and skill strengths as well as the interests of the aspiring employee/tax payer.  Vocational evaluators make recommendations based on knowledge of the labor market and the skills required for success in the occupations.  We can identify occupations that match the individuals worker profile so that there is greater likelihood that the employment placement will be successful and in an area of interest, both of which will help foster the individuals longevity on the job and a career path.  Individual is a key word, as vocational evaluation services are individualized.If there is an issue on the job, the vocational evaluator can help assess and resolve the problems.  The evaluator can go to the job site to observe the employee and determine strategies, accommodations, and  low-tech assistive technology that could be effective, just as these are considered at other points in the vocational evaluation process.   The evaluator could determine whether more comprehensive assistive technology assessment is warranted.  The evaluator can coordinate with the employee, rehabilitation counselor, and employer to address the issues and, thus, promote saving the job.  Vocational evaluation services can save rehabilitation agency funds by providing focus for employment goals and by helping to save current jobs.  With effective assessment and planning, the number of persons who return for additional services can be reduced.  Other agency funds can be saved by the evaluator verifying that a potential student has the academic skills suggestive of success in a training or education program before the individual attempts such a program and risks experiencing disappointment.  I have supervised interns enrolled in the George Washington University (GWU) Collaborative Vocational Evaluation Training program.  I have been very impressed with the breadth of their knowledge, and I have learned from them.  I had been comforted knowing that there would be qualified persons available to fill my position when I retire in a few years.  Most of my vocational evaluator colleagues in this state agency are approaching retirement, as well.  I am distressed that RSA funding for the GWU vocational evaluation program is scheduled to end.  There are few other vocational evaluation graduate programs, and they all dont offer comprehensive career preparation.  I dont want my rehabilitation counselor colleagues and consumers to lose a service that I view as valuable, a significant aspect of my identity, and to which I have committed my entire career.  I also dont want persons hired who received their education from some of the other vocational evaluation graduate programs which do not seem comprehensive:  I have found by conversing with graduate students at vocational evaluation conferences who received financial support for vocational evaluation that their knowledge of vocational evaluation is limited.  Apparently, the focus of their coursework and internship was rehabilitation counseling or other priorities that were only marginally related to vocational evaluation.  Unlike rehabilitation counseling where there may be other counselors on site, training vocational evaluators on the job is challenging because there is often no other vocational evaluator at the same site. Now, with this RSA request for comments, my fear and dismay that the graduate education programs will end this fall is diminished.  I am optimistic that my beloved profession will be well staffed by graduates of quality vocational evaluation programs.  Sincerely, Patricia A. McCarthy, M. Ed., CVE, PVE, PPSLLead Vocational EvaluatorDivision of Rehabilitative ServicesVirginia Department for Aging and Rehabilitative Services5904 Old Richmond Highway, Suite 410 Alexandria, VA   22303 ", "comment_id": "ED-2014-OSERS-0011-0004", "comment_url": "https://api.regulations.gov/v4/comments/ED-2014-OSERS-0011-0004", "comment_date": "2014-06-13", "comment_time": "04:00:00", "commenter_fname": "Patricia", "commenter_lname": "Mccarthy", "comment_length": 5000}, {"text": "As a United States Air Force veteran, I believe that disability and rehabilitation research should be granted the highest priority. Funding for the Advanced Rehabilitation Research Training (ARRT) Program would provide essential training for researchers to begin advanced policy research in these areas. Though this program is not specifically targeted for the study of service related disability and rehabilitation, medical breakthroughs often lead to advancements in more than one area. Making this training program a priority may just be the start of those medical breakthroughs and lead to a better life for myself and my fellow disabled service members. ", "comment_id": "ED-2014-OSERS-0011-0002", "comment_url": "https://api.regulations.gov/v4/comments/ED-2014-OSERS-0011-0002", "comment_date": "2014-05-16", "comment_time": "04:00:00", "commenter_fname": "Tiffany", "commenter_lname": "Golden", "comment_length": 659}, {"text": "Dear Ms. Ashby, I am writing to comment on the Proposed Priority- regarding Rehabilitation Training: Rehabilitation Long Term Training ProgramsI am a 50-year-old employment support specialist for the VA Department for Aging and Rehabilitative Services.  I come to my current position with 15 + years experience providing employment support to adults and students with disabilities.  I am also currently enrolled in the Certified Vocational Evaluation Training program at George Washington University.  Why at 50 would I have the desire to achieve a Masters degree in Vocational Evaluation?  Because I have come full circle in my belief in and the understanding of the critical role that vocational evaluation plays in the successful employment to persons with disabilities.  When I started in the world of placement for individuals with significant disabilities, I would just work with them at what they demonstrated they could perform or expressed what they thought they liked.  While I could get them jobs, those jobs did not necessarily equate to success in or happiness with their employment.  In the early 1990s while, I knew the common sense approach, I needed training that is more formal.  I began taking some Masters class in transition; during that time, I was introduced to the specialized training and education in order to more effectively deliver person centered supports.  My career paused for child rearing and upon my return after an 8-year hiatus, I returned to providing employment support to the unemployed.  I came to realize the value in being able to quantify a persons aptitude and ability.  Having that information is critical to increasing an individual with disabilities self-confidence and their successful entry and/or return to work.  I was disappointed to discover that the availability of vocational evaluation training programs is very limited.  This is concerning because vocational evaluation differs from other assessments, as it focuses on work, and includes real work labor market information.  This real work evaluation coupled with the intensive training that Masters level program provides, ensures that the individual being evaluated is informed and educated by a professional who has a full arsenal of knowledge regarding assistive technology, accommodations and labor market information to inform and educate the job seeker and guide them to a successful career path. I respectfully request that you consider expanding the number of graduate programs available for Vocational Evaluation, as it is a critically important piece in rehabilitation. Janice Chory ", "comment_id": "ED-2014-OSERS-0011-0006", "comment_url": "https://api.regulations.gov/v4/comments/ED-2014-OSERS-0011-0006", "comment_date": "2014-06-13", "comment_time": "04:00:00", "commenter_fname": "Janice", "commenter_lname": "Chory", "comment_length": 2684}, {"text": "We are writing to express our enthusiasm and support for this priority.  We strongly believe that the development of a research policy fellowship has the potential to have significant impact on disability and rehabilitation and has broad application across NIDRRs three domains of individual well-being:  1) community living and participation; 2) employment and 3) health and function.  The proposal for a 2-year fellowship offers the opportunity for fellows to fully engage in the educational and training experience and develop competencies that will increase the fellows ability to effectively conduct policy research that has meaningful impact.  Many of the critical issues in the domains noted above are complex in ways that require extensive collaboration, networking, research and time. A two-year fellowship provides the necessary platform.  It could be of value to have flexibility as to whether the fellow needs to be in residence for both years.  One option could be a residential fellowship that is more didactic in the first year followed by an option for various placements in the second year.  In our experience of the Health and Aging Policy Fellows Program, we have found that in addition to the educational orientation and training component of the program, the mentorship and network are extraordinarily important, not only during the fellowship year but in an ongoing way.  The alumni network provides members with lifelong colleagues that can support each other, facilitate and catalyze initiatives in the field long after the completion of the fellowship year.  There are a number of complementary fellowship programs that may provide strong partnerships for this proposed priority, and may be able to jumpstart the development of an aligned network of colleagues who are committed to supporting initiatives aligned with this priority. This priority will contribute significantly to developing leaders in areas that are critical to the changing needs of the American population in terms of addressing the needs of individuals with complex and enduring health conditions, individuals with disabilities, and the aging population.  The focus across the span of health, employment and community living will have broad application and impact.  We will be very excited to see this program move forward.", "comment_id": "ED-2014-OSERS-0011-0005", "comment_url": "https://api.regulations.gov/v4/comments/ED-2014-OSERS-0011-0005", "comment_date": "2014-06-13", "comment_time": "04:00:00", "commenter_fname": "Kathleen", "commenter_lname": "Pike", "comment_length": 2371}]}, {"id": "CMS-2009-0117", "agency": "CMS", "title": "Medicare and Medicaid Programs; Electronic Health Record Incentive Program", "update_date": "2016-01-19", "update_time": "14:57:01", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "CMS-0033-P", "comment_id": "CMS-2009-0117-1956", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0117-1956", "comment_date": "2010-04-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 10}, {"text": "Please find comments submitted on behalf of Arizona Health-e Connection on the Proposed Rule for Meaningful Use.", "comment_id": "CMS-2009-0117-1085", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0117-1085", "comment_date": "2010-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 112}, {"text": "AnMed Health - Comments on CMS Notice of Proposed Rulemaking on the Medicare and Medicaid Electronic Health Records Incentive program.", "comment_id": "CMS-2009-0117-1105", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0117-1105", "comment_date": "2010-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 134}, {"text": "University of Wisconsin Hospital and Clinics was just recognized with a HIMSS Analytics Stage 7 Award which represents the highest level of the HIMSS EHR Adoption Model. UW Hospital and Clinics is one of two Acadmic Medical Centers in the country to achieve this level. Despite our fully integrated EHR, achieving the benefits of HIT is more demanding and takes longer than proposals imply. We invested heavily in risk identification and mitiigation activities prior to the implementation of the various components of the EHR. We conducted FMEAs to evaluate our cutover plans from our old systems to our new, identifying what could go wrong at each and every step. Based upon the assigned risk priority number, we developed and implemented risk mitigation strategies for those items with the greatest risk. Even with aggressive preparation and training, we experienced significant numbers of close calls and actual patient safety events during go-lives. Even now, a year after CPOE implmentation, we are still making changes to improve the system.", "comment_id": "CMS-2009-0117-1348", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0117-1348", "comment_date": "2010-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1057}, {"text": "The National Council recommends the Proposed Rules clarify that Community Behavioral Healthcare Organizations are key participants in this and other Federal Health Information Technology (HIT) initiatives to ensure that individuals with mental illnesses and addictions and their healthcare providers have equal access to the benefits of HIT.The Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the economic recovery bill passed by Congress, establishes a program of incentives for the meaningful use of Electronic Health Records (EHRs) thorugh Medicare and Medicaid to support the widespread adoption of EHRs to improve health outcomes, care delivery, population health and cost efficiency.  These goals cannot be achieved without clear inclusion and active partipation of CBHOs, which currently are a critical part of the healthcare delivery system and the safety network.", "comment_id": "CMS-2009-0117-1334", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0117-1334", "comment_date": "2010-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 946}]}, {"id": "HHS-OS-2019-0011", "agency": "HHS", "title": "Confidentiality of Substance Use Disorder Patient Records", "update_date": "2024-03-11", "update_time": "10:35:44", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Gentlemen:I have read the proposed changes to 42 CFR. These proposed changes will weaken the confidentiality of 42 CFR.  It is a crack in the door making it easier to finally destroy 42 CFR.  There are far too many government regulations now.  Bureaucratscreate power for themselves with more regulations.  I urge you to put these proposed in file 13 where they belong.", "comment_id": "HHS-OS-2019-0011-0020", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0020", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Bill", "commenter_lname": "Barnard bs", "comment_length": 384}, {"text": "This proposal is abominable. Patient confidentiality is an extremely important human rights issue, especially in the case of mental health and substance abuse. If this proposal passes, it will discourage addicts from seeking treatment for fear of privacy violations.I repeat: If this proposal passes, ADDICTS WILL NOT SEEK TREATMENT.This proposal is a step in the wrong direction in terms of privacy and harm reduction. ", "comment_id": "HHS-OS-2019-0011-0376", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0376", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Jennifer", "commenter_lname": "Lambert", "comment_length": 440}, {"text": "As a physician dedicated to the treatment of patients with addiction, I understand and respect the need for special regulations that protect our patients.  However, current requirements under 42 CFR Part 2 present huge barriers for essential communications between providers of health care.  As an example, successful treatment of patients with opioid addiction requires the collaboration of physicians with substance abuse counselors.  Failure to do so limits the effectiveness of the treatment program and places the patient at greater risk for recidivism.  I have seen the challenge of getting information to understand what treatments were provided at a detox and rehabilitation center as well as communication with agencies that specialize in mental health.  Over the past decade, governmental agencies have tried to decrease barriers in sharing of information.  Health Information Exchanges have been created to support those efforts.  As it is currently written, 42 CFR Part 2 would require recurrent permission to share information with any such exchange.  Please Please reduce the barriers in the exchange of information between those caring for the same patient.  It is an unnecessary burden and will harm patients.  ", "comment_id": "HHS-OS-2019-0011-0380", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0380", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Schaffrinna", "comment_length": 1227}, {"text": "As if being a chronic pain patient isnt stigmatizing enough....Now there seems to be a push to profit off of our painful conditions by opening our medical files to anyone who wants to see them.  It is no different for someone who takes medications for stigmatizing disorders like AIDS or HIV or herpes. Although no one can say that our problems with pain are caused through our own fault, we are stigmatized nonetheless.  I strongly disapprove of actions that seek to reduce patient confidentiality for chronic pain patients like me.  ", "comment_id": "HHS-OS-2019-0011-0391", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0391", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 540}, {"text": "October 21, 2019Re:42 CFR Part 2  Confidentiality of Substance Use Disorder Patient Records Proposed Rule (SAMHSA 4162-20; RIN 0930-AA32)Dear Ms. Avula: I strongly support patient privacy rights and the confidentiality of substance use disorder (SUD) treatment records, and offerAsthe following comments regarding the proposed modifications to 42 CFR Part 2 (Part 2) in the August 26, 2019 Notice of Proposed Rulemaking (NPRM).  As an addictions nurse with over 30 years of providing direct clinical care to persons with substance use disorders, I can say that patients will not feel comfortable sharing openly about their struggles and challenges if they fear that disclosures were not private and protected from access by law enforcement.  To keep people alive, we need to keep them in care; to keep them in care, we need to provide a safe space for them. I have serious concern over the proposals to weaken patient confidentiality in favor of law enforcement, insurance companies, and other third parties who do not provide care. These proposals, together with the recent SAMHSA proposal of RIN 0930-AA30 to amend Section 2.63 and permit greater law enforcement access to confidential communications,  would greatly compromise patients privacy rights and conflict with the stated purpose of the regulations: to ensure that a patient receiving treatment for a substance use disorder in a Part 2 program is not made more vulnerable to civil and criminal legal consequences, or discrimination than an individual with a substance use disorder who did not seek treatment. Moreover,  SAMHSAs proposed changes in both sets of rulemaking would discourage people from seeking or staying in treatment, particularly for individuals living in areas that are already heavily policed (e.g., communities of color, immigrant communities, and low-income neighborhoods), which would lead to further disparate health outcomes for these populations and more unnecessary and harmful interventions with the criminal justice system: I agree with SAMHSA that coordinating care for patients with substance use disorders should be a priority.  As such, I do support the rules proposal to amend the consent form requirements, which would permit patients to authorize disclosures outside of healthcare settings by simply naming the entity authorized to receive information, and without needing to name every individual within that entity. I have observed that the current consent requirements (naming individual recipients) frequently interfere with a patients ability to authorize disclosures to a number of non-healthcare actors that assist people living with SUD, including supportive housing services, social workers, lawyers and advocates, courts, and criminal justice officials.  I do support this proposed change. However, I am extremely concerned that, if finalized, other numerous provisions of the NPRM would significantly weaken patient privacy protections and prevent many people from seeking lifesaving SUD care.  As a result, I strongly urge SAMHSA to withdraw these sections of the NPRM as detailed below:  Statement Opposing Proposed Change to Orders Authorizing the Use of Undercover Agents and Informants (Section2.67)I oppose the proposed change to place undercover officers in a treatment setting for up to 12 months, since it profoundly compromises the confidentiality of all patients in treatment and serves as another disincentive for people needing SUD services to seek treatment, especially in communities that routinely have a significant law enforcement presence (such as, communities of color, low-income neighborhoods, and immigrant communities). Further, SAMHSA did not include any data or analysis in the NPRM from the Department of Justice to document the need for this change. This proposal is particularly concerning given the simultaneous proposal by SAMHSA to weaken the requirements for court orders authorizing disclosure of confidential communications, and statements made by SAMHSA indicating that extremely serious crimes may include any range of crimes that fall within the definition of drug trafficking.  I agree with SAMHSA on the importance of coordinated care and that more clarification is needed about how Part 2s privacy rules apply to integrated care settings. I would welcome an ongoing discussion with all SUD stakeholders and revised proposals by SAMHSA to promote care integration without sacrificing Part 2s guarantee of patient confidentiality protections.Thank you for your attention to these comments. I also wish to indicate support for the comments on the NPRM submitted by the Legal Action Center.Donna Beers MSN, RN-BC, CARNAssociate Director, Care Continuum HEALing Communities Study MassachusettsBoston Medical Center617 414.6633", "comment_id": "HHS-OS-2019-0011-0400", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0400", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Donna", "commenter_lname": "Beers", "comment_length": 4969}, {"text": "As a representative of Reintegration Support Network, a youth-focused recovery community organization, we urge SAMHSA TO WITHDRAW THESE SECTIONS OF THIS NOTICE OF PROPOSED RULEMAKING: Greater disclosures of patient records without consent to entities not involved in direct patient carePlacing undercover officers in a treatment setting for up to 12 monthsIncluding opioid treatment program (OTP) patient records in prescription drug monitoring programs (PDMPs), because of the level of law enforcement involvement in PDMPsExpanding access to states central registries, which would permit providers to request information from the database about a patients medication for opioid use disorderChanging the definition of records to exclude records disclosed orally to a patients primary care providerThese changes would discourage people from seeking or staying in treatment, particularly individuals living in areas that are already heavily policed. ", "comment_id": "HHS-OS-2019-0011-0428", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0428", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Jamie", "commenter_lname": "Jacobs", "comment_length": 993}, {"text": "As a Clinician that works primary with the SUD population, I would strongly advocate AGAINST this. I have found that many of my SUD clients refrain from really engaging in treatment, out of fear that their confidentiality will be at risk. While this is currently not true, it can create feelings of mistrust on the part of the client and can prevent the client from actively engaging in treatment.  For a SUD client opening up fully while in treatment can prevent or even delay the process of growth, development, and overcoming an SUD issue. I BEG YOU TO PLEASE RECONSIDER THIS!!!!. If for no other reason, please put yourself in the shoes of an SUD client. Would you want your confidentiality compromised? What is the real purpose of this? and most importantly who is this helping and how is it helping?", "comment_id": "HHS-OS-2019-0011-0353", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0353", "comment_date": "2019-10-01", "comment_time": "04:00:00", "commenter_fname": "V", "commenter_lname": "Z", "comment_length": 810}, {"text": "As a licensed mental health counselor in the state of Maryland, I am writing to speak against any weakening of current laws protecting the privacy of mental health clients struggling with substance use disorders. It is of primary importance that all such individuals know that their privacy will be protected when they seek counseling--and, it is of primary importance for their well-being and recovery prospects, that substance-addicted persons do seek the support that counseling provides. Please stand for the privacy of all persons seeking help for their mental health, including those who who are addicted to one or more substances. Thank you.", "comment_id": "HHS-OS-2019-0011-0361", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0361", "comment_date": "2019-10-01", "comment_time": "04:00:00", "commenter_fname": "Laura", "commenter_lname": "Hollister", "comment_length": 658}, {"text": "Public health experts agree that people living with substance use disorders are more likely to seek out and stay in treatment if they know their treatment records will not be unnecessarily disclosed to others without their knowledge or permission. My states P.D.M.P. is now routinely being used by some medical providers as part of pre-employment physical examinations and D.O.T. medical examinations.  Individuals using M.A.T. (medication assisted treatment) are routinely being denied employment or denied renewal of their D.O.T. examination card, on the basis of information contained in the P.D.M.P.  This use of the P.D.M.P. runs contrary to the very intent of 42 C.F.R. Part 2.   I request that the proposed rule directly address the appropriateness of utilizing the P.D.M.P. in occupational medicine.  Thank you for your consideration of this issue. ", "comment_id": "HHS-OS-2019-0011-0004", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0011-0004", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Kevin", "commenter_lname": "Catney", "comment_length": 892}]}, {"id": "FDA-2022-D-1847", "agency": "FDA", "title": "Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency", "update_date": "2022-11-03", "update_time": "13:44:18", "purpose": "Nonrulemaking", "keywords": ["CDER", "2022-329", "Exemption and Exclusion", "from Certain Requirements", "of the Drug Supply Chain Security Act", "for the Distribution", "of FDA-Approved Naloxone Products", "During the Opioid Public Health Emergency", "Open"], "comments": [{"text": "My son died September 11th, 2019 from an accidental overdose. He had overdosed twice before he died and it was only because of Narcan was he able to live another day. I have been talking to pharmacist, doctors, and the public in general and it is unbelievable how little they know about this lifesaving drug. I implore the FDA to please invest in a campaign of awareness concerning Narcan so that we can Save Just One. Someone dies every 5 minutes from an overdose or poisoning in this country. We are losing an entire generation.", "comment_id": "FDA-2022-D-1847-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0004", "comment_date": "2022-11-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 530}, {"text": "We are talking about lives here! The lives of the person who tried pot for the first time and it was laced with Fentanyl. The addict who couldnt no more and his overdose was a suicide attempt. We should have vending machines at every corner with Naloxone!. I understand regulations are necessary to keep individuals safe, but the individuals that need Naloxone are those not following regulations. I thank you for absolutely taking the initiative to lift regulations temporarily while we can get these numbers down. We should not limit a lifesaving medication by restricting it to prescription. Have not only harm reduction organizations carry it but recovery community organizations, rehabs, schools, libraries. Make it AVAILABLE! Easily accessible. ", "comment_id": "FDA-2022-D-1847-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0003", "comment_date": "2022-09-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 756}]}, {"id": "FDA-2017-P-5396", "agency": "FDA", "title": "Request that the FDA immediately seek removal of oral and transmucosal UHDU opioid analgesics from the market", "update_date": "2022-02-11", "update_time": "16:25:25", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "Changes in Opioid Prescribing in the US", "American College of Medical Toxicology", "National Safety Council", "Assoc of State and Territorial Health Officals", "Centers for Disease Control and Prevention", "American Academy of Pain Medicine", "American Pain Society", "UHDU Opioid Analgesics", "OxyContin 80 milligram tablet", "oxycodone", "UHDU opioids", "CDC Guideline", "fatal overdose", "50\u2013100MME", "20 MME", "opioid use disorder"], "comments": [{"text": "I am writing for my husband who is in too much pain to form sentences. He has been removed from his pain medication after 8 years with the same doctor. It is inhumane for the government to decide who is in pain and how much medication they need. Pain patients are committing suicide because they see no way out of the pain they have from failed surgeries AS, cancer,other diseases, end of life pain.Please think, if this was your family member, how would you feel if they were in excruciating intractable pain every day. The pain medication was working, they had a life, now they dont. They cant work any more or participate in life. Not only are they in pain but they are going through severe withdrawals.  Is this what the govt intended when it began to blame long term pain patients for the opioid crises? What about the fake fentanyl being manufactured in China? In Nebraska this week enough of this manufactured or fake fentanyl was found to kill 5M people. Is this the goal  Please, have compassion for those who are dying, in agony and cant take a pill.I have seen that prescriptions for narcotics are down by 70% while death from fentanyl has risen 110% Cant anyone see what is happening? This chart is from MD but I have read other states are the same.", "comment_id": "FDA-2017-P-5396-0138", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0138", "comment_date": "2017-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1291}, {"text": "I do understand the misuse of opiates but I have been on IR Oxycodone as a Chronic Pain Patient there are risk of over takingmedication but as your report says this has been in the ages of 13 to 25 mainly and those ages are very low and the over doses very high. I could understand not wanting anyone in hose age groups not being on that many MME but the Older people that have had Chronic Pain for many years knows the risk to look for and when not to take the medication during those times. Our Government has going why to far trying to stop a street drug problem that has been going on for years in one year and forgetting about Chronic Pain that can not be fixed with surgery or therapy. Some of use had surgery and came out worse than when we had it from no fault of our own and now have no one who will take s own as patients because of the damage done from our first surgery where does that leave us? i even understand wanting to stop the 30 mg oxycodone but this is going to cause more pills to be dispensed at 20 mg. I feel 120 mme would be more realistic than 90 mme at the lower dose per 4 to 6 hours.", "comment_id": "FDA-2017-P-5396-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0006", "comment_date": "2017-09-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1117}, {"text": "Studies are showing that under treating pain is already contributing to the increase of over dose on heroin and fentanyl. The CDC ignored warnings that this would happen. Further restriction will have dire consequences for millions and society as a whole", "comment_id": "FDA-2017-P-5396-0326", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0326", "comment_date": "2017-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 254}, {"text": "Too many rare disorders we know so little about because of limited research funding. Many cause chronic pain which leads to total disability if not properly treated.  Keep chronic pain people working  thriving in life instead of in bed on heating pad unable to concentrate. Pain causes accidents: i ran a red light because while driving, i couldnt concentrate  almost hit a car with kids in it. I did what dr told me - i got up  started moving, but pain will cause more deaths than drug addictions anyday of the week. Untreated pain kills in more ways than acknowledged by anyone.", "comment_id": "FDA-2017-P-5396-0341", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0341", "comment_date": "2017-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 595}, {"text": "It is irresponsible and cruel to leave those in chronic pain without opioid medication. They are the most effective medications for chronic pain.", "comment_id": "FDA-2017-P-5396-0405", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0405", "comment_date": "2017-11-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 145}, {"text": "Vote no on HR 6 so it will protect the chronic pain patients", "comment_id": "FDA-2017-P-5396-1631", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1631", "comment_date": "2018-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 60}, {"text": "People suffer from multitude of diseases which can cause intractable pain/ chronic pain and their doctors do tests to arrive at a diagnosis so they can treat them. Its unconscionable that an organization whose name reveals their bias which was arrived at sadly because one of their children had addiction disease and died from overdose would repeatedly attempt to interfere in doctor patient relationship. Furthermore its absolutely incomprehensible that an org armed with the power of federal government would rather see disabled people suffer pain than admit their efforts are harming thousands if not millions of people. If you have a rodent in your yard are you going to blame your house cat? Statistics are proving the overdose increases are due to illegal street drugs, not prescriptions. This org would beat the house cat because the rodents in the yard are multiplying. If you do not identify the problem correctly all efforts to solve it will fail. Ive seen multiple accounts of surgeries, including hip replacements, being done but patients are not receiving pain rx. Has this county lost its mind? There is an old saying you can lead a horse to water but you cant make him drink. You can talk to an addict til youre blue in the face but if they. are not willing, you cant make them stop unless you lock them up. It took years for me to get a diagnosis of my autoimmune disease. It has affected all my bones and now my organs. My pain never ends and at times is comparable to child birth. If I was unable to have pain rx I would not be able to participate in daily activities. I cant even hold a phone because of pan and numbness in my hands, and this is the least of my challenges. Dont discount my life because someone else decided to try drugs and misuse them due to addiction receptor disease. I may be disabled but should not be discounted. Dont ban these meds and please stop harassing doctors who are trying to help people have some semblance of a normal life.", "comment_id": "FDA-2017-P-5396-0569", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0569", "comment_date": "2018-01-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2032}, {"text": "You Really Need to stop reducing opioid meds because you Know as well as Anyone with Internet that its NOT prescribed opioid meds causing this! Its the Street Drugs including illicit and illegal drugs period!", "comment_id": "FDA-2017-P-5396-1636", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1636", "comment_date": "2018-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 218}, {"text": "Ive dealt with degenerative disc disease, CRPS, fibromyalgia, raynauds disease and tachycardia. Because if all my health issues Ive had to search for medication and treatments that worked best for me. These health issues will never go away completely so I search for the best quality of life. Ive found the best combination for me is watch my diet, physical therapy, chiropractic care, stretching, pain medication and other treatments like stem cell injections. This combination is what works. Pain medication is essential in this combination so that I can get up daily and be productive running my internet talk show. Ive advocated for the chronic pain committed for over 2 years. What PROP is suggesting will not change the overdose numbers in the way you would think. It will cause overdose rates to go up, more suicides and people will develop other major health issues due to the effects one has in high levels of pain. Im an example of this. My doctor tapered me below the 90mme for over a year and I developed tachycardia due to thigher blood pressure and constant out of control pain. FDA please let doctors make the decision as to what each patient should have for medications and treatments. ", "comment_id": "FDA-2017-P-5396-1633", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1633", "comment_date": "2018-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1212}, {"text": "As a pain patient I see more  more of the medications used to treat our disease, and yes chronic pain is a disease, being taken from us in the name of saving addicts. I come from a family of addicts and I have deep compassion for this horrendous disease but I do not think its treat should be done at the detriment of millions of others who suffer needlessly now that you have taken our pain medications away. I have tried to reach out to Mr. Kolodny only to be blocked by him on Twitter. We speak at hearings but it falls on deaf ears. The CDC openly admits to using improper data when coming up with PROP guidelines yet none of this matters to you. I have to ask myself why? Why are you slowly removing the tools that very capable intelligent doctors use to help people with legitimate pain. I can guarantee I tried every alternative treatment available. My bank records are proof of this. I am now broke from paying for these treatments. Neither me nor my friends want to be on pain medication but until our illnesses have a better safer treatment, you cannot deny opioids work, they are noninvasive, and are inexpensive. Have none if considered that you are only one accident, one fall away from being in our shoes? We are educated people who have a lot to give to society if only we could get out of bed. Are you aware that people are now canceling much needed surgeries because they fear not having pain control after their procedure. Mastectomies done without pain control. Open heart surgery; no pain control. I am sure you are well aware of the toll pain takes on the body in the form of increased heart rate, blood pressure, anxiety, adrenal stress. The list goes on. The worst of which is the decision that life is not worth living anymore when you must live each and every moment in pain. Yes, I am talking about choosing suicide over a daily struggle of missing out on being with your children, grandchildren, working, cleaning your home, loving your spouse, going to school, even just being able to walk to the bathroom. Why? Why must I see each day another regulation that denies help to those in pain? Are we worthless to society? I am beginning to believe the answer is yes.", "comment_id": "FDA-2017-P-5396-1627", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1627", "comment_date": "2018-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2196}]}, {"id": "FDA-2017-N-4515", "agency": "FDA", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments", "update_date": "2017-12-21", "update_time": "14:08:00", "purpose": "Nonrulemaking", "keywords": ["International Drug Scheduling", "Convention on Psychotropic Substances", "Single Convention on Narcotic Drugs", "Ocfentanil, Carfentanil, Pregabalin, Tramadol,", "Cannabidiol, Ketamine, and Eleven Other", "Substances", "Request for Comments", "OPEN"], "comments": [{"text": "Cannabidiol most definitely has medical value and does not belong in schedule I in relation to the Controlled Substances Act.  This should be already known by the Department of Health and Human Services, but I will list it here anyway.  The Department of Health and Human Services has held a patent on the medical value of cannabinoids since 2003 (patent number 6630507) for their value as neuroprotectants.  I will attach the abstract of 6630507, but it states specifically that CBD is beneficial because it avoids toxicity.  CBD alone does help alieve a degree of inflammation and pain.  Cannabis in its entirety with its entourage effect involving all terpenes, all cannabinoids, and all other compounds working in synergy are what would be most beneficial to patients suffering with conditions that are not presently treatable with modern options in medicine.  The modern world is recognizing the benefits of the cannabis plants and its components.  As a patient, I can testify to the fact that both cannabidiol on its own, and the cannabis plant in its many forms has helped to relieve a great degree of my pain at times when I believed that I would no longer be able to survive, and when nothing else would work.  Allopathic medicine is not always the answer.   I am thankful to the FDA for awakening to the benefits of CBD and for acknowledging the scientific evidence that is being presented the world over.  CBD has also been shown to improve cognition in multiple studies of impairment.  Dr. Mechoulam is a researcher in Israel who hasbeen conducting US research on cannabis since 1964.  That is the year he began receiving $100,000 per year from the USNational Institutes of Health to begin researching the effects of cannabis and to determine medical benefits or effects.He received $100k per annum until 2010, and concluded long ago that there were medical benefits.  In an interview that appeared in Newsweek, Mechoulam stated, Having seen the clear medical benefits of cannabis over more than 50 years of research, he is baffled that theres still reluctance to embrace marijuana as medicine. We believe modern science is going ahead, right? he asks. Well, its not. When insulin was discovered in the 1920s, it became a drug in months. Cortisone was discovered in the late 1940s, and it was made into a drug a year or two later. Anandamide was discovered 23 years ago and has still never been administered to a human being. Im not sure thats progress.  Anandamide is a different cannabinoid other than CBD, but he has also researched CBD.  CBDforDiabetes Mechoulam has been testing CBD on mice bred to have a version of type1 diabetes that manifests around age 14 weeks. He and his co-workers treated these mice with CBD for their first 6-7 weeks of life, then tested them 6-7 weeks later and found that only 30% had developed diabetes (compared to 90-100% given placebo).  CBD did not just prevent onset but blocked development of diabetes. In a follow-up experiment the mice werent given a course of CBD until age 14 weeks, when they were developing diabetes. They were then tested at age 24 weeks, and again only 30% of the treated mice were found to have diabetes. In other words, CBD did not just prevent onset but blocked development of diabetes. Examination of the insulin-producing islets showed that only 8% were intact in the untreated diabetic mice, whereas 77% were intact in the mice treated with CBD.  I believe that here we have something very promising, Mechoulam said. We plan to have a clinical trial starting next week treating patients, and hopefully at the next meeting I will tell you that all of them are cured. LetshavesomemoreCBD Cardiologists working with mice at Hebrew University have found that CBD treatment at the time of a heart attack can reduce infarct size by about 66%. I am not going to list all of the wonderful things that CBD and THC do.  I will say that they act as balancing agents to oneanother.  MY FINAL SUMMARY IS TO DESCHEDULE CBD AND KEEP IT DESCHEDULED FROM THE CSA.  I BELIEVE THAT ALLCANNABINOIDS SHOULD REMAIN DESCHEDULED (THE NATURALLY OCCURING CANNABINOIDS).ALSO TRAMADOL, KETAMINE, AND PREGABLIN SHOULD NOT BE SCHEDULED SUBSTANCES.  SCHEDULING OF ANY OF THE SUBSTANCES I LISTED MAKE IT HARDER ON PATIENTS THAT ARE ALREADY SUFFERINGTO OBTAIN THE MEDICATIONS THEY MUCH NEED TO BE ABLE TO OBTAIN A BETTER QUALITY OF LIFE.PLEASE READ THE ATTACHMENTS AS SUPPORTING DOCUMENTATION.  PLEASE RELY ON SCIENTIFIC DATA.  PLEASELISTEN TO THE PEOPLE.  PLEASE RELY ON CURRENT DATA!!!  THANK YOU FOR THE OPPORTUNITY TO PROVIDEMY INPUT.  ", "comment_id": "FDA-2017-N-4515-0436", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-0436", "comment_date": "2017-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4941}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.david wettermandalassabre@aol.com1444 s old Bruceville RoadBruceville, Texas 76630", "comment_id": "FDA-2017-N-4515-1643", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1643", "comment_date": "2017-08-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1782}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Colleen Grahamcoll_rtz@hotmail.comHome, 130 w 4th aveSan Manuel, Arizona 85631", "comment_id": "FDA-2017-N-4515-1651", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1651", "comment_date": "2017-08-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1778}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.Ive had six spinal surgeries I need a 7th from C2-C7 which has been done but needs reworked. I have ankylosing spondylitis, hep C and fibromyalgia. Ive almost died and the only reason Im breathing is from CBD oil. This government is destroying sick peoples ability to get help and you almost killed me. Have a conscience and start helping the Vets.. You are killing the men and women that would died for their country. This is a shame. Save our vets.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask ", "comment_id": "FDA-2017-N-4515-1813", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1813", "comment_date": "2017-08-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1934}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Christopher Allamanchristopher.allaman@gmail.comG26 Forest HtsButler, Pennsylvania 16001", "comment_id": "FDA-2017-N-4515-1821", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1821", "comment_date": "2017-08-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1788}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.I am reformed opioid addict - drugs prescribed by licensed VA doctors to treat crippling arthritis.  I would probably not be alive today, were it not for cannabis.  Yet Federal drug policy prohibits doctors from using a wonderfully effec", "comment_id": "FDA-2017-N-4515-1852", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1852", "comment_date": "2017-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1922}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Jason McGrathjsnmcgrath1977@yahoo.com44 Foxwood Road Bear Creek , Pennsylvania 18702", "comment_id": "FDA-2017-N-4515-1871", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1871", "comment_date": "2017-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1784}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.jacob haskinshaskins.jacob@gmail.com32592 N cherry Creek RDQueen Creek, Arizona 85142", "comment_id": "FDA-2017-N-4515-1857", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1857", "comment_date": "2017-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1785}, {"text": "Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Arturo Valadezxtremeaj25@gmail.com613 CandlegloWindcrest, Texas 78239", "comment_id": "FDA-2017-N-4515-1862", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1862", "comment_date": "2017-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1769}, {"text": "CBD works , faster and longer for me then any pain pill , and no constipation , as I need it everyday , I rub it on my knuckles for instant relief from my arthritis at night , also on my shoulder that has had 2 rotator cuff surgerys a month apart, then in the morning I rub it on my back as I have a separated vertabre with a protruding disc for 30 yrs L5/S1 talk about great relief for a stiff sore morning back, but dont believe me TRY IT !!!! if it doesnt completely remove all the pain it takes away enough to make life more enjoyable ,and NO you dont get high from it , please try it youll find relief, I have also used on a stiff neck / great for that also.   ", "comment_id": "FDA-2017-N-4515-1847", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1847", "comment_date": "2017-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 696}]}, {"id": "FDA-2017-N-6502", "agency": "FDA", "title": "Opioid Policy Steering Committee prescribing intervention \u2013 exploring a strategy for implementation; Public Hearing; Request for Comments", "update_date": "2018-03-27", "update_time": "16:22:09", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Im disabled spinal chord injury + tbi, w/spinal chord degeneration since 1982. Im submitting info on behalf of chronic, terminally ill and intractible pain patients across my state. My daily regime faces a number of challenges, and thats fine. However the difference between being completely bed ridden with daily home health care for most basic needs or leading a productive life as a contributing citizen is adequate pain management. Ive been under the care of the best in nation.Most of us have been screened by no fewer than 4 specialists in pain management and abide by contracts /or monitoring programs for safety. Thats also fine. If you research, youll learn intractible, chronic and terminally ill pain patients are not addicts, Addiction is a seperate disease. We and our doctors know you do not care to learn the difference, do not care if a percentage of disabled patients are left to suffer and die in coming years, but we do! Most of us have battled years to regain mobility, and ability over disabilities in an ablist society. We have the same rights to be heard, be treated as most appropriate regardless of required opioid dosages or brands. We the disabled persons have fought for the right to equal access, and a level playing field, so we may partake in lifes work, play and liberties. Our requirement for daily medication is; and should be viewed no differently than, a diabetic requiring insulin. Our Doctors, not our government, are best trained to know the best treatment plan(s). I do not doubt heroin from Afghanistan may be plaguing the black market, or illicit fentanyl may be a problem, however to limit our access to needed medication is misguided and cruel. Our pain management clinics are already multi tiered top level trained professionals in thier field serving only candidates carefully screened, monitored and appropriately treated. You work for us. It took many of us years to reenter the workplace and to advocate for a level playing field for ourselves and others. You have a duty to see that not one single patient with documented pain loses their access to  required medications. No one who has not attended Medical School and further specialized in pain management/anesthesia per our USA medical doctors licensing and specialization criteria should attempt to overreach in determining appropriate patient care without guidance from the same. Patients are suffering, and more will suffer with any further cut backs to an already austere program. Thank You for your time.", "comment_id": "FDA-2017-N-6502-0334", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0334", "comment_date": "2018-03-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2532}, {"text": "Both of my sons are diagnosed with Sickle Cell disease. Now my younger son is 17 years old and only in the last 2 years he was offered a pain relaxer which works so much better for his pain. Everywhere we go its an arguement. Doctors are deciding to push these drugs on us even if we dont want them. Here in Newark, NJ advocating has become so hard on us. It is life and slow death for us please. The Sickle cell community is only Allowed to have  morphine, oxycodone, dilaudid or fentinyl. WhY? Please hear me. My oldest son is a sophmore at LIU Post. He seems mentally slower. Classwork takes everything he has to give physicalky and mentally. The hospitals act blind to other pain management  options. I am so sad. All I want is my family to survive. And live and thrive our American dream. Now I run Lion Hearts the Michelle Reinoso Foundation. To benefit youth and famies fighting Sickle cell disease. My mother was a fantastic nurse, always put her full trusr in he4 practitioners. Medicine has not made significant progress in this field in many years. Transitioning medicayion should be offered but its not. With these being the only options patients suffering painful crisis are labeled as addicts for asking for the medication prescribed to them. These opiods cause nueral damage, joint damage, delayed comprehension and depression. The beain builds a tolerance to these opioids so always needing more for relief. This just sad at every turn. My organization is anti narcotic. We want to bring patient advocasy, get well badkets, healthy lifestyle and sincere understanding. PLEASE hear us!!! lionheartsofnj.org ", "comment_id": "FDA-2017-N-6502-0409", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0409", "comment_date": "2018-03-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1622}, {"text": "As a member of Families for Intractable Pain Relief (FIPR) and both a medical professional (PharmD) and a Severe Intractable Pain Patient myself, I strongly support the following FIPR response listed below regarding the Opioid Policy Steering Committee Prescribing InterventionFIPR position:  We have no problem with a policy that requires written justification above a set opioid prescription threshold, whether that be 90 MMED per CDC Guidelines or 80 MMED from another guideline.  However, we oppose any attempt to further specify threshold amounts by clinical indication, i.e. specific diagnosis or set of symptoms.   Every patient is unique.  An opioid dose that works well for one patient may be inadequate for another patient with the same clinical indication and may constitute over-medication for still a third patient.  Determination of appropriate dose is best left to the judgment and discretion of qualified pain physicians in consultation with the patient and family members.  Documentation should become part of the patients medical chart to be retained by the physician.  We should not impose additional requirements upon physicians to provide certain forms or documents to insurance payers.  The physicians treatment plan should reflect his or her seasoned judgment and insurers should be required to pay for what is prescribed.ONE SIZE WILL NEVER FIT ALL.  STOP TRYING TO ACHIEVE UNIFORM DOSING.  IT WILL ONLY CAUSE HARM.  My further response is listed below in the files provided.", "comment_id": "FDA-2017-N-6502-0501", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0501", "comment_date": "2018-03-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1551}, {"text": "United States Pharmacopeia request for extension on the commenting period", "comment_id": "FDA-2017-N-6502-0075", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0075", "comment_date": "2018-02-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 73}, {"text": "People with chronic pain should not be denied medication that can improve their ability to function and give them some quality of lifesyle rather than be laid up in bed or stuck in a chair and then develop other illness due to inactivity.  Pain increases stress and inhibits healing and the ability to have a meaningful life. People become depressed.  It is cruel to deny anyone the right to pain relief.  You will see undermedicated post surgical patients getting increased blood clots, atelectasis and pneumonia because they wont want to move due to pain.  The height of the opiod epidemic according to the opening statements in painweek 2017 was around 2010-12.  Everyone should listen to that on youtube, because pain doctors are standing up for the rights of their patients as well.  And now there is no distinction between deaths from heroin and fentanyl or illegal drugs from those obtained by prescription and not diverted.  The news and papers lump them all as opioid deaths in an effort to imply it is prescription medication. It makes the numbers look skewed in what the reason is if it all appears as opioid deaths.  People who have been taking pain medication for a while for chronic pain are less likely to overdose than opioid naive people.  Most will never misuse their meds, ask for early refills or do anything except take them directly as ordered.  Yet these proposed rules punish everyone in an effort to catch a few.  There has been heroin on the streets for a very long time and yet i hear very little in how the effort to stop illegal drug trafficking has improved.  But to punish people that do everything right in their treatment as an effect to show some improved statistic number winning the opioid epidemic is sad.  ", "comment_id": "FDA-2017-N-6502-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0015", "comment_date": "2018-01-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1744}, {"text": "As a chronic pain patient, I have to speak out on the current state of healthcare in the USA. When you need a primary care physician, you make a call to see if they are accepting new patients, the first question they use to ask was do you have insurance?. Now the first question is, are you currently taking pain medicine? or we do not prescribe pain medicine.  Did you know that urgent care facilities have signs posted as soon as you walk in stating we do not prescribe narcotics. The number one complaint/ailment that cause people to seek medical attention is pain. We are living longer, a blessing or a curse? The facts will come out, the war on drugs will not be won because they are targeting the wrong people! Chronic pain patients, the disabled  elderly do not abuse their medication. We are randomly drug tested, submit to random pill counts,  visit our doctors office every month for refills. We want to have a quality of life  have tried every available treatment to address our pain. The fact is, opioids are excellent pain reducing medication when taken correctly. Let our doctors treat us. When I read of another incident where a chronic pain patient was unable to find a doctor, or their medication was greatly reduced due to the CDC guidelines, or even worse, they have been cut off  cannot find a doctor who is willing to prescribe pain medicine  has committed suicide. These stories are every day occurrences  no one seems to care. Please understand the difference in chronic pain patients  drug addicts. Its really quite easy, chronic pain patients want to live  work  contribute to society. The drug addict wants to escape life, they know they could die but their need to get high rules their life. The addicts will always abuse as they go to the streets for their drugs. The statistics are very misleading. The people that have overdosed  will continue to, are using heroin  fentanyl. The term opioid epidemic is incorrect  has caused harmful, irrefutable damage for the chronic pain patient. Until you understand  verbalize in correct terminology the responsible drugs that are killing people, nothing will change. You will continue to hurt the very vulnerable of our population. Stop this now before more innocent die in agony when there is legal, effective medication that helps.", "comment_id": "FDA-2017-N-6502-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0046", "comment_date": "2018-01-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2426}, {"text": "My name is Laura, Im 33, and permanently disabled from Ehlers Danlos syndrome and Fibromyalgia, occipital neuralgia, CCI and a permanent injury to my left SI joint from being hit by a drunk driver.  Im housebound  the pain is so bad. My pain is at a level 7-8 avg daily, but without my medications, I literally cannot function at all. Im literally bedridden without them- so even the little help they give is better than nothing. And the ones Im on are the only that help! Ive tried everything else, as well as physical therapy to keep what little strength I have, which I wouldnt be able to cope with, without them. Being that I have EDS many other medications Ive tried I cannot metabolize normally- and that is why the others havent worked and I am now on the ones I am. Please consider there are many of us like this out there. We arent addicts but just those who need help and sometimes, these meds are the only thing that help keep us even slightly functional to take care of ourselves.", "comment_id": "FDA-2017-N-6502-0117", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0117", "comment_date": "2018-02-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1032}, {"text": "Dear Sir.Ill be 62 soon,I have lived in pain many yeas now ,I hurt my back at the Gym back in 1994 we are now in 18.I was 34 years old I did  ok till 95 downhill from there but I did not want to go on pain meds. I suffered  so  Had all the best DrsSo I was to office to office trying to fine something that would help now we are not Jhon on T.V.   that got out of  bed with a back sore and he takes Alive . This pain is so very bad my right leg feels like its on fire the left foot no feeling ,from my belly around my right hip and down the leg into the foot excuse please my hand writing for I have to stand up sitting is not good to me !  Anyway I had surgery in 99 Dr. Simeone at Jeff did it . I was so happy Ill be a new woman not in time I was much worst tried everything injections, Radio F , did it all because I was afraid to go on meds. Well in got so bad I could not  get out of bed anymore my mother did everything for me house work helping me into the bathroom From getting all the needles oh I tried the S.C.S test   There was not hope pain like this you think how can it be so bad never did I think i would feel this kind of pain till I was going to die. 1994 till 2004 now I cant get out of bed or sit take a bath. 2004 I seen and he was the real thing Dr. had to put me on meds.   My hubby always said Thank the Lord your on meds. I think you be gone now I have R.S.D Aracknoisi scar around the L/5 nerve roots. Well this is hurting many in pain cancer , anything Why do they want to see people dye ??? Because they are cant take it .And the opening up of Heroin clinics wait till they are deart I cant see that and people with chronic pain, cancer gets no help locking Drs up   ??? Put them in jail sorry Myself and more like me are killing themselves, My meds. are all most gone Im standing to write this all Im saying is there had to be a better way need to go but Docs even wanted to put the morphine   pump in me I said no the meds. may not work they told me. You have no clue  about pain you much have this  debilitating pain to understand I need help why dont the news tell the side of people in pain and how it is killing many 65 pain groups on Face book there is one very sad people that have lost their loved one due to suicide. Losing more now ! I dont think anyone cares Im I right?/ Without Im in bed 24/7 there is no Quality to life at all Please help make a better way? Dr.s no what they are doing something has to be done I cant live in 10 pain everyday can you ?This is not coming from me all pain people I dont hurt no one Please I need help with everything When I walk I have to use a cane wheeling chair would be no good because I cant sit in my meds. I did have Quality but now Im in bed very hard  to live like this.The sick  Disabled it looks to me no one cares, This is very backwards I lost my Dr, I had for 15 years he was there for 40 Then seen a new one he got out of it he was not going to see his people in pain and let me tell you this pain is so bad and unforgiving . Please, Please Help Me .Thank You For Your Time,I cant stand anymore would love to see someone face to face!!!.renee Steiger ", "comment_id": "FDA-2017-N-6502-0121", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0121", "comment_date": "2018-02-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3391}, {"text": "Please consider the law abiding pain sufferers when deciding to punish us for the abuse and illegal acts of others.If it wasnt for my pain  medication I would not have been able to continue to work and raise my two sons as a single mother.One is now a United States Marine and the other Suma Cum Laude graduate working to restore the California desert while waiting for his opportunity to serve this great nation. ", "comment_id": "FDA-2017-N-6502-0126", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0126", "comment_date": "2018-02-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 434}]}, {"id": "USCBP-2021-0009", "agency": "USCBP", "title": "Mandatory Advance Electronic Information for International Mail Shipments", "update_date": "2022-06-22", "update_time": "12:15:52", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "To the attention of Secretary Mayorkas:The American Consumer Institute Center for Citizen Research (ACI) would like to take the opportunity to address the Mandatory Advance Electronic Information for International Mail Shipments interim final rule (IFR) issued by the Department of Homeland Securitys U.S. Customs and Border Protection (CBP) to implement portions of the Synthetics Trafficking and Overdose Prevention Act (STOP Act; P.L. 115-271, Title VIII).  The Synthetics Trafficking and Overdose Prevention (STOP) Act was designed to help law enforcement and security agencies to identify and prevent hazardous substances, such as synthetic opioids and other dangerous items, from traveling through the U.S Postal Service (USPS) into the United States. ACI has touted the critical nature of such measures and has previously noted, The solutions created by the STOP Act will give law enforcement the tools necessary to begin stemming the intrusion of illicit items in the nations mail system. Specifically, this entails requirements on the USPS to collect and monitor advanced electronic data on shipments that enter the country. Such responsibilities would parallel the practices used by private delivery companies, which track every package and gather key data on the contents in order to assist coordination with U.S. Customs and Border Protection other federal securities entities. The STOP Act as written provides a clear schedule for accelerated levels of compliance that has allotted U.S. institutions to set their own frameworks for operational change and resource adjustments in order to meet objectives. The measures of the law are rightfully thorough in that they establish provisions for the myriad of elements of potentially exploitable delivery. The posture of the IFR as proposed would undermine this comprehensive configuration and thus jeopardize the overall purposes of the STOP Act.   In order to regain the trust of consumer communities in logistics and delivery markets, it is incumbent upon DHS to transparently detail the inflows of mail and packages and correspondingly provide data on the actions taken to assess each item, such that stakeholders and lawmakers can ascertain how exactly USPS and CPB are making good on assurances in this critical arena. The circumstances surrounding the origin of the law should remain apparent for the Department, and more broadly for the Administrations awareness. Unfortunately, for a 12-month period ending this past September, more than 87,000 Americans died of a drug overdose, surpassing the toll from any year since the opioid epidemic began in the 1990s.  The continuation of such trends heightens the concern for muting policies or laws that are actively working to prevent dangerous substances from entering our country. In a statement submitted by Robert Cintron Vice President, Logistics of United States Postal Service to the Permanent Subcommittee on Investigations of the Homeland Security and Governmental Affairs Committee, USPS was able to see the advance electronic data (AED) percentage for inbound international packages peak at 67 percent in January 2020, up from almost zero AED in the six years prior. While this is a demonstrated improvement, it is still cause for concern as the law called for an extensive grace period in the lead up to 100 percent compliance by January 1, 2021. Cintron admitted that AED progress reversed as the coronavirus pandemic affected international shipments but expressed his belief that once international mail recovers, he expects the AED will as well. While there is no accounting for the exact effect the coronavirus pandemic had on this effort, the USPS is still responsible for fulfilling its obligations.ACI further acknowledges and respects the USPS Inspector Generals role in assessing compliance, however concerns remain about the reticence of transparency and the redactions of key information that remain shielded from public review in their report.  Limiting the obfuscation in this regard, wherever feasible, and similarly elucidating the criteria through which foreign nations may be considered for any form exemptions, would represent prudent action on the part of the Department.In closing, we trust that the Department shall not be unduly influenced by the notions that enforcement of AED obligations could hypothetically prompt retaliation from foreign postal services.  Direct causation cannot be automatically assumed and such potential externalities are largely immaterial to actions dictated by the statutes of the law.  Ultimately, the STOP Act provisions must be held up to its full lifesaving potential in service to American consumers. Thank you for your consideration. Respectfully,Steve PociaskPresident/CEO American Consumer Institute1701 Pennsylvania Avenue, NW, Suite 200Washington, DC  20006ATTACHMENT: PDF includes footnotes and letterhead", "comment_id": "USCBP-2021-0009-0006", "comment_url": "https://api.regulations.gov/v4/comments/USCBP-2021-0009-0006", "comment_date": "2021-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5093}, {"text": "I dissent, 100%, and heres why. Treatment and education work, prohibition never has. This is a ridiculously convoluted, failure of a proposal. This act is supposed to stop opiodsspecifically fentanylfrom entering the country. But its not. Instead, I am now getting perfectly legal substances seized, returned to the sender, taking months to arrive, or possibly even scammed. These are supplements like piracetam, choine bitartrate, creatine, PEA (phenylethylamine),  and NAC (n-acetyl-cysteine, which literally saved my life when doctors couldnt help me at all.) I have used these items for years; they are completely legal, non-addictive, and safe. I have friends who have had clothing (not imitation clothing either, but simple things like a scarf from a grandmother), pictures, and even raw honey from Europe, be returned to the sender or just disappear. Lost to the backlog at the ISC locations, or maybe just stolen. Ill never know. This is beyond unacceptable. AED has already failed and it has only just started. Now, there are countries that refuse to ship anything to the United States, and the ones that still do, dont guarantee delivery or provide tracking information, so internet scamming has exploded. The USPS has been pushed past the breaking point. The backlog is insane and unacceptable. The USPS is directly affected to the point that they cant even guarantee next day domestic delivery anymore. Unacceptable. Need I mention the cost of running this program? You all know the figures. Theyre ridiculous. Returning parcels to other countries at the expense of the people is not what our taxes are meant for. Especially when we have an exploding homeless population across the country, a failing infrastructure, a police force in desperate need of new and more thorough training so people trust them again and dont fear them, as well as a broken healthcare system that has enslaved us. No longer can we rely on saving money by importing our prescribed medications, but we have to pay the outrageous prices of big pharma so we can stay alive and healthy. Were now slaves to the FDA, discretionary CBP tactics, and big pharmaceutical companies. We have lost yet another freedom. As for people importing the research chemicals that have reportedly intoxicating effects; this is just another form of prohibition, and prohibition has been proven time after time to not work. It only makes criminals. The war on drugs failed long ago and only gave rise to organized crime, money laundering, murder, and the worlds largest prison population. People are going to experiment with drugs just as they have all throughout recorded history. At least, before this proposal, they knew what they were getting and where it was coming from so the manufacturer could be held accountable. Now, we will have illegal, underground labs selling chemicals made by a guy that is not trained in chemistry and has no idea what he is doing. People will use his product, they will get sick, injured, or die and he will never be held accountable. And those deaths will be a direct result of AED. AED will make criminals that make poison that kills people. That is a certainty. Bear in mind, these are words coming from a man who has had half his immediate family drink themselves to death or overdose, and understands the situation intimately. Treatment and education are the only proven methods for success. Not imprisonment, not prohibition, *TREATMENT* and *EDUCATION*. This was a program that was started to stop opiods, but its stopping everything. Its ruining the postal system, costing more tax money, costing consumers more money, and severely limiting our freedoms. Its not acceptable and its not the United States. The United States was founded on the idea of freedom, but its feeling more like a prison every day. ", "comment_id": "USCBP-2021-0009-0020", "comment_url": "https://api.regulations.gov/v4/comments/USCBP-2021-0009-0020", "comment_date": "2021-06-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3947}, {"text": "To the attention of Secretary Mayorkas:The American Consumer Institute Center for Citizen Research (ACI) would like to take the opportunity to address the Mandatory Advance Electronic Information for International Mail Shipments interim final rule (IFR) issued by the Department of Homeland Securitys U.S. Customs and Border Protection (CBP) to implement portions of the Synthetics Trafficking and Overdose Prevention Act (STOP Act; P.L. 115-271, Title VIII).  The Synthetics Trafficking and Overdose Prevention (STOP) Act was designed to help law enforcement and security agencies to identify and prevent hazardous substances, such as synthetic opioids and other dangerous items, from traveling through the U.S Postal Service (USPS) into the United States. ACI has touted the critical nature of such measures and has previously noted, The solutions created by the STOP Act will give law enforcement the tools necessary to begin stemming the intrusion of illicit items in the nations mail system. Specifically, this entails requirements on the USPS to collect and monitor advanced electronic data on shipments that enter the country. Such responsibilities would parallel the practices used by private delivery companies, which track every package and gather key data on the contents in order to assist coordination with U.S. Customs and Border Protection other federal securities entities. The STOP Act as written provides a clear schedule for accelerated levels of compliance that has allotted U.S. institutions to set their own frameworks for operational change and resource adjustments in order to meet objectives. The measures of the law are rightfully thorough in that they establish provisions for the myriad of elements of potentially exploitable delivery. The posture of the IFR as proposed would undermine this comprehensive configuration and thus jeopardize the overall purposes of the STOP Act.   In order to regain the trust of consumer communities in logistics and delivery markets, it is incumbent upon DHS to transparently detail the inflows of mail and packages and correspondingly provide data on the actions taken to assess each item, such that stakeholders and lawmakers can ascertain how exactly USPS and CPB are making good on assurances in this critical arena. The circumstances surrounding the origin of the law should remain apparent for the Department, and more broadly for the Administrations awareness. Unfortunately, for a 12-month period ending this past September, more than 87,000 Americans died of a drug overdose, surpassing the toll from any year since the opioid epidemic began in the 1990s.  The continuation of such trends heightens the concern for muting policies or laws that are actively working to prevent dangerous substances from entering our country. In a statement submitted by Robert Cintron Vice President, Logistics of United States Postal Service to the Permanent Subcommittee on Investigations of the Homeland Security and Governmental Affairs Committee, USPS was able to see the advance electronic data (AED) percentage for inbound international packages peak at 67 percent in January 2020, up from almost zero AED in the six years prior. While this is a demonstrated improvement, it is still cause for concern as the law called for an extensive grace period in the lead up to 100 percent compliance by January 1, 2021. Cintron admitted that AED progress reversed as the coronavirus pandemic affected international shipments but expressed his belief that once international mail recovers, he expects the AED will as well. While there is no accounting for the exact effect the coronavirus pandemic had on this effort, the USPS is still responsible for fulfilling its obligations.ACI further acknowledges and respects the USPS Inspector Generals role in assessing compliance, however concerns remain about the reticence of transparency and the redactions of key information that remain shielded from public review in their report.  Limiting the obfuscation in this regard, wherever feasible, and similarly elucidating the criteria through which foreign nations may be considered for any form exemptions, would represent prudent action on the part of the Department.In closing, we trust that the Department shall not be unduly influenced by the notions that enforcement of AED obligations could hypothetically prompt retaliation from foreign postal services.  Direct causation cannot be automatically assumed and such potential externalities are largely immaterial to actions dictated by the statutes of the law.  Ultimately, the STOP Act provisions must be held up to its full lifesaving potential in service to American consumers. Thank you for your consideration. Respectfully,Steve PociaskPresident/CEO American Consumer Institute1701 Pennsylvania Avenue, NW, Suite 200Washington, DC  20006", "comment_id": "USCBP-2021-0009-0007", "comment_url": "https://api.regulations.gov/v4/comments/USCBP-2021-0009-0007", "comment_date": "2021-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5034}, {"text": "It is very interesting to see how the border crisis can relate to other issues and upcoming issues being brought to America. I didnt read too far into depth but I did not see any suggesting of the invar go created by Joe Biden, I wish there was more pictures of the border crisis just to get a gist of what is going on over there.", "comment_id": "USCBP-2021-0009-0003", "comment_url": "https://api.regulations.gov/v4/comments/USCBP-2021-0009-0003", "comment_date": "2021-05-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 335}]}, {"id": "DEA-2020-0031", "agency": "DEA", "title": "Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act:  Dispensing and Administering Controlled Substances for Medication-Assisted Treatment", "update_date": "2023-01-05", "update_time": "11:23:11", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "To Whom it May Concern,The Colorado Pharmacists Society, a 501c(6) organization representing pharmacy professionals (pharmacists, technicians and interns) in the state of Colorado would like to take the opportunity to SUPPORT the following with respect to the Interim Final Rule:Administration of long-acting injectables by non-data waived practitioners.  Ask for the DEA to confirm that non-data waived health-care practitioners (HCPs) can administer long acting injectable forms of controlled substances subject to having a prescription data waived HCP.Pharmacists ability to administer long-acting injectables.  Ask the DEA to confirm that pharmacists are considered HCPs and that they can (subject to state laws) administer long-acting forms of injectable controlled substances subject to having a prescription from a data waived HCP for the patient.   This confirmation is especially import for rural patients who are more likely close to a pharmacy than a data waived HCP.  This also makes sense given the rise of telemedicine that has taken place during the COVID19 pandemic Thank you,Emily Zadvorny, PharmD, BCPSExecutive DirectorColorado Pharmacists Society", "comment_id": "DEA-2020-0031-0045", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0045", "comment_date": "2021-01-04", "comment_time": "05:00:00", "commenter_fname": "Emily", "commenter_lname": "Zadvorny", "comment_length": 1231}, {"text": "11 / 02 / 2020 COMMENTS:  I have practiced medicine for 37 years and currently, I am the Chief Medical Officer at Urgent Point in Los Angeles, CA.  I have been a DATA 2000 provider since 2001 and I have successfully treated thousands of patients over 20 years who suffer with chronic pain disorders and opioid use disorder.  Over 20 years, my perspective on the treatment of opioid use disorder utilizing MAT has become more realistic because I have observed a dysfunctional medical system misunderstand the general approach to the treatment of opioid addiction.There is no doubt that we do not have enough providers to treat opioid addiction.  However, the problem is more complex and just allowing more providers to treat more patients will not necessarily reduce our countries epidemic of opioid use disorder.  Currently 4% of the worlds populations in the United States consumes 80% of the opioids produced by our world.   Unfortunately, many of the providers who undergo training on the use of MAT do not fully understand that opioid use disorder is a condition that requires at minimum 6 months treatment and often requires a longer period of time.  Unfortunately, opioid addiction treatment has been treated as though opioid addicts are similar to alcoholics and residency training and AA oriented treatment programs in the United States have resulted in the emphasis being that addicts must approach their opioid addiction from an AA behavioral emphasis and this has caused many opioid addicted individuals to be undertreated because providers insisted on rapid tapering off BUPRENORPHINE early in treatment or forced patients to use lower doses of BUPRENORPHINE early in therapy.   It is this emphasis that has resulted in opioid addicts early relapse and re-addiction to opioid drugs. MAT should be offered as chronic therapy, like we treat all other chronic disorders ie. Diabetes, hypertension, heart disease, headaches, etc.  The average treated individual is on 16 mg daily of BUPRENORPHINE to reduce 90% or more of opioid craving.  It is only while opioid craving is extinguished that addicts are able to change behavior over time.  The danger in the DEA changes is that more providers will be created and it will be easier to provide therapy but, if attitudes remain the same, we may say increased misuse and diversion.  Our system of addiction treatment spends more money on keeping patients in residential treatment than to just treat people and monitor them as outpatients.  In Europe, providers treat patients for years and rigidly control the use of prescriptions with the primary care physician in control.  In the U.S. the only drug that needs to be dispensed from the office is SUBLOCADE.  In residential treatment, physicians can prescribe SUBOXONE for dispensing under rigid prescription controls.  At discharge, the pharmacy should be the dispensing entity, not the physician provider.  I am glad that the DEA is changing the dynamics of access to treatment but, the overall approach to treatment must undergo a coordinated management approach that includes provider education and a focus that emphasizes necessary therapeutic approaches rather than to add cost to treatment  by forcing unneeded cookie cutter AA management requirements.  It is important to remember that Methadone is a form of MAT and the only requirement is to present to the clinic daily.  AA management is not required.  Buprenorphine is a better alternative because it is one of the safest medications ever produced.  The insistence on AA philosophy over medication therapy has resulted in rigid treatment.  Patients on an average of 16 mg daily will have opioid craving blocked and can change behavior without having to fight the opioid craving that drives addictive behavior.  Providers should focus on monitoring of care and maintaining sobriety over forcing AA attendance.   The primary point is that BUPRENORPHINE dispensing really doesnt require inpatient or residential treatment for the most part.  As Methadone treatment has proven, it is the blocking of opioid craving that is the primary effect of MAT.  I hope that my comments are helpful and provide a rationale observation regarding how opioid use disorder treatment should be viewed.  Opioid addiction treated from the primary care office, like we treat most chronic disease is how we will successfully address our current epidemic of opioid addiction.  It will be much less costly and more effective if we focus on how MAT should be instituted.  The Residential treatment and addiction treatment center political lobby are focused on the most-costly therapies and will only perpetuate the current ineffectual opioid treatment approaches.  Any changes in the prescribing of MAT must include an aggressive education program for providers that is uniquely mandated for the treatment of opioid use disorder. Thank you and I am happy to continue this in-depth discussion in the future.Sincerely,Rick Chavez, M.D.", "comment_id": "DEA-2020-0031-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0002", "comment_date": "2020-11-10", "comment_time": "05:00:00", "commenter_fname": "Rick", "commenter_lname": "Chavez", "comment_length": 5094}, {"text": "As the only pharmacist in the North Carolina General Assembly I believe North Carolina is on the frontline of the opioid crisis. One proven solution is the use of long acting injectable formulations of buprenorphine. It is vital that all individuals diagnosed with opioid use disorder have the necessary access to important forms of medication for treatment. The interim final rule currently contains unnecessary restrictions that would hinder patient access. First, the fourteen-day rule does not take into account that it may take longer than 14 days to arrange for a patient to visit a clinic to receive the injection or that currently medications obtained via buy-and-bill options are permitted to be stored for periods far exceeding 14 days. In order to ensure proper access, the ability to store injectable medications should be extended to at least 60-days.Secondly, in many instances, data 2000 waived practitioners, while able to prescribe injectable buprenorphine, may not have a facility to administer the injections. To accommodate this, non-data waived practitioners should be permitted to administer injections ordered by a data waived provider. This should include pharmacists who may administer injections ordered by data waived providers. This can ensure that patients in rural areas, residential care facilities, and those receiving regular treatment via telemedicine can receive life-saving medication to treat their opioid use disorder.", "comment_id": "DEA-2020-0031-0031", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0031", "comment_date": "2020-12-22", "comment_time": "05:00:00", "commenter_fname": "Representative wayne", "commenter_lname": "Sasser", "comment_length": 1471}, {"text": " January 4, 2021Drug Enforcement AdministrationAttn: DEA Federal Register Representative/DPW8701 Morrissette DriveSpringfield, VA  22152-2639 RE: Notice of Proposed Rulemaking Request for Comments-Implementation of the Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication Assisted Treatment (SUPPORT Act of 2018)RIN 1117-AB55/Docket No. DEA-499Scripps Safe, a leader in pharmaceutical and controlled substance anti-diversion solutions, fully supports expanded access to opioid recovery and treatment for patients and communities.  Scripps Safe is concerned that the proposed regulations do not require adequate physical security to prevent controlled substance diversion for OTPs (Opioid Treatment Providers, one of our largest markets), so we offer some specific recommendations.  By considering and implementing our recommendations, the Drug Enforcement Administration (DEA) will provide greater control, transparency and accountability by OTPs storing, inventorying, dispensing, administering, and disposing of the controlled substances they handle. Overall, many of the applicable regulations (21 C.F.R.  1301.72-.76) governing controlled substance security are outdated and subject OTP facilities to increased risk for diversion as stated.  We have found that diversion is common in the OTP space due to lack of guidance and codification of requiring current available sophisticated technologies by over 20 vendors.  Currently diversion occurs among 12-14% of healthcare practitioners, mid-level practitioners and non-practitioners costing our nation countless lives and some $78.5 + billion a year.   Employee pilferage accounts for roughly 48% of pharmacy thefts.   DEA should enhance controlled substance security requirements through a robust program utilizing the latest technologies for OTP services and for all registrants security handling requirements. Updating simple, very low-cost, widely and commercially available solutions would strengthen the proposed regulations by protecting against diversion.  As an example, allowing a currently DEA approved Group 1R combination dial lock on a UL Listed narcotics boxes carrying multiple units of Suboxone, Methadone, Ketamine or Buprenorphine with access by several medical professionals as outlined in this proposed rulemaking, lacks adequate accountability and control.  We suggest that DEAs outdated regulations be enhanced by requiring the following to support robust treatment access to patient care program while minimizing the risk of diversion:Purpose-built pharmacy and narcotics safes with UL Type 1 electronic access control systems with cloud or PC based software for managing and auditing all lawful users for reporting and accountability. Records should be pulled monthly and kept for two years.Low-cost electronic inventory control that complies with the Drug Supply Chain Security Act (Track  Trace/ Chain of Custody Control) and state laws to prevent adulteration and/ or substitution. Records should be pulled monthly (or as per updated state regulations) and kept for two years. Additional security features such as constant supervision video surveillance and monitoring to meet most state health codes. Video storage for up to two years. To ensure a seamless transition, we recommend that these additional measures be temporarily exempt for facilities that currently have an existing dial combination locking security safe in place and allow them to keep those storage and/ or dispensing units until they fail or up to twelve months after implantation of the proposed regulation, whichever occurs first. The combination Group 1R locks can inexpensively be swamped out onsite in less than one hour with a new electronic UL Type 1 by over 3,500 licensed locksmiths throughout the USA for only a few hundred dollars in total. In addition, OTPs should be required within the next 12 months to transition over to electronic record keeping with monthly audit logs to track inventory and administration of controlled substances. If utilizing a hub (pharmacy or central narcotics storage) and spoke model (treatment facilities), especially those with multiple locations, this information should be centralized with the responsible individual on the DEA registration or the authorized designee.  Such IP technology is readily available to push/pull this data via an IP/ WiFi network to provide greater constant supervision and oversight when licensed healthcare professionals constantly move around facilities as needed. Safe Scripps appreciates the opportunity to comment on DEAs proposed OTP regulations. We look forward to working with the DEA in the future on this and CSA security issues. Respectfully Submitted,Christopher von Zwehl, MASVP/ RX Security Expert1-844-4Safe-Rx (472-3379)chrisvz@scripps-safe.com www.4SafeRx.com", "comment_id": "DEA-2020-0031-0055", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0055", "comment_date": "2021-01-05", "comment_time": "05:00:00", "commenter_fname": "Christopher", "commenter_lname": "Von zwehl", "comment_length": 5358}, {"text": "The united States is no doubt in the middle of an opioid crisis.  The acceptance of medication assisted therapy by providers, patients, insurance companies and the general public is long overdue.  We now have several excellent options including naltrexone, buprenorphine and methadone.  The most recent advance is the availability of long acting injectable buprenorphine.  The restriction known as the 14 day rule puts undue burden on the use of this valuable product.  Often times a patient is unable to be scheduled in the 14 day window of opportunity.  Further complicating this situation is the soon to be available weekly injectable product.  It is my understanding that this product will be shipped with 4 (four) separate weekly injections.  The 14 day rule would hinder all but the use of the first injection in this situation. A reasonable solution would be to extend the allowance to 60 days.  Most patients are transitioned from sublingual to the injectable buprenorphine and a stable patient is commonly given anywhere from 7 to 60 days worth of medication until the next appointment.  By extending the 14 day rule to a 60 day rule, there would be sufficient time for the patient and provider to arrange a regular follow up after the product is received by the provider.Furthermore, for the past several years pharmacists have successfully administered multiple other medications prescribed by physicians.  The administering of injectable buprenorphine by pharmacists appropriately trained should be considered for this as well.  There are many physicians who are DATA-2000 wavered who do not have the staffing to administer the medication.  Others will find that it is much more convenient for the patient to receive their medication at the pharmacy and continue with their follow up at their physicians office for care of their opioid use disorder.We should be exploring ways to remove barriers to care for this disease while maintaining excellent and appropriate service and follow up by well trained providers.  ", "comment_id": "DEA-2020-0031-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0039", "comment_date": "2021-01-04", "comment_time": "05:00:00", "commenter_fname": "William", "commenter_lname": "Santoro", "comment_length": 2047}, {"text": "RIN 1117-AB55-DEA-499", "comment_id": "DEA-2020-0031-0046", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0046", "comment_date": "2021-01-04", "comment_time": "05:00:00", "commenter_fname": "Ricquitta", "commenter_lname": "Johnson", "comment_length": 21}, {"text": "Joseph DuranDirector of Policy and PlanningUS Department of Veteran Affairs 3773 Cherry Creek North DriveDenver, CO 80209RE: AQ31-Proposed Rule - Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists (Docket ID: VA-2020-VHA-0023) Thank you for the opportunity to comment on the proposal to eliminate copayments for Opioid Antagonists and Education on the Use of Opioid Antagonists. As a Masters of Public Health candidate, and a harm reduction advocate, I am writing to encourage this rule to be passed.I applaud the DVA for bringing this topic to the attention of regulators. This is an issue that is critical to public health and the future of our nation. For decades, the opioid crisis in the United States has devastated communities, and the Veteran population has not been exempt. Opioids are highly addictive and have historically been prescribed to veterans to help them manage chronic pain. Research has shown that Veterans have a higher risk of harm due to opioids and accidental poisonings when compared to non-veterans. From 2010-2016, the overdose rate from opioids rose by nearly 10% within the Veteran community. We have the tools and the power to reduce mortality and morbidity rates associated with this crisis, and they should all be fully utilized to prevent more deaths. Aligned with Federal RulesSince 2016, federal rules have allowed for the considerations in this document. The proposed amendment would simply solidify what is already agreed upon by several government agencies, and make it easier for veterans to access the care they need. By being in agreement with the current laws, DVAs proposal could eliminate a significant barrier to care while upholding their commitment to protect Veterans. Additionally, the proposed definition of a high-risk Veteran is broad, and captures a diverse range of Veterans who benefit greatly from this clarification. Current Barriers to Care - Providers Play a Role The Veterans Health Administration reports that less than 35% of patients with an opioid use disorder are prescribed treatments, including opioid antagonists, despite data that shows their effectiveness to save lives. This is due to several barriers that include a lack of education about these treatments, provider stigma, and providers perception of lack of patient interest. Providers can be considered the gatekeepers to prescription drugs, and should be properly educated on the communities they serve to minimize harm. Therefore, provider education should also be included in the amendments to the education rule. Providers who serve veterans should have mandatory education on how the Veteran community is specifically impacted by the opioid crisis, and how to assess when a person may need an opioid antagonist. Furthermore, the education component of the amendment will help patients learn how to advocate for themselves, and teach individuals how to be more comfortable with using the medication properly. Affordability Saves LivesThe elimination of copayments is a fantastic policy to make sure is followed. Data shows that poverty within the Veteran community has been steadily rising, which can impact how people can afford medications and treatments. Amongst Veterans 18-34, the poverty rate is 12% compared to 9% of Veterans ages 35-54. However, Veterans 68% and older have a poverty rate of 48% - the highest of all age groups. These two numbers are essential to highlight for several reasons. In the US, people over 26 years of age are most likely to use prescription opioids, which places them at risk for opioid use disorder. Additionally, veterans 65 and older likely have comorbidities and are at increased risk for chronic pain. Additionally, Veterans aged 50 and older have the highest suicide rates amongst the population. DVA reports that opioids played a role in over 40% of all suicide and opioid deaths in 2017.  When these facts are compounded with the growing poverty rates in these age groups, there should be significant worry about Veterans being able to afford their life-saving treatments. Ensuring that the policy to not charge a copay for opioid treatments is critical to the health of this community.  Free education and access to opioid antagonists are essential to preventing accidental deaths, and decreasing morbidity. ", "comment_id": "DEA-2020-0031-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0011", "comment_date": "2020-11-23", "comment_time": "05:00:00", "commenter_fname": "Michaela", "commenter_lname": "Jackson", "comment_length": 4466}, {"text": "The barriers to medical-assisted treatment (MAT) are unfortunate and illogical. I recognize that some of this may be statutory rather than regulatory, but as a practicing emergency physician it is very odd that with standard training and a DEA license, I can prescribe opioid analgesics that lead to substance use disorder but not the substantially safer medications to help treat substance use disorder. Any regulatory barriers to MAT should be lowered as much as possible as the impact of the opioid epidemic is unfortunately vast. We see  treat many patients in the ED for substance use disorder and medications such as buprenorphine are well within our scope of practice, and safer than most other controlled substances. The potential impact in helping vulnerable patients is enormous.N. Seth Trueger, MD, MPH, FACEPAssistant Professor of Emergency MedicineNorthwestern University  Northwestern Memorial Hospital", "comment_id": "DEA-2020-0031-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0008", "comment_date": "2020-11-12", "comment_time": "05:00:00", "commenter_fname": "Nathan", "commenter_lname": "Trueger", "comment_length": 946}, {"text": "Patient care is not predictable, especially with a population suffering from OUD. A treatment plan is often delayed/disrupted by unforeseen circumstances (court/legal issues, job, relapse, family, medical provider schedule, etc).  The patient and practice should not have to bear the burden.  Starting the process over after 14 days is taxing on staff and slows down our efforts to help patients suffering from this epidemic.  Patients and practices will benefit if the period is extended or waived on this class of medication.    ", "comment_id": "DEA-2020-0031-0033", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0031-0033", "comment_date": "2020-12-22", "comment_time": "05:00:00", "commenter_fname": "Angela", "commenter_lname": "Williamson", "comment_length": 531}]}, {"id": "FDA-2019-P-1679", "agency": "FDA", "title": "Requests that the FDA revoke orphan drug designation for Sublocade (buprenorphine extended-release) injection for treatment of opiate addiction in opiate users, currently referred to as opioid use disorder", "update_date": "2019-11-07", "update_time": "16:23:01", "purpose": "Nonrulemaking", "keywords": ["revoke orphan drug designation for Sublocade", "(buprenorphine extended-release) injection for", "treatment of opiate addiction in opiate users,", "currently referred to as opioid use disorder", "OPEN", "Goodwin Procter LLP", "Braeburn, Inc.", "Citizen Petition", "CDER"], "comments": [{"text": "Andrea G. Barthwell, M.D.  D.F.A.S.A.M.", "comment_id": "FDA-2019-P-1679-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0046", "comment_date": "2019-05-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}, {"text": "I know firsthand the devastation of the Opioid Addiction crisis. My husband and son have struggled with addiction for many years. My nonprofit organization Maryland Heroin Awareness Advocates (MHAA) is requesting the FDA to please strip the orphan designation granted to Sublocade. Every individual is different and no single treatment will work for all of them. The more available treatment options we have will save lives, and are necessary to curb the massive deaths from opioid intoxication. This is definitely not a rare disease, and too many people who suffer dont have access to quality, long term treatment. We need to bring more medically  assisted treatments to market  not keeping treatments that have been found to be safe and effective off the market. The FDA needs to be on the side of patients and bring more treatments to the market.The FDA should strip Sublocade of its orphan designation and ensure that more needed treatments are available to help stem this crisis.", "comment_id": "FDA-2019-P-1679-0048", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0048", "comment_date": "2019-05-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1009}, {"text": "Medication assisted therapy is proven to be effective for patients in abstaining from use and remaining in treatment programs as well as reducing their risk of overdose. Our options are currently limited and restrictive, as they dont provide many opportunities for patients with less than perfect adherence. Just as we have seen with injectable antipsychotic medication, removing the variable of adherence for such an important disease state keeps people healthy longer. Compared to schizophrenia, this often means saving lives for patients with opioid use disorder. The classic definition of an orphan drug does not apply to this product and we need access to as many tools as possible to help these patients. Allowing another medication option will only give us more versatility to treat all patients in a way that works best for them. ", "comment_id": "FDA-2019-P-1679-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0040", "comment_date": "2019-05-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 838}, {"text": "A medication such as buprenorphine cannot he considered an orphan drug when it  is being used as the principle medication to treat a disease that has been declared a public health crisis. The FDA has stated that they are invested in making it easier for new treatments to be made available for the treatment of opioid use disorder however their actions show otherwise. As a treatment provider who sees the damage this disease causes to individuals and their families, I see the urgent need to have every life saving treatment made available today and not in 7 years from now.", "comment_id": "FDA-2019-P-1679-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0028", "comment_date": "2019-04-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 575}, {"text": "I write in my capacity as Professor of Psychiatry at NYU School of Medicine and as a NIDA-funded researcher focused on clinical trials for OUD.  In the midst of an opioid crisis that affects several million people directly, plus family, friends, communities, there is a compelling need for a broad range of treatment options, and there seems to be no justification for orphan drug status, nor orphan disease exclusivity, neither on the basis of the size of the population, nor on the size of the market, nor exclusivity on the basis of similarity.  People need all of the pharmacotherapy options available, including various formulations (and durations of action) of buprenorphine, extended release naltrexone, methadone, etc.  CAM2038, an alternative long-acting form of buprenorphine, differs substantially from Sublocade insofar as it can be initiated without a 7-day sublingual run-in period, making it the only long-acting opioid treatment that can be initiated directly in emergency departments (critical settings in which to intervene and save lives), and it does not contain NMP which precludes Sublocade use in pregnancy.  ", "comment_id": "FDA-2019-P-1679-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0031", "comment_date": "2019-04-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1144}, {"text": "The opioid epidemic is taking lives in my community and impacting many people that I love. Granting orphan drug exclusivity will limit the treatments available to those who need them most. This makes no sense whatsoever. Right now, we need MORE treatments on the market, NOT less. Please reverse this terrible decision immediately.", "comment_id": "FDA-2019-P-1679-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0030", "comment_date": "2019-04-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 331}, {"text": "I am the Director and Founder of No More ODs, Inc. a Savannah Harm Reduction Coalition. We train and equip first responders, schools, restaurant staff, individuals or anyone that may come into contact with someone at risk of an opiate overdose, on how to identify an opiate overdose and how to reverse it.   After a life is saved, it is imperative to have resources available in order for the person to be able to live a healthy life of recovery. We need to be able to give options and choices to find the right fit for their Opioid Use Disorder. I lost my son, Austin, to an opiate overdose 14 years ago.  He didnt have the options available for a medically treated recovery.   Granting orphan exclusivity to Sublocade would block other, needed treatments from being available to patients who need more options.  Please do not grant orphan exclusivity to Sublocade, and please revoke its orphan drug designation. We need to ensure that patients can access to all safe and effective medications.", "comment_id": "FDA-2019-P-1679-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0043", "comment_date": "2019-05-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1020}, {"text": "Hello.  I am writing in reference to the petition being filed by Goodwin Procter against the FDAs decision to grant Sublocade orphan drug status.  As a dual board certified Addiction Specialist and Family Medicine Physician, I work as a Regional Medical Director for CleanSlate Centers.  We provide treatment to 13,000 patients in 11 states with OUD every day.  I have personally had more than 15 years prescribing buprenorphine products.On 1/10/18, Governor Wolf rightly declared the opioid epidemic an official statewide disaster in my home state of Pennsylvania following President Trumps declaration in October of 2017.  Pennsylvania had 5559 opioid overdose related deaths in 2017.  This is an all hands on deck disaster that demands every tool in the shed to be available for our patients. I very much appreciate the benefit that buprenorphine related medications have brought to the table in treating this epidemic.  I strongly believe that buprenorphine is directly accountable for countless lives saved during this crisis.  I regularly see patients go from hopelessness to holding down a job and resurrecting their families in a matter of months or even weeks when they go through our program.However, I firmly believe that as Alan Leshner, the former director of NIDA declared All treatment works for some patients.  No one treatment works for all patients.  On the frontlines treating this epidemic, it is vital that we are given as many tools as possible.  Indiviors product is a good product; however, it falls short in many instances.  Having a product that is only injected once a week and indicated for induction in addition to maintenance in the treatment of OUD is invaluable.  I strongly urge you to please revoke the orphan drug status for Sublocade and allow other innovative people to continue to supply the medical world with much needed tools.  ", "comment_id": "FDA-2019-P-1679-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0047", "comment_date": "2019-05-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1931}, {"text": "I write this comment in my capacity as a former Governor of New Jersey and as the Chairman of President Trumps Commission on Drug Addiction and the Opioid Crisis.During my time as Governor I declared the opioid crisis a public health emergency and passed package of bills that expanded access to treatment and reduced opioid prescriptions by over 26% in its first year. I know that one of the keys to dealing with the crisis of losing 72,000 Americans a year is to make more medication assisted treatment available to more people in the throes of addiction.The FDAs decision to deny access to a buprenorphine depot injection treatment is against public policy and contrary to one of the specific recommendations of President Trumps Commission which I chaired. As an aside, the President himself has adopted that recommendation and 64 others from his Commission.The reason for the decision is even more wrong headed--an illogical application of the Orphan Drug designation and resulting exclusivity. This is a decision that must be revisited to further add to the medical communitys arsenal to deal with this deadly addiction crisis.The Orphan Drug Act was enacted to encourage research and development of treatments that may otherwise go undiscovered. Buprenorphine is in no way, shape or form an orphan drug. There are millions of American suffering from addiction who could benefit from additional therapies to deal with their disease. This action by the FDA is contrary to that laudable and necessary goal of the Commission and, just as importantly, contrary to the intent of the law as enacted. The exclusivity decision was meant to compensate for an otherwise unprofitable drug. Quite to the contrary, Sublocade is projected to be extremely profitable.This 1994 decision is no longer consistent with public health needs of 2019. The FDA must look at the needs of millions of Americans and make more treatments, not fewer, available to those in need. The FDA actions are not consistent with Administration policy. The FDA actions are contrary to implementing effective public health policy for this country. The FDA designation of Sublocade as an orphan drug is contrary to the law as passed and injurious to the public it is supposed to serve.I urge the FDA to rescind this decision and to make more treatments available to those who suffer from the disease of addiction. As a former Governor and Chairman of the Presidents Commission on this very topic, I have spent a great deal of time studying this issue in detail. I am convinced that rescinding this will save lives. Isnt that one of the key missions of the FDA? I hope that is true on behalf of millions of families from New Jersey and across America who are suffering today and frantically searching for hope.Respectfully,Chris Christie55th Governor of New JerseyChairman, Presidents Commission on Drug Addiction and the Opioid Crisis ", "comment_id": "FDA-2019-P-1679-0054", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0054", "comment_date": "2019-05-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3023}, {"text": "While both CAM 2038 and Sublocade are both injections for the extended delivery of buprenorphine in the treatment of OUD, there are many differences between the two.  With these differences, come several unique advantages and disadvantages found in each.  Flexibility between weekly and monthly preparation, as well as a shorter run-in period, are just two examples of considerations when CAM 2038 may offer an advantage over Sublocade to better meet the needs of a certain cohort of OUD patient.It is important that doctors and patients have many treatment options in the battle against this public health emergency.  There is no one size fits all treatment for the complex disease of opioid use disorder and the doctor will need many tools in the toolkit. Buprenorphine is a very effective treatment molecule in the treatment of OUD.  Demand for access to OBOT care has soared over the past 10 years in many areas, outpacing our healthcare systems ability to provide this care.  With the rapid growth in demand for buprenorphine, it seems inconceivable to me that it could be considered for orphan drug status by the FDA, regardless of the delivery system. I strongly recommend that the orphan drug status for Sublocade be reconsidered to allow doctors and patients the option between these two effective, but different, treatments.", "comment_id": "FDA-2019-P-1679-0036", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0036", "comment_date": "2019-05-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1381}]}, {"id": "FDA-2018-N-3685", "agency": "FDA", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plant and Resin; and 8 additional substances; Request for Comments", "update_date": "2019-03-04", "update_time": "13:05:41", "purpose": "Nonrulemaking", "keywords": ["International Drug Scheduling", "Convention on Psychotropic Substances", "Single Convention on Narcotic Drugs", "ADB-FUBINACA", "ADB-CHMINACA", "Cyclopropyl Fentanyl", "Methoxyacetyl Fentanyl", "para-Fluoro Butyrfentanyl", "Tramadol", "Pregabalin", "Cannabis Plant and Resin", "FRDTS# 2018-820", "CDER", "James R. Hunter", "OPEN"], "comments": [{"text": "Please rethink your stance on medical cannabis. I truly believe in the healing power of a patients right to choose their medicine and more natural is better. I benefit from medical marijuana in my state of Pa. I have overcome opioid addiction and chronic pain and depression issues. Knowing that no matter what medical problems I have in my future, having access to medical marijuana is enough to help me with my pain and anxiety and depression.", "comment_id": "FDA-2018-N-3685-4850", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4850", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 450}, {"text": "In regards to Cannabis Plant and Resin, I believe that anything less than full legalization is criminal.  It makes criminals of decent citizens, and it drives the plant to an unregulated black market.  With medical legalization prevalent, with growing consensus worldwide that the war on drugs is causing more harm than good, and finally with full legalization approved in Canada I believe that  the United States and the world should follow.  In doing so forgive the sentences of  past and current non-violent cannabis offenders and expunge their cannabis related records.  Finally, apologize for the destruction that the war on drugs has caused.As for the others on this list.  I recommend personalized treatment for substance abuse.  Follow Portugals lead and give help to those afflicted, not a criminal record!May this world come together in peace.  For we are far too divided.", "comment_id": "FDA-2018-N-3685-4879", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4879", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 907}, {"text": "Yes marijuana should be legalized or at the very least not be a schedule 1 drug. Alcohol is terrible, give people a chance to relax with a nice calming drug that you basically cant OD on. Reap the benefits of the tax money while creating a completely new Billion dollar industry. ", "comment_id": "FDA-2018-N-3685-4818", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4818", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 285}, {"text": "Cannabis is a medicinal herb that is well documented through history and is crucial to treating my glioblastoma that is predicted to kill me in six months if I cant access the herb. Classifying it as a schedule I drug is an abrogation of science, and criminalizing access and research is a crime against humanity. The only rational classification for the herb and its natural derivatives is none at all. Pharmaceutical derivatives introduce side effects, greatly increase cost, and significantly diminish the healing effect of the natural plant.", "comment_id": "FDA-2018-N-3685-4886", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4886", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 560}, {"text": "Yes, marijuana should be legalized.  This will also accelerate research into the healing properties of the plant, which could lead to more uses for the different plant. ", "comment_id": "FDA-2018-N-3685-4984", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4984", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 169}, {"text": "Legality aside, schedule reduction for Cannabis Plant and Resin is more than warranted.THC has a physically unreachable toxicity threshold, and causes no immediate threat to health. Alcohol, a legal and controlled substance, has a toxicity threshold among the lowest of all substances; the CDC reports During 20102012, an annual average of 2,221 alcohol poisoning deaths (8.8 deaths per 1 million population) occurred among persons aged 15 years in the United States. which makes it one of the leading causes of preventable deaths in the United States for that time frame. Comparatively, cannabis use has caused 0 toxicity related deaths in not only the same time frame, but all of recorded history.https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6353a2.htmCDC reports pertaining to other drugs currently on the same schedule, and drug overdoses in general:During July 2016June 2017, among 11,045 opioid overdose deaths, 2,275 (20.6%) decedents tested positive for any fentanyl analog, and 1,236 (11.2%) tested positive for carfentanil. Fourteen different fentanyl analogs were detected.https://www.cdc.gov/mmwr/volumes/67/wr/mm6727a4.htmIn 2016, there were more than 63,600 drug overdose deaths in the United States. Factually, none of these were caused by the consumption of cannabis. Thats 63,600 Americans who died in one year because they consumed too much alcohol, or too much of any other drug. 0 Americans have ever died as a direct result of consuming too much cannabis.https://www.cdc.gov/nchs/products/databriefs/db294.htmSetting aside arguments which could be made for recreational legalization at a federal level, and for the theraputic effects of other non-psychoactive substances (such as CBD, cannabinoids, and terpenes; anything not THC) that are present in cannabis, its plain to see that the drug is not dangerous enough to remain on the Schedule 1 controlled substances list.If the FDA truly has the American Publics best interests at heart, then cannabis will be removed from the schedule 1 controlled substances list, as a first step in the right direction. ", "comment_id": "FDA-2018-N-3685-5016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5016", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2207}, {"text": "With the now long history of successful cannabis distribution in the medical fields, it no longer makes sense to have it banned as a highly dangerous substance. Coupled with the data showing increased safety and reduction in crime in states with recreational legality, the federal ban is no longer sensible.With a state level choice by citizens to determine availability and true ability to research usage, we are best able to stop the problematic sides of the issue. Real research can be done to find both the positives and negatives of cannabis usage by the public. Children can be better insulated in the same fashion as they are for alcohol and tobacco plus the criminal justice system will be more efficient. The cost of criminalizing cannabis far outweighs the benefits and the volume of low level prosecutions stops prosecutions for high level crime.So my opinion is that federal decoupling of legality and state level selective choice makes the most sense for the nation.", "comment_id": "FDA-2018-N-3685-5064", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5064", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 989}, {"text": "The Cannabis Plant and Resin have already been legalized in many states, with even more putting it to a vote as soon as this coming November in one way or another. The war on cannabis happened long before we had our current scientific studying capabilities, and as such it has never had a true chance to be studied as a legitimate medicine. On top of this, the original reasons for its outlawing were highly suspect to begin with, chiefly influenced first by the business motivations of William Randolph Hearst (in conjunction with poorly attended congressional hearings and shoddy scientific studies), and later by the political motivations of the Nixon administration and the then burgeoning pharmaceutical industry, more than scientific merit. Its time we see the writing on the wall: If it wont be legalized for recreation at a federal level, the American people obviously want, at bare minimum, for Cannabis and Cannabis Resin to be changed to a Schedule IV or V drug so that it can be properly studied and the voters can make informed decisions on whether or not to continue its legalization.Speaking of the current scheduling of Cannabis and Cannabis Resin, its pretty difficult to make a coherent argument for how these drugs fit the description of other Schedule I narcotic. The definition for Schedule I narcotics per the DEAs website is as follows: Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Not only do Cannabis and Cannabis Resin have currently accepted medical uses (treating epileptic seizures, for example), but how is it possible to assert that a drug has a high potential for abuse if theres a dearth of coherent, factual, peer-reviewed scientific study on that subject? Without scientific evidence the scheduling must be based on hearsay, and that our government would enact rules or regulations based on hearsay is a terrifying realization.There are many other reasons why Cannabis and Cannabis Resin should be rescheduled but unfortunately theres simply not enough room in this comment to discuss them all. Its time to do right by the American people, and the ethical core that guides their principles, and reschedule Cannabis and Cannabis Resin to Schedule IV or V so it can be properly studied, after which the American people can finally be allowed to do their job: Make an educated decision on the ongoing legality of the substance.", "comment_id": "FDA-2018-N-3685-5068", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5068", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2528}, {"text": "Marijuana should be legal !  It helps many people and does little harm, especially compared to alcohol.  The tax payer burden for incarcerating marijuana users is also unacceptable.  ", "comment_id": "FDA-2018-N-3685-5072", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5072", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 193}, {"text": "Cannabis Plant and Resin most certainly should be re-scheduled. It has medicinal benefit.  My dad has a severe case of RLS and has been on every prescription drug to combat it.  He loses sleep and has to take heavy sedatives to sleep.  I feel like cannabis would be a great option for him, but he refuses because it is not allowed in his state.  I also work with children with seizures and have seen its medicinal benefit for them.  I also think it should be re-scheduled so that recreational users can use it.  I would much rather have a stoned partner, than one that is drunk on alcohol all the time.  I also think if we have the ability to tax cannabis, we could benefit our roads, schools, and poverty issues across the states. Fentanyl should be shut down at the production line. I have had two close friends, and countless others lost their lives as a result of Fentanyl.  It doesnt even deserve a scheduling, it shouldnt be around period.", "comment_id": "FDA-2018-N-3685-5028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5028", "comment_date": "2018-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 960}]}, {"id": "EPA-HQ-OGC-2023-0212", "agency": "EPA", "title": "Proposed Settlement Agreement in Center for Biological Diversity v.  Environmental Protection Agency, No. 22-1164 (D.C. Cir.)", "update_date": "2023-05-22", "update_time": "11:56:44", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Intervention by right. EPA refusal to perform non-discretionary executive duty as National Response Authority of a hazardous release of mercury over reportable quantity. For NRC to be delegated properly, then it means having mechanisms of enforcement for non-reporting and non-compliance.  Saying no records and no jurisdiction indicates non-liability has become more important to EPA than ensuring compliance in homeland security protocol, however.  Delegation does not mean regional directors can just sweep it under the rug whenever they feel like it. Where is the final authority?  Where is executive command? Because this is how terrorism happens, which is the purpose of the NRC in the first place. Hello people?!!", "comment_id": "EPA-HQ-OGC-2023-0212-0003", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OGC-2023-0212-0003", "comment_date": "2023-04-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 744}]}, {"id": "FDA-2010-N-0560", "agency": "FDA", "title": "Amendments to General Regulations of the Food and Drug Administration ", "update_date": "2021-09-01", "update_time": "18:07:23", "purpose": "Nonrulemaking", "keywords": ["ctp", "amendments", "general regulations"], "comments": [{"text": "As an RN specializing in Occupational health, I have seen first hand the effects of tobacco in the work place.  Employees who smoke have more lost work time from illness which places a burden on fellow employees and the company in general.  Smokers in the workplace tend to take more breaks than those who dont smoke, leaving others to carry the load a lot of the time.  This creates much discord among smokers and non.It has also been noted that smokers have more workers compensation claims than non-smokers.  Most likely because they are lacking oxygen to their joints and muscles and are injured more easily as a result.Advertising cigarettes in a non-glamorous way seems to be the first step in helping people move away from the initial attraction of smoking.  Certainly, making the regs tighter on smokers and tobacco also makes sense.  As an addictive substance we have an obligation to offer help to those trying to quit, and to make tobacco companies financially responsible for their role in reeling people into the addiction.", "comment_id": "FDA-2010-N-0560-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-N-0560-0003", "comment_date": "2011-01-18", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1081}]}, {"id": "FDA-2018-P-4338", "agency": "FDA", "title": "Request that the FDA refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FD&C Act, including NDA No. 209774 submitted by SpecGx LLC (\u201cMNK-812\u201d), with an indication or any other labeling that suggests that the product is appropriate for chronic use.", "update_date": "2019-04-18", "update_time": "15:28:24", "purpose": "Nonrulemaking", "keywords": ["CITIZEN PETITION", "PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES,", "INC.", "PMRS", "opioid product", "SpecGx LLC (\u201cMNK-812\u201d)", "abuse-deterrent labeling", "NDA No. 209774", "Roxicodone", "Reference Listed Drug (RLD)", "chronic pain", "opioid addiction", "Citizen Petition (FDA-2017-P-1359)", "OxyContin 10 mg, 20 mg, and 40 mg tablets", "(NDA 20-553)", "CDER"], "comments": [{"text": "Im 46 years old  12 years ago my life changed forever. That was the year I had my 1st (up to 7  my neurosurgeon says about every 5 years I will need another) Spinal Fusion which was a disaster  left me with permanent Nerve damage  in Chronic Pain.  After so many surgeries  so much trauma involving my spinal Nerves I also ended up w a disease called CRPS. My pain is horrendous  I fight everyday just to get out of bed  to shower these days.  A year ago I wasnt this bad, I could actually go w my mom to a store  maybe lunch that day but now w the CDC laws my meds have been cut in half. So now its been 2 times in my life where I have lost everything  the most important part that was just taken away now was my quality of life. For 12 years Ive been on these opioid medications  Ive never had a medication emergency, never ran out earlier than I should, never changed pharmacies, etc. I followed every rule  now Im getting punished because of the addicts!! Its not fair...without meds or even life as it is now, Im only 46 years old, I cant live the rest of my life this way. Please dont throw the disabled  the chronic pain patients away. Our lives matter ", "comment_id": "FDA-2018-P-4338-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0021", "comment_date": "2019-03-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1220}, {"text": "Shameful request ! This kind of rhetoric is forcing millions of pain patients to suffer needlessly. After 20 years of Pain it was OxyContin that helpedmore than any other pain reliever. Stop this madness now.", "comment_id": "FDA-2018-P-4338-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0020", "comment_date": "2019-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 213}, {"text": "This commentary is in response to the citizen petition posted by Pharmaceutical Manufacturing Research Services, Inc. pertaining to pending and future approvals of opioid products. This commentary will be in response to two of the major requests posed in this petition; to no longer approve any opioid medication with an indication of chronic pain and to refrain from approving any opioid with abuse-deterrent labeling. It should be noted that the petition is certainly aiming to solve a major public health crisis; the abuse and misuse of opioid continues to rise in the United States and has resulted in an unprecedented amount of opioid overdose deaths. It has been a major goal of the current administration, the FDA and many public health organizations to have a greater control on opioid distribution and use and this commentary should not discount the continued efforts that are needed to combat the opioid epidemic. Instead, this commentary should be used to evaluate and strengthen the current arguments of this petition. As noted in the petition, chronic pain is defined as pain persisting for longer than 1 month beyond resolution of the underlying insult, or pain persisting beyond 3 months. While the petition calls to refrain from approving and other opioid medications for chronic pain, we should question if this medication could benefit end-of-life palliative care or severe chronic pain from serious illness such as cancer. An article in the AMA Journal of Ethics discusses the goals of a physician in end-of-life care and the use of opioids1. The article notes that a physician should aim to benefit the patient and minimize the burden of doing so, strive to preserve life and provide comfort in dying, and meeting individual needs and those of society. It could easily be argued that a new opioid, with immediate release technology, could provide comfort in dying to the patient and meet the needs of society, better than current opioids, by employing abuse deterrent technology. While it is important that we are cognizant of opioid addiction, it is also important to remember the intended use of these medications and ensure that individuals with chronic pain have fair access to all prescriptions availableThe second point of commentary is on the petitions request to refrain from approving any opioid product with abuse-deterrent labeling. Its important to properly label prescriptions and if advanced technology has been used it an effort to curb abuse it is proper to note that on the bottle. Its possible that another name should be used in place of abuse-deterrent, such as diversion technology, but manufacturers should be rightfully credited with this technology and there should be some notation on the bottle of the new formulation. Also, in rebuttal of the petition, there are current articles that note that abuse-deterrent technology is effective is reducing the possibility of both intranasal and intravenous use2. Immediate release tablets are designed to transform from a pill into gel when an abuser attempts to crush or inhale the pill. The gel will also cause a burning sensation if its attempted to be snorted intranasal in a greater attempt to deter this abuse. There are many thorough and well thought facts included in this petition and it should be thoughtfully considered by the FDA. Its clear that as a country, we need to be more conscious and considerate of the prescriptions that we approve and think about long-term implications before approving and NDA. Opioid use needs to be monitored more closely to deter abuse but it needs to be ensured that individuals with chronic pain have access to new medications and technology. We cannot deny patients in pain from their right to fair and just treatment and pain reduction. Sources:1. https://journalofethics.ama-assn.org/article/common-misconceptions-about-opioid-use-pain-management-end-life/2013-052.  https://www.ncbi.nlm.nih.gov/pubmed/29308593", "comment_id": "FDA-2018-P-4338-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0019", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3988}, {"text": "I am a citizen of the USA I am 64 year old and am disabled since 2008 Before that i worked two jobs and never did drugs never smokes and on occasion drink a glass of wine or beer on a holiday or birthday.I am frustrated with the way I have recently been  treated by my doctors and medical staff because of our government ! I for many years have had Cronic pain with my fibromyalgia and arthritis with generative disc desease and other issues like depresion cronic anxiety .Thats enough as of now.I have been taken of my pain meds because of my anxiety medication mind you It has taken me many years to find the right combinations of medications and I have had no problem till now my phyciatrest has worked with me and other primary doctors to find something that works and that are in the so called guidelines now They have not been successful .I have also never misused My medicines I am not an addict  just a person in pain. My life has totally been turned upside down I am not able to watch my grand children or go to family functions because of all this I am not able to live the life I once lived It was not perfect but it was liveable I of coarse am not alone in this there are many more .They cry in pain and they feel alone because our government has failed them .We know there is a drug epidemic those that abuse and misuse even sell horrible drugs to innocent people even children But we should not be the ones targeted. 90 percent of senior citizens do not misuse or over dose on theres or someone elses medications .I AM LIKE I SAID SPEAKING FOR ME AND OTHERS LIKE ME THIS IS WRONG AND SOMETHING NEEDS TO BE DONE PLEASE HEAR OUR VOICES CALLING FOR HELP WE DO NOT DESERVE THIS IS UNCONSTITUTIONAL! ", "comment_id": "FDA-2018-P-4338-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0023", "comment_date": "2019-04-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1724}, {"text": "I am just one person that represents the chronic illness community. I feel like something that isnt mentioned in this discussion is that this is a last resort treatment for many of us. We dont abuse this medication and use it as directed as one pice of a multifaceted treatment plan that includes things like yoga and meditation.  I feel like if you truly want to address this issue the answer lies in finding better treatment for chronic illnesses. I dont understand the logic behind saying its appropriate for people not to deal with pain for a few days after surgery or an injury but not for chronic illness.  Pain is very distressing to the body which is the whole reason we use it as a treatment and long term distress causes more health conditions.  I cant speak for everyone but through the last 15 plus years Ive been dealing with chronic pain and illness I have gone off of opiates to try different medications and while opiates arent ideal no treatment is and for most of us they play a pivotal role in our ability to function everyday. Chemo isnt an ideal treatment neither is insulin, but when you are ill you only have the options available to you. Like anything there are people who exploit things to their benefit. I dont see how taking treatment that isnt being abused from an already vulnerable population. I agree these meds were being over prescribed but if there is any appropriate use for these meds it would be for chronic and terminally ill people who have to be on supervised treatment the rest of their lives. Many people start abusing these drugs due to the lack of info and oversight that has already transpired and cutting them off with no medical guidance. Taking treatment from those who have been using it appropriately would make an already vulnerable population absolutely desperate. We are not being represented or advocated for and would hope that we are not neglected and the decision will be left to the Dr and patient. This treatment is a big responsibility and should be treated as such. I see the top Dr in my state for my condition and he has been absolutely phenomenal in the guidance and treatment I have received from him and I feel grateful he wasnt a dr feel good and knows how to properly prescribe the lowest doses for as long as possible. I had been to drs prior to him that were totally over prescribing and I advocated that to the dr I see now.  My point is with chronic illness every moment of every day is a major task to overcome there are days I can barely get from my bed to the bathroom . Thats managing my illness with several meds and yoga and meditation when we finally get our regimens to a point where we can atleast take care of the bare minimum to survive its a huge blessing and throwing a wrench in someones treatment plan throws their lives in absolute upheaval for weeks months maybe years. We all have people that count on us too.  Nothing is going to magically fix the damage the lack of oversight has caused and taking the only treatment options we have when there is nothing to replace it with is just as irresponsible. So I dont know how you measure or quantify if something truly gives relief to someone that is ill but I can tell you this if they didnt give me relief from my illness I wouldnt take them as part of my treatment many antidepressants and neurological meds for chronic pain and illness like Lyrica have just as violent and as many side effects and you have to ween off of them because the body becomes physically dependent or addicted to them. Ive had to do this several times from several so called treatments. Not every treatment works for everyone so please lets leave this to the patients and their drs who have exhausted all the options and would love for new treatments to be available and are anxiously hoping they do but until that time I still have to be a functioning member of society. Thank you for your time", "comment_id": "FDA-2018-P-4338-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0022", "comment_date": "2019-04-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3909}, {"text": "I agree that those that abuse opioids and any other narcotic is making it next to impossible to get any narcotics prescribed if you have chronic pain or acute stress such as PTSD. I am 100% service connected total and permanent disabled and any narcotics that I was receiving and were helping me are being discontinued with no replacements of meds that do anything to help control my symptoms. Then when I was sent through the program to see a civilian doctor, they did two surgeries on me but would not prescribe any pain control because they said the VA wont let them and my VA doctors refused to prescribe any pain medication to me either because of the opioid crises. They consider every narcotic off limits if its an opioid or not and my urine is checked for any drugs every three months or more often. I am at the mercy of the  VA and the doctors have obviously been told to take everyone off narcotics and not to prescribe any. If a civilian doctor does write a prescription for me I have to get it rewritten by a VA doctor before I can get it filled and they wont rewrite them. Medical marijuana is legal in my state but they wont discuss its use or the use of CBD which is totally legal to use. Having to go civilian for care will make this problem even worse because of what I have stated. Also I received this email to comment on the changes to the VA on April 10th but it states that all comments had to be received by sometime in March. This seems like it will be a bad deal for us veterans just by the way I was contacted about it over a month after comments were being considered. I would appreciate a response to my statement and would like to include that I was a registered nurse in the USAF and civilian.", "comment_id": "FDA-2018-P-4338-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0024", "comment_date": "2019-04-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1723}]}, {"id": "CMS-2009-0088", "agency": "CMS", "title": "Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs", "update_date": "2021-03-26", "update_time": "01:07:31", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Please see the attachment.", "comment_id": "CMS-2009-0088-0046", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0046", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 26}, {"text": "Takeda Pharmaceuticals North America, Inc. (Takeda) appreciates the opportunity to comment on the proposed rule published by the Centers for Medicare and Medicaid Services (CMS) concerning changes to the Medicare Advantage and Medicare Part D programs.   Takeda is one of the nations leading pharmaceutical companies and is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.  We currently market oral diabetes, insomnia, gastroenterology, and hyperuricemia treatments.  We also seek to bring innovative products to patients through a robust pipeline that includes two new unique compounds in late-stage development for the treatment of Major Depressive Disorder.  Takeda is encouraged by several provisions that CMS is proposing to refine and implement the Medicare Part D program especially in the areas of medication therapy management programs and maximum allowable cost sharing amountsto name a few.  Because of our current research and development activities that have the promise to enrich the lives of Medicare beneficiaries, our comments focus on the provisions in the proposed rule concerning Part D protected classes.   Takeda commends CMS for focusing on these critical issues regarding protected drug classes on Part D formularies.  However, we are concerned that the new interpretations CMS proposes of the Medicare Improvements for Patients and Providers Act (MIPPA)  176 provisions could erode essential beneficiary protections and contravene Congress intent in enacting this provision.  An unduly restrictive policy on MIPPA protected classes could have very serious consequences for Medicare beneficiaries, and strong beneficiary protections have been key to the success of the Part D benefit. Takeda therefore supports an approach that preserves and builds on the beneficiary protections in CMS current classes of clinical concern policy, and we encourage CMS reconsider its new proposed interpretations of the MIPPA  176 provisions.  Specifically, we request that CMS not finalize its proposals interpreting the terms restricted access, major or life-threatening clinical consequences, and significant need for access to multiple drugs.  Instead, we ask that CMS consider alternatives that we describe below, which better reflect the text and intent of MIPPAs protected classes provisions.  Consistent with that approach, Takeda also urges CMS to recognize antidepressants (an existing class of clinical concern) as a MIPPA protected class and that the agency use notice and comment rulemaking to establish the protected categories or classes of drugs and any exceptions to the protected classes.", "comment_id": "CMS-2009-0088-0062", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0062", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2820}, {"text": "Please review document - CMS-4085-P", "comment_id": "CMS-2009-0088-0026", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0026", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 35}, {"text": "Dear Ms. Frizzera: WellPoint, Inc. (WellPoint) appreciates this opportunity to comment on the Centers for Medicare  Medicaid Services (CMS) proposed Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs, published on October 22, 2009.  We commend the efforts of CMS to ensure the delivery of quality services to beneficiaries enrolled in Medicare Advantage and Medicare Part D plans.  As a committed participant in the Medicare Advantage and Part D programs, WellPoint looks forward to working with CMS to ensure beneficiary access to robust medical and prescription drug coverage under the Medicare program.WellPoint appreciates this opportunity to offer our suggestions for ways in which CMS might strengthen beneficiary protections, increase program transparency, and ensure participation by strong, qualified plans.  We look forward to working with CMS to uphold these objectives.  Should you have any questions or wish to discuss our comments further, please contact Jennifer Boyer at 202-628-7831 or Jennifer.Boyer@WellPoint.com. Sincerely, Elizabeth P. HallVice President, Public Policy", "comment_id": "CMS-2009-0088-0076", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0076", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1217}, {"text": "Subpart C 422.100 Maximum OOP costs amount for Medicare Parts A/B servicesComparing local MA plans to Regional PPO (RPPO) as the reason for all local MA plans to include an annual out-of-pocket cap on members total cost-sharing liability (for Part A and Part B services) did not take into consideration the substantial difference in network or medical management between these product types.  Maintaining an optional out-of-pocket for local MA plans will provide beneficiaries richer benefits above Traditional Medicare and maintain affordable premiums for the beneficiary.  By requiring out-of-pocket maximums, it is not only reducing choice for beneficiaries and increasing premium prices, it will impact utilization and medical trend that ultimately impacts Traditional Medicare.  As has been experienced with Commercial Health Insurance, more benefit requirements increases utilization and premiums, and more beneficiaries will default to Traditional Medicare due to cost.  Member materials and the plan compare tools developed by CMS and MAOs assist beneficiaries in making informed choices.  Additionally, by requiring plan offerings with meaningful differences and the non-renewing of low-enrollment plans, the concern about too many complex choices and beneficiaries not being able to confidently compare health plans and make meaningful choices has already being addressed.  Special Needs Plans, particularly D-SNPs, should be excluded from the requirement to add a maximum out-of-pocket requirement.  States often cover cost sharing for dual eligible members who qualify for cost sharing protection, which would negate the necessity for an OOP limit.  Additionally, D-SNPs already must provide Part D at the benchmark and offer plans without a Part C premium.  Requiring an out-of-pocket cap, in addition to absorbing these costs, would be an undue financial burden on the MAO.Subpart C 422.100 and 423.104 Maximum allowable cost sharing amount for Medicare Parts A/B services and prescription drugsClarity is required on how CMS will review  cost-sharing levels and whether these levels are discriminatory.  In previous call letters, the specific benefits (such as DME, home health, and renal dialysis) were listed.  These areas of concern should already be known and should not change on an annual basis.  The broad statement in determining acceptable cost-sharing levels does not take into account actuarial equivalency and the ability to design plans that provide choice for additional or richer benefits in other areas important to beneficiaries.  For example, maximum Part D brand cost-sharing levels will impact the ability to offer Part D generic $0 copay (supported by a robust generic formulary with equal alternatives to brand drugs); therefore, ultimately inhibiting the greater affordability and access to Part D drugs to these beneficiaries and premiums.  This will ultimately impact CMS benchmarks.Subpart C 422.112 Network Adequacy for MA PlansTiers for plan membership size (or development of provider/member ratio) should also be included in the determination of minimums to take into account plan/membership size and access need.  Additionally, certain minimums should be adjusted based on the unique needs of SNP membership (Dual and Chronic). We recommend that CMS continue to afford an opportunity for the plans to provide narrative descriptions of how access will be accommodated or alternatives offered in the event the plan cannot meet a particular CMS-established access parameter in a specific geography.  Additionally, we recommend that CMS make allowance for market-specific access pattern alternatives, particularly in markets that have experienced consolidation of physician and hospital systems.Subpart C 423.120(b)(2)(v) Clarify the MIPPA 176 Protected Classes formulary provisionCMS should state whether this will be set forth in sub-regulatory guidance or regulations.Plans would prefer formal guidance allowing them the opportunity to give comments to CMS.  If changes are made to the protected classes, CMS must give ample notice to plans well in advance of the bidding cycle. Full transparency of the process (three stages) should be the standard.  Plans should have the opportunity to review the data and recommendations of new classes as CMS is going through each of the three stages. Subpart C 423.120(b)(3)Transition ProcessWhile we appreciate CMS efforts it is unclear what constitutes a reasonable effort. It is highly unlikely the plan would have sufficient information to reach the out of network provider. We would encourage CMS to dialogue with the industry  to review operational challenges. Subpart C Generic equivalent disclosure 423.132  We would support CMSs original decision to require disclosure of generic equivalent pricing.  Many plans already have programming in place to support this practice and removing it would require substantial process changes for Long Term Care only.  Additionally, while we agree with CMS that enrollees could not make a change at the time of purchase, they would have the opportunity to change at a later date (the next time a prescription is filled) and should be informed of generic pricing differences.  Furthermore, it is vitally important that this information be included on EOBs, as EOBs are used to identify Fraud, Waste and Abuse.  Subpart D 423.505 Allow collection of all PDE data elements to be collected for non-payment purposes  CMS should state specifically who the grantees are and that limits will be made as to who has access to this data listing limits such as research companies or drug manufacturers.  Subpart G Risk Adjustment Data Validation Appeals  We support CMS allowing organizations the opportunity to 1) submit signed provider attestations for physician and other outpatient medical records with missing or illegible signature and/or credentials that could result in payment error, and 2) to dispute certain types of medical record review-related errors through the use of a documentation dispute process, and 3) appeal CMS RADV payment error calculation.We would recommend CMS allow the attestation process for inpatient records as well.  While we recognize the logic CMS uses to determine inpatient record attestations would be unnecessary, we would respectfully submit there are circumstances, just as with outpatient medical records, when a provider will fail/neglect to sign the record.We would recommend adding an appeal process to the attestation review and determination process and urge CMS to reconsider.  While we recognize CMS authority in this matter, there could be and likely will be legitimate circumstances in which final negative decisions should be reviewed and reconsidered. We understand CMS desire to streamline processing and limit organizations ability to dispute medical record documentation reviews to operational errors (those associated with the collection and processing of medical records for audit).  However, legitimate disputes over interpretation of specific issues and processes can arise.  We would urge more flexibility in determining what disputes can be reconsidered, including issues that arise when an organization feels there are interpretation issues with one or more reviewers/levels of review.Subpart J 423.466 Time limits for COBCMS proposes a three-year timeframe for plans to adjudicate COB claims.  We would recommend that the timeframe for adjudication be limited to 18 months to align it to PDE submissions.Subpart K 422.502 and 423.502 Compliance Measures/AnalysisWe would urge transparency and CMS consideration with regard to SNP plans and what measures will be used to determine outliers.  Consideration in determining outliers for SNPs seems warranted since measures for SNPs may be skewed in terms of clinical performance based on the population the SNP serves.  If CMS is considering using star ratings as evidence of poor performance and denial/non-renewal actions, we would respectfully ask that CMS be very transparent in what data will be collected, and ask to be provided with updates on data collection changes or additions as early in the process as possible.  Additionally, we would ask for transparency on how plans will be compared to each other, and whether like plans are being compared to each other in determining outlier status.  We would ask for thoughtful consideration of how, when a SNP may be part of an overall CCP contract, it would be rated and compared to other SNPs. We would respectfully request such methodology of any and all denial and non-renewal actions be shared with all plans. Subpart M Standard 423.568 Timeframe for coverage requirements   As these are paper claims and manual processes must exist in order to process payment, we would recommend CMS consider allowing plans to make determinations and affect payment within 30 days to allow for the manual payment processing.  Requiring plans to make determinations and payments within 14 days would require significant process changes that would be overly burdensome to plans, particularly considering the enrollee has already received medication.  In lieu of allowing plans to process payment within 30 days, CMS should consider postponing the requirement to process payment within 14 days until 2011 to allow for systems/process upgrades. In addition, PBM check runs are on a cycle and this change would be it difficult to meet the 14 day timeframe.  Subpart M 422.622 and 422.626 Generic Notice Requirements  If delivery of the notice is no longer the responsibility of the MAO, we would like to suggest adding that the development of the notice is no longer the MAOs responsibility in order to clarify.  Subpart O 422.750 and 423.750 Deny Contract Qualification Applications Based on Past Contract PerformanceWith the consideration of a SNP plan we would urge transparency and CMS consideration with regard to what measures will be used to determine outliers.  Consideration in determining outliers for SNPs seems warranted since  measures for SNPs may be skewed in terms of clinical performance based on the population the SNP serves.  If CMS is considering using star ratings as evidence of poor performance and denial/non-renewal actions, we would respectfully ask that CMS be very transparent in what data will be collected, and early updates on data collection changes or additions.  Additionally, we would ask for transparency on how plans will be compared to each other, and whether like plans are being compared to each other in determining outlier status.  We would ask for thoughtful consideration of how, when a SNP may be part of an overall CCP contract, it would be rated and compared to other SNPs. We would respectfully request such methodology of any and all denial and non-renewal actions be shared with all plans. We would ask that CMS take into consideration the needs of the state(s) a SNP would support and allow for expansion if the SNP is current in fulfilling contractual obligations to CMS. Subpart P 422.773(c)(2)  Requirements for LIS eligibility: expand the deeming period for LIS eligible beneficiaries to cover at least 13 monthsTable 2, page 88, indicates that this provision is going to expand the deeming period for LIS eligible beneficiaries to cover at least 13 months. However, the text in section 8, pages 107-109 and in the Regulation 423.773(c.) (2), page 425 indicates that the deeming period is remaining the same as it is today.  Deeming period is for full calendar year depending on receipt of deeming/redeeming status. A member, under the current policy and that being codified on page 425, could be eligible for LIS for as little as 7 months or as many as 18 depending on when the member was deemed.Subpart V 422.2262 and 423.2262 Required Use of Standardized Model Materials under Parts C/DWhen developing standardized materials, we would urge CMS to be more flexible with SNP materials in order to allow plans the opportunity to describe benefits and services. It is vitally important SNPs have ample free text to develop a piece of member material that delivers clear, concise information.  As in the past, it may be necessary to grant integrated SNPs or D-SNPs with state contracts exceptions to using certain standardized materials as well as the specific timeframes that may be associated with those standardized materials.", "comment_id": "CMS-2009-0088-0094", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0094", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 12792}, {"text": "The educational requirement does not take into consideration those companies or locations that have existing compliance programs that include specific training on fraud waste and abuse. This training is provided during orientation and annually.  Furthermore, Codes or Standards of Conduct discuss reporting of any FWA related concerns.  As required by the DRA of 2005, providers who have at least $5 million in annual Medicaid revenues are required to provide training on false claims and whistleblower protection.   In short,  all of the components now required of MAOs by CMS are already in place and have been for some time in our respective organizations.  It appears that there are a number of MAOs who have been willing to accept a providers current training as meeting their requirements. However,  there are others that are insisting on presenting their version of the training, much of it totally irrelevant to our employees, e.g., prescibing drugs is not meaningful to a certified nursing assistent.  Other MAOs have been reported as completely nonresponsive to inquiries. I am aware that compliance programm are currently voluntary but I personally am not familiar with any LTC provider which has not implemented such a program. Thanks you for considering my comment.", "comment_id": "CMS-2009-0088-0063", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0088-0063", "comment_date": "2009-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1315}]}, {"id": "FDA-2018-D-1098", "agency": "FDA", "title": "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations", "update_date": "2021-09-17", "update_time": "11:25:41", "purpose": "Nonrulemaking", "keywords": ["2013-289", "Metered Dose Inhaler (MDI) and Dry Powder", "Inhaler (DPI) Drug Products - Quality", "Considerations"], "comments": [{"text": "Comment - 1-How many serial analyzes are recommended for acceptance criteria in validation studies to be performed for APSD preliminary routine analysis on line 918-919. Can we use the 10 percent limit as the change in the stability study on line 1417-1418 as the batch to batch limit in routine analysis?Comment - 2 - Lne 978 and line 1035 have the same table number. At line 1027 you are directed to table 8,but table 8 does not exist. Please correct your error. Line 1035 should be typed as table 8 correctly", "comment_id": "FDA-2018-D-1098-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0011", "comment_date": "2018-06-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 531}, {"text": "Comments from SRF Limited are enclosed.", "comment_id": "FDA-2018-D-1098-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0013", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}, {"text": "Comments from The Association for Accessible Medicines (AAM) on behalf of our member companies, regarding Docket FDA-2018-D-1098: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations.", "comment_id": "FDA-2018-D-1098-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0023", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 220}, {"text": "1- Does Other organic impurities in Table 4 refer to individual impurity in HFA-134a?2- What would constitute a good justification for not using PTIT approach for measuring Delivered Dosage uniformity (DDU)?3-  Lines 865 and 866 state that the volume of collection for Delivered Dosage Uniformity (DDU) should not exceed 2 L at a constant flow rate. Can the agency explain why is there a limit to the volume of collection for DDU analysis?4- Can Effect of Patient Use study be performed on samples from PK study for generic developers?  ", "comment_id": "FDA-2018-D-1098-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0014", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 569}, {"text": "Cipla has following Comments on section IV. A. of the guidance:Comment no. 1:We understand, to obtained consistent physical attribute of micronised drug substance, it is critical to have consistent physical attribute (i.e. morphology, Polymorph, particle size  amorphous content) of in-put non-micronised drug substance.  Hence, we propose to include requirement for demonstrating consistent physical characterisation in three consecutive non-micronised batches and corresponding micronised batches.Comment no. 2:Guidance specify Morphology tests should be part of release and stability specifications. Under Morphology, guidance specify examples like  shape, crystal habit, texture, surface area, and rugosity. Different techniques are used to determine above listed characteristics. For e.g. Shape and crystal habit is determined by using G3 morphology and/or SEM techniquesIGC-SEA or BET technique is used for Surface area determination.Cipla believe, above characteristics studies can be part of one time characterisation requirement in three consecutive micronised and non-micronised batches along with stability of three micronised. Once consistency is demonstrated, Industry need not be including these tests as part of routine release and stability specifications.  Comment 3:We request Agency to provide guidance to Agency on  preferred Analytical method to be used for above characteristics test like rugosity, Texture etc.", "comment_id": "FDA-2018-D-1098-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0007", "comment_date": "2018-05-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1603}, {"text": "In Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality ConsiderationsGuidance for Industry, there is likely an type error. In the page 44, the talbe D is named One-sided Tolerance Interval Factors (k1) for 95 Percent Confidence Level and 90 Percent Coverage37. When search 2.566 in the reference 37 (Hahn and Meeker, Statistical Intervals  A Guide for Practitioners, John Wiley and Sons, Inc), this number appear in the Table A.12d named Facters for calculating Normal distribution one-sided 100(1-)% Tolerance Bounds and the corresponding P is 95% and corresponding Confidence level is 95%\uff0cbut the talbe D is labeled with 95% Confidence Level and 90 Percent Coverage. This is a discrepancy. please clarify it. Thanks.", "comment_id": "FDA-2018-D-1098-0032", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0032", "comment_date": "2021-09-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 789}, {"text": "IDD-Xpert has following comments :Comment n1 : line 853 - typo comment - replace Dosage by Dose to be consistent with Table 6 terminology (line 823).Comment n2 : line 924 - the following part of the sentence the mass balance (i.e the amount of drug substance deposited on all surfaces from the VALVE to the equipment filter)... involves to calculate the total ex-valve. However the mass balance is compared to the range between 85 and 115 percent of TDD. TDD according to line 655 corresponds to  the mass of drug delivered from the mouthpiece per actuation, i.e the total ex-device. Please could you specifiy if mass balance needs to be calculated from the total ex-valve or the total ex-device?", "comment_id": "FDA-2018-D-1098-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0010", "comment_date": "2018-05-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 776}, {"text": "This QC Draft Guidance makes no reference as to how combination products, both MDIs and DPIs, such as LABA/LAMAs, LABA/ICS and LABA/LAMA/ICS are to be assessed in vitro. One could assume that for combination products, each API should be assessed individually, but in my view, these requirements should be defined in the guidance document rather than leave it to interpretation.  There is also no reference to other non-COPD, asthma indications and the QC assessment for inhaled drugs, MDI, DPI, nebulizer) prescribed for their treatment.", "comment_id": "FDA-2018-D-1098-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0009", "comment_date": "2018-05-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 537}, {"text": "1) The scope should be extended to also include spacers - plastic parts used as an accessory in conjunction with MDI to assist the administration of the drug to elderly and young children who have difficulty in breathing. These components are potentially changing the DDU and also influence potential leachables from the plastics.  The plastics used in these spacers can contain both pigments and / or dyes to impart color and additives to provide anti-static properties to the surface.2) Controls for incoming materials. (line 528)  Since USP has defined a risk based strategy of how to assess drug contacting materials in the recent publication USP661.1 materials of construction  reference should be given to this standard. This sets out a logical approach to materials design and control.  Table 6 and Table 7 should also make reference to this standard.3) Line 959  - same as point 2.4) Reference in addition to ICH-Q3D elemental impurities should be considered. The limitation of USP661.1 is that it only looks for extractable metals that you expect to find in the plastics as carry-over of catalyst from the polymerization process. However immediately the plastic is colored ( as is the case in most of the MDI and DPI), there are many more possible metals that should be considered, and appear in the list in the ICH-Q3D and USP232.  Recommend that specific reference should be made to both standards.  5) There is no reference to change control. The industry seems to think that providing they carry out a qualification test on final parts and 3 batches, then nothing changes. They are quite surprised to understand that a polymer and / or color can change in its ingredients, still have the CAS Nr and % but have an effect  on DDU or leachables.   It should be clearly stated that the materials used in the plastic parts should have documented evidence of change control being implemented. Ideally these materials should have a DMF conforming to latest FDA standard. ", "comment_id": "FDA-2018-D-1098-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0004", "comment_date": "2018-05-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2091}, {"text": "Dear sirPrimimg and reprimg Drug product characterization studies needs to be done only at single time point", "comment_id": "FDA-2018-D-1098-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1098-0030", "comment_date": "2020-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 113}]}, {"id": "TTB-2015-0011", "agency": "TTB", "title": "Establishment of the Tip of the Mitt American Viticultural Area", "update_date": "2016-07-21", "update_time": "09:46:54", "purpose": "Rulemaking", "keywords": ["alcohol", "wine", "American viticultural areas", "viticultural areas", "alochol labeling", "Tip of the Mitt", "Michigan"], "comments": [{"text": "This is an important step for Michigans economy.  This is a REALLY GOOD for all Michiganders.  Lets get this approved!", "comment_id": "TTB-2015-0011-0013", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0013", "comment_date": "2015-09-11", "comment_time": "04:00:00", "commenter_fname": "Carol", "commenter_lname": "Weston", "comment_length": 138}, {"text": "As testament to the growth of the wine industry within the proposed AVA; when we first planted our vineyard within the proposed AVA just a couple years ago, there were four wineries established that would eventually become members of the Bay View Wine Trail.  There are now nine wineries on this trail and more in the pipeline (1), along with other wineries that are not a part of the trail but sit within the proposed AVA.  With Michigans wine industry sales doubling in the past 10 years (2) and the number of wineries growing from 42 in 2005 to 117 in 2015 (2,3), its clear that Michigans wine industry is still, very much, in its growth stages.  The rapid rise of wineries in currently established AVAs in the region just southwest of the proposed Tip of the Mitt AVA, the Leelanau Peninsula and Old Mission AVAs, speaks to the potential for the proposed AVA.  Despite the wine industry within the AVA being predominately just a few years old, it is already winning awards in competitions as large as the Finger Lakes International Wine Competition (4).  Thus, it is clear that there is enough winemaker talent within the region to continue to drive recognition of the proposed AVA.  With two million tourists stepping foot inside Michigan wineries annually (2), the establishment of the Tip of the Mitt AVA will further enhance the regions ability to promote its local wine industry, as tourism already plays a hugely significant role in the region.  With an established grape growers association (Straits Area Grape Growers Association, the petitioner of the AVA), an established wine trail and ever increasing numbers of vineyard acreage and wineries, the establishment of the Tip of the Mitt AVA is the apparent next step in cementing the future of the local wine and grape industry.  Thank you for taking the time to consider the Tip of the Mitt AVA petition!Brendan PrewittOwner, Harvest Thyme Farm  VineyardsMember, Straits Area Grape Growers Association(1) http://bayviewwinetrail.com/wineries/(2) https://www.michiganwines.com/article?news_id=5article_id=139(3) https://www.michiganwines.com/docs/Industry/growth_of_mi_wine_oct06.pdf(4) http://www.fliwc.com/results/2014results.asp (see results for Mackinaw Trail and Crooked Vine wineries)", "comment_id": "TTB-2015-0011-0015", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0015", "comment_date": "2015-09-14", "comment_time": "04:00:00", "commenter_fname": "Brendan", "commenter_lname": "Prewitt", "comment_length": 2419}, {"text": "The proposed Tip of the Mitt AVA will be one of the northern most AVAs.  Its climate, soil, and relationship to the surrounding cold waters of the Great Lakes makes it a challenge to growing most cash crops let along wine grapes.However, with the new varieties of complex hybrid vines coming from breeders (U of MN, Cornell, T. Plocher,etc) for cold climates, a group of grape growers and winery owners have accepted this challenge and put money, time and effort forward.We are like startups in silicon valley and we are growing.  This new AVA will help us expand and produce more and better grapes for wine-making and consumer acceptance.I appreciate the TTBs consideration and efforts in helping all of us get the Tip of the Mitt AVA approved.Regards,Geoff  Gail FreyOwners Crooked Vine Vineyard  WineryMembers Straits Area Grape Growers Association  Bay View Wine Trail", "comment_id": "TTB-2015-0011-0007", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0007", "comment_date": "2015-08-26", "comment_time": "04:00:00", "commenter_fname": "Geoff & gail", "commenter_lname": "Frey", "comment_length": 971}, {"text": "  Twenty years ago my vineyard and a local winery were the only ones growing grapes in the Cheboygan area. In the last few years we have seen a new generation of vineyards are emerging in Northern Michigan. The younger generations are increasingly learning modern viticultural and enological methods from their schools, friends, and working at a number of wineries in the region. People are excited about the possibility that the region could be designated as a Viticultural Area.  The more vineyards that are planted, the better chance we have of finding these locales that produce profound bottles of wine from Norther Michigan and the United States.  I urge you as a Regulations Board members to approve this request establishing the Tip of the Mitt Viticultural Area in Northern Michigan.Thank you for your time Charles N. Veneros", "comment_id": "TTB-2015-0011-0012", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0012", "comment_date": "2015-09-11", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Veneros", "comment_length": 871}, {"text": "The Tip of the Mitt is a much needed and much anticipated designation for growers and winemakers within the proposed AVA.  This area is unique in many ways including but not limited to soil, climate, water quality and tourism.  The Tip of the Mitt Viticultural Area will help advance the interest in viticulture and help promote the agritourisom industry bringing much needed jobs to this area.  Thank You to ALL that helped make this possible.Sincerely,Jim PetersPresidentStraits Area Grape Growers Association   ", "comment_id": "TTB-2015-0011-0006", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0006", "comment_date": "2015-08-17", "comment_time": "04:00:00", "commenter_fname": "James", "commenter_lname": "Peters", "comment_length": 534}, {"text": "Establishing the Tip of the Mitt as an AVA is critical to the economy of our region.  In past decade, we have seen the number of vineyards and wineries increase phenomenally, from one winery in 2005 to 13 today.  Nearly all of the grape growers and wineries are growing and fermenting cold hardy varieties specific to our area.  The grapes and the wines produced in our region are unique to the northern-most part of Michigan and they complement the local food offerings in our restaurants and resorts.  North Central Michigan College has been very active in supporting the Straits Area Grape Growers Association with educational programs and job skills training to help support the grape growers and wineries in our region.  The partnership is strong and the growth in this industry has been phenomenal.  Many of our viticulture students are now working in the industry and some even have opened new wineries.  The establishment of the Tip of the Mitt Viticulture Area is critical to the continued growth of the grape and wine business in our region and to the overall health of our economy.  We hope you consider these facts and approve the request.  Helen Leithauser, Corporate  Community Education Training Coordinator, North Central Michigan College, Petoskey, Michigan.  ", "comment_id": "TTB-2015-0011-0011", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0011", "comment_date": "2015-09-11", "comment_time": "04:00:00", "commenter_fname": "Helen", "commenter_lname": "Leithauser", "comment_length": 1282}, {"text": "Tip of theMitt AVA-  With the increased interest in wines and point of origin of grapes, the Tip of the Mitt AVA is, I believe, a necessary distinction to assist the present and future wineries in this area.  They all need grapes.  Northern Michigan grapes, to further their acceptance in the world of wine.  Our AVA would increase the Pure Michigan aspect.  Our varieties cannot be grown everywhere.   Northern Michigan soil, and Northern Michigan sunshine make our grapes unique.", "comment_id": "TTB-2015-0011-0014", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0014", "comment_date": "2015-09-14", "comment_time": "04:00:00", "commenter_fname": "Corinne", "commenter_lname": "Martin", "comment_length": 493}, {"text": "To Whom It May Concern, Im writing in support of the establishment of the Tip of the Mitt AVA in the northern lower peninsula of Michigan. As an Agricultural Innovation Counselor with Michigan State Universitys Product Center, I have worked with several wineries and vintners in the proposed area over the past 5 years. I have been impressed by the rapid development of these ventures and of the progress of the entire business cluster in our area. This is in no small part to the fact that key individuals and strategic partners in both industry and education have worked extensively in order to help build this wine region. Now, following the brutally cold winters of 2014 and 2015, area growers planting cold hardy varieties are being given a serious and second look by some of the most established vintners in the State. I think the future looks bright for these businesses as they capitalize on the areas unique agricultural features and the 100+ year tradition of traveling up north to enjoy some of the states most beloved tourist and resort destinations. Having worked with wineries in both the AVAs directly to our geographic south, on the Old Mission and Leelanau Peninsulas, I understand the marketing opportunities that are created for a winery once an AVA is established. One of those opportunities is the ability to produce and sell estate bottled wines; I think this could offer the Tip of the Mitt wineries a unique and eventual competitive advantage as more and more cold hardy vines come into production. My final comments are regarding the proposed name, Tip of the Mitt. A part of my role at the Michigan State University Product Center is to assist clients with branding their business or product; I understand the importance of a unique and evocative name. Tip of the Mitt very accurately describes the geographic area that the proposed AVA encompasses. While it may be a reference that is unique to those with Michigan literacy, it would seem to be no more or less colloquial than other AVAs... Virginias Rocky Knob or Washingtons Horse Heaven Hills.  I have recently worked with another non-profit group that considered Tip of the Mitt as a name for their new organization, because it perfectly described the area they intend to represent. While they ultimately decided against the name in deference to another well-known non-profit that uses Tip of the Mitt, this group came to the conclusion that is was the only name that accurately defined a similar geographic area that is being considered for the AVA.  It is exceedingly difficult to find a perfect name to brand a product, a business, or an AVA. Most certainly, a name should evoke something to both those businesses who will share in the brand, and to those most likely to be customers of the brand. I feel Tip of the Mitt accomplishes both of these objectives.  Sincerely, Wendy WielandInnovation Counselor, Michigan State University Product CenterGreening Institute, Michigan State University ExtensionOffice Location: Harbor Springs, MI (inside the proposed AVA) ", "comment_id": "TTB-2015-0011-0017", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0017", "comment_date": "2015-10-06", "comment_time": "04:00:00", "commenter_fname": "Wendy", "commenter_lname": "Wieland", "comment_length": 3292}, {"text": "Having the proposed AVA (Tip of the Mitt) approved will recognize northern Michigan as viable grape growing region which will help not only the current growers,but interest more farmers to get involved with the wine industry. Since I have started growing grapes ten wineries have opened within the proposed AVA. This has been great for the tourist trade in the area which has also helped with employment. Thank you for  your consideration.", "comment_id": "TTB-2015-0011-0018", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0018", "comment_date": "2015-10-06", "comment_time": "04:00:00", "commenter_fname": "Perry", "commenter_lname": "Nelson", "comment_length": 439}, {"text": "Relative to the proposed Tip of the Mitt AVA I first want to thank you for all the work you have put into looking at and moving forward with the approval.As a grape grower of cold hardy wine grapes of four different cultivars, I am so pleased to see the numbers of new growers increasing as well as the interest in growing grapes to supply the growing number of wineries in northern Lower peninsula of Michigan. The are seven new wine is that were not open four years ago when I first planted grapes.  There are more wineries in the development stages planning to open within the next year or two which will need grapes.I believe strongly that approval of the Tip of the Mitt AVA would most beneficial in promoting the grape industry in northern MI with the thousands of tourists wanting to taste wines made from our cold hardy cultivars.Again thank you for your moving forward on this.Budd and Katherine WagnerOwners. Wagner 8th Day VineyardMember of Straits Area Grape Growers Association", "comment_id": "TTB-2015-0011-0009", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2015-0011-0009", "comment_date": "2015-09-11", "comment_time": "04:00:00", "commenter_fname": "Harry \"budd\"", "commenter_lname": "Wagner", "comment_length": 1076}]}, {"id": "EPA-R04-OAR-2020-0177", "agency": "EPA", "title": "Multi-State Ethanol Rule", "update_date": "2021-03-04", "update_time": "01:17:06", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Root access please", "comment_id": "EPA-R04-OAR-2020-0177-0019", "comment_url": "https://api.regulations.gov/v4/comments/EPA-R04-OAR-2020-0177-0019", "comment_date": "2020-08-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 18}]}, {"id": "FDA-2017-N-6189", "agency": "FDA", "title": "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes", "update_date": "2018-08-21", "update_time": "14:52:20", "purpose": "Nonrulemaking", "keywords": ["CTP"], "comments": [{"text": "To Whom It May Concern:The FDAs proposal to limit the levels of nicotine in cigarettes is noble yet will likely not be effective. While I understand that there is much research left to be done on the addictive quality of cigarettes based on their nicotine content, and while I think this research could have other important implications, it does not seem that limiting the market to this extreme will provide any long-term solution. Even in the case of the proposed long-term phase out as opposed to the immediate decrease in nicotine levels, there will be immediate and extreme backlash from a community reliant on nicotine products - due to the extremely addictive quality you reference. For those addicted to cigarettes, having decreased access to the nicotine levels they seek will likely have numerous unintended consequences. Instead of turning to less dangerous alternatives, smokers could do the opposite by using an unregulated underground market. More addictive alternatives to cigarettes could become more desirable in the scenario that strong cigarettes are no longer available. Because of these challenges to this regulation, it seems to me that a more effective and forward-thinking use of resources, research, and funding would be to continue focus on preventative action. Preventing young people from picking up cigarettes in the first place, no matter what level of nicotine they contain, will do more to mitigate the future impact of nicotine addiction on the next generation and generations to come. And focusing this effort outside of just traditional cigarettes, and towards other popular methods of consuming nicotine, will broaden this impact. Because of the potential unintended consequences of setting a maximum nicotine level in cigarettes, I do not believe this regulation would achieve its intended effect and that efforts would be better off directed elsewhere. ", "comment_id": "FDA-2017-N-6189-6416", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-6416", "comment_date": "2018-07-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1941}, {"text": "To whom it may concern:I disagree with the FDAs proposal to regulate tobacco in cigarettes. If this were to pass, to what extent will the government ever stop trying to regulate our or impose on our freedoms. Cigarettes are not the only thing consumed by Americans that are carcinogenic. Look at bacon and prosecessed meat as stated in this article: http://www.reportingthetruth.com/world-health-organization-officially-declares-bacon-is-as-harmful-as-cigarettes/. Will the FDA outlaw bacon next? As the article (which I did not write) states, this is a common sense issue. I feel as though the government is trying to play the role of parenting to Americans and gaining way too much control. This proposal is not just something that I disagree with but should this law pass, this will affect my family as well. Being the wife of a tobacco farmer, this crop supports our entire family, three children, 20+ employees and our entire community. Please reconsider passing this proposal. ", "comment_id": "FDA-2017-N-6189-6408", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-6408", "comment_date": "2018-07-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 998}, {"text": "To Whom It May Concern: I am writing today to submit my comment on the Food and Drug Administrations (FDA) possible rule that would essentially ban all cigarettes on the market today by mandating that the levels of nicotine be nearly 98 percent lower than current levels.  There is no combustible product on the market today that meets these unreasonable standards, making this a de facto ban on all cigarettes.The possible rule being considered would be disastrous for my business and tobacco growers across the region, jeopardizing jobs and the entire economy, as the overwhelming majority of cigarettes sold by tobacco retailers and wholesalers are produced here in the U.S. from domestically grown tobacco. Such a drastic regulatory change would be particularly burdensome, if not impossible, for tobacco growers and our employees.  It would impact nearly every aspect of our business---from planting to cultivating to harvesting---as the FDAs possible rule would render all tobacco plants grown today obsolete and unusable.  Many tobacco farmers are small, family-run businesses, and would face significant difficulties implementing and affording this change. This possible rule could also have serious negative repercussions for domestic manufacturing and U.S. jobs, especially since the vast majority of cigarettes sold in the United States are manufactured here using American-grown tobacco.  The FDA should consider the negative economic ripple effect this possible regulatory change would have on the broader economy and well-being of the communities our industry supports. This possible rule goes too far and would limit adult tobacco consumers choices and hurt tobacco growers.  Please keep in mind the impact this possible rule would have on tobacco grower, the jobs we provide, and the economies of the regions and states in which we operate. ", "comment_id": "FDA-2017-N-6189-3307", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3307", "comment_date": "2018-07-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1992}, {"text": "To Whom It May Concern: Please do not move forward or even consider a possible new nicotine rule that would require the nicotine level in cigarettes to be nearly 98 percent lower than they are today. Such a move would amount to a ban on all cigarettes currently available to my adult tobacco customers and have a direct negative impact on my business as well as other tobacco retailers and wholesalers across the country.This possible standard, which may not even be achievable, could undermine my business and threaten the larger economy---especially if it is enacted without giving smokers a significant increase in alternative, less harmful tobacco product options and access to truthful, accurate information for smokers about the benefits of switching to these products. Removing regulatory barriers to less harmful products would benefit not only consumers and public health, but also the many stakeholders who depend on tobacco products for revenues, like growers and tobacco retailers and wholesalers.Cigarettes sales have a sizeable impact on my business---and adult smokers usually end up purchasing more than just their tobacco products, driving more sales. Whats more, local tobacco retailers and wholesalers provide jobs, support the economy, and contribute tax revenue---all of which could be negatively impacted by this possible new rule. It could also have serious negative repercussions for domestic manufacturing and U.S. jobs, especially since the vast majority of cigarettes sold in the United States are manufactured here using American-grown tobacco. The FDA should not enact any new rule regarding the nicotine level in cigarettes without thinking through the consequences it could have on local businesses like mine, our employees, and the customers we serve.   ", "comment_id": "FDA-2017-N-6189-3301", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3301", "comment_date": "2018-07-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1906}, {"text": "Response to the FDA-2017-N-6189 for Tobacco Product Standard for Nicotine Level of Certain Tobacco Products. Consideration to lower the nicotine content of cigarettes many lead to increased number of cigarettes smoked to get to the harmful level of nicotine. With increased in smoking comes increased 2nd hand exposure to cigarette smoke. Seeing that reducing the nicotine content of cigarettes does not change the number or composition of cancer causing chemicals placed in cigarette. Reducing nicotine may not be a healthy move for the many", "comment_id": "FDA-2017-N-6189-3254", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3254", "comment_date": "2018-07-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 542}, {"text": "To Whom It May Concern: The FDA should not consider imposing this possible rule as it is unreasonable and would unfairly target adult tobacco consumers by essentially banning the legal products they prefer without having widespread access to and information about alternative, less harmful tobacco products. A mandate that cigarettes have nearly 98 percent less nicotine than current levels would be a de facto ban on all cigarettes currently on the market.   By effectively banning these products---without first creating a market for less harmful alternative tobacco products---the FDAs possible rule is simply unfair and unreasonable.Beyond just adult smokers, this possible rule would hurt our economy. A de facto ban on cigarettes would threaten American tobacco growers and manufacturing.  Given that the vast majority of cigarettes sold in the United States are manufactured domestically from American-grown tobacco, such an severe regulatory mandate would have a serious negative impact on U.S. manufacturing, agriculture, and jobs.The FDA should focus its resources on a comprehensive plan that reduces harm and risk for adult tobacco consumers through proven strategies to prevent initiation, encourage cessation, and by the development of reduced risk alternatives to cigarettes that adult smokers like.  Please reconsider this drastic regulatory change.  ", "comment_id": "FDA-2017-N-6189-3077", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3077", "comment_date": "2018-07-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1487}, {"text": "To Whom It May Concern: I am writing today to submit my comment on the Food and Drug Administrations (FDAs) possible new rule concerning the nicotine levels in cigarettes.  By mandating that the levels of nicotine be reduced nearly 98 percent, this possible rule would essentially ban all cigarettes on the market today.  This possible rule is unfair to adult smokers, and may not even be achievable.  The FDA should not move forward without considering the impact it would have on adult smokers as well as our larger economy.Once again, the government is trying to solve a problem by restricting choice rather than by giving adults more alternatives.  Rather than reduce choice for adult smokers, the FDA should focus on giving adult smokers more options and access to a wider choice of less harmful tobacco products, and truthful, accurate information about the benefits of switching to them.  Instead, this de facto ban would simply target adult smokers for purchasing the legal products they prefer.FDA should focus resources on a comprehensive plan to reduce harm through proven strategies to prevent initiation, encourage cessation and by fostering the development of reduced risk alternatives to cigarettes that are satisfying to adult smokers.Please do not consider such a severe and unfair proposal. ", "comment_id": "FDA-2017-N-6189-3083", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3083", "comment_date": "2018-07-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1434}, {"text": "To Whom It May Concern: The FDA should not consider imposing this possible rule as it is unreasonable and would unfairly target adult tobacco consumers by essentially banning the legal products they prefer without having widespread access to and information about alternative, less harmful tobacco products. A mandate that cigarettes have nearly 98 percent less nicotine than current levels would be a de facto ban on all cigarettes currently on the market.   By effectively banning these products---without first creating a market for less harmful alternative tobacco products---the FDAs possible rule is simply unfair and unreasonable.Beyond just adult smokers, this possible rule would hurt our economy. A de facto ban on cigarettes would threaten American tobacco growers and manufacturing.  Given that the vast majority of cigarettes sold in the United States are manufactured domestically from American-grown tobacco, such an severe regulatory mandate would have a serious negative impact on U.S. manufacturing, agriculture, and jobs.The FDA should focus its resources on a comprehensive plan that reduces harm and risk for adult tobacco consumers through proven strategies to prevent initiation, encourage cessation, and by the development of reduced risk alternatives to cigarettes that adult smokers like.  Please reconsider this drastic regulatory change.  ", "comment_id": "FDA-2017-N-6189-3085", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3085", "comment_date": "2018-07-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1487}, {"text": "To Whom It May Concern: I am opposed to the possible new nicotine rule the FDA is currently considering in the form it is presented.  If enacted, it would be unfair to adult smokers, threaten our economy, and may not even be technically achievable. Please oppose this effort.Before implementing any nicotine standard the FDA should ensure that adult smokers have access to a much greater variety of less harmful alternatives, and to information about the benefits of switching to them. FDA should focus resources on a comprehensive plan to reduce harm through proven strategies to prevent initiation, encourage cessation and by fostering the development of reduced risk alternatives to cigarettes that are satisfying to adult smokers. If a rule such as the one being considered were enacted, it would basically remove all cigarettes and cigars currently on the market today.  This is essentially a de facto ban on the products many adult tobacco consumers prefer as there are currently no combustible tobacco products on the market today that meet the unreasonable restriction the FDA is considering.  Everyone can support reasonable regulations, but this goes too far.  Not only would this possible rule target adult tobacco consumers and limit their choices and the options available to them, but it could seriously hurt U.S. tobacco growers and manufacturing.  The overwhelming majority of cigarettes sold in the United States are manufactured right here by American manufacturers using tobacco grown here.  A de facto ban on cigarettes would have a devastating impact on the manufacturing and agricultural sectors, as well as the jobs they support.This possible rule is unfair and would have far too many unintended, negative consequence. Please keep my views in mind and do not advance such a severe regulatory mandate. ", "comment_id": "FDA-2017-N-6189-3044", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6189-3044", "comment_date": "2018-07-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1945}]}, {"id": "FDA-2022-N-2673", "agency": "FDA", "title": "Safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription use; Request for Comments", "update_date": "2023-01-20", "update_time": "13:40:36", "purpose": "Nonrulemaking", "keywords": ["Safety and effectiveness of certain naloxone", "hydrochloride drug products for nonprescription", "Request for Comments", "CDER", "FRDTS 2022-446", "OPEN"], "comments": [{"text": "As a licensed HCP I support that all naloxone products should be moved from prescription to OCT status. The FDA choosing not to evaluate all products (even the 8 mg intranasal product KLOXDXADO and the 5 mg ZIMHI) to OTC is beyond perplexing. Move naloxone to OTC NOW! ", "comment_id": "FDA-2022-N-2673-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0003", "comment_date": "2022-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 279}, {"text": "Komen", "comment_id": "FDA-2022-N-2673-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0002", "comment_date": "2022-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5}, {"text": "I am writing to submit my support for nonprescription/over-the-counter access to naloxone formulations across the United States. I am a PhD health researcher whose dissertation focus was on opioid use disorder and harm reduction. Naloxone saves lives, it is as simple as that. Increasing access to naloxone can help reduce overdoses and overdose deaths. Naloxone cannot be used recreationally, and there has been no scientific evidence of significant harm related to naloxone administration that outweighs the risks of opioid overdose. ", "comment_id": "FDA-2022-N-2673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0004", "comment_date": "2022-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 536}, {"text": "ZIMHI is an amazing product! ", "comment_id": "FDA-2022-N-2673-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0071", "comment_date": "2022-12-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 29}, {"text": "Please allow naloxone to be distributed over the counter! In fact, if there is a way to have it available OTC for free - that would be the best harm reduction our country could provide to our citizens. It is a public health mechanism to save lives. My clinical practice is treating substance use disorders and I get out all the narcan I have. It is the best way to reverse an overdose and it needs to be readily available to everyone.", "comment_id": "FDA-2022-N-2673-0066", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0066", "comment_date": "2022-12-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 434}, {"text": "We have decades of experience showing that laypeople with minimal training can successfully use naloxone to save lives. FDA desperately needs to make naloxone available over-the-counter in order to eliminate the myriad bureaucratic barriers that stem from its current status as a prescription-only product. While recent efforts, like the clarification related to the DSCSA, have gone a long way toward making naloxone easier to procure by harm reduction programs, they do not get rid of all hurdles. Additionally, making naloxone OTC would help protect end users who are sometimes harassed by police for having a prescription-only medicine. While I welcome FDAs initiative to encourage sponsors to apply for OTC status for certain formulations and dose strengths, FDAs preliminary assessment unfortunately leaves out the products with the longest track record of community use  0.4 mg/mL intramuscular naloxone. The evidence of success of community naloxone programs is largely built upon the long use of IM product by lay bystanders. These decades of experience show that it is appropriate and safe for community use  especially by people who use drugs who are most often the frontline responders. This product is truly the backbone of the harm reduction naloxone response. And importantly, it is much more affordable than intranasal and autoinjector products. FDA should go further than simply encouraging companies to apply for OTC status for certain IN and autoinjector products. The agency should itself initiate an OTC switch for the widely used IM formulation. Not doing so risks giving the appearance that this critically important formulation is a second-tier product, which will have real implications for the harm reduction programs that rely on it, and for the people who use it.", "comment_id": "FDA-2022-N-2673-0067", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0067", "comment_date": "2022-12-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1819}, {"text": "As a public health nurse, I strongly support the availability of over-the-counter naloxone. Naloxone is a life-saving medication that is safe and effective for the reversal of opioid overdose. In fact, naloxone is far safer than many currently available over-the-counter products. Many states allow widespread dispensing of naloxone, which has been shown to be a public health benefit.With increased access, the public would also benefit from widespread education campaigns that explain the signs of opioid overdose, how to respond, and how to access effective treatments for opioid use disorder (of which the gold standard is opioid agonist medications). OTC naloxone may have the added benefit of normalizing carrying naloxone and destigmatizing the use of opioids. While much more is needed to destigmatize drug use and addiction, OTC naloxone would be a small step in this direction.", "comment_id": "FDA-2022-N-2673-0075", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0075", "comment_date": "2022-12-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 907}, {"text": "With the increase of synthetic fentanyl and opioid-related deaths across the country, expanding access and eliminating barriers to Narcan is pertinent. I work in patient access in the pharmaceutical industry for an unaffiliated company. I have no ties to this legislation or companies involved other then Im the daughter of a recovering addict. I found my dad cold and blue, from an opioid-overdose. I called 911 and when the paramedics used 4 cans of Naloxone to save his life that night. The paramedics said if they wouldve arrived 15 seconds later, he wouldve died. My dad has overdosed multiple times but this was the closest call and it was directly in front of me. Had I had access to Narcan OTC, I wouldve administered it myself waiting for the paramedics to arrive. A friend lost her boyfriend to an accidental overdose due to synthetic fentanyl being laced. She to found him cold and blue, administered CPR, the paramedics used multiple cans of Narcan and could not revive him. It was simply too late and the fentanyl was too strong. Another family member overdosed on thanksgiving, his friend had a prescription for Narcan, and  administered narcan and saved him on the driveway. I then submitted documents to get him baker acted and on the road to recovery. Addicts do recover, they just need the opportunity to do so and having Naloxone OTC without a prescription provides that opportunity. The proposed switch will expand consumer access and save lives. Personally, I would always keep Narcan in my purse in case anyone needs me to administer it. Increased access to Naloxone is vital to the public. ", "comment_id": "FDA-2022-N-2673-0077", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0077", "comment_date": "2023-01-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1641}, {"text": "I support over-the-counter availability of naloxone due to the overwhelming likelihood that the people responding to an overdose will not have had the ability to obtain a prescription. A lifesaving, time-sensitive drug should not be gated behind a doctors prescription, particularly when the people most likely to use it will be recalcitrant to openly admit they are users of illegal drugs. ", "comment_id": "FDA-2022-N-2673-0100", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0100", "comment_date": "2023-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 398}, {"text": "I support making Naloxone over-the-counter available to anyone who needs this emergency life-saving drug. It is time to arm people, agencies, and drug-users with a tool that prevents loss of life. Make Naloxone OTC!", "comment_id": "FDA-2022-N-2673-0126", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0126", "comment_date": "2023-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 225}]}, {"id": "FMCSA-2000-8456", "agency": "FMCSA", "title": "Conforming Amendments to DOT Drug and Alcohol Rule", "update_date": "2021-02-10", "update_time": "01:23:42", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Under 382.107 definitions, DOT agency means... you list parts 653 and 654.; however, the FTA has eliminated these and combined the two in a new section 655. Perhaps the definition should express this as well.Under Subpart B, 382.201 Alcohol concentration, and 382.301(d)(5) you state the driver cannot work with an alcohol concentration of 0.04 or greater, yet in 382.307(e)(2)(i), you state the driver cannot drive until the concentration is less than 0.02. Also, 382.505(a) states drivers greater than  0.02 and less than 0.04 cannot drive.  Should not 302.201 and 382.301 (d)(5) likewise be less than 0.02?Thank you,Stuart M. Kagan, MD, MPHMedical Review Officer", "comment_id": "FMCSA-2000-8456-0002", "comment_url": "https://api.regulations.gov/v4/comments/FMCSA-2000-8456-0002", "comment_date": "2001-05-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 695}]}, {"id": "USN-2016-HQ-0002", "agency": "USN", "title": "Privacy Act of 1974; System of Records (alteration, N05350-1, Navy Drug and Alcohol Program System)", "update_date": "2020-10-22", "update_time": "01:11:55", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "It is always important to keep records of most things and above all a persons well being formany reasons, principally if that person is involved in the US Navy. It is even more so essential to keep records if that personhas a history or present state of a drug or alcohol addiction. This is a very proficient on process that will undoubtedly help maintain records and authority according to their state of being. A very crucial part when it comes to taking control in certainexpertise in the US Navy; A total improvement success.", "comment_id": "USN-2016-HQ-0002-0002", "comment_url": "https://api.regulations.gov/v4/comments/USN-2016-HQ-0002-0002", "comment_date": "2016-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 549}]}, {"id": "DEA-2007-0113", "agency": "DEA", "title": "Combat Methamphetamine Epidemic Act of 2005: Fee for Self- Certification for Regulated Sellers of Scheduled Listed Chemical Products ", "update_date": "2021-12-02", "update_time": "01:00:36", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am concerned about the impact of this regulation on small businesses thatdistribute legal drugs containing small amounts of these chemicals.  Much of theregulatory material is devoted to discussing the fact that the fee ? which willbe $16 initially, and adjusted thereafter ? is rather low, and thus will notadversely impact small businesses.  This rationale is troublesome, however, forseveral reasons.  First, because each location ? including each location amobile vendor visits ? requires an additional self-certification, thisregulation could get very expensive very quickly for mobile vendors (who,potentially, may be among the smallest businesses).  In addition, as the DEAadmits, the fee may increase greatly depending on the ?utilization? of theadjudicatory procedures in coming years.  Furthermore, the CFR materials do notmake any clear predictions as to how the fee wavier for those already registeredwith the DEA will affect the fee in future years ? if many fees are waived, thefee for paying self-certifiers can be expected to increase.Moreover, I am concerned by the impact on small businesses since the fees arenot graduated based on the volume of sale.  While the CFR materials assume theimpact will be small - $16 and an estimated three hours in regulation time,totaling $100 per year ? I?m not sure this adequately represents the risk. Small businesses will decide whether to continue selling these drugs based onwhether the benefits of doing so outweigh the costs.  Because I think that theCFR materials undervalue the costs to small businesses of training, making spacebehind the counter, and now paying the fee, I am concerned that small sellerswill cease distributing these products, adversely affecting their customers. Since these small businesses may be more likely to exist (and predominate) insmall towns and rural areas, this regulation may adversely anddisproportionately affect those populations.  While the DEA argues that it isunsure whether it has the statutory authority to obtain the informationnecessary from businesses to institute a waiver for smaller ones, some type ofvoluntary information-sharing mechanism seems like an obvious but unexploredpotential solution.  ", "comment_id": "DEA-2007-0113-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2007-0113-0004", "comment_date": "2007-11-29", "comment_time": "05:00:00", "commenter_fname": "Erica", "commenter_lname": "Ross", "comment_length": 2404}]}, {"id": "SAMHSA-2022-0001", "agency": "SAMHSA", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) (Revised)", "update_date": "2022-06-14", "update_time": "14:14:08", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "This is completely absurd and unjust! It is time to move past these destructive policies. If a persons physician believes it is in ones best interest to use a medicine, then the federal government should not be able to hold this against the person due to a failed test. This is very un-American! Cannabis is a very safe, and effective medicine. We should embrace it as such.", "comment_id": "SAMHSA-2022-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0007", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Richard", "commenter_lname": "Rousseau", "comment_length": 384}, {"text": "Although I believe Oral Fluid testing is a good thing for quick non dot testing, I think it is offering many opportunities for Cheating for DOT testing.  There will be more and more companies that will begin to do their own testing with their Employees which leaves the opportunity for friends and colleagues testing each other and promotes collaboration between Staff and Employee", "comment_id": "SAMHSA-2022-0001-0023", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0023", "comment_date": "2022-04-26", "comment_time": "04:00:00", "commenter_fname": "Bill", "commenter_lname": "Kincaid", "comment_length": 381}, {"text": "I believe that medical cannabis users should be exempt from fedral drug screen failures.", "comment_id": "SAMHSA-2022-0001-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0022", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "his is slightly insane but a logical outcome of the federal governments continued refusal to change its outdated, disproven, and harmful categorization of cannabis as a Schedule I drug.", "comment_id": "SAMHSA-2022-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0019", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Alexi", "commenter_lname": "Martinez", "comment_length": 192}, {"text": "This rule is founded on completely archaic ideas about cannabis and how it affects an individual. There is no science backing up the non-legitimacy of medical use cases for cannabis where in many circumstances, actually improves the life of the person who uses it. Personally I have suffered from high anxiety/depression and PTSD and using cannabis before bed helps me immensely to calm down and get good rest. Without it I typically have night sweats/terrors that severely affects my performance the next day. Using cannabis before bed however allows me to function fully the next day and show up to work and other responsibilities with a clear and balanced mind. The harmless nature of this drug truthfully should allow it to be legal federally. Even for non medical patients, it is far safer to be taken recreationally than something like alcohol. Having cannabis be a schedule 1 drug is completely erroneous but while states have laws allowing it to be used medically, we should honor that and not move retroactively. Progress needs to be made here to establish facts about cannabis instead of digging in our heels based off assumptions made by politicians from decades ago. More and more research is coming out showing the benefits of cannabis and how truly harmless it can be. We need to be a country that creates rules based off these facts in order to maintain the sense of freedom that we cherish here. ", "comment_id": "SAMHSA-2022-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0021", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Eric", "commenter_lname": "Florence", "comment_length": 1412}, {"text": "SAMHSA 2022-0001 is a throwback to a relic of reefer-madness legislature. All of this is the politically neurotic outcome of the federal governments continued refusal to change its outdated, targeted, and medically harmful categorization of cannabis as a Schedule I drug. Please look yourself in the mirror and explain this, a physicians authorization or medical recommendation for a Schedule I substance is not an acceptable medical explanation for a positive drug test. Ill help, its a back asswards loophole to apply to try to regulate an innoxious substance. Its also funny how the most addictive substances known to man are considered safe enough to assign to Schedule II; live with yourself knowing that you helped fuel a crisis that ruins lives and kills people because of a nonsensical mindset of ignorance, greed, and fear. You wont read it but heres to you, cheers; https://www.npr.org/2022/02/25/1082901958/opioid-settlement-johnson-26-billion, https://www.newsnationnow.com/health/where-do-us-opioid-trials-settlements-stand/.", "comment_id": "SAMHSA-2022-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0011", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1091}, {"text": "As a qualified SAP from 05 to present I am in support for Oral Fluid Testing but with the following caveats: 1) ONLY Urine Testing should be used for the RTD Return to Duty test. 2) There should be no change to the SAP being the sole author of any employees mandatory Follow up Testing Plan. The SAP is the one in the entire RTD process who is spending up to hours of time providing a clinical assessment and applying diagnostic criteria with backend recommendations for education or treatment or both. Thus, upon any employee compliance the SAP should be the only Service Agent type deciding the amount of Follow-up Tests but also if they recommend ORAL or URINE for Follow-up tests. I would advise that all Follow up Tests are URINE TESTS only. The Oral Test appear from what I read to be the way to go for Pre-employment Test, Randoms, Reasonable Suspicion, Post Accident etc but the RTD and Follow up Test should ALWAYS be Urine based. If there is a choice on either for Oral and Urine testing for RTD and Follow-up Testing this call should ONLY be for the contracted SAP to make and never the employer or 3rd party TPA. ", "comment_id": "SAMHSA-2022-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0027", "comment_date": "2022-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1135}, {"text": "Comment on SAMHSA 2022-06884I am an operations manager at a public transit authority and think adding the ability to conduct drug testing using oral fluids will be a benefit felt across the board. Our organization would certify staff to be able to self administer oral fluid testing as well as use a clinic. Drivers would still have to go to a clinic for BAC testing, so we would not self administer that test. It takes a lot of planning and resources to pull drivers off route for random testing, send them to the clinic, wait at the clinic, then coordinate getting them back on route. Being able to self administer random testing will simplify the process and make it more convenient to test at all times of service. Our practice would be to use urine tests for pre-employment, return to duty, and follow up. In the cases of shy bladders or the inability to produce a large enough specimen, we would be open to transitioning from urine to oral fluids before exhausting the time limit. We prefer pre, return, and follow-up to be more structured through a clinic and to use urine, especially for return and follow-up. In response to the question of whether or not to allow opposite gender techs to observe urine collection, our team was split. The male point of view was it makes no difference. The human resources and female recommendation was to have it observed by the same gender. Past experiences show female staff were already stressed about being observed. To have the collection observed by a male would further exacerbate the situation. Just because someone is going through the follow up process doesnt mean they should lose their dignity. We understand in smaller communities it may be harder to find same gender techs to observe urine collections, but we dont have the issue in our area. In response to the question of whether or not refusing an opposite gender observer constitutes a refusal to test, we assumed that the regulation wouldnt require same gender observers. We would recommend calling that a refusal to test. If your test requires observing, you must have already tested positive. We cannot give someone the ability to cheat the system if they know there arent many same gender techs. In summary, lets get oral fluid testing up and running and relieve some of the burden placed on organizations to maintain compliance with drug testing. A separate soap box issue I would like to see movement on is THC levels testing to remove the current zero tolerance policy that can last for up to 60 days after last contact/consumption. Safety sensitive industries need a better answer than zero tolerance when cannabis products and marijuana use are rising as fast as they are now. Zero tolerance is hurting staff retention and recruiting.  ", "comment_id": "SAMHSA-2022-0001-0030", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0030", "comment_date": "2022-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2811}, {"text": "This suggested language should be stricken: The Department also proposes to add a new item iii to this section stating that a physicians authorization or medical recommendation for a Schedule I substance is not an acceptable medical explanation for a positive drug test. Under the CSA, a Schedule I substance is defined as a drug, chemical, or other substance with no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. (Ref. 13) The DEA maintains the current listing of controlled substances on their website.The government should not meddle in health-related decisions made by a medical professional.  You are relying upon an executive order that is nearly 36 years old to justify invasive urine testing for huge numbers of employees.  Please vote to remove this added language and respect the recommendations of medical professionals. ", "comment_id": "SAMHSA-2022-0001-0041", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0041", "comment_date": "2022-06-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 986}, {"text": "Just keep adding rules and adding rules and you will deplete the already suffering transportation sector,when you dont have food on the the grocery store shelves or gas to put in your car or toilet paper to wipe your but because you have no truck drivers to bring it to you,when you cant get food to feed your children,then I suppose you will second guess yourselves and all these nonsense rules you are making.Why dont you just sit back and keep getting that salary that you do nothing to earn and stop making up rules.....Just remember that trucks move America and if trucks are not moving neither are you!!!", "comment_id": "SAMHSA-2022-0001-0043", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0043", "comment_date": "2022-06-14", "comment_time": "04:00:00", "commenter_fname": "David", "commenter_lname": "Measles", "comment_length": 635}]}, {"id": "FDA-2019-N-2514", "agency": "FDA", "title": "Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing", "update_date": "2019-11-22", "update_time": "12:45:40", "purpose": "Nonrulemaking", "keywords": ["2019-368", "CDER", "Standards for Future", "Opioid Analgesic Approvals and Incentives", "New Therapeutics to Treat Pain and Addiction", "Public Hearing", "Open"], "comments": [{"text": "I am a chronic pain patient. Opioid restrictions have hurt me and many of my friends, and killed some we know. Doctors are cutting their patients off cold turkey, or forcefully tapering them against their will extremely quickly. They are citing the CDCs 2016 Guidelines, which are for ACUTE cases, not chronic cases. The DEA is actively prosecuting doctors for treating chronic pain patients at appropriate levels, to the point that so few providers remain that we have a pain epidemic in our country. We have 25 million americans with high impact pain, pain that debilitates them. Another 40 million with chronic pain. Pain is the NUMBER ONE reason people go to the doctors. And you cant even get it treated anymore. At least 1 in 10 suicides are associated with chronic pain. Pain kills. Pain ruins lives. And we so highly prize preventing addictions that arent even occuring from prescriptions - a long term study of chronic pain patients found .56% became addicted after 6 months of use. Less than 1% - and acute patients rarely get pain medication outside of surgery and often not even then, now. Our government is publishing LAWS about the amount of MME that a drug can have - are our politicians doctors, then? How is this their job? Statistically speaking this is an illicit FENTANYL and HEROIN crisis, not an opioid crisis. Restricting prescription pain medications this heavily, when the prescription pain pill problem has been solved and over-solved for years, only hurts pain patients and doesnt help addicts. We need to address illicit heroin and illicit fentanyl. We need people to understand that illicit fentanyl isnt the same as fentanyl in a hospital, and that illicit drugs are extremely unsafe and contain pollutants. We need to address the problems underlying drug addiction and decrease access to street drugs, not conveniently slap on a band-aid that sounds good by restricting pain pills even more. Many individuals cant even get their medication, thanks to federal opioid budget cuts of up to 80% in the case of some opioids this year alone. Pharmacies run out. Individuals are left in terrible, life threatening withdrawals or in agony for days. Insurance companies no longer feel compelled to pay for opioids since physicians are uninclined to prescribe them and no one is likely to enforce punishment on a doctor for NOT giving pain medication. In fact, when I was with a chronic pain friend during her hospitalization for severe, hard to treat pain, she asked for a lidocaine IV. This is non-opioid, non habit forming. They told her that they couldnt do her IV, and then they cut her pain medication in HALF. She was in so much pain she wanted to die already, and now her pain tripled and she was going through withdrawals. They left her like this for over a day. They did not care. They cared only that their asses were covered and they werent prescribing more than 60 MME. This is essentially a genocide against pain patients and chronic illness patients, who are dying by the thousands of heart attacks from pain and suicide. Did you know the number one condition putting someone on disability is chronic pain, most often back pain? I wish our country luck when the economic impacts of this many additional disabled individuals, unable to work, hits. Pain meds help maintain functionality, the ability to work, and quality of life. Please include pain patients properly using medication in your panels, so our voice is heard. Our need for these medications should not be threatened due to others actions, and it has been, unintentionally or intentionally. Impact is greater than intent. Please make EXPLICITLY clear  in any future legislation that these bills do NOT apply to chronic, intractible pain patients. I have a genetic disease. There is no cure. There is no treatment. My joints dislocate multiple times a day, my brain pressure rises causes agonizing headaches. My bones ache due to inflammatory conditions and autoimmune conditions. I spend every waking moment in pain, and I am 22. Pain medication gives me the ability to go to school and have some quality of life. Without it, I would be home bound. And it is constantly in threat. We live in fear. Help us. ", "comment_id": "FDA-2019-N-2514-0057", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0057", "comment_date": "2019-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4284}, {"text": "I can agree that there needs to be new methods of pain management researched to help combat the terrible opioid crises that this country is going through. I do wonder though what potential ingredients would be used in this analgesic, and if though the FDA says there is no risk of addiction, there could be a dependence on the analgesic as well. I also question how available this type of pain management will be since opioids are more readily available, thus the reason we have the crisis we do. In the risk-benefit analysis are we also taking those who are already addicted to opioids into consideration and are we also considering that addiction is a disease and the possibility that even with the treatment of pain will the dependency on the opioids be combated?  I can appreciate that the FDA is having this meeting to discuss different options, but are the voices of those addicted or their families voice going to be heard or will it be overshadowed by the opinions of those in the medical field or in pharma sales. I do hope that there can be a real resolution to this crisis and perhaps the suggestion of a non-addictive analgesic is the right answer. I also hope that in finding a solution to the opioid crisis, we can then work on the treatment of those on other addictive drugs without the use of suboxone. Living in an area where the opioid crisis is very prevalent I would like to see more ways to help combat this, and I would like to see more people be open to the discussion of different treatments for those in pain. I think too many times we overlook the reasons why people become addicted in the first place. The pharma company, yes I do know it was one particular family, that created oxycontin and hydrocodone that is the substances that are at the very heart of this crisis, should be held responsible for the crisis that was created, and hopefully have no part in creating new ways to combat pain. I also have the hope that this forum will be able to show that not all persons are receptive to the same type of pain management and can in some way look at individuals when coming up with solutions. Yes, the analgesic is a great start but there are some who may not be receptive to topical treatments. The FDA needs to research how to take what non-addictive properties are in the analgesic that they are trying to develop and apply those to an oral type of medicine. 2. Should sponsors of new opioid analgesics be required to demonstrate some comparative advantage relative to existing analgesics? If so, what new authorities would be necessary to impose a comparative advantage requirement for opioid analgesics?3. If so, how should that comparative advantage be defined?a. Can it be quantified?b. Should the assessment encompass any potential comparative advantage, including, e.g., safety advantages that reduce the prevalence or consequences of abuse or misuse by non-patient populations?c. For any given application, to which existing products should the proposed new product be required to demonstrate comparative advantage? Any other opioid approved for the same analgesic indication(s) for which approval is sought? What are the implications if the new product only offers a comparative advantage over some of the other opioid products approved for the same indication(s)?......These questions that are being asked are going in the right direction, and I agree that the advantages of the analgesic should be defined. I do also like that the patients are actually being thought of, though it does still seem like they see patients as just a number and not actually as a person. Human beings are at the core of this problem and there is a need to make sure that we look at the patients, addicts, and those who will need pain management in the future as such. We have to look at them as humans not just as some numbers or as some statistics. ", "comment_id": "FDA-2019-N-2514-0090", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0090", "comment_date": "2019-10-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4045}, {"text": "Im a CHRONIC PAIN PATIENTS WHO SUFFERING in UNBEARABLE PAIN BECAUSE of BEING DENIED PAIN MEDICATIONS that work to make my life bearable. Why take a way what has worked FOR so MANY years for so many ..if you had CHRONIC PAIN you would know what Im talking about. But you dont. How can anyone live with them SELVES knowing what you ARE doing to US. Letting us SUFFER UNTIL WE CANT HANDLE ANYMORE pain and are forced to  COMMIT SUICIDEYou know its not PRESCRIPTION DRUGS that is the problem ITS ILLEGAL DRUGS that ARE KILLING PEOPLE..And you continue to let us SUFFER UNTIL Death. Someones going to be RESPONSIBLE FOR our DEATHS and SUFFERING. This is the WORST CRIME in HISTORY AGAINST CHRONIC PAIN PATIENTS AND VETERANS WHO ARE SUFFERING in UNBEARABLE PAIN BECAUSE WERE DENIED the LIFE SAVING PAIN MEDICATIONS AND MORE SUICIDE DEATHS BECAUSE WE CANT HANDLE the PAIN ", "comment_id": "FDA-2019-N-2514-0060", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0060", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 915}, {"text": "These comments are submitted in response to the Federal Register notice Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction, Docket FDA-2019-N-2514.  This is a written version of comments made orally at the September 17, 2019, Food and Drug Administration (FDA) public hearing on this topic.", "comment_id": "FDA-2019-N-2514-0095", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0095", "comment_date": "2019-11-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 351}, {"text": "This is an anonymous post.I have read many of the comments for this issue. I have lived with chronic pain for many years. I have seen the damage that the CDC requirements have done to pain patients. It has decimated entire medical clinics, pharmacies and families all across the United States. I ask the reader this; if you took this issue and superimposed it to say, car accidents, would the results be the same? Would there be as passionate a response?Car accidents kill many more people a year then overdoses.People purposely abuse their privilege, not right,  to drive. People completely control their texting or drinking or using drugs or being tired that affects their driving capabilities that end both theirs and innocent peoples lives. Why hasnt the public demanded that individuals cars be taken away? That cars become illegal? Demand stricter regulations on cars? You dont even hear people complaining about it in the same fashion. Look at gun rights. After a severe shooting, activists demand the restriction of gun laws, etc.The NRA states its the people but not the guns. And the fact is, taking away a persons ability to own a weapon, a person who follows ALL the laws makes little sense when the bulk of criminals could care less about gun laws and acquire their weapons illegally. Hurting law abiding citizens by punishing them for merely following the law makes little sense. Unless its about the STATEMENT and not the actual action. The SAME can be said for what is happening all across America now. The fact is, if all of these governmental agencies and nurses and the CDC and everyone who is calling for and achieving the taking away of pain medicine from legitimate pain patients and pain clinics and pharmacies were truly interested in fightingTHE WAR  ON DRUGS, wouldnt they want their efforts to yield results? Attacking legitimate pain patients or even considering prescriptions legally acquired to be in any way related to the elicit fentanyl and heroin overdose deaths and current opioid crisis would be like comparing drunk driving deaths to heart attacks . They are COMPLETELY DIFFERENT issues and the current culture would be like attacking heart surgeons ability to perform to correct and curb drunk driving. It makes little sense other then as a political statement in a political environment. Just because legitimate pain medication can be be used to overdose on  and the fact that opioid medication is technically related to heroin or fentanyl, does not mean destroying pain patients ability to get medicine will stop fentanyl or heroin from being brought in and abused. In fact, it makes it WORSE! To compare the two is like saying that heart attacks and drunk driving deaths both deal with people dying and trying to cut off the head to cure the head ache . Because what is happening in the United States right now is madness and is ONLY helping the entities making the statements. Its not helping people in pain for legitimately documented injuries and conditions that have NEVER abused their medication ever. Its not helping people that are being denied pain relief during surgeries. Its madness. Its not helping doctors offices just trying to help people compassionately. I talked to a doctor that told me he was bringing the ENTIRE medical office down to a 60 MG morphine equivalent. Not for any medical purpose but only a legal one. So every single patient is considered the same. All addicts. ALL being accused of being just like the heroin and fentanyl dealers and junkies. All being lumped together. It would be like saying a murderer and a war hero that has taken lives are both the same. Technically the actions are related, but the INTENTIONS are light years apart. So unless we are going to start putting war heros in prison for life, we need to STOP THIS MADNESS NOW. There are so many other ways to look at this situation. The point is that punishing people for treating pain with medication that is merely scientifically related to the drugs being sold illegally and causing the MAJORITY of the deaths is not rational,  or appropriate. We are never going to eliminate pain. We are not going to stop the headache by cutting off the head. By what is happening now accusing people of selling their prescriptions without any proof or reasoning at all. It MAKES NO SENSE. Even if we made pain medication illegal it would not stop the drug crisis. AT ALL. It will make it WORSE. The rationale that taking legitimate prescriptions off the street simply because someone following the rules could be lying or diverting their medication is like saying that we should eliminate cars because someone could get drunk and kill someone. Many more people are driving without killing someone. Many more people are using their medication because they NEED it. And lets say we take all the cars away? We would not be able to go to work, to live to eat to survive. THE EXACT same thing happening to legitimate pain patients out there. ", "comment_id": "FDA-2019-N-2514-0084", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0084", "comment_date": "2019-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5072}, {"text": "Why should people with chronic pain or cancer be denied pain relief because a segment of the population has no will power or self-control? People need to be held accountable for their choices. The government loves to enable people so that they do not have to face the consequences of their actions. I have rarely taken an opioid because I dont like how they make me feel, but I dont want to be denied access to them, if I ever do need them for pain management.", "comment_id": "FDA-2019-N-2514-0086", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0086", "comment_date": "2019-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 460}, {"text": "Gabapentin prescription renewal now requires me to visit my prescribing doctor every Three (3) months. This is a difficult requirement for we senior citizens who have spinal stenosis. I spent 2 hours in my doctors office today filling our paper work and will be required to return to my prescribing doctor in 3 months to get a refill prescriptions. The FDA should be more aware of the administrative burden they place on drugs like Gabapentin which can not possibly be a candidate for drug abuse.", "comment_id": "FDA-2019-N-2514-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0023", "comment_date": "2019-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 496}, {"text": "Looking for new treatments or releasing new meds is a good thing to do.  Ignoring what the CDC, FDA, DEA HHS and more did to Chronic and intractable pain patients needs to be fixed.  You need to do more then release a clarification that no one paid attention to.  What happened was the  opposite of what you intended to happened.  A new more aggressive and intimidating campaign against the chronic pain community to force new tapers and doctors to stop the pain medication and abandon their patients.What will you do to fix this or help the over 50 million chronic pain patients you caused and destroyed the lives of these patients.  Like an addict its not about the person its about the friend, family and anyone who knows this person.  There are millions of us some say as much as 50 million to 100 million of people living in chronic intractable pain.In 2016 CDC in section on how to continue treatment of a patient on LTO. They were asked if they wanted to taper and if the answer is no keep the patient on the same does.  The CDC guidelines said to offer a slow taper and go over the risks.  This did not happen did it?What else happened?  Suicides and driving patients to the street for relief. A huge amount of death because no one read the guidelines.  Go back and fix this before you attempt new treatments and pain medication.  The guidelines were written to help primary care physician to start a chronic pain treatment for new patients.  It was never meant for patients taking LTO.Go back and let the doctors treat their patients with the same pain medication for years.  Give us back our doctors, let them out of jail, give us back our medication and stop the DEA.Most of all admit what you did.  Admit in 2015 you were warned what would happen if the guidelines were released as is and you did it anyway.  Admit you inflated the number of overdose deaths related to prescription pain medication.  Admit you released the correct numbers 1 year after reviewing the death certificates.  Admit it took you 4 years to release clarification to the 2016 guidelines and you have known it for 4 years and you are causing more problems and hurt to pain patients.  Admit to the propaganda released and you set back on your asses and let it happen.  Go before congress and admit what you did to us.  My storyI was with my pain doctor for 20 years at the same clinic and on the same dosage when on 4-23-17 the medication that controlled my pain were stopped.  I arrived for routine follow-up when a new doctor I have never seen walked in to tell me he is stopping all pain medication for each person within one month.  It took me six months to find clinic to accept me as a patient and he treated me like a new patient.My worst pain is from 4 different migraines including chronic cluster migraines, several ruptured disks from a back injury and severe disk degeneration.  Spinal Bifida, Scoliosis, Fibromyalgia , chronic kidney stones and more.8-23-2018 I had one of the worst cluster migraines on its 5th day, the pain, a flair up from my disk rupture was acute and my chronic kidney stones started dropping.  This was my 4th kidney stone episode this year.  I was in horrific pain.I have a pain contract so my son called the clinkic to let them know he was taking me to the ER.  He was told he could take me but under no circumstances could they give me any pain medication. My son called 3 more times; on the 3rd call was told we needed permision from the doctor and he already left for the day.  No one told him about me.  The next day he was told the same and the next appointment we were told the same.No one should suffer horrific pain. Our doctors abandon us pharmacists profile us and refuse to fill our prescriptions even for cancer.  A family pet would never be allowed to live in pain. The family would show mercy and let the pet go to sleep.Before April 2017 I was happy, able to work, involved in many craft projects and saw my daughter and grandchildren often and they live 40 miles away.  Because of the migraines my husband created a dark room and I spend most of my time in there.  My back and other causes make me change positions every hour.  I do not get much sleep.  After months of appointments I said to that doctor I think about suicide every day sometimes every hour because of the pain.  He did not evan look at me and walked out the door.Help me before I become a  statistic.As chronic pain patients (CPP) most of us live in terror, horrific pain, anxious, depression, torture, sick, dark, isolation, anger, sad, cry, worthless, alone, jobless, misunderstood, fear, insomnia, helpless, broke, scared, scared of surgery, hopeless and at times hopeful.We have a disability and because of that disability we suffer discrimination just like every group of people.  Our doctors abandoned us pharmacist profile us and the public treats us as addicts.  No pharmacist wants to fill a prescription fo pain medication even for cancer.", "comment_id": "FDA-2019-N-2514-0037", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0037", "comment_date": "2019-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5095}, {"text": " I am having irreparable damage being done to my health after being forced off a medicine dosage, I have been prescribed safely for over twenty-six years. I need to be tapered off this drug SAFELY so as to cause NO HARM to the genetic bone disease, Alkaptonuria/Ochronosis, rare genetic disease which causes bones to go black and brittle  hence why its also called black bone disease.AKU is caused by a missing enzyme which means patients cannot fully breakdown a toxic acid called homogentisic acid (HGA). HGA attacks bones and cartilage, causing severe pain and disability as life progresses. The way I have been forced off a medicine I had taken for so long is hurting my heart along with causing the HGA levels to attack my bones even more than they already have, causing this disease to spread even more through my body. OCHRONOSIS causes bones to grind against each other cutting off nerve endings its a severely painful disease, only treatment that is listed, for this disease is taking pain medicine- there is NO other treatment listed for this disease, except a medicine that has just came out but is not attainable as of yet, which does not take away the pain of the disease, but, helps with the cause. I am on a list to get it one day- I am trying very hard to stay healthy enough. Ochronosis is perhaps the oldest known metabolic diseases on the planet- found in Female Egyptian Mummies, yet there is no cure. I am TIRED of being treated like a criminal -because I was born with a genetic disease! I have been abandoned by my doctor, and he did not refer to to another doctor, as he had always promised me. I have been treated like a criminal at my pharmacy, that I had gone to for over thirty years, one day they are my loyal store and the next, they were treating me like a crook. I was forced off my medicine dosage and NOW the rare incurable bone disease OCHRONOSIS/Alkaptonuria, is getting worse and worse everyday! I do not want to become totally bed ridden suffering a life with the pain of this disease that turns your bones black after it eats away all the cartilage between the bones causing them to grind and scrape against each other , it has attacked the valves to my heart, my kidneys and liver. And, now my entire cervical spine has been totally damaged. The doctor I had for 32 years was able- thru having me change my diet, do chiropractic help and cortisone shots, was able to keep this disease from spreading, it had stayed in my neck and hip for over twenty-six years, but, now it is spreading down my spine. By being denied my pain medicine dosage without being able to ween off of it at required 10% at a time , and made to live in total pain day and night. I can no longer get the exercise I need that kept this disease from building up in my joints, it is now eating away all the cartilage-turning my bones black, causing my urine to turn black. I am praying I can find doctor who will help me lower my need for the opioid medicine, that I was put on for twenty-six years in a SAFE way, the harm being done to me now, there is no cure from, which makes me desperate! I do not wish to become dependent and more sickly, when I was so independent for so many years. I have no where or one to turn to. PLEASE I NEED HELP! I bought my own home in my early thirties, I was the first female camera operator doing ENG field work in Los Angeles, I have a FCC 1st Class Radiotelephone License that entitled me to run and operate any television or Radio station in America. Yet, after I bought my land and home, I found out after five botched surgeries that I had a rare genetic bone disease that was non operative and has no cure. I still was able to stay independent, Until, the misapplied CDC Guidelines forced me off a medicine I had been taking responsibly and safely for over twenty-six years- This has caused this disease to now, start attacking my heart and rest of my cervical spine. I pray that revision of CDC Guidelines and allowing doctors to do their jobs without being persecuted  will give me back my life and I can grow old with dignity. Please contact me and let me know if you can help. - its means everything to me. Please watch this video if you have any questions about my disease : https://www.youtube.com/watch?v=7PpQU3wrdlMt=30sCDC and the FDA has put out warnings to never force a patient off a medicine they have taken for as long as I have been made to take this medicine. The irreparable injury being done to me, I am scared, I will end up totally cripple. I ask you to please help me to live the decent life I WAS LIVING without the pain of this disease. I have MRIs and X-Rays and any other records you are welcome to view, I thank you for your time and help in this matter. = Mahalo Nui Loa, ", "comment_id": "FDA-2019-N-2514-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0034", "comment_date": "2019-08-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4769}, {"text": "  Hello  My name is Dennis Shivers  Im 66 years old and was injured while working back in 1994. I will try to keep this short and to  the point.. I injured my neck and had pain in neck,arms and shoulders. I searched for a year with endless amount   of   Drs. to find relief from this pain. I layed on a couch or bed during this time literally crying from the pain.I thought to many times ofending my misery.   I had one more appointment with a Dr. He recommended I see a specialist,which I did. His answer was to burn the nerves in my neck,shoulders and arms. When I went back to Dr. he asked what I thought of the specialist. I told him the guy was nuts and I wouldnt do it. He then prescribed a pain medicine and told me to try it. He explained he was starting at a lowdosage and would adjust until it took care of pain. After roughly a month we had the dosage that we felt was right. When I  wake up in the morning it feels like I never injured myself!  I was able to do things again. I could do work around my house,play with my kids, I had 85 % quality of life. I could not believe the difference.I was taking 80mg of Oxycontin three times a day and had 20 mg of Oxycodone for break through pain. And it was needed. I was active my whole life. Im not the one to sit. So when a day came and I pushed to much the breakthrough med was a life saver.  So for 25 years I had a quality of life, I was able to function play with my kids. I never thought I would be able to do this  again.   And then this crisis came about. This is where I will condense. First off CDC.FDA. and other agencies all jumped to  end this crisis One of the first things they did,was take pain medicine away from me and the 100 million Chronic Pain  Patients across the country. You all blamed prescription pain medicine for the over doses across the country. Some Bozo  came up with a formula that renowned scientists called junk science. Im referring to this absurd Morphine Milligram Equivalent scale. There is no research or any scientific study to back this ludicrous law. Beside cutting back on our pain  medication,politicians ran to make this law. So now you can only get 100 mg of a pain medicine,which is absurd. You cant group patients together and use a one dose fits all on them. Everyone metabolizes medicine differently. So what painmedication and dosage that works for you,doesnt mean it will work for me. The other problem is the grouping of all the over doses. First off with said agencies storming and threatening Dr.s for writing pain medicine scripts,Drs. wont write scripts for patients for fear of going to prison or losing their license to practice. So pain prescriptions dropped drastically,but over doses climbed. Something isnt right. ODs should have dropped to according to the agencies. The problem is95% if not more over doses are caused by illegal heroin and Fentanyl. Now if we wanted to be transparent the govt would say it was a heroin OD or Fentanyl OD  But they dont,because it wouldnt fit the agendaSo because of this myself and 100 million C.P.P. are suffering because we are being deprived our medicine.   Im back to where I was 25 yrs ago. Laying in bed or on a couch with no life,in pain and wondering if I should just end the misery. Im not only in physical pain now,but because of the anxiety and stress of worrying if I will get my little bit of medicinenext month or will my Dr. stop writing in fear of being arrested etc etc.  Im asking first off if you could add a grandfather clause to any new laws where patients that were on a set dosage for years and were able to live as close to a normal life as we could be exempt from new restrictions. And if you could please reconsider the MME. Please listen to DRs and researchers who know about this. Please dont listen to these self proclaimed experts ex: Kolodny who has punked everyone and might out do Bernie Madox in fraud.   Thank you for allowing me to express my opinion. I hope we can fix what has been blown up and is hurting the ones  hurting already,the Chronic Pain Patients. We didnt ask to be injured. We are asking for the pain medicine we deserve  so we can live as close to a normal life as our injury will let usRespectfullyDennis Shivers  ", "comment_id": "FDA-2019-N-2514-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0005", "comment_date": "2019-07-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5049}]}, {"id": "FDA-2018-P-2851", "agency": "FDA", "title": "Requests that the FDA refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FD&C Act, including NDA No. 22324 submitted by Pain Therapeutics, Inc., with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use.", "update_date": "2019-04-25", "update_time": "21:54:28", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "refrain from approving any pending or", "Pharmaceutical Manufacturing Research Services,", "Inc", "future application for an opioid product", "submitted pursuant to section 505(b) or 505(j)", "of the FD&C Act,", "including NDA No. 22324 submitted by", "Pain Therapeutics, Inc., with a proposed", "indication or any other labeling that suggests", "that the product is appropriate for chronic use", "OPEN"], "comments": [{"text": "Just so you know. After 7 surgeons 4 neuro, 3 ortho medical science cannot fix me. I like so many people and conditions are left with a small glimpse of what our lives used to be. All that can be done for me now is to control the pain. Now so many of you irresponsible people want to take away the only thing I have left? Limited mobility? I have been taking opiates for my pain for 5 years. Never built a tolerance, never odd, never been to a hospital for complications with the medicine. You have (you should have by now, studies have shown it, why dont you read?) My brain does not associate a reward with  medicine. My pain eats it all up. It would be equal to you taking a Tylenol. To me is all it is  a glorified Tylenol but after months of suffering and trying everything under the sun the opiate was the only one that could take it. The irresponsible actions of the CDC (which may very well be illegal, irresponsible at best) have already killed scores of innocent patients when at your command there Dr turned their back on them and their pain. That blood is already on your hands, how much more do you need to soak in the blood of innocent Americans. They are dying as I write you. The mind and body can only take so much.  I hope you never have to experience it. If you do it may already be too late for you as you will get no reprieve from your pain because of your recent actions. The thing about pain is, it comes for everyone, no one is immune. Dont matter how much money, how important, how great you feel today. You may very well be next. Thats when you will understand that Americas Drs and health system turned their back on you or maybe your mother,father,son,daughter. Its coming, maybe not today, not tomorrow but it will affect someone close to you. When they cry in agony you need to tell them you did that. You had to re-brand the heroin epidemic by telling people that Drs did it. You have to suffer too protect someone that will find a way anyway and any drug to abuse. Dont believe me? What was common at the beginning of the 20th century? Idiots were shooting up peanut butter oil.way.", "comment_id": "FDA-2018-P-2851-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0030", "comment_date": "2018-12-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2181}, {"text": "I would like to comment on the citizens petition : Refrain from approving any pending or future application for an opioid productsubmitted pursuant to section 505(b) or 505(j) of the FDC Act, including NDA No.22324 submitted by Pain Therapeutics, Inc., with the proposed indication ofmanagement of pain severe enough to require daily, around-the-clock, long-termopioid treatment and for which alternative treatment options are inadequate.There are enough pain medications available to the public without it being necessary for the FDA to approve any other opioid for pain control. It has been noted that every day, more than 115 people in the United States die from overdosing on opioids, and last year 72,000 Americans died last year due to overdosing on drugs (National Institute of Health, 2018, p.1).  The total number of overdoses in annually exceeds deaths from HIV, guns, and car accidents.  Moreover, 21 to 29 % of those who are prescribed opioids abuse them, and 12% will develop an opioid disorder, while 6% who use opioid will eventually transition to heroine.  Statistics show that 80% who abuse heroine first abused opioids.  It has been further noted that the Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017, and opioid overdoses in large cities increase by 54 percent in 16 states in 2017 (National Institute of Health, 2018, p.1).  Despite these facts,  the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a danger to public health. The drug Dsuvia, is an opioid that is 10 times stronger than fentanyl, and has been used in the military for soldiers in severe distress, as it can be dissolved for quick pain relief under the tongue (silverman, 2018, p.1).. This is certainly not necessary, especially with the nationwide opoiod epidemic and continued deaths from this terrible disease.  Many children are born to parents who are addicted to opioids and face a long journey ahead of them ranging from withdraws to in and out of foster homes. This needs to be stopped immediately and refraining from approving any future opioids is a start.  References:The Opioid Crisis. (2018). The National Institute of HealthSilverman, E. (2018). Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl", "comment_id": "FDA-2018-P-2851-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0031", "comment_date": "2018-12-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2440}, {"text": "I am writing in strong support of the section of the petition that reads that the FDA should refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FDC Act, with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As stated in the CDC Guideline, Although opioids can reduce pain during short-term use, the clinical evidence review found insufficient evidence to determine whether pain relief is sustained and whether function or quality of life improves with long-term opioid therapy. While benefits for pain relief, function, and quality of life with long-term opioid use for chronic pain are uncertain, risks associated with long-term opioid use are clearer and significant.1The CDC Guideline noted the real lack of longer-term trials of opioids for chronic pain. The recent year-long SPACE Trial at the Minnesota VA Hospital2 meets the criteria that the CDC was looking for in determining longer-term efficacy.  Nonopioid treatment was associated with significantly better pain intensity than opioid treatment. While the result was probably not clinically significant, it certainly did not provide support for efficacy of opioid treatment. It is time for the FDA to reconsider this indication (management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate) for existing drugs.  The standard of safe and effective is simply not met.  References:1.Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.2.Krebs EE, Gravely A, Nugent S, et al. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018;319(9):872882. doi:10.1001/jama.2018.0899", "comment_id": "FDA-2018-P-2851-0035", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0035", "comment_date": "2019-02-07", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2233}, {"text": "I fully agree with and support this petition.  I do not believe it goes far enough as further opioid, manmade or organic, should not be licensed for manufacture, distribution or prescribed, but, until such time as that occurs this petition is areasonable step in a logical direction leading to the removal of opioids and derivatives from circulation.", "comment_id": "FDA-2018-P-2851-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0034", "comment_date": "2019-02-07", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 360}, {"text": "Are all yall just evil idiots? First of all its a proven fact pain is pain, cancer has nothing to do with it. Pain is all relative to the person and disease or injury. Im a professional with a broken back who functions fine on an opioid. Why arent hypocrites like yall trying to stop the soring alcoholism problem by banning scotch. You cant govern morality and governing something you dont personally suffer with is just immoral and ideological wrong. You understand that some patients have been using opioids for 20 plus years without any issue whatsoever. That includes children with horrific diseases such a spina bifida, grandma with arthritis the veterans with bullet holes and missing limbs from Vietnam. All use an opioid for many years to take away enough pain to manage their days, without addiction or incidents. Its time the cdc came clean on lying to the public with there false information along with the FDA! We have an illegal illicit heroin and illicit Fentanyl and illicit drug crisis,  we have never, until the manufactured one had a prescription drug crisis! Marijuana a class 1narcotic is now legal, and patients under the care of a physician are told to think through your pain or use hypnosis or some sudo bs! I say my body my choice! The rest of yall can go F yourself! I hope the very people pushing this no opioid nonsense is in a horrible car accident or their children get cancer, we will see how you think about pain control then you hypocritically stupidity morons! If you read this, Ive usec an opioid for years, I work I function because I have relief , take it away Im done.Any physician would fall for this crap should have their license removed! Your oath said do no harm meaning treat me that includes pain! ", "comment_id": "FDA-2018-P-2851-0029", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0029", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1769}, {"text": "FDA:I have been following FDA approvals and activities concerning opioids since the loss of my son and have researched oxymorphone extensively.  This citizens petition sums up many of the failures that have led to this horrific epidemic.  I am unclear as to why the FDA will not take action.  I do not understand why the FDA will not protect public health and ensure drug safety!  1)Enriched Enrollment was an industry driven decision for profit (not based of efficacy or safety) 2)The original approvals were not proven to be effective with the indications allowed3)ADF  Is nothing but a marketing scam and proven to NOT be a valid label4)Oxymorphone should have NEVER been put back on the market!  Clinical trials were manipulated, and the effects have been devastating. 5)Opioids have been marketed and distributed inappropriately and NOTHING has been done! Many years from now looking back at this what will be said about this Federal Agency in history books?  No one stopped it, no one cared enough to protect the citizens of the United States of America from greed and despair.  Lives have been lost that could have been saved if only those who were put in positions at the FDA had integrity and morals to do the right thing. What will it take?  How many have to die?   ", "comment_id": "FDA-2018-P-2851-0032", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0032", "comment_date": "2018-12-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1531}]}, {"id": "DEA-2021-0004", "agency": "DEA", "title": "Schedules of Controlled Substances: Removal of Samidorphan from Control", "update_date": "2021-12-02", "update_time": "01:00:43", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Please see uploaded file for comments.Daniel Gruener, MD", "comment_id": "DEA-2021-0004-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0004-0004", "comment_date": "2021-01-13", "comment_time": "05:00:00", "commenter_fname": "Daniel", "commenter_lname": "Gruener", "comment_length": 66}]}, {"id": "FDA-2016-N-3710", "agency": "FDA", "title": "Evaluation of the Food and Drug Administration\u2019s Education at the Point of Sale Campaign", "update_date": "2018-06-08", "update_time": "08:39:15", "purpose": "Nonrulemaking", "keywords": ["PRA Staff", "Education at the Point of Sale Campaign", "OO", "OPEN", "2017-879"], "comments": [{"text": "RAI Services Company (RAIS) Comments: Docket No. FDA-2016-N-3710, 81 Fed. Reg. 80,075 (Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administrations Education at the Point of Sale Campaign)", "comment_id": "FDA-2016-N-3710-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-N-3710-0003", "comment_date": "2017-01-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 284}, {"text": "By Brian PalmerI keep hearing about how beneficial hemp is for the environment, and what a shame it is that U.S. farmers arent allowed to grow it. Is hemp really that eco-friendly?With the possible exception of soy, no plant has managed to spawn so many different products, and as much controversy, as hemp. You can buy hemp clothing, hemp paper, hemp milk, hemp oil ... the list goes on. A Canadian company has even built an electric car out of hemp. Advocates talk about the leafy plant like its going to reverse global climate change. Opponents think its merely a Trojan horse packed with potheads hoping to get your children stoned.The plant is a Schedule 1 controlled substance in the United States, which means you need special permission to grow it regardless of THC content. Canada and several European countries now allow their farmers to grow hemp with THC content below 0.3 percentone-tenth as strong as the weakest marijuana. (These countries require hemp farmers to pre-register their plots for cultivation and use certified low-THC seed. The government also checks their crop periodically for THC content.) The United States has held off, largely because a government helicopter that flies over a farmers field cant tell the difference between hemp and marijuana. For this reason, raw ingredients for all U.S.-manufactured hemp products must be imported.Hemp is so versatile in part because it can be grown for either seed or fiber. The seeds yield milk, oil, and other food products, and are particularly popular among vegans, who have trouble working omega-3s (PDF) into their diets. The fiber is used for paper and clothing. Sailors have been using hemp rope and sails for centuries, and the crops abundance was crucial during the Revolutionary War.So is hemp the answer to all our environmental problems, or just boring pot? It depends on what you want to use it for, and what you compare it to. For now, lets focus on textiles, the most traditional and common use.A 2005 report by the Stockholm Environment Institute compared the water, land, and energy requirements of cotton, polyester, and hemp textiles. While the study is the most comprehensive investigation of this issue, the results were unsatisfyingly mixed.Producing the raw ingredients for any textile consumes more energy than any other stage in the process. Different production techniques, however, can significantly increase or reduce the impact. Since pesticides and herbicides account for more than one-half of the energy in farming either hemp or cotton, organic methods are responsible for less carbon-dioxide emissions. Overall, organic cotton required less energy than organic hemp, but the margin was fairly small. Polyester, a petroleum-based synthetic fabric, was the clear loser by a 3-1 margin, because it takes so much energy to extract the oil required to make it.While cotton requires less energy to grow and process than its competitors, it uses a lot of land. The fabric of our lives needs approximately twice as much territory as hemp per ton of finished textile, the land-use miser of the bunch. Further complicating matters is the inverse relationship between chemical use and land requirements. While organic farmers can save on energy by cutting synthetic pesticides and herbicides, their yield per acre drops. Polyester, a synthetic fabric made from petroleum, does almost as well as hemp on land use. Apparently, you can get more fabric from an oil field than a cotton field.Cotton is the big loser, once again, when it comes to water. The cotton plant needs about 50 percent more water per season than hemp, which can grow with little irrigation. (Its so prolific that the overwhelming majority (PDF) of cannabis plants uprooted by the Drug Enforcement Administration every year are a wild relative of hemp. Its no coincidence they call the stuff weed.) Cotton also tends to be grown in parts of the world where water is scarce. More than one-half of the worlds cotton fields rely on irrigation, because it grows in some relatively dry regions, like Egypt, Chinas Xinjiang province, California, and Texas.When you add processing into the equation, cotton uses more than four times as much water as hemp. Polyester is difficult to compare, because its not an agricultural product. But some studies suggest its the least water-intensive of the bunch, using just one-thousandth as much water as cotton. (In fact, water is a byproduct of polyester processing.)So where does all this leave us? Without a clear winner, unfortunately. Theres an argument to make for polyester, but the nonrenewability of synthetic textiles raises serious concerns. Overall, hemp appears to be slightly easier on the environment than cotton, considering its superior on water and land requirements, and only slightly worse for energy use. But is the DEA responsible for all of our environmental woes? Hardly.", "comment_id": "FDA-2016-N-3710-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-N-3710-0008", "comment_date": "2017-11-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5088}, {"text": "I support this. - Catherine Corn", "comment_id": "FDA-2016-N-3710-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-N-3710-0002", "comment_date": "2016-12-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 32}]}, {"id": "DOD-2015-HA-0109", "agency": "DOD", "title": "TRICARE; Mental Health and Substance Use Disorder Treatment", "update_date": "2020-10-22", "update_time": "01:30:50", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The accreditation body, CARF is a great partner to the DoD goal of increasing its veterans Behavioral Health benefits, and the Proposed Rule, entitled TRICARE: Mental Health and Substance Abuse Disorder Treatment.CARF has excellent standards that guides its accredited groups to deliver the highest level of services to all.I am encouraging the DoD to approve CARF as an accreditor under TRICARE regulations because many groups like MedMark ay be eligible to become part of its network.  We see that we may be of service to the area veterans.  We currently serve a handful of veterans that are able to afford paying for this service.  Many other veterans will benefits from our service if DoD will approve CARF as an accreditor.thank you for your efforts!", "comment_id": "DOD-2015-HA-0109-0016", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0016", "comment_date": "2016-02-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 785}, {"text": "People experiencing substance use disorders are often stigmatized and are less likely to seek assistance without an external motivating factor.  This is especially true for our military members and their families, as they are limited to seek services from their virtual employers through the VA system.  The proposed changes will benefit our veterans by allowing them greater freedom to seek services at an earlier stage in the addiction process.  By offering a variety of treatment programs and modalities, the VA will shift from force fitting an individual into the program available and start matching individuals to programs based on individual needs, strengths, abilities, and interests.The proposed changes will also have a positive impact on community based providers and enhance local economies by streamlining the requirements for community based institutions to become participating providers.  ", "comment_id": "DOD-2015-HA-0109-0025", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0025", "comment_date": "2016-02-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 915}, {"text": "CARF is the best possible accreditation agency to credential providers to work with TRICARE.  We are CARF accredited and am very happy with the quality of the review they provide.  I have total confidence in CARF.", "comment_id": "DOD-2015-HA-0109-0032", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0032", "comment_date": "2016-02-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 213}, {"text": "We at Midwestern Connecticut Council of Alcoholism are responding in support of this Proposed Rule, and the expansion of services for TRICARE beneficiaries. The reduction of barriers to funding of services will expand options and access for veterans and their families needing treatment for mental health and substance use disorder. If aligned with MHPAEA and ACA parity regulations, this a great step forward for this population.  Midwestern Connecticut Council of Alcoholism have received numerous calls from men and women either active in the service or retired that have Tricare as their insurance and are very willing to provide mental health, alcohol and substance abuse treatment to them as well as their family members.  We at Midwestern Connecticut would appreciate the opportunity to join the Tricare network of providers and serve the needs of the Tricare members and their families in our community and surrounding areas.As a CARF accredited facility we additionally support the expansion of accreditation options to meet the accreditation mandate of the Proposed Rule for network providers, and particularly support the approval of CARF International.", "comment_id": "DOD-2015-HA-0109-0048", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0048", "comment_date": "2016-02-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1189}, {"text": "Dear Mr. Levine, We at Family Service of Rhode Island, accredited by the Council on Accreditation (COA), support the Defense Departments proposed rule, Tricare: Mental Health and Substance Use Disorder Treatment. The expansion of mental health and substance use disorder (SUD) services to more service members and their families is extremely important in helping our organization meet their needs. Furthermore, we support the acknowledgement of the need for recognition of additional accreditation bodies. While Tricares comprehensive certification standards were once considered necessary to ensure quality and safety, these comprehensive certification requirements are now proving to be overly restrictive and, at times, inconsistent with current industry-based institutional provider standards. There are currently several geographic areas that are inadequately served because providers in those regions do not meet Tricare certification requirements, even though they may meet the industry standard. The proposed rule seeks to streamline Tricare regulations to be consistent with industry standards for authorization of qualified institutional providers of mental health and SUD treatment. We fully support this change as it will result in an increase in the number of providers and in the geographic areas covered by services. Reducing administrative barriers and aligning the services and supports with those of other medical/healthcare benefits is the right thing to do for military members and their families. Sincerely,Margaret Holland McDuff, CEO", "comment_id": "DOD-2015-HA-0109-0131", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0131", "comment_date": "2016-03-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1621}, {"text": "As a person living with a mental health condition as well as having family members who have served in the military, I want to send my support for these efforts by the DOD to update Tricare to ensure there is parity between physical and mental health / substance use disorders. Removing the barriers and stigma that get in the way of individuals having access to care is a critical step to take.It is important that ALL Americans, but particularly those who have served our country, have access to the care they need in order to live well.  ", "comment_id": "DOD-2015-HA-0109-0179", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0179", "comment_date": "2016-04-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 560}, {"text": "The proposed rule does not allow for intensive outpatient treatment or partial hospitalization programs for TRICARE beneficiaries who are younger than 13 years of age. My son was five when he first started to see and hear things. By ten he was suicidal. At 14 he made a real attempt, and at 15 he is in his third partial hospitalization. The majority of kids he is in treatment with are half his age. Its these under 13 kids who without treatment will end up in Judi or worse yet in a pine box. Theres no age people catch mental illness and there is no cure. It manifests when it wants and therapy is often a parents only hope. Its already hrs enough to get treatment lets not limiti it by some arbitrary age. ", "comment_id": "DOD-2015-HA-0109-0139", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0139", "comment_date": "2016-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 754}, {"text": "We at Turning Point Counseling Services in Fairbanks, Alaska are responding in support of this Proposed Rule, and the expansion of services for TRICARE beneficiaries. The reduction of barriers to funding of services will expand options and access for veterans and their families needing treatment for mental health and substance use disorder. If aligned with MHPAEA and ACA parity regulations, this a great step forward for this population. We additionally support the expansion of accreditation options to meet the accreditation mandate of the Proposed Rule for network providers, and particularly support the approval of CARF International.We are a We are CARF accredited  outpatient treatment program which includes, Psychiatry, Intensive Outpatient Substance Use Disorder treatment, Mental health therapy, Trauma informed yoga and mindfulness training among other services designed specifically for treating patients experiencing PTSD and Addiction as well as all other DSM V diagnoses in a holistic and integrated way. We have for years hoped to treat veterans and Tricare beneficiaries and have been stonewalled by Tricare. It has never made sense to me why this restriction  was in place, but have been unable to make any headway. In our community there is no provider that can provide SUD treatment to Tricare beneficiaries which means that regardless of ASAM placement criteria, they must be sent to inpatient treatment. We have two bases here locally! This is tantamount to sending a laceration patient to the ICU. It is poor patient care. I whole heartedly support this measure and welcome and follow up questions. Respectfully, Gunnar Ebbesson", "comment_id": "DOD-2015-HA-0109-0035", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0035", "comment_date": "2016-02-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1660}, {"text": "We at Catholic Charities, Inc. accredited by the Council on Accreditation (COA), support the Defense departments proposed rule, Tricare: Mental Health and Substance Abuse. The expansion of mental health and substance use disorder services to more servicemembers and their families is extremely important to our organization. Furthermore, we support the acknowledgement of the need for recognition of additional accreditation bodies. We would like to advocate for the COA to be included as an approved accrediting body. COA is recognized in over 220 instances by international, federal, state, and provincial governments in the U.S., Canada, and abroad. MS has only one approved provider for Tricare members.  That is a psychiatric hospital, Brentwood, in Jackson, MS.  This severely limits, particularly the outpatient services, that the servicemembers and their families can receive. Thank you for your consideration.", "comment_id": "DOD-2015-HA-0109-0084", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0084", "comment_date": "2016-03-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 933}, {"text": "As a participant in the Depression and Bipolar Support Alliance, and on behalf of those with the lived experience of depression or bipolar disorder, I support the efforts of DOD to update the Tricare Program to:ensure parity between mental and substance abuse disorders and other medical conditions,reduce administrative barriers to access mental health benefit coverage, andimprove access to substance abuse disorder treatment for TRICARE beneficiaries.It is important that all Americans covered under a health insurance program benefit from coverage parity.Please help continue the fight against the stigma on mental health illness by providing the medical services needed. ", "comment_id": "DOD-2015-HA-0109-0110", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0109-0110", "comment_date": "2016-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 711}]}, {"id": "USCG-2004-17455", "agency": "USCG", "title": "Validation of Merchant Mariners' Vital Information and Issuance of Coast Guard Merchant Mariner's License and Certificates of Registry", "update_date": "2020-11-06", "update_time": "01:03:13", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "As President of the Great Lakes Passenger Boat Association I represent our twenty, Tour and Ferry operators.  Our membership is extremely concerned about the impact and burden imposed by the recent rule requiring mariners to report to a REC for identification verification and fingerprinting.  GLPBA members employ over 130 USCG licensed personnel.  Many of these employees live over a day\u0092s drive time from Toledo, OH or St. Louis, MO the closest RECs (licensed personnel from two members would have a 1600 mile round trip to Toldeo).  The cost of mileage, lodging, meals and time away from work is an unacceptable burden on businesses and their employees.In these rules there seems to be little if any consideration for efficiency. Does it make sense to have hundreds of people per year traveling hundreds of miles for a procedure that takes 20 minutes to perform.  Is it possible for mariners to be ID\u0092d and electronically finger printed at a local MSU?  or could a \u0093memorandum of agreement\u0094  be arranged with a partner agency within the Dept. of Homeland Security, allowing them to check ID\u0092s and electronically scan fingerprints for the REC?  One size does not fit all and some creative problem solving could resolve this issue as a win-win for the USCG REC and the mariner.Our members businesses and their licensed personnel would appreciate your serious consideration of this issue.Sincerely,Mike RadtkePresident, Great Lakes Passenger Boat AssociationMarine Operations Manager, USCG 100 ton MasterMadeline Island Ferry LineLaPointe, WI 54850", "comment_id": "USCG-2004-17455-0114", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0114", "comment_date": "2006-03-09", "comment_time": "05:00:00", "commenter_fname": "Michael", "commenter_lname": "Radtke", "comment_length": 1629}, {"text": "Please hold up on rule making untill you get more input from the river people", "comment_id": "USCG-2004-17455-0118", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0118", "comment_date": "2006-03-10", "comment_time": "05:00:00", "commenter_fname": "Don", "commenter_lname": "Weymiller", "comment_length": 82}, {"text": "March 8, 2006To whom it may concern,I would like to express my concerns regarding the extra time and expense for mariners, such as myself to travel at least twice to my local R.E.C. for any future license renewals. The new rule proposed would require one trip for finger printing and a second to obtain documents in person. This rule will place a daunting burden on mariners that do not live close to their respective R.E.C.s  Not all mariners are home for months at a time.  Crew rotations vary from (day on / day off) to (two months on / one month off) in most limited tonnage fleets. Traveling 450 miles or more, one-way is next to impossible for some licensees without taking unscheduled absences from their rotations. Travel, lodging, food, pay loss and document expenses will burden some of these salaries. It seems incomprehensible to me that a mariner can renew their United States Passport via the United States Postal Service but, the United States Coast Guard can not accept this procedure because of reasons that are unclear or overbearing.  Our pictures and fingerprints are recorded in our files from the procurement of our first document. A quick look into our jacket could reveal whether the face in the picture, matched with the fingerprints are the applicants. The State Department can do this after ten years. Five years should not require more training. This would take minimal effort compared to two personal appearances by every mariner from G.V.A.s to Masters.  Our R.E.C.s have not shown that they can handle the extra traffic! It takes two months to get your documents back for one appearance now. Will it take four or more for two?In closing, our time home is being consumed more and more by regulatory procedures, training and employee shortfalls. Our younger generation coming into the workforce will not put up with all this bureaucracy and workload. Time home and pay are the only real attributes that keep this workforce in place now.  This new rule will only drive the United States Merchant Mariner another step closer to extinction.  The United States Coast Guard should be encouraging the renewal of documents and experienced labor not driving them away.Thank you for the chance to express my concerns.Regards,Captain Kenneth C. Graybill III", "comment_id": "USCG-2004-17455-0119", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0119", "comment_date": "2006-03-10", "comment_time": "05:00:00", "commenter_fname": "Kenneth", "commenter_lname": "Graybill iii.", "comment_length": 2356}, {"text": "Requiring mariners to travel to a REC for fingerprinting and ID check when renewing documents and licenses is an excessive burden to the mariner.With recent changes to regulations and requirements to keep licenses current, it has become a significant burden just to keep a license at all.I currently hold a Master Oceans to 1600/3000 and have been licensed for over 25 years. Due to the extreme expense and burden of recent changes, i.e. STCW, MMDs, I am only able to use my license to the 100 ton level.   Now you are adding considerably more expense to retaining the license. At the current rate of increase in the burden of retaining and maintaining my license, I will have to seek an alternative career.  As a merchant seaman for all my adult life, and too old to start over, I find this additional burden quite unacceptable.", "comment_id": "USCG-2004-17455-0111", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0111", "comment_date": "2006-03-09", "comment_time": "05:00:00", "commenter_fname": "Charles", "commenter_lname": "Cross", "comment_length": 854}, {"text": "I am writing regarding the recent interim rule published on January 13, 2006 regarding new identification procedures required for mariners.I am a recently qualified Coast Guard Masters applicant.  As part of the application process, I submit two fingerprint identification cards along with my application.  Unfortunately, I had no idea the rules were going to be changed and I mailed my application on January 13 and it was not received by the Toledo REC until two days later.The finger prints with my application were taken at the Police Department in the city of Edina, MN.  I am a resident of Edina and they would only do fingerprints for residents.  They require proof of identification via a picture ID.  Under the new interim rule, I am required to go to Toledo and present to them a valid picture identification and either a birth certificate or valid passport.Requiring people to go to a regional examination center seems burdensome and a significant additional expense.  I don\u0092t think I can fly to Toledo from Minneapolis and back in one day.I understand the need for additional security requirements in the post 9/11 era but there are a lot of ways to achieve the same purpose without the additional burden.  A few of those alternatives are as follows:1.There are numerous federal law enforcement offices throughout the country, such as the FBI, US Marshall\u0092s Office, Immigration authorities, etc.2.There are numerous Coast Guard offices that can be used instead of the REC\u0092s.3.The fingerprinting entity could require the same identification as the Coast Guard, i.e. a valid picture driver\u0092s license and a valid passport or birth certificate.Understanding the need for additional security, I would ask that you balance that need with the cost and burden of severely limiting where a person can be fingerprinted.I should also point out that most, if not all, of the people in my testing group were lucky enough to get their applications in before the unknown date of January 13, 2006 and do not have the extra burden and cost of going to Toledo.Thank you for your consideration.", "comment_id": "USCG-2004-17455-0145", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0145", "comment_date": "2006-03-15", "comment_time": "05:00:00", "commenter_fname": "Mark", "commenter_lname": "Condon", "comment_length": 2302}, {"text": "To whom it may concern,I am the Captain-in-Charge of the ferry boat the MV Sugar Islander II.  She is a 24 car passenger vessel that shuttles between Sault Ste. Marie, MI and Sugar Island, MI.  We have 10 men that hold their 100 Gross Ton PCV Masters ticket.The matter of fingerprinting for every transaction regarding our licenses has been brought to my attention.In these uncertain days I can certainly understand the need for due diligence regarding licensing procedures for anyone who has control of a vessel the size of the Sugar Islander II and the hundreds of souls it carries on a daily basis, 365 days a year.On the other hand, this fingerprinting/ID mandate, I feel, could be handled in several simpler ways that would be much less costly to the licensee and at the same time be just as effective.For us, here in Sault Ste. Marie, to travel all the way to Toledo for simple fingerprinting every time we wish to upgrade or even simply renew our licenses, would be costly and frankly just a plain old nuisance.  It would involve two days of driving, loss of wages, motel expenses, etc.In my instance, I earned my license in 1981.  I understand the need for the Dept. of Homeland Security to keep a tight rein on people in our profession.  However, after twenty seven (plus) years, I will not, suddenly, become a terrorist or any threat to Homeland Security.  To make that kind of journey in question is simply a case of overkill.I have no problem having my fingerprints in your database, I just believe there are far simpler and less costly (to the mariner) ways to accomplish this.  Whether it be by being printed by local law enforcement, the closest Michigan State Police post, or even the nearest U.S. Coast Guard base---all would be acceptable.  But a 400+ mile trip to Toledo is, as I said, overkill.Surely there is a FAR better solution to getting Mariners fingerprints on file than this complicated, costly solution that has been proposed.Thank you for your time and the opportunity to respond.Sincerely,Douglas M. BisdorfCaptain-in-Charge", "comment_id": "USCG-2004-17455-0159", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0159", "comment_date": "2006-03-20", "comment_time": "05:00:00", "commenter_fname": "Douglas", "commenter_lname": "Bisdorf", "comment_length": 2147}, {"text": "I am submitting comments in regard to docket ID USCG-2004-17455, Validation of Merchant Mariners\u0092 Vital Information.  I have problems with your proposed rule change requiring a licensed mariner to appear in person at a USCG REC for license renewal or upgrades.  I understand that heightened security measures are needed, especially post 9/11, but this new requirement of appearing in person at one of the limited REC locations after original license issuance is unnecessary and unreasonable.  The region I am employed as a mariner is the Great Lakes and travel to and from REC Toledo can easily take more than one day.  This new requirement is not just inconvenient, but can also be a costly burden placed on us mariners\u0092.  Since the CG License is not used as a picture identification it is unclear what this new requirement is actually solving in the field.  If you are trying to head in this direction for security purposes then look into a major regulatory change and marry up the documentation and licensing processes and streamline the whole bureaucracy.  Actual compliance in the field under the current system is still working with a piece of paper as a license with just a name on it, no picture or other biometrics.  In the field compliance is not there yet to tie this license to whoever is holding it in the field with whatever fake ID they may have if they are actually a terrorist trying to sail under a fraudulent license.  At this time forcing us mariners to show up in person at the REC for renewal or upgrade doesn\u0092t really solve the field compliance issue.  In closing, if this requirement goes forward and you feel the need to have an independent verification of the mariner\u0092s identification and fingerprint, after the original issuance, than leverage other local agencies or provide more locations for mariners\u0092 to get the process completed.  Your plan to use just the 17 USCG REC\u0092s is unsatisfactory.  Also, don\u0092t tie this identification and fingerprinting visit it into the rigid renewal and upgrade administrative process within the specific REC.  Work in flexibility for this piece of the process and allow walk up service at any REC at the mariner\u0092s convenience.  Also let them walk up at any time during the renewal period.  You already have the original information in the computer system.  The goal is to re-verify the mariner\u0092s identification and fingerprints for the action on the license.  Let the rest of the REC administrative process to evaluate expertise, character, and fitness for duty stay in the established rigid cycle.  I urge you to not place additional bureaucratic and costly blocks to a mariner\u0092s livelihood.", "comment_id": "USCG-2004-17455-0165", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0165", "comment_date": "2006-03-21", "comment_time": "05:00:00", "commenter_fname": "Timothy", "commenter_lname": "Cherry", "comment_length": 2658}, {"text": "I am writing to voice my concern about the electronic fingerprinting requirement.  If this requirement passes, it will cause considerable undo harm in the renewal process of my 100-ton great lakes master license this fall.  The two closest REC are 2-1/2 days of wages plus expenses.  There is an electronic device 200 miles away in Minneapolis at the US Marshall Service.  That federal agency is located in a one-days time for me and my 12 fellow daptains.  I hope something reasonable can be worked out.  Thank you.  Joni Brooks ", "comment_id": "USCG-2004-17455-0171", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0171", "comment_date": "2006-03-27", "comment_time": "05:00:00", "commenter_fname": "Joni", "commenter_lname": "Brooks", "comment_length": 540}, {"text": "Our four captains are characteristically present at each annual vessel inspection. For each of them in turn to travel to either St. Louis or Toledo amounts to two days of travel time, a hundred dollars for fuel, overnight accommodations. We knowo our USCG marine inspectors and vice versa. Wouldnt this waste of energy and resources be better served using personnel in place? The local MIO. Its far more cost-efficient to send electronic equipment to user sites than to send people.  ", "comment_id": "USCG-2004-17455-0172", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0172", "comment_date": "2006-03-27", "comment_time": "05:00:00", "commenter_fname": "David", "commenter_lname": "Strzok", "comment_length": 499}, {"text": "I do not believe there is a need for somebody to have to appear in person at a REC to check their ID and fingerprints.  I think the Coast Guard should document how many cases they know of where they received incorrect fingerprints, or issued a license to someone other than the person who should have received it.  I think the requirements they used in the past should be sufficient without putting an undue travel burden on applicants who live a long way from a regional exam center.", "comment_id": "USCG-2004-17455-0023", "comment_url": "https://api.regulations.gov/v4/comments/USCG-2004-17455-0023", "comment_date": "2006-02-01", "comment_time": "05:00:00", "commenter_fname": "Roy", "commenter_lname": "Beasley", "comment_length": 489}]}, {"id": "PHMSA-2007-28136", "agency": "PHMSA", "title": "Safety Regulations of Hazardous Liquid Pipelines Transporting Ethanol and Other Bio Fuels", "update_date": "2021-02-10", "update_time": "01:39:39", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "NAPSR Comment on PHMSA Policy Notice", "comment_id": "PHMSA-2007-28136-0011", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-2007-28136-0011", "comment_date": "2007-10-22", "comment_time": "04:00:00", "commenter_fname": "Ron", "commenter_lname": "Law", "comment_length": 41}]}, {"id": "DEA-2020-0005", "agency": "DEA", "title": "Registration Requirements for Narcotic Treatment Programs with Mobile Components", "update_date": "2021-12-13", "update_time": "15:33:40", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "As a current staff member of Mental Health America helping those with mental illness, substance abuse and addiction, I firmly support this proposed rule. To create an environment easier for those battling addiction and exerting efforts to get help, its essential to eliminate the tedious repetitive steps that could be avoided. To best support those overcoming addiction, national, state and local ratings, and accredited narcotic treatment programs (NTPs), it is important to factor waiving separate registration. By creating multiple steps of repetitive registration, some addicts and those in need may be deterred from completing the NTP. Its important to consider the advantages of modern technology to create alternate strategies. I firmly agree that this proposed rule and regulation change would support detoxification treatments and have far greater benefits than deficits on the American people. While creating more widely available services with less tedious steps of registration, in return, it will reduce the likelihood of relapse. As stated in Part II Scope of the Proposed Rule, as long as requirements of this rule honor HIPAA and protect patients through security, record-keeping and reporting, this would be a step in the right direction to combat the opioid crisis in the U.S. ", "comment_id": "DEA-2020-0005-0024", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0024", "comment_date": "2020-04-15", "comment_time": "04:00:00", "commenter_fname": "Stephanie", "commenter_lname": "Garrison", "comment_length": 1318}, {"text": "I would like to support the Drug Enforcement Administration (DEA) proposed revision to the existing regulations for narcotic treatment programs (NTPs) to allow a mobile component associated with the registered program to be considered a coincident activity. This revision could eliminate a potential barrier to programs that are reaching to areas that are underserved. It coincides with the Center for Disease Controls overarching goal of achieving health equity, eliminate disparities, and improve the health of all groups while decreasing premature death. People in rural areas have a complex mix for lack of access to care. In addition to being rurally located often times 200 miles from a provider, they tend to live below the poverty level. These compounded barriers reduce the chance of patients obtaining treatment that is greatly needed. Opening opportunities to reach the communities at need can potentially decreasing the triple fold opioid overdose death rate that has occurred over the years. This proposal is consistent with public health and safety in providing a much-needed service to an otherwise unreachable area that can satellite to multiple areas but stay within the confined of the state. Mobile units can be a safe, budget friendly approach to brick and mortar building that involve costly expenses and overhead. Research has proven that patients receiving medication assisted therapy are more likely to remain in treatment and less likely to partake in illicit opioid use. Something more has to be done. We are losing this battle at the cost of over 70,000 American lives. ", "comment_id": "DEA-2020-0005-0027", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0027", "comment_date": "2020-04-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1647}, {"text": "As a social worker and a professor Iwrite in support of this change. I am deeply concerned about peoples access to treatment during this pandemic and feel that this change could help saveLives. ", "comment_id": "DEA-2020-0005-0053", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0053", "comment_date": "2020-04-27", "comment_time": "04:00:00", "commenter_fname": "Casey", "commenter_lname": "Bohrman", "comment_length": 204}, {"text": "I support this proposal to revise DEA regulations for narcotic treatment programs to allow a mobile component associated with the registered program to be considered a coincident activity. Increasing access to life saving opioid use disorder treatment is paramount in mitigating the consequences of our Countrys opioid epidemic. Going forward, we should continue to increase access to medications for opioid use disorder, rather than re-implement archaic polices that restrict access to care and cause additional harms and restrictions to and on people who use opioids. We must continue to use science to guide our decisions, while reflecting on how our bias and subjective experiences impact how we react to these deviant and negative health behaviors.   ", "comment_id": "DEA-2020-0005-0078", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0078", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Thomas", "commenter_lname": "Cole", "comment_length": 761}, {"text": "I am primary care physician, addiction medicine specialist and instructor at Yale School of Medicine. My research aims to improve the health of people with opioid use disorder. Myself and colleagues have previous demonstrated there exists a substantial urban-rural disparity in geographic access to methadone for opioid used disorder (https://doi:10.1001/jama.2019.12562 and  https://doi.org/10.1016/j.drugalcdep.2020.107968) which creates a large mismatch in demand for methadone treatment services and supply of such services within the Unites States. I support the proposed change by the DEA to again allow mobile NTP within the United States to begin to address this disparity in geographic access to methadone. Resistance to expanding access to methadone for opioid use disorder is often grounded in concerns about diversion and overdose due to greater methadone use. However, these concerns continue to overstate (or fail to define) the actual risk of harm due to these concerns. The likely harm from diversion of methadone   is small compared to the risk of overdose and death from continued use of heroin or fentanyl. Therefore, even if small levels diversion and methadone overdose are associated with actions which expand methadone access, these harms are likely to be easily overshadowed by the overdose deaths prevented by allowing people with opioid use disorder to switch from using heroin or fentanyl to methadone treatment. It should be noted that while suboxone is an alternative medication for this population it also faces shortages in access and does not meet all patients needs make methadone access essential. This change in policy is long overdue and it is worth stating that these changes alone will not address the disparities in methadone access our team has previously described, but it is a small step in the write direction. Additional regulatory and systems changes will be need to ensure universal access to methadone. Sincerely,Paul J Joudrey, MD, MPHProgram in Addiction MedicineYale School of Medicinepaul.joudrey@yale.edu", "comment_id": "DEA-2020-0005-0080", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0080", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Paul", "commenter_lname": "Joudrey", "comment_length": 2106}, {"text": "April 14, 2020Uttam DhillonActing AdministratorDrug Enforcement AgencyUnited States Department of Justice8701 Morrissette DriveSpringfield, VA 22152Dear Acting Administrator Dhillon:I am writing on behalf of the City of Philadelphias Department of Behavioral Health and Intellectual disAbility Services (DBHIDS) to communicate support for the Drug Enforcement Agencys (DEA) proposed rule regarding registration requirements for narcotic treatment programs (NTPs) with mobile components, as published in the Federal Register on February 26, 2020. DEA proposes to revise the existing regulations for NTPs to allow a mobile component associated with the registered program to be considered a coincident activity that does not need a separate registration.DBHIDS supports a range of services for children, adults, and families, including mental health services, substance use treatment services, early intervention services, and intellectual disAbility services. Our mission is to strengthen and serve individuals and communities so that all Philadelphians can thrive.DBHIDS unreservedly supports the proposed rule as a measure to make effective and appropriate substance use treatment services available to those people who most need them. The families and communities of Philadelphia have struggled greatly with the current opioid crisis, and despite the diligent and creative work of dedicated public servants across various City agencies the toll in morbidity, mortality and human suffering of opioid use disorders is still mounting. While our City continues to work on addressing this crisis in innovative and flexible ways, more is clearly needed.In the course of our work serving people who have opioid use disorders, we have become convinced of the value of medication assisted treatment (MAT) in promoting recovery and limiting the harms caused by the disease of addiction. MAT, which entails the administration of opiate agonists such as methadone or buprenorphine, has been shown to improve outcomes when delivered as part of a comprehensive behavioral health treatment program, or when delivered alone. Accordingly, we support measures such as this proposed rule which will tend to increase the availability of MAT to people who could benefit from it.Many of the individuals we serve experience disadvantages in multiple intersecting respects. They are far more likely to be impacted by the social determinants of health. They may suffer the impact of systemic racism. They may live in impoverished communities, or lack reliable access to transportation resources. They may experience insecurity in their access to food or housing. A recent study of the New Jersey Medication Assisted Treatment Initiative (NJ-MATI) indicated that people facing these challenges were most effectively served by mobile medication units (MMUs), which were more accessible and therefore better able to meet the needs of these individuals, as well as individuals who presented with more severe symptoms of opioid use disorders.For these reasons, DBHIDS believes that the proposed NTP mobile component rule will be an aid to us in our mission to promote the thriving of all Philadelphians. We applaud the efforts of the DEA in this regard and look forward hopefully to the promulgation and implementation of this rule.Sincerely,David T. JonesCommissionerDepartment of Behavioral Health and Intellectual disAbility Services", "comment_id": "DEA-2020-0005-0076", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0076", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Benjamin", "commenter_lname": "Locklair", "comment_length": 3558}, {"text": "I support the  proposal to allow mobile Narcotic Treatment Programs to operate without separate registration. The proposal would make maintenance and detoxification treatment more available while requiring safeguards to minimize the risk of methadone and other controlled substance diversion.", "comment_id": "DEA-2020-0005-0077", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0077", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 292}, {"text": "I support the DEAs proposal to revise regulations for narcotic treatment programs to allow a mobile component alongside the brick and mortar building. As someone who works at the intersection of those experiencing homelessness, leaving incarceration and OUD, this is something we have long been championing and asking for. Being able to prescribe with fewer barriers and reach the client where they are, is the definition of evidence based treatment- which MAT is considered the gold star.  This is something that is brought up regularly within provider meetings and I am very happy to see this being researched. ", "comment_id": "DEA-2020-0005-0081", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0081", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Amanda", "commenter_lname": "Cowan", "comment_length": 628}, {"text": "As a healthcare provider, I know that methadone is an important and effective intervention for opioid use disorder and helps prevent deaths from overdose. You must allow mobile delivery of this life-saving medication  ", "comment_id": "DEA-2020-0005-0085", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0085", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Victor", "commenter_lname": "Rodionoff", "comment_length": 218}, {"text": "As a physician who is certified in both Internal Medicine and Addiction medicine who works with homeless communities, I completely support this effort. I think the way that NTPs are structured now, more vulnerable segments of the population are often missed.Having a mobile component would facilitate treatment expansion for more marginalized communities.THis would benefit rural settings as well", "comment_id": "DEA-2020-0005-0082", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0005-0082", "comment_date": "2020-04-28", "comment_time": "04:00:00", "commenter_fname": "Cheryl", "commenter_lname": "Ho", "comment_length": 406}]}, {"id": "PHMSA-RSPA-2004-18730", "agency": "PHMSA", "title": "Hazardous Materials:  Enhancing Rail Transportation Security for Toxic Inhalation", "update_date": "2021-02-10", "update_time": "01:39:44", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I HAVE WORKED AS A CONDUCTOR WITH BNSF SINCE 1998 AND HAVE SEEN VERY LITTLE SECURITY AT ALL IN RAILYARDS AND MAIN LINES WHICH ALL TRAINS MUST TRAVEL ON. I THINK BNSF SHOULD DO MORE TRAINING ON THESE ISSUES AND IMPROVE OVERALL ON ITS SECURITY TO HELP MAKE OUR COMMUNITIES SAFER AND A SAFER WORKPLACE FOR THOUSANDS OF RAILROADERS. BNSF HAS MADE RECORD BILLION DOLLARS PROFIT IN THE LAST 3 YEARS AND KEEP TAKING MORE FROM THE UNION WORKERS POCKET. HEALTHCARE COST KEEP GOING UP AND NO RAISES AND JOB CUTS. THE RAILROAD FUTURE PLAN IS TO REDUCE OUR CREW SIZE FROM 2 PERSON TO HAVING ONLY ONE PERSON ON A TRAIN THAT IS CARRYING SEVERAL HAZARDOUS MATERIALS AND ALL DUE TO THEIR STATE OF ART ETMS COMPUTER TRAIN SAFETY SOFTWRE THAT WILL KEEP THE TRAINS FROM COLLIDING BUT NOTHING TO DO WITH HOW UNSAFE IT IS TO HAVE ONLY ONE PERSON TRAVELING MILES AWAY FROM ANY MEDICAL ATTENTION IF NEEDED IF AN EMERGENCY WERE TO ARISE. THIS WOULD ALSO ONLY LEAVE ONE SET OF EYES ON THE ENGINE FOR THE OVERALL SAFETY OF THE WHOLE ENITRE TRAIN THAT MAY BE UP TO 8,000 FT LONG AND TWO SETS OF EYES ARE ALWAYS BETTER THAN ONE AND MUCH SAFER WHEN TRAVELING WHICH RAILROADER DO DAILY ON 12 HOUR TRIPS THAT LEAD TO 12+ HOURS ON DUTY THEN ONLY 10 HOURS OFF DUTY BETWEEN TRIPS WITH NO GIVEN SCHEDULED DAYS OFF MOST RAILROADERS HAVE THE SAME SCHEDULE ON CALL EVERYDAY 24 HOURS A DAY 365 DAYS A YEAR AND WORK EVERYDAY UNLESS YOU TRY TO REQUEST A DAY OFF WHICH THEY DONT WANT TO GIVE US BECAUSE WE ARE USUALLY SHORT HANDED AND SOMETIMES EVEN WHEN WE ARE NOT. THE RAILROADS HAVE POLICIES TO FIRE YOU IF TAKING TOO MANY DAYS OFF EVEN IF DUE TO FATIGUE. RAILROADS HAVE REDUCE CREW SIZES DRAMATICALLY IN THE LAST 20 YEARS WE HAVE GONE FROM 5 MEN CREWS DOWN TO 2 SINCE THERE ARE NO CABOOSES ANYMORE, AND NOW THEY WANT MORE REDUCTION SO THEY CAN PROFIT MORE IN THIS INDUSTY THIS IS NOT A SAFE ROUTE IN ANY WAY FOR THE WORKERS OR THE COUNTRY. RAILROAD COMPANIES NEED BETTER SECURITY, MANAGEMENT, BETTER WORKING CONDITIONS TO INLCUDE REGULAR WORK SCHEDULES FOR UNION EMPLOYEES THAT MOVE THE FREIGHT ACROSS THE COUNTRY.", "comment_id": "PHMSA-RSPA-2004-18730-0122", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0122", "comment_date": "2007-01-29", "comment_time": "05:00:00", "commenter_fname": "Kevin", "commenter_lname": "Kime", "comment_length": 2098}, {"text": "Your plan to remove the placards from railcars containing TIH substances is illconcieved at best. The current placarding system is easily understood by first responders and internationally accepted. Why would you propose dismantelling a system that has been documented to have saved lives and place our first responders in grave danger in response to a perceived threat. From all indications terrorist suspects do their homework before initiating an attack and removal of palcards would not deter them from using railcars as a weapon if they so desired.  The only effect removal of the placards would have, is in unnecessarily increasing the risk already associated with the job of first responders!", "comment_id": "PHMSA-RSPA-2004-18730-0023", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0023", "comment_date": "2004-10-04", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Labinski", "comment_length": 716}, {"text": "Omitting railcar ID on toxic material will pose a greater risk to the public and first responders than terrorist activity. The potential release and subsequent damage will be far greater during anticipated accidents than criminal activity. CONTINUE PLACARDING!!! ", "comment_id": "PHMSA-RSPA-2004-18730-0024", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0024", "comment_date": "2004-10-05", "comment_time": "04:00:00", "commenter_fname": "Peter", "commenter_lname": "Putchinski", "comment_length": 268}, {"text": "Rail security comments supplement 2    DOT proposed reg2  18  07Fred Millar    Friends of the Earth[I would like to incorporate as part of my statement for the record, by reference, the DC re-routing court case documents, in the US District Court for the District of Columbia, collected at www.oag.dc.govunder the heading \u0093CSXT v. DC\u0094.]Overview comments:\u0095Hazardous materials (hazmat) will continue to be important to the US economy.\u0095Many of these products are most efficiently and safely carried by rail, just as are other bulk commodities such as grain, coal, etc.\u0095Safe transport of the most hazardous chemical (hazmat) cargoes by rail will always require trained and alert rail workers as the first line of defense for the workforce and the community against catastrophic releases --  and as the first responders to emergencies as well.\u0095In a homeland security context, The National Intelligence Estimate and other evidence suggests that US cities should fear more serious attacks and that the rail system may well provide a very attractive target and fearsome weapons (especially hazmat cargoes). \u0095A sustainable chemical and rail industry requires sensible prevention measures in order to avoid, wherever possible, terrorism-caused disasters in railyards, in cities or in ports that could bring hasty, unplanned and severe regulatory consequences.\u0095Many citizens, city councils, and rail workers are seeking a protective re-routing of some (less than 1% of the total cargoes) of the most dangerous through hazmat cargoes (e.g., especially TIH or poison gas cargoes) around our HTUAs (46 High Threat Urban Areas, as already designated by the US DHS and given much funding to upgrade their security).\u0095This re-routing of through cargoes does not solve all rail hazmat security vulnerability problems, but it yields a significant, immediately achievable and permanent risk reduction.  Re-routing is far more effective than the oft-proposed alternatives to re-routing:  physical security measures such as guns, guards and gates [and lights and cameras] \u0096 all of which require permanent maintenance, and all of which, experts all agree, will ultimately fail in the face of a determined attack. (cf. London cameras)In its recently proposals,  FRA and industry partnership efforts aim to make improvements in hazmat railcar dwell time in major target cities is explicitly to reduce the vulnerability by 25%.   This is an unacceptably modest goal.\u0095It is in no one\u0092s interest to have ineffective or pretend regulations. The Bush Administration, both in the enactment of the last-minute Congressional Appropriations rider on chemical facility security and in the proposed rail security regulation, has relied on the same basic, fatally flawed regulatory strategy:  ?provide industry with preemptive federal rule?but also with maximum \u0093flexibility\u0094 under very loose standards, and with no standard of adequacy in the achievement of security (i.e., no Design Basis Threat to measure against as in nuclear plant regulatory context)?require long list of \u0093factors\u0094 that must be considered for re-routing?no single risk-reduction measure can be mandated by the government, even if it is the most effective (this is designed to counter any mandatory Inherent Safe Technology, which in transportation means re-routing)\u0095Protective re-routing to non-target rail corridors usually involves re-routing on rail lines through smaller towns and cities, yielding the double benefit, as professional emergency managers have asserted, of eliminating the security risks AND significantly reducing the consequences of an accidental release.\u0095These double benefits will accrue BOTH to at-risk citizens and to rail workers. \u0095The railroads have up to now (CSXT and NS in the DC case, and UP speaking for all in the Chicago hearing) led the efforts to block initiatives by HTUAs to protect themselves (nine have introduced local re-routing ordinances).\u0095The railroads have stubbornly insisted on their right to ship WMD cargoes through HTUAs on their established routes, set up decades/centuries before terrorism in the US became a credible threat, that endanger millions.\u0095The railroads (AAR) have even testified in Congress in 2005 and 2006 that with the enormous risks they suffer high and rising insurance premiums and can get only $1B of private insurance in case of toxic gas disaster, so this becomes a \u0093bet the business\u0094 situation for the railroads.\u0095Disregarding mounting opposition from the public and scores of critical investigative reports in the media showing no security in the US rail system, the railroads have taken the substantial public relations heat for this business-as-usual. \u0093Stay the Course\u0094 stance, while the chemical shippers have hidden behind the skirts of the railroads.\u0095Major chemical shippers have significant economic clout and could be mandating that the carriers avoid HTUAs with their most dangerous cargoes.  But the shippers have been reluctant to risk the wrath of the railroads and the higher fees they fear would be imposed for this policy and program of protecting HTUAs.\u0095The RRs veneer of asserted rationales for staying the course turn out to be false:  cost, inconvenience, shifting risks.  Convincing evidence in the DC ordinance Federal District Court case showed that none of these held water.\u0095Railroads have refused in court to enter into the normal interchange agreements that could route the most dangerous hazmat cargoes around HTUAs.  \u0095Interchange agreements are routinely used and the life blood of the industry, used by CSXT and Norfolk Southern fully 1  million times a year for their own commercial purposes.\u0095In these legal, legislative and media-forum disputes on protective re-routing, RRs have mobilized strategies to get protection from an assumed structure of federal preemption, and to trust that a railroad-friendly federal government will allow them to continue Business as Usual routing.a.Bush Administration federal railroad regulators including at FRA and at STB have not acted to protect High Threat Urban Areas. And have actively opposed efforts by DC to mandate protective hazmat re-routing.b.The Republican-dominated Congress in the last session blocked hazmat re-routing bills proposed by Democrats:  Senator Biden and Rep Markey.  \u0095Railroad analysts have suggested that the deeper level of (narrow and short-sighted) railroad economic \u0093rationality\u0094 involves:  a.maintaining the economic dominance of a de-regulated and mostly duopolistic corporate interest over competing corporate interests (captive shippers) and b.fear of the potential re-assertion of government control in ordering one railroad to interchange cargo with another \u0093in the public interest\u0094 (as a less railroad-friendly future STB could choose to do within its explicit charter language)\u0095Protective re-routing involves mobilizing a protective government that cares about worker and community interests and that does not rely disastrously on the private sector to make life-and-death decisions. (cf. New Orleans protection and cleanup)", "comment_id": "PHMSA-RSPA-2004-18730-0147", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0147", "comment_date": "2007-02-20", "comment_time": "05:00:00", "commenter_fname": "Fred", "commenter_lname": "Millar", "comment_length": 8526}, {"text": "I beleive this to be a bad plan to remove placards.  It will put MANY persons @ risk. We on the receiving will have NO way to prevent the contamination of our hospital causing complete shutdown due to hazardous material. I understand the risk os some misguided terrorist, but citizens, first reponders, first receivers and may others will be harmed by not knowing. ", "comment_id": "PHMSA-RSPA-2004-18730-0076", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0076", "comment_date": "2004-10-22", "comment_time": "04:00:00", "commenter_fname": "Robert", "commenter_lname": "Mcbride", "comment_length": 385}, {"text": " COMMENTS BY FRIENDS OF THE EARTH ON THE INTERIM FINAL RULE, HAZARDOUS MATERIALS: ENHANCING RAIL TRANSPORTATION SAFETY AND SECURITY FOR HAZARDOUS MATERIALS SHIPMENTS; RAILROAD SAFETY ENFORCEMENT PROCEDURES; INTERIM FINAL RULE AND PROPOSED RULE  49 CFR PARTS 172, 174, AND 209DEPARTMENT OF TRANSPORTATIONPIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATIONFEDERAL RAILROAD ADMINISTRATIONDocket No. PHMSA-RSPA-2004-18730   RIN 2137-AE02[Page numbers citations below are to the Federal Register version of the Interim Final Rule from April 16 2008, Implementing recommendations of the 9/11 Commission Act of 2007  p. 20755 ff.]   http://edocket.access.gpo.gov/2008/E8-8185.htmIntroduction:  Friends of the Earths comments for the record on the Interim Final Rule, which will become effective June 1, 2008, can perhaps assist in showing some ways forward for future, more promising rail security regulation.  As advocates of protective hazmat re-routing, post-9/11 we were active in Washington DC and 10 other major cities which introduced ordinances to mandate such re-routing, for through shipments both by rail and by truck.  Some 25 media stories showing lack of effective rail security helped prompt a national debate and the eventual introduction in Congress of national re-routing legislation, which in turn led to this unfortunate rule.   We commented very critically in the Washington DC public meeting on February 1, 2007 and later electronically on the earlier proposed rule from December 21, 2006.  Our four previous submissions are in the federal docket 18730 at the new federal website:  http://www.regulations.gov/fdmspublic/component/main?main=DocketDetaild=PHMSA-RSPA-2004-18730We unsurprisingly found the current Interim Final Rule did not change to eliminate any of our fundamental objections.We were warned:  Over a few years we have been fairly explicitly warned about the Bush Administration agencies politicized intentions regarding this rule.  Three remarkable examples will make this clear:1.Sometime in 2006, in an undated Synopsis of a Briefing memo in the obscure US Department of Transportation (DOT) rulemaking docket (Docket 18730, Document # 118), the DOT representative to a meeting with representatives of nine railroads and the Association of American Railroads (AAR) candidly reassured the railroads, describing the federal agencies quite politicized rulemaking intentions to extend explicit federal preemption in routing matters and the minimal governmental oversight the rule would entail:  HM-232 PHMSA [Pipeline and Hazardous Materials Safety Administration] and FRA [Federal Railroad Administration  both part of DOT] are working on this [new routing regulatory proposal] now with DHS [Department of Homeland Security].   It addresses the comments received as a result of the [DOTs] request for comments August 16, 2004.This is being promulgated in order to address the concerns of the D.C. judge [US District Court Judge Emmet Sullivan] that wanted to halt routing through D.C.   Hopefully, this will reinforce the preemption law and help keep the carriers out of court and able to run your trains over your best established routes.  It will require that commodity data be available on a route specific basis for each calendar year. The data needs to be available within 90 days of the end of the previous year.  The data will include the total number of shipments on the route segment, along with the number of origins and destinations along the route segment. They [the agencies] are not going to ask that this data be submitted, just available upon request.[Fuller context in APPENDIX ONE below.]2.    In the DOTs own April 2006 Regulatory Assessment and Regulatory Flexibility Analysis, the agency baldly states:  re-routings as a result of this proposed rule will be infrequent and so [we] havenot attempted to estimate the additional [railroad] cost incurred by them. (p. 23))3.And FRA head Joseph Boardman was similarly even more publicly blunt in describing the rule during a recent DOT/DHS national conference call for reporters, fending off their persistent inquiries on the likely re-routing impacts of the rule in protecting target cities: Federal Railroad Administrator Joseph Boardman, who made the announcement [April 16, 2008] , said any changes in shipment routes would depend on the mandated analysis. He refused to predict how many, if any, routes would be eliminated or moved. This is about routing, not rerouting, Boardman said. Anybody that is predicting no change, I think is premature. My expectation is that some routes for hazardous materials will be safer routes. [our emphasis][Feds adopt routing regs for deadly rail tankers  Inside the Bay Area, by Erik N. Nelson, Staff Writer   4  16  08]Furthermore, Mr. Boardmans quote illustrates a key obfuscating mechanism which the railroads, the AAR, and the Bush Administrations federal agencies employ in systematically trying to discredit the value of protective re-routing, as we will discuss below.  In their rhetoric and in this rule, they deliberately conflate security and safety issues, and relentlessly suggest publicly and in this regulation that re-routing for security will most likely lead to unacceptable safety risks. In a key passage FRA outlines concisely its continued reliance on corporate shippers and railroads, the agencys refusal to act strongly (absent an immediate known terrorist threat in a given city) to protectively re-route around target cities, and its own weighting of transportation safety issues over security, a leftover pre-9/11 agency stance identical to that of the railroads, and which has decisively shaped this regulation:  [20761] FRA has met with the rail carriers [in Section 333 meetings, other stakeholders excluded] to discuss modeling and routing options, and has held separate meetings with rail shippers of chlorine and anhydrous ammonia. Further meetings with the rail carriers are anticipated. Projects agreed to through the conference may need the approval of the STB in order to be implemented.    In light of these efforts, and in the interests of system safety, we will not ban movement of the specified hazardous materials through densely populated or other sensitive areas. Rerouting of hazardous materials shipments over longer, more circuitous alternative routes, most of which traverse urban areas at some point, could actually increase safety and security risks. Rerouting to avoid certain areas could add hundreds of miles and several days to a hazardous materials shipment. Those additional miles and days could be on rail infrastructure less suitable to handling hazardous materials. Such rerouting could also result in additional switching and handling of rail cars and more time in rail yards. Longer distances and transit times, increased car handling, and more time in rail yards contribute to an increase in the safety risks to railroad workers and the public inherent in rail transportation in general and the transportation of hazardous materials. As well, military installations, power plants, and other potentially attractive terrorist targets are purposely located on or near rail lines rather than in major metropolitan areas. Such facilities could be placed at greater risk if the Federal government were to require rerouting of highly hazardous materials to avoid densely populated areas. Finally, we would suggest that transportation security is enhanced if terrorists cannot determine whether or when hazardous materials may be rerouted. Such flexibility, provided its use is not made[[Page 20762]]public, decreases the likelihood that a target will be where a terrorist may expect it to be.    Moreover, the 9/11 Commission Act does not direct the Federal government to mandate specific rail routes for security-sensitive materials; rather, Sec.  1551 of the Act specifically directs the Secretary of Transportation to ensure that the final rule requires rail carriers to select the safest and most secure route to be used to transport security-sensitive materials based on a safety and security assessment of the current routes utilized and practicable alternative routes.    We continue to believe that en route safety and security measures will be most effective when tailored to a railroads specific circumstances and operations. Rail carriers are in the best position to assess security risks along the full length of the routes available to them and to target enhanced safety and security measures to identified vulnerabilities. Appendix D to the rule lists the wide variety of factors that a carrier must consider in choosing the safest and most secure route.Railroad insiders have suggested what we consider the only way to make sense of the railroads seemingly counter-productive determination to avoid any serious government-mandated protective re-routing.   The underlying political-economic aim of railroads and their Bush Administration and Congressional supporters is to block any actions in the homeland security area that might set a legal precedent that could be used by captive shippers who are actively seeking that Congress re-regulate the railroads.  A long period of the North American railroads operating without effective government oversight is threatened by captive shippers issues, the current desires of the railroads to seek massive government funding for capacity expansions, and scattered grassroots fights over expansion of rail capacity and over intermodal terminal sites, noise and pollution, and congestion.At the most basic level of regulatory strategy, DOT notably locates the new regulation within the existing Safety and Security Plan section, Subpart 1 of the federal hazmat [hazardous materials transportation] regulations in 49 CFR Part 172.   And for an implementation mechanism, DOT explicitly refers to its existing and also minimalist post-9/11 hazmat Security Plan regulation HM-232, which like the routing rule grants maximum flexibility to the railroads and has no standard of adequacy.  The new rule vaguely states:  railroads security plans must include measures to minimize the safety and security vulnerabilities identified through the route analyses  [20763]   The lack of federal standards in these hazmat transportation security regulations means no accountability, no way of knowing whether we are more secure as a result of the regulations, and no serious governmental oversight possibilities.The industry and FRA conflation of security with safety has been muddled still further by the railroads success in lobbying Congress to include practicable commercial considerations, so that the astonishing new list of 27 factors (see Rule, Appendix D) an individual railroad must consider when evaluating alternative routes is augmented by commercial factors including existing customer relationships.   (see #3 below)The core routing provisions of the 9/11 Commission Act (Section 1551) might look at first glance to be a new national consensus on protective rail re-routing:The Secretary of Transportation shall ensure that the final regulation requires each railroad carrier transporting security-sensitive materials in commerce to annually review and select the practicable route posing the least overall safety and security risk in accordance with this section. ---- 9/11 Commission Act, Section 1551  In fact, however, by lumping together security, safety and commercial practicability as major factors (notably, unweighted in the legislation), the provision allows the current US DOT to grant the railroads so much flexibility (in the current routing rule) as to virtually guarantee a federal rubber stamp on the status quo of rail hazmat routing through all 60 target cities of cargoes which the federal regulators have previously characterized as potential weapons of mass destruction.    During the national debate the Association of American Railroads (AAR) says we have had on re-routing since 9/11, the railroads have often said that because of their liability concerns, they were willing to enhance security by protective re-routing where possible, but not if ordered by a local High Threat Urban Areas ordinance, only if the federal government ordered it.   Then they used their lobbying clout to ensure a weak federal law that would allow a correspondingly weak federal routing regulation.So despite the large increase in public and media concern about the massive consequences of potential terrorism using freight rail cargoes, sensible protective re-routing will not be achieved anytime soon, if ever.   Most likely re-routing will come not until after a terrorist attack (successful or not) [as the Governor of New Jersey lamented in a post-9/11 TV interview] using such hazmat cargoes the railroads have pre-positioned for such possible deadly use.  A similar lack of government foresight and preventive action explains why the ten chlorine tank cars sitting in plain view at the Blue Plains Water Treatment Plant in Washington DC were not removed, and the facility switched to the non-catastrophic alternative chemical (bleach), until after the al Qaeda attack on the Pentagon on 9/11. On the other hand, despite the dampening impact intended by this rule, it is likely that widespread public pressure for protective re-routing will continue.  Indeed, CSXT Railroad recently declared in the federal docket that since 9/11, the US public has reconsidered what is an acceptable risk: The support of the public, and of many policy makers, has greatly eroded since 9/11.  Now the railroads are harshly criticized for transporting these [TIH, or  Toxic by Inhalation poison gas cargoes] Our companys reputation has been assailed[and] vilified in the media.  TIH cannot simply continue to move by railroad indefinitelyEven if the potential for ruinous liability were somehow erased, the widespread social disapproval of TIH transport by rail would remain.    http://dmses.dot.gov/docimages/pdf101/456287_web.pdfCSXT is being carefully misleading here  the key issue in the current debate is the unnecessary routing of through shipments of poison gases and other dangerous rail cargoes into target cities, which re-routing advocates maintain can be remedied by routing onto non-target routes.   The railroads are routing such cargoes through all our major cities still, even without being able to buy adequate insurance, as they have declared in Congressional testimony during the last three years.  One can only conclude that this is a situation the insurance industry calls moral hazard, meaning that the railroads, quite aware of potentially massive numbers of deaths and property losses in a terrorist attack using rail cargoes, are counting on just the kind of huge federal taxpayer bailout that the airline industry received for their massive losses in the aftermath of the 9/11 attacks.***********************************************Brief Legislative and Regulatory Background:  For many years after 9/11,  the Bush Administration promoted in the freight rail security area, as in mass transit and chemical facility security, only voluntary action by corporations to beef up security.  This hands-off stance contrasted with much stronger regulatory mandates imposed on the airline passenger and port security areas, and critics in and out of Congress often highlighted how federal attention and funding went disproportionately to the regulated areas.  Congress has also found voluntary measures insufficient regarding chemical facility security, where similar attractive targets exist, and mandated federal security measures.  In the rail area, voluntary measures have very recently been seen as insufficient by FRA regarding the railroads too-leisurely voluntary plans to upgrade rail tank car design, so FRA has recently proposed regulations to replace the whole fleet in the near future.  The rail industry argued to Congress  that their ownAAR-led  industry efforts and  the previous purely voluntary  Supplemental Security Action Items requests made by DOT and DHS of the rail industry were yielding dramatic results in improved security, but Congress did not find these arguments compelling. The railroads had been feeling the heat [cf. CSXTs quote above] from numerous critics of routing of through chemical shipments into major target cities.  So the new Congressional leaders were seen by alarmed railroad supporters as likely to regulate in this area.  DOT hurriedly put forward on December 21, 2006  a Proposed Rule on routing, but it was widely seen as quite weak and a too-obvious attempt to pre-empt the new Congress slated to take over in January 2007 .  Much of that proposed rule has survived, however, in this new Interim Final Rule. The newly Democratic Congress eventually enacted the 9/11 Commission Act (signed by the President on August 3, 2007, with Section 1551 on routing [including railcar storage]), both responding to widespread post-9/11 public pressure (media, ordinances, etc) and explicitly rejecting a totally voluntary approach in freight rail security, but mandating only quite weak federal involvement in rail routing.The legislative history of the re-routing bill HR 1 and the subsequently enacted  9/11 Commission Act  was starkly uneven regarding re-routing, with a compromise House bill gaining bipartisan approval in two House committees and on the House  floor, but a Senate bill with somewhat stronger mandates was soundly defeated on the floor.  Railroad positions prevailed in much of the final conference committee- enacted bill. The Act said a new DOT rule should be based upon the 2006 DOT-proposed rule, but also mandated ways in which the new rule should go beyond it.  Congress explicitly added some important concepts and mandates, such as for railroads to consider interchange agreements in order to accomplish re-routing, and explicitly defining routing as including interim storage of the covered chemicals (poison gases, explosives and radioactive cargoes  the later DOT rule did not extend coverage to Liquefied Petroleum Gas but did explicitly include anhydrous ammonia)  in urban railyards and sidings.  Overall, however, the Act was not strong enough to provide a decisive national mandate for re-routing that would be immune to further wholesale weakening  by subsequent DOT rulemaking, as outlined below.[US DHS, with its Transportation Security Administration, has been relegated to a junior partner relative to the long-established DOT/FRA in rail security regulation. DHS  is not central to the rail routing regulations, but instead has taken on the narrower task of trying to beef up physical security in urban railcar storage, some of which would be necessary even if through shipments were re-routed.  US GAO has recently testified (GAO-08-651T) in Congress that, while DHS reports it has done vulnerability assessments  in eight major target cities with poison gas rail corridors and site visits to some 300 rail facilities nationwide, DHS efforts to improve freight rail security are still largely in the early  stage.  GAO identified serious challenges for DHS including devising standards and performance goals and deploying an adequate force of inspectors.  DOT is supposed only to consult with DHS on rail security routing matters.]  Summary Critique of the April 16, 2008 Interim Final Rule: These regulations not-so-subtly endorse and support the dangerous urban hazmat routing status quo.  They are seemingly designed, however, to convey a false sense of security regarding the federal effort involved, rather than effect serious security risk reduction.  The Bush Administration, along with the US railroads, have for years vigorously opposed local target city protective re-routing efforts, although a Federal District Court in 2005 upheld the path-breaking re-routing ordinance (enacted on a 10-1 vote in the Washington DC Council) as legal and not preempted by the Federal Rail Safety Act.  The Administration and CSXT railroad, however, stubbornly continued their legal challenges to the DC ordinance and reportedly threatened other concerned cities with similar lawsuits.  Ten more major US target cities and two states (NY and TN) eventually introduced routing ordinances but did not enact them, waiting to see how the lawsuit against the DC ordinance would fare.  [The new rule now has made the legal case moot.]And now the railroad-friendly Administration is misleading the media and the public, suggesting these proposed DOT regulations are requiring railroads to route hazardous materials in a way that will promote homeland security risk reduction.  In fact these regulations are instead devised mainly (1) to preemptively crush protective city and state regulations on re-routing, (2) to keep at-risk citizens in the dark by smothering in yet more veils of official secrecy the documents showing the grave potential chemical release risks to our cities and the lack of progress in reducing these risks, (3) to spare the US railroads from any inconvenience or even minor expense in having to cooperate actually to re-route through hazmat cargoes onto available alternative routes, (4) to deploy a non-regulatory approach which disguises the absence of any federal standard for risk reduction, the absence of a credible federal oversight role, the absence of any real role for state and local officials, and the absence of any transparency or accountability.1.Preemption of non-federal laws.  The rule is explicitly and strongly preemptive and designed to discourage any future state and local re-routing legislation.  There is a real legal problem, however, for the railroads in the newly proposed DOT routing rule.  In many respects these regulations offer so much flexibility to the railroads as to be virtually non-regulations, in which the alleged new standards for adequacy in security risk reduction are either very vague or unspecified.  It remains to be seen if judges will look favorably on this kind of non-regulation as really occupying the field of security regulation and therefore able legally to preempt conflicting local and state laws.The DOT rules unsubtle bias against re-routing is clear in its explanation, using the merely shift the risk rhetoric identical to that of the railroads, for why federal preemption is needed: [20767] As we have indicated elsewhere in this rule, rerouting of hazardous materials to avoid densely populated or sensitive areas may well increase safety and security risks. Moreover, routing restrictions or prohibitions enacted by states or local governments transfer safety and security risks to other areas but do little to achieve enhanced safety and security for the rail transportation[[Page 20768]]system as a whole. We note that virtually every urban and suburban jurisdiction in the United States has a population density that is a matter of concern in planning for and regulating hazardous materials transportation; if all of the jurisdictions located on or near rail routes were to enact routing restrictions applicable to the rail transportation of hazardous materials, such transportation would come to a virtual standstill. The provisions adopted in this interim final rule will reduce the overall risks posed by the movement of explosive, PIH, and radioactive materials by rail, without imposing an undue burden on transportation.2.New secrecy measures.    The broad expansion of secrecy with a new category of Chemical-Terrorism Vulnerability Information (CVI) designations proposed by the companion DHS rail security regulation, and corresponding SSI (Sensitive Security Information) secrecy regimes for virtually all new documentation in the DOT proposed regulation, means the key rail security evidence (both vulnerabilities and available alternatives) will be carefully kept away from the public, and available only to those few officials whom the railroads and US DOT decide have a need to know.  Citizens and public officials will continue to lack information, e.g., from US DHSs many target city vulnerability assessments, from the railroads own security plans under the earlier HM-232 rule, and from the individual railroads route analyses and route selections under this rule, so we will never be able to judge progress or lack of same in hazmat rail security.  It will be trust us forever.3.Minimization of High Threat Urban Area (HTUA) rail hazmat re-routing that might inconvenience the railroads.  A close reading of the proposed DOT regulation reveals that it makes it as easy as possible for a railroad to continue to avoid re-routing.  The regulation sets out a long series of 27 new factors, many of which are totally non-security-related, which railroads MUST consider in future selection of safest and most secure routes.  This mandatory process makes it very unlikely that any protective re-routing, especially any involving interchanging cargoes with another railroad, would occur.  It is noteworthy that, presumably using these factors, no railroads have voluntarily re-routed around any of the 60 major target cities since 9/11.  The only analogous development we can cite is that reportedly for the few days after 9/11, when officials feared quick follow-on attacks on available US targets, government and railroad decision-makers forced the most dangerous poison gas railcar cargoes off the rails and into some kind of safe haven storage.  Shipments later resumed with no discernible protective re-routing.DOT says re-routing must be based on each individual railroads own considerations of factors involving security AND safety AND commercial practicability:  As discussed in theproposed rule, commercially practicable means that the route may be utilized by the railroad within the limits of the railroads particular operational constraints, and further, that the route is economically viable for the specific commodity, route, and customer relationship (p. 31, DOTs Regulatory Assessment, in the federal rulemaking docket).In short, the key flaw in this Rule is that the federal government will not force one railroad to interchange its most dangerous cargo over to another railroad to go around    a target city.  The overall result of this generous federal grant of flexibility is entirely predictable.  As DOT fully expects and astonishingly states in the Regulatory Assessment:re-routings as a result of this proposed rule will be infrequent and so [we] havenot attempted to estimate the additional [railroad] cost incurred by them. (p. 23, DOTs Regulatory Assessment) 4.Deployment of a thoroughly non-regulatory approach.  The main mechanisms employed by DOT here are interlocking:   the absence of any federal standard for risk reduction, the absence of a credible federal oversight role, the absence of any real role for state and local officials, and the absence of any mechanisms for transparency or effective accountability.  This is very largely a faith-based rule, as opposed to deploying a vigorous regulatory program.   Throughout DOT emphasizes its reliance on the railroads: we expect that carriers  will make these decisions in good faith, using the financial management principles generally applied in other business decisions affecting safety and security. [20761]   DOT will expect a rail carrier to make an informed decision, balancing all factors and the best information available.  [20756]  DOT will expect railroads to make conscientious efforts to developlogical and defendable systems [for route analyses and route selection].  [20766]DOT has decided regarding freight rail security, it is clear, to speak softly, since it does not intend to carry a big stick, in contrast to the federal regulatory regimes imposed in other homeland security areas such as airlines, port security and border security.Key Features of the Interim Final Rule that will make re-routing virtually impossible: 1.The DOT rule leaves the individual railroads to make all key decisions, and DOT takes a hands-off regulatory role, except rhetorically.   This stance contrasts starkly with that of the US Coast Guard, which has beefed up its staff for the Congressionally-mandated review and approvals of the security plans for roughly 7500 vessels and 7500 on-shore port facilities in its maritime security regulatory regime.  The Coast Guard also forces all parties in its numerous port-specific Area Maritime Security Committees to cooperate openly and regularly in coordinated efforts to reduce security risks. DOT does not contemplate beefing up its already understaffed rail security inspection and enforcement workforce, and cannot hope to substantively review more than a handful of the routing analyses and route selection documents from the 7 major railroads (in multiple major target cities) and 100 short line railroads carrying the covered hazardous cargoes.  The few DOT reviews that do occur will no doubt focus entirely on whether the paperwork even exists, as has occurred regarding the DOTs previous Security Plan regulation.  In the Interim Final Rule discussion DOT states:       [20765]  We are not implementing a submission and approval process for security plans and route analyses. The review and approval of hundreds of security plans and analyses would be extremely resource-intensive and time-consuming. Moreover, the 9/11 Commission Act does not provide for an approval process for route selections made by rail carriers. During FRAs normal inspection process, inspectors will review security plans, route analyses, and route choices for compliance with applicable regulations to ensure that the chosen route is the safest and most secure practicable route as supported by the analysis done by the carrier. If the inspection identifies deficiencies in the route analyses, security plan, or manner in which the plan is implemented, the deficiencies will be addressed using FRAs existing[[Page 20766]]enforcement procedures. Inspectors will have the discretion to issue notices of non-compliance or to recommend assessment of civil penalties for probable violations of the regulations. As indicated above, FRA may require a rail carrier to use an alternative route if the carriers chosen route is found not to be the safest and most secure practicable route available.  Immediately after rejecting any more prescriptive approaches, DOT nonetheless does assert that it intends to aggressively oversee railroads route analyses and route selection determinations and will use all available tools to enforce compliance with the rule. As the agency with primary responsibility for railroad safety enforcement, FRA will incorporate review and inspection of route analyses and selections into its inspection programs. FRA inspectors may offer suggestions for modifying or improving the analysis or make changes to a route if the route selection documentation or underlying analysis is found to be deficient. If an inspectors recommendations are not implemented, FRA may compel a rail carrier to make changes and/or assess a civil penalty. Further, if the carriers chosen route is found not to be the safest and most secure practicable route available, FRA may require the use of an alternative route. [20756]These assertions of a potentially vigorous federal regulatory pressure are compellingly belied by various other indications current and historical:DOT does reserve hypothetically the right to override a railroads deficient route selection and even though the agency has said it will do so only in the most exigent of cases, this possibility raised much concern among railroads.  So DOT obligingly also published a companion proposed rule in the same April 16, 2008 Federal Register [20774-20778] in which at industry request it laid out an elaborate set of procedural safeguards for appeals by industry to any such pending or decided DOT override.  The main problem remains how could the agency determine what is deficient.   Notably, there is no such appeal process offered for state and local officials or citizen groups aggrieved by railroad routing decisions.    The rule sets out no federal standard for (nor even any guidance on) the adequacy of railroads routing analyses and selection  so any federal challenge to routing analyses and decisions will be subject to endless litigation by the railroads.  [This approach is consistent with DOTs HM-232 Security Plan regulations promulgated earlier, in which DOT also highlighted its basic approach in HM-232 of leaving ultimate hazardous materials routing decisions to the rail carriers. ]FRAs record is of weak enforcement capabilities and a long history of snugly relations with the railroads, as the New York Times vividly documented in a Pulitzer Prize-winning 2004 series by Walt Bogdanich.The rule says FRA will be the only enforcing agency:  the agencies perhaps marginally more inclined to enforce stringently, DHS/TSA [Transportation Security Administration] and DOT/PHMSA, are explicitly cut out of any independent enforcement role, only allowed to try to inject themselves in some kind of cooperation with FRA as the lead agency.DOT expects enforcement needs to be minimal  no new resources have been asked for by DOT.  There was a DHS review process originally mandated in Section 1444 of HR 1, to be funded at $2 million per year for 3 years, but this was dropped completely in the final Section 1555.DOT expects the additional scrutiny of routing documents to add only minimal burdens to existing FRA inspections.  Based on FRAs record in the Security Plan regulations overall, the agency can be expected occasionally to cite paperwork violations regarding routing documents, but levy no fines at all. (See Prine)Even if railroads find security problems along their current routes, they may continue to use them if they add mitigating measures they deem make the route secure enough  in their own judgment.  These are decisions many will think need to be made by public security officials.Clearly, if an alternative route, after analysis, is determined to be the safest and most secure practicable route, the carrier would either designate it as the primary route or identify and implement mitigating measures to improve the safety and security of the analyzed primary route. Each carrier will be required to use the practicable route posing the least overall safety and security risk, based on its analysis. [20762] 2.   DOTs rule virtually metastasizes the likely impacts, and never attempts to put limits on the impacts, of  the 9/11 Commission Acts unfortunate basic compromise provisions which allow economic practicability to be decisive in routing analyses and outcomes: In this interim final rule, we are adopting a requirement for rail carriers to identify and analyze all practicable alternative routes, rather than a ``commercially practicable route as proposed in the NPRM. We note in this regard, however, that the identification of an alternative practicable route must necessarily include a determination of its commercial practicability. Congress recognized this by including in Sec.  1551(d) a requirement for the alternative route analyses to include the potential economic effects of using an alternative route. Accordingly, we expect rail carriers to address whether a route is economically viable in light of, but not limited to, market conditions, legal and regulatory requirements, and the economics of the commodity, route, offeror, and consignee. A practicable alternative route is one that may be utilized by the railroad within the limits of the railroads particular operating constraints and, further, is economically viable given the economics of the commodity, route, and customer relationship. The question of commercial practicability must be reasonably evaluated by each rail carrier as a part of its analysis based on the specific circumstances of the route and proposed traffic. If using a possible alternative route would significantly[[Page 20761]]increase a carriers operating costs, as well as the costs to its customers, the carrier should consider and document these facts in its route analysis. 3.   DOT could have interpreted the 9/11 Commission Act in a very different way, setting up a tough federal regulatory program with real standards, designating stringent oversight, etc., but would have been risking backlash from the railroads, de-regulated since 1980.   So the agency in this rule has established the most minimal government regulatory role, in an impressively-crafted series of interlocking decisions:a.The fact that DOT will not take possession of route analyses and selection documents means these documents will not be accessible through FOIA requests, which removes one potential external mechanism for accountability.b.Individual railroads are left to analyze and select routes.  DOT admits this is difficult to implement and to oversee.  The rule does not even specify any common format for the railroads to use in their no doubt complex and perhaps bewilderingly different route analyses and route selection documents, which makes any oversight virtually impossible either by DOT or by other federal bodies such as Congress or the Government Accountability Office.  The analyses, DOT furthermore says, could involve methods which are quantitative, qualitative, or a combination.c.Cooperation among railroads (e.g., the utterly normal interchange agreements which would be vitally necessary for most of the genuine risk-reduction re-routing arrangements that could be achieved around major target cities) must, pursuant to the weak language of the Act, be considered, but is not mandated by DOT.  Each railroad must analyze possible alternative lines, but only the ones over which it has authority to operate (as explicitly allowed in the Act).  Congressional drafters were aware that mandating cooperation and interchanges among railroads would be necessary for re-routing, but railroads won weakening language that renders the probability of this happening as virtually nil.  The rule does leave some ambiguity regarding a railroads using its trackage rights to re-route:   [20761]  As we acknowledged in the NPRM, in many cases, the only alternative route in a particular area may be on another carriers system. A rail carrier would not be obligated to analyze an alternative route over which it has no authority to operate. Likewise, in some cases, no alternative route will be available; in those instances, no alternative route analysis would be required. This is particularly true in the case of regional or short-line railroads that are often the only rail carriers in a given geographic area. However, as discussed below, carriers must consider the use of interchange agreements when identifying practicable alternative routes.    When an alternative route is available, the carrier must analyze that route and document its analysis, including the safety and security risks presented by the alternative route, any remediation or mitigation measures in place or available, and the economic effects of using the alternative route.    Under arrangements known as ``trackage rights, it is not uncommon for a carrier to conduct train operations over a rail line that is owned, dispatched, and maintained by another carrier. Such arrangements typically grant the trackage rights tenant little or no control over the track and associated infrastructure, including many of the factors set forth in Appendix D. In completing the route analysis required by this interim final rule, a carrier may identify specific risk mitigation measures that are outside its ability to accomplish. Because it is essential that safety and security measures be coordinated among all responsible entities, it is incumbent upon the tenant carrier to work with the owner of the track to evaluate the vulnerabilities and identify measures to mitigate the risks. If measures required by this interim final rule cannot be implemented because another entity refuses or fails to cooperate, the carrier must notify FRA. As stated in the Compliance and Enforcement section of this interim final rule, FRA retains the authority to require use of an alternative route until such time as identified deficiencies are mitigated or corrected.d.Instead of proposing a new federal standard, therefore, for cooperation among railroads and for adequacy of security risk reduction, DOT resorts to what it calls institutionalizing an assessment process and prescribing uniform assessment criteria [20762]:  offering in Appendix D a list of 27 new factors each individual railroad must consider.  This list conflates wildly disparate factors involving security and safety.  Commercial practicability has been omitted from the new Appendix D list of 27 factors and now is seen as a kind of major independent mega-factor on a par with safety and security.  One indication of DOTs struggle to think outside the box of its traditional role in transportation safety is the very nearly unchanged Appendix D in the Interim Final Rule.In this interim final rule, we are adopting the list of factors as proposed in the NPRM, with modifications for consistency with requirements of the 9/11 Commission Act. Specifically, we are adding high consequence targets, as defined in Sec.  1551(h)(2) to the list of factors that must be considered.[20766]In the new Appendix D, of the 27 factors that must be considered for routing:  a.1-11, 16, 19, 20, 22, 24-26 are safety factorsb.12-15, 17-18, 21 and 27 (perhaps) are security factorsc.23 and 27 (primarily) are economic factors There is no precedent we can find for this approach, namely, lumping together very disparate variables which are virtually impossible to put into any kind of sensible comprehensive assessment methodology, in the existing academic literature on catastrophe avoidance routing.  A leading expert in this field bluntly states that of course it all depends on the weighting of the factors.  Significantly, DOT does not even try to rank these factors, as asked by the explosives industry [20766], and does not (yet) even offer any guidance [e.g., in other chemical risk regulatory programs such as under EPCRA, the Clean Air Act Amendments of 1990 (Section 112 r) and Pipeline Safety] on what they admit will be the crucial weighting decisions, leaving these to each railroad in a completely non-transparent process, guaranteeing maximum bias toward the status quo and no accountability.e.DOT and DHS did agree with industry how these factors are weighted and used is an extremely important aspect of an overall safety and security risk assessment methodology.  So they concluded that some weighting methodology with a federal blessing would be useful to railroads as they decide on routing selections.  This is mentioned explicitly in the rule.  [20766]  For Fiscal Year 2005 DHS unabashedly gave a $5 million grant to an allegedly independent organization  the Railroad Research Foundation, whose president is also president of AAR.  DOT/FRA apparently has the federal agency project oversight, and reportedly AARs spokesperson Nancy Wilson is project manager.  DOT has not involved environmental or state and local or environmental stakeholders in tool development.  DOT expects the tool [which we expect to be an extremely technically challenging effort to produce a pseudo-scientific-looking methodology for balancing the 27 factors] to be available sometime in 2008.  Again, the likely outcome is utterly predictable: the railroads since 9/11 have NEVER voluntarily re-routed while presumably considering these factors, since their own weighting biases have --  in every single case -- meant that business-as-usual triumphed, and reckless routing has continued through 60 major target cities.  The only partial exception is very revealing:  the voluntary CSXT re-routing around their photo-op line, the I-95 line, one of their two lines through Washington DC, after years of citizen and media pressure.  In the DC court case (see CSXT v. DC documents at www.oag.dc.gov ),  CSXT said they would refuse to interchange its most dangerous cargoes and use the nearby Norfolk Southern alternative route around DC, through small towns like Luray VA.  They would send these instead on their next available CSXT route, a long ludicrously more dangerous, looping route through the target cities of Cincinnati, Cleveland, Buffalo, Syracuse, Albany and finally south through the NY City metro area to Northern New Jersey destinations.  We presume CSXT is in fact using this routing as a public relations necessity, in order to avoid what had become their iconic photo-op line which featured ominously photogenic chlorine tank cars running just four blocks in front of the US Capitol Buildingf.The DOT rule leaves no significant role for state and local officials:  they can only supply information on local threats, but have no institutionalized power to influence decisions, much less any veto [20759].   DOT and the railroads continue to be very stingy about sharing even hazmat commodity flow information with data-starved local officials, and certainly never with the public, even though the individual chemical cargoes are clearly placarded for all to see.  [One suspects that it is the proprietary security of the information which is the overiding reason for this withholding of information which the railroads have readily available in their operations computers] :The City of Cleveland, Ohio, suggests that we revise the proposal in the NPRM to require rail carriers to share the commodity data with local governments responsible for the geographic areas through which hazardous materials are transported. We agree that state and local governments should have access to such information, provided access to the information is limited to those with a ``need-to-know for transportation safety and security purposes, and further provided that such information may not be publicly disclosed pursuant to any state, local, or tribal law. Because of the security sensitivity of the commodity data, it is not appropriate for it to be broadly disclosed to government or private entities. We note that AAR Circular OT-55-I provides for disclosure of certain commodity flow data, upon request, to local emergency response agencies and planning groups. At a minimum, such information is to include rank-order identification of the top 25 hazardous commodities transported through the community. [20759] In a starkly revealing contrast, moreover, DOT proposes, regarding urban storage of hazmat railcars (which HR 1 and the Act defined as part of routing), a very different mechanism to prevent any risk-reducing change in the current dangerous storage patterns, which mechanism was suggested by ACC and accepted into the Interim Final Rule by DOT.  That is, DOT will give all corporate parties a veto during mandated consultation on chemical railcar  storage issues. [20764]  g.The DOT rules enhanced secrecy measures for hazmat security eliminate both any outside pressure for accountability and any of the Congressionally-mandated Right-To-Know mechanisms available in similar chemical facility risk situations.  There is no thought that an informed public has the right to know what routing decisions have been made or to influence the results.h.In its minimizing cost-benefit defense of the rule, instead of using as their benefit measure (as other security regulations have done) the large death tolls and enormous multi-billion dollar costs of a major terrorist attack that the rule might help avert (e.g., the 9/11 attacks in 2001 that killed 3000, or the 1995 Oklahoma City truck bombing that killed 168), DOT used a recent chlorine accident releasing one railcar, the 2005 Graniteville SC accident that killed 9 people, in total estimated by DOT as costing a mere $126 million. [ 20769]   This again perhaps illustrates a clueless agencys conflation of security with safety issues, or some kind of agency denial of the real possibility of a successful terrorist attack using hazmat.  But more likely it serves only to be more commensurate with, and justify somehow, the very small investment that this virtually non-regulation will demand from the railroads and the government.  See the tiny costs of the rule outlined at 20769.The cost benefit analysis again shows the DOT basically punting the hard routing decisions over to the railroads, allowing that these decisions will require judgment and necessarily be subjective, displaying a series of  regulatory abdications and rhetoric which overall do not take seriously the need to protect target cities:  Estimating the security benefits of the new requirements is challenging. Accident causation probabilities can be estimated based on accident histories in a way that the probability of a criminal or terrorist act cannot. The threat of an attack is virtually impossible to assess from a quantitative standpoint. It is undeniable that hazardous materials in transportation are a possible target of terrorism or sabotage. The probability that hazardous materials will be targeted is, at best, a guess. Similarly, the projected outcome of a terrorist attack cannot be precisely estimated. It is assumed choices will be made to maximize consequences and damages. Scenarios can be envisioned in which hazardous materials could be used to inflict hundreds or even thousands of fatalities. To date, there have been no known or specific threats against freight railroads, rail cars, or tank cars, which makes all of these elements even more difficult to quantify. Security plans lower risk through the identification and mitigation of vulnerabilities. Therefore, rail carriers and the public benefit from the development and implementation of security plans. However, forecasting the benefits likely to result from plan implementation requires the exercise of judgment and necessarily includes subjective elements.  [20769]i.The DOT routing rule, at the suggestion of Dow Chemical, exempts from coverage any hazmat railcar storage on private track, private sidings, offerors or consignees facility  [20759-60].   So state and local officials can still regulate safety and security in some ways in these facilities. No jurisdiction is doing so to our knowledge.  Most officials do not even know the distinction between private track and railroad track  storage on the latter is preempted by the DOT rule  not where these types exist in their jurisdictions.j.This rule is designed to be very cheap for railroads [see 20770].  The estimated cost for data and analyses for the 100 small railroads ($3-20 million revenue annually) is estimated by DOT to average $2776.70/year  not significant.  The total costs are estimated at $831,000/yr for information and record-keeping.Overall, the whole impact and costs of this exercise in federal non-regulation are tiny:  for the new proposed DOT rail security program, DOTs Regulatory Assessment estimates costs to all railroads at $19.4 million total over a 20-year period.   As for the estimated burden on the government: No additional inspection time [by FRA inspectors] will be required to comply  DOT guesses railroads are already spending between $45m-$495 million on safety AND security.  DOT tellingly does not even attempt to separately estimate the two costs.   The counterpart DHS proposed chain of custody regulation, for hazmat railcar storage in cities, offers some useful, if very belated, measures for beefing up physical security, but even its larger scope ($162 million cost to industry over 10 years) is tiny compared with post 9/11 federal security efforts in aviation or ports.  The DHS-proposed measures, moreover, arguably offer much smaller risk reduction benefits than re-routing the railcars to avoid cities altogether, and DHS makes no attempt to compare these types of benefits.  As the Security Chief of the London Transit Authority usefully and forcefully warned US security officials after four simultaneous bombs in 2005 killed about 50 Londoners, We had 7000 cameras in our system, and they did not prevent a single attack.   Physical security measures, security experts agree, always ultimately will fail.  Releasing a poison gas cargo in a large city seems clearly the easiest way terrorists can fulfill their stated goal to kill many more Americans in their next set of spectacular attacks than the 3000 killed on 9/11.   Re-routing through cargoes wherever possible is essential as a first major risk reduction measure.  APPENDIX ONE:   FRA reps excerpt of summary re meeting with railroad reps NPRM docket 18730    Document no 118The FRA reps summary from the meeting discusses future regulatory proposals on hazmat routing (my emphasis):PHMSA and FRA are working on this [new routing regulatory proposal] now with DHS.   It addresses the comments received as a result of the [DOTs] request for comments August 16, 2004.This is being promulgated in order to address the concerns of the D.C. judge that wanted to halt routingthrough D.C. Hopefully, this will reinforce the preemption law and help keep the carriers out of court and able to run your trains over your best established routes. It will require that commodity data be available on a route specific basis for each calendar year. The data needs to be available within 90 days of the end of the previous year. The data will include the total number of shipments on the route segment, along with the number of origins and destinations along the route segment. Theyare not going to ask that this data be submitted, just available upon request. The chemicals of concern will be Class 1.1  1.2 explosives, bulk TIH, and highway route controlled quantities of radioactive material.It requires a route analysis with alternates, andcomparisons of the alternate routes to include thepotential economic effects of using the alternate routes.Specific measures to address the risk must be identifiedand incorporated into the carriers safety and securityplan.Components of the regulation include;Trip lengthSignalsVolume shippedTrack classGrade and curvature*Known threatsGrade crossingsIconic structuresPlaces of congregationVenuesEnvironmentally sensitive areasPopulation density along route*Emergency response capability** FRA will attempt to have these elements removed.This will come out as a NPRM in the mid-November toDecember time frame.http://www.regulations.gov/search/search_results.jsp?No=130sid=119C4B1342FBNe=2+8+11+8053+8054+8098+8074+8066+8084+8055Ntt=18730Ntk=AllNtx=mode+matchallNs=P_FRPublish_Date|1N=0css=0APPENDIX TWO:27 new factors the individual railroad must consider in routing:1. Volume of hazardous material transported;2. Rail traffic density;3. Trip length for route;4. Presence and characteristics of railroad facilities;5. Track type, class, and maintenance schedule;6. Track grade and curvature;7. Presence or absence of signals and train control systems along the route (dark versus signaled territory);8. Presence or absence of wayside hazard detectors;9. Number and types of grade crossings;10. Single versus double track territory;11. Frequency and location of track turnouts;12. Proximity to iconic targets;13. Environmentally sensitive or significant areas;14. Population density along the route;15. Venues along the route (stations, events, places of congregation);16. Emergency response capability along the route;17. Areas of high consequence along the route, including high consequence targets as defined in  172.820(c);18. Presence of passenger traffic along route (shared track);19. Speed of train operations;20. Proximity to en-route storage or repair facilities;21. Known threats, including any nonpublic threat scenarios provided by the Department of Homeland Security or the Department of Transportation for carrier use in the development of the route assessment;22. Measures in place to address apparent safety and security risks;23. Availability of practicable alternative routes;24. Past incidents;25. Overall times in transit;26. Training and skill level of crews; and27. Impact on rail network traffic and congestion.", "comment_id": "PHMSA-RSPA-2004-18730-0204", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0204", "comment_date": "2008-05-15", "comment_time": "04:00:00", "commenter_fname": "Fred", "commenter_lname": "Millar", "comment_length": 65376}, {"text": "Comments of the Association of American Railroads", "comment_id": "PHMSA-RSPA-2004-18730-0212", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0212", "comment_date": "2008-05-19", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Rush", "comment_length": 49}, {"text": "Comments of Norfolk Southern Corporation", "comment_id": "PHMSA-RSPA-2004-18730-0211", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2004-18730-0211", "comment_date": "2008-05-19", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Rush", "comment_length": 40}]}, {"id": "CMS-2010-0196", "agency": "CMS", "title": "Medicare Program; Medicare Coverage Gap Discount Program Model Manufacturer Agreement and Announcement of the June 1, 2010 Public Meeting", "update_date": "2021-03-26", "update_time": "01:07:43", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Filed Electronically Via http://www.regulations.govJune 21, 2010  U.S. Department of Health and Human ServicesCenters for Medicare and Medicaid Services SUBJECT:Comments on CMS-4151-NC on the Medicare Coverage Gap Discount Program Model    Manufacturer Agreement Dear Sir or Madam: On May 21, 2010, the Centers for Medicare and Medicaid Services (CMS or the agency) published a Notice in the Federal Register regarding its Medicare Coverage Gap Discount Program Model Manufacturer Agreement (Agreement), announced a meeting to discuss that Agreement, and invited written comments on that Agreement from interested parties.  The Agreement is part of CMS implementation of the Medicare Part D Coverage Gap Discount recently enacted into law in Section 3301 of the Patient Protection and Affordable Care Act (H.R. 3590), as amended by Section 1101 of the Health Care and Educational Reconciliation Act of 2010 (H.R. 4872) and codified in portions of the Social Security Act.  In part, the statutory changes authorize CMS to implement a discount program for certain Medicare Part D patients through rebates ultimately paid by pharmaceutical manufacturers to Part D Plan Sponsors under certain conditions (the Discount Program). As an $11 billion global leader in medical devices and supplies, diagnostic imaging agents, pharmaceuticals and other healthcare products, Covidien has an interest in how this Discount Program is constituted and implemented. Prior to the Notice of the Agreement, CMS had already issued a draft Guidance on the Medicare Part D Coverage Gap Discount program on April 30, 2010 and invited comments on that draft.  After a brief comment period ending on May 14, 2010, CMS quickly finalized that guidance on May 21, 2010, on the same day it published the Notice inviting comment on the Draft Agreement.  At the outset, Covidien is concerned that CMS may not have completely considered all of the comments it received on the draft Guidance since there was only one week from the close of the comment period until the issuance of the final Guidance.  Accordingly, Covidien wishes to express its concern that CMS take more time to ensure that it adequately considers all comments on the Agreement since the terms of the Agreement will be constitute final action for manufacturers as they will be unable to negotiate changes and will not be empowered to initiate or request changes once the Agreement is signed and in place.Overall, Covidiens primary concerns are overall vagueness and imprecision in the Agreement as well as the lack of clarity regarding expectations of both parties to the Agreement.  Specifically, Covidien wishes to make the following comments: Please Clarify the Role CMS and its Third Party Administrator (TPA) Will Play in the Process of Paying Part D Plans the Applicable Discounts When reading the statute, as amended, two aspects of Congress expectations of CMS role with regard to the Discount Program are clear.  First, Congress forbade the Secretary from handling any of the payments directly through specific prohibitions.  Secondly, and on the other hand, Congress did allow for the possibility that the Third Party Administrator (TPA) hired by CMS to administer the Discount Program would be empowered to handle and facilitate payments by manufacturers since the statute authorizes the TPA to receive, distribute, or facilitate those payments.  In the Final Guidance, however, CMS entirely dismissed the first two of those three options and determined that the TPA will only facilitate those payments by generating the invoices sent to manufacturers and receiving confirmation of payments made and received.  In the Final Guidance, CMS concluded that this approach is most consistent with the statute.Covidien strongly disagrees with CMS conclusion.  The agencys conclusion that this construction of the statute is most consistent with its language absolutely ignores two of the three descriptors in the definition of the TPAs role in the process.  A more meaningful application of the terms of the statute is that Congress intended the TPAs to play a significant role in the entire process for disbursement of payments from the manufacturers to the Part D Sponsors.  While there is some leeway given to CMS in defining this role, clearly the statutes wording indicates the Congressional intent that the TPA is to play a large role in the process  larger than invoicing and confirming payments.In addition, an expanded role for TPAs, beyond that of invoicing and confirming payments makes sense from an organizational standpoint for the Discount Program.  It would also allow the TPA to accurately and timely reconcile the prospective payments it will be making on behalf of CMS to the Part D plans with the actual payments made by manufacturers as it processes the payments through to the Part D plans.  This would be an earlier reconciliation of the prospective payments than the annual reconciliation anticipated by the Final Guidance.  The annual reconciliation anticipated by the Final Guidance would allow Part D plans to hold both the prospective payments and also the actual payments for up to a year  all the while depriving CMS and the government treasury of that money.  It is doubtful that this outcome was part of the Congressional intent in passing the statute.The Proposed 14 Day Turnaround Time for Manufacturers to Pay the Invoices from the Discount Program is Unreasonable and UnclearWhile the provision in the Agreement that requires manufacturers to pay the invoices they receive from the TPA to the Part D plans within 14 days may be intended to reflect the statutory window allowed for Part D plans to pay pharmacies for claims, this does not make sense based on the monthly prospective payment provision from CMS to Manufacturers in the Final Guidance.  CMS attempt to make the manufacturers payment terms reflect those required of Part D plans to their pharmacies would make sense but for the fact that CMS will be paying the Part D plans the prospective payments prior to the Plans even having to pay any discounts.  In addition, the Final Guidance anticipates a yearly reconciliation of the prospective payments versus actual payments.  This means that Part D plans will be receiving their prospective payments from CMS prior to the beginning of a given month, their actual payments from manufacturers within 14 days of invoicing, but not have to reconcile the prospective to the actual until months, possibly up to 12 months, after the first prospective payment is received.  Under this approach, there should be little or no burden on the Part D plans, financially speaking, if manufacturers are allowed a more reasonable time frame to process the invoices due to CMS advancing the prospective payments under this scheme.At the same time, manufacturers are being asked to process hundreds, possibly thousands, of invoices, all received in one day, within two weeks.  While pharmaceutical manufacturers are sophisticated organizations, they are not organized to process invoices in high volume in short turnaround times, especially once a quarter.  At this time, Covidien does not accept payment requirements of less than 60 days in any of its commercial contracts.  To require us to pay these invoices in 14 days will amount to an onerous requirement by CMS that we will potentially need to add staffing and/or re-engineer our accounts payable functions to accomplish something that is not evidently the intent of Congress in the statute.  In addition, we are forced by other government requirements on publicly-traded companies including Sarbanes-Oxley to have financial controls in place that guarantee our organization has properly reviewed, and substantiated both the accuracy and need to pay all invoices as part of the approval process.  Doing so for the potentially voluminous claims data underlying the amounts invoiced under the Discount Program and conducting the appropriate due diligence prior to initiating payment means that 14 days between the invoice and payment is too short a timeframe for all of these activities to be done in a controlled and fiscally responsible manner. This reality has been acknowledged in the design of other similar government programs involving related payments.  The TriCare Rebate program allows 70 days from receipt of data and invoices before payment is due and the Medicaid Rebate program allows 38 days.  To require that the invoiced amounts be paid for this Discount Program in up to one fifth of the time as these similar programs seems unrealistic and arbitrary.  CMS should follow the lead of similar government programs and change the payment cycle in its Draft Guidance to a more realistic time to prevent undue financial pressure on manufacturers since the prospective payments are designed to prevent these discounts from creating undue financial pressure on the Part D plans.In addition, the Agreement is unclear on exactly when the 14 day period begins.  Is it intended to commence when the invoice is generated, when the invoice is sent, or when the invoice is received?  Given the short amount of time that the contract allows for payments to be reviewed and processed, and the current versions potentially large penalties for failure to pay on time, this is a key question that must be clarified prior to finalization of the Agreement.Please Clarify whether the Discount Program Payments will be Made by Manufacturers to Part D Plan Sponsors or to Individual PlansBetween the Final Guidance and the Agreement, it is unclear whether manufacturers will need to make payments to Individual Part D plans based on their PDEs or to Part D Sponsors, each of whom may be running multiple plans.  This is a key point that should be made clear in the Agreement since that is where manufacturers payment obligations will be created.  It may mean a difference between hundreds of invoices and thousands of invoices for an individual manufacturer.  Clarity in the Agreement will allow for manufacturers to begin preparing for the process well before the actual invoices arrive. Please Clarify What Sort of Documentation of Electronic Payment Will Need To Be Transmitted to CMS by Manufacturers Within One Day of Payment Being Made to Part D Sponsors  The Agreement, at Section II (m), requires manufacturers to provide CMS with electronic documentation in a manner specified by CMS that details the successful transmission of such payments of quarterly discount payments to Part D Sponsors.  This provision needs to be clarified to provide exactly what documentation CMS is going to require prior to the Agreement being finalized.  It is difficult for a manufacturer to commit to such a requirement, without understanding clearly what it entails or at least what it is anticipated to be at the outset.  At this time, after thorough review of this provision we remain unsure as to exactly what documentation, and at what level of detail, could be provided to CMS to meet this requirement. The Dispute Process for Manufacturers to Note Dubious or Questionable Invoice Items Is UnfairThe Dispute Process outlined in the Agreement in Section V seems to be premised on the conviction within CMS that there is so much oversight of its Part D programs that the invoices will be incorruptible.  The agency said as much in its Public Meeting when the issue was raised as CMS responded by outlining the amount of oversight, internal and external audit, and review already in place over the program. Unfortunately, based on manufacturers experience with previous programs such as the Medicaid Rebate program and the Tricare Rebate program, that is not usually the case.  In both of those programs, each of which have some of the same oversight that CMS has described, there are consistent and frequent mistakes in the billing process that need to be disputed and settled, as evidenced by the volume of PPAs  (prior period adjustments) under the Medicaid Rebate program.  It is unrealistic to expect that there will be no errors in the discount program since it will also be driven from individual claims data where many of the problems originate.  The Part D plans have acknowledged as much in their comments on the Draft Guidance when they suggested the need for them to be able to initiate retroactive revisions to correct mistakes.  Coincidentally, on June 1, 2010, the same day that CMS was assuring the attendees at the Public Meeting on the Agreement of the soundness of its controls around the PDE data, the OIG released a report criticizing those same controls and urging that they be strengthened.As it stands now, however, manufacturers will be expected to pay all claims  even if they are facially and obviously incorrect. A glaring example is if an invoice contains discount information for a product that is not one of a manufacturers products.  CMS may believe that this will not happen due to its oversight, but it happens consistently with both Medicaid Rebates and Tricare Rebates, even years after the programs have matured.  Similarly, there may be a claim with a typographical error in quantity which magnifies the claim by thousands so that a company that normally pays $30,000 a quarter in discount payments may be invoiced for $3,000,000 for a quarter.  Based on the existing rebate programs this is not an unrealistic scenario, but under the draft Agreement, the manufacturer would have no recourse but to pay and then recover  or try to do so.  It is not reasonable to expect manufacturers to pay blatantly incorrect and burdensome amounts just because they were invoiced by the governments TPA.  We strongly urge this be rectified in the Final Agreement. The Secretary Should be Obligated to Provide Manufacturers with Sufficient Information at the Time of Invoicing to Justify Payments and to Allow for Meaningful DisputesThe Agreement fails to outline the information that manufacturers will be provided to support the invoiced amounts.  For that information to be useful, and for the Dispute provisions of the Agreement in Section V to have any meaning, that information needs to include sufficient detail of the claims level information to provide the manufacturers with a meaningful opportunity to dispute.  Covidiens recommendation is that this information should be similar to, if not identical to, the information provided by Tricare to support its rebate invoices.  This information is claims-level information that identifies the drug, the pharmacy, the prescription number, the quantity in the prescription, the amount adjudicated, the amount paid by the Part D plan, and the amount requested to be reimbursed.  Anything less than this will mean that manufacturers have no ability to review and dispute the amounts they are being required to pay due to a lack of data as to what constitutes and justifies those invoiced amounts. The Agreement Designates the Secretary as the Sole Decision Maker Regarding a Beneficiarys Eligibility for the Discount Which is At Odds with the Final Guidance Placing that Responsibility Solely with the Part D Sponsor Due to Availability of InformationIn Section III (g), the Agreement states that the Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretarys determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer.  Yet, in the Final Guidance and in the Public Meeting, CMS made it clear that the Part D plans are the only parties with the access to all of the necessary information to determine, on a transaction-by-transaction basis, whether a beneficiary qualifies for the Discount Program at any time for any transaction.  This latter position seems irreconcilable with the Secretary being the sole source of information regarding beneficiary eligibility.  Either the Part D plans or the Secretary is most capable, but not both.  We strongly urge CMS to clarify this section of the Agreement. The Penalty Provisions Fail to Distinguish Between a Late Payment and a Failure to Pay Meaning that a Payment Delayed by One Day Potentially Creates a Burdensome Obligation for a 25% Civil Monetary Penalty In Section IV (a), the Secretary is authorized to impose a Civil Monetary Penalty (CMP) on manufacturers that sign the Agreement but fail to pay the discount invoices without defining what failing to pay means.  For example, it could mean simply not paying within 14 days.  If that is the case, the penalty 25% of the amount owed is unreasonable.  On the other hand, the CMP might be intended to apply to manufacturers who consistently and flagrantly fail to pay for extended periods, in which case the penalty might be more appropriate.  This section needs to be clarified, but in any event CMS should provide a means for an intermediate remedial provision to address administrative-type errors such as late payments.  The Medicaid Rebate program and the Tricare program include interest provisions to apply to late payments and have larger, more significant penalties allowed for manufacturers that do fail to pay over a significant period.  Similar provisions should be included in this Agreement. Adjustment Clause in Sec. V.(d) Suggests that Future Adjustments Will Be Made Based on Items that are not Within the Knowledge of Manufacturers or CMS but Not Otherwise Required to Be Disclosed by the Agreement.This clause allows adjustments to future discount payments if, in part, there are changes to the negotiated rates upon which the discount payments are based.  This is unfair, however, because these changes would be based on information that CMS has indicated it has no direct knowledge of, the negotiated rates between Part D plans and dispensing pharmacies.  Similarly, the manufacturers awareness of the negotiated rates does not begin until an invoice is received.  Accordingly, the parties are trying to agree to future changes based on information to which neither party has access or control.  This seems potentially burdensome as a vague and undefined commitment that manufacturers are being required to make.  It also seems unnecessary, because manufacturers are already committed, elsewhere in the Agreement, to reimbursing all Part D plans for all discounts appropriately given.  The anticipated future changes, once they are actual discounts, will be within the scope of the Agreement already.  Therefore, this clause is, at best, unnecessary and potentially very unfair when it relies on information outside the knowledge of either party so it should be deleted.The Definition of a Discount that a Manufacturer is Obligated to Make Under the Agreement fails to Limit it to Applicable BeneficiariesIn Section 1 (c) of the Agreement, the term Applicable Discount is defined without respect to the status of the underlying beneficiary which are detailed in Section I (a) under the definition of Applicable Beneficiary.  Further, in Section II (a), the manufacturers obligation to pay Applicable Discounts is described, once again without reference to the status of the underlying beneficiary or the term Applicable Beneficiary.  Without these references, the contract arguably creates an obligation on the part of a manufacturer to pay any discount granted by a Part D plan without regard to whether the Part D plan has properly established that the underlying beneficiary qualifies under the contract as an Applicable Beneficiary, i.e. that the beneficiary is in the coverage gap; is not a member of a qualified retiree program or the recipient of an income-related subsidy, etc.  Without that qualification, it appears that the obligations the contract creates for manufacturers are broader than described or authorized by the Statute.   The Agreement Requires Manufacturers to have Electronic Connectivity to Receive Medicare Part D Discount Information Report Without Defining the Type or Extent of Such ConnectivityCMS has to be clear in its expectations particularly since it is asking for an open-ended commitment from manufacturers.  To create a broad requirement without providing details, when CMS clearly has expectations at this time of what their process will require, is needlessly indefinite and confusing.  The Agreement will allow the Secretary to make changes as necessary to the program requirements going forward, but reasonable notice of CMS current expectations should be given to manufacturers being required to sign the Agreement.  This same comment applies to any expectations CMS may have with regard to electronic invoicing, electronic payments, or other electronic data exchanges that it anticipates being requirements of Discount Program participation.Covidien appreciates the opportunity to comment on the draft Agreement in order to try to develop the best document, and accordingly the best Discount Program, possible.  Sincerely,  Brian D. ElsberndSr. Compliance CounselCovidien Pharmaceuticals", "comment_id": "CMS-2010-0196-0025", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0196-0025", "comment_date": "2010-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 22407}, {"text": "Cynthia G. Tudor, Ph.D. Director, Medicare Drug Benefit and C  D Data Group Craig Miner, R.Ph, J.D.Senior Technical Adviser, Medicare Drug Benefit and C  D June 21, 2010Re: Medicare Coverage Gap Discount Program Model Manufacturer AgreementDear Drs. Tudor and Miner,The National Viral Hepatitis Roundtable is a coalition of more than 175 public, private and community based organizations dedicated to the elimination of viral hepatitis in the United States.  Our primary focus is on chronic hepatitis B and chronic hepatitis C, which disproportionately affect people color and of lower social and economic status. Research into new therapies for hepatitis B and C are ongoing and several promising new treatments are in development.I am writing to express our concern with the CMS draft agreement for manufacturers for participation in the Medicare Part D Coverage Gap Discount Program.  Specifically, we believe that the restrictions on labeler codes and disallowance of mid-year agreements may cause delays in access by Medicare recipients to new, innovative drugs from manufacturers who are bringing a drug to the market for the first time.  We recommend CMS establish a process for new companies to enter into the Medicare Part D Coverage Gap Discount Program agreement with CMS mid-year.  The community we serve needs and deserves a timely review consistent with your other drug benefit review practices. In many cases, their lives are depending on it.Sincerely, Martha SalyDirector", "comment_id": "CMS-2010-0196-0010", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0196-0010", "comment_date": "2010-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1572}, {"text": "1.The definition of manufacturer appears to include repackagers.  How are repackager products going to be treated? 2.There is a general concern about how the electronic list of NDCs will be updated and communicated out to Plan Sponsors. Could you clarify the requirements around maintaining the online electronic database? We recommend CMS include a requirement that manufacturers have to make sure they provide current data information electronically as well as NDCs. We believe this requirement could mitigate the risk of claims being adjudicated incorrectly based on incorrect NDCs.3.We are concerned that the manufacturer contract does not include language related to the distinction of this discount program from the rebate agreements. The overall risk is that monies will be taken from rebate agreements and affect the overall DIR.  While there has been guidance delineating expectations, there has not been any formal requirements placed on these manufacturers.In order to mitigate this risk, we recommend the following contractual language:The Manufacturer hereby acknowledges that the discounts payable under this Agreement shall not change any negotiations between Part D sponsors or other entities with the Manufacturer to obtain additional rebates, discounts, or other price concessions for drugs purchased in the Coverage Gap or throughout the Part D benefit.  CMS expects that the Manufacturer will continue to engage in such negotiations and provide such price concessions on applicable drugs available throughout the Part D benefit and in the Coverage Gap.4.We agree with the language CMS provides regarding the penalty on late payments and believe this remedy will ensure Part D sponsor will be made whole for any cost incurred by the delay in payment.5.We agree with the language CMS provides regarding the requirement of manufacturers to pay invoices being disputed. We believe this will alleviate any burden on plans.6.As demonstrated in the statistics provided at the June 1, 2010 Gap Conference, drug manufacturers are sharply increasing the price of drugs included in this Discount Program, thereby circumventing the intent of this legislation. In order to deter this behavior, we believe a possible remedy would be to include a clause ensuring no price increases through the contract year. 7.Due to a general concern about the affect on brand drug utilization during the gap, we would like CMS to track brand drug utilization and brand price increases in applicable brand drugs once the discount program starts on 1/1/2011.8.In the event a manufacturer decides to terminate an agreement, will CMS provide language on how to handle the associated phone calls? Will CMS provide model letters describing how we should communicate this change to beneficiaries?", "comment_id": "CMS-2010-0196-0028", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0196-0028", "comment_date": "2010-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3159}, {"text": "Thank you for the opportunity to provide comments on CMS-4151-NC Medicare Coverage Gap Discount Program Model Manufacturer Agreement.", "comment_id": "CMS-2010-0196-0005", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0196-0005", "comment_date": "2010-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 133}, {"text": "Re:Medicare Coverage Gap Discount Program Model Manufacturer AgreementDear Ms. Tudor and Mr. Miner,The Caring Ambassadors Program advocates for people living with lung cancer and hepatitis C. While the disease states are very different, the needs of the patients are strikingly similar. Both disproportionately affect people of lower social and economic status and both are in great need of new and better therapies. We are concerned with CMS draft agreement for manufacturers for participation in the Medicare Part D Coverage Gap Discount Program.  As we understand it, the reliance on labeler codes in combination with not allowing mid-year agreements may cause delays in access and availability to new, innovative drugs from manufacturers who are bringing a drug to the market for the first time.   We recommend CMS establish a process for new companies to enter into the Medicare Part D Coverage Gap Discount Program agreement with CMS mid-year. Without a process for permitting new companies the opportunity to enter into an agreement with CMS when a new therapy first comes to market, beneficiaries may not have access to that new therapy for an extended period of time.  The community we serve needs and deserves a timely review consistent with your other drug benefit review practices. In many cases, their lives are depending on it.Sincerely,Lorren SandtExecutive Director", "comment_id": "CMS-2010-0196-0024", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0196-0024", "comment_date": "2010-08-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1451}]}, {"id": "FDA-2018-D-2382", "agency": "FDA", "title": "Opioid Use Disorder:  Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability ", "update_date": "2020-10-02", "update_time": "12:12:23", "purpose": "Nonrulemaking", "keywords": ["CDER", "2018-300", "Opioid Use Disorder:  Endpoints for", "Demonstrating Effectiveness of Drugs for", "Medication-Assisted Treatment", "Draft Guidance for Industry", "Availability", "OPEN"], "comments": [{"text": "I dont think that every person should be treated the same and have to go by the same guidelines! Every person is different and have different problems going on. As a 47 yr old grandmother I believe that i was treated as if i was some kind of drug addict!! I have been on opioid pain medication for several years. i have have several medical problems- which include partly of chronic pain, fibromyalgia, severe bone deterioation, 2 slipped disc in my back, had 2 complete knee replacements, sciatica, and the list goes on.  I went to all my appointments, complied with all the rules and was told they needed to cut me back because the according to the fda rules i was over medicated!  it became harder and harder for me to get my medication, and i was treated like a common drug addict because of the fda laws and rules! i dont think i was treated fairly by any means!!!! i am almost 50 yrs old and wish my life was not as it is.  I am also in end stage renal failure, so i get dialysis 5 days a week and when a person   is on dialysis it takes most of the medication out of your system  so by the time i had built anything up in my system I would be dialyized so i had to start all over again the next to get anything built up!!!! The fact that i was on dialysis had NO play in the factors of how much medication i was allowed a day.I dont think the same rules should apply to every person since everyone has different circumstances for the reason they are medicated. I wish Jeff Session would have to live a day in my shoes then have someone tell him NOPE your too medicated! So i believe each persons circumstances should be taken into consideration.  when they are prescribed pain medication., especially if they have YEARS of medical documentation of reasons fffor being on the the medication. And with all the new rules laws surrounding being on opioids it has made it just about impossible to get any help! Unless I want to pay 100s of $ because many pain doctors do not take insurance anymore", "comment_id": "FDA-2018-D-2382-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0004", "comment_date": "2018-08-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2004}, {"text": "I dont think that every person should be treated the same and have to go by the same guidelines! Every person is different and have different problems going on. As a 47 yr old grandmother I believe that i was treated as if i was some kind of drug addict!! I have been on opioid pain medication for several years. i have have several medical problems- which include partly of chronic pain, fibromyalgia, severe bone deterioation, 2 slipped disc in my back, had 2 complete knee replacements, sciatica, and the list goes on. I went to all my appointments, complied with all the rules and was told they needed to cut me back because the according to the fda rules i was over medicated! it became harder and harder for me to get my medication, and i was treated like a common drug addict because of the fda laws and rules! i dont think i was treated fairly by any means!!!! i am almost 50 yrs old and wish my life was not as it is. I am also in end stage renal failure, so i get dialysis 5 days a week and when a person is on dialysis it takes most of the medication out of your system so by the time i had built anything up in my system I would be dialyized so i had to start all over again the next to get anything built up!!!! The fact that i was on dialysis had NO play in the factors of how much medication i was allowed a day.I dont think the same rules should apply to every person since everyone has different circumstances for the reason they are medicated. I wish Jeff Session would have to live a day in my shoes then have someone tell him NOPE your too medicated! So i believe each persons circumstances should be taken into consideration. when they are prescribed pain medication., especially if they have YEARS of medical documentation of reasons fffor being on the the medication. And with all the new rules laws surrounding being on opioids it has made it just about impossible to get any help! Unless I want to pay 100s of $ because many pain doctors do not take insurance anymore", "comment_id": "FDA-2018-D-2382-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0005", "comment_date": "2018-08-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1997}, {"text": "There should be clear and unambiguous language that placebo control trials should not be designed. All endpoints should be compared to a standard of care; either buprenorphine or methadone treatment. Superiority or non-inferiority studies should be standard practice. ", "comment_id": "FDA-2018-D-2382-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0017", "comment_date": "2019-03-07", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 268}, {"text": "We approve of the FDAs assistance with the nation-wide epidemic concerning opiods. The guidance set forth by the FDA assist sponsors in developing drugs for a medication-assisted treatment of opiod use disorder, which could greatly reduce the growing number of deaths this nation faces everyday. The trials outlined are closely monitored and the patients are frquently assesed for adverse events, whcih the guidline outlines. The Guideline also specifically outlines the way a sponsor could report an outcome and change in drug use pattern. Overall, the guidance tackles the issue of the opiod epidemic and provides assistance for those trying to help. The guidance also allows for a more uniform breakdown in outcomes of patients and a variety of endpoints that can be reached. We approve of this guidance and the work of those involved to help those in need.", "comment_id": "FDA-2018-D-2382-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0008", "comment_date": "2018-10-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 865}, {"text": "People who abuse drugs and become addicted  will always find a way to get high whether the drug is legally prescribed or not . Chronic pain patients shouldnt be punished for addicts bad decisions . Youre killing me witholding medicine to improve the quality of my life . I am in control of my actions . I never abused drugs. I never failed drug tests , I am always compliant with pain contracts for 16 yrs ! I am not an addict !  Stop the torturing of people who live their lives in pain. You are destroying my quality of life ! Youre destroying my familys quality of life ! Would you watch your mother , Father  or your child scream in pain day after day ? I seriously doubt you would .I am a human being ! Treat me like one ! End the ridiculous  War on Drugs ! It didnt work for alcohol ! Speaking of alcohol. Not everyone who drinks it becomes an alcoholic .", "comment_id": "FDA-2018-D-2382-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0007", "comment_date": "2018-09-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 886}, {"text": "Since Subutex is an opioid medication used for medication assisted addiction treatment, I am assuming comments regarding that medication are welxome too. Subutex has saved my life. I was using extremely dangeous amounts of other opiates daily and after receiving Subutex, I have not touched another drug or opiate! Personally, I feel Suboxone, Bunavail and Zubsolv are all a joke. They are NOT as effective as the plain Buprenorphine and I am deathly allergic to them and no one knows the issues the long term use of Naloxone may cause and many people are becoming immune to it which means more people will die from overdose. I feel the Naloxone should be REMOVED from the medications and just plain Buprenorphine be administered. Another issue is, pharmacies are refusing to fill prescriptions for Buprenorphine for people because they say they dont carry the medication, cannot accept new patients or just because they dont want to. Also many pharmacies REFUSE to accept insurance for Buprenorphine but will accept the same insurance for any other medications they carry and this seems like it should be illegal. I had to go to mail order through OptumRX for this reason and I have to do a few days without my medication. There should be NO LIMIT on the number of patients a pharmacy can have. Also pharmacies should have to bill your insurance for Buprenorphine if they accept the insurance for ANY medication! Another thing is, pharmacies should have to fill prescriptions written by doctors in their state whether the patient resides there or not and a patients home state should honor a prescription written in any state. People seeking treatment cannot get their medications filled and its RIDICULOUS. Its time someone steps in and makws it easier to obtain medication for addiction treatment. Getting a prescription is easy but getting it filled is impossible and more people are going back to street drugs but unfortunately they have no choice.The FDA needs to step in and help out. These medications with Naloxone need taken off market and some studies done on them. They are terrible medications. Suboxone is a horrid medication that is actually dangerous and so are its alternatives! Something needs done with making access to treatment for addiction and getting addiction treatment medications filled at pharmacies easier. The restrictions need lifted and pharmacies need to fill peoples medications without the hassle. I personally checked at 100 different pharmacies in PA, WV, MD and OH trying to get my medication filled with no success. I either had to pay xash when my insurance does pay for it, they said they werent taking new patients, didnt carry it and refused to order it or just plain refused because they did not want to or because I live in WV or because my doctor is in PA. Its impossible for people trying to actually get clean and better themselves to get their medications! We need help!", "comment_id": "FDA-2018-D-2382-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0003", "comment_date": "2018-08-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2994}, {"text": "Research should reflect real world situations in order to make measurable improvements in the context of the current epidemic.  1)Typically, 70-80% of those with SUD are using multiple substances.  In light of this, published research should not simply include benefits for the target drug (e.g., opioid, alcohol, etc.) but for the full spectrum of substance use behaviors.  Failure to do so risks known increases in other drug use when one pathway is blocked as seen in the recent article by Tanum et al. (2017) which found an increase in cocaine and benzodiazepines in the buprenorphine treatment group.   2)Typically, most individuals on medication assisted treatment discontinue medication use within the first few months (Morgan et al., 2017).   In light of this, outcomes should include longer term measures, and include improvement that continues after cessation of the medication, just like penicillin or nicotine replacement.  3)Typically, like remission rates of other illnesses such as cancer, recovery rates increase with longer lengths of cessation of drug use up to five years.  In light of this, effectiveness should be measured with outcomes no less than one year, preferably three years, in order to obtain results that are most reflective of benefit to the long-term outcomes. 4)Typically, like taking half a dose of penicillin, improper treatment can lead to short term gains but longer term widespread worsening of the condition.  Therefore, while short term outcomes are beneficial for interventions such as naloxone, with medications intended to treat substance use disorder, there should be long term measure of the improvement. 5)Placebo controlled trials are the gold standard of research, and necessary research designs in order to determine that one approach is better than another.  However, in the context of opioid agonist medications, it is impossible to design such an experiment, since individuals will know they received a placebo when they start experiencing withdrawal from the opioid.  This is problematic in determining efficacy, and therefore conclusions should be appropriately tempered. Comments should be added to reflect these research related outcome issues. Thank you for your consideration. ", "comment_id": "FDA-2018-D-2382-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0016", "comment_date": "2018-10-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2502}, {"text": "re:  Medications intended to provide symptomatic relief of opioid withdrawal are not considered46 treatments for OUD, but these medications may be useful as an initial step in bringing patients47 into treatment with drugs intended to reduce the risk of returning to illicit opioid use.49 Efficacy trials of medications for the treatment of OUD have typically employed a randomized,50 blinded, controlled trial design. For medications intended for use as initial therapy, patients are51 generally new entrants to treatment (i.e., actively ill and not currently receiving other drug52 treatments for OUD), and these trials employ active controls with a superiority or noninferiority53 design. Designs generally incorporate standard-of-care nonpharmacologic treatments as well as54 active medications available on a rescue basis, with patients requiring rescue transferred out of55 the protocol to standard care. For medications intended to reduce the risk of relapse, patients56 already stable on other treatments are studied, and in general, the comparator should be an57 approved therapy. rescue treatments are critical; as with any disease, continued pharmacologic treatments are equally critical to engage the person in treatment and sustained health. ", "comment_id": "FDA-2018-D-2382-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0006", "comment_date": "2018-09-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1341}]}, {"id": "EPA-HQ-OAR-2015-0202", "agency": "EPA", "title": "Recordkeeping and Reporting Related to E15", "update_date": "2022-04-13", "update_time": "01:10:49", "purpose": "Nonrulemaking", "keywords": ["E15, Ethanol, survey", "Complex Model, 10 volume percent (vol%) ", "ethanol, 15 vol% ethanol (E15)", "retail stations, Product ", "misfueling, label, gasoline blend", "Reid vapor Pressure (RVP)"], "comments": [{"text": "To Whom it may concern  As a retiree on limited income I find it very troubling that you are even considering this for approval for summer use especiallyin the marine industry with recreational boaters. This fuel is known and proven to destroy motors on vessels as it eats thru certainparts of the motor and supply lines that feed fuel to our motors. That being said also will cause extremely hazardous conditions when fueling. God forbid one of the fuel lines rupture and fuel gets into the bilge causing explosive conditions.The E10 that we purchase currently is bad enough and has proven to be costly to me already and I can only imagine the effects that this E15 would have.    I reach out to you on behalf of all boaters in the same position as I to turn down the E15 regulation . As a boater , I have enough to worry about with the fuel I am forced to use at the current time.I remainGeorge Meissler Jr2966 Wexford roadBensalem,Pa., 19020mousey10850@verizon.net", "comment_id": "EPA-HQ-OAR-2015-0202-0012", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0012", "comment_date": "2019-03-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1237}, {"text": "I am not in favor of E15, It has not been proven to be a good option for most cars and trucks.", "comment_id": "EPA-HQ-OAR-2015-0202-0023", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0023", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 99}, {"text": "Im totally against the increase of ethonal fuel sold here in pa. It is very detrimental to 2 stroke engines and the like , and straight gasoline is not a available just anywhere to be had.", "comment_id": "EPA-HQ-OAR-2015-0202-0028", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0028", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 193}, {"text": "I am against any ethanol in gasoline, let alone 15%. I am also against any subsidization of the ethanol industry. That is called crony-capitalism. With all due respect, I am also against un-elected bureaucrats enacting rules and regulations. I am afraid that it doesnt matter what people like me think, administrative agencies are going to do what the political agenda bureaucrats in these agencies want to do anyway.", "comment_id": "EPA-HQ-OAR-2015-0202-0040", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0040", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 458}, {"text": "I live in South Dakota having the ability for our farmers to sell corn for ethanol would be huge boost to our economy. It would also help a lot with gasoline prices especially during the summer and the prices spike so much. I feel we only need to have labeling on the pumps to explain people which vehicles are authorized to which ones are not an allowed to sell all year round", "comment_id": "EPA-HQ-OAR-2015-0202-0056", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0056", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 377}, {"text": "Please do away with E-85 fuel. Last summer I couldnt buy any fuel for my Harley motorcycle and put this into my bike to get me to another station. It eat up all my rubber gaskets and ruined my engine. Now I have a $5000 boat anchor. It would be nice to send you that bill. Do away with this harmful fuel. Use the corn to feed the people. Just gas is way more efficient to run vechicals and we should of never been forced to use E-85 fuel in the first place. Thank you,Neil DeWitt ", "comment_id": "EPA-HQ-OAR-2015-0202-0058", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0058", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 500}, {"text": "I am all for less regulation of ethanol sales, among other things.  If this can help reduce the subsidies (welfare) that the growers require to produce the ethanol, this is definitely a step in the right direction.  However, if the plan is to funnel more subsidies (welfare) to the growers because they are losing money, perhaps the ethanol fuel needs dropped in favor of the growers producing cash yielding crops and lessening their dependence on tax payer monies.  For instance, if the growers were to grow corn for distilling into spirits instead of fuel, perhaps that would reduce or eliminate the need for subsidies (welfare).As a consumer, my benefit from ethanol is supposed to be lower gasoline prices on the blended fuels.  In western South Dakota, a lot of stations are marginally lower and sometimes the same price.  The last estimate I heard was there should be a $0.14 per gallon difference in E-10, but that was many years ago.  I see around $0.10 at best, but thats a rare occasion.  Its time to stop wasting time, resources and money.  Actually, it has been that time for decades.  Now do it!", "comment_id": "EPA-HQ-OAR-2015-0202-0063", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0063", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1128}, {"text": "i am against e15.  it ruins car engines", "comment_id": "EPA-HQ-OAR-2015-0202-0065", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0065", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}, {"text": "Thank you for allowing comments on this exciting opportunity, please go forward with the year round sales of E-15, it is a win-win situation for all involved.", "comment_id": "EPA-HQ-OAR-2015-0202-0066", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0066", "comment_date": "2019-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 158}, {"text": "Growing corn for fuel defies common sense.  It still requires fossil fuels to harvest and is incompatible with all 3 of my vehicles; model year 1983, 2004, and 2007.  It is NOT better for environment when the water required for processing is considered.  It also requires yet more effort and therefore more cost to ship another type of fuel.  The United States would be a much better place without the socialist construct of forcing everyone to subsidize farmers for growing this crop.  ", "comment_id": "EPA-HQ-OAR-2015-0202-0088", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2015-0202-0088", "comment_date": "2019-04-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 487}]}, {"id": "FDA-2008-P-0116", "agency": "FDA", "title": "Requesting Expansion of Availability of Nicotine Replacement Therapy to Consumers Who Use Tobacco - CLOSED", "update_date": "2022-01-05", "update_time": "01:03:08", "purpose": "Nonrulemaking", "keywords": ["NRT", "CDER", "nicotine", "tobacco", "replacement therapy", "CLOSED"], "comments": [{"text": " As someone who works with tobacco users young and old every day I am very muchin favor of the proposed changes in NRT labeling. People who smoke and want toquit need to have it be easier to get medication than it is to buy another packof cigarettes. Being over the counter is not sufficient.Individuals should be able to buy treatment as readily as they can buycigarettes, in convenience stores and any store that sells tobacco. I dontthink this should be optional. I think that stores that sell tobacco should berequired to sell nicotine replacement products as well. In addition a personshould not be faced with having to pay $40.00 for 2 weeks worth of nicotinepatch or $5 for a pack of cigarettes. If dailly doses of patches were availablethey would only have to pay $3 for a single patch. It makes no sense to make iteasier to buy cigarettes than it is to buy treatment when the treatment isactuallly cheaper but costs more due to being packaged as a pack of 14 insteadof a single days allotment. It is also important to  label the products so thatpatients will not be frightened by a patch that could save their lives thinkingit will cause them to have a heart attack if they smoke a cigarette while on thepatch since this is not true. Products need to be labeled so that it is clearthat they are so much safer than cigarettes there is really no comparison. Allof these recommendations have particular benefit for those who have low incomewho are of course the ones most likely to continue to smoke. These changesshould help them in their efforts to quit tobacco by making it more financiallyfeasible for those who dont have medical coverage for tobacco treatment.Although there are many states that provide free nicotine patches there arestill at least half of the states that do not provide free patches through thetelephone helpline. California , where I live and work is one state that doesnot provide free patches and regulation changes like those proposed will help tooffset this problem.I am extremely hopeful that these bold recommendations will be followed soon sowe can continue to stem the tide of deaths due to smoking.Cathy McDonald, MD", "comment_id": "FDA-2008-P-0116-0036", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0036", "comment_date": "2008-08-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2321}, {"text": " Medicinal nicotine products should be widely available to consumers.  They should be available wherever cigarettes are sold, in package sizes that can be competitively priced with cigarettes, and with package information that accurately informs smokers about the risks and benefits of medicinal nicotine relative to continued cigarette use.  Widespread availability of medicinal nicotine likely will increase smokers access to and use of the products, as well as smokers familiarity and experience with the products.  As smokers become more experienced using these products, their chances of quitting smoking successfully will likely increase.  Jim", "comment_id": "FDA-2008-P-0116-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0020", "comment_date": "2008-04-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 703}, {"text": "As a Nurse Pracititoner I have seen the harm caused by primary and secondhand smoke, such as in Chornic Obstructive Pulmonary Disease, Lung Cancer, and asthma exacerbations.  One of the actions that may/will help people quit and thus expose fewer people to secondhand smoke is to make nicotine replacement more accessable.  Please allow broader availability of nicotine replacement for example that it be sold in the same places that cigarettes are sold ie liquor stores and gas stations.  These same locations sell aspirin and Tylenol, why not nicotine replacement?  Thank you for your attention to this matter.Susan H. Ward, MSN, APNP", "comment_id": "FDA-2008-P-0116-0035", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0035", "comment_date": "2008-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 681}, {"text": "As a coordinator for a tobacco cessation program, I urge the FDA to adopt the recommendations in Dr. Daines petition.  Not only would these recommendations help people quit tobacco, they would also help people who slip and start using tobacco again after quitting.  If we really want to help people end tobacco use, this is a good way to do so!", "comment_id": "FDA-2008-P-0116-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0043", "comment_date": "2008-09-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 381}, {"text": "When providing cessation counseling you find that many people want to quit and they actually go through the process.   Unless a program is providing free Nicotine Replacement Therapy (NRT), cessation is difficult for those who need to maintain their quit status and want to use NRTs.   Not having access or resources available tends to create a barrier to treatment with no true accountability.  From a treatment perspective, if the FDA makes the products more consumer friendly, more individuals, especially those in underserved communities, will notice that the pharmaceutical industry is interested in their well being by bringing the prices and units to a level that is considered affordable.  The tobacco industry knew exactly what to do when they began to market, package and price their products.  They made it look appealing to the consumer.  Now its time for treatment to look just as appealing.", "comment_id": "FDA-2008-P-0116-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0038", "comment_date": "2008-08-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 968}, {"text": "There is no reason why those who choose to quit cigarette smoking shouldnt have readily available access to over the counter nicotine replacement therapy at affordable for all prices.  For the good of the public health, and the cost burden of smoking tobacco products, help make NRT readily available to all who desire it and need it!!thank you, Margaret Murphy, RN MS", "comment_id": "FDA-2008-P-0116-0029", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0029", "comment_date": "2008-08-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 413}, {"text": "The detrimental effects of cigarette smoking are well documented, and nicotine clearly is not the worst constituent.I highly support suggested labeling changes, and cost/pricing alterations to make these products more widely accessible. ", "comment_id": "FDA-2008-P-0116-0044", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0044", "comment_date": "2008-09-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 257}, {"text": "Cold Turkey has always been the best way to quit smoking.  NRT is very ineffective.  The American Cancer Societys 2003 Cancer Facts and Figures report asserts that 91.4% of all successful long-term quitters quit entirely on their own.  A 2006 Australian study found that 88% of all successful quitters quit smoking cold turkey and that cold turkey quitters were twice as likely to succeed as those using the nicotine patch, nicotine gum, nicotine inhaler or Zyban (bupropion). http://whyquit.com/whyquit/LinksCAids.htmlThe loosening of regulations on the places and means in which NRT is sold is just an excuse for the pharmaceutical companies to expand their market share of an ineffective and costly product.Jeremy Richards, Ph.D.", "comment_id": "FDA-2008-P-0116-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0040", "comment_date": "2008-08-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 807}, {"text": "Roswell Park Cancer Institute strongly supports the State of New York Department of Health - Citizen Petition that requests the FDA to increase access to over-the-counter nicotine replacement medications.  ", "comment_id": "FDA-2008-P-0116-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0031", "comment_date": "2008-08-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 216}]}, {"id": "FDA-2018-N-0987", "agency": "FDA", "title": "Patient-Focused Drug Development on Opioid Use Disorder; Public Meeting; Request for Comments", "update_date": "2021-03-26", "update_time": "01:01:57", "purpose": "Nonrulemaking", "keywords": ["2018-86"], "comments": [{"text": "The rules regarding opioid use are getting ridiculous.  You are hurting chronic pain patients!  Every month, we must see our Pain Management Doctor and pray that he isnt going to try to wean us off our medications.  I take a 12 hour in the morning and at night, with two breakthrough pills inbetween.  I am barely able to function with my pain but there is no way I can try to request my dosage to be upped during this current climate, and I have been on the same dose for 3 years following a very large tumor removed from my spinal canal that has now become arachnoiditis.  Opioids are the ONLY thing that seems to let me have halfway of a life currently.  If I did not have them, I would not be able to function AT ALL due to my pain and limited ability to move throughout my day.  Please, when you start putting these restrictions on paid meds, you MUST think about the chronic pain community.   We have NO OTHER OPTIONS for pain management, especially living in a State where marijuana and even kratom are illegal.  If I had to live with this pain and no opioids at all, I would probably just kill myself.  This is barely a life, but taking my meds allows me to make coffee for my family, shower, and do minimal cleaning.  I wouldnt be able to do anything without my meds, and by making this so difficult, I am totally afraid to ask for something stronger even though my condition is even worse than it was three years ago.  Why are we not exempt from any kind of restrictions if we have pain that is never going to go away and are permanently disabled?  Dont we have a right to try to be as normal and pain free as other people?  Im tired of feeling ashamed every time I go to my appt and have to do demeaning things like drug tests, fill out pages of paperwork, etc.  This is not right!!!  If we go to pain management, we are obviously complying and will comply so dont make us suffer for those who are straight up drug users and oding on stuff that they dont legitimately need.  The people who are seeing their doctors each month are complying so please...enough with the restrictions!  And bring us MORE choices on pain pills!  Or medical marijuana! Or both preferably!  Its inhumane this current climate for me and fellow pain sufferers!!!  Its our bodies and we are not children! Id love to put my name on here but I dont need to be flagged!!!  One day, you will all see why we are scared.  If you get in a car accident or something and have pain like we do, you will understand why we need to be able to keep getting our medication.", "comment_id": "FDA-2018-N-0987-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0025", "comment_date": "2018-05-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2598}, {"text": "This whole meeting seems to be on the effects that opioids have on a person using these pain medicine.  However, you are not taking into consideration the many people who take these for many years to have some quality of life.  When a person is injured with permanent pain or has a medical condition where pain is constant, these opioids give them a little quality of life. To live with constant pain without these medications, life is not worth living. Yet, you expect those people to stop a drug cold turkey.  That is impossible.  These people are not drug addicts but depend on these drugs to survive through the pain. We were originally told that anyone on this medication before 01/2018. that they could continue their meds.  Now, the dose has been cut and another drug has been ordered,which was tried in the past and did not relieve the pain.If you want to stop people from O.D.ing, go to the Police Departments and get a list of all the people who have been arrested for the use and selling of these drugs and deny them!  Dont take away the only hope we elder people have of any quality of life. My understanding was if you do not increase the mgs or the dosage, you may be dependent but not addicted.  Now you want us to go to a pain clinic, we have, did not work! It now takes 6 months to get an appointment and another 2 months for shots, so in the meantime, are we going to have withdrawals?  It looks to me like we may have to become alcoholics to numb the pain!  Just consider what you are doing to the legitimate opioid users. Thank you.", "comment_id": "FDA-2018-N-0987-0052", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0052", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1569}, {"text": "I am a father of a 37 year old son who has been diagnosed with a neurological disease called RSD/CRPS from a car accident he had when he was 17 in highschool.  RSD/CRPS is rated on the McGill Pain Index as the highest known pain, above removal of a finger, or even childbirth.  He describes it as having gasoline poured on his skin and set on fire when it is not in control.  Over the last 20 years, we have tried everything we could find to stop the pain including hyperbaric oxygen treatment, anti-inflammatory drugs, tens units, hypnotic therapy, chiropractic therapy, physical therapy, too many to remember them all. For the first 10 years after the accident my son had absolutely no life, bed ridden or chair ridden in our living room.  Getting out of the house to go to the doctor was the majority of his life. About 10 years ago we found a pain management doctor who placed him on high dosages of long acting morphine and fast acting opioids. 1900MME daily plus 8mg daily of klonopin. After 4 months on the drug, he began regaining his life back.  6 years ago, even though he was legally disabled, he went to work full time for 4 years.  In August 2016 the government arbitrarily imposed its 90 MME rule, the one treatment fits all mentality. He no longer can work.  It took my son 10 years to reduce his pain medications by 65%. In January of 2017 he was on 960MME daily. Since the government intervention beginning in February of 2017, he has been forced to reduce his pain medications by another 65%, and in the process he lost his pain management doctor he had for 10 years.  He is now on 280MME and with this new pain management doctor will continue to be reduced on his pain medications. It took 6 months to find a new pain management doctor due to the 90MME regulation. To complicate matters, 10 years ago (by the same pain management doctor) he was also placed on a long acting benzodiazepine (klonopin) to combat nerve pain and the anxiety related to it. Now there has also been a restriction made that patients are not supposed to have both morphine/opioids and benzodiazepines.  It took my son 10 years to reduce 50% of his benzodiazepine.  He was expected to remove himself completely off of the benzodiazepine (4mg daily) in 4 months or completely remove himself off of the morphine and opioids.  He could not complete either task of complete removal of either drug and this is why he lost his pain management doctor of over 10 years,He has been physically tortured for the last 22 months, and is losing his life due to crippling pain again.  Due to these forced pain medication reductions, his heart rate has been exceeding 200 bpm and his blood pressure has gone as high as 230/140. Since the reductions he has been placed on (4) blood pressure medications to keep him from having a stroke.  Being on that many blood pressure medications causes him to feel severely depressed, which prior to these reductions was not the case. The pain could actually kill him.  His sleep cycle is all but non-existent.  The forced reductions has also caused periodic states of mental instability, which he never had issues with before Were all worried that his depression will eventually take his life.  ", "comment_id": "FDA-2018-N-0987-0062", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0062", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3272}, {"text": "Ibogaine (or 18-MC)Its been ignored long enough to the point of willful negligence. ", "comment_id": "FDA-2018-N-0987-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0016", "comment_date": "2018-04-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 94}, {"text": "What is being done at a local level to prevent judges and correctional facilities from discriminating against those seeking or receiving methadone treatment?Methadone being withheld and refused to inmates precipitating withdrawal with INTENT to punish.Judges mandating forced detoxification  from methadone, or incarcerating those who refuse to, and/or fail to do so.Judges sentences including mandated levels of care, as if they are licensed healthcare providers capable to determine best practices.Judges including in probation guidelines that methadone/suboxone treatment programs will not satisfy the requirements for drug treatment to complete probation.", "comment_id": "FDA-2018-N-0987-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0008", "comment_date": "2018-04-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 684}, {"text": "Hello: Seems to me, maybe incorrectly... that [both big pharma AND] the FDA do a good job of shoving the Ibogaine topic to the background.  Just 30-days ago, as of April 20th 2018, I was FREED from a literal 30-year dependence (OK, addiction) to prescription opioids!  That freedom was gained within mere hours of a ONE-TIME TREATMENT with Ibogaine Hydrochloride at https://BajaIbobaineCenter.com in Rosarito, BC, Mexico.Either the FDA and big pharma will [eventually] work together and explore via clinical trials the Ibogaine promise, or there WILL BE an uprising within the patient community, Im sure!  Ibogaine, Ibogaine Hydrochloride, norIbogaine and the root of it all, the Iboga plant needs immediate focus!  -Stanley Poe / northwest, Ohio", "comment_id": "FDA-2018-N-0987-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0010", "comment_date": "2018-04-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 800}, {"text": "Later I will forward a letter written on behalf of a patient who after 10 years had his buprenorphine discontinued by insurance and we wrote the letter to the insurance commission and they are in process of investigating.In the midst of an opiate death epidemic why would anyone refuse an effective Sched III opioid, Buprenorphine for pain??Most insurance cos. are doing this. Only a few medicaid committees will allow it for pain. Washington St. a positive example. Idaho and other NW states would rather have everyone take opiates. Hmmm, in view of the epidemic, why should this happen?? Talk about a no-brainer. Well rub your fingers together, it is all about money. The drug insert that insists on the use of Suboxone, which is 3x subutex is a problem as well. Subutex is safe and generic. We have been using it off-label for years for pain. Still not cheap, but a lot cheaper than dying. By itself, and no CNS issues, no ODs reported, on buprenorphine. Even ins. companies are still forcing that, even though 30%  GI intolerance is an issue due to the naloxone. Clearly the drug is safe, even when used IV. But, guess what, the drugs pharmacokinetics by itself (agonist/antagonist) give it a ceiling beyond which it blocks itself and can make you sick if you take too much. . This feature makes it unattractive to the majority of abusers. It ceases giving a high and being fun. That is one reason no ODs reported and it is such a great drug for addicts. Insurance cos keep reading the drug handout and refuse to make wise decisions, and even some certified MDs do too.  It is abused and sold, but that is ok for the recipient. They need it to relieve their withdrawal, if they can find a certified doc to rx., which they cant. Docs can learn to do this without a course. They do so for opiates, which are a lot more dangerous to rx. Finally what kind of pain med do you want for your family, a safe one or an opiate that can cause OD deaths, especially if available for theft in your med cabinet? IV drug was approved for pain years ago and my surgeon daughter who used it during residency in 2000 reports it works great and no issues for post op pain. Maybe fentanyl will be needed if you break a leg, especially if you already take it for anything else, including addiction.  Recently 2 opiate use disorder pts had a headon and broke their legs. Ortho called for anesthesia and they used a general with ketamine, which can cause dissociative thinking in adults. A good trade, no?  Good solution, docs. By the way, the vets are way ahead of us, finding it effective for their patients in an oral solution. In a few years the medical community and general public will all realize the safety and effectiveness of buprenorphine, and it will become the go to drug for pain. Cost and insurances that want to cut down allowed doses are the only barriers now. ", "comment_id": "FDA-2018-N-0987-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0038", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2934}, {"text": "I saw two patients in the hospital this evening with endocarditis, a life-threatening infection of the heart, due to intravenous injection of buprenorphine-naloxone. One is 29, and was just told today that his heart is inoperable and he should be put on hospice. I asked the other to put her thoughts on paper, and this is what she wrote:Im a mother of 3 beautiful, smart, wonderful children (whom I have lost custody of due to IV drug use). It all really took off 4 years ago when I was introduced to Suboxone. I had been sick, throwing up sick, for a week, with no relief in sight. I was in the bathtub feeling like I was dying when my brother came in and told me he had something to make me feel better instantly. And yes, I wanted relief! He fixed me up a rig full of Suboxone and injected it into my arm. Within 5 minutes I was setting at the kitchen talbe, eating cereal and feeling much better. From that day on I was an IV Suboxone user. Me or my brother neither one had it prescribed, so we bought it off the street. I wish I had never ever ever met Suboxone. I didnt know none of the risks of using it the way I did (IV). It sets up infection in your blood, heart and possibly your brain. It can take a year to fully detox from. I have been in the hospital for 3 weeks and will be here for another three so they can run antibiotics continuously to rid my body of infection. I was on the verge of death when I first got here. but Im grateful for this rock bottom Ive finally hit. Its taken me almost dying to realize my worth and to open my eyes up to how bad drug use is everywhere. If my story can help just one person then Ill forever be happy. Im still very sick but getting better, one day at a time!!", "comment_id": "FDA-2018-N-0987-0069", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0069", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1770}, {"text": "Since before my force taper from 450MME for 11yrs I was able to care for myself, my family, my 83 yr old mother, 76 yr old mother inlaw.  Since the beginning of my force taper I am bed bound and unable to care for myself.  My husband has had to cut back on work to care for our whole family.  We are being foreclosures on our home because of my lupus, fibromyalgia, severe DDD with 3 herniated disks, chronic fatigue and other autoimmune diseases.  I dont no what we are going to do now!  I am so scared and in chronic pain 24/7!  Please help me help myself!  My high dose narcotics were helping me live a life.  Still in pain but nothing like this. I beg you to stop this CDC Guidelines, etc so I can get my life back if it not already too late.", "comment_id": "FDA-2018-N-0987-0060", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0060", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 746}, {"text": "Thank you for hearing our stories. It is my sincere prayer that you read them with open hearts and minds. I am a 54 y/o woman with spinal stenosis, bulging and herniated disks, fusion and bone spurs in C 3-6 stemming from an accident in 1998. The initial pain was excruciating and I was given opioids for one month. My pain subsided in the weeks to follow and I spent the next 11 or so years in discomfort at times that I would treat with Tylenol or Ibuprofen. The only time I had a thought of opioids was when the subject came up in the news. I mention this to bring light to the fact that my exposure did not cause me to become an addict. I went on to enjoy a full life filled with physical activities that I loved such as running, hiking, spelunking, not to mention raising three kids and owning and operating a very demanding construction company.Fast forward 11 years... My neck began to give me trouble, it was hurting worse and more often. I found myself running less, hiking less and being thankful that the kids were older and no longer needing my role as soccer mom. I began to see a wonderful chiropractor who was adamant about never cracking my spine. While I truly liked him as a person and respected his profession, he was not helping me. I asked him about surgery and was told I was not a good candidate.  My neck was getting worse, and fast. In 2009 my sister was diagnosed with stage 4 colon cancer. With no husband or children to help her I took on the job of caregiver, a job I wouldnt have missed for the world. However, it was during this time that I sought a Drs care once again for my neck pain. I was referred to a pain management specialist in her state of Ohio. He prescribed low-dose oxycontin which afforded me the opportunity to care for my sister without having down time due to my own pain. I saw that specialist for almost a year before I returned home, opioid dependant and had several days of discomfort and thought I would go back to otc medications, which I suffered through for the next couple months (Still not an addict) before seeing a specialist here to treat my pain once again. His treatment had allowed me to enjoy my life as any normal person would. I hiked, worked, enjoyed my grandchildren, etc., etc. I have been with this Dr. since 2011. Over the years my tolerance has risen to my highest dose of 180 MME per day. This was working for me. It was working well.  Due to the CDC recommendations my doctor was bullied into going against best practice and I was tapered by 25%, then most recently, 33% of that for a total of a 50% reduction in medication and what my Primary Care Dr. refers to as a cocktail of other drugs in its place, which includes a 500% increase in Gabapentin  (from 600mg per day to 3000mg per day), 150mg Voltaren, 75mg Soma and Tramidol as needed. This has led to a virtual collapse in my life. I can no longer do the small things that most people take for granted. Things such as my own grocery shopping (4 times out of 5), no thought of going on a hike or planning a day at the zoo with my grandchildren. We have a family reunion planned this summer, which I had to back out of, as the thought of traveling and participating in large functions for a week is a distant dream. I spend most days gingerly counting my steps, careful not to step too hard or try to navigate any uneven terrain - if I can manage to walk at all. I am increasingly isolated from family and friends, which I will admit, depresses me at times.It is baffling to me how the CDC can scare good doctors into stopping treatment for pain patients that gives us quality of life! I implore you to take this power away from them.  I have read that even they say their arbitrary recommendations were not researched, nor do they apply to chronic pain patients.This is the short version of my story. Thank you for taking the time to consider it in your Drug Development Policy.Sincerely,Beckie", "comment_id": "FDA-2018-N-0987-0059", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0059", "comment_date": "2018-06-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4036}]}, {"id": "FDA-2017-D-6878", "agency": "FDA", "title": "Hypertension: Developing Fixed-Dose Combination Drugs for Treatment", "update_date": "2018-03-28", "update_time": "16:20:03", "purpose": "Nonrulemaking", "keywords": ["2017-1001"], "comments": [{"text": "Hypertension: Developing Fixed-Dose Combination Drugs for Treatmentit is very true, majority of hypertensive patients are on a combination of anti hypertension medication. may be its long time in the coming to have a written document on how to combine HTN medication, especially for primary care providers.A lot of drugs are a combination of at least 2 already, which is a great advance in medicine! I dot think physicians should try any medication, combination or single, and track results, not just leave the patient on a medication indefinitely not knowing whether its working or not.These upcoming new developments in fixed dose combinations should be suggestive, not a regulation however as I would like to beleive that Doctors have enough training and knowledge to make the final decision when it comes to their patients, and not be told but regulatory government companies.Thank You for your consideration,", "comment_id": "FDA-2017-D-6878-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-6878-0004", "comment_date": "2018-03-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 938}, {"text": "THE FIXED COMBINATION DOSE TREATMENT FOR HYPERTENSION IS IDEAL FOR PATIENTS WHO DO NOT LIKE TO TAKE MULTIPLE DOSES OF MEDICATION. HOWEVER, FOR SEVERAL YEARS NOW INSURANCES, INCLUDING MEDICARE D PLANS, HAVE REFUSED TO PAY FOR COMBINATION MEDICATIONS. PROVIDERS HAD TO SEPARATE THE COMBINED INTO TWO DIFFERENT PRESCRIPTIONS IN ORDER FOR PATIENTS TO AFFORD THE TREATMENT. THANK YOU.BILLIE JANICE GRANTHAM-NAPIER, DNP, FNP-CDOCTOR OF NURSING PRACTICE, FAMILY NURSE PRACTITIONER", "comment_id": "FDA-2017-D-6878-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-6878-0003", "comment_date": "2018-01-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 498}, {"text": "We congratulate the Agency on this guidance and believe it outlines several important clarifications and improved pathways. The rationale for better blood pressure control and better blood pressure combinations is well made.We would like to offer three points of discussion:1.We support the statement The FDA encourages sponsors to market dose combinations that represent clinically meaningful titration steps, but would like to make some related points on this matter:-It would be helpful to quantify this requirement - perhaps at least a 3.0/1.5 mmHg difference between titration steps.-We see a risk of a double standard being introduced, as the proposed standards for titration steps for combination therapy have not been applied to monotherapy, and the vast majority of up-titration steps within monotherapy regimens confer blood pressure (BP) reductions of 3.0/1.5 mmHg.1 Since presumably it is not feasible to revise monotherapy labels, we suggest it would be appropriate to add information to the labelling of dual combinations on the effects of up-titration of the monotherapy components within the combination, by way comparison. For example, for a combination of AB the effects of titration across dose versions of AB would be reported alongside previous evidence on the effects of dose titration for drug A and drug B separately.  -We see the potential that clinically meaningful could be misinterpreted as clinically identifiable. Consideration should be given in the labelling to note that the signal-to-noise ratio for BP measurements means that on an individual basis it is practically impossible to reliably determine the size of the blood pressure change from any individual dose titration step. We suggest that in clinical practice, drops in BP in the weeks and months after initiating treatment are often wholly attributed to that treatment or treatment up-titration step, when in fact they are substantially due to the effects of regression to the mean - hence prescribers can easily overestimate the efficacy of initial treatment, or an early up-titration step. But also, sometimes true treatment efficacy can be masked by the play of chance in BP levels at different clinic visits.2.We support the use of the advocated figure Probability of Achieving Systolic Blood Pressure Less Than 140 mmHg and suggest this could be improved with the addition of a time dimension, and plots for SBP 130mmHg as well as 140mmHg. Furthermore, we advocate an additional figure outlining the evolution of treatment effects over time, with placebo-corrected differences from baseline plotted weekly. A major reason for treatment inertia is the belief that the full treatment effect is yet to emerge and that it takes many months for the full pharmacological benefits to be apparent.2 Informative data assessing treatment effect evolution over time from a placebo-controlled setting would therefore be helpful for prescribing clinicians. 3.Finally, we note that the guidance does not anticipate labelling to reflect the benefits of fixed-dose combinations (FDCs) for improving adherence and overcoming treatment inertia, resulting from the many and varied barriers for patients, physicians and payers in following hypertension treatment algorithms. Furthermore, one of the most important benefits appears to be in overcoming barriers to treatment initiation (or re-initiation) and up-titration among people who are undertreated.34 Previous trials have often focused on FDC vs the monocomponents taken as separate pills, in tightly controlled settings in which adherence has been optimized in order to assess equivalence over short periods of time and support a substitution indication - such trials are not informative regarding the role of FDCs in overcoming treatment inertia in real clinical practice. We note the challenges for a regulatory agency in including comparison groups that are usual care i.e. heterogeneous and often suboptimal. And furthermore, we note that in clinical trials the usual care group often receives care that is in fact better than average, which will tend to lead to underestimation of the benefits of FDCs compared to true usual care. We would suggest nonetheless The Agency provide guidance on study design for Sponsors seeking to add an improvement in adherence to the labelling of an FDC.Anthony Rodgers, Abdul Salam, Emily AtkinsThe George Institute of Global HealthUniversity of New South WalesSydneyAustralia1.Law MR, et al. BMJ  2003;326:1427-31.2.Ferrari P, et al. Reasons for not intensifying antihypertensive treatment (RIAT): a primary care antihypertensive intervention study. Journal of hypertension. 2004;22(6):1221-9.3.Webster et al. International journal of cardiology. 2013;170(1):30-5.4.[22 March 2018]. Available from: http://www.acc.org/latest-in-cardiology/articles/2018/03/07/15/53/mon-8am-triumph-low-dose-triple-combination-bp-lowering-pill-acc-2018.", "comment_id": "FDA-2017-D-6878-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-6878-0005", "comment_date": "2018-03-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5535}]}, {"id": "NRC-2016-0185", "agency": "NRC", "title": "NRC Enforcement Policy Revision; Processing Fitness-for-Duty Drug and Alcohol Cases", "update_date": "2019-05-28", "update_time": "11:03:06", "purpose": "Nonrulemaking", "keywords": ["fitness-for-duty"], "comments": [{"text": "I support this.Catherine Corn", "comment_id": "NRC-2016-0185-0009", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0009", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Catherine corn", "commenter_lname": "Catherine corn", "comment_length": 39}, {"text": "Please Look at all of these nuclear worker/nuclear supervisor failures for fitness of duty at nuclear power stations--http://enformable.com/?s=fitnessTherefore, please keep monitoring nuclear workers /supervisors as stringently as is necessary for such an important job.Thank you.", "comment_id": "NRC-2016-0185-0004", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0004", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 341}, {"text": "You must continue to do your job and supervise the nuclear workers and watch for their being drugged up or drunk.  You are supposed to be a regulator and monitor the nuclear power stations-utilities.  A drunk or drugged up worker or a marijuana stub found every few months is very serious.  The US NRC needs to stop having weird party luncheons and get to work.  ", "comment_id": "NRC-2016-0185-0002", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0002", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 373}, {"text": "ID: NRC-2016-0185-0001The Nuclear Regulatory Commission needs to not only continue regulating but to expand its job as a regulator of Fitness of Duty at nuclear sites rather than formally cease to regulate and throw it to the nuclear utilities-industry, as appears to be its current plan.  As is routinely the case, the NRC is also violating the clear writing rule, so it is impossible to be certain of what this proposal is about.  The Fitness for Duty rule should be zero tolerance and expanded to uranium mining and any other nuclear sites which you are supposed to supervising.  You must not only continue to regulate, oversee, and investigate drug and alcohol use at nuclear power stations and nuclear fuel sites, but should increase and improve oversight.  It is important that there is a public record of these events.  It would be a good idea to have a system where workers can only access the site after a breath test.  Furthermore, you need to have someone who has decent mastery of the English language write these documents, as required under the clear writing rule.   ", "comment_id": "NRC-2016-0185-0012", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0012", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1160}, {"text": "Im in favor of this revision. If  the U.S. Nuclear Regulatory Commission believes that they need to make improvements towards the supervision of their licensees employees than I believe its a positive change. With this new rule change, I hope that the NRC will feel as if they can oversee drug and alcohol enforcement policies efficiently. It was noted in the docket that in March of 2008, the NRC found Instances of individuals violating FFD DA procedures at licensee sites. These types of cases result from a range of issues including failed drug tests, alleged attempts to subvert FFD testing, alleged possession or use of illegal drugs or alcohol, or alleged misuse or failure to report the use of prescription drugs. This explains that theres a need for the NRC to have more authority over this kind of safety, and I think the change will be a step in the right direction for better safety. ", "comment_id": "NRC-2016-0185-0008", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0008", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Audrey", "commenter_lname": "Anonymous", "comment_length": 938}, {"text": "Dear NRC,RAdiation Free Lakeland are a voluntary nuclear safety group in Cumbria, UK.  We have thousands of supporters from all walks of life.  We strongly object to any weakening of the drugs testing regime for workers at nuclear installations. We strongly oppose drugs testing being carried out by the industry itself.  This self monitoring excludes any public scrutiny and increases the risk of nuclear accident, damage to public health and the environment.  Drugs Testing regimes should be carried out by autonomous  regulators and NOT by the nuclear operators or companies involved.  Our members who have worked in the nuclear industry tell us that nuclear workers are no different to the rest of society and that drugs are accessible.  To leave monitoring to the industry would be deliberately reckless.  NRC Must Ensure Scrutiny. Yours sincerely,MArianne BirkbyOn behalf of Radiation Free LakelandLA77DJUK", "comment_id": "NRC-2016-0185-0006", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0006", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Marianne", "commenter_lname": "Birkby", "comment_length": 967}, {"text": "I encourage you to keep  monitoring and investigating nuclear workers for drug and alcohol and not leave it to the utilities-fuel fabrication companies.This needs to be done By the NRC as an independent exercise. ", "comment_id": "NRC-2016-0185-0005", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0005", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "David", "commenter_lname": "Holman", "comment_length": 213}, {"text": "And,  of course, the NRC should continue to monitor safety issues that have direct proportional effects to danger to the public. It should go without saying that a part of that would be insuring that plant operators be fit for duty.", "comment_id": "NRC-2016-0185-0011", "comment_url": "https://api.regulations.gov/v4/comments/NRC-2016-0185-0011", "comment_date": "2016-12-02", "comment_time": "05:00:00", "commenter_fname": "Kathryn", "commenter_lname": "Bankston", "comment_length": 237}]}, {"id": "CCC-2011-0001", "agency": "CCC", "title": "Tobacco Transition Payment Program;\r\nCigar and Cigarette Per Unit\r\nAssessments", "update_date": "2014-11-05", "update_time": "13:49:44", "purpose": "Rulemaking", "keywords": ["tobacco", "Cigar and Cigarette Per Unit", "Tobacco Transition Payment Program"], "comments": [{"text": "General Comments ", "comment_id": "CCC-2011-0001-0003", "comment_url": "https://api.regulations.gov/v4/comments/CCC-2011-0001-0003", "comment_date": "2011-05-03", "comment_time": "04:00:00", "commenter_fname": "Jame", "commenter_lname": "Deers", "comment_length": 17}, {"text": "Gereral Comments. ", "comment_id": "CCC-2011-0001-0004", "comment_url": "https://api.regulations.gov/v4/comments/CCC-2011-0001-0004", "comment_date": "2011-05-03", "comment_time": "04:00:00", "commenter_fname": "Parodi", "commenter_lname": "Company", "comment_length": 18}]}, {"id": "FRA-2001-11212", "agency": "FRA", "title": "Alcohol/Drug Regulations; Temporary Post Accident Blood Test Procedures", "update_date": "2021-02-10", "update_time": "01:34:21", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "this is a good rule", "comment_id": "FRA-2001-11212-0002", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2001-11212-0002", "comment_date": "2011-11-02", "comment_time": "04:00:00", "commenter_fname": "John", "commenter_lname": "Anonymous", "comment_length": 24}]}, {"id": "CMS-2010-0258", "agency": "CMS", "title": "Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes (CMS-4144-P)", "update_date": "2021-03-26", "update_time": "01:07:31", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Resubmitting NHIA January 11, 2011 comment letter as a Word file.  Previous submission was a pdf file.  Comments on both formats are identical.", "comment_id": "CMS-2010-0258-0126", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0126", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 143}, {"text": "The Alliance of Community Health Plans (ACHP) appreciates the opportunity to comment on the proposed rule published in the Federal Register on November 22, 2010 relating to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs for Contract Year 2012. ACHP is a national leadership organization representing community-based and regional health plans and provider organizations that collectively provide health care and coverage for approximately 18 million Americans.  Our members are not-for-profit health plans or subsidiaries of not-for-profit health systems; most cover substantial numbers of Medicare Advantage enrollees. Member plans share longstanding commitments to their communities, close partnerships with providers, and substantial investments in the innovative approaches and infrastructure necessary to provide health care that is coordinated, affordable and high quality.ACHP appreciates the work that CMS has done to implement provisions of the Affordable Care Act to date.  In the current proposed rule, we are especially pleased that CMS has moved forward on the Medicare Advantage quality incentive provisions, reflecting Congressional intent to incorporate value-based payment across Medicare.  In this letter, we discuss a number of areas where our member plans have expressed concerns about the proposed rule and recommend modifications.  Please see detailed recommendations in the uploaded file.  ", "comment_id": "CMS-2010-0258-0161", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0161", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1476}, {"text": "Please accept my comments on the proposed rule to set a threshold of 10% for translated Medicare materials.  Even in California, where we have a very diverse population, many languages would be dropped from translated materials with this threshold.  A 5% threshold is a much more appropriate one and is consistent with the many California administrative, regulatory, and legislative threshold, not to mention the DHHS OCR guidance letter on Title VI.At Asian Health Services (community health center in Oakland, CA), we routinely translate written communications with our patients, even for those who make up less than 3% of our patient population.  This means our materials are routinely written and produced in English, Chinese, Vietnamese, Korean, Khmer and many times in Tagalog too.Thank you for your attention to this very important issue for limited English speaking health care purchasers.  ", "comment_id": "CMS-2010-0258-0242", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0242", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 919}, {"text": "On behalf of Lincoln Behavioral Services and myself, I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here. I am Chair of the Board of Directors of Lincoln Behavioral Services, a Community Mental Health agency.The 10% standard is far too high.  A more appropriate standard would be 5% of population, or 500 persons in service area.  10% should not be used here.  Many of our clients are refugees or immigrants who have limited English.  If they cannot receive written materials in a language they can understand, they cannot access theiir services and are deprived of equal protection of the law.", "comment_id": "CMS-2010-0258-0020", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0020", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 665}, {"text": "On behalf of myself and the millions of LEP seniors, I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here.  I am the Director of Health Education for the California Family Health Council and have been assisting public health providers in improving their responsiveness to the linguistic and cultural health care needs of their clients. The 10% standard is far too high.  A more appropriate standard would be 5% of population, or 500 individuals served in an agency as a whole(includes multiple clinic sites), whichever is lower.  10% should not be used here. The impact on our clients when they cannot get documents in a language that they understand is enormous. This population is very vulnerable, not only because of their age and their increasing health needs, but also because of their limited reading skills. their ability to manage their health conditions is compromised when they are given materials that they cannot read.  The regimens provided are usually very complicated and must be followed precisely as indicated (i.e., cataract surgery requires the use of 4 to 8 different types of eye drops before and after surgery, in different dosages and at different times). One client not understanding their regimens is one too many.  The consequences of not understanding can be devastating, especially with this population who often times have multiple health conditions.  Are health outcomes no longer important to our health care system?", "comment_id": "CMS-2010-0258-0034", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0034", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1495}, {"text": "I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here.  I am daughter of two immigrant parents, a former teacher in an immigrant community, and an immigrant rights advocate; I know the struggles faced by non-English speaking individuals and families.  I also know that smaller immigrant populations are often overlooked in our attempts to the service the larger, more common ethnic groups.  The 10% standard will only perpetuate this neglect of smaller linguistic groups.  A more appropriate standard would be 5% of population, or 500 individuals served, whichever is lower.  10% should not be used here.  Furthermore, access to documents in a language that the individual understands is especially critical in the health care field since it often involves technical and medical language that even intermediate English speakers may not understand.  Finally, the income based disparities in health care services and outcomes has been well documented by Dr. Paul Farmer and others, and this 10% rule will only exacerbate this growing divide.  For the foregoing reasons, I ask that the new rule apply the 5%, or 500 individuals served, standard.", "comment_id": "CMS-2010-0258-0049", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0049", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1189}, {"text": "The proposed rule change that would result in a new, higher threshhold of 10% of a population as the trigger point at which Medicare plan documents must be translated into the recipients language is TOO HIGH!  This would have a huge impact on communication with Limited English Proficient Medicare recipients, and would ultimately lead to poor care and poor outcomes, potentially increasing health care costs in the aggregate.  As a health care professional with many years of experience in working to improve improve language access for LEP patients, and who has seen first-hand the impact of language barriers in health care, I strongly urge that this threshhold be set at 5% of the population or 500 individuals as the trigger for translation of plan documents into non-English languages.Sincerely,Sharon Englert, MBADirector, Patient Relations and Interpreter ServicesLoyola University Health System(708) 216-5142", "comment_id": "CMS-2010-0258-0025", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0025", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 967}, {"text": "On behalf of myself, my employer - Language Line Services, and the individuals who will be most affected by this rule - the millions of limited English proficient patients who utilize Medicare services, I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here.  I have personal experience with a similar rule.  As a former New York State Health Official back in 2006, we worked closely with the healthcare industry and the patient advocate organizations to develop a regulation which provided enhanced patient equity for limited English proficient patients while also providing a reasonable and cost-effective threshold for the healthcare providers.  The 10% standard is far too high.  A more appropriate standard would be 1% of population.  This is the standard that was used by the New York State Department of Health.  This standard is codified in 10NYCRR 405.7 of the New York State Health regulations.  I think that CMS should review this regulation and discuss with officials from the New York State Department of Health how this threshold was arrived at and the impact of the threshold.  I personally feel that the 1% threshold goes a long way to reduce healthcare disparities that exist between English speaking patients and those that have limited English proficiency.  Any threshold higher than 1% continues a policy of providing unequal treatment for these individuals.  Additionally, studies have shown that with better communication - both written and oral - higher patient satisfaction is achieved as well as improved health outcomes.  With the US population becoming more diverse, it is time for CMS to set a positive example for the country and select a 1% threshold. ", "comment_id": "CMS-2010-0258-0026", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0026", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1748}, {"text": " I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here.  I am a graduate student at University of Pennsylvania, studying TESOL - teaching English to the students of Other Languages. I interact many bright and smart students of diverse ethnic and age group, who makes our society more fruitful and posperous. The 10% standard is far too high.  A more appropriate standard would be 5% of population, or 500 individuals served, whichever is lower.  10% should not be used here.Because this will really affect my students, their parents and family, this issue is rather personal to me. Please consider altering this law, to make every individuals need and concern.Thank you.", "comment_id": "CMS-2010-0258-0041", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0041", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 747}, {"text": "On behalf of the National Center for Youth Law (NCYL), I wish to comment on the 10% threshold for translating Medicare plan materials that is codified here.  I am a staff attorney at NCYL and represent Medicaid-eligible children, many of whom have limited English proficiency or whose parents or adults who make healthcare decisions for them have limited English proficiency.  A core element of NCYLs work for these children is to ensure that they and the adults making healthcare decisions for them receive adequate notice of services available under Medicaid as well as notice of reductions, terminations, and denials of services and their right to a fair hearing.  Although the proposed regulations at issue are intended to affect only adult Medicare beneficiaries, such regulations could set precedent for regulations governing Medicaid and other health plans and health insurance exchanges currently under development, including those affecting children.  The 10% standard is far too high.  If a similar standard was used for Medicaid plans, many of our clients would not receive translated materials.  This could greatly impact their ability to access important services or exercise their right to a fair hearing if important services are reduced, terminated, or denied.  A more appropriate standard would be 5% of population, or 500 persons in service area, which would affect a much smaller population.  10% should not be used here.", "comment_id": "CMS-2010-0258-0103", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0258-0103", "comment_date": "2011-02-24", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1459}]}, {"id": "HHS-OS-2019-0008", "agency": "HHS", "title": "Pain Management Task Force Meeting with CMS", "update_date": "2019-07-08", "update_time": "14:31:42", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Dear Sirs and Madams,I am a Thoracic surgeon in Manchester NH and want to share my experience with you regarding Cryo-analgesia nerve block application for post thoracotomy and VATS lung surgery pain. I have been utilizing the Atricure Cryo-sphere prob for the last six years on over 400 cases of both thoracotomy and Minimally invasive VATS and robotic cases. I have seen a dramatic reduction in post operative narcotic requirement post op in many cases No narcotics have been needed. A recent study published in the AATS journal has shown that 14% of post thoracotomy and 9% min invasive VATS lung surgery patients are at sig risk for opiod addiction. I have just submitted an abstract to the AATS for publication demonstrating that in a single institution case comparison review we document a overall five fold reduction in post op narcotic use in patients who received cryo-analgesia. This highly effective procedure is not reimbursed for as such the hospital has to absorb the cost for the technology. I believe it would be much more utilized across the US if hospitals could be appropriately reimbursed. This procedure has added a critical advantage in my post operative care with improved outcomes and significantly reduced need for narcotics.Please feel free to contact me if you have further questions.Thank you,SincerelyCurt Quinn", "comment_id": "HHS-OS-2019-0008-0027", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0027", "comment_date": "2019-07-08", "comment_time": "04:00:00", "commenter_fname": "Curtis", "commenter_lname": "Quinn", "comment_length": 1365}, {"text": "Hello,I am a trauma surgeon working in two busy level one trauma centers in Florida, Delray Medical center and St. Marys medical center, Florida. As a trauma surgeon I encounter and treat the widest range of all  conceivable causes of acute and chronic pain. From the cancer patient that in addition to the chronic pain due to  cancer has suffered a traumatic event due to a motor vehicle crash.  A gunshot victim that has acute pain due to the devastating injury Which then will be complicated by expected chronic pain.  The child that was burned in a family barbecue in over 30% of her body, and many more. We have great solutions to help manage acute pain but when it comes to chronic / prolonged pain especially in trauma we try to decrease over use of narcotics.  I would like to bring forth to the committee additional modality for pain control that has been overlooked and in my experience has decreased my narcotic outpatient prescription by more than 80%.  This Remarkable decrease in the use of narcotics were specifically affective patients that suffered severe traumatic chest wall injury.   Cryo-ablation, Nurolysis of intercostal (thoracic) nerves  by means of freezing the nerves provides relief from pain from an approximate. 4 to 5 months.  This new approach has reduced my dispensing narcotic practice by more than 80%. This is a remarkable amount. The major impediment to allow even wider use of this technology is directly related to the lack of reimbursement.   The side effects is numbness at the injured site for a period of 4 to 5 months followed by  recovery of the sensation at the injured site long past the time that the injury required to heal. while obviating the need for narcotics to aid in pain  management. Please consider allowing reimbursements for this procedure that affords a remarkable alternative that proven to be safe.  Thank you, Nir J. Hus,  MD, PhD, FACS. Trauma Surgery,General Surgery,Acute Care Surgery,Trauma  Surgical Critical CareDelray Medical Center, Delray FL. Assistant Professor of Surgery School of Medicine, Florida Atlantic University, FLDrNirHus@gmail.com", "comment_id": "HHS-OS-2019-0008-0025", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0025", "comment_date": "2019-07-08", "comment_time": "04:00:00", "commenter_fname": "Nir", "commenter_lname": "Hus", "comment_length": 2191}, {"text": "I  want to comment on the opioid crisis that is plaguing our society with false propaganda about overdoses. I am a disabled retired Electronics Technician at 63 years old and worked at it for years and carried heavy equipment practically each time I had a job to do which included near at least 40 pounds of test equipment.  My body aches from head to toe. I have a condition of my neck since 1987 called Cervical Spondylosis and had to work through the pain until about 2006 until my body could not take it anymore. During the late 1990s to the turn of the century I was diagnosed with Lumbar Spondylitiis after I fell on my tailbone and it would not heal. About the turn of the century I worked for a wireless corporation and was sent on simple jobs such as just walking through the New Orleans Convention Center with a small phone when my back gave out and it was either call 911 or find an empty corridor in which I could lie down which I did to recover enough to get home to take my pain pills and muscle relaxer (Soma) winch helped so much and now cannot get a prescription for.them... THANK YOU FOR THAT!  Since the turn of the century, Ive had 2 right breast surgeries, a torn meniscus surgery in which Im about to have on my other knee. An abdominal hernia surgery and a Total Knee Replacement Surgery with another knee in the wake of the same fate. Now I am racked with pain of arthritis and just because other people do not have or have been lucky enough not to feel this pain, want to ban pain medications because someone overdoses, they feel they must take everything off of the shelves. I know a few addicts and believe me, they just dont OD from prescription drugs. They like to add Heroin, Xanax, Soma when it was available, benzodyazapines, cocaine and Meth and I dont mean one at a time either. They will take as much as they want with no regard to what may happen. I also think the government wants to blame the pharmaceutical industry, doctors and pharmacies for their overdoses. I think this is propaganda to throw people off because the real problem is in the streets and the DEA and other Federal agents want to throw the attention on something they can control instead of kingpins such as Pablo Escabar or El Chapo who someone will step in there shoes when they are gone. So they (The Feds) can control the FDA and regulate what drugs we take instead of going after the big fish to keep their election going. So go ahead and take away our pain meds so we can just lie in bed all day suffering hoping we will die soon to get some form of relief. Also if you do take pain meds off of the shelves, have you thought what legitimate pain sufferers might do to get relief. Probably go to the streets. Now do you want to make a junkie out of a legitimate pain sufferer? Think about it.  THANK YOU FOR LETTING ME BLOW OFF A LITTLE STEAM BUT IT IS TRUE!", "comment_id": "HHS-OS-2019-0008-0002", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0002", "comment_date": "2019-06-12", "comment_time": "04:00:00", "commenter_fname": "Paul", "commenter_lname": "Ross", "comment_length": 2893}, {"text": "As a thoracic surgeon, I see the impact chest pain has on patients with rib fractures and chest surgery. Patients can have debilitating pain for weeks. The typical treatments of pain like this are narcotics, but studies suggest that patients who take narcotics for more than 6 weeks are at higher risk of taking narcotics for months. Regional anesthesia can be used to provide relief for these patients. Exclusion of regional anesthesia from the global billing period is a significant disincentive to utilization of these techniques. I believe that this exclusion has a perverse effect of increasing long term narcotic use, which is fast becoming a national health emergency. Please consider excluding regional anesthesia from the global billing period.", "comment_id": "HHS-OS-2019-0008-0013", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0013", "comment_date": "2019-07-08", "comment_time": "04:00:00", "commenter_fname": "Christopher", "commenter_lname": "Towe", "comment_length": 765}, {"text": "My 23 year old pain is insane! I have massive rods and metal holding my back together and in 24 unbearable pain constantly and with new restictions I cant even get out of bed! ", "comment_id": "HHS-OS-2019-0008-0003", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0003", "comment_date": "2019-06-24", "comment_time": "04:00:00", "commenter_fname": "Robert", "commenter_lname": "Sheerin", "comment_length": 181}, {"text": "The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM)  commends the Pain Management Best Practices Inter-Agency Task Force for its final report for non-opioid, best-practice options to manage acute pain. The NCCAOM appreciates the Task Forces commitment to addressing the countrys pain and opioid crisis by recognizing and supporting non-pharmacological pain-management options.  The NCCAOM seeks to ensure the publics safety and well-being by establishing and promoting national, evidence-supported competence and credentialing standards for the acupuncture profession. Each year, the NCCAOM certifies 1,200 -1,500 acupuncturists and represents almost 18,000 nationally board-certified acupuncturists. In recent years, the NCCAOM has advocated for acupuncture services as a supplement to, or replacement for, opioid prescriptions for chronic and acute-pain complaints. The NCCAOM applauds the final reports multimodal approach that includes medications, nerve blocks, physical therapy, and other modalities such as acupuncture for managing acute pain.  The NCCAOM also appreciates the final reports biopsychosocial care models to promote a multidisciplinary approach to treating chronic pain. The NCCAOM specifically supports the Task Forces following initiatives: Section 2.1  Approaches to Pain Management:  Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes whenever possible, using the Veterans Administrations (VA) and the Department of Defenses (DOD) collaborative, stepped, pain-care model.Section 2.6  Complementary and Integrative Health: Grow the evidence base to standardize and implement complementary and integrative pain-management options.  Section 3.3  Education: Educate patients and practitioners about recommended non-opioid, non-pharmacological treatment options to make them aware of the available, personalized treatment options.Section 3.4.2  Insurance Coverage for Complex Management Situations: Recognize and address the barriers that inadequate reimbursement presents to facilitate payment models that recognize and reimburse holistic, integrated, multimodal pain management. Section 3.4.3  Workforce:  Increase the pain-specialist workforce such as certified acupuncturists and create incentives for multidisciplinary pain-management teams and programs of excellence to treat diverse and complex pain conditions. oThe NCCAOM strongly recommends that efforts to integrate practitioners into the healthcare delivery system should ensure these clinicians meet appropriate training requirements. oThe Final Report highlights the VAs efforts to provide collaborative, integrative pain care to its beneficiaries. In doing so, the VA has expanded access to acupuncture for all covered veterans, and help ensure patient safety and quality by requiring NCCAOM board certification for all of its acupuncturists. This standard helps ensure that all practitioners are qualified to provide reliable, high-quality care to patients. Other entities should use the VA model to develop appropriate workforce requirements for pain- management practitioners. The NCCAOM thanks the Task Force for prioritizing efforts to improve pain management across the country, and looks forward to continuing to support efforts in the acupuncture environment. The NCCAOM stands by as a resource and partner combatting opioid misuse, overuse, dependency. Please contact Molly Giammarco, Senior Manager, Government Relations for the NCCAOM, with any questions. ", "comment_id": "HHS-OS-2019-0008-0024", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0024", "comment_date": "2019-07-08", "comment_time": "04:00:00", "commenter_fname": "Molly", "commenter_lname": "Giammarco", "comment_length": 3930}, {"text": "Vanila M. Singh, M.D., MACMChief Medical Officer, Chair, Pain Management Task Force, Office of the Assistant Secretary for Health and Human ServicesDr. Singh and Honorable Members of the Task-Force,Thank you for the opportunity to comment on the upcoming meeting between the Pain Management Best Practices Inter-Agency Task Force and the Health and Human Services (HHS) department.  We are looking forward to the discussion on payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues outlined in section 6032 of the SUPPORT Act.Our comments in this letter will focus on the potential clinical benefit with medical devices used during open cardiac and thoracic surgery (with acute pain associated with a thoracic intervention) and the lack of coverage and incremental payment options available for providers for non-opioid pain management modalities.Cardiac and Thoracic Surgical Procedures: Medical Device SolutionsThere are over 500,000 cardiac and thoracic (CT) surgical procedures annually.  According to the Society Thoracic Surgeons (STS), 1 in 7 (~14%) of patients undergoing CT surgery are at increased risk for long term opioid addiction (~70,000 annually).  In May 2018, then FDA Commissioner Scott Gottlieb testified before Congress on the agencys approach to this crisis, There are also a lot of medical device alternatives and we have approved over 200 different ones that help treat pain.  Non-opioid medical device strategies for managing pain have the potential to make a significant impact for this important clinical problem.  One such treatment available is cryothermic nerve ablation, which is a procedure that freezes peripheral nerve endings near the site of surgical incision to temporarily block the transmission of pain signals to the brain after surgery.  Currently, there is a FDA 510K-cleared medical device available for cryoablation (the AtriCure cryoICE and cryoSPHERE probe). This technique can be used with a variety of cardiac and thoracic surgical procedures, such as heart valve replacement, coronary artery bypass, pneumonectomy, thoracoabdominal interventions, lung transplants, thoracic trauma, and pectus repair.  The procedure adds 10-15 minutes to the total surgical procedure time.  The ablated nerve endings grow back over 30-60 days post-surgery, and during this time pain sensation near the incision site may decrease, and the need for opioid use is potentially decreased. (See studies referenced below).However, incremental payment for the hospital for adding cryoablation to the existing cardiac/thoracic procedure does not exist. The current CMS payment mechanism does not allow incremental payment for this procedure. We specifically would like HHS/CMS to consider the following:1.Cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management is considered a second adjunctive procedure, and under the current CMS inpatient payment system, only one MS-DRG is allowed payment during the patient inpatient stay2.Cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management has been available for a number of years, and is not eligible to meet CMS New Technology Add-on (NTAP) criteria3.The lack of additional hospital reimbursement for cryoablation for nerve block during surgery, for the specific treatment of post-operative pain management has limited patient access for opioid sparing procdures4.We ask HHS/CMS to consider alternative payment options for opioid sparing medical devices that are used adjunctively during surgery for the specific purpose of post-operative pain management; e.g. incentive payments, CMMI quality programs, add-on payments, etc.We thank HHS for considering medical devices as one part of the solution in the opioid epidemic.  We are available to discuss this important topic further and look forward to working with HHS and CMS to advance best care for patients.Sincerely,Michael Ferguson, PhDVice President, Healthcare Economics and ReimbursementAtriCureReferencesGraves. C.E., et al. Intraoperative intercostal nerve cryoablation during the Nuss procedure reduces length of stay and opioid requirement: a randomized clinical trial. Journal of Pediatric Surgery in press, (2019).Harbaugh, C.M., et al. (2018). Comparing outcomes with thoracic epidural and intercostal nerve cryoablation after Nuss procedure. J Surg Res, 231: 21723.Kim, S., Idowu, O., Palmer, B., Less, S.H. (2016). Use of transthoracic cryoanalgesia during the Nuss procedure. J Thorac Cardiovasc Surg,151(3): 8878.Keller, B.A., et al. (2016). Intercostal nerve cryoablation versus thoracic epidural catheters for postoperative analgesia following pectus excavatum repair: preliminary outcomes in twenty-six cryoablation patients. J Pediatr Surg, 51(12): 20338.", "comment_id": "HHS-OS-2019-0008-0005", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0005", "comment_date": "2019-06-24", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Ferguson", "comment_length": 5257}, {"text": "CMS opioid prescribing guidelines neglected to exclude Sickle Cell Disease (SCD) from the guidelines. The result was unnecessary suffering by patients affected by SCD. Physicians used these guidelines and under treated the severe pain associated with SCD. CMS therefore had to later clarify these guidelines. It is my hope that this error is not repeated. Prior to the opioid crisis patients living with SCD were already struggling with receiving adequate and timely acute and chronic pain control. This experience has escalated due to the current environment. I speak as a retired physician who cared for patients with SCD and an individual living with SCD.", "comment_id": "HHS-OS-2019-0008-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0006", "comment_date": "2019-06-24", "comment_time": "04:00:00", "commenter_fname": "Gwendolyn", "commenter_lname": "Poles", "comment_length": 658}, {"text": "It is essential to practice safe and effective pain management for individuals who have acute and chronic pain. Pain can have a significant effect on someone and cause them to have multiple health related diseases. It can affect the way you sleep, eating right, and exercising. It can also change your mood and work and can keep you from spending time with your friends and family (ASOA, 2018). Opioids are beneficial to someone for acute pain to help manage it, especially after surgeries or a broken bone. Opioids are not safe to be on every day because they can cause respiratory depression and very addictive. This is why it is important for people who have chronic pain to find alternative ways that work for an individual, so they dont have to deal with chronic pain for the rest of their life. This also should be covered with insurance since the individual cant help it. Many alternatives can be used. For examples like Acetaminophen, Ibuprofen, Naproxen, exercise, physical/massage therapy, counseling, acupuncture, cryotherapy, steroid injections, radiofrequency ablation, neuromodulation, and possibly anti-seizure medication. Doctors should help their patients find a specific treatment that works for their patient and help get them to get it covered with insurance. Medicare and Medicaid should include these treatments in coverage for individuals so they dont have many other health problems related to chronic pain, which will cost more money in a long way. Pain management is an important topic that should be discussed and continued to be managed for individuals.", "comment_id": "HHS-OS-2019-0008-0007", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0008-0007", "comment_date": "2019-06-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1581}]}, {"id": "CMS-2009-0058", "agency": "CMS", "title": "Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010", "update_date": "2016-07-11", "update_time": "09:27:52", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.Sincerely,Jonathan Rhodes, M.D.", "comment_id": "CMS-2009-0058-5087", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5087", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3955}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a senior anesthesiology resident, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare Anesthesia Teaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.Thank you for your time and consideration.", "comment_id": "CMS-2009-0058-5203", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5203", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3945}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-5210", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5210", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3889}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-4682", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-4682", "comment_date": "2016-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3889}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-5259", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5259", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3894}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-5292", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5292", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3889}, {"text": "To Whom it may concern:I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare Anesthesia Teaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.Thank you very much for your time.Julius Zsohar III, M.D.Dallas, TX", "comment_id": "CMS-2009-0058-5260", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5260", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4005}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-4727", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-4727", "comment_date": "2016-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3859}, {"text": "I am writing to offer comments on the proposed rule for the 2010 Physician Fee Schedule.  As a practicing anesthesiologist, I am particularly concerned about the portion of the proposed rule relating to Section 139: Improvements for Medicare AnesthesiaTeaching Programs.In 2008, Congress passed, as part of MIPPA, the Medicare Anesthesiology Teaching Funding Restoration Act to restore full Medicare payment to academic anesthesiology programs.  Before passage of the bill, Medicare payment to our programs had been cut in half each time an attending oversaw two residents on cases that overlapped.  To this end, I am very pleased that the proposed rule appropriately recognizes this statutory change and proposes to pay the full Medicare fee for cases involving a teaching anesthesiologist and one or two residents (that are not concurrent to other cases) or one resident case that is concurrent to another case paid under medical direction payment rules. I strongly believe that CMS made the correct decision for these cases.I further believe that CMS made the correct decision with respect to payment for anesthesia services furnished by a teaching nurse anesthetist with a student nurse anesthetist, as well as the payment policy for an anesthesiologist, or an anesthesiologist and nurse anesthetist jointly, with a student nurse anesthetist. It is encouraging to see that CMS recognizes the significant differences in experience, education and other qualifications between anesthesia residents and student nurse anesthetists.However, I am disappointed that after acknowledging We do not have data on the extent to which anesthesia handoffs occur during resident or other cases, or whether quality of anesthesia care is affected CMS chose to narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.  Anesthesia handoffs are a common and necessary part of running a quality and efficient operating room, especially in academic settings where the cases are often longer and more complex than in smaller, non-teaching settings, and where medical expertise is often needed to teach a particular skill or to staff a particular case at any given time.  To arbitrarily raise this issue now directly contradicts anesthesiologys nationally recognized patient safety record, as well as the Congressional intent of providing full funding for overlapping cases as they are currently staffed in every academic program in the country.Anesthesiology is proud of its reputation for quality and the recognition it has received for such efforts by the Institute of Medicine and other sources. We achieved this reputation with current practice, not despite it. Handoffs are a normal part of anesthesia care. They allow smooth, seamless and safe treatment of patients.  Prohibiting anesthesia handoffs would have a ripple effect throughout operating rooms by creating staffing problems in hospitals, which would in turn lead to longer wait times and generally compromise safe and efficient patient care.In the final rule please implement the option that was articulated, but not proposed, and permit different anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia case.  This will ensure that anesthesiology residency programs receive full Medicare payment for overlapping cases, just as Congress intended.", "comment_id": "CMS-2009-0058-5299", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2009-0058-5299", "comment_date": "2016-01-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3859}]}, {"id": "FDA-2008-N-0448", "agency": "FDA", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid (GHB); Ketamine; Dextromethorphan; N-benzylpiperazine (BZP); 1-(3-trifluoromethylphenyl)piperazine (TFMPP); 1-(3-chlorophenyl)piperazine (mCPP); 1-(4-Methoxyphenyl)piperazine (MeOPP); 1-(3,4-methylenedioxybenzyl)piperazine (MDBP); Gamma-butyrolactone; 1,4-Butanediol", "update_date": "2022-01-05", "update_time": "01:03:23", "purpose": "Nonrulemaking", "keywords": ["cder", "James R Hunter"], "comments": [{"text": "Comment submitted by Hyman, Phelps  McNamara on belhalf of Jazz Pharmaceuticals Inc.", "comment_id": "FDA-2008-N-0448-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0028", "comment_date": "2013-02-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 89}, {"text": "Jazz Pharmaceuticals believes that the current scheduling is appropriate and further revision to Schedule 2 or 3 would not serve the public health interests.  Please see attachment.", "comment_id": "FDA-2008-N-0448-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0008", "comment_date": "2008-10-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 191}, {"text": "To whom it may concern,We represent the Narcolepsy Network, a patient support organization for people with narcolepsy, their families, friends and treating professionals.We are just completing a very succesful conference for our members.Many of our members use Xyrem (sodium oxybate) and feel that they have been able to lead a normal life since they started using this medication.Two of us work in the office at the Narcolepsy Network and we are only able to do this work, because we use Xyrem. Before Xyrem, the quality of life of two of our staff members was negligible and their sense of self value was one of unimportance. One has narcolepsy with cataplexy. Eveline Honig, Executive Director of the Network does not have narcolepsy, but has seen many people function so much better in their work and personal lives after they started using Xyrem. The people we know have been very responsible with their Xyrem regimen.Sincerely,Eveline Honig, MD, Executive Director, NNJoyce Scannell, Office Manager, NNKathleen Randell, Accounting Manager, NN", "comment_id": "FDA-2008-N-0448-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0005", "comment_date": "2008-10-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1158}, {"text": "October 3, 2008Division of Dockets Management(HFA-305)Food and Drug Administration5630 Fishers Lane, rm. 1061Rockville, MD 20852Re: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs;  Dextromethorphan , 73 Fed. Reg. 51823 (September 5, 2008) [Docket No. FDA-2008-N-0448]Dear Sir or Madam:We are pleased to provide comments to the Food and Drug Administration on our perspectives related to the impact of potential international restrictions being placed on dextromethorphan.  The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies. Its more than 170 chain member companies include regional chains with a minimum of four stores to national companies. NACDS members also include more than 1,000 suppliers of pharmacy and front-end products, and nearly 90 international members representing 29 countries. Chains operate more than 39,000 pharmacies, and employ a total of more than 2.5 million employees, including 118,000 pharmacists. They fill more than 2.5 billion prescriptions yearly, and have annual sales of over $750 billion. For more information about NACDS, visit www.NACDS.org.Dextromethorphan is a safe and highly-effective antitussive.  It is non-addictive.   It is the most common ingredient in over-the-counter cough medicines in the United States.  Dextromethorphan has no practical alternative.  It was approved by the FDA in 1950s to replace codeine in cough syrups to prevent codeine abuse. When used in therapeutic doses, dextromethorphan produces very few side effects and has a decades-long history of safety and efficacy.  We ask FDA to recommend to WHO that dextromethorphan not be subject to additional action by WHOs Expert Committee on Drug Dependence after the April 2009 pre-review.   Additional action is not warranted, and could lead to substantial negative impacts upon U.S. citizens.1.Legitimate use of DextromethorphanDextromethorphan is the most commonly used antitussive in the United States.  It is available without a prescription, but is also included in some combination prescription products.  It has been commercially available as an antitussive since the 1950s, and has a long and well-established history of safety.  It is very well tolerated and is highly efficacious in the treatment of acute coughing, especially related to respiratory infections.  It is available in both solid and liquid dosage forms.  It is used for both adult and pediatric patients.  2.Abuse of DextromethorphanAlthough dextromethorphan is an inherently safe substance, we are aware of reports of individuals taking massive doses, such as 25 times or more of the recommended dose, to achieve a hallucinogenic effect.   Most of this abuse is of the finished, commercially-available products, which are swallowed whole.  To our knowledge, chemical extraction is extremely rare.  We are not aware of any routes of administration for abuse besides oral.  This inappropriate use is among teenagers; in fact, the abuse of prescription and non-prescription medications commonly found in home medicine cabinets is a problem somewhat unique to the current generation of teenagers.  This abuse, and how to address it, are common topics of debate and concern among policymakers.  We expect the abuse of these products by teenagers to wane over time both as a result of successes from educational and similar efforts to reduce abuse, and as the novelty of abusing these products diminishes.3.Control of DextromethorphanSince dextromethorphan in not an addictive substance, it is not subject to the controlled substance laws of the United States federal or state governments. It is commonly available in nonprescription preparations, and can be purchased at most retail outlets in the country.  While the ingredient is not subject to controls and while we are unaware of any reports of unfinished dextromethorphan being illegally diverted from the supply chain, it is important to note that we recognize there are reports of isolated incidences of teens purchasing the unfinished, bulk ingredient as a drug for abuse.  Because unfinished dextromethorphan can pose a greater risk given unknown doses and an ability to take extremely excessive amounts, the National Association of Chain Drug Stores supports bills before the U.S. Congress to make the illicit distribution of unfinished dextromethorphan illegal.  Neither the House nor the Senate bill would schedule dextromethorphan in a finished product form, and the Senate bill would prohibit possession or distribution of unfinished dextromethorphan by anyone who does not have a legitimate need for it.4.Impact of SchedulingIf dextromethorphan were to be placed under international control, we fear that it would lead to unnecessary and burdensome restrictions on American consumers ability to access highly safe and effective antitussive preparations.  International controls would likely lead to increased controls in the United States, such as requirements for a practitioners prescription, or even scheduling under the Controlled Substances Act.  This may lead to unnecessary increases in health care costs due to consumers having to seek office visits with practitioners in order to obtain prescriptions to treat common colds and coughs.  Moreover, this would likely lead to greater abuse of codeine, a substance that is well-known as being potentially addictive and for which abuse does occur.  Many states in the United States do allow for the purchase of codeine-based antitussives without a prescription.There is no practical alternative to dextromethorphan available.  The only other FDA-approved over-the-counter cough suppressant available in the United States is diphenhydramine, which causes drowsiness.  Diphenhydramine is commonly used as an over-the-counter sleeping pill.  This somnolescent effect renders diphenhydramine an unsuitable alternative.5.ConclusionWe believe that it would not be appropriate to subject dextromethorphan to international controls.  It is not an addictive substance, its abuse is limited to a teenage sub-culture, and such abuse is dissimilar from the types of abuse we find related to Schedule I-V controlled substances.  Its abuse appears to be related to peer pressure and novelty, as opposed to physical addiction.  There is insufficient evidence that the abuse or potential abuse of dextromethorphan constitutes a public health and social problem warranting international control.  To the extent that there is local abuse of dextromethorphan, there are no indicators that international controls would address the situation.  Instead, in the isolated countries where abuse has been reported, the course taken in the U.S. provides a far better solution:  raising parental awareness and limiting access of the active pharmaceutical ingredient in its unfinished form to only those with a legitimate need.  If dextromethorphan were to be subject to international scheduling, it could have significant negative impacts on U.S. citizens, who may have no reasonable alternative to treat their coughs.  We urge the U.S. government to recommend to the World Health Organization and its Expert Committee on Drug Dependence that dextromethorphan not be considered for further action.We thank you for the opportunity to share our views with FDA on the legitimate uses of dextromethorphan, the impacts of potential scheduling changes on dextromethorphan, and related issues.   If we can provide further information or assistance, please do not hesitate to contact me at knicholson@nacds.org or 703-837-4183.Sincerely,Kevin N. Nicholson, R.Ph., J.D.Vice PresidentPharmacy Regulatory Affairs", "comment_id": "FDA-2008-N-0448-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0003", "comment_date": "2008-10-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 8659}]}, {"id": "DOT-OST-1996-1132", "agency": "DOT", "title": "Notice of Proposed Rulemaking - Amendment to Definition of \"Substance Abuse Professsional\"", "update_date": "2015-05-26", "update_time": "10:31:44", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comments of Certification Examining Board of LASACT, Inc.", "comment_id": "DOT-OST-1996-1132-0028", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0028", "comment_date": "1996-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 57}, {"text": "Comments of Council on Alcohol  Other Drug Abuse, Inc.", "comment_id": "DOT-OST-1996-1132-0012", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0012", "comment_date": "1996-04-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 59}, {"text": "Comments of IBSAC Iowa Board of Substance Abuse Certification, Ron Alexander, Marcia A. Matthews, Step Industries, Inc., New Hampshire Technical Institute", "comment_id": "DOT-OST-1996-1132-0023", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0023", "comment_date": "1996-04-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 164}, {"text": "Comments of Olcott  Associates, Consultants.", "comment_id": "DOT-OST-1996-1132-0010", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0010", "comment_date": "1996-04-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 49}, {"text": "Comments of PCACB Pennsylvania Chemical Abuse Certification Board.", "comment_id": "DOT-OST-1996-1132-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0002", "comment_date": "1996-04-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 66}, {"text": "Comments of The Wisconsin Association of Alcohol and Drug Abuse Counselors, Inc. WAADAC.", "comment_id": "DOT-OST-1996-1132-0009", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0009", "comment_date": "1996-04-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "Comments of United Behavioral Health Services.", "comment_id": "DOT-OST-1996-1132-0016", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0016", "comment_date": "1996-04-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 46}, {"text": "Comments of The Montgomery Area Court Referral Program, Inc.", "comment_id": "DOT-OST-1996-1132-0014", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0014", "comment_date": "1996-04-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 60}, {"text": "Comments of Vermont Alcohol and Drug Abuse Counselors Association.", "comment_id": "DOT-OST-1996-1132-0029", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0029", "comment_date": "1996-04-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 66}, {"text": "Comments of the Arizona Board for Certification of Addiction Counselors.", "comment_id": "DOT-OST-1996-1132-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1132-0004", "comment_date": "1996-04-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 72}]}, {"id": "VA-2017-VHA-0004", "agency": "VA", "title": "AP94 - Interim Final Rule - Fertility Counseling and Treatment for Certain Veterans and Spouses", "update_date": "2019-03-07", "update_time": "08:26:27", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Given that thousands of veterans suffer from the inability to reproduce naturally after combat or training and could benefit from the IVF treatments, it is important to note that each attempt costs $12,000, not including the medications that can cost up to $5,000, which is a lot for anyone to pay out of pocket. I do feel that for veterans with service-connected disabilities the costs should be handled, ultimately costing the veteran and their spouse nothing. I also agree with the combination of the previous comments from Morgan Rector and Julianna Duncan saying that if it was not a full service-connected injury causing them to be incapable of naturally reproducing, then the cost should be dealt with to an extent, but not fully by The Department of Veterans Affairs. I also think Steven Hams question over coverage of fertility treatments for veterans with PTSD should be examined within the regulation. ", "comment_id": "VA-2017-VHA-0004-0010", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0010", "comment_date": "2017-03-08", "comment_time": "05:00:00", "commenter_fname": "Trisha", "commenter_lname": "Gomel", "comment_length": 918}, {"text": "I have attended the past few Veterans Affairs hearings and this issue continuously arose. All references to this topic have been completely positive and there are many wishes to continue the support for FY 18. I am in accordance to these views. I believe veterans held up their promise to serve this country and the least congress can do is make sure they are served to the best of this nations ability. I agree with Trisha Gomels comment when she stated her feelings in regards to veterans with service-connected disabilities. Their costs should be covered, ultimately costing the veteran and their spouse nothing. I am also in accordance to Steven Hams question over coverage for veterans with PTSD. I think there should be evaluations for all IVF patients and spouses, as well as further evaluations for those who may be borderline on mental health issues. ", "comment_id": "VA-2017-VHA-0004-0012", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0012", "comment_date": "2017-03-15", "comment_time": "04:00:00", "commenter_fname": "Alysse", "commenter_lname": "Bustos", "comment_length": 875}, {"text": "Given the information and statistics on genitourinary injuries it should be a top priority to add fertility counseling and treatments for certain veterans to the Veterans Health Care Act. It is unfair for veterans not to have the ability to procreate because of injuries sustained at work. Also this will take stress away from current active duty, because there will no longer be a need to have children as soon as possible. With so much medical advancement for IVF the costs for treatment are no longer as high as they once were. Steven Hams comments on fertility treatment for individuals with PTSD should also be further looked at. Treatments such as IVF may not be necessary for mental situations but fertility counseling maybe a cheaper solution for these situations. ", "comment_id": "VA-2017-VHA-0004-0015", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0015", "comment_date": "2017-03-21", "comment_time": "04:00:00", "commenter_fname": "Steven", "commenter_lname": "Gullan", "comment_length": 783}, {"text": "I would like to know why my son Collin Nesbitt had to pay for IVF when he got cancer while he was in the military and lost his ability to have kids do I have to contact President Trump to get this taken care of he should be re embersed for have to pay for this.John NesbittFather of Collin Nesbitt", "comment_id": "VA-2017-VHA-0004-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0004", "comment_date": "2017-02-14", "comment_time": "05:00:00", "commenter_fname": "John", "commenter_lname": "Nesbitt", "comment_length": 307}, {"text": "I believe that The Department of Veteran Affairs should cover all In Vitro Fertilization costs for any veterans that were injured in service which resulted in the inability to naturally reproduce and their spouses. These people were selflessly serving our country and they deserve the opportunity to start a family of their own and build a life for themselves. It is the least we can do for them since they give up so much and risk their lives for the United States. Plus, In Vitro Fertilization can be very expensive and not many people can afford to do such a thing, especially veterans coming out of the service who may not have a concrete career to pay for it. I support this proposal and these new regulations and hope that this proposal is passed and that our veterans are given the choice to start their own family. ", "comment_id": "VA-2017-VHA-0004-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0008", "comment_date": "2017-02-21", "comment_time": "05:00:00", "commenter_fname": "Julianna", "commenter_lname": "Duncan", "comment_length": 823}, {"text": "my name is Tobi, am 28. I have always aspire to be a military personnel since I was little which i later change my mind. this is basically because of an uncle (US Army) that turned impotent after a severe injury during war. he is 54years old and he has no child (contrary to his wish). now he can not afford to pay for IVF likewise his insurance. implementing this rule will not only give hope to these kind of veteran but could also encourage more military aspirants.", "comment_id": "VA-2017-VHA-0004-0011", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0011", "comment_date": "2017-03-09", "comment_time": "05:00:00", "commenter_fname": "Tobi", "commenter_lname": "Olu", "comment_length": 473}, {"text": "My husband is service connected for testicular cancer and can no longer have children we recently paid out of pocket 17,000 and when we called champva and went to billing at Local VA hospital no one knew anything about this at all. Luckily my husband spoke infront of the senate committee of veterans affairs about PTSD in Sacramento at the capital building and has some of the senates personal numbers. I think he should call them about this.", "comment_id": "VA-2017-VHA-0004-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0005", "comment_date": "2017-02-14", "comment_time": "05:00:00", "commenter_fname": "Alena", "commenter_lname": "Nesbitt", "comment_length": 443}, {"text": "Submitted in response to RIN 2900AP94Fertility Counseling and Treatment for Certain Veterans and SpousesThe American Society for Reproductive Medicine appreciates the opportunity to comment on the amendments made by the Department of Veterans Affairs to its regulations allowing fertility counseling and treatment to be made available to certain veterans and their spouses.ASRM is a multidisciplinary organization of nearly 8,000 professionals dedicated to the advancement of the art, science, and practice of reproductive medicine. Distinguished members of ASRM include obstetricians and gynecologists, urologists, reproductive endocrinologists, embryologists, mental health professionals and others. Members of this countrys armed services, injured in active duty in a way that results in their inability to have children without the use of medical treatment, deserve to receive the treatments they need to build their families regardless of whether they seek this treatment while still serving or after separation from service.  Therefore, we are in support of the work the Veterans Administration is doing to develop policy and clinical guidelines, consistent with those of the Department of Defense, for providing fertility care and IVF treatment to our veterans.With 2.8 to 5% of combat injuries to US troops involving genitourinary trauma and the great majority of the injured under the age of 35, there is a definite need for fertility care for this population. While the VA has been able to provide certain fertility treatments, the agency has until now been prohibited by law from offering in vitro fertilization, preventing it from providing precisely the care needed by some of those who have been most severely injured. We remain very concerned, however, that the legislation that allows expanded assisted reproductive services, i.e., IVF, through the VA is temporary.  The need for IVF among injured veterans and their spouses is not going to disappear when the benefit included in the appropriations bill expires on September 30, 2018. The amendment made to VA regulations operates to bring the fertility treatments provided in the Veterans medical benefits package into line with the fertility treatments available through the DoD to active duty personnel, which is exactly where they need to be and where they need to stay.ASRM, working with veterans organizations and infertility patients organizations, will continue to advocate for repeal of the ban on VAs provision of IVF and to make IVF a permanent part of the Veterans medical benefits. We hope to be able to achieve this by the time the amendment expires.", "comment_id": "VA-2017-VHA-0004-0016", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0016", "comment_date": "2017-03-21", "comment_time": "04:00:00", "commenter_fname": "Eleanor", "commenter_lname": "Nicoll", "comment_length": 2725}, {"text": "I applaud the Department of Veteran Affairs for establishing the amendment to the services that are currently provided to veterans. I am glad to read (and agree) with the various comments in support of the VA offering fertility treatments to veterans suffering from the inability to procreate due to a service related injury. I believe that veterans should be able to obtain various medical care for them to live a healthy and fulfilling life. ", "comment_id": "VA-2017-VHA-0004-0014", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0014", "comment_date": "2017-03-21", "comment_time": "04:00:00", "commenter_fname": "Kayleigh", "commenter_lname": "H", "comment_length": 444}, {"text": "Im 100% service connected for testicular cancer the va paid for sperm collection I was referred to a infertility clinic by urology my wife was referred to same clinic for IVF we paid 17,000 out of pocket and it worked we have twins on the way her last treatment was October 2016 twins due June 2017. I am seeking reimbursement for the IVF. If anyone has information please contact me at collin.nesbitt@gmail.com Thank You", "comment_id": "VA-2017-VHA-0004-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0003", "comment_date": "2017-02-14", "comment_time": "05:00:00", "commenter_fname": "Collin", "commenter_lname": "Nesbitt", "comment_length": 426}]}, {"id": "EPA-HQ-OAR-2018-0775", "agency": "EPA", "title": "Modifications to Fuel Regulations to Provide Flexibility for E15; Modifications to RFS RIN Market Regulations", "update_date": "2022-04-16", "update_time": "01:03:47", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I strongly object to the introduction of E15 as a fuel. Given that ethanol free gas is not available for marine use within a few hundred miles of my area, it is likely that E10 would become unavailable too. With the existing problems that boaters face with E10, such as water absorption and phase separation, fuel hose and material compatibility,  I believe that the problems would only be worse with E15. Another point is that with the price of a 150 hp outboard at over $12,000, the warranty is void if fuel with more than 10% ethanol is used and the manufacturer warns of damage from such fuel. Keep in mind  that while boating can be fun and safe, introducing a less reliable fuel will result in more engine failures and given that some of these will occur in hazardous areas or conditions (such as offshore, in shipping channels or in bad weather), it is a needless risk to the public.leonard.simoncek@verizon.net", "comment_id": "EPA-HQ-OAR-2018-0775-0685", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0685", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 933}, {"text": "E15 is a safe fuel for vehicles and should be an option for consumers (like myself) to buy year round at any fueling station I want.  There is no reason fuel station owners should not be allowed to sell this product all year if they so desire based on their customer demand.  The oil refiners are allowed to sell their product all year without modification, etc and they are using RIN prices as a false excuse for wanting continued practices that only increase their profits while decreasing consumer options and damaging the air quality for those of us that breath air each and every day.", "comment_id": "EPA-HQ-OAR-2018-0775-0704", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0704", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 589}, {"text": "Government-mandated ethanol from corn has done nothing but drive our production agricultural system into an unsustainable and unrecoverable cycle of over-production. Please dont add insult to injury by expanding the use of ethanol from corn, farmers (and therefore, the taxpayers) will pay the eventual price for this government overreach.Ethanol is and should be an important part of our energy mix into the future. Ethanol FROM CORN is inefficient, does little to better the environmental impact of its use over fossil fuels, and moves us closer to a 1980s-style farm crisis by further incentivizing over-production. What happens to corn producers when a cellulosic ethanol enzyme is found and plants convert from corn to corn stover or biomass? The ethanol companies advocating for this policy will be just fine because the politicians theyve bought and paid for will make sure of it, but corn farmers will be left out in the cold AND it will destroy the worldwide corn market.Keep the government out of the free market - you cant even run a post office for crying out loud!", "comment_id": "EPA-HQ-OAR-2018-0775-0707", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0707", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1112}, {"text": "Joint comments (abridged) by ActionAid USA, Clean Air Task Force, Earthjustice, Mighty Earth, and Sierra Club on the Environmental Protection Agencys (EPA) proposed rule - EPAHQOAR20180775 - Modifications to Fuel Regulations to Provide Flexibility for E15; Modifications to RFS RIN Market Regulations published in the Federal Register at 84 Fed. Reg. 10584 on March 21, 2019. ", "comment_id": "EPA-HQ-OAR-2018-0775-0885", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0885", "comment_date": "2019-05-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 376}, {"text": "As an owner of a recreational boat I am concerned with the proposal to allow the year-round sale of gasoline containing 15% ethanol (E15) and its potential to damage my boats engine. I am also concerned that the expanded sale of E15 will make it difficult to find fuel, such as ethanol-free and E10 gasoline, that will not damage my engine.We, as boaters, have a lot invested in our engines, and we want to be sure that if we leave the launch ramp, our motors will not fail us due to the inadvertent use of E15. My professional mechanic urged me to never use ANY fuel with ANY alcohol in my boat engine. E15 availability would just make the possibility greater that some fuel dock might use the wrong fuel.I urge the EPA to withdraw this rule until a more robust mis-fueling mitigation program can be developed and adopt appropriate regulations to ensure a supply of fuel that is safe for marine engines. Thank you for your attention to my concerns.", "comment_id": "EPA-HQ-OAR-2018-0775-0690", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0690", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 974}, {"text": "Allow E15 for year round purchase. It will help farmers, the economy, our reduction of fossil fuel usage, and the environment as it burns cleaner.", "comment_id": "EPA-HQ-OAR-2018-0775-0735", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0735", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 146}, {"text": "Allowing E15 all year long is a great thing. Get this approved and move it forward.", "comment_id": "EPA-HQ-OAR-2018-0775-0736", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0736", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 83}, {"text": "The EPA needs to reject its proposal to allow year-round sales of E15 fuel.  Ethanol is hard on engines and drastically reduces fuel economy, due to its much lower energy content 76,000 btu/gal. vs. 116,000 btu/gal.  Even a lot of newer vehicles owners manuals say not to use fuel with more ethanol than E10.  Also, E15 is damaging to any small engine and nearly all boat engines.  The only reason E15 is being considered is because of the Renewable Fuel Standard, which was heavily backed by special interest groups like the ethanol lobby.  The law itself is out of date, as new drilling techniques have made the U.S. the largest producer of crude oil and natural gas in the world.  There is no reason to burn more corn in our gas tanks, when it is needed for food.E15 serves no real use, other than placating big-moneyed special interest groups and fulfilling artificial quotas, plus, ethanol requires tax payer subsidizes to be affordable.Vote NO on expanding E15!", "comment_id": "EPA-HQ-OAR-2018-0775-0738", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0738", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1002}, {"text": "I highly approve of e-15 ", "comment_id": "EPA-HQ-OAR-2018-0775-0739", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2018-0775-0739", "comment_date": "2019-05-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 25}]}, {"id": "DEA-2020-0007", "agency": "DEA", "title": "Registration and Reregistration Fees: Controlled Substance and List I Chemical Registrants", "update_date": "2021-12-02", "update_time": "01:00:58", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "My pharmaceutical company has ended contracts with the Department of the Treasury Internal Affairs Revenue Division. IRS", "comment_id": "DEA-2020-0007-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0009", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 120}, {"text": "With President Trump it always comes down to numbers. Polls! Electoral college votes! Inauguration crowds! Stock market highs! Unemployment rates!Due to the Covid-19 pandemic this has become more challenging. But Trump has continued looking for a number he could brag about. First he bragged about Americas low number of cases... which is now the highest in the world, in fact higher than the next six countries combined. Then he boasted about our relatively low mortality rate. Not only is this a bizarre statistic to crow over, the US now has more deaths than the next two countries (soon to be three) - and one of the worst deaths per population ratio on the planet. Lately Trump has bragged about how many tests weve conducted. Brilliant. Its like saying After the horse left the barn we installed the worlds best padlock.Since all of these numbers have exploded in Trumps fat face, hes shifted to attacking the numbers. Maybe were over counting Covid-19 deaths, while other countries are under counting. Maybe were doing too many tests. Maybe the worst case scenario was too low, so Trump should be given credit for saving millions of lives rather than causing over 87,000 deaths. Maybe the bad numbers are all Obamas fault.There is one number that says it all: 45. Thats the number of the Worst. President. Ever.", "comment_id": "DEA-2020-0007-0013", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0013", "comment_date": "2020-05-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1422}, {"text": "DEA 501 A", "comment_id": "DEA-2020-0007-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0004", "comment_date": "2020-03-17", "comment_time": "04:00:00", "commenter_fname": "Mendy", "commenter_lname": "West", "comment_length": 9}, {"text": "RIN 1117-AB51/Docket No. DEA-501MGP Response to DEA Proposed Registration Fees Increase 05-07-2020Morton Grove Pharmaceuticals, Inc. (MGP) is a small pharmaceutical manufacturer bordering the northwest side of Chicago that employs 177 people.  In addition to our manufacturer registration, MGP has the following registrations:Analytical LabImporterExporterList I Chemical ImporterMGP has a commitment to a vibrant DEA compliance program ensuring all MGP registrations adhere to the laws/regulations of the Controlled Substances Act (CSA).  MGP Standard Operating Procedures (SOPs) for DEA compliance are the cornerstone of that commitment, and we continually enhance those SOPs.  As a registrant who takes controlled substance compliance very seriously, MGP appreciates this opportunity to express concerns over the proposed increase in registrations fees published on March 16, 2020 in the Federal Register.   The publishing in the Federal Register of a proposed fee increase in the midst of a worldwide Covid-19 Pandemic seriously affecting both public health/safety and the economy was poorly timed.  Proposing increased registration fees, especially to small businesses like MGP, during an unprecedented worldwide health pandemic with looming economic uncertainties is not wise in these circumstances.  We recommend tabling these proposed fee increases and the comment period until January 2021 at the earliest.    In the interim, MGP proposes two alternative avenues for assessing registration fees: assessing fees based on the size of the business or having registrants with a significant history of CSA violations pay much higher registration fees.  Both proposals are discussed in more detail below.In the first proposal, registration fees would be assessed based on the size of the business (number of employees, annual earnings, etc.) for Type B registrants.  As a manufacturer, MGP competes with much larger corporate entities that have multiple facilities and more employees.  The proposed annual fee increases for MGP in the following categories amount to substantial increases for a small business:Manufacturer $3,699.00 from $3,047.00  *$652.00 increaseAnalytical Lab $296.00 from $244.00*$52.00 increase Importer $1,850.00 from $1,523.00*$327.00 increaseExporter $1,850.00 from $1,523.00*$327.00 increaseList I Importer $1,850.00 from $1,523.00  *$327.00 increaseMGP would pay an extra $1,685.00 annually.  Small businesses have to forecast sales revenue and subsequently plan operating costs in advance of their fiscal year.  While MGP can modify its operating budget for the increased registration fees, it places a financial burden on a small employer serving an important function manufacturing oral liquid and topical pharmaceutical products.  The second pathway proposed having registrants with a significant history of CSA violations pay dramatically increased registration fees is a viable option worth exploring.  Our nation has struggled with an ongoing opioid epidemic for over a decade resulting in thousands of lives lost, many people suffering from their addiction to opiates, heavy burdens on the nations healthcare system, and significant financial costs to state, county and local governments.  It is well documented that specific manufacturers and wholesale distributors contributed to this epidemic by turning a blind eye to CSA laws/regulations allured by sales of opioid medications and profits over their responsibilities as DEA registrants.  DEA registrations are issued with the understanding that any registrant must act responsibly with controlled substances.  Thus, these registrants could be assessed the significantly higher registration fees.  This format rewards compliance for both large scale business model registrants and small business registrants like MGP.   In conclusion, MGP asks that the DEA table the proposed increase in registration fees and its comment period until January 2021 as our nations priority now is to focus numerous resources on public health/safety measures to fight the Covid-19 Pandemic.  At that time, MGP would welcome discussion on the two alternative avenues for assessing registration fees: assessing fees based on the size of the business for Type B registrants and/or having registrants with a significant history of CSA violations pay much higher registration fees.  ", "comment_id": "DEA-2020-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0007", "comment_date": "2020-05-11", "comment_time": "04:00:00", "commenter_fname": "Tim", "commenter_lname": "Lenzi", "comment_length": 5511}, {"text": "I am writing against the increased fees. I think the Agency needs to show where and how the money is going in some sort of spreadsheet or that some sort of OIG audit should be done on the DEA fee account, because some of the numbers that are cited in the NPRM seem a bit fishy.Hiring more people does not seem to be the answer. Enforcement clearly isnt working on the opioid epidemic; policy doesnt seem to be working either, because DEA has made very few of the deadlines Congress set for them, or because they have certain documents floating in the ether that the public needs answers to. The Agency seems to be very reactive instead of proactive, and the agency seems to think that by giving it more money to hire these additional people to carry out these essential functions the opioid epidemic will be magically solved.", "comment_id": "DEA-2020-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0006", "comment_date": "2020-04-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 857}, {"text": "DEA 501 A", "comment_id": "DEA-2020-0007-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0002", "comment_date": "2020-03-17", "comment_time": "04:00:00", "commenter_fname": "Mendy", "commenter_lname": "West", "comment_length": 9}, {"text": "Docket Number DEA 501A", "comment_id": "DEA-2020-0007-0003", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0007-0003", "comment_date": "2020-03-17", "comment_time": "04:00:00", "commenter_fname": "Mendy", "commenter_lname": "West", "comment_length": 22}]}, {"id": "EPA-HQ-OAR-2022-0829", "agency": "EPA", "title": "Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles", "update_date": "2024-03-13", "update_time": "09:45:45", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Federal officers, employees, and all Administrative agencies have no right, authority, or power Congress has not been vested by the pre-existing limitations of The Constitution of the United States of America. All rights not delegated are reserved to the people of the several States. The people are the sovereign power administering government by their agents. RE: U.S. v. Morrison, 529, U.S. 598, 607; 120 S.Ct. 1740; 146 L.Ed. 2d 658 (2000). Bond v. U.S. 529 US 334 (2000). Officers enforcing unlawful acts against the people are liable personally for their actions. Power corrupts and absolute power corrupts absolutely. The sworn oath of officers and employees of the United States is to support the Constitution for the United States. Any law or act repugnant to the Constitution is an act of war and treason against the States and the people of the States, from the beginning. Marbury v. Madison, 5 U.S.,137,174,176 (1803).", "comment_id": "EPA-HQ-OAR-2022-0829-0497", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2022-0829-0497", "comment_date": "2023-06-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 930}]}, {"id": "FDA-2018-P-3355", "agency": "FDA", "title": "Requests that the FDA recategorize Naloxone 4mg Nasal Spray from Legend (prescription only) to over-the-counter status.", "update_date": "2022-11-17", "update_time": "14:40:09", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "recategorize Naloxone 4mg Nasal Spray from", "Legend (prescription only) to over-the-counter", "status", "Oregon Pain Guidance"], "comments": [{"text": "As an infectious diseases specialist who was a pioneer in HIV/AIDS research, I have seen first-hand  the impact of an epidemic has on affected individuals, their families and loved ones, and on the public health of a community.  I am now working at the intersection of infectious diseases and the injection opioid epidemic and on developing harm reduction services in rural West Virginia. West Virginia leads the country in opioid overdose fatalities, with the highest rate per 100,000 by a wide margin. Widespread access to naloxone is key to curbing the overdose fatality rate.Not only does naloxone meet the medical criteria for OTC designation, but  the continued difficulties that both people who inject drugs (as well as their families and friends) encounter in obtaining this life-saving medication-- despite state laws meant to facilitate access-- has been well-documented in published studies, including here in West Virginia which is at the epicenter of this devastating epidemic.OTC access-- as long as the naloxone is affordable-- will go a long way to solving the problem of getting naloxone into the hands of the people who actually need it, especially in rural areas where 911 help can be a 20-minute ride away. This loss of primarily young lives is a public health emergency, and there is no more important mission in healthcare than saving lives. Readily accessible naloxone is essential to that mission.", "comment_id": "FDA-2018-P-3355-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0012", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1446}, {"text": "Increasing the accessibility and availability of Naloxone will save lives.  I was a pharmacy technician at the time condoms were moved from behind the pharmacy counter out to the shelves in the Health and Beauty section of a local Target store, and since I stocked those shelves I saw at first hand the increase in sales of these products.  There was no prescription requirement on these products, it was simply removing one step (asking the pharmacist or technician for the product).  Eliminating the need to ask for a prescription, present the prescription to the pharmacist, and then be offered counselling on the product will reduce stigma and possible embarrassment; this will lead to more instances of Naloxone in the possession of those that could benefit.  The only downsides I can see are whether insurances will continue to pay for this product once it is OTC, and what the cost of the product would be (i.e., above the copay amounts the patient would have paid had the product been filled as a prescription).", "comment_id": "FDA-2018-P-3355-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0015", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1019}, {"text": "There are too many people dying from lack of availability.  Also the cost remains too high but should be reduced as an over the counter item.", "comment_id": "FDA-2018-P-3355-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0007", "comment_date": "2018-11-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 141}, {"text": "An effective health intervention is one which is sound in and of itself and which is well-timed.  Making naloxone widely available is sound in itself and it would be desperately well timed.In the past 3 years Ive trained about 200 people to use naloxone.  They include frightened parents, stressed counselors, and nurses, lab techs, patients and prescribers.  Laypeople readily understand how to use nasal naloxone.  Ive seen the light go on in someones eyes because they have one more thing now that could save their child or a client they are meeting in the home. The range of health literacy among these has been great.  No one has been mystified by the training. What upsets people is the idea of meeting an overdose without it. Fentanyl is like a runaway train in the switch yard of the opioid epidemic. Its the steepest graph among the 3 describing opioid overdose death.  Because the onset of overdose is so quick our best chance to save lives is to have naloxone widely available in our communities.  Making naloxone over the counter is a strong step in that direction.  While it does not in itself bring the price down, over the counter status is likely to help by expanding the number of people who would access it.  If the projected number of deaths, let alone total number of overdose events, for the next decade is approximately 500,000 (AJPH Oct 2018 Humphreys et al) that is a market, unfortunately.The risk profile for naloxone is nearly zero. Its benefit immense.  It is actually a deterrent to abuse:  in order to breath the victim must also suffer withdrawal. As one of the 70 signers of this petition to FDA to make naloxone over the counter I hope FDA will find that it is sound, compassionate and timely to agree with our request.", "comment_id": "FDA-2018-P-3355-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0009", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1812}, {"text": "I submitted a comment about 10 days ago but have not either seen it posted or gotten a rejection.  Is there a better way to submit?  Others have asked about how to comment.  Thanks!", "comment_id": "FDA-2018-P-3355-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0010", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 181}, {"text": "Why should an addict who purchases illegal drugs on the street in order to get high  (not for legitimate pain relief) be able to get over the counter help, while mllions of americans with painful medical conditions are forced to suffer because medication that helps them has been forcibly reduced to a level where it does not work, or worse, completely removed? US taxpayers and honest Americans should not be paying the price in pain or tax dollars to fix someone elses medical problem. If people in pain cannot get their medication over the counter (and we do not me nsaids which destroy kidneys, liver, cause blood condition problems), OR by prescription, than there is absolutley no reason why someone with an addiction disorder should be able to get their meds OTC. Figures Lie and Liars Figure  Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard A, Lawhern, NPR 11/16/17http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.htmlThe Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935The truth about the US opioid crisis  prescriptions arent the problemMarc Lewis is a neuroscientist and author on addiction, The Guardianhttps://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptionsCDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, J Singer, 3/22/18https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-highAre Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.https://www.ncbi.nlm.nih.gov/pubmed/28402482Message to CDC: Tear Down Your Walls of Silence!, 8/20/18,Richard Lawhern, PhDhttps://www.painnewsnetwork.org/stories/2018/8/19/message-to-cdc-tear-down-your-walls-of-silenceCDC: Most Overdoses Involve Illicit Opioids, 8/31/18 Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/8/31/cdc-most-overdoses-involve-illicit-opioidsOne in 10 Suicides Linked to Chronic Pain, 9/12/18, Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/9/12/one-in-10-suicides-linked-to-chronic-painChronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System, Annals of Internal Medicine 9/11/18http://annals.org/aim/fullarticle/2702061/chronic-pain-among-suicide-decedents-2003-2014-findings-from-nationalCDC: 50 Million Americans Have Chronic Pain, 9/13/18, Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/9/13/cdc-50-million-americans-have-chronic-painCDC Prevalence of Chronic Pain and High-Impact Chronic Pain Among AdultsUS, 2016, Weekly / 9/14/18 / 67(36);10011006, MORBIDITY  MORTALITYhttps://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htmStop Calling it an Opioid CrisisIts a Heroin and Fentanyl Crisis, JEFFREY SINGER, 1/9/18https://www.cato.org/blog/stop-calling-it-opioid-crisis-its-heroin-fentanyl-crisisDiversion of Blame and the Opioid Crisis, 9/4/18, Richard Dobson, MDhttps://www.painnewsnetwork.org/stories/2018/9/4/diversion-of-blame-and-the-opioid-crisisB.C. doctors cant limit opioids or discriminate against pain patients: collegeCAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/Fentanyl  Heroin Deaths Lead Soaring Overdose Rate, 12/21/17https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-medsWhy Untreated Chronic Pain is a Medical Emergency 1/28/18http://www.pharmaciststeve.com/?p=23988Untreated Chronic Pain can Kill!  6/20/17 Suzanne Stewarthttp://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.htmlJ Geurin, Staff sgt US Air Force (Honorably Medically Discharged)Served 1997-2008 https://www.regulations.gov/document?D=FDA-2018-N-1621-1264Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227Response Opioid Policy Steering Committee Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MDUniversity of Alabama at Birmingham School of Medicine  Yale School of Medicine https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938attachmentNumber=1contentType=pdfTime: Report: Chronic, Undertreated Pain Affects 116 Million Americans, Maia Szalavitz 6/29/11http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/War On Opioids Punishes Desperate Pain Patients, The Peoples Pharmacyhttps://www.peoplespharmacy.com/2017/03/13/war-on-opioids-punishes-desperate-pain-patients/comment-page-3/#comments", "comment_id": "FDA-2018-P-3355-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0006", "comment_date": "2018-09-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5271}, {"text": "Thank you for receiving our petition.  This is a much needed step in the right direction to keeping our community and families safe from accidental overdose.", "comment_id": "FDA-2018-P-3355-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0011", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 162}, {"text": "I am writing to support making naloxone available as an OTC medication. As a practicing physician it is clear that this increased availability will save many lives and produce minimal harm or risk. ", "comment_id": "FDA-2018-P-3355-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0014", "comment_date": "2018-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 203}, {"text": "To FDA Advisory Committee:This letter is in support of reclassifying naloxone nasal spray to over-the-counter (OTC). I ask the committee to reflect on the positive access changes that OTC has had on other drugs. Specifically, in 1996 the FDA approved nicotine as an OTC. An article published only one year later found use of the medications has increased by 152% compared with prior prescription use. Additionally, the study reported, with increased use of an efficacious treatment; OTC nicotine medications are estimated to yield from 114,000-304,000 new former smokers annually in the United States.Its important to remember that an OTC would NOT prohibit us from still prescribing naloxone if deemed necessary. OTC naloxone status removes barriers for those who wish to buy it without the worry/stigma from having to ask a pharmacist for it or schedule an appointment with a doctor.Access to the study can be found at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1759603/pdf/v006p00306.pdf", "comment_id": "FDA-2018-P-3355-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0016", "comment_date": "2018-12-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1037}, {"text": "Two articles have recently been published in the Journal of American Medical Association which highlight barriers to opioid antidotes despite state and local actions to improve the ease of access for those who are themselves, caring for, on around at risk individuals.The Journal of American Medical Association (JAMA) Articles published 11/13/2018:    Naloxone Accessibility Without a Prescriber Encounter Under Standing Orders at Community Pharmacy Chains in Texas    Provision of Naloxone Without a Prescription by California Pharmacists 2 Years After Legislation ImplementationAs a pharmacist, I know first-hand that barriers outlined the articles and news reports below are real. Classifying naloxone as an over-the-counter (OTC) measure needs to be a priority for the FDA for the following reasons: .    OTC will help remove the stigma (real or perceived) that has been shown to impact whether a person will likely come into a pharmacy and buy naloxone or not. Simple example: more condoms sold if they are accessible on a shelf rather than behind the counter. Product placement and the removal of required interactions with pharmacy staff has been showed to improve access as this removes buyer stigma.I have spoken to many patients that do not want the naloxone claim processed via their insurance for fear of how this could impact them later. Fear of information breach or how insurance carriers could view a naloxone purchase has yet to be looked or regulated.    OTC will allow for full pricing transparency. Manufactures often raise the cost of their products however since this rarely leads to changes in co-pay their actions go unnoticed/unchecked by the end user. A low tier placement or low co-pay by insurance carriers should never be misconstrued as access as the real costs are found in the claims which many never seen publicly.     Additionally, it is well documented that OTC equates to price stability and often even an overall price drop. OTC also decreases the cost to the healthcare system who are now covering (paying) naloxone.    This WILL increase access, just look at Canada who has made it OTC.  https://jamanetwork.com/journals/jama/article-abstract/2714519https://jamanetwork.com/journals/jama/article-abstract/2714520https://www.statnews.com/2018/11/13/some-pharmacies-limit-access-to-naloxone-studies-show/https://www.huffingtonpost.com/entry/naloxone-narcan-pharmacy-research_us_5bec7165e4b0a2569fd1320c", "comment_id": "FDA-2018-P-3355-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0008", "comment_date": "2018-11-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2627}]}, {"id": "DEA-2021-0003", "agency": "DEA", "title": "Suspicious Orders of Controlled Substances", "update_date": "2024-02-17", "update_time": "01:00:31", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Thank you for allBest RegardsMr.Rungsun Gunkoom", "comment_id": "DEA-2021-0003-0021", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0021", "comment_date": "2020-12-02", "comment_time": "05:00:00", "commenter_fname": "Rungsun", "commenter_lname": "Gunkoom", "comment_length": 62}, {"text": "I am writing to express my support for the DEAs implementation of 21 CFR Section 1300-1301. As is the PDDA already requires that distributors of controlled substances make an effort to investigate, report and maintain record of any suspicious orders. The addition of the two-option system of reporting in 21 CFR  1301.78 would make the procedure for dealing with suspicious orders much clearer registrants while leaving them with leeway to deal with orders they are able to clear of suspicious circumstances as long as they maintain records on the due diligence that cleared the order. Additionally, according to the DEAs own findings this regulation would eliminate a grey area in reporting which has allowed registrants to neglect maintaining proper records of due diligence, and in some cases report suspicious orders after they have already been filled.While there might be some concern that this regulation would impose additional costs upon registrant firms the proposed rule complies with the RFA and will actually end up saving registrants an estimated total of $2,931,000 via the use of the ARCOS Distributor Tool which was developed to ease the cost of due diligence on registrants as well as the use of the DEAs central database for reporting suspicious orders.  Overall, there is little reason to not pass what is functionally a standardization of reporting procedures in a wider legislative effort to stem the abuse of controlled substances.", "comment_id": "DEA-2021-0003-0035", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0035", "comment_date": "2021-03-31", "comment_time": "04:00:00", "commenter_fname": "Andres", "commenter_lname": "Oliver", "comment_length": 1474}, {"text": "Pharma Logistics agrees with and supports excluding reverse distributors from the proposed rule. However, based on review of regulatory text in 1301.74(b)(3), we believe that the following statement may be written incorrectly:orders placed by registrants to DEA registered reverse distributors requesting the return ordestruction of controlled substances, are not distributions subject to the provisions of this part.Pharma Logistics formally requests the DEA to reword this statement to read as follows:orders placed by DEA registered reverse distributors to registrants", "comment_id": "DEA-2021-0003-0038", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0038", "comment_date": "2021-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 607}, {"text": "RIN 1117-AB47/Docket No. DEA-437Personally, this is very important as suspicious substances need to be better monitored. The Drug Enforcement Management should not be the only one to be participating this. There should be multiple collaborations in order to strengthen reals regarding suspicious substances. In addition, not just drugs should be monitored but also suspicious objects like seeds such as what we see spreading across the United States with mystery seeds sent from China with no return address. In order to keep the people safe, regulations needs to be strengthen in order for this to be successful. ", "comment_id": "DEA-2021-0003-0004", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0004", "comment_date": "2020-12-02", "comment_time": "05:00:00", "commenter_fname": "Sophia", "commenter_lname": "To", "comment_length": 624}, {"text": "This is a great way to fight the opioid epidemic. Making sure that orders are monitored for suspicious activity will help to nip problems in the butt before they start, ", "comment_id": "DEA-2021-0003-0025", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0025", "comment_date": "2020-12-02", "comment_time": "05:00:00", "commenter_fname": "Maggie", "commenter_lname": "B", "comment_length": 169}, {"text": "As a licensed healthcare practitioner, I think it is thoughtful to specifically include the questions pertinent to another agencys investigation of the content of an order received under suspicious circumstances (ORUSC) report at the initial instance the busy practitioner or technician is able to provide the associated details. However, in my experience, while electronic submissions are generally fast when functioning correctly, I recall several occasions this past year where downed powerlines from heavy storms or tornadoes, electrical fires, and rolling power outages prevented the computer systems from accurately submitting any documentation or receiving electronic prescription submissions. During such unfortunate circumstances, should an ORUSC take place, it would help to provide a PDF downloadable option or a paper form submission for a pharmacist or technicians to keep on hand in the pharmacy in advance in case an unusual request is placed at a time when the electricity or wireless connections are not functioning properly. In addition, for health care professionals that may have to submit such reports on the go, having a version of this submission form easily accessible from a tablet or mobile device is highly desirable, especially for EMTs or pharmacy support staff with a printable or PDF downloadable option to keep in the pharmacy for the required two year time duration. At times certain employees may be too busy to check e-mails during the workday, but the ease of submission and the seven-day window to verify details and the suspicious nature of the ORUSC are extremely helpful when trying to determine the severity of the suspicious activity and how to handle the circumstances documented in the report. My only concern is that if a report were indeed suspicious, the seven-day window would need to ensure that if a report was filed by a diligent healthcare practitioner or other support staff, that another worker implicated in possible drug diversion would not be able to readily interfere and close the otherwise valid investigation to avert suspicion. I hope that the seven-day time frame will encourage all parties to do their part in sorting out the issue in a timely, productive manner to improve pharmaceutical practice.", "comment_id": "DEA-2021-0003-0033", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0033", "comment_date": "2021-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2279}, {"text": "Regarding RIN 1117-AB47/Docket No. DEA-437,The efforts to regulate suspicious orders of controlled substances, as well as clarifying the procedures a registrant must follow when suspicious orders have been received, are exceptional tactics in mitigating the act of drug diversion. This proposed rule is valuable to the welfare of the country as it battles an ongoing opioid epidemic. Furthermore, the two-option blueprint of record-keeping makes for an effective database. Along with others, I agree that a revision to the amount of time designated to scrutinizing documents may be necessary for eventual research purposes, though there may only need to be an extension of about two or three years onto the initially-proposed duration. As pointed out by a previous commenter, medical records are kept for seven years, so the current two-year maximum of this DEA proposal seems a bit underestimated. Besides this area, the overall strategy of documentation should provide for better tracking application and the prevention of substance abuse. Thank you for your consideration on this matter.", "comment_id": "DEA-2021-0003-0036", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0036", "comment_date": "2021-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1095}, {"text": "United Veterinary Services Association (UVSA) Comments Docket No. DEA-437", "comment_id": "DEA-2021-0003-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2021-0003-0039", "comment_date": "2021-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 73}]}, {"id": "EPA-HQ-OPP-2008-0879", "agency": "EPA", "title": "HMAE Registration Review: 2-((hydroxymethyl)-amino)ethanol", "update_date": "2021-03-05", "update_time": "01:17:45", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Comments by the FIFRA Endangered Species Task Force", "comment_id": "EPA-HQ-OPP-2008-0879-0005", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPP-2008-0879-0005", "comment_date": "2009-03-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 51}]}, {"id": "FDA-2022-N-3226", "agency": "FDA", "title": "Opportunity for Feedback on Development and Dissemination of Educational Materials on Rare Disease Drug Development", "update_date": "2023-05-01", "update_time": "16:08:55", "purpose": "Nonrulemaking", "keywords": ["CDER", "Opportunity for Feedback on", "Development and Dissemination of Educational", "Materials on Rare Disease Drug Development", "OPEN"], "comments": [{"text": "Comment from Praxis Precision Medicines", "comment_id": "FDA-2022-N-3226-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0014", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}, {"text": "Comment from Chiesi Global Rare Diseases", "comment_id": "FDA-2022-N-3226-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0016", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 40}, {"text": "I am a parent of a child who died of a rare and fatal neurodegenerative disease. I am also a registered pediatric nurse. My comments were published as a letter to the editor of Update Magazine and are shared with permission from the Food and Drug Law Institute. After reading the article, Senate Bill and FTC 6(b) Study Turn the Heat on Pharmacy Benefit Managers Amid Drug Pricing Concerns, by Tiffany Jang  David Shotlander, I thought about what I recently learned about the drug Zolgensma, approved by FDA in May 2019 as a gene therapy to treat Spinal Muscular Atrophy (SMA) in children less than two years old. The gene therapy is a one-time intravenous infusion treatment that may eventually become the standard treatment for SMA.[1] In 2019, it was the most expensive drug the world had ever seen at $2.125 million.[2]I recently attended a Newborn Screening Bootcamp hosted by the EveryLife Foundation for Rare Diseases. At the conference, we were told by a genetic counselor that there are 428 fundraisers on one online fundraising platform, created by families that are raising funds for their children with SMA, and that many of these families are seeking donations for the gene therapy, Zolgensma, and associated medical costs with SMA.Access to a rare disease gene therapy is not a question of availability, but of cost. Drug companies set their own prices when selling the products they have created. Without any competition for a gene therapy like Zolgensma, these companies can set whatever price they want.[3] The price tag of $2.125 million makes the drug unobtainable for most families. Additionally, insurance companies can make it difficult for families to access these expensive treatments. Prior authorization (PA) is a common health insurance practice to ensure that the treatment is medically necessary, and it continues to frustrate patients.[4]Zynteglo ($2.8 million) and Skysona ($3 million) are gene therapies approved by FDA in 2022. Along with Zolgensma, they are the three most expensive drugs the world has ever seen.[5] There are hundreds of gene therapies currently being developed and in clinical trials.[6] When any of these therapies are FDA-approved, families will not be able to afford the multimillion-dollar price tags. Will there be thousands of families creating online fundraisers for these gene therapy medicines?To avoid this possibility, we need new reimbursement models that can ensure appropriate patient access to much-needed treatments. One approach suggested by Senator Cassidy from Louisiana is for Medicaid, or some other government program, to pay for gene therapies, so commercial payers would not have to cover them. Instead, it would be fully funded by public funds. Society, as a whole, pays for these therapies as opposed to the insurance pool to which the patient belongs at the time the therapy is given.[7]Gene therapies are potentially curative for many terrible rare diseases. Rare disease patients need a way to pay for these medicines.[1] Carmen Fookes, Why is Zolgensma so Expensive? Sept. 5, 2022, https://www.drugs.com/medical-answers/zolgensma-expensive-3552644/ (accessed Nov. 16, 2022).[2] Christopher Rowland, The FDA Approves a Gene Therapy that is the Most Expensive Drug in the World. The Washington Post, May 24, 2019,https://www.washingtonpost.com/business/economy/the-fda-approves-a-gene-therapy-that-is-the-most-expensive-drug-in-the-world/2019/05/24/57c66500-7e4a-11e9-8ede-f4abf521ef17_story.html.[3] Julia Hawley, How Pharmaceutical Companies Prices Their Drugs, Sept. 30, 2022, https://www.investopedia.com/articles/investing/020316/how-pharmaceutical-companies-price-their-drugs.asp, (accessed Nov. 16, 2022).[4] Allison Inserro, How Prior Authorization Can Impact Patients with Rare Disease. Feb. 28, 2022, The American Journal of Managed Care, Feb. 28, 2022,https://www.ajmc.com/view/how-prior-authorization-can-impact-patients-with-rare-disease.[5] Leigh Ann Anderson, 10 Most Expensive Drugs in the US. Oct. 17, 2022, https://www.drugs.com/slideshow/top-10-most-expensive-drugs-1274 (accessed Nov. 17, 2022).[6] Press Release, FDA Continues Strong Support of Innovation in Development of Gene Therapy Products. U.S. Food and Drug Administration, Jan. 28, 2020, https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products.[7] Bill Cassidy, How Will We Pay for the Coming Generation of Potentially Curative Gene Therapies? June 12, 2019, https://www.statnews.com/2019/06/12/paying-for-coming-generation-gene-therapies/ (accessed Nov. 17, 2022).", "comment_id": "FDA-2022-N-3226-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0002", "comment_date": "2022-12-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4893}, {"text": "Comments from the Rare Disease Company Coalition", "comment_id": "FDA-2022-N-3226-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0010", "comment_date": "2023-03-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 48}, {"text": "Comment from GenSight Biologics", "comment_id": "FDA-2022-N-3226-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0015", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 31}, {"text": "See comment letter from BioMarin Pharmaceutical Inc.", "comment_id": "FDA-2022-N-3226-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0023", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 52}, {"text": "Comment from Aeglea BioTherapeutics Inc.", "comment_id": "FDA-2022-N-3226-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0022", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 40}, {"text": "Ultragenyx Pharmaceutical would like to thank the agency for the opportunity to provide comments.", "comment_id": "FDA-2022-N-3226-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0021", "comment_date": "2023-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 97}, {"text": "Comments from Stealth BioTherapeutics", "comment_id": "FDA-2022-N-3226-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0008", "comment_date": "2023-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 37}, {"text": "Regulatory considerations for rare disease drug developmentWith increasing use of next generation sequencing, new very rare monogenetic diseases are more and more diagnosed, ending an often long diagnostic odyssey. Some pathogenic variants affect only one or a very small number of individuals (N1+). In these circumstances, standard clinical development, including randomized controlled studies for dose finding, safety and efficacy are not feasible. Further, many of these extremely rare diseases have a severely debilitating and life shortening course. Some of these diseases could be beneficially impacted with individualized precision drugs, such as antisense oligonucleotides (ASOs) and other emerging therapeutic modalities. However, costs and timelines for a standard preclinical development and CMC package are prohibitive when developing therapeutics for one or only a handful of individuals. This situation represents an ethical dilemma and a grave healthy inequity, leaving devasted families scrambling to find a therapy or fund a therapeutics development for their (dying) child.While the agency has issued draft guidances for sponsor-investigators examining individualized ASO drug products for severely debilitating or life-threatening diseases, uncertainty remains if the agency would consider the same guidance for a commercial sponsor, and if the guidance was applicable for an ASO that could treat a few patients (i.e. more than two patients, but too few to permit conduct of a meaningful controlled clinical trial). Further, to the best of our knowledge, there is no guidance for a commercial sponsor seeking approval for an ASO that is being investigated in a single or very few individuals with no or very limited existing longitudinal disease data to use as non-treatment controls. EveryONE Medicines, a private biotechnology company committed to develop individualized precision therapeutics, including ASOs, for N of 1 or a few (N1+) pediatric patients with a severely debilitating and life-shortening monogenetic CNS disorder, would appreciate feedback from the agency on the following regulatory considerations:1) Are the draft guidances for sponsor-investigators also applicable to commercial sponsors, given that the medical urgency for individualized ASOs for a single or very small number of patients is the same?  2) Are the draft guidances also applicable to examining an investigational ASO in situations with more than two patients, but too few to permit conduct of a meaningful controlled clinical?3) Opportunities to demonstrate a favorable risk/benefit in such very rare cases with the goal to get approval for an individualized precision therapeutic.Thank you.The team at EveryONE Medicines", "comment_id": "FDA-2022-N-3226-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-3226-0004", "comment_date": "2023-01-23", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2794}]}, {"id": "FDA-2019-N-1845", "agency": "FDA", "title": "Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments", "update_date": "2021-02-18", "update_time": "11:37:44", "purpose": "Nonrulemaking", "keywords": ["2019-208", "CDER", "Notice", "Fixed-Quantity Unit-of-Use", "Blister Packaging for Certain Immediate-Release", "Opioid Analgesics for Treatment of Acute Pain", "Request for Comments", "OPEN"], "comments": [{"text": "January 07, 2021Stephen Hahn, MDCommissionerFood and Drug AdministrationC/O Dockets Management Staff (HFA-305)5630 Fishers Lane, Rm. 1061Rockville, MD 20852RE: Docket No. FDA-2019-N-1845, Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for CommentsDear Commissioner Hahn:On behalf of Adam and Marybeth Gillan, and their daughter, Maisie Lucienne Gillan, we urge you to take action in packaging safety and technology advancements to mandate blister packaging for any medication lethal to an infant or child. These medications, known as one pill kills, are over-prescribed in high quantities. The packaging is intended as safe, but the functional use of the prescription and its traditional pill bottle container creates untold opportunities for mishandling, miscounting, and access to children.The Gillans daughter, at a neighbors home, came across a methadone pill no one even knew was missing. Hours later she was dead, and it took an autopsy to understand why. From the criminal justice system to the current regulatory environment around opioids and patient safety, Maisie was failed at every turn, cast off as an unforeseeable tragedy.Between 1999 and 2017, more than 9,000 children and teenagers died from opioid poisoning in the United States, including 650 children under 5 years old, according to the Centers for Disease Control and Prevention. These are tragedies that left 9,000 parents to bury their children.We can do better and we must do better. Layers of protection are available to protect patients from harming themselves or others. Blister packaging alone may not have saved Maisies life, but that layer of protection would have clearly identified a pill as missing, or it may never have been lost in the first place. Lives are at stake, and too many, including Maisies, have already been lost.Sincerely,A concerned parent", "comment_id": "FDA-2019-N-1845-0152", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0152", "comment_date": "2021-01-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2087}, {"text": "Opioids should be in blister packs. These one kill pills have taken babies from too many families simply from poor packaging. Please consider the safety of the youngest members of our society. ", "comment_id": "FDA-2019-N-1845-0149", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0149", "comment_date": "2021-01-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 207}, {"text": "Your request says active pain but if you launch this it will be done across the board and those of us that have chronic pain will then be negatively impacted again! There is no need for this and please stop trying to force new rules to an already convoluted process. We dont need any more rules or changes or additions added to the reason why we wont be able to get our pain medication. We are responsible adults and we are not the problem! Its illegal drugs, please focus on that. ", "comment_id": "FDA-2019-N-1845-0073", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0073", "comment_date": "2019-06-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 482}, {"text": "I am a registered recovery room nurse from MA and I welcomed the idea of unit-dose blister packs for distribution. Currently, surgeons always order 30 plus tabs of opioid analgesics for procedures that might just need a days supply. Patients go home all of this extra medication which might lead to misuse. I welcome the idea of the blister packs but most importantly I like the discussion on how to dispose of these medications. Either education on the back of the packaging on how to dispose of these medications properly or mail pouches for easy return are both good options.", "comment_id": "FDA-2019-N-1845-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0031", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 583}, {"text": "Blister packages are difficult to open for seniors and others with compromised dexterity. They are not child proof and may expose children to a higher risk of ingestion. I applaud efforts to address opioid misuse and accidental exposure. The proposed blister packaging requirement is costly with limited to no benefit. Prescribing smaller quantities and allowing partial fills of CII medications will better address opioid concerns. ", "comment_id": "FDA-2019-N-1845-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0016", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 433}, {"text": "I feel that as a retail pharmacist the economics as well as storage space for unit dose packaging would be hard on the average store. It would be okay if pharmacies bought 100 packs of unit/dose (like hospitals have) and then dispensed 10 or 15 tabs,eg, in a container. However if manufacturers started making specific 10 or 15 packs that pharmacies had to buy and store it would create a security problems in the pharmacy to find storage room for all the different sizes made. Right now we just have bottles of 100 tabs which take up much less room and easily be kept in small secure lockers.Thank You", "comment_id": "FDA-2019-N-1845-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0003", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 607}, {"text": "Blister packs could be a good option for acute pain patients following surgery, but increasing cost and making access of the medication more difficult for chronic pain patients would be adding to the disastrous policies that have severely affected chronic pain patients.  These patients, who responsibly use and manage their medication, often use different doses depending on their pain at the time (i.e., they may need 8 mg in the a.m. and 4 mg later in the day).  Furthermore, there are many conditions, which make blister packs difficult to impossible to use for chronic pain patients. Those with conditions such as rheumatoid arthritis or Ehlers Danlos often experience difficulty using and pain in their hands. The greatest issue impacting the opioid crisis is illegally obtained drugs such as heroin and carfentanil. For those chronic pain patients who have a proven history of responsibly using their medication, we need to be making life easier for those who are suffering unimaginable pain and treat them humanely and compassionately vs. like addicts.  ", "comment_id": "FDA-2019-N-1845-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0009", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1074}, {"text": "The pack is fine for those who can absorp pill form.  Roux EnY Gastric by paas patients have malabsorption problems. Our vitamins have to be in Liquid, Chewable, Crushable in order to get absorptions. Plus the cost is the key of affordable. $8.00 or $10.00 co payment is reasonable co paymrent.Anything above this price is not affordable. . I cant afford $40.00 a prescription. If I cant get the pain medication that  I should be on because of the Roux En Y gastric by pass  cost I guess I just have to suck it up with an Nsaid. Which could cause more harm to my pouch  lower intestines. I guess Medicare wont mind if they have to pay for unesscessary expenditures at the Er or energency surgeries.", "comment_id": "FDA-2019-N-1845-0026", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0026", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 728}, {"text": "I like the idea of having set blister quantities. It makes following the MME limits easier for prescribers and helps take some of the pressure off pharmacists. Often, pharmacists feel like they are playing a police officer role with opioids. However, I have two concerns. Firstly, will there be a push to have prescribers use just this blister pack amounts? What will stop them from continuing to write differently than the recommended amounts? Secondly, will this negatively impact drug diversion? Will this create a demand for these packaged drugs because it shows they havent been tapered with and easily identifies the drug name since the name would be printed on the back of the blister package? ", "comment_id": "FDA-2019-N-1845-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0028", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 706}, {"text": "This regulation may be good for short term use after minor surgery to control pain. Many people who get these meds for knees surgeries and such end up  seeking more and more meds and some doctors fail to properly monitor or the patients get meds outside of proper channels.  This leads to addiction and abuse.  But the numbers of those who become addicted to opioids by legal scripts is very small and those who get addicted usually are because of dependency and use of illicit or illegally obtained drugs.Right now it is hard to find a doctor willing to provide ANY opioids for any patient due to the oversight by State agencies, the FBI and DEA.  I had surgery and I was sent home to heal with no pain medication due to the recent attack on pain doctors who were properly treating pain patients but could not treat with laws written for rehab of addicts.Where I live, I can go two blocks and find any illicit drug any pain suffer would want and more.  So those who are weak have a way to get these drugs outside of bubble pack distribution.  Now I am not negative about the process for some patients but this failed to address chronic pain patients which includes millions around the countryBefore becoming disabled by pain, I worked for a primary contractor at a special one of a kind DOE facility in the Southwest.  I was a Nationally Certified Environmental Trainer who was responsible for compliance training, research and program construction.  I even wrote programs included in the first two permits required for operations by the EPA and the State EPA.I have read almost every regulations and guideline included the FDA and CDC and found that each fail to address patients especially chronic pain that if lifelong.  Many like me require lifelong treatment and monitoring by a pain specialist.  But this industry is being halted by these current regulations.Right now it is impossible with most of the other regulations.  I have researched most using the Federal Code of Regulations, the Federal Registry, State Regulations, CDC and FDA Guidelines.  Each may only have a brief statement on chronic pain but then apply conditions for abuse and addicts on these patients with no room for individual care for each condition being unique.While this change might help, many doctors may still refuse to supply medications to patient for fear of reprisal from government.  Along with this issue, at least two major drug stores have decided not to provide opioids to any patients.  That being Walmart and Walgreens.  I visited both while having scripts and was told that their corporate offices had stopped allowing any of their branches to provide such medication even with legal scripts.  So these were refusing medical treatment because of fear of legal action buy the government.So this might help with minor pain over a short period of time, there is a much larger looming need for real legislation for chronic pain that allows for treatment and not punishment.", "comment_id": "FDA-2019-N-1845-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-1845-0013", "comment_date": "2019-06-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3036}]}, {"id": "FDA-2014-N-1359", "agency": "FDA", "title": "Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting", "update_date": "2015-04-16", "update_time": "15:33:59", "purpose": "Nonrulemaking", "keywords": ["cder", "2014-701", "CDER2014175", "Opioid"], "comments": [{"text": "Please find comments provided by Par Pharmaceutical, Inc., Spring Valley, NY.  This submission includes a cover letter and Appendix which contains Pars responses.", "comment_id": "FDA-2014-N-1359-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-1359-0024", "comment_date": "2015-01-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 167}, {"text": "With 100 million Americans experiencing chronic pain we need to find safer and more effective therapies.   Research has begun to suggest that abuse-deterrent opioids are safer than those without such properties.Therefore, I urge the FDA to require all extended-release opioid formulations on the market to have a minimum level of abuse-deterrent properties. This would not eliminate all abuse, addiction and overdose deaths related to opioids. It would, however, be a small but significant step forward.Industry and payers will need time to adjust to this required safety measure. Therefore, I urge the FDA to set a date  perhaps 2020  for this requirement to take effect.But the FDA must not stop there. Payers are reluctant to encourage use of these safer products because of added cost.  And as long as opioids without abuse-deterrent properties are available, industry has no incentive to create these safer analgesics. To eliminate these barriers, the FDA must remove all extended-release opioid formulations without abuse-deterrent properties from the market by a set date, perhaps 2020.    But there is another serious issue to consider. A move to more expensive abuse-deterrent formulations could lead to the less expensive methadone being prescribed for post-operative, cancer and chronic pain. Methadone represents less than 3% of all opioids prescribed for pain but is associated with 25-30 % of all unintentional overdose deaths. More methadone could lead to more overdose deaths. This would be a terrible unintended consequence. Research has shown that many of the deaths associated with methadone are due to physician errors in prescribing.  This is usually due to a knowledge deficit.  If payers wish to keep methadone available because it is inexpensive, those payers should have to demonstrate that providers are trained to prescribe it. Such payers would include Medicare, Medicaid and workers compensation. Since the FDA cannot require physician education I recommend that methadone be removed from the market for the treatment of pain until manufacturers or payers can demonstrate that prescribers have the minimum competency to prescribe it.  The rationale is that methadone must not remain the only low-cost option. The mechanism for demonstrating competency is not yet clear, and a process and criteria would need to be established. To be clear methadone should remain available for the treatment of addiction.  My suggestion applies only to methadone prescribed for the treatment of pain. To sum up, I urge the FDA to:Require abuse-deterrent properties in all extended-release opioid formulations on the market by 2020Remove extended-release opioid formulations without abuse-deterrent properties from the market, also by 2020Simultaneously, remove methadone for pain from the market until adequate training of prescribers can be demonstrated.Thank you.Lynn Webster MDVP Scientific AffairsPRA Health SciencesSalt Lake City, Utah801-892-5140WebsterLynn@PRAHS.com", "comment_id": "FDA-2014-N-1359-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-1359-0013", "comment_date": "2015-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3250}, {"text": "Statement by Alexander KrausFDA Public Meeting: Abuse-Deterrent (AD) FormulationOctober 30, 2014Good afternoon. My name is Alexander Kraus and I am VP Product Development  Technical Affairs at Grnenthal USA, Inc.  Grnenthal USAs German parent company has developed and licensed abuse deterrent technology and patents to opioid manufacturers in the United States.We believe that ADF technologies are a valuable tool to reduce prescription drug misuse, abuse and diversion and, when the necessary quality requirements are being met, can provide additional safety and benefit to prescribers, patients and society.In-vitro testing of products which are designed-to-be abuse deterrent is a critical element of ADF development. Results from scientifically rigorous, protocol-driven, in-vitro tests are key to understanding the properties of emerging ADF technologies and their applications. Although we support the concept of a standard in-vitro test battery, it will not be sufficient to assess the full potential or certain weaknesses of a product aiming to provide abuse deterrence.  And, depending on the approach and technology, new tests will always have to be conducted, in addition to the standard battery, that reflect specific circumstances relevant to the active ingredient or the formulation used.. This will ensure the most comprehensive insights into the strengths and weaknesses of a product and will inform manufacturers about the design of pharmacokinetic and abuse liability studies in order to assess whether a product may prove to show meaningful abuse deterrence in the community. However, in-vitro tests alone are not sufficient. The impact of a given technology on abuse deterrence is highly dependent on the subjective experience and sensation in individuals that seek euphoria and reward from abusing prescription drugs. To our knowledge, to date there is no established relationship between the parameters used in clinical abuse liability studies, like I am feeling high or I would take this drug again with the in-vitro properties of a formulation or even with the descriptive changes in systemic exposure to the drug after manipulation of the product. The unpleasant experience from insufflating a sample of course particles after manipulating a crush-resistant tablet or from an otherwise locally aversive agent cannot be predicted from in-vitro data or systemic blood concentrations alone as several factors add to the cumulative performance of the product. Therefore, we request that FDA will continue to base its pre-market assessment of products that apply for abuse deterrent labeling, be it NDAs or ANDAs, on an   integrated and rigorous in-vitro, pharmacokinetic and abuse liability testing. This approach is reflected in FDAs decisions on abuse deterrent products to date and is consistent with the concepts as laid out in existing FDA guidance documents. Grnenthal will be glad to assist FDA in advancing the science of abuse deterrence and to develop meaningful standards and concepts for in-vitro, pharmacokinetic, and abuse liability assessments. We believe that ADF technologies are an invaluable tool in the battle against prescription drug abuse and that these technologies can provide additional safety and benefit to prescribers, patients and society.Thank you for the opportunity to testify today!", "comment_id": "FDA-2014-N-1359-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-1359-0015", "comment_date": "2015-01-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3403}, {"text": "See Attacched", "comment_id": "FDA-2014-N-1359-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-1359-0033", "comment_date": "2015-04-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 13}, {"text": "Comments of the Generic Pharmaceutical Association for FDA-2014-N-1359-0001:  Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications.", "comment_id": "FDA-2014-N-1359-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-1359-0025", "comment_date": "2015-01-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 159}]}, {"id": "FDA-2019-P-5922", "agency": "FDA", "title": "Requests that the FDA take certain actions with respect to electronic nicotine delivery systems to curtail youth initiation and use and to encourage the development and adoption of nicotine products with lower health risks", "update_date": "2020-05-05", "update_time": "15:14:59", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CTP", "Respira Technologies, Inc.", "Electronic Nicotine Delivery Systems", "Youth Initiation", "Development", "Adoption", "Nicotine Products", "Lower health risks", "Open"], "comments": [{"text": "Were so close to being the generation that ends smoking combustible cigarettes. Its time for the FDA to help us get over the edge by providing further regulation to curtail youth vaping as well as invest in and further support technologies that mitigate the harmful effects of combustible cigarettes. ", "comment_id": "FDA-2019-P-5922-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-5922-0012", "comment_date": "2020-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 311}]}, {"id": "VA-2017-VHA-0023", "agency": "VA", "title": "AP46-Supplemental Notice of Proposed Rulemaking-Prosthetic and Rehabilitative Items and Services", "update_date": "2021-06-11", "update_time": "13:18:47", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "See Uploaded File.", "comment_id": "VA-2017-VHA-0023-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0005", "comment_date": "2017-10-19", "comment_time": "04:00:00", "commenter_fname": "Roland", "commenter_lname": "Roberts", "comment_length": 18}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0068", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0068", "comment_date": "2017-11-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0094", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0094", "comment_date": "2017-11-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0126", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0126", "comment_date": "2017-11-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0130", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0130", "comment_date": "2017-11-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0163", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0163", "comment_date": "2017-11-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0174", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0174", "comment_date": "2017-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0191", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0191", "comment_date": "2017-11-16", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "I am writing today in order to offer comments on the proposed rule entitled, Prosthetic and Rehabilitative Items and Services that was published in the Federal Register on October 16, 2017.  The stated purpose of the proposed rule is to, revise its medical regulations related to providing prosthetic and rehabilitative items, primarily to clarify eligibility for prosthetic and other rehabilitative items and services, and to define the types of items and services available to eligible veterans.While I understand the need of the Department of Veterans Affairs (VA) to establish formal regulations in order to ensure continued coverage for medically necessary prosthetic services, I am deeply concerned regarding the provisions of the proposed rule contained in section 17.3240 entitled, Furnishing authorized items and services.  This section, in part, states that solely the VA will determine whether VA or a VA-authorized vendor will furnish authorized items and services to veterans.  The proposed section goes on to state that the VA would clarify in regulation that, this administrative business decision is made solely by the VA to eliminate any possible confusion as to whether a veteran has a right to request items or services generally, or to request specific items or services from a provider other than the VA, and to clarify for the benefit of VA-authorized vendors that VA retains this discretion as part of our duty to administer this program in a legally sufficient, fiscally responsible manner.  The proposed regulations at  17.3240 appear to directly contradict the longstanding policy of the VA regarding a veterans right to receive prosthetic services through the VA directly or through a VA contracted provider as well as the provisions of the Veterans Access, Choice and Accountability Act of 2014.Since the creation of the Veterans Administration in 1930, providers of artificial limbs and braces have worked closely with the VA to ensure that veterans have complete access to high quality, clinically appropriate, prosthetic and orthotic care.  Whether services were provided directly by the VA within their own facilities or by private companies through a contractual arrangement, the needs of the individual veteran has always been paramount in how care is delivered.  The proposed rule completely disregards: (1) respect for the Veterans right, like other Americans, to participate in the choice of who they entrust with delivering key components of their health care; and (2) the long history of cooperation between the VA and its contracted prosthetic and orthotic providers, as well as the clinical needs of the individual veteran, by proposing regulations that authorizes the VA to exercise sole discretion as to how prosthetic and orthotic care is delivered to veterans.  The proposed rule goes so far as to state that the decision regarding how care is delivered is an administrative decision.  I could not disagree more.  The delivery of appropriate prosthetic and orthotic care is not an administrative issue, it is a clinical issue; one that should be made based on the clinical needs of the individual veteran, not the administrative needs of a government agency.I am truly perplexed by the proposal to completely remove the veterans right to choose to receive service from a VA contracted provider as it is in direct conflict with testimony from top VA officials who have repeatedly reinforced the right and opportunity of Veterans to work with providers of their choice who can best meet their clinical needs.  On October 24, 2017, in testimony before the House Veterans Affairs Committee, Secretary Shulkin stated the following: Veterans should get more choice in the say of their care.  Nobody should feel trapped in the VA system.This is just one example of repeated testimony by VA officials that support the right of the veteran to receive care from their chosen provider.I urge you to revise the language contained in section 17.3240 of the proposed rule to bring it in line with the VAs longstanding position, with the intent of the Choice Act,  and with the public statements before Congress by the Secretary and others assuring Veteran choice of where and from who they receive their orthotic/prosthetic care.  The elimination of the veterans right to choose to receive prosthetic and orthotic services directly through the VA or through a relationship with a contracted provider is in nobodys best interest and it is certainly not an administrative decision.  It is a deeply personal decision that must involve input from all involved parties but especially from the veteran.  Publication of a final rule without affirming the rights of the veteran would be a true disservice to those who have dedicated their lives to serving their country.", "comment_id": "VA-2017-VHA-0023-0192", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0192", "comment_date": "2017-11-16", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4859}, {"text": "My name is Melissa Stockwell and I am a combat wounded above the knee amputee. I lost my leg in 2004 and in the past 13 years I have thrived as an amputee, competing on the elite level in athletics, become a mom of 2 and truly have done more in my life with one leg than I ever would have done with two. I strongly believe that this is because I have been able to get prosthetic care from the vendor of my choosing and choosing to use a 3rd party instead of the services at the VA. I have been able to get my prosthetic care from someone who specializes in high activity amputees to include those in need of specialized biking and running legs, as I do. This is the case for many of my friends who are also Veterans and receive prosthetic care outside if the VA. While I am grateful for the services that the VA provide and choose to use them for everything except for prosthetics, I urge you to please vote no for this bill. By giving myself and others the choice of where to get prosthetics care, you will help us be able to maintain the quality of life we want to life and continue to thrive in our community. Thank you.Melissa StockwellCombat Wounded, 20042x ParalympianMother ", "comment_id": "VA-2017-VHA-0023-0269", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0023-0269", "comment_date": "2017-12-11", "comment_time": "05:00:00", "commenter_fname": "Melissa", "commenter_lname": "Stockwell", "comment_length": 1211}]}, {"id": "FDA-2014-N-0233", "agency": "FDA", "title": "Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics; Request for Comments", "update_date": "2014-08-22", "update_time": "11:57:35", "purpose": "Nonrulemaking", "keywords": ["cder", "cder2013144"], "comments": [{"text": "The Notice seeks commentary on PREVENTING ACCIDENTAL USE by someone for whom the medication was not prescribed. This is a critically-important objective because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Divert-X packaging is assembled in pharmacies in order to have a broad impact. A dispensing system must be agnostic to dose, dosage form, and manufacturer to cater for all the forms of Controlled Substances that are diverted and misused. The broad applicability of Divert-X will greatly assist its adoption if shown to be effective. Unit dose packaging that meets F1 level requirements will be suitable for packaging any medication regardless of toxicity. Based on current Poison Prevention Packaging Act (PPPA) criteria (1-2), a blister system certified to an F1 level is far safer than a certified pharmacy dispensing bottle (assuming both fail). Specifically, if F1-certified packaging fails, then a single dose is available to a child; conversely, if a pharmacy dispensing bottle fails, then the entire contents are available to the child. Hence, blister systems have a role in opioid safety because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing mandates (3). While factory-assembled blister packs have been certified to an F1 level, no child-safe features have been added to any blister system assembled in a pharmacy because no market need has existed to date. The main existing market for pharmacy-assembled blisters is long-term care facilities, and these facilities are exempt from PPPA requirements because their medication management practices are similar to hospitals. All Vatex products will achieve F1 certification prior to commercialization.The Notice also seeks commentary on packaging approaches to minimize in-home theft of medication by teens, visitors, caregivers, etc. Because blister packaging allows inventory assessment via a quick visual inspection and because blister packaging averts substitution schemes that use lookalike pills, this will have a preventive impact.  Additionally, patients using Divert-X can obtain recent dose-removal times via telephone, text message, etc. in order to conduct their own diligence. Most importantly, Divert-X provides strong incentives for returning unused medications soon after they are dispensed. These incentives are the subject of a separate submission to this docket (search for Safe Disposal). Because Divert-X will be challenged by users who are looking to subvert it, the packaging must possess many features to dissuade tampering but highlight it when it occurs. A tamper assessment by the pharmacist is the final step in the Divert-X cycle prior to obtaining a final score. Vatex is advantaged by the fact that the adhesives already in use for in-pharmacy assembly are far stronger than the materials used to make the packaging. Vatex has assessed products from all North American manufacturers of pharmacy-fill cards; in all cases, the cardstock and foils fail when attempts are made to disassemble or subvert a blister card. The strength of the seal itself serves as a child-safety feature. The strength of the seal relative to the materials of construction is a key in making tampering evident. Tamper-resistance features and child-proof features augment each other, and they are tested together under PPPA certification.The PPPA provides and mandates all details needed for child-resistant package testing, but the packaging must also be useable by senior adults in order to obtain any certification. Hence, the PPPA also provides mandated protocols for determination of the Senior Adult Use Effectiveness  score (1-2). The design of PPPA trials, for children and senior adults, are mandated to a very high level of detail, to include items such as the text of all allowable verbal interactions between testers and participants, the text of consent forms to be used, and scoring requirements. All Vatex products will achieve F1 certification prior to commercialization.[please see the accompanying PDF attachment to view the references]", "comment_id": "FDA-2014-N-0233-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0012", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4899}, {"text": "The problem with opioids is not, generally speaking, a problem to be solved with technology. The problem is that there are too many legal opioids, and that physicians are too quick to prescribe them:- One in seven pregnant women has been prescribed an opioid at some point during her pregnancy (http://www.medpagetoday.com/PainManagement/BackPain/44603)- Nearly 50 percent of adolescents who visit a doctor complaining of a headache receive a prescription for one or more narcotics (http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/44647)- More than 25 percent of Americans who use opioids for non-medical indications 200 or more days per year have been prescribed these drugs by a doctor (http://www.upi.com/Health_News/2014/03/03/Prescription-painkiller-abusers-often-get-them-from-a-doctor/UPI-70241393880460/)With the average doctor visit lasting less than 20 minutes (http://www.asrn.org/journal-world-news-nursing-report/7-average-doctor-visit-grows-by-32-seconds-over-10-years.html), many physicians dont feel they can take the time to discuss pain management strategies -- or lifestyle changes -- with patients who visit them complaining of chronic pain. The situation is even worse in emergency rooms, where doctors may prescribe painkillers to addicts just to clear the decks for true emergency patients. Approving more painkillers -- opioid analgesics and others -- is only going to make it easier for doctors to take the easy way out and prescribe them for people who could solve their pain problems another way. Creating a new surveillance state, in which people prescribed pain medication are tracked, is not the solution. There is little enough medical privacy in this country. The FDA seems to think that it can make everyone happy by making dangerous drugs plentiful (nice payout to pharmaceutical firms) and then handing out naloxone auto-injectors for when things go wrong. Sometimes, the right answer is to do less: approve fewer pain drugs, prescribe pain drugs less often, track fewer patients. Ask people to manage their pain in other ways -- lose the weight that is causing the back pain, take the physical therapy that will make movement less painful, go through a pregnancy without the lifestyle drugs that will harm your baby. ", "comment_id": "FDA-2014-N-0233-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0005", "comment_date": "2014-05-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2317}, {"text": "The Notice seeks information on the EFFECTIVENESS and ACCEPTABILITY of interventions that can be applied to reducing the prescription drug crisis.  Vatex leverages established behavioral science to reduce diversion and misuse of Controlled Substances.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles this problem directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The theory of action for our efforts is straightforward and evidence-based: checks  balances for oversight of psychoactive, addictive drugs promote thoughtful use, safer behaviors, and accountability. The Vatex hardware advancements are described in a separate submission to this Docket (search for Hardware Design) and are used to gather objective data on actual medication-use behaviors. These objective data are currently unavailable for individual patients. The application of proprietary analytics for assessing behavioral markers collected by the packaging is used in a management system designed to reduce diversion and misuse. The management system is termed Active MTM and is described in a separate submission to this Docket (search for Management Systems).Several behavioral big data analogies to the Vatex approach exist. For example, insurers use real-time analytics to remotely uncover dishonest doctors and prevent pay and chase schemes (1). Brick-and-mortar and online casinos use real-time analytics to intervene in gambling addiction (2). Efforts of online gambling companies to identify problem gamblers are directly analogous to Divert-X because all data are collected remotely, in real-time, in fine detail, and are related to addiction (2-6).  Another analogy is the proprietary credit scoring systems used by the consumer finance industry known as debt-repayment risk algorithms (7-9). The study of hidden human behavior has become central to several subfields of economics and finance (10). Because of this longstanding research focus, the behavioral and economics literature has firmly established that people are more accountable for their actions when they are being scored or merely aware that they might be scored (10-30), but the scoring system must remain somewhat opaque so that it is not subverted. For example, details of banking algorithms (used to score customers and employees) are tightly-held secrets (10). Similarly, the detailed methodology behind medication-use scoring will not be shared with the public generally in order to leverage behavioral science and to protect from subversion.Vatex sees strong parallels between the human desire to be seen as a good credit risk (rewards include improved loan pricing, employability in high-value positions, lower insurance rates (31-32)) and the desire to be seen as a credible patient (rewards include enhanced trust between provider and patient, straightforward access to needed medications, improved care quality). Bringing trust back to Controlled Substance prescribing and reducing patient-access disparities are key long-term Vatex goals. Employing a sophisticated device as an integral part of dispensing will emphasize to the patient, the family, and caregivers the serious safety risks associated with Controlled Substances. Because many people do not understand the risks of their medications, the packaging itself serves to warn (a behavioral nudge (33)) and should result in greater caution being taken to comply with prescribed regimens. Hence, the Divert-X packaging emphasizes safe-use and educational principles.Precedent from the medical, behavioral, and economics literature show that Divert-X is likely to be a high-impact system. Vatex is combining key refinements of historical systems with its own innovation to address a pressing problem. The medical literature is replete with studies (34-37) showing that compliance to medications not regulated by DEA can be increased through a variety of actions with corresponding improvements in health and cost. Improving compliance to Controlled Substance regimens is much more challenging, however, because overconsumption is spurred by experimentation and addiction, because of the financial windfall for those patients who divert their ongoing prescriptions (38-43), and because current clinical tools cannot separate authentic patients from those exaggerating the intensity and duration of disease (44-49). Hence, the literature describing methods that improve Controlled Substance adherence is sparse. A single Europ [please see the PDF provided for the full version with references]", "comment_id": "FDA-2014-N-0233-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0013", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5135}, {"text": "The Notice seeks information on PAYER INCENTIVES and the feasibility of implementation of interventions that can be applied to reducing the prescription drug crisis.  Innovative packaging that reduces opioid misuse can generate significant economic benefit by reducing the excess medical costs consequential to abuse and fraud. Outcomes improving financial returns for private and public healthcare payers will drive implementation of an evidence-based drug safety system.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles prescription medication abuse by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The insurance community - private, Medicare, Medicaid, workers compensation, self-insured employers, and VA - will be the customer base for Divert-X. The market for an IT service to infer patient behavior towards opiates and other Controlled Substances and to provide actionable information must be developed. Vatex expects that data from Divert-X pilots will successfully demonstrate the identification of anomalous patient behaviors and reduction in the misuse and diversion of medications. This will allow an estimate to be made quantifying the economic benefit from the introduction of Divert-X. The economic outcome will be used to petition medical insurance companies and government payers that the use of the system will generate significant healthcare savings for their organizations. Currently there are no technology-driven methods to differentiate between legitimate opiate patients and those abusing and diverting. Without effective tools, medical practice involving Controlled Substances has devolved to speculative, ineffective patient profiling (1-5), spawning numerous lawsuits and administrative actions (6-9), documented discussion of how to lie to patients (10-12), public battles between pharmacy and physician groups (13-15), and uncertainty expressed by DEA in court regarding how to establish the legitimacy of prescriptions (16). In the 2011 Government Accounting Office publication Prescription Pain Reliever Abuse (17), DEA officials report that based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not. As a result of the inability to identify and take broad action against diverters, the DEA increase their quota for opiate and Controlled Substance production based on demand- which naturally includes diverted medications. The recent Compounded Annual Growth Rates for opiate and stimulant DEA quotas are a staggering 27.0% and 33.4% respectively (18-19). Because Divert-X establishes dose-level accountability, it will reduce fraud, street medication supply, and diversion. It will provide an objective means to identify patients who are misusing opiates and other Controlled Substances and provide a novel method to combat the epidemic.The Vatex sales channel will be direct to insurers. We expect that insurers will mandate the use of Divert-X for opiates and other Controlled Substances for their patient populations once they are convinced of the magnitude of savings that it will generate. The high volume of Controlled Substance prescribing will ensure that pharmacies are responsive to the dictates of health insurance payers to dispense using Divert-X. In order to facilitate the cooperation of pharmacies, the Divert-X device is designed so that it can be filled in a very efficient manner with only a moderately longer pharmacy process. A dispensing fee for Divert-X will be paid to the pharmacy that is in excess of and in addition to standard medication dispensing fees. Divert-X adoption will therefore create a new source of revenue for the pharmacy, which will facilitate co-operation.Extrapolation from a 2007 insurance industry estimate (20) suggest that opiate misuse results in at least $100 billion in excess annual medical costs for insurers driven by the costs of emergency room visits, increased physician visits, diagnostic and drug-test spending, falls and other accidents, and abuse treatment programs. When this economic burden is considered against the annual volume of 200 million opiate prescriptions, abuse and fraud can be estimated to cause an average hidden cost burden of $500 in excess medical spending added to every prescription. Vatex corporate goal is to reduce Controlled Substance misuse and   [please see the PDF provided for the full version with references]", "comment_id": "FDA-2014-N-0233-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0022", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5080}, {"text": "Friday, June 6, 2014Colleen Brennan, Center for Drug Evaluation and ResearchOffice of Surveillance and EpidemiologyFood and Drug Administration 10903 New Hampshire Ave., Bldg. 22, Rm. 4410 Silver Spring, MD 20993-0002Re: Docket No. FDA2014N0233; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics Ms. Brennan,PillGuard Medication Delivery Systems appreciates the opportunity to comment on innovative packaging, storage, and disposal systems, technologies or designs (designs) that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others. In 2003, Dr. Robert Muncy and I were discussing the widespread abuse of controlled prescription medications in areas of Kentucky. As doctors, we were concerned that legitimately prescribed medications were being diverted and abused in many ways. Hoping to help alleviate the complex problems and the human tragedy associated with the widespread and growing abuse of dangerous prescription drugs, we wanted to create a device that would both reduce current levels of prescription drug abuse, and help prevent future abuse of prescription medications. Moreover, we wanted to increase public health and safety in our communities. We further realized that both our state and federal governments could benefit from a reduction in the skyrocketing costs for law enforcement, criminal justice, health care, and social services associated with prescription drug abuse. We saw a need for a better-protected pill bottle designed to prevent diversion of dangerous medications and took the idea to the University of Kentucky Center for Manufacturing.Powerful prescription medications can be life saving when taken under the supervision of a physician, but when abused, they can be just as life threatening as illicit drugs. The team concluded that the new kind of pill dispenser envisioned by the doctors should be one that: (a) would allow dispensing of a prescribed medication only in the prescribed amount no faster than the prescribed rate; (b) would detect tampering if someone were to try to break open the container or to otherwise forcibly remove the medication early; and (c) upon detection of tampering, pharmacists could be alerted.The PillGuard medicine dispenser will address the prescription drug abuse problem by allowing doses of dangerous drugs only at carefully regulated times. Controlling the time of delivery for addictive medication will deter over dosage and criminal action. Misrepresenting the facts and current state of our company, commenter Divert-X (ID: FDA-2014-N-0233-0010) indicated that our company closed in early 2014 due to reimbursement factors. On the contrary, this past week we launched a pilot program at the James A. Haley Tampa VA Medical Center to demonstrate the effectiveness of the device on our nations veterans. The Department of Veterans Affairs likely recognizes the immense danger to the take as needed approach and attributes that approach to the growing issue of abuse of controlled substances. While PillGuard, other limited access devices, tamper-resistant formulations, smart blister packaging, dispensing and behavioral monitoring systems, and other abuse deterrent technologies will not likely eliminate our nations prescription drug abuse problem, they can deter a large percentage of illegal abusers. With more assurance that the patient will not take their pills more frequently than prescribed or sell them all on the street, physicians can be more willing to prescribe these highly addictive medications when they will improve the patients health. The attachment recommends specific device characteristics and addresses several of the topics of interest.We thank the FDA for allowing us to comment on this important matter and pledge our support to the FDA in fighting this national epidemic.Sincerely,Dr. Anthony McEldowneyCEO, PillGuard Medication Delivery Systems(304) 514-9426anthony.mceldowney@rammllc.com", "comment_id": "FDA-2014-N-0233-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0019", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4236}, {"text": "The Notice seeks commentary on the subject of systems that could prevent or deter misuse and abuse without diminishing access for patients with legitimate prescriptions.  This is indeed a critically-important issue because provider-patient trust has been lost.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles this problem directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Regarding patient access issues, our hypothesis is that providers, if given an objective, evidence-based method to judge the behaviors of their patients, will treat their patients with trust rather than trepidation.  Secondarily, those patients showing aberrancy will receive guidance and assistance that should greatly improve patient care quality.The inability to judge motive and intent is fundamental to all Controlled Substances that are addictive or coveted by diverters.  Differentiation of patient motive is the most important problem to be solved because it affects all Controlled Substances, all authentic patients, and all formulations.  The truth of this statement is demonstrated by our realization that criminals (diverters) and addicts crowd out the authentic patients, driving the production and sales of Controlled Substances ever higher.  According to the GAO, DEA officials said that, based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not. [U.S. Government Accountability Office Report Number GAO-12-115, Dec 22, 2011.]  We expect that the growth trend shown below will continue until a behavioral differentiation system such as Divert-X is established as a new standard of care.[please see the accompanying PDF attachment to view the chart]If there were any doubt that patients sell their pills, then a study conducted in Florida is instructive.  A university-based survey team that had engendered trust with regional criminals conducted a scientific study during 2008-10.  They found that 44% of pill dealers specialized in accessing their supplies from local, insured patients who feigned intensity and duration of illness for financial gain; given that this study was conducted during a time when open-air prescription markets (pill mills) were tolerated in Florida, insured patients are surely a more important contributor to the supply chain in 2014. [Rigg KK, Kurtz SP, Surratt HL. Patterns of prescription medication diversion among drug dealers. Drugs (Abingdon Engl). 2012;19(2):144-155. PMCID: 3365597.]Because of the high profitability of the black market, honest and authentic patients are effectively pushed to the back of the line.  Rather than diminishing access, Divert-X is intended to improve access for those patients who are authentic and who demonstrate safe use.", "comment_id": "FDA-2014-N-0233-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0008", "comment_date": "2014-05-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3429}, {"text": "The Notice seeks commentary on SYSTEM INCENTIVES AND WORKFLOW ISSUES associated with adoption of new medication management systems. It is important that pharmacy workflow disruptions are minor and thus not an impediment to adoption relative to financial and other benefits afforded to stakeholders. It is critical that packaging and medication management systems (a) are agnostic to dose, dosage form, and manufacturer; (b) do not force pharmacies to alter their supply chains and preferred vendor networks; and (c) need not be adopted by pharmaceutical manufacturers.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Payers will capture the bulk of financial returns from the implementation of Divert-X and its management system, Active MTM. Active MTM is the subject of a detailed submission to this docket (search for Management Systems). Adoption will reduce spending by abating fraud and by reducing medical spending (clinic visits, falls and other accidents, addiction, etc.) caused by patient misuse of Controlled Substances. Payer incentives have been addressed in a separate response submitted to this docket (search for Payer Incentives). The reputation of the medical industry generally  of its prescribers, pharmacists, and corporations  will increase by adopting proven abatement systems. The prescription drug abuse epidemic has exposed the public to the rudimentary state of current Controlled Substance management systems and controls and has become an egg-on-face event for the industry. Adoption will also lower the enforcement burden on conscientious medical providers, because they can demonstrate a track record of diligence, enhancing community trust.  Although financial incentives are not shared equally, the various types of incentives outlined below are of high value and are aligned among the participants. Active MTM incents pharmacies and other providers to take more responsibility for Controlled Substance disposition and medication-use behaviors. In order to facilitate the cooperation of pharmacies, the Divert-X device is designed so that it can be filled in a very efficient manner with only a moderately longer pharmacy process. Filling Divert-X in the pharmacy is critical to success because it does not change pharmacy purchasing preferences and makes the intervention broadly and immediately applicable to most dosage forms, doses, and manufacturers. History shows that product-specific interventions are expensive, slow, and have failed to change the magnitude of the national crisis. Divert-X utilizes cold-seal assembly of the single-use smart blister packaging  a process already used by pharmacies nationally. Cold-seal assembly requires no capital equipment or dedicated bench space in the pharmacy, yet it provides a seal that is stronger than the paperboard used to house the individual doses.Pharmacies charge payers a fee for the act of dispensing and a separate fee for the medication itself. A dispensing fee for Divert-X will be paid to the pharmacy that is in excess of and in addition to standard medication dispensing fees. Because the medication sourcing and the medication charge (to payers) will not change under Divert-X, pharmacies will have the same level of profitability from this sales category. The high volume of Controlled Substance prescribing will ensure that pharmacies are responsive to the dictates of health insurance payers to dispense using Divert-X. Divert-X adoption will therefore create a new source of revenue for the pharmacy, which will facilitate co-operation.Regarding pharmacy reimbursement and workflow, Vatex will establish a new HCPCS dispensing fee (a substitute for the bottle-fill fee) that we call a drug-safety system fee, or DSS fee. Here is an example of a pharmacy transaction: instead of the payer or payers designee replying to a benefits query with an electronic OK to fill message, the payer would instead reply with a fill using DSS message for any medication of concern.  These instructions can only be fulfilled by pharmacies that participate in the Divert-X System or a competing evidence-based system and, because Controlled Substances are among the most commonly prescribed medications in America, market forces would drive adoption by the pharmacy industry.  A part of the DSS fee will flow to the pharmacy and  [please see the PDF provided for the full version including a summary table]", "comment_id": "FDA-2014-N-0233-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0024", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5108}, {"text": "The Notice seeks information on MANAGEMENT SYSTEMS that could prevent patient harm by helping prescribers monitor for signs of abuse or diversion by facilitating effective patient management and follow-up.  This is the core function of the Divert-X System that provides actionable real-time information to cause discovery and integrate follow-up.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The pilot of Divert-X includes an additional layer of management tools for prescribers, pharmacists, and payers that is termed Active MTM.  Medication Therapy Management (MTM) is a well-regarded and proven drug safety approach that is used by all insurers that offer Medicare plans.  The goal of MTM is to identify and intervene in complex poly-pharmacy cases so that patient safety and care efficiency (e.g., spending) can be assured.  These interventions are typically made by physicians and pharmacists who have the specialized training and practice focused on clinical pharmacology issues.  The interventions are mandated, scheduled regularly, and comprised of written, patient-specific guidance and reporting.  Unfortunately, MTM is uncommon for Controlled Substance safety enhancement because 1) prescribing of Controlled Substances is voluminous and 2) addiction, misuse, and diversion are deeply hidden behaviors  hence, MTM resources cannot be targeted with any efficiency.Because MTM principles are not used to guide therapy with Controlled Substances, Vatex employs a healthcare analytics approach, Active MTM, to nominate patients who appear to need help.  The principles of Active MTM are depicted in Figure 1 below.  Under the current system, there is a paucity of information surrounding the intent, motive, and medication-use idiosyncrasies of each patient.  Pharmacies lack detailed clinical and diagnostic information and are essentially bystanders in the process.  Clouding the clinical picture further, nearly all Controlled Substances treat diseases that lack objective measures for diagnosis and follow-up such as pain, anxiety, and ADHD.  As a result, patient self-report  known to be unreliable when addiction or street sale is involved - drives spending for excessive clinical, diagnostic, and pharmacy services.[please see the accompanying PDF attachment to view Figure 1]Active MTM is the Vatex approach to uncovering hidden fraud and to indentifying and helping patients who are misusing their medications.  Active MTM uses real-time, objective data collected from Divert-X devices, combined with state PMP data and insurer records, to afford rapid nominations for MTM intervention.  As shown in Figure 1, all parties have access to patient-specific objective information and scoring and so, they are aware that significant checks  balances exist.  The current islands of autonomy (see Figure 2) that now exist will be disrupted, and this should cause each act of prescribing and dispensing to be more thoughtful.  For example, repetitive prescribing or dispensing in the face of external red flags will be more quickly noticed by other participants on the healthcare team because of broadly dispersed data. Prescribers take direct clinical responsibility for the care of patients but, unique to the Controlled Substance arena, they must also shoulder significant regulatory and law enforcement burdens.  Hence, patient care and access suffer because of overburdening, fear, and lack of training and interest in law enforcement techniques.  The addition of objective data beyond patient self-report allows for a broad shift of risk and responsibilities that can be easily adopted by any system and any payer.  Active MTM is scalable and transferrable among healthcare systems, all of which are afflicted by the prescription drug abuse crisis.  Comparison of Figure 1 (Active MTM) with Figure 2 (current system) shows the additional risk shifting and checks-and-balances that are afforded by Active MTM.  By adding Divert-X monitoring, patients showing addictive or diversionary behaviors can be objectively nominated for intervention by an MTM Provider, specifically trained to address substance abuse issues, who can assist and share responsibilities. Active MTM should cause a major shift in risk and accountability and should improve care quality and access to care.  Figure 2 below shows the structure of the current  [please see the PDF provided for the full version with figures]", "comment_id": "FDA-2014-N-0233-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0021", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5081}, {"text": "The Notice seeks commentary on methods and systems to help ensure SAFE DISPOSAL. Because the Divert-X System is a drug-safety system that establishes a closed loop of distribution that begins and ends at the pharmacy, strong incentives can be employed to cause the return of unused medications for destruction.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Figure 1 shows a DEA-generated summary of the closed loop of distribution that is federally mandated for Controlled Substances.  Unfortunately, as noted by the question mark, the loop is not truly closed because contemporary management systems have no disposition information for medications that have been transferred to patients. Stated differently, no one knows where the tablets, capsules, patches, etc. go after they leave the pharmacy. When prescribed quantities exceed the needs of the patient, the spare doses often remain in homes for long periods of time. Unused doses in homes are one source of supply for non-medical use, particularly for people who have not progressed beyond occasional experimentation. While prescription take-back programs organized by DEA have destroyed 4.1 million pounds of unused medications since 2010 (1), these programs are stopgap measures offered while long-term solutions proceed through the federal rule-making process. The Secure and Responsible Drug Disposal Act of 2010 (2) establishes in-pharmacy disposal boxes and mail-back procedures for patients to return unused Controlled Substances for destruction.  As of this writing (May 2014) DEA leadership claim that the rulemaking process will be completed quickly because all external-agency steps are complete (3). While Divert-X is compatible with all principals and rules associated with the Act, it goes one step further by adding incentive mechanisms to encourage return and safe disposal soon after dispensing.While details of the Divert-X System are provided in other submissions to this docket (search for Management Systems and Patient Confidentiality and Hardware Design among others), Figure 2 shows the general features of a prescription cycle. Return of the device is the most important part of the cycle that is related to drug disposal. Completing the closed cycle for a single prescription, the packaging and electronics are returned to the pharmacy for tamper assessment by the pharmacist, for recovery of the reusable electronics, and for disposal of unused medications. Return of the intact packaging and device are fundamental to maintaining a record of high behavioral scores that would result in the patient being viewed as and treated as compliant  all necessary for trust and a basis for continued prescribing. In the case of an ongoing prescription for a chronic condition, doses may go unused and prescriptions may change because of tolerability or any number of other clinical or practical reasons.In the case of short-term prescriptions in support of conditions that are expected to be self-limiting, we expect to see innovation from payers. For example, a number of incentive programs such as coupons or in-store rewards can be offered to prompt the return of unused doses (known to exist because of the Divert-X data) soon after dispensing.  These alerts may come from the payer (whose incentive is to reduce the clinical costs of prescription drug abuse) or from the dispensing pharmacy (whose incentive is to generate another in-store visit). In either case, the public will view these steps as professional stewardship of medications that have safety concerns.As discussed, authentic patients on chronic therapy have a natural incentive to obtain high scores. Additionally, payers are incented to help close the loop  and recover unused medications  in order to reduce their abuse-related costs. Because the insurer will be financially responsible for the economic value of lost devices, payers have a second reason to encourage, incent, and properly explain to patients the need to close the loop. Vatex believes that alignment of patient and payer self interests can be more effective in reducing the crisis than law enforcement, regulation, and education.[please see the PDF provided for the full version with figures and references]", "comment_id": "FDA-2014-N-0233-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0023", "comment_date": "2014-06-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4916}]}, {"id": "FDA-2012-P-1028", "agency": "FDA", "title": "Safety Concerns Regarding Buprenorphine for Opioid Dependence-CLOSED", "update_date": "2013-05-30", "update_time": "08:33:02", "purpose": "Nonrulemaking", "keywords": ["CDER", "buprenorphine", "opioid", "dependence", "reckitt benckiser", "pharmaceuticals", "rbp", "rld", "nda", "anda", "subutex", "suboxone", "hc1", "naloxone", "child-resistant", "pediatric", "radars", "riskmap", "rems", "2012-8052", "CLOSED"], "comments": [{"text": "Actavis Inc. Comments to Docket No. FDA-2012-P-1028 (1-31-2013)", "comment_id": "FDA-2012-P-1028-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0014", "comment_date": "2013-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 63}, {"text": "This memo is submitted to provide a correction to the Reckitt Benckiser Pharmaceuticals -- Response to Amneal Comment (Doc ID: FDA-2012-P-1028-0005)", "comment_id": "FDA-2012-P-1028-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0006", "comment_date": "2012-12-11", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 148}, {"text": "Reckitt Benckiser Pharmaceuticals -- Response to Amneal Comment", "comment_id": "FDA-2012-P-1028-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0005", "comment_date": "2012-11-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 63}]}, {"id": "EPA-HQ-OAR-2020-0448", "agency": "EPA", "title": "E15 Labeling", "update_date": "2023-01-05", "update_time": "11:17:21", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I own motorcycles and cars. I was against E-15 as it is not compatible with most boats, cars, motorcycles, home generators, chain saws, and lawn mowers, snow blowers and so-on.  It is also bad for the environment, but thats not the issue here.  There is a serious risk of expensive engine damage here, and fires when the seals leak because of the high concentration of ethanol. Ethanol eats rubber.  You have to do better on the labeling at the pumps.  Why not just have large labels on each pump handle that say E10, E15, and NoE for non-ethanol gasoline?  On E15, you could add Not compatible with many vehicles, may cause engine damage. Use ONLY with E15 certified engines. Color code it. Red for E15, Blue for E10, and Gold for non-ethanol gasoline.  Post a 5x7 label on all fuel pumps explaining it.You have to realize that your audience is everything from the seriously uneducated to mechanic hobbiests. Some of us get it immediately, others dont have the interest, ability, or time to consider the differences.  Keep it simple. make it obvious, otherwise saving the environment (which this is not doing), will be very costly to many people who cannot afford expensive repairs. ", "comment_id": "EPA-HQ-OAR-2020-0448-0013", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0013", "comment_date": "2021-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1216}, {"text": "The requirement requiring all New UST Installations or Replacements requiring the equipment to be compatible with 100% ethanol blends will be a excessive financial burden on the industry.  There is a significant difference in E25 compatible equipment and E100 equipment.The majority of Fuel Dispensing locations are dispensing blends less than 25%, by requiring all locations to be compatible with 100% ethanol blends it will be an additional burden on the industry.  For locations choosing to dispensing blends above E15 or E25, they can provide a compatibility certification for high ethanol blends.  Only site choosing to dispense higher ethanol blends should be the only locations required to purchase high ethanol blend equipment.The cost of providing just one fueling dispenser which is compatible with 100% ethanol is an additional $ 8,000, per dispenser.Prior to the ruling be enforced the EPA should ensure that products are available and that manufacturers are capable of providing certifications.  Pipe dope is one of the materials where certified compatibility is difficult to obtain.Dale PeltierSioux Equipment Co1310 East 39th Street NSioux Falls, SD   57104", "comment_id": "EPA-HQ-OAR-2020-0448-0005", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0005", "comment_date": "2021-02-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1237}, {"text": "EPA - The existing label on E15 is confusing to the consumer and discourages choices that protect human health and the environment.  Ethanol is a direct replacement to toxic BTEX components in gasoline; encouraging greater use of higher blends like E15 make the air safer to breathe for every American whether they drive or not.  Please eliminate this onerous and misleading label requirement.", "comment_id": "EPA-HQ-OAR-2020-0448-0082", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0082", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 393}, {"text": "I urge you to fix onerous labeling and infrastructure limits holding back the sale of 15 percent ethanol blends.The existing E15 label is confusing and outdated. As our nation faces down the dual challenges of climate change and toxic air pollution from fossil fuels, its imperative that the EPA act immediately to support access to cleaner renewable fuel blends for all Americans. Addressing labeling and allowing sales of E15 through existing fuel infrastructure are critical steps toward reducing greenhouse gas and tailpipe emissions. These important updates will provide fuel retailers, biofuel workers, and family farmers the certainty they need to deliver on the promise of E15 and give motorists more earth-friendly and affordable options at the pump.  Thank you for your consideration.", "comment_id": "EPA-HQ-OAR-2020-0448-0086", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0086", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 829}, {"text": "As a supporter of equipment manufacturing, I urge you to change the labeling and infrastructure barriers that artificially depress the sale of 15 percent ethanol blended gasoline.The current E15 label designed to inform consumers of the correct dose of ethanol blended fuels is confusing and outdated. Today E15-approved cars, trucks, and SUVs in the U.S. represent more than 97% of vehicle miles traveled. Consumers have driven over 19 billion miles on the cleaner-burning fuel, and retailers have had millions of transactions, all without a single reported issue. Rural America continues to face many economic challenges. Expanding demand for clean biofuels, like ethanol, not only supports farmers, creates jobs at ethanol plants, but also helps drive demand for off-road equipment.   The EPA should fix the few remaining regulatory hurdles blocking E15. Doing so will support off-road equipment manufacturers, rural America, and the economy as a whole. ", "comment_id": "EPA-HQ-OAR-2020-0448-0089", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0089", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 992}, {"text": "I urge you to fix the onerous E15 labeling and infrastructure limits holding back the sale of 15 percent ethanol blends.E15 and higher ethanol blends will play a vital role in supporting our rural economy, and removing roadblocks to that will benefit everyone.Thank you for your consideration.", "comment_id": "EPA-HQ-OAR-2020-0448-0078", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0078", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 313}, {"text": "I urge you to fix onerous labeling and infrastructure limits holding back the sale of 15 percent ethanol blends.The existing E15 label  originally intended to inform consumers of  the appropriate and lawful use of the fuel  is confusing and outdated.. During his campaign, President Biden emphasized the importance of biofuels to our communities, our climate, and our economy. His EPA should move swiftly to fix the few remaining regulatory barriers blocking E15 and affirm the vital role biofuels play in supporting green jobs and decarbonizing the transportation sector.  Thank you for your consideration.", "comment_id": "EPA-HQ-OAR-2020-0448-0087", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0087", "comment_date": "2021-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 637}, {"text": "Please see the attachment.", "comment_id": "EPA-HQ-OAR-2020-0448-0062", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0062", "comment_date": "2021-04-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 26}, {"text": "Re:Docket ID No. EPA-HQ-OAR- 2020-0448E15 Fuel Dispenser Labeling and Compatibility With Underground Storage TanksTo:www.regulations.govThe Division of Consumer Equitability, which exists within the Nevada Department of Agriculture, is composed of the Weights  Measures, Metrology, and Petroleum Technology programs. The missions of the division are to ensure that the consumer is safeguarded through consumer protection, and to ensure a fair and equitable marketplace for businesses. The following comments are submitted in the context of consumer protection.Our comments are targeted solely towards Section II. E15 Fuel Dispenser Labeling Revisions. The Nevada Department of Agriculture stands in opposition to the elimination of required dispenser label requirements for E15.Subsection B (page 5097) states that the opportunities for misfuelling have been reduced as the number of light-duty vehicles from MY2001 and older in the national fleet have decreased. In Nevada, however, we have found that there are still a substantial number of vehicles within the states fleet for which E15 is inappropriate. Data received from the Nevada Department of Motor Vehicles for Fiscal Year 2020 indicated that 284,692 light-duty vehicles were registered in Nevada from MY2001 or older. This number accounts for more than 15% of registered gasoline-powered vehicles. The use of E15 in pre-MY2001 vehicles can cause damage to automotive systems. It is also worth noting that motorcycles are still not approved for the use of E15 fuel.  There is also an economic concern for Nevada consumers. The state of Nevada imports nearly 100% of the gasoline sold in the state, with approximately 70% of that fuel originating in California. The limited sources of gasoline for import into Nevada and the high volume that originates in California has an adverse impact on prices in Nevada. Historically, gasoline prices in Nevada run well above both the National and the PADD 5b averages.The above is meant to illustrate and emphasize economic choices made by consumers in Nevada. Regardless of whether the economy is strong or weak, fuel trends and prices will play a large role in consumers spending patterns.E15 dispensers should continue to be labeled so that consumers will not inadvertently use fuels that may harm their vehicles.  Eliminating the requirement for E15 labeling at the dispenser, especially in light of the significant part of the state fleet being inappropriate for E15 usage, and gasoline prices historically well above the national and PADD averages, will lead to an environment where it will not be difficult for Nevada consumers to misfuel their vehicles. We thank you for the opportunity to comment on this important matter.Regards,William S. Striejewske, PhDSenior Petroleum ChemistNevada Department of AgricultureDivision of Consumer Equitability775-353-3792 wstriejewske@agri.nv.gov", "comment_id": "EPA-HQ-OAR-2020-0448-0023", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0023", "comment_date": "2021-04-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3160}, {"text": "Specialty Equipment Market Association (SEMA) Comments", "comment_id": "EPA-HQ-OAR-2020-0448-0094", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2020-0448-0094", "comment_date": "2021-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 54}]}, {"id": "FDA-2016-P-4094", "agency": "FDA", "title": "Request that the FDA to (i) require proposed generic versions of Intranasal (IN) naloxone products to provide specific pharmacokinetic (PK), device, stability and Chemistry, Manufacturing and Controls (CMC) data, as set-out herein, within the ANDA, to support the interchangeability of generic IN naloxone and the IN naloxone Reference Listed Drug (RLD); (ii) not to approve any", "update_date": "2017-05-30", "update_time": "11:27:51", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "2016-6877", "OPNE", "Adapt Pharma Operations Ltd", "Intranasal", "naloxone products", "pharmacokinetic", "device, stability and Chemistry", "Manufacturing and Controls", "interchangeability of generic", "IN naloxone and the IN naloxone"], "comments": [{"text": "See uploaded file. ", "comment_id": "FDA-2016-P-4094-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-4094-0004", "comment_date": "2017-05-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 19}]}, {"id": "FDA-1981-N-0012", "agency": "FDA", "title": "OTC Weight Control Drug Products for Human Use", "update_date": "2021-05-05", "update_time": "01:00:33", "purpose": "Nonrulemaking", "keywords": ["May 19", " 2000- vol93", "University", "yale", "stroke", "CONTROL", "DIET", "OTC", "STIMULANT", "WEIGHT", "PPA", "HAZARD", "AMPHETAMINE", "ADVERSE REPORTS 1991-2000"], "comments": [{"text": "Having read the proposed rule for Docket No. FDA-1981-N-0012, I agree whole heartedly with for benzocaine to have a non-mongraph status versus the proposed monograph status (category I) for over-the-counter (OTC) weight control use. In researching the docket proposal, there has not been sufficient data provided by the petitioners.  The data provided was not substantial and from the documentation was not well controlled.  Without adequate data, it would not be prudent to make a determination regarding benzocaines suitability for over-the-counter use for weight loss. Additionally, the manufacturer has not replied to the commissions response to their 1992 petition; the commission responded in 1993. Without any further correspondence from the manufacturer the commission could only assume that the manufacturer agrees with the unsuitability of benzocaine as an over-the-counter weight-loss product.  In reviewing, other consumer advocacy groups we found no references for or against this proposed rule.  However, I firmly advocate the proposed rule for benzocaine to have a non-monograph status. Very Respectfully,Brad Cecil ", "comment_id": "FDA-1981-N-0012-0051", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1981-N-0012-0051", "comment_date": "2011-04-04", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1165}]}, {"id": "CMS-2012-0012", "agency": "CMS", "title": "Medicaid Program; Covered Outpatient Drugs (CMS-2345-IFC2)", "update_date": "2021-04-21", "update_time": "01:00:30", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think that Medicaid needs to evaluate reimbursement for outpatient drugs related to mental health.  With the way the economy has been recently, many people losing their jobs, enrolling in Medicaid, and possibly becoming depressed (or any other mental defect), people may be using other types of drugs for these conditions.", "comment_id": "CMS-2012-0012-0112", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2012-0012-0112", "comment_date": "2012-04-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 324}, {"text": "Charles Cole Memorial Hospital is a critical access hospital located in north central Pennsylvania. We have a cancer center at our facility which serves a very remote/rural population. The exclusion of orphan drugs for critical access hospitals is a hardship for an organization such as ours due to our cancer program. Critical access hospitals should not have been excluded from orphan drugs at all. In addition, a drugs orphan status is misinterpreted as having orphan status beyond the indication for its original reason for gaining orphan status. For example, a drug may have received orphan status 20 years ago for its original indication and today that same drug may have 5 additional indications not associated with the original but the drug continues to maintain orphan status for all indications. The exclusion of in-patient drugs for our organization is also a hardship. In our last fiscal year, we had 1.1 million dollars in charity care. The ability for us to purchase our in-patient drugs at 340B pricing would help in offsetting these losses which are substantial for an organization our size. Your consideration for clarifying the issues related to orphan drugs as well as allowing in-patient drugs to be purchased under the 340B program would insure that we will be able to continue valuable services to our uninsured and underinsured population in our region.Thank you", "comment_id": "CMS-2012-0012-0117", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2012-0012-0117", "comment_date": "2012-04-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1410}, {"text": "While I understand that CMS calculates and posts all product URAs on a quarterly basis, I also understand that it remains the responsibility of the manufacturer to do that calculation themselves.  Within the line extension (LE) alternative URA calculation, it will be important for a company with a LE to obtain the URA information for the initial product.  I see many challenges with this action.  First being, will the LE company have extra time to do their calculation as it is entirely possible that the initial product calculation details are not complete and entered into the DDR system before the 30th day.  Second is how willing will one company be in supplying reimbursement detail to a competitor?  What is to stop the LE company from using that detail to alter their contract management strategies with state programs in order to better compete (or shut down the competition) with the initial brand product?  By forcing companies to share this information, you run the risk of obliterating a companys marketing strategy, and quite possibly that product within the state and federal programs.  Third, where does the responsibility lie for the accuracy of these numbers? If the initial product numbers are incorrect, and the LE company uses those numbers as submitted to them (not knowing they were incorrect), will the LE company be out of compliance because they made their calculations and decisions off of a number that was not correct?  And what about restatements?  If the initial product is restated, does the LE company also have to restate and reconcile their rebates, PHS pricing, etc.  The myriad of challenges with this provision is a potential snowball. ", "comment_id": "CMS-2012-0012-0028", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2012-0012-0028", "comment_date": "2012-04-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1683}, {"text": "The language in the proposed rule seems to raise doubt about how many manufacturers are doing their quarterly calculation.  Does CMS expect all manufactures to calculate their quarterly AMP by adding all sales for the quarter and dividing that result by the total number of units in that quarter ((M1$+M2$+M3$)/(M1Units+M2Units+M3Units))?  Or do they intend to have the calculation being the three monthly AMPs divided by 3 ((M1AMP+M2AMP+M3AMP)/3)?  And if it is the divided by 3 calculation, does CMS recognize that the AMPs will be artificially inflated by that formula?", "comment_id": "CMS-2012-0012-0007", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2012-0012-0007", "comment_date": "2012-03-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 572}, {"text": "I do not support this proposed change.", "comment_id": "CMS-2012-0012-0059", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2012-0012-0059", "comment_date": "2012-04-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 38}]}, {"id": "FDA-2016-D-0785", "agency": "FDA", "title": "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products", "update_date": "2017-11-22", "update_time": "10:26:14", "purpose": "Nonrulemaking", "keywords": ["2015-181", "General Principles for Evaluating", "Abuse Deterrence of Generic Solid Oral", "Opioid Drugs Products", "2016-932"], "comments": [{"text": " My name is Jennifer Ford, and I have fibromyalgia. Including chronic pain, chronic fatigue, depression, anxiety, degenerative disc disease, COPD, just to name a few. I am able to barely maintain some level of a normal life with pain levels of a 5-6 on a good day. This is with the use of three hydrocodone a day. No more, no less. I receive a prescription of 90 per month. Thats 3 a day, for 30 days. Take that away from me, and I have no idea what Ill do. Please leave chronic pain patients alone. We are patients, not addicts.13", "comment_id": "FDA-2016-D-0785-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0008", "comment_date": "2016-05-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 556}, {"text": "No more opioid guidelines that hurt the Chronic Pain community. My doctors are refusing medications they themselves put me on. We matter, the quality of our lives matter and our voices need to be listened to. Addiction within our community is very rare. ", "comment_id": "FDA-2016-D-0785-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0016", "comment_date": "2016-05-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 254}, {"text": "I have taken opioids on and off for 30 years responsibly and safely. I have adhesive arachnoiditis. Without these meds many chronic pain patients will have no quality of life. What the government is doing is outrageous. You can buy codeine over the counter in Canada. It is not a gateway drug to heroin. Although the money grubbing addiction industry would like you to think so. The problem is heroin coming into the country from Mexico and China. If you want to fix the drug problem fix that. A new study shows that opioid overdoses peaked in 2012. Even if you take opioids off the market you will still have addicts acquiring it on the streets. You are throwing the baby out with the bath water. Patients who suffer everyday with excruciating pain rely on these medications to bring the pain down to a tolerable level. We take our medications responsibly. Any physician who says to take oxycodone off the market has no compassion. There is a place for opioids in medicine when the are prescribed responsibly. Pain patients are just getting warmed up! If you think were going to tolerate this treatment you are wrong! ", "comment_id": "FDA-2016-D-0785-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0025", "comment_date": "2016-06-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1124}, {"text": "I my name is James I have a chronic pain disease called rsd or crps. I use some of these drugs to control my pain and help me get through my day. There are many of us in the same position as I am. If you put uncentsable regulations on this we are going to be the ones that suffer from this for others stupidity pleases stop and think about the people that need this to get though our days and nights and to be able to spend time with our families. There are other ways to weed out the people that are abouseing theses drugs. I know we as the people of this country dont really matter to you people on any of these maters, but maybe just maybe for once in your time in office you will do the right thing and help the people that put you there. If you all had to spend one day in any of our shose you would understand where we are coming from. PLEASE PLEASE STOP AND THINK BEFORE YOU TAKE ANY ACTION ON THIS. If you were one of use you would be doing all you cant to take a different position on any of this.", "comment_id": "FDA-2016-D-0785-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0043", "comment_date": "2016-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1016}, {"text": "Dr. Glapinski, I am a chronic pain sufferer and one who is DEPENDENT on oxycodone for a QUALITY OF LIFE. In reading your comment, you are aware that chronic pain pts depend on opiods and are in agreement, and then you turn around and say ban oxycodone. Just because you are against it for what ever reason, there are MANY LEGITIMATE chronic pain pts who retain a QUALITY OF LIFE by taking oxycodone. I have tried nearly all of them over the course of ten years. Opiods were my last resort, first came years of physical therapy, massage, chiro, accupuncture, epidurals, discographies, OTC AND NSAIDS that tore my stomach and liver up, facet injections, trigger point injections, nerve blocks, steriods, nerves burned, TENS, and two FAILED spinal fusions that left me with severe nerve damage. Oxycodone happens to be the one medication that agrees with me and takes my unbearable pain to a tolerable level, when I was on the right dose. Because of all these INHUMANE restrictions by the CDC, FDA, DEA and the government, Legitimate pain ots are having their once stable dose lowered to INEFFECTIVE DOSES or totally stripped of them, leaving many in agony and severe withdrawal. Shame on any of you doctors who abandon their patients. We are suffering from incurable conditions that cause severe pain, I beg God to take me daily. Would you do that to your Mom? Could you sit back and watch your loved one be at war with their body, stabbing, burning, crushing, piercing, pains, the emotional and mental toll it takes on a person, If your loved one got relief by taking opiods, would you want them to have some QUALITY OF LIFE and enjoy what they can or strip them of the only treatment they gave them some relief, force them to remain bedridden, shut off from society, many are turning to suicide to escape the pain. You doctors took an oath to do no harm. I get the DEA is targeting all our drs, there is way more harm being done to the chronically ill, we are being FORCED to suffer, to exist in hell, All the doctors thruout this country who believe in helping the suffering, especially when weve tried the alternative therapies OUR BODIES could take, its physically, mentally and emotionally exhausting fighting this battle, then the stigma that is thrown on our backs, shame on all of you dra for not standing alongside the suffering. Perhaps if you treated each person as if you would your mom, maybe there would be compassion and empathy brought back into the dr/patient relationship. I see and hear nothing but NEGLECT, ABUSE, DEGRADING, DISCRIMINATION AGAINST LEGITIMATE PAIN PTS. Another fact is there is no opiod epidemic. The CDC used false data, even admitted to MISCLASSIFYING MANY heroin and fentanyl deaths, doubling and tripling one persons death, legit pain pts who committed suicide were listed an overdose, if alcohol or any other illicit drugs played a part the CDC looked the other way, they created mass hysteria that the media and government took off with, constantly demonizing a chronic pain pts LIFE SAVING MEDICATIONS. The CDC created FALSIFIED STATISTICS MADE TO FIT THE GOVERNMENTS ADDICTION DRIVEN AGENDA. Chronic pain pts are LAW ABIDING citizens who have DEBILITATING INCURABLE CONDITIONS, who have tried whatever was put in front of us by the medical community to get relief. We dont BREAK THE LAW, WE DONT ABUSE, SELL, SHARE, SNORT, OR ANYTHING ELSE TO OUR LIFE SAVING MEDS. WE ARE SICK FOR GOD SAKE. We are treated HORRIBLY by the medical community, treated like everyone is a pill seeking junkie, addict, and criminals. I am so fed up with paying the high price with my health and overall well being because of those who CHOOSE TO ABUSE, people who CHOOSE TO BREAK THE LAW, WHO CHOOSE TO POP DRUGS, OR GET DRUNK OFF ALCOHOL, PEOPLE WHO CHOOSE TO DESTROY THEIR BODIES, Addicts are given all kinds of opportunities to get help, all kinds of doors open for them, hell even the government passes out clean needles to shoot their drug of choice up with and safe houses to go get high and shoot up. When an addict, someone who CHOOSES TO ABUSE , fails a drug test during treatment they are given  chance after chance, they arent kicked out and turned away, A LEGITIMATE chronic intractable pain pts are turned away, judged and labeled as addicts, pts who have been with their drs for years and were on the same stable dose that worked for them are having meds reduced or taken away thru no fault of our own, for following the rules, getting drug tested monthly, shamed at the pharmacy, if you even find a pharmacy to fill your LEGAL lifesaving medication. Nearly all chronic pain pts have suffered for years and have years of medical records documenting their DEBILITATING INCURABLE conditions, usually has had many MRIs scans, tests, etc.These debilitating conditions only continue to worsen over time, so why are we decreasing legit pain pts meds when the doses really should be increased. How would it make you feel if your own mother were so poorly neglected!?", "comment_id": "FDA-2016-D-0785-0056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0056", "comment_date": "2016-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5013}, {"text": "1.Although the theme of the guidance seems, as expected, to proof that tested generic formulation (T) is not inferior to an approved AD reference formulation (R) and some studies were designed to test T against R directly, e.g. syringeability, introducing the control formulation (C) in some studies, e.g. extractability, created some confusion between qualifying an original brand name AD formulation (R) and a generic.  We believe that, for generics, T should be tested directly against R, with no need for a third formulation (control), unless one route of abuse was not considered/listed on the R label.2.There is no clarity if in-vitro testing need to be done or at least verified by a third party laboratory to avoid manufacturers bias which we have noticed as a third party lab.3.The draft guidance, as well as the previously approved AD guidance, focus on opioids but we believe that it should cover, also, non-opioids of potential abuse, e.g. amphetamines or molecules that can be precursor for recreational drugs, e.g. pseudoephedrine.4.Smoking simulation study listed 233C as a definite temperature for heating but from our experience, this temp was not good to volatilize morphine or oxycodone and for which we needed to optimize the heating conditions.  Not sure why the paper ignition temperature was used to set up this figure noting that different heating techniques including direct heating a drug on a piece of aluminum foil or putting a drug directly on ignited charcoal, e.g. hookah, have been used.  We believe that, smoking simulation studies should be optimized first using pure compounds and select the most effective heating condition/temp to test an AD formulation. 5.The guidance did not mention core separation as a part of physical manipulation for formulations with API is enclosed in a core within a hard shell.6.The guidance did not mention saline solution for extractability or syringeability where its a potential solvent that can be easily obtained by a drug abuser and safely injected.  In this regard, for generics, we believe that all or representative solvents which were used to qualify an R should be used for T.7.For particle size distribution following physical manipulation, 500 micron was used as a cut-off; does this mean no particle size characterization is needed below 500 micron?8.Free base isolation; 233C for 2-15 minutes was listed to dry up a precipitated base without a rationale.  From our experience, different temperatures and/or different heating times can be needed and noting that 233C was already suggested for smoking simulation, heating some compounds at this temp for 15 minutes may cause significant loss.9.Liquid-liquid extraction was not listed but from our experience, after proper optimization, it was an efficient tool to isolate some opioids.10.The guidance did not handle AD formulation which depend on conjugation of an active moiety to a pharmacologically inert side chain which needs to be cleaved inside the human body for slow release of the active molecule.11.The guidance suggest 28 to 18 for syringeability and we suggest to consider either 28 or 27 as the latter is common and such small bore size should not make a difference compared to 28.", "comment_id": "FDA-2016-D-0785-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0003", "comment_date": "2016-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3791}, {"text": "I dont understand why you think that going after physicians  their patients, specifically chronic pain patients is going to somehow make this heroin epidemic lessen or disappear. I am a woman who was born with severe JRA at 15 months old, have had several surgeries,  other diagnoses along the way........Fibromyalgia, CFS, seemingly untreatable bi-lateral hip bursitis, constant back spasms,   the list goes on.  I have for over 10 years been under the care of my wonderful rheumatologist  have ALWAYS listened to her, followed all directions,  more importantly NEVER, EVER given her reason to think I was doing anything otherwise.  I am a perfect patient.   My pain meds make my life liveable  when I say that....I mean my kind of liveable.  I am permanently disabled so nothing is perfect, BUT being able to make dinner for my family at night  do some light housekeeping is only because of my pain meds.  And now you want to make it harder?  For what? Why?  To eliminate what you think is the reason for heroin?  Look around, do some more research.  We have above pharmacy grade opiates coming across our borders  drug dealers are selling it to addicts. Thats NOT us. Under 5% of the chronic pain community become addicts. Do we depend on our meds?  Yes, but for living, for function,  so we are not bedridden.  We arent getting high, we are getting some relief.  Theres a HUGE difference between physical dependence  psychological dependence. We are not in the latter group. Diabetics rely on their insulin, we rely on pain management. There is really no difference. Every medication comes with risks. You overdose on an over the counter medication too. Its called personal responsibility  because some dont practice that, you make ALL pay?  You have already made getting our meds tougher with changing the scheduling class, breathing down the necks of our doctors, making them so scared to actually treat their patients now, pain contracts, random urine tests,  pill counts, etc, etc......  What else do you want??  After all those things were implemented NOTHING changed with the addicts. In fact in one city next to me the drug use  overdoses have actually doubled since then!  Seems like you are barking up the wrong tree.  I get my meds, keep them in a fire safe locked box  practice good medication safety, but now I feel that at any moment my rheumatologist could pull the rug out from under me because of fear, or because you come up with some other crazy rule/regulation.  She has already stated that it is out of her hands  she actually told me she will not longer prescribe pain meds to new patients, only the ones that are already on them. Really?  Find another way to control this epidemic, because last I checked drug addicts dont hang out at rheumatologist, neurologist, or oncologists offices.  Go after the drug dealers  the border. Please leave those of us that do nothing wrong alone. Will you release the suicide rates in the chronic pain community when they go off the charts?   Because I have already read of SO many,  in many cases it happened because a physician got scared  just stopped their meds cold turkey, which is incredibly dangerous  in my opinion medically unethical. Those people end up in the ER  are treated like subhuman beings. Wow, thats really good medical care. Let the rheumatologists,  neurologists, oncologists,  pain clinic physicians do their job. None of us want to be on these meds, but we have come to them because we have tried everything else. I have done physical therapy several times  got cortisone shots every 3 months for over 4 years. Give me a break!  Until the scientists  researchers come out with some other medication and/or treatment that works as good as opiates, leave us alone. There are also so many of us that cannot take the conventional medications for our diseases because we have really horrible side effects,  opiates end up being our safest most effective treatment.  Why punish the innocent people just trying to live a semi-normal life? When are you going to stop punishing the wrong group of people?  Why should we pay for others bad decisions? I am disgusted  I dont deserve to be treated like this.  The way pharmacists look at us, treat us,  even lie about how they cannot fill our prescriptions is beyond ridiculous. Thankfully I have a wonderful pharmacy.  I ran a chronic pain support group on line for over 4 years  I heard the horror stories. They have been so bad I was forced to stop running the group.....between the stress  my own illness, well.....I just felt I had nothing left to give my members. Everything looks dim for them,  thats a sad state of affairs for people that have no choice,  who were born with horribly painful diseases  illnesses. They arent addicts, they are patients. Shame on the medical community, the government, the DEA,  the CDC. You arent doing your job, you are just creating another problem. Looks good on paper maybe? Horrible!", "comment_id": "FDA-2016-D-0785-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0023", "comment_date": "2016-06-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5186}, {"text": "We are real chronic pain patients with real pain...........not drug addicts!", "comment_id": "FDA-2016-D-0785-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0071", "comment_date": "2016-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 76}, {"text": "The regulations against opiate pain medicine has been devastating to my family, to people I care about and to myself personally. I am not a pain patient or user of opiates but my husband who has been disabled for 20 years is a chronic pain patient. These regulations put him through on-going trauma, and pain. Our basic human  rights are violated. We are not allowed to live where we want to, or in the state we want to, because we are prisoners to proximity to a doctor who will prescribe the essential medicine. To get this medicine he must submit to urine tests which violate his 5th amendment rights. Law enforcement doesnt belong in doctors offices and hospitals! Basic human rights are disregarded in this failed War on Drugs created by Nixon for racist and evil objectives. Stop restricting medicines! Stop your war against the American people! Leave pain patients alone. Stop blaming suicides on pain medicine and look at the patients in chronic pain who are told that their only source of relief has been outlawed! Stop criminalizing self-medication. You are not supposed to control other peoples choices with their own bodies. Citizens of the United States are back to having to reclaim their rights to self ownership.", "comment_id": "FDA-2016-D-0785-0078", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0078", "comment_date": "2016-07-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1267}, {"text": "Why are you not going after other patients medications? Start taking  medications for those suffering from all other conditions too!  SMH!!  ", "comment_id": "FDA-2016-D-0785-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0033", "comment_date": "2016-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 141}]}, {"id": "HUD-2016-0050", "agency": "HUD", "title": "FR-5890\u2013P\u201301 Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD- Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing", "update_date": "2021-01-07", "update_time": "01:31:39", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "On behalf of the National Association of Housing and Redevelopment Officials (NAHRO), I am are pleased to offer the following comments in response to the proposed rule (FR-5890-P-01) entitled Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD-Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing.", "comment_id": "HUD-2016-0050-0021", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0021", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 368}, {"text": "Please see comments from the National Housing Conference. ", "comment_id": "HUD-2016-0050-0009", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0009", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 58}, {"text": "Comments of Webpass, Inc. on HUD Proposed Rule FR 5890-P-01Webpass is a San Francisco-based internet access service provider.  We own and operate our own Ethernet network and currently serve San Francisco, Oakland, San Diego, Miami, Chicago, and Boston. Google Fiber recently agreed to acquire our company.We urge HUD to adopt the Internet Franchise policy framework.  Webpasss proposed Internet Franchise policy  (https://webpass.net/franchise)  directly addresses the issues in this rulemaking. Creating a new set of rules for a small subset of properties--those supported by HUD--is not helpful. HUD should adopt broadly applicable internet access rules that can be a model for the whole country.  The Internet Franchise declares internet access service a public utility and offers franchise status to approved providers, creating a legal landscape where the best options flourish. The proposed rules include:   - high-speed internet-grade cabling in new buildings and major renovations   - access to properties for any franchisee requested by a tenant   - no kickback agreements or discriminatory riser management policies   - access to poles and conduit for approved franchisees   - streamlined local permitting. Professor Susan Crawford describes how the Internet Franchise can help, in her recent article at https://backchannel.com/the-new-payola-deals-landlords-cut-with-internet-providers-cf60200aa9e9#.vjp5ichiv.  Internet service in America is not what it should be. Most consumers have two choices, the phone company and the cable company. There is a lot more we can do to improve the competitive environment and internet service overall. The U.S. has the same technology as other countries with great internet service. Japan, South Korea, and the like dont have any unique access technology. Technology is not the difference. These countries are home to newer, denser cities, and that significantly lowers the cost of building and deploying a network. But that is still not the whole story.  Looking at the history of technology in the U.S., back when lots of small companies launched small telephone networks that served a geographic area, those networks did not have the legal authority to serve the entire area.  They needed to enter buildings and use the public rights of way for manholes, poles, and other structures to build the network efficiently. The problem was solved by creating telephone franchise rules, which authorized a telephone company to provide service inside a jurisdiction in return for serving everyone in the jurisdiction, or universal service. Almost every structure in the U.S. has access to a landline phone connection today, even though nobody really uses them anymore!Fast forward to the early 1970s, when the cable television industry started. Same problem, same solution. Many small cable companies needed access to public rights of way to build video networks. Again, new rules formed the foundation of video (cable) franchises. Over time, cable service spread to a majority of homes. Interestingly, the concept of universal service was not applied to video franchises, so cable companies can typically only install equipment in buildings with an owners permission.Fast forward again to today. Companies have been building internet networks for 20 years, but the concept of an Internet Franchise has never taken root. That means every internet provider must forge its own path to market without a clear legal framework. Meanwhile, the companies that hold voice or video franchises dominate the market, due to their established networks that were built for a franchised service and retrofitted for internet. New competitors like us can obtain a voice or video franchise, but that requires them to offer those services. Phone and cable companies are internet companies in everything but name, but they must retain their legacy classifications to protect their franchise rights.Cellular phone companies are also internet companies in everything but name. Since the introduction of the iPhone, they pass much more internet traffic than voice traffic, but they are bound by a third set of regulations that has not adapted to the realities of consumer choice. Meanwhile, fiber companies promise unlimited bandwidth, but they are regulated under a fourth set of rules that render fiber networks the most expensive to build, Google Fiber being the best example. Since launching six years ago, Google has rolled out the service slowly to a relatively small geographic footprint.The idea that you can regulate internet companies in four distinct regimeslandline phone service, video service, cellular carriers, and fiber providersis destined for the dustbin of history. The internet is the internet regardless of the technology used. We need an Internet Franchise framework to unite the regulatory environment. Ubiquitous connectivity is achievable, and HUD can show the way. --These views have been published at Xconomy.com. ", "comment_id": "HUD-2016-0050-0007", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0007", "comment_date": "2016-07-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5146}, {"text": "NDIA represents leaders of community organizations, public libraries, local governments, housing authorities and other institutions working in our communities to reduce digital disparities among our neighbors. Our affiliates help millions of disadvantaged Americans to join the 21st century mainstream through digital literacy training, public Internet access, affordable home broadband services, and digital inclusion advocacy. On behalf of this unique network of experienced community leaders and practitioners, NDIA advocates digital inclusion policies based in our shared conviction that broadband adoption is most effectively promoted by collaborative, community-driven efforts that combine affordable home broadband service, public broadband access, and technology training and support provide by trusted community partners.NDIA does not, itself, possess special expertise or experience in the areas of affordable housing development and financing, so we will not comment independently on the specifics of the proposed rule.But we do wish to add our support for some key points made in comments submitted by two of our affiliates which do possess that kind of expertise and experience: The National Housing Conference, and the City of Seattle, WA.", "comment_id": "HUD-2016-0050-0014", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0014", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1288}, {"text": "The Utah Governors Office of Economic Development submitted these comments for Docket No. FR 5891-P-01 and would like the agency to consider these comments in  FR 5890-P-01 as well.", "comment_id": "HUD-2016-0050-0004", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0004", "comment_date": "2016-07-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 186}, {"text": " Miss Doris A.  Thomas is requesting funding for the creation and development of HUD Funded New Construction and substantial rehabilitation of multi family rental housing for seniors, veterans, and women. Philadelphia , Pa has a significant vacancy rate in affordable rental housing due to the lack of developers for affordable homes. We desire to create affordable housing units with the installation of the Broadband Infrastructure. We have two vacant lots located in North Philadelphia and the Kensington section of Philadelphia. Our goal and mission is to end homelessness for veterans and create some new affordable housing units with the free or low cost  wifi service located in the persons home. ", "comment_id": "HUD-2016-0050-0020", "comment_url": "https://api.regulations.gov/v4/comments/HUD-2016-0050-0020", "comment_date": "2016-07-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 714}]}, {"id": "CDC-2020-0001", "agency": "CDC", "title": "Developing a Workplace Supported Recovery Program: A Strategy for Assisting Workers and Employers with the Nation\u2019s Opioid and Substance Use Disorder Epidemics:  Request for Information", "update_date": "2020-08-06", "update_time": "07:34:45", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Inclusion in a Workplace Supported Recovery Program (WSRP) is pertinent to ending the opioid epidemic in the U.S. Resources, such as alternatives to opioids for pain relief, should be at the forefront of this initiative. It could be increasingly difficult for employees struggling with opioid use working in larger companies to get all of the resources they need, as they may need specialized attention that cannot be given in a large company. Employers should be fully aware of the recoverees past and be able to recognize the signs of an eminent relapse. This will require some sort of training for employers or managers and their willingness to participate fully in being a part of a (WSRP). Although employers may be weary of the time-consumption this program could take, they may be more willing to partake if there is some sort of incentive to them to participate. However, the incentive should be regulated as to prevent employers from taking advantage of the incentives without fully holding up their end of the deal as well. ", "comment_id": "CDC-2020-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0007", "comment_date": "2020-04-14", "comment_time": "04:00:00", "commenter_fname": "Jessica", "commenter_lname": "Anonymous", "comment_length": 1039}, {"text": "I am interested in researching this project in Hawaii.", "comment_id": "CDC-2020-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0020", "comment_date": "2020-07-17", "comment_time": "04:00:00", "commenter_fname": "Cari", "commenter_lname": "Craig", "comment_length": 54}, {"text": "Local communities of recovery have historically been the place for persons in early recovery to find and obtain a job.  Any future workplace recovery program should be developed collaboratively with recovery community organizations who know of recovery supportive employers.Any future workplace supported recovery program should - provide potential employers information on the benefits of hiring persons in recovery  - be inclusive of and collaborative with grassroots recovery community organizations familiar with local and regional recovery friendly employers - consider incentivizing the hiring or persons in recovery as a way to expand opportunities for persons in early recovery and improve recovery outcomes- reduce barriers to employment for person in recovery who may have historic arrest records that would keep them out of productive employment.Thank you for the opportunity to commentWilliam Stauffer LSWThe Pennsylvania Recovery Organizations - Alliance ", "comment_id": "CDC-2020-0001-0024", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0024", "comment_date": "2020-07-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1028}, {"text": "On behalf of our more than 100,000 member physical therapists, physical therapist assistants, and students of physical therapy, the American Physical Therapy Association appreciates the opportunity to submit comments in response to the Centers for Disease Control and Preventions request for information on Developing a Workplace Supported Recovery Program: A Strategy for Assisting Workers and Employers with the Nations Opioid and Substance Use Disorder Epidemics.APTA thanks CDC for the opportunity to comment on this proposed rule. We look forward to working with the agency in the future to help promote access to nonpharmacological options to pain management, including physical therapy. Should you have any questions regarding our comments, please contact Steve Postal, Senior Specialist of Regulatory Affairs, at stevepostal@apta.org or 703/706-3391. Thank you for your consideration. ", "comment_id": "CDC-2020-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0021", "comment_date": "2020-07-21", "comment_time": "04:00:00", "commenter_fname": "Steve", "commenter_lname": "Postal", "comment_length": 913}, {"text": "General Questions1. What elements, attributes, activities, and resources should be involved in a Workplace Supported Recovery program (WSRP)? Describe why inclusion would benefit a WSRP.--I think it would be helpful to have some kind of flowchart that would direct an employer on whether a person with a criminal history and SUD should proceed with hiring. This would require research into WSRP and outcomes so employers could understand which applicants would have the highest chance at success. It may need to be unique to certain industries or job types (e.g., manual labor, office work, etc). It should include modifiable factors that the person could change to increase their odds of success, not just demographics that the person could not alter.2. How do the elements, attributes, activities, and resources that make up WSRPs vary by industry and establishment size?--I think further research would be needed on this. see #1.3. What WSRPs or related approaches are you aware of? Do any of these programs have evaluation or other outcome measures available?--I am not familiar with WSRP approaches and the research behind them.4. Are you aware of any programs that may help employers fund or otherwise develop WSRPs? If so, what are they?--No, I am not.5. What information is available about possible benefits for employers in hiring and/or retaining workers who are in recovery from substance misuse or a substance use disorder?--Not sure6. What are the biggest concerns, fears, or challenges around WSRPs? If available, please provide any data or information to support these concerns.--From what Ive heard: fear of ongoing criminal activity, substance use at work or under the influence on the job, fear of worker injury7. What training related to this effort would be of value to managers/supervisors? To workers?--SUD as a medical issue, not necessarily a legal issue.Questions About Workplaces8. Are you aware of policies that organizations (including yours) have in place to address substance misuse and substance use disorder and, if so, what are they? (e.g., pre-employment drug testing, hiring, dismissal, disability, medical leave, benefits, and compliance with or implementation of Fair Labor Standards Act provisions)--We have pre-employement drug testing and can be randomly drug tested, although Im not sure random, ongoing drug testing is utilized much if at all.9. Which parts of your organization are involved in issues related to substance misuse or substance use disorders among your workers? (e.g., employee bargaining units, occupational health, safety department, human resources department, Employee Assistance Program)--Employee health, HR, EAPQuestions About Workplaces With a Recovery Program in Place10. What services are offered as part of the program? Are there any limits or restrictions on these resources (e.g., position in organization, duration, eligibility)? If so, what are they?--Not aware of any services11. Are any of these services available to employees dealing with the substance use disorder of another person, such as a spouse/partner, child, parent, or close friend? If so, what are they?--EAP12. What major challenges and successes has your program had?--No program, but there should be one in my opinion and adequate research for it to be evidence-based to provide employee an employer adequate confidence that both will remain safe while the employee works and continues to support their recovery.", "comment_id": "CDC-2020-0001-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0004", "comment_date": "2020-03-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3587}, {"text": "July 12, 2020To: National Institute for Occupational Safety and HealthNIOSH Docket Office1090 Tusculum AvenueMS C-34Cincinnati, Ohio 45226-1998Federal e-Rulemaking Portal: www.regulations.govRegarding Developing a Workplace Supported Recovery Program: A Strategy for Assisting Workers and Employers with the Nations Opioid and Substance Use Disorder Epidemics: Request for InformationI support the development of a workplace support and recovery program for employers to help assist employees struggling with a substance use disorder.  The United States is in the midst of an opioid epidemic and specific programming needs developed to assist employers in their quest to help employees struggling with any type of substance use disorder.  Although employee assistance programs offer many needed services to help employees struggling with  mental health and substance use disorders, they are not enough to target the emerging trend of polysubstance use disorders and dual diagnosis disorders.  Specific drug and alcohol programming could help target this evolving epidemic and help restore wellness and recovery through the convenience of employee offered services.  Sincerely,Lisa Lewis PHMNP, MSN, RN", "comment_id": "CDC-2020-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0019", "comment_date": "2020-07-13", "comment_time": "04:00:00", "commenter_fname": "Lisa", "commenter_lname": "Lewis", "comment_length": 1371}, {"text": "A Workplace Recovery Program would be beneficial to many employees who struggle with a substance abuse disorder. A program would help decrease the number people each year in the United States who die from a drug overdose. Workplaces without a drug free policy are experiencing the negative affects of employees with a substance abuse problem then workplaces where a drug free policy is in place. Companies without a drug policy in place tend to experience morale problems and damage to the reputation of the company (Milios, 2017). If a company has an employee who part takes in drug use this said employee will experience negative workplace incidents and violence. By creating a Workplace Recovery Program companies will see a change in the reputation and experience less employee incidents and violence. Employers would not struggle to keep employees would are talented from a substance abuse disorder (Sammer, 2018). Employees could return to work after treatment is finished and still be productive. Research has shown that having a Workplace Recovery Program helps improve employees productivity, health, and quality of life (Milios, 2017). If a company has a Workplace Recovery Program, they can save $4 in health care cost. From past research it was been discover that there are several advantages to having a Workplace Recovery Program to address substance abuse issues. The first advantage is that companies have a framework in place for those with a substance abuse disorder. Someone who has a problem does not want to lose their only source of income. This allows the employer to request certain demands from the employee by having them acknowledge they have a problem. It is hard to cover up a substance abuse problem at work. Your peers can notice strange behavior that may not seem normal. If employers notice an employee abusing drugs during work hours, they can take note of it. When an employee does agree to seek treatment by participating in a work recovery program the employer can monitor the employee (Milios, 2017). The employer can check in to see that the employee is actively engaging and making progress. If the employee is not making progress and leaves meeting early the employer can pull them aside and talk to them. In the United States you will see that 97% of companies with greater than 5,000 employees, 80% of companies with 1,000 to 5,000 employees, and 75% of companies with 250 to 5,000 employees have some sort of program in place (Milios, 2017). In the end a Workplace Recovery Program would be a win for everyone. They help employees with life changing addiction and are extremely cost effective for employers. By providing a recovery program it can only make things better instead of worse. It can help improve the worker safety, health, productivity, and profitability.ReferencesMilios, R. (2017). Why your workplace should support substance abuse treatment. Retrieved from: https://www.recovery.org/pro/articles/why-your-workplace-should-support-substance-abuse-treatment/Sammer, J. (2018). Time for new approaches to employee substance abuse and addiction? Retrieved from: https://www.shrm.org/resourcesandtools/hr-topics/benefits/pages/new-approaches-employee-substance-abuse-addiction.aspx", "comment_id": "CDC-2020-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0011", "comment_date": "2020-04-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3351}, {"text": "Please see the attachment for a brief overview, I hope this review sparks questions that we can take a deeper dive intoI would love an opportunity to discuss in more detail...", "comment_id": "CDC-2020-0001-0010", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0010", "comment_date": "2020-04-22", "comment_time": "04:00:00", "commenter_fname": "Scott", "commenter_lname": "Elam", "comment_length": 185}, {"text": "Q1. What elements, attributes, activities, and resources should be involved in a Workplace Supported Recovery program (WSRP)? Describe why inclusion would benefit a WSRP.I would advocate the adoption of SBIRT, Screening, Brief Intervention and Referral to Treatment for alcohol and substance use disorder, this is a public health approach to universally screen employees for risky or hazardous alcohol or substance use. SBIRT emphasizes using a validated screening tool to better understand the risk score the their employees substance use which will help better understand if they employee would benefit from a brief intervention or needs a referral to treatment with a outpatient or inpatient facility. SBIRT training also includes developing motivational interviewing techniques to help motivate the employee toward positive behavior change. SBIRT is cheap to train and adopt. Implementation does not require any special equipment but simply a empathetic person to help ask the right questions and navigate the EAP system with them. Q7. What training related to this effort would be of value to managers/supervisors? To workers?Substance use education is very limited to most professions and within the public school system. We have an abstinence-only approach to substance use, which is not successful. I think having mangers and supervisors undergo a 1-hour CE regarding addiction, how to recognize it and what to with an employee with an addiction, would be highly beneficial. This will help them understand that addiction is a chronic disease and we have ways to treat it. ", "comment_id": "CDC-2020-0001-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0002", "comment_date": "2020-02-28", "comment_time": "05:00:00", "commenter_fname": "Melissa", "commenter_lname": "Cheng", "comment_length": 1605}, {"text": "The challenge of workplace recovery programs is in creating something that works and is valued by all participants. First and foremost is the primary issue of protecting the life of an addict and turning them into productive and stable citizens. The second issue is motivating employers, because while employers may be the first to see the effects of opioid addiction through missed work, it may be easier to simply fire the individual. Employers unable to carry the financial burden of providing support for known recovering addicts will simply avoid the issue by terminating employment. It would seem that job security would serve to disincentivize addicts, but perhaps job performance benchmarks could be devised in cooperation with employers and a third party. While addicts can sometimes hide discovery from family, employers can find themselves in a position of providing motivation for recovery, but at what cost to business? Will employers be required to pay for programs? Oftentimes employees who struggle with addiction are late to work or miss their shift, leaving employers and co-workers to recover the workload. Recovering addicts pose an increased rate of death by overdose, placing them in a unique situation with employers, who may be in a position to help them-IF the addict demonstrates a desire to recover. Any workplace protocols or measures set in place to help recovering addicts must be based on worker transparency (with employer) and willingness on both employee and employer to cooperate with the recommended program. Effective support measures for recovering addicts must also include an aspect of psychological monitoring, again not at the expense of the employer. I would like to know how employer support would address addictive and psychological behaviors in opioid users? In cases where there is a supportive family unit or established case history of addictive behaviors and possibly rehabilitation efforts, it seems reasonable that workplace measures would be most effective when coordinated through a third party to maintain privacy laws. Due to the variation of jobs impacted by those facing opioid additions, one approach might be to assign a third-party counselor, similar in scope to the probation officer. This recovery advocate would be assigned to individuals who have been referred by a supervising doctor, following an application process and interview. The recovery advocate then works with the individual and the employer, in cooperation with current psychiatric support to devise meaningful support in keeping with the goals of the employee and concerns of the employer. ", "comment_id": "CDC-2020-0001-0008", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0001-0008", "comment_date": "2020-04-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2631}]}, {"id": "DOT-OST-2016-0189", "agency": "DOT", "title": "Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Synthetic Opiates and Minor Amendments", "update_date": "2018-01-10", "update_time": "08:47:39", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comments from the Association of Flight Attendants-CWA, AFL-CIO", "comment_id": "DOT-OST-2016-0189-0037", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0037", "comment_date": "2017-03-17", "comment_time": "04:00:00", "commenter_fname": "Heather", "commenter_lname": "Healy", "comment_length": 63}, {"text": "  I Dajuan Leavell a previous employee under the federal Department Of Transportation in Toledo, Ohio will love to comment on the 49 rule of shy bladder. I think that the MRO evaluation process under the shy bladder situation is not reasonable at all.I understand that an individual could hold his or her urine in for 3 hours due to them knowing the results will be positive. Although what about the ones that are negative without a medical history and documentations of urinating problems? They do not get to prove there innocents and they could also loose there livelihood. This is very unfair! its almost like robbery of your career to a existingmedical condition that was currently discovered. There has got to be a better way to prove your innocents in this situation. Its hard to believe the MRO will consider a highly probable condition without medical documentation. I even offered blood and a hair test. YOU LOOSE GOODRELIABLE EMPLOYEES this way. I had never failed a drug test in my life. It hurts so bad its like being convicted of a crime you didnt do. I committed 5 years to my employer no call offs and worked when the needed me, no discipline nothing on my file or record. And this shy bladder situation is a joke when you dont look further into the situation. It could be somethingthat an employee will find out when its too late and lost there job!! You guys have to do better than that!! Thank You for taking the time out to here me out. Please feel free to give feedback. My email is dajuanleavell23@gmail.com", "comment_id": "DOT-OST-2016-0189-0009", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0009", "comment_date": "2017-01-30", "comment_time": "05:00:00", "commenter_fname": "Dajuan", "commenter_lname": "Leavell", "comment_length": 1598}, {"text": "March 24, 2017   VIA Federal eRulemaking Portal   Docket Management Facility U.S. Department of Transportation 1200 New Jersey Ave., SE West Building Ground Floor Room W12-140 Washington, DC 20590-0001   Subject: Docket No. DOT-OST-2016-0189   Dear Docket Clerk,   The San Francisco Municipal Transportation Agency (SFMTA) appreciates the opportunity to review the U.S. Department of Transportations (DOT) proposal to revise its drug testing program regulations as follows: Align DOTs regulated-industry drug testing with the Department of Health and Human Services (HHS) laboratory drug testing requirements; Add clarification to certain existing drug-testing provisions; Remove outdated information from DOTs current regulation; and, Remove the requirement for employers and C/TPAs to submit blind specimens.We are in agreement and support the proposed changes. SFMTA would also like to take this opportunity to express its interest in commenting on other aspects of the DOT regulations that are not currently open as part of this proposed rulemaking, such as post-accident testing, definition of an accident, and when drug testing is deemed appropriate. For example, we believe that the current definition of accident may not be broad enough to encompass other situations for which testing may be appropriate, such as serious safety violations, e.g., signal violations.   Specifically, we would welcome an opportunity to comment formally on the following sections of the Code of Federal Regulations (CFR): 49 CFR 655.4: Definitions, Accident; 49 CFR 655.43: Reasonable Suspicion Testing; and, 49 CFR 655.44: Post-Accident Testing.    We strongly encourage DOT to initiate a formal discussion on these issues as soon as possible. If you have any questions or require additional information, please do not hesitate to contact me at 415.701.4720 or Ed.Reiskin@sfmta.com.   Sincerely, Edward D. ReiskinDirector of Transportation  ", "comment_id": "DOT-OST-2016-0189-0070", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0070", "comment_date": "2017-03-27", "comment_time": "04:00:00", "commenter_fname": "Edward", "commenter_lname": "Reiskin", "comment_length": 2318}, {"text": "Comment provided by: Lisa Bradley; Certified Training SolutionsRE: DOT-OST-2016-0189-0038We would like to express a similar opinion regarding 40.33, commented by SAPAA.The concern is the requirement for all collectors, BATs, STTs, SAPs, and MROs to subscribe to the free ODAPC list-serve.  This is an excellent idea, and we stress to our trainees that they need to sign up for updates online and that it is their responsibility to keep up with Regulation changes.  However, please consider allowing more time (beyond the October 1, 2017 effective date) for all of these service agents to subscribe to the email updates list.  We intend to communicate to our clients that they must subscribe to the list; however, we believe there will be many service agents that may not be aware of the requirement in such a short time (and thereby, be out of compliance once the Rule takes effect).   We believe that allowing a bit more time for more service agents to hear about the Rule will result in a higher compliance rate once it goes into effect.Some of our clients in covered industries have also expressed concern, since they are responsible for ensuring they use only compliant service agents.  A question to consider is:  Who is responsible for ensuring that all of these BATs, Collectors, etc. actually are on the email updates list and how will it be enforced? Example:  A trucking company uses a collection site/clinic for their urine drug collections, and the DER initially checks to ensure that all currently-employed collectors and BATs are subscribed to ODAPCs list-serve.  However, there is often a lot of turnover in these types of positions at clinics and collection facilities.  If every DER at every covered-company has to call every service agent (and document) frequently -possibly even daily to truly ensure full compliance - this will create significant new costs and record-keeping burdens on covered employers that may not have been considered in the new language.Thank you for the opportunity to comment.", "comment_id": "DOT-OST-2016-0189-0054", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0054", "comment_date": "2017-03-23", "comment_time": "04:00:00", "commenter_fname": "Lisa", "commenter_lname": "Bradley", "comment_length": 2085}, {"text": "I believe that all drivers, in any instance, need to be tested for any kind of drug in their system because it is very unsafe to drive, specially, commercial vehicles under the influence of drugs because these drugs do not let people react as the normally would.", "comment_id": "DOT-OST-2016-0189-0032", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0032", "comment_date": "2017-03-09", "comment_time": "05:00:00", "commenter_fname": "Miguel", "commenter_lname": "Lopez", "comment_length": 262}, {"text": "Dear Regulators, Ive worked over 20 years in this industry as a marketing rep for a SAMHSA certified lab, a collector-trainer and for a TPA. In my job, I communicate with labs, collection sites, TPAs, BAT techs and employers on the DOT regulations and collection requirements. I agree in the addition of the synthetic opioids and believe this would greatly increase safety for the public and help provide intervention to those who suffer with drug addiction. I also agree with the minor changes mentioned. I do feel the collector training should include the following scenarios for mock collections as a minimum: 1. Standard mock collection (no errors)  2. Shy bladder   A. The normal scenario where the donor eventually provides a full specimen within range  B. The unusual scenario where the donor stays all 3 hours, is compliant, but does not provide a specimen.  3. A specimen offered where the specimen is either temp out of range or appears to be tampered and the donor agrees to the 2nd observed collection. #4 would be the 2nd observed collection, also talking about the other scenarios when an observed collection may be ordered and 5. A refusal to test (being disruptive, not follow collection instruction, etc.) and 5B: Items a donor can refuse to do (i.e. not initial bottles seals or sign the COC form or provide a full SS #, that does not cancel the test when the donor follows all other guidelines. I find when you cover all of these items with mock collections, there are less errors and better retention. I also have found some SAMHSA certified labs have found the ability to test beyond the limited description for substitute specimens in order to capture the use of synthetic urine, (which is a real problem, and needs to be addressed). I believe the actual DOT positive drug test rate is far higher than reported. Labs should be able to use proprietary methods without having to fully disclose what they are except to the MRO who views the test result and the SAMSHA certified labs who would do a secondary confirmation test to verify the same result. Its a little like computer viruses and hackers, labs are always trying to stay one step ahead of the bad guys who would tamper with a test, but under the current DOT regulations, they have to give out the formula on how to do it. This really is a 2nd subject that deserves its own rulemaking. There are currently SAMSHA certified labs that have effectively shut down the majority of use of these kind of tampering agents with NON-DOT tests, the same should be true for DOT testing since the technology is available. I would not advise not adding this subject to the existing recommendations as this would only delay the opioid panels from being added.   The current DOT collector guidelines do not address electronic chain of custody forms in either training guidelines or in practice guidelines. Its recommended that the collector must go through the DOT collector training using standard paper chain of custody forms, and that if the collector will be using electronic chain of custody forms, must have additional training from the vendor on how to properly process the electronic chain of custody form on-line. In addition, common errors include the collector dismissing the donor without providing a specimen without fully allowing for the 3 hour time frame because they are closing for lunch or for the day. This should be a collector error and fatal flaw. I also think unless the site can reliably provide male and female collectors, they should not be able to offer to do a DOT collection, since some observed collections will be initiated during the collection (i.e. specimen temp out of range) which cannot be predicted in advance. I think its also a disservice to claim to offer DOT breath alcohol without having the confirmation(i.e. breath alcohol test) available at the site. The reason is while the clear majority of alcohol saliva tests are negative, when one is positive it most likely is for reasonable cause or post-accident scenario where the outcome is critical. It would also be helpful to include in the observed collection procedure on how to handle a transgender collection. Most collectors agree that the legal sex that is registered on the donors drivers license, however this is a thorny issue with many opinions, so would further recommend this subject have its own rule-making period.  I would also recommend that the opioid panel be flexible enough that the employer and/or MRO can order additional opioid testing not in the expanded panel (i.e. Fentanyl) as the drugs of abuse are constantly evolving and users will continue to change their drugs of abuse in order to avoid detection. ", "comment_id": "DOT-OST-2016-0189-0056", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0056", "comment_date": "2017-03-24", "comment_time": "04:00:00", "commenter_fname": "Esther", "commenter_lname": "Miller", "comment_length": 4849}, {"text": "March 24, 2017Anthony R. FoxxSecretary of TransportationAttention: DOT-OST-2016-0189U. S. Department of Transportation1200 New Jersey Avenue, SE.West Building Ground Floor Room W12-140Washington, DC 20590-0001Re: DOT-OST-2016-0189 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Certain Schedule II Drugs to the Department of Transportations Drug-Testing Panel and Certain Minor AmendmentsDear Secretary Foxx:As a registered nurse, doctorate student of family nursing practice at the University of Minnesota, and a member of Minnesota Advance Practiced Registered Nurse (APRN) Coalition, I appreciate the opportunity to comment on the 1/23/2017 proposed rule (DOT-OST-2016-0189) regarding the amendment to the Department of Transportations drug-testing panel, as part of the drug-testing program regulation, to include four additional opioids, namely oxycodone, oxymorphone, hydrocodone, and hydromorphone. Advanced practice registered nurses (APRN) strive to improve patient access to quality, cost-effective health care, and work in collaboration with patients to optimize health, concurrently managing multiple health conditions and morbidities, including painful manifestations requiring analgesic therapy.  The choice of analgesic is based on accurate evaluation and diagnosis of the origin of pain, some which require the use of opioids to treat moderate-to-severe pain.  While practitioners strive for judicious and appropriate opioid prescription, opioid over-prescription is still a very real problem affecting our health care system (Centers for Disease Control and Prevention [CDC], 2016).   As you are aware, nearly 250,000 opioid prescriptions were written in the U. S. in 2013, and nearly two million Americans were dependent on or abused opioid prescriptions in 2014 (CDC, 2016).   1.Modification of the drug-testing panelThe amendment proposes to include four additional opioid medications to the list of the Department of Transportations drug-testing panel, including oxycodone, oxymorphone, hydrocodone, and hydromorphone.  As a future APRN, I support this proposal, as these medications are among some of the most abused, resulting in approximately 91 opioid overdose-induced deaths every day in this country (CDC, 2016).  As you know, opioids have depressant effects which result in pain relief, but also can potentiate a state of euphoria, making them subject to misuse (Strain, 2017).  Prescription opioids including those listed in the referenced proposal, have a high risk of developing tolerance, dependence, addiction, and abuse (CDC, 2016). Those who have developed a tolerance may show no external signs of effect despite having opioid use, and may maintain employment and daily functioning (Strain, 2017), yet can still have side effects such as sedation and blunting of cognitive function (McAllister 2016).  As you know, blunted senses can affect an individuals ability to operate machinery including motor vehicles, affecting those using this type of transportation.  While opioid medications have valid and appropriate use to treat moderate-to-severe pain, the degree to which they are abused or are the cause of substance dependence supports the proposed addition to the drug-testing panel for the Department of Transportation.  I support the proposed change in language from opiates to opioids as defined by the description within the proposal, delineating the difference between these two umbrella terms, and expanding the definition to include opiates and semi-synthetic compounds identified above.  The definition of opioids is supported by experts in the field, and therefore, I have no recommendations to modify the language further (National Alliance of Advocates for Buprenorphine Treatment [NAABT], n.d.). Thank you for considering my comments on this important proposed rule.  I look forward to collaborating efforts to continue to improve public health and transportation industry safety for our citizens. Sincerely,Lena Hess, BSN, RN, DNP student References:Centers for Disease Control and Prevention [CDC]. (2016). Injury prevention  control: Opioid overdose.   Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html McAlister, M. J. (2016). Treating chronic pain. Retrieved from http://www.instituteforchronicpain.org/treating-common-pain/tolerance-to-opioid-pain-medications National Alliance of Advocates for Buprenorphine Treatment [NAABT]. (n.d.). Opiates/opioids. Retrieved from https://www.naabt.org/education/opiates_opioids.cfmStrain, E. (2017). Opioid use disorder: Epidemiology, pharmacology, clinical manifestations, course, screening, assessment, and diagnosis.  Retrieved from https://www.uptodate.com/contents/opioid-use-disorder-epidemiology-pharmacology-clinical-manifestations-course-screening-assessment-and-diagnosis?source=search_resultsearch=opioid%20toleranceselectedTitle=1~43", "comment_id": "DOT-OST-2016-0189-0064", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0064", "comment_date": "2017-03-24", "comment_time": "04:00:00", "commenter_fname": "Lena", "commenter_lname": "Hess", "comment_length": 5144}, {"text": "NPRM Comments submitted on behalf of First Advantage.", "comment_id": "DOT-OST-2016-0189-0068", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0068", "comment_date": "2017-03-27", "comment_time": "04:00:00", "commenter_fname": "Josephine", "commenter_lname": "Kenney", "comment_length": 53}, {"text": "With a BS in Business, 25+ years of Human Resources, Safety and Compliance work experience, I have worked for several companies who employ commercial drivers and operate under DOT regulations. The DOT Drug  Alcohol Program has included the same 5-panel drugs for as long as I can remember. As everyone knows, over time new prescription drugs are invented, approved and prescribed by Doctors. In my experience, Commercial Drivers are one group of employees who seem to a) have access to and b) desire the use of narcotic (specifically opiate) class drugs. This may be due to the need/desire to drive longer hours (stay awake), boredom, or actual medical conditions caused from sitting in a truck for hours on end, over many years.The new proposal for Transportation Workplace Drug  Alcohol Testing to add the most abused drugs is essential to the safety of everyone. From an employers standpoint, I can assure you that most commercial drivers are well aware of the drugs which will test positive in a urine screening, and those which are not tested. It is very frustrating to employers when use and possible misuse of certain prescription drugs, such as opiates, is present, but not included as part of the drug screening guidelines.  Personally, I think it would be a wise decision of the USDOT to include language with the new proposed rule to include a three to five year review period, allowing the DOT to review the program and add certain drugs, such as opiates, based on the most abused drugs at each time period. Without the ability to review and include new prescription drugs with known dangerous side effects when operating a vehicle or equipment, this issue will be a never-ending struggle to protect drivers, passengers and the public.As the Safety Manager of a Motor Carrier, I speak for several companies who are happy with the new proposed rule. Anyone who does not want the safety of commercial drivers and the public to be the first goal, either do not care about safety or have a hidden agenda. It is important to remember, prescribed drugs, including opiates are legal if used correctly; it is unlawful to consume a prescription drug without a prescription; which should be enforced the same as for all employees, regardless of his/her position within a company, or self-employed.  Lastly, I think it would be very beneficial for the DOT to investigate the misuse of methadone, suboxone, and other opiate-blocking medications, which are becoming the most widely desired and misused type of drug. These drugs require special testing and commercial drivers (and employees) are aware these drugs are not tested as part of the Drug  Alcohol Program (both Workplace and DOT). These drugs are extremely powerful and include long-lasting, dangerous side effects. I am aware of several vehicle accidents, one involving a death, caused by one driver consuming methadone and passing out while operating the vehicle. Many doctors are prescribing these drugs to offset the abuse of some opiates, but unfortunately, they include the same side effects, especially when misused. Thank you for your time,Teresa Creasy", "comment_id": "DOT-OST-2016-0189-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0003", "comment_date": "2017-01-25", "comment_time": "05:00:00", "commenter_fname": "Teresa", "commenter_lname": "Creasy", "comment_length": 3231}, {"text": "Please excuse me if this is a duplicate comment, since I have no record of a previous contact. I am commenting on the DOT workplace drug testing change which would remove any non-urine testing in the area of paruresis (shy bladder) cases. I am hoping that this change would in no way weaken the shy bladder protocol currently in effect. Of course, allowing oral fluid drug testing as an alternate to urine-only would alleviate this problem and ensure honesty in all those who are being tested.", "comment_id": "DOT-OST-2016-0189-0025", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0025", "comment_date": "2017-02-22", "comment_time": "05:00:00", "commenter_fname": "Thomas", "commenter_lname": "Haj", "comment_length": 538}]}, {"id": "DEA-2019-0013", "agency": "DEA", "title": "Management of Quotas for Controlled Substances and List I Chemicals", "update_date": "2023-08-31", "update_time": "08:33:18", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The restrictions of opioids after the CDC guidelines have caused undue hardships on all people who experience pain, acute and chronic. Suicides are up in people with chronic pain as are the number of people who have turned to street drugs. I have seen comments from chronic pain patients that say in order to get relief maybe the best way is to claim addiction in order to get methadone. Methadone is not a drug to utilize  with its side affects on heart rhythm.  It can cause sudden death.      I probably wont survive if my dose is reduced anymore because of the severity of my injuries due to a car accident 37 years ago.  I am wheelchair bound now. I have seen ads for new rehab facilities opening everywhere near me at the same time pain clinics are closing. Soon there wont be places for people suffering to go. Please dont cut production on opioids. ", "comment_id": "DEA-2019-0013-0115", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0115", "comment_date": "2019-11-05", "comment_time": "05:00:00", "commenter_fname": "Rue", "commenter_lname": "Anonymous", "comment_length": 907}, {"text": "All this is doing is controlling what doctors can and will give their patients. More Cruel and unnecessary suffering by CPP. More government over reach I dont need the DEA in my doctors office. We are not drug addicts and treating as such as caused cruel and unnecessary suffering and pain. Stop the genocide on CPP.  ", "comment_id": "DEA-2019-0013-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0011", "comment_date": "2019-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 318}, {"text": "There must be a system in place to manage the effects of inaccurate quotas. No one with pain significant to warrant use of opioids should be left without access to these life saving pain medications. The effects of this include needless suffering, heart attacks,  strokes,  withdrawal, suicide,  medical collapse and death. It is a significant hardship and sometimes impossible for intractable pain patients to pharmacy shop, looking for a pharmacythat has the needed medicine. This practice also flags the patient detrimentally. This is a no win situation for the sickest and most vulnerable subset of the population. Intractable pain patients do not divert their pain medicine as they need them for their own use. This should be taken into consideration. The unsafe,  inhumane practice of using other classes of medicines to manage postoperative pain in the absence of opiates, leads to unnecessary suffering and untenable side effects such as liver and kidney failure. There must be a back up system in place. Thank you. ", "comment_id": "DEA-2019-0013-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0010", "comment_date": "2019-10-24", "comment_time": "04:00:00", "commenter_fname": "Concerned", "commenter_lname": "Citizen", "comment_length": 1036}, {"text": "Please take into consideration the people who have legitimate reasons to take opioids and do not abuse them! I have Ehlers Danlos Syndrome which is a very painful hereditary connective tissue disorder. In my group alone, I have heard horror stories about people whos Drs have lowered or discontinued their pain control. Many of these people have committed suicide because they cant take the pain. Please listen to some of them and hear their stories before you make a decision. I am fortunate in a way because of my bodys response to most meds, my Dr implanted a pain pump (intrathecaly) which has its own issues itself and not for everyone. Tank you so much!", "comment_id": "DEA-2019-0013-0124", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0124", "comment_date": "2019-11-06", "comment_time": "05:00:00", "commenter_fname": "Lori", "commenter_lname": "Perez", "comment_length": 689}, {"text": "My life has been taken away by pain that was only controllable with opoids.  I have since been taken off due to doctor fear and now Im bedridden.  ", "comment_id": "DEA-2019-0013-0237", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0237", "comment_date": "2019-12-23", "comment_time": "05:00:00", "commenter_fname": "Christian", "commenter_lname": "Woodward", "comment_length": 152}, {"text": "Further reduction to opioid medication will only result in more suffering and suicide due to excruciating pain not being controlled. WHY must chronic pain patients continue to pay with their lives for street drug addicts behavior? This is inhumane and soul crushingly cruel. As DEA agents, you MUST know where the problem is and where its not. Go after the street drugs and cartels, God speed. There needs to be separation of street drugs and prescription pain medication when it comes to research. There needs to be separation between addicts and chronic pain patients before anyone is truly helped and the suffering and suicide is addressed. Please consider this before YOUR actions become genocide. ", "comment_id": "DEA-2019-0013-0259", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0259", "comment_date": "2019-12-26", "comment_time": "05:00:00", "commenter_fname": "Michelle", "commenter_lname": "Anonymous", "comment_length": 707}, {"text": "The war on street drugs will never be won, but that is where your war is. Please continue to fight the good fight without dragging suffering chronic pain patients into all of this. We are not the problem. Addicts and chronic pain patients MUST be separated before anyone is truly helped. This would be a great start if you really want to begin to walk back the insane mistake made by the CDC guidelines that started this whole mess. Weather they want to take responsibility or not, the blood of all CPP suicides is on them. Knowing this, why in the world wouldnt they admit their mistake and immediately retract and carefully (with the help of pain management physicians) In plain english make it right? This should have been done a long time ago before innocent families had to watch their loved ones suffer such inhumane torture. Some to the point of suicide. Never in my lifetime would I have ever believed that this great country would force such suffering on their own citizens. It physically sickens me. Please tell me that (WE) are better than this. Please tell me that all of this suffering and death wasnt the agenda. There are innocent physicians in prison. This left whole practices full of abandoned CPPs. I can tell you from experience, its near impossible to find another physician to accept a new CPP who is on opioids. Your organization has terrorized them to the point that they are abandoning pain patients altogether. There are still wonderful caring physicians who would like to properly treat their patients and end their suffering but their hands are tied by YOU! This insanity must end. It only makes sense that the addiction specialists head the addiction plan and the pain management physicians and experts head the chronic pain plan. Please do whatever it takes to get it done right away. There are so many suffering and so close to giving up. I beg you to get it done so theres not one more loved soul that couldnt wait any longer.", "comment_id": "DEA-2019-0013-0086", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0086", "comment_date": "2019-11-04", "comment_time": "05:00:00", "commenter_fname": "Michelle", "commenter_lname": "Bannasch", "comment_length": 1958}, {"text": "Dear Sirs,I am a chronic pain pt. have been on opioids for 20 years. I have tried to see about rehab but was told by a top inpatient rehab facility I had a preconceived notion about opioids and pain. Nothing they could give me would work because I needed stronger meds to control my pain. No I was not addicted only dependent.  I need the meds to survive and live, even walk and perform personal care. There is no one I know who have ever abused their meds or anyone elses.  Please dont decrease the number of opioids being produced.  The reasons there were a few problems were drug companies pushing the use and saying they were less addictive and certain doctors overprescribing. If I am unable to obtain oxycodone or fentanyl patches I cant live. ", "comment_id": "DEA-2019-0013-0095", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0095", "comment_date": "2019-11-04", "comment_time": "05:00:00", "commenter_fname": "Michelle", "commenter_lname": "Anonymous", "comment_length": 805}, {"text": "Chronic Pain Patients are the Lepors of 2019. We are denied Human Rights, Civil Rights and HIPPA protection. I am a Chronic Pain Patient, and I have trouble every month getting my pain prescription filled. More often than not the pharmacy cant fill my prescription because they cant get any Percocet in.  And yes I have done every pain treatment out there prior to using opioids for my severe, relentless, unbearable constant pain. This includes; otc medications, heat/cold therapy, physical therapy, massage therapy, acupuncture, tens-unit, multiple cortisone injections, multiple nerve blocks both freezing/burning, biofeedback, spinal cord stimulator, as well as multiple spinal surgeries prior to being put on opioids for chronic pain treatment. In attempts to treat my chronic pain without using opioids. I had no choice but to try all I have listed or I would not be prescribed opioids, which were the only effective pain treatment. While all nonopioid treatments were ineffective the surgeries did bring feeling some back where I had been numb however: some treatments did indeed hurt me with a spinal cord injury, so never will I be out of pain. Along with that Im having more surgeries so I can have pain pump implant. The implant will not eliminate my pain however; Im hoping to at least be able to get my pain reduced to the level it was before my pain meds were cut in half. Along with my diagnosis of chronic pain, which is easily seen on my NCS/EMG, MRIs, X-rays, I now have pain induced high blood pressure, which has me becoming a stroke risk due to under-treated pain. My blood pressure was 200/116 at my Dr. appointment I immediately took my pain meds, but earlier than I was supposed to, 20 minutes after my reading was 130/70. I dont have high blood pressure I do have pain.This attack on opioids are causing many pain patients other life long health problems. I know this can become a permanent problem and the constant high blood pressure can lead to heart disease for me and all because of the opioid hysteria and Thats what it is. When are chronic pain patients going to be considered? None of us want to live in pain, many have already committed suicide, many have died from untreated and under-treated pain, many are forced to navigate the streets to obtain pain relief, where are our rights? Who will defend us? Val Windsor ", "comment_id": "DEA-2019-0013-0094", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0094", "comment_date": "2019-11-04", "comment_time": "05:00:00", "commenter_fname": "Valerie", "commenter_lname": "Windsor", "comment_length": 2386}, {"text": "PLEASE HELP US CHRONIC PAIN PATIENTS WHO ARE SUFFERING IN UNBEARABLE PAIN BECAUSE WERE DENIED THE LIFE SAVING PAIN MEDICATIONS THAT MAKE LIFE BEARABLE MORE SUICIDES DEATHS BECAUSE WE CANT HANDLE THE PAIN  Buy letting there be a SHORTAGE of PAIN MEDICATION available FOR PAIN PATIENTS AND surgeries and bad ACCIDENTS,bad MEDICAL conditions AND pain that does not stop like it should and BECOMES CHRONIC. Pain MEDICATIONS ARE a small part in this war on ABUSE its the ILLEGAL DRUGS that ARE KILLING PEOPLE AND ADDICTS. We are the American people WHO you are hurting and betraying and KILLING us .taking our PAIN MEDICATIONS away is so wrong. CHRONIC PAIN PATIENTS ARE SUFFERING from HEART attacks the pain is so intense. Why are you doing this to us ?? You think you or your FAMILY are safe from CHRONIC PAIN...YOUR DEAD WRONG..I WOULD OF NEVER BELIEVED THAT YOU COULD BE IN THIS MUCH HORRIFIC PAIN AND SUFFERING YEAR AFTER YEAR AND IT NEVER STOPS UNTIL IT HAPPENED TO ME WHEN YOU HAVE A BAD ACCIDENT OR MEDICAL CONDITION OR BAD SURGERY AND YOU END UP WITH CHRONIC PAIN YOU WILL SUFFER TO UNTIL YOUR DEATH ", "comment_id": "DEA-2019-0013-0107", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2019-0013-0107", "comment_date": "2019-11-05", "comment_time": "05:00:00", "commenter_fname": "Kim", "commenter_lname": "Buchholtz", "comment_length": 1119}]}, {"id": "FDA-2017-N-5608", "agency": "FDA", "title": "Opioid Policy Steering Committee", "update_date": "2018-03-08", "update_time": "11:28:23", "purpose": "Nonrulemaking", "keywords": ["2017-818"], "comments": [{"text": "Please stop this witch hunt!!! I hope and pray none of you ever have to live like I do!!!  If these guidelines were put out just to family practice Drs then why has no one stepped up to tell these pain specialists to continue treating their pain pts... its heroin killing people!!! You are taking away someones only ability to function, without my meds I cant be a good wife and/or mother, Ive done back and neck injections and they dont help with my chronic everyday pain, I did physical therapy until it stopped working, these meds werent my first choice but they gave me my life back and now youre literally killing people because they see no hope anymore and they kill themselves because the pain is too much to handle, Im curled up in the fetal position when my pain isnt under control and not able to take care of my family and bawling my eyes out!!! The state and/or government shouldnt be this involved in a Dr caring for their patient and no two patients are the same either, its not a one size fits all ", "comment_id": "FDA-2017-N-5608-0155", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0155", "comment_date": "2017-11-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1085}, {"text": "Hello, I am a medical professional, chronic pain sufferer and concerned citizen. It is well-known that the current crisis is fueled by heroin and illicit fentanyl more than pain medications and that we are repeating history. When we shut the pill mills down without offering any help to the patients who used them, we created a heroin epidemic that is the main source of overdoses today. Now, we are cutting off legitimate pain patients in the same manner without seeing the harm that does. After being abruptly cut off, these patients are in immense, unbearable pain and either commit suicide or buy fentanyl-laced prescription medications from street dealers, which causes them to overdose. Again, we are contributing to the opioid epidemic with short-sighted and overreaching policies.  Doctors are no longer prescribing these medications like they did in the past and are stopping entirely in some cases due to fear. We do not put the blame on a doctor if their diabetic patient goes against medical advice and is harmed due to noncompliance, yet we continue to prosecute pain management doctors when their patients harm themselves by going against medical advice. Why?When we do actually get treatment for chronic pain patients who have been cut off, we put them on opioid maintenance medications like Suboxone. So, we essentially take them off of their opioid maintenance program just to put them on a new, more expensive one and treat them like criminals. Again, why? The only way that we are going to solve this crisis is by focusing on the real problem: Addiction. Until we overhaul our addiction treatment and make it more affordable, less confusing and more effective, we will always have a problem with opioids. We need to stop focusing so much on legitimate patients who require these medications to be productive members of society and instead focus on helping those who are addicted. It does not matter how many guidelines or policies or laws you make regarding pain medications, none of them will do any good. So far, in fact, they have really only made things worse. Please, for the sake of Americans across this country, begin focusing your efforts and money on addiction treatment that actually works. Only then will anything change. Thank you. ", "comment_id": "FDA-2017-N-5608-0156", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0156", "comment_date": "2017-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2314}, {"text": "After numerous surgeries over the years for severe endometriosis, I was left with chronic pelvic pain due to scar tissue (that is aggravated by prolonged standing) and a condition called Pudendal Neuralgia (nerve damage that causes severe pain in the groin, vaginal and anal area with any amount of sitting) making it unbearable for me to sit for longer than 20 minutes. In fact, I had to give up a good government job because of the pain and was largely bed-ridden until I got into a comprehensive pain management program.  For the past twelve years my pain has become manageable, and my life restored to some level of normalcy, with a number of pain medications that include opioids.  The dosage is low (from 10mg to 30mg of Oxycodone per day) and I am permitted to take them as needed, up to the aforementioned maximum dose, since my pain level varies from day to day depending on the nature and extent of my activity.  I would like to point out, however, that my dosage has not changed in the entire twelve years I have been on this treatment regimen.  Like so many other chronic pain sufferers, I do not...or should say dare not...abuse these medications as they mean the difference between a life worth living or wishing to die due to severe daily pain and activity restrictions.   While illegal drug abuse and addiction is certainly a situation that needs to be addressed, please DO NOT punish those of us who depend on these medications for chronic pain relief by imposing unreasonable regulations that tie the hands of the responsible and ethical medical professionals running comprehensive programs of carefully monitored pain management...such as the one I attended until the new burdensome regulations made it impossible for them to continue their practice and they were forced to close down. ", "comment_id": "FDA-2017-N-5608-0247", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0247", "comment_date": "2017-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1817}, {"text": "Is it necessary, is it safe, to include acetaminophen to every hydrocodone pill?  Why cant you release an acetaminophen-free drug to reduce liver damage?", "comment_id": "FDA-2017-N-5608-0251", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0251", "comment_date": "2017-11-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 158}, {"text": "I have have four back surgeries and have been on and off opiates for over 30 years. I all that time I have stayed around the same dose of my opiate medication for the past 10 years even though my back has gotten much worse. As you can image I have have had many non-FDA approved epidural (which none worked) NSAIDs that gave me 3 bleeding ulcers and 3 nights in ICU, PT, acupuncture,biofeedback and all other types of treatment, creams and braces. What I have found that allows me to get out of bed so I can live on my own is my opiate medication. My medication also helps me get to the store, helps me stand to fix my meals, exercise to keep my weight down and then to have enough relief to sleep when it is time too. The result that have been used have been faulse and we all know this is about money. Meanwhile you should ask you this question since these medications are so hard for people who really need them to get them prescribed to them why is more people dying each year from opiate overdoses? Basically the more the government gets involved in taking pain medication away from chronic pain patient and punsihing doctors who are treating us the more people who have died and will continue to do so. Get rid of the CDC requirement for chronic pain patients.Below is what I deal wih every day", "comment_id": "FDA-2017-N-5608-0357", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0357", "comment_date": "2017-12-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1310}, {"text": "Please work on making more medication like Ultram and Nucynta, which are less likely to cause addiction, but still help chronic pain patients to function. Dont just turn your back on chronic pain patients without offering a solution. Please keep in mind that chronic pain patients are not the enemy, are not all abusers, misusers. Please keep chronic pain patients and their daily agony in mind when trying to solve this issue. Denying people relief who are in extreme pain is probably why a lot of people turn to obtaining them illegally. Yet, many doctors offices are doing just that, and offering no other solutions. That seems like it will just make the problem even worse, not better. And forcing people to suffer to an extreme because of someone elses actions seems cruel.", "comment_id": "FDA-2017-N-5608-0394", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0394", "comment_date": "2017-12-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 793}, {"text": "People that are suffering from chronic pain such as Complex Regional Pain Syndrome which there is no cure for and is rated the highest pain level on the McGill Pain Scale are suddenly being told by their pain management doctors that their dose of pain meds will be lowered or are being cut off cold turkey. People with this disease are not abusing their meds, they are urine tested. These meds make it able for them just to get out if bed. Its not fair that the doctors have to be afraid of losing their licences. They should not be told how to treat their patients.This disease Complex Regional Pain Syndrome is known as the Suicide Disease because people cant take the pain anymore. It affects all the limbs, internal organs and much more. You have no idea how many have taken their lives already. People in their 20s, mothers and fathers, and many more. If the FDA and the Center for Disease Control keep dictating these rules to pain management doctors there is going to be a lot more suicides. We should not have to be punished for the real drug addicts. We do not choose to have this disease and should not have our pain meds be taken away. I know of hundreds already going through this. The pain management doctors should be able to treat their patients as they seem fit. Thank you", "comment_id": "FDA-2017-N-5608-0461", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0461", "comment_date": "2017-12-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1338}, {"text": "A one size fits all dosing limit on opioids cannot be established. It fails to take into account the variations in individuals such as their condition, level of pain, genetic drug metabolism differences, and differences in ability to absorb in the GI tract. What suits one will never suit all. This needs to be left between the doctor and the patient to establish what is safe and effective for that individual and their needs. I am a multiple rare disease patient, who suffers from severe intractable pain caused by my conditions. I have Adhesive Arachnoiditis, Ehlers-Danlos Syndrome, Chiari Malformation 1.5, cerebellar slumping, CRPS, and chronic spontaneous cerebrospinal fluid leaks. A year and a half ago, my own pain management group forceable tapered all patients down to 90 mme. This took my own dosage, which I had been stable at for 8 years, down by 2/3rd. My pain became so severe that I could no longer function; I could not sleep, and when I did I had nightmares because of my pain. I could not even think; the pain was like a roar, and it drowned out even my own thoughts. It was not only terrible mentally; suffering that level of pain 24 hours a day had serious consequences for my physical health. The stress on my body caused my conditions to progress must faster, which meant losing the use of my arm and hand. I eventually finally left that pain practice when I reached a breaking point, and was very lucky to find a doctor willing to treat me as an individual. At that point, the constant stress of high pain had caused me to go into adrenal fatigue, and my cortisol level was close to 0. I had literally burnt out my adrenals, trying to withstand an inhuman level of suffering. Had I not gotten proper treatment for my pain at that time, I may have died.I tell you my story as an example of why arbitrary dosage limits are harmful. Access to effective pain treatment must be preserved for chronic patients. ", "comment_id": "FDA-2017-N-5608-0490", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0490", "comment_date": "2017-12-22", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1973}, {"text": "The majority of chronic pain patients use their meds as prescribed. We deserve to be treated with respect. Please stop taking our meds away from us. This will only cause more suicides and more people to turn to street drugs for help. ", "comment_id": "FDA-2017-N-5608-0555", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0555", "comment_date": "2017-12-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 234}, {"text": "I have been suffering with chronic pain for over half my life. Ive got years of MRIs showing Im getting worse, It took me awhile to start taking pain medication, I was grateful to be able to function and do what needed to be done. Now my medication has been cut drastically, I  am not able to move without pain, its unfortunate that people like me who suffer everyday, are now paying for people who have taken advantage just because. Its not right to have people such as myself to suffer, and are now bedridden due to the pain. What saddens me most of all is patients like me have turned to illegal drugs, and because they are unable to deal with the pain. Which in my case is now 24/7, I  refuse to go for the marijuana card because I do not like how it makes me feel. CBD oil does not help either and being financially unable to purchase it even if it did. Something has to be done, as I didnt put myself on the medications that helped me function. Now Im doing the best I can to raise my teenage son, which isnt much. The Dr. Im seeing now my appts are a 4 go 6 hr wait. He doesnt listen to me, I go in for trigger point injections 23 total and theyre painful they help a few hrs and are for fibromyalgia only. As for my other health conditions are being ignored. Please I need help as I dont know what else to do. ", "comment_id": "FDA-2017-N-5608-0721", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0721", "comment_date": "2018-01-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1388}]}, {"id": "MSHA-2008-0011", "agency": "MSHA", "title": "Duplicate- See MSHA-2008-0014.   Alcohol- and Drug-Free Mines: Policy, Prohibitions, Testing, Training, and Assistance", "update_date": "2019-09-04", "update_time": "01:01:02", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am concerned that the option of immediately dismissing a miner for use of prohibited substances on mine property and during working hours in not allowed under the rule.I need to be able to dismiss any employee that uses drugs or alcohol at work, and all other policies allow this option.I would prefer to dismiss a miner found using or under the influence of prohibited substances.The only formal Drug and Alcohol abuse policy we have is DOT required and compliant.  Under this plan, an employee found using alcohol at work is dismissed instantly.  Many other employees, under no formal policy, would also be instantly dismissed for using drugs or alcohol at work.Now, MSHA is proposing that under identical circumstances, I may not dismiss a miner for violating a formal policy !Who pays for the SAP counseling ?  Who pays for return to work and follow up testing ?  How long must I offer job security ?ANY employee, miner or otherwise, needs to be dismissed upon positive test results, or when found using drugs or alcohol at work !", "comment_id": "MSHA-2008-0011-0016", "comment_url": "https://api.regulations.gov/v4/comments/MSHA-2008-0011-0016", "comment_date": "2008-09-24", "comment_time": "04:00:00", "commenter_fname": "William", "commenter_lname": "Snyder", "comment_length": 1151}, {"text": "Federal and state employment laws generally permit an employer to have a zero tolerance policy forbidding the use of alcohol and controlled substances in the workplace, and permitting discipline (up to and including termination) for violation of that policy.  After decades of ever-increasing awareness of the societal toll of alcohol and drug abuse, there are a wide variety of federal, state and local public health programs (and a wide array of private sector programs) addressing this toll.  Against the well-developed background, MSHAs proposed rule is a poor solution in search of a non-existent problem.  For this reason, Oil-Dri Corporation of America and its affiliates strongly object to the proposed rule.MSHA would be exceeding its authority provided by Congress in requiring a mine operator to re-assign anyone to another position for any reason, and to require a mine operator to extend job security to anyone in violation of any employment matter.  MSHA cannot direct the workforce.The proposed rule would only require mine operators to offer job security to those miners who violate the alcohol- and drug-free mine policy for the first time provided they follow the SAP treatment recommendations and required return-to-duty procedures.MSHAs current requirement is clear and concise, and extending the current requirement to the coal industry should be the initial and logical step. Intoxicating beverages and narcotics shall not be permitted or used in or around mines. Persons under the influence of alcohol or narcotics shall not be permitted on the job.Larry R. EvansCorporate Health  Safety ManagerOil-Dri Corporation of AmericaP.O. Box 380, 28990 Georgia Hwy 3 NOchlocknee, GA 31773Office229-574-4270Fax229-574-4260Toll Free  800-634-0315 x4270Cell478-986-7635larry.evans@oildri.com", "comment_id": "MSHA-2008-0011-0011", "comment_url": "https://api.regulations.gov/v4/comments/MSHA-2008-0011-0011", "comment_date": "2008-09-16", "comment_time": "04:00:00", "commenter_fname": "Larry", "commenter_lname": "Evans", "comment_length": 2183}, {"text": "Most of the mines I am familiar with already have a zero tolerance policy for drug and alcohol use. The three mines I supervise all have a written zero tolerence policy with pre-employment testing and random testing. This is expensive but I believe it works to keep our work place safe. There is no question in our workforce on what is expected and the consequences if an employee violates the policy. To require a company to reassign an employee caught under the influence after he knowingly violated that policy and to have that company accept the expense and business disruption that goes with sending them out for assistance is wrong. It doesnt stop substance abuse because those that are prone to use drugs or alcohol on the job know they get a second chance if caught.  ", "comment_id": "MSHA-2008-0011-0018", "comment_url": "https://api.regulations.gov/v4/comments/MSHA-2008-0011-0018", "comment_date": "2008-09-24", "comment_time": "04:00:00", "commenter_fname": "Woody", "commenter_lname": "Sanderson", "comment_length": 838}]}, {"id": "PHMSA-RSPA-2000-8417", "agency": "PHMSA", "title": "Drug and Alcohol Testing for Pipeline Facility Employees", "update_date": "2021-02-10", "update_time": "01:40:43", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comments of the Iowa Utilities Board in Docket No. RSPA-00-8417, Notice 1 - Drug and Alcohol Testing for Pipeline Facility Employees", "comment_id": "PHMSA-RSPA-2000-8417-0003", "comment_url": "https://api.regulations.gov/v4/comments/PHMSA-RSPA-2000-8417-0003", "comment_date": "2001-06-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 132}]}, {"id": "FDA-2014-N-0189", "agency": "FDA", "title": "Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products", "update_date": "2024-03-06", "update_time": "12:14:00", "purpose": "Rulemaking", "keywords": ["ctp", "ctp20092", "0910-AG38", "open", "2014-850", "Deeming Tobacco Products To Be Subject to the", "Federal Food, Drug, and Cosmetic Act, as Amended", "by the Family Smoking Prevention and Tobacco", "Control Act", "Restrictions on the Sale and", "Distribution of Tobacco Products and Required", "Warning Statements for Tobacco Products", "Final rule", "Gerie Voss or Katherine Collins", "Office of Regulations", "Center for Tobacco Products", "2015-660"], "comments": [{"text": "As a brick-and-mortar retail tobacconist, I would like to respond to the April 25, 2014, Notice of Proposed Rulemaking (NPRM) on the deeming of tobacco products under the Family Smoking Prevention and Tobacco Control Act. There are several aspects of the proposed deeming regulations that could have a devastating impact on my small business, Blue Havana II Cigars, located in Alpharetta, GA.  First, I oppose the arbitrary price point of $10 for a cigar to be deemed premium.  My inventory, all of which are premium cigars, range in price from $3 to $40 per cigar with the average selling price in the $5 to $7 range.  Additionally, as a retailer, wholesale price fluctuations, differing state tax rates, or a promotional event in my shop could cause a cigar to move from the premium category. Such inconsistencies in the marketplace could impose a significant regulatory burden on me as a small business owner.Secondly, I oppose the imposition of a costly pre-market review process for premium cigars. Pre-market review would be cost prohibitive for many manufacturers, effectively eliminating their ability to release special editions and seasonal blends. Such products are a distinctive aspect of the industry and a large part of my business.Thirdly, I oppose a ban on sampling. Product sampling is an integral part of the unique experience at a premium cigar shop. A sampling ban would prohibit consumers from being able to try new products in my shop and at cigar charity events, which drive consumer purchasing. Given the typical price point and celebratory nature of premium cigars, customers are less likely to purchase an unfamiliar product.For the aforementioned reasons, it is critical that the FDA consider the difference between premium cigars and other tobacco products when drafting the final regulations. Premium cigars are an adult product, without the habitual use patterns of mass-market tobacco products. Existing state law prohibits the sale of products to minors. As a small business owner, I take that obligation to my community very seriously.I urge you to exempt premium cigars from the final FDA regulations. Imposing one-size-fits-all regulations on a diverse suite of tobacco products is a step in the wrong direction for the FDA. Thank you for the opportunity to submit comment on the proposed deeming regulations.Sincerely,Jim Luftman, Member/ManagerBlue Havana II, LLC dba Blue Havana II Cigars", "comment_id": "FDA-2014-N-0189-8056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0189-8056", "comment_date": "2014-06-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2519}, {"text": "I would like to point out the absolute economic disaster you are attempting to cause through these proposed regulations on, smokeless tobacco. Now the primary focus of this comment is on the issue of electronic cigarettes, but if we want to use correct terminology and not slang as you do we would call them, Personal vaporizers, or Advanced Personal vaporizers. The proposal you have made targets the entire e-cigarette industry, this is an obvious attempt to shut down the small business market that dominates the industry as of current. The whole idea of regulation of these products comes from a need for safety yes we all get it, but the FDA as well as everyone else knows that these regulations have a wide and sweeping range that aims to make it so only big pharmaceutical companies and big tobacco companies can afford to run the e-cigarette industry in order to maintain current government tax profits. The articles of this that I demand are changed are the requirement of new, nicotine gels (which is not a proper way to describe e-liquid) to be reviewed by the FDA. Doing so would be like making dove contact you every time they put a new scent in their soap. On top of this the requirement that all products after 2007 must be tested for the market is outrageous, I understand making all products after the regulations go into effect go through this process, but these products will have been on the market for 8 years already (every hear of ex-post facto law). Your regulations are to harsh on a product little is known about I believe that these proposed regulations on the electronic cigarette industry need to be lessened or pushed back to a later date until real scientific prof is given as to weather these products are harmful or not. E-cigs have saved people from smoking cigarettes weather the FDA wants to accept it or not the fact is that with these regulations you are assisting in the deaths of tens of thousands of Americans. Its time that the Food and Drug administration stands by facts and science not common misconception and rumor over these products. Until real evidence is given to the general public regarding these products the FDA is committing a major ethical violation by regulating the whole industry. If you will not hear our voice now then be ready be cause the CASAA is fight you at every turn and for once THE PEOPLE will take the power god has given to them which is exemplafied in the Federal Constitution of the United States of America and stand up for their right to vape, and I promise you if you dont work with us and compromise you are only adding another nail to this countries ever closing coffin.", "comment_id": "FDA-2014-N-0189-3770", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0189-3770", "comment_date": "2014-06-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2703}, {"text": "AEMSAs PRA submission to OMB", "comment_id": "FDA-2014-N-0189-10852", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0189-10852", "comment_date": "2014-06-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 33}, {"text": "As an adult who enjoys premium cigars, I urge the FDA to remove the $10 price definition, and any other price requirements from the definition of premium cigars. Premium cigars should be defined only by their construction and composition, and not by their price. Cigars priced $10 and above currently represent a very small fraction of the premium cigar industry and this arbitrary number would result in serious damages to an industry and a hobby thats very important to me and millions of other Americans. If regulation of this 1,000-year-plus pastime is absolutely necessary, I ask only for fair and rational requirements. A $10 minimum price point is neither fair nor rational. Thank you for your consideration of my concerns. ", "comment_id": "FDA-2014-N-0189-28747", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0189-28747", "comment_date": "2014-06-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 743}, {"text": "As a premium cigar consumer, I urge the Food and Drug Administration (FDA) to exempt premium cigars from the proposed deeming regulations issued on April 24, 2014. The new proposed regulations will infringe on my rights as a cigar consumer: the freedom to enjoy a variety of premium cigars; The freedom to patronize small businesses across America who will now find their livelihood at risk; The freedom to assemble with fellow cigar enthusiasts because of intrusive government intervention into an adult pursuit.  These devastating new restrictions on premium cigars and the businesses that manufacture and sell premium cigars, must recognize that premium cigars, are not what Congress intended with the Family Smoking Prevention and Tobacco Control Act.  I urge the FDA to consider the following:I personally enjoy cigars and tobacco pipes, but besides my personal enjoyment of these products, my income relies on these products. I work at a small tobacco store in Greenville, SC and I absolutely love what I do and the people I interact with on a daily basis. I pray that you will take me and all of the individuals who will be affected into consideration as you seek to further the involvement into premium tobacco. Most of all, I plead to you NOT TO RAISE PRICES in any capacity. I meet so many people from different walks of life in my shop and other shops when I travel. People, who just like me, enjoy a good cigar and the camaraderie it brings. Please do not interfere with our personal enjoyment of premium tobacco. People like being together, and premium cigars are also an important part of the moments of solitude that we all need in life.The federal government should not be interfering with that type of camaraderie, fellowship, and personal pursuit. Thank you for considering my opinions and my voice on this matter.", "comment_id": "FDA-2014-N-0189-42853", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0189-42853", "comment_date": "2014-07-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1887}]}, {"id": "EPA-HQ-OAR-2022-0707", "agency": "EPA", "title": "Protection of Stratospheric Ozone: Updates Related to the Use of Ozone-Depleting Substances as Process Agents", "update_date": "2023-12-12", "update_time": "08:40:15", "purpose": "Rulemaking", "keywords": ["Controlled Substances", "ODS", "Ozone-Depleting-Substances", "Process Agents"], "comments": [{"text": "The Montreal Protocol is deemed one of the most successful international environmental treaties as it was the first treaty to achieve ratification by all countries in the world. It has created unprecedented results in reducing ozone-depleting substances (ODS) and greenhouse gases. According to the UN Environment Programme, the Parties have phased out 98% of ODS globally compared to 1990 levels. With a significant portion of ODS being greenhouse gases, the Protocol has also contributed to protecting the climate and recovering the ozone layer. With the United States leaving and re-entering the Paris Agreement, it is essential to demonstrate that the country is still committed to international cooperation and environmental protection. With more transparent reporting and recordkeeping, the US can demonstrate its commitment to improving climate protection globally and accurately documenting its contribution. The EPA has put concerted efforts into replacing ODS with non-ozone-depleting substances, but there are still circumstances when using ODS is necessary. Decision X/14 of the Protocol permits the use of ODS as process agents. All parties must submit an annual report detailing process agent emissions, containment technology, and production and importation of controlled substances for use as process agents to the Secretariat. The proposed rule by EPA defines precise recordkeeping and reporting requirements for US entities.EPA has compared the difference between applying TRI and GHGRP approaches. The TRI approach does not require the entity to report the source of its information or the emission factors used. With EPA suspecting only six entities will be impacted by this proposed rule, none of which are small entities, the GHGRP approach is more reasonable. Because this approach would require the entity to use specific methodology and report more detailed information, the data is more consistent and manageable for EPA to validate.In EPAs draft memo for emission reporting for process agents, the methods described for different processes are often engineering calculations, chemical engineering principles, or engineering assessments, which allow estimates to be created for various process components based on specific assumptions and knowledge. These methods are more likely to produce more reliable emissions data than the mass balance approach. A mass balance approach requires the quantification of the process inputs and outputs. When calculating ODS emissions from process agents, the accuracy of the inputs and outputs of the process is a concern, so the emission factors produced from a mass balance method may be more unreliable. Subsequently, setting one testing method for different processes instead of allowing multiple is reasonable. Although permitting multiple methods would enable the entities to use the form best suited to their available resources and expertise, there are few entities that this rule impacts. Consistent, validated information is better for evaluating process agent emissions in the United States and provides more reliable information to the Secretariat. Based on this review, EPA should finalize the rule as proposed. The rule will provide more consistent, reliable, validated data to be reported to the Secretariat. With the United States making up the most consumption of ODS for process agents and creating the most emissions out of any country under the Montreal Protocol, improving recordkeeping and reporting is vital to accurately representing emissions in the United States and understanding the global impact of those emissions. ", "comment_id": "EPA-HQ-OAR-2022-0707-0017", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2022-0707-0017", "comment_date": "2023-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3639}, {"text": "Comments provided in the uploaded file.  ", "comment_id": "EPA-HQ-OAR-2022-0707-0019", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2022-0707-0019", "comment_date": "2023-12-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 41}]}, {"id": "CDC-2017-0043", "agency": "CDC", "title": "Evaluation of Medication-Assisted Treatment (MAT) for Opioid Dependence ", "update_date": "2017-08-21", "update_time": "08:52:53", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Ibogaine should be considered for descheduling or rescheduling, as it holds immense therapeutic promise for the treatment of addiction, and it is already being used with great success in other countries, and the U.S. if falling behind. Ibogaines illegality is part of why overdoses are a problem. ", "comment_id": "CDC-2017-0043-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2017-0043-0003", "comment_date": "2017-07-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 302}]}, {"id": "FDA-2017-P-1911", "agency": "FDA", "title": "Request that the FDA ensure follow on products citing BUTRANS as the reference listed drug are as safe and effective as BUTRANS. CLOSED", "update_date": "2017-07-21", "update_time": "12:33:01", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Kleinfeld Kaplan & Becker, LLP", "BUTRANS", "buprenorphine", "reference listed drug", "Purdue Pharma L. P.", "CLOSED"], "comments": [{"text": "This war on opioids is actually a war on  chronic incurable diseases.  A war on chronic pain disease patients who benefit from opioid medications.  Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases. The fiction, widespread hysteria and distorted truths about this opioid epidemic, is killing legitimate chronic pain disease patients who use their medications responsibly.  We are patients.100 million Americans have one or more chronic incurable pain Diseases.  As the CDC, DEA, FDA, Medicaid and Medicare,  and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication.  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about NOT addressing these drugs as dangerous and addictive.  When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication.   Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease.   Chronic pain disease patients are now the epidemic.   The addiction rate of chronic pain disease patients is .02-.6 %.  We do not misuse or abuse our medications.No other disease medication is scrutinized.  We, as patients, are being denied,  dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications.   Our Drs are afraid to treat us humanely, ethically and adequately.   We have a disease that medication is readily accessible and beneficial to us and we are being denied.   We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl.  This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them.  We have our privacy invaded, we no longer are able to have doctor/patient confidentiality.  We now have insurance agencies,  pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians. Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.  The specific causes of deaths also needs to be closely investigated.  The opioid in the persons system needs to be specified.  Was it an illegal opioid,  was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out.  These Government agencies do not want that information out, due to the fact that this opioid epidemic, would then be debunked.Lets put the shoe on the other foot.  Restricting or taking away our medications is like FORCING people who do not want this medication to take it.  One day those against these medications will need them but they will be denied.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible. Without access to these life saving medications,  we are unable to do so.  We want to live, not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.  These agencies are not physicians.   They are trying to doctor us, patients, without a medical license.   They are also trying to police our physicians.  This is a war on a disease, medications, physicians and patients. We, chronic pain disease patients, need help.  All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them.  We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief. The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl,  illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS.  Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications. WE ARE PATIENTS NOT ADDICTS! !", "comment_id": "FDA-2017-P-1911-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-1911-0004", "comment_date": "2017-07-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4632}]}, {"id": "ONDCP-2020-0001", "agency": "ONDCP", "title": "Designation of Emerging Drug Threats in the United States ", "update_date": "2022-06-22", "update_time": "12:26:41", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The United States has failed to recognize or act upon marijuana as a drug threat, despite clear violation of international treaties.  The health harms are more apparent and societal and environmental harms will outstrip alcohol and tobacco.  Never before has there been such a public health and safety concern over a plant, which at one time, was fairly benign, but now, with rising potencies is associated with violence, driving fatalities, increased youth access, use, and addiction, and negative impacts to the unborn.  The United States must act accordingly and reign this in quickly before we lose generation of youth, destroy our environment, and to protect the public health and safety.", "comment_id": "ONDCP-2020-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0014", "comment_date": "2020-06-19", "comment_time": "04:00:00", "commenter_fname": "Kenneth", "commenter_lname": "Finn", "comment_length": 693}, {"text": "Im  a 59 year old chronic pain patient with 4 autoimmune diseases. Ive bad 20 surgeries in 17 years. There are no cures for the diseases I have. Ive have tried multiple modalities to help ease my pain. I started with a pain management doctor 10 years ago. My pain had  been kept to a tolerable level when Im on pain medication. I have some quality of life now, but its not as good as it could be since the CDC guidelines came out. My medicines were changed and dosages lowered. I try to stay active visiting a gym. Im not expecting my pain medication to take away all my pain.I Just want to be able to do a few things. Ive had to give up so many things because of the pain I suffer everyday. Its Not just me and my Doctor in the exam room anymore. Now the government is telling my doctor what he can and cant prescribe. I do not have an addictive personality or do my pain meds make me high. I always pass my drug screenings and pill counts. I havent done anything wrong but Im being treated like a criminal. Please let doctors be doctors again and use the DEA to clean up our streets where the illegal  heroin and fentanyl are killing people. My heart breaks for all the chronic pain patients who are suffering to the point of wanting just to die so the pain will stop. I chose to do this anonymously because I dont want anymore restrictions put on my medical history. Im scared to death this has gone way too far with patients. ", "comment_id": "ONDCP-2020-0001-0018", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0018", "comment_date": "2020-06-19", "comment_time": "04:00:00", "commenter_fname": "Kerry", "commenter_lname": "Anonymous", "comment_length": 1519}, {"text": "ONDCPs criteria that enables the country to be proactive in monitoring and identifying emerging drug threats to avoid public health crises has the potential to reverse destructive drug trends. The implementation of the sliding scale, both individually and holistically, allows for a more complete threat evaluation. There are three areas in which we can improve these criteria in order to prevent another crisis similar to the opioid epidemic. The first would be to prioritize or re-categorize these criteria to focus on the proactive measures, such as monitoring online discussions. Secondly, we must avoid the racial disparity experienced with the opioid crisis. Lastly, our outdated approach of smothering drug markets to force prohibition should be at the forefront when developing and implementing these criteria.It would benefit all to prioritize or re-categorize these criteria based on preventive measures versus compiling data of newly diagnosed substance use disorders or measuring morbidity or mortality, when the damage has been done. Through identifying these avenues of discussion or activity early, we can increase interventions to keep the emerging drug threat at bay.   We also want to avoid racial divide over potentially criminalizing by prioritizing based on racial characteristics. The narrative that todays heroin users are largely white and that heroin suppliers are largely black and Latino has contributed to the publics willingness to address opioid use less punitively (Werle and Zedillo, 2018, p. 326). This has created massive disparities in our prison system. We must not prioritize criteria or use language that unfairly highlights a particular racial or ethnic group more than another.    Lastly, we must eliminate our reaction to smother drug markets, which actually makes the problem worse. Look at the Volstead Act during prohibition. Werle and Zedillo (2018) state that it did far more to change what Americans drank than how much (p. 330). Just as with the opioid crisis, eliminating access just pushes production, transportation, sale, and use underground. In addition, overdoses are more common following cessation of naltrexone treatment than among either untreated heroin users or maintenance users (Werle and Zedillo, 2018, p. 328). This may slightly benefit Big Pharma by allowing continuation of production and supply of a potentially dangerous drug; however, as a public-health focus, it is more dangerous if we try to eliminate the drug completely. We would benefit by removing or revising criteria that encouraged suppression that lead to illicit products, such as heroin, fentanyl, or synthetic opioids.Some may object that this approach of rehabilitation versus criminalization by lowering access thresholds would risk providing a[n] acceptable means for people to initiate drug use (Werle and Zedillo, 2018, p. 338). However, this has not held true in countries, such as Switzerland, taking this public-health approach. With these aspects in mind, we should re-categorize and reword the criteria, basing it on priority, equality, and a public-health approach instead of criminalized suppression. Through this proposed policy, we will see lives saved and decreased healthcare costs.", "comment_id": "ONDCP-2020-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0020", "comment_date": "2020-06-19", "comment_time": "04:00:00", "commenter_fname": "Brian", "commenter_lname": "Kerska", "comment_length": 3344}, {"text": "This comment addresses the Office of National Drug Control Policy (ONDCP) specifically 21 CFR Part 1401 (RIN 3201-AA02) entitled Criteria for Designation of Emerging Drug Threats in the United States. To determine the emerging drug threats a committee was created and established 11 proposed criteria to identify emerging drug threats and I would like to propose an additional criteria to specifically address the vulnerable population of children aged 12-18, for whom drug abuse can be particularly debilitating, by examining federal, state, local and tribal data for the emergence of use of new or evolving drug, class of drugs, or other substances in this population. This new proposed criterion should exclude substance abuse disorder because waiting for children to develop a substance abuse disorder as written in criteria 7 will prove to be too late. This additional criterion is important because drug misuse has been shown to increase with age starting in early adolescence and peaking in early adulthood (McGorry et al., 2011). With this fact in mind, interventions that aim to stop or postpone the onset of drug use should be targeted to a specific population before or during adolescence (McGorry et al., 2011). In order to effectively decrease the burden of emerging drug trends and its effect on medical and public health, the ONDCP must be able to carefully consider the adolescence population and quickly determine patterns to avoid another opioid crisis. Many are aware of the health hazard that adult opioid abuse poses in the United States, however the effect of opioid abuse on children is often overlooked. Opioid abuse is a major public health issue for children in the United States and is clearly evident with the increasing number of emergency department visits by young children and adolescents for poisoning by prescription opioids (Allareddy  Rampa, 2017). Emerging drugs threats in adolescence must be identified and action must be taken early to prevent future public health hazards.References: Allareddy, V.,  Rampa, S. (2017). Opioid abuse in children: an emerging public health crisis in the United States. Pediatric Research, 82(4), 562-563.McGorry, P., Purcell, R., Goldstone, S., Amminger, G. (2011). Age of onset and timing of treatment for mental and substance use disorders: Implications for preventive intervention strategies and models of care. Current Opinion in Psychiatry, 24(4), 301-306. ", "comment_id": "ONDCP-2020-0001-0033", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0033", "comment_date": "2020-06-30", "comment_time": "04:00:00", "commenter_fname": "Nicole", "commenter_lname": "Lieber", "comment_length": 2478}, {"text": "Dear ONDCP,I wish to strongly oppose the legalization of cannabis across USA.This has major effects internationally and is a clear and present danger to the health of the population of the rest of the world as well by virtue of the major leadership role which USA plays in the international community.Cannabis is also a clear and present threat to the coming generations - at least four generations and probably more - by virtue of its well documented heavy epigenetic footprint.  Cannabis has been shown to act on both DNA methylation and histone modifications and even reduces histone synthesis.  Reduced synthesis of histone proteins necessarily implies that the controls over gene transcription are reduced, just as occurs in cancer, aging and in many congenital anomalies.A frightening and very detailed geotemporospatial consideration of the US epidemiology of four areas of:1)Mental Illness2)Autism3)Congenital Anomalies4)Pediatric Cancerhas been compiled by me in an as yet unpublished book entitled Cannabis Indictment: Heritable Cannabis Epidemiology: Neurotoxicity, Genotoxicity, Teratogenicity and Carcinogenicity and is available at this Dropbox linkhttps://www.dropbox.com/sh/9es9yzrqnfon7sn/AAAIjoHKOomx-7d38NRry5oNa?dl=0 On geospatial criteria 38 of the 62 congenital defects tracked by CDC are shown to be linked with cannabis exposure.  On risk ratio criteria (Prevalence ratios, the same as used by CDC epidemiologists) 44 of the 62 defects tracked by CDC are shown to be elevated in states with higher cannabis exposure.These are very concerning findings by any metric.Similarly many detailed documents addressing these issues are also available at this Dropbox link.https://www.dropbox.com/sh/pq64wseep2x7evu/AAA7cmAGg4qfUvJCOe6gsFyaa?dl=0 We presently have seven papers in Submission to various general and geospatial medical journals relating to the subjects of:1)Mental illness in USA2)Autism in USA3)Atrial Septal Defect in USA4)Downs Syndrome in USA5)Phocomelia in USA6)All Congenital Defects in the High Cannabis Area of Northern New South Wales in Australia7)Cannabis potentiation of Coronavirus infection rate across USA.When these seven papers were compiled I had mastered geospatial analysis in R from CRAN (using packages spdep and splm).  Now I have also mastered inverse probability weighting and eValue techniques which allow me to formally investigate CAUSAL relationships using well established methods.Work on CAUSAL RELATIONSHIPS is complete in the three domains of:1)Atrial septal defects2)Cannabis-coronavirus interaction and 3)Autism.IN EACH CASE THERE IS VERY STRONG EVIDENCE THAT CAUSAL RELATIONSHIPS EXIST BETWEEN CANNABIS EXPOSURE AND EACH OF THESE THREE METRICS.IN VIEW OF THE HIGH LEVEL OF STATISTICAL SIGNIFICANCE SHOWN AT GEOSPATIAL ANALYSES, WITH MANY P10 -16 I FULLY EXPECT THE CAUSAL ANALYSIS TO ALSO BE STRONGLY POSITIVE IN THE OTHER FOUR KEY DOMAINS EXAMINED.It will not be lost on ONDCP I am sure that Downs syndrome is a major genetic defect which has risen three times over the last forty years when one factors in the very high rates of abortion conducted for major genomic errors in most jurisdictions.  ELEVATED RATES OF DOWNS SYNDROME CONSEQUENT TO CANNABIS EXPOSURE NECESSARILY DOCUMENTS MAJOR HUNDRED MEGABASE SCALE CANNABIS-RELATED GENOTOXICITY.Atrial septal defect of course is one of the commonest of all the cardiovascular defects which itself is the commonest group of congenital anomalies, which are the leading cause of infant and child death under five years in USA and many other nations worldwide.Dropbox is used due to the size and number of the files concerned.Similar relationships were seen in Hawaii, Colorado and in our published geospatial analysis of all Canadian birth defects and or Canadian neural tube closure birth defects.This submission should be kept confidential as some of the documents quoted are still embargoed pending publication.However they are provided on this occasion for the benefit of the Government of USA, the health of the global population and in the developmental interests of many generations yet to be born.Thankyou for considering these weighty facts.Yours sincerely,Professor Dr Albert Stuart Reece,University of Western Australia,Edith Cowan University,Australia.", "comment_id": "ONDCP-2020-0001-0015", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0015", "comment_date": "2020-06-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5192}, {"text": "Substance abuse in the United States is a widespread, costly and devasting situation. As a healthcare provider, I appreciate the effort of the Office of National Drug Control Policys (ONDCP) creation of 11 criteria for identifying and monitoring emerging drug trends in the United States. These criteria are broad but appropriate to identify emerging drug trends in hopes to prevent the development of another opioid like crises in the future.  As suggested in criteria 9, increasing online discussion of evolving drug threats is a great step to educating the public on emerging trends. Obviously, much of society spends a lot of time seeking out information online and having scientifically backed resources available to the public can eliminate gaps in knowledge. In addition, facilitating the communication with local healthcare providers in primary care, emergency departments and poison control centers can assist in identifying emerging drug trends. I know the ONDCP aims to open the dialogue online but I do believe opening up communication with healthcare providers in communities seeing spikes in misuse of these drugs would add to the data, surveillance and ultimate prevention of drug abuse. A focus on primary prevention will help mitigate issues of drug threats and proper dissemination of educational materials in waiting rooms, offices and lounges assists in getting the information out to the public in a safe and effective manner (Phillips et al., 2017). ReferencePhillips, J., Lim, F.,  Hsu, R. (2017). The emerging threat of synthetic cannabinoids. Nursing Management, 48(3), 22-30. https://doi.org/10.1097/01.NUMA.0000512504.16830.b6", "comment_id": "ONDCP-2020-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0027", "comment_date": "2020-06-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1748}, {"text": "To the ONDCPs Emerging Threats Committee,Regarding your request for public comments on issues specified in your Criteria for Designation of Emerging Drug Threats in the United States, Id like to provide my thoughts.  I am a registered nurse (RN) whose experience largely consists of urban emergency department (ED) practice, and am currently a Doctor of Nursing Practice (DNP) student in the Family Nurse Practitioner specialty.  I can certainly anecdotally corroborate the Committees statement that increases in ED visits are generally consistent with emerging drug trends; in particular, my experience of caring for patients believed to be under the influence of synthetic cannabinoids (e.g. K2) comes to mind.  With respect to the proposed criteria in general, I feel that the Committee has developed a comprehensive list that would reasonably facilitate designation of a substance as an emerging drug threat, and interpretation of findings based on a sliding scale is appropriate based on individual circumstances depending on the substance.  Related to criterion 4, I feel that comprehensive screening for what seem to be emerging drug threats during these visits, hospitalizations, or treatment admissions may play a particularly important role; patients may present seeking treatment for a substance use disorder unrelated to the emerging drug threat, however they may be using this novel drug in addition to the substance they are seeking treatment for (ONDCP, 2020, p. 29367, column 1, para. 3).  Although they are pursuing care for a different drug use disorder, a patient who endorses use of the emerging drug may still have pertinence in the interest of tracking its prevalence in a given region.  As a potential emerging threat, these substances may not yet be associated with any particular pathologies, overdoses, or patterns of presentation, which can make defining the substance difficult.  Despite the prevalence of patients presenting with these substance use disorders in ED settings, as described by Hawk and DOnofrio (2018), the EDs role in screening and facilitating intervention is still lacking.  If the Committee were to place greater emphasis on comprehensive screening for all substance use disorders in the ED and facilitating pursuit of treatment, theres potential for uncovering more information regarding these emerging drug threats and using these methodologies to inform interventions.  Potentially incorporating a reporting requirement in EDs for these new substances for measurement purposes, regardless of new or novel clinical illnesses that may develop in those users, may also be beneficial (ONDCP, 2020, p. 29367, column 1, para. 3).  By screening ED patients in particular for emerging drug threats (and all substance use, for that matter) irrespective of novel substance-related pathology, insight may be gained regarding trends and pertinent epidemiological information that can be used to guide future study and make recommendations for the public.ReferencesHawk, K.,  DOnofrio, G. (2018). Emergency department screening and interventions for substance use disorders. Addiction Science  Clinical Practice, 13(18), 1-6. https://doi.org/10.1186/s13722-018-0117-1 Office of National Drug Control Policy [ONDCP]. (2020). Criteria for designation of emerging drug threats in the United States. 85(95), 29366-29368. https://www.regulations.gov/document?D=ONDCP-2020-0001-0001 ", "comment_id": "ONDCP-2020-0001-0026", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0026", "comment_date": "2020-06-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3563}]}, {"id": "VA-2018-VHA-0013", "agency": "VA", "title": "AP00 - Proposed Rule - Definition of Domiciliary Care", "update_date": "2018-09-25", "update_time": "08:35:58", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "To Whom This May Concern,I am currently conducting research on the homeless population in regards to the crisis here in the County of Los Angeles.  I understand that we cannot tackle the issues of homelessness all at once, and that there are specific unique demographics who choose not to accept social services to get them out of this state of homelessness.  However, it is my proposal that those in charge of our city and state governments begin to focus on vulnerable and valuable demographics such as homeless veterans.  These are individuals who in some shape or form, have contributed to our military taking a oath to service to our country.  By focusing attention towards a small-medium size demographic it allows funds appropriated a chance to take hold and implement change on this smaller percentage of homeless people.  Thus making a dent in the population as a whole.  After reading the proposed rule, I support that these types of services are meant to be temporary and not permanent.  Who would or should aim to be homeless their entire life?  There should be intrinsic and extrinsic motivational factors that contribute to the individuals motivation to get themselves out of their current state.  I am a firm believer in rehabilitation when it comes to this demographic.  From my research, subsidized and affordable housing are two of the primary goals to attain when making strides to improve this homeless group.  This Domiciliary Care rule supports the services that homeless veterans need such as mental health, counseling, and substance treatment.  While providing them with a chance to implement change in their life, while creating realistic timelines to facilitate progress. ", "comment_id": "VA-2018-VHA-0013-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2018-VHA-0013-0004", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "F", "commenter_lname": "Chavez", "comment_length": 1723}, {"text": "One of the reasons I chose AP00- Proposed Rule- Definition of Domiciliary care, is because I have two brothers, one active duty and one retired. As they are getting older wanted to know what was out there regarding their future care, as they are getting older. Plus since the Medical care is changing and what is being covered through the government, I felt that this would be something to explore and get information on. I appreciate the care that is covered under this proposed rule. Appreciate the domiciliary program being authorized to provide eligible veteran with a home and coordinated ambulatory care as needed. Plus, it also allows the VA to provide a temporary home to certain veteran, which includes the furnishing of shelter, goods, clothing and other comforts of home, and as well as medical services. This rule also allows me to pass on this information to the clients at the Social Services Agency,that I deal with on a daily basis that are Veterans and think that there is no help for them and in turn there is. The best part that I agree with is the Mental Help that is also offered through the (MH RRTP) Mental Health Residential Rehabilitation Treatment Program. There are so many homeless Veterans dealing with PTSD, BI-Polar and other Mental illnesses so I hope that this proposed rule continues to be commented on and voted on as a positive.", "comment_id": "VA-2018-VHA-0013-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2018-VHA-0013-0005", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Ann", "commenter_lname": "Williams", "comment_length": 1369}, {"text": "To whoever this may concern,After reading through the proposed rule, I want to first commend the effort to amend the current definition of domiciliary care. With a father who is affiliated with the VA and has benefits, topics of this nature do perk my interest as a direct family member is a stakeholder. The clarity and brevity of this amendment to the rule is fair: it desires to include Mental Health Residential Rehabilitation Treatment Program as another medium of domiciliary care. This seems to be an issue where the regulation came before the development of the Mental Health Residential Rehabilitation Treatment Program back in 2005. Therefore, the bureaucrats are clearly active in updating the current rules. This amendment doesnt necessarily provide more concrete benefits but remind VA members that domiciliary care does not equate to permanent housing. This eliminates the grey area of veterans demanding accommodations for the rest of their lives. While this is debatable, providing VA members housing for the rest of their lives is a massive cost. By giving better defined rules, it allows the VA to set parameters to what they have to offer to veterans. I wholeheartedly agree with this step forward for clear and concise rules.", "comment_id": "VA-2018-VHA-0013-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2018-VHA-0013-0003", "comment_date": "2018-04-09", "comment_time": "04:00:00", "commenter_fname": "Jamal", "commenter_lname": "Mays", "comment_length": 1260}, {"text": "This amendment to the definition of the domiciliary care program will include Mental Health Residential Rehabilitation Programs. I agree with the addition and inclusion of Mental Health Residential Rehabilitation to the definition of domiciliary care. In 2005, the VA designated all Mental Health Residential Rehabilitation Treatment Centers as domiciliary care. The definition is outdated and the VA is amending the rule to advance what is already incorporated in the definition of domiciliary care. This amendment will also make clear domiciliary care is not permanent housing. I believe making it clear that domiciliary care does not offer permanent housing is beneficial to veterans and the families of veterans. Clearly knowing what the program does and does not offer will help veterans and their families make better decisions when it comes to the welfare of the veteran. As a veteran myself, I like to know what I can and cannot receive from a program. I want all the information to be up to date and clear so I can make the best choices when it comes to my health. I believe that is what this amendment will achieve.  ", "comment_id": "VA-2018-VHA-0013-0006", "comment_url": "https://api.regulations.gov/v4/comments/VA-2018-VHA-0013-0006", "comment_date": "2018-05-04", "comment_time": "04:00:00", "commenter_fname": "Arthur", "commenter_lname": "Yanez", "comment_length": 1127}]}, {"id": "SSA-2010-0010", "agency": "SSA", "title": "Recovery of Delinquent Debts--Treasury Offset Program Enhancements", "update_date": "2019-06-12", "update_time": "01:02:37", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I feel that in conforming with existing treasury regulations regarding debt the SSA should use language that is understandable to people with disabilities as to the new regulations.", "comment_id": "SSA-2010-0010-0002", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2010-0010-0002", "comment_date": "2011-04-05", "comment_time": "04:00:00", "commenter_fname": "Benjamin", "commenter_lname": "Kerensa", "comment_length": 181}, {"text": "I agree with the proposal associated with Docket No. SSA-2010-0010.  I believe that it is necessary to hold individuals accountable for repaying borrowed money and giving back over payments.  In short, being a fiscally responsible citizen. I would make two suggestions, that individuals be given ample notice before monies are reclaimed and that individuals are thoroughly informed before they enter into an agreement or contract that may eventually fall under this proposed rule.", "comment_id": "SSA-2010-0010-0003", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2010-0010-0003", "comment_date": "2011-04-26", "comment_time": "04:00:00", "commenter_fname": "Cathy", "commenter_lname": "Smith", "comment_length": 480}]}, {"id": "FDA-2020-D-1640", "agency": "FDA", "title": "Cannabidiol (CBD) Enforcement Policy; Draft Guidance for Industry; Availability", "update_date": "2020-11-25", "update_time": "13:43:21", "purpose": "Nonrulemaking", "keywords": ["2020-502", "ORA", "CVM", "CDER", "CFSAN", "Guidance for Industry", "Cannabidiol (CBD) Enforcement Policy", "OPEN"], "comments": [{"text": "Overview:Cannabidiol is widely used over the counter and is espoused to be a virtual miracle cure for many diverse ailments. Critical to the process of determining what is real and what is false in such regard is determining standardization of the substance. In addition, many preparations of OTC cannabidiol have been found to contain a variety of contaminants including significant percentages of delta-9-THC thus making such a preparation essentially a marijuana preparation. Specifically, The Draft Guidance on Cannabidiol addresses the recommended oral CBD solution to be 100mg/ml, and in addition recommends that such preparations contain no more than 0.10% THC. The guidance also outlines processes to assure the appropriate Botanical Raw Material as the source for the cannabidiol. This guidance will significantly move forward the availability and study of CBD in a controlled and scientific manner, rather than current widely variable environment that we exist in. I support the guidance as proposed as an expert in Pain Management and Addiction with approximately forty years experience with and expertise in marijuana and the use of related cannabinoids. ", "comment_id": "FDA-2020-D-1640-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0003", "comment_date": "2020-10-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1212}, {"text": "I am a Master of Public Health student with the Milken Institute School of Public Health at the George Washington University, and I am currently taking a course titled Prescription Drugs, Policy, and Public Health.  As such, this notice piqued my interest as I have begun to learn more about pharmaceuticals, the Food and Drug Administration (FDA) approval process, and more over the past several months. Given that the FDA approved cannabidiol use with Epidiolex a couple of years ago, the Draft Guidance on Cannabidiol seems to set clear expectations for the pharmaceutical and cannabidiol/marijuana industries and I believe that the FDA should proceed with taking the next steps to finalize the guidance.Cannabidiol can not only be found as an ingredient in a wide variety of cosmetics, especially lotions, creams, and balms, but also in teas, drink mixes, and more these days. Not only that, but a quick search of the internet can yield more recipes featuring cannabidiol than one could fathom, including recipes for salad dressing. That said, the FDAs own consumer-facing website clearly states that it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.1 It goes on to indicate that the FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason, and some CBD products are being marketed with unproven medical claims and are of unknown quality.1 This conflict between messaging from the FDA and available products and recipes online creates a potential safety hazard for the everyday consumer.With having a clear framework laid out in the draft guidance, the pharmaceutical and cannabidiol/marijuana industries should be able to apply for an in vivo bioequivalence study waiver more quickly, and therefore hopefully provide a safer, more regulated product to the public sooner. If cannabidiol were to become a more standardized product, it could be expected that the FDA and the public would be better able to track and report on adverse reactions or outcomes following its use, and therefore increase the safety for the public. Since Epidiolex is the only cannabidiol drug that has been approved for the treatment of seizures associated with multiple syndromes in minors,2 assuming other companies would be able to meet the bioequivalence requirements, this would allow for the development of other brand name drugs and generic drugs that would help ensure more patients in need can have better options. Given that minors and those with chronic conditions are populations that are being addressed with Epidiolex, this could also help pave the way for more equitable research on cannabidiol use in vulnerable populations, as they are often overlooked in pharmaceutical and research studies.Additionally, this seems, to me at least, like an excellent next step in greater collection of data for users of cannabidiol for research implications. A recognized strength, route, and dosage form of a 100 mg/mL oral solution (which limits tetrahydrocannabidiol concentrations), as laid out in the guidance, will enable uniformity in product delivery that will help researchers be able to have a uniform base level that may not be as easy to attain in unregulated cannabidiol products. The additional data that can be collected will only help strengthen the FDAs ability to help the pharmaceutical and cannabidiol/marijuana industries conduct research into the aforementioned unproven medical claims and address the unknown quality concerns. By finalizing the guidance, the FDA will not only play a key role in advancing science and research, but will also help let consumers know that they are using a regulated, consistent, and reliable product that has been approved by the FDA.References1. What You Need to Know (And What Were Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis 2. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms", "comment_id": "FDA-2020-D-1640-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0004", "comment_date": "2020-11-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4526}, {"text": "I have no background in public health or in food  drug efficacy and safety. But I do have an opinion. Specifically I think that President Trump is a liar, a crybaby and a sore loser.Georgia Secretary of State, a so-called Republican (RINO), wont let the people checking the ballots see the signatures for fraud. Why? Without this the whole process is very unfair and close to meaningless. Everyone knows that we won the state. - President TrumpFirst off as opposed to running campaigns, overseeing elections is a nonpartisan process. But President Trump only cares about loyalty, which means supporting him regardless of the facts. This is why he whines about Obama judges, angry Democrats and now RINOs.Second if the Trump campaign had a problem with ballot counting procedures, they should have brought this up months before the election. But now that theyve lost they want to change the rules.And last, only delusional MAGA morons think that Trump won the state. Everyone with a functioning brain knows that he lost not only Georgia but other must-win states including Pennsylvania, Michigan, Wisconsin, Nevada and Arizona.So listen up, Donnie. Youre a loser. You got crushed by 72 electoral votes and over 6 million popular votes. Youre fired, simp.", "comment_id": "FDA-2020-D-1640-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0005", "comment_date": "2020-11-23", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1364}]}, {"id": "DOT-OST-2006-24112", "agency": "DOT", "title": "Procedures for Transportation Workplace Drug and Alcohol Testing Programs:  Revision of Substance Abuse Professional Credential Requirement", "update_date": "2015-05-26", "update_time": "10:25:30", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I would like to say that I find it unfair that every other licensing board has had to have approval from all 50 states before being approved to do SAP work and there are concessions being made for MFTs. I think if the DOT is serious about having SAPs truly be the gatekeeper for public safety then they need to keep a high and consistent standard for every licensing board and not take shortcuts because of political expediency.   ", "comment_id": "DOT-OST-2006-24112-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2006-24112-0003", "comment_date": "2006-03-13", "comment_time": "05:00:00", "commenter_fname": "Rob", "commenter_lname": "Sullivan", "comment_length": 476}]}, {"id": "VA-2016-VHA-0003", "agency": "VA", "title": "AP35 - Proposed Rule - Copayments for Medications\nBeginning January 1, 2017", "update_date": "2018-07-11", "update_time": "01:04:02", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Thank you for allowing comment on AP35 - Id like to take a minute to dissect the new tiered prescription medication program that the VA has proposed to take effect January 1, 2017. I am against a tiered medication program. Tier 2 medication costs will not change from the $8.00/$9.00 cost, however 35% of medications will be put in this classification vs every medication currently prescribed (100%). Tier 3 Includes medications that retain patent protection and exclusivity and are not multi-source medications. 15% of medications utilized by veterans fit in this categoryThe result is an inadvertent penalty for veterans who are benefiting from the newer medications still under patent, the veterans who are sickest and have no other options for treating their medical conditions using the rational of name-brand/patented medications being more expensive outside of the VA. This is purely a cost-recovering measure for the VA at the expense of the veteran. The issue of raising costs on the effect of complianceRaising the co-payment may create a situation in which veterans pick and choose which medications they will fill based on $11.00 vs $5.00 rather than the blanket $8.00/9.00 currently charged. A veteran can get two Tier 1 medications filled for $10.00 vs. one Tier 3 for $11.00.Table 1 Table 1 is an example of yearly costs of tiered medications, current regulation, and potential annual savings. Again, we find that the veterans with no option other than patented, Tier 3 medications will pay twice plus the amount of copay per year than those who can be treated with Tier 1 medications. Typical User of Tier 1The VA states that the veterans saving the most through this new tiered program are those using Tier 1 generic medications. Referring again to Table 1, the typical user of Tier 1 medications will pay, by estimates, $150.00 per year at $5.00 per medication compared with the current $240.00 per year at $8.00 per medication. Let me tell you why I feel this is a cost comparison that is defraying another issue veterans have with the VA prescription service: At Walmart, a 90 day supply of selected generic prescriptions is $10.00. At the VA, a 90 day supply of Tier 1 generic is $15.00.  $20.00 difference per year for three Tier 1 medications is $60.00 more than patrons of Walmart. For two Tier 1 medications, it is a yearly cost of $40.00 more than Walmart patrons will pay. I find it hard to believe that the VA has less bargaining power with pharmaceutical companies than Walmart. I also find it hard to believe that Walmart appreciates its customers more than my country appreciates my military service. Thank you for allowing me to comment on an issue that will affect hundreds of thousands of veterans. ", "comment_id": "VA-2016-VHA-0003-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0005", "comment_date": "2016-02-25", "comment_time": "05:00:00", "commenter_fname": "Adrienne", "commenter_lname": "Esposito", "comment_length": 2923}, {"text": "comments enclosed. ", "comment_id": "VA-2016-VHA-0003-0009", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0009", "comment_date": "2016-03-07", "comment_time": "05:00:00", "commenter_fname": "Lorena", "commenter_lname": "Ferrara", "comment_length": 19}, {"text": "I have just read the proposed rule and I believe it to be fair and equitable, I like the tier levels to establish  the co-payments, how ever I do think there needs to be a pool of emergency funds that a Veteran can use each year if they are unable to afford their co-payment. It can be set up so they have a certain amount of times they could use this fund.  But I do believe that any Veteran that was in a war or conflict or has served over 20 years should be covered 100% no co-payments at all.", "comment_id": "VA-2016-VHA-0003-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0008", "comment_date": "2016-02-29", "comment_time": "05:00:00", "commenter_fname": "William", "commenter_lname": "Witham", "comment_length": 496}, {"text": "This looks like it will be a great way to help veterans have more affordable prescriptions while maximizing the quality of treatment they receive. However, I feel that in (b)(2)(i)(E) if 40% of veterans are experiencing hypertension, that hypertension medication be included in the service connected medications, and therefore exempt from payment.", "comment_id": "VA-2016-VHA-0003-0007", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0007", "comment_date": "2016-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 347}, {"text": "I think that this rule will help Veterans. My reasoning for this is because most medication you receive from the VA is generic medication. However, not all medication has a generic counterpart, therefore resulting in higher prescription costs. The new rule with the tiers will allow veterans to get the proper medication and not have high out of pocket costs. ", "comment_id": "VA-2016-VHA-0003-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0004", "comment_date": "2016-02-24", "comment_time": "05:00:00", "commenter_fname": "Jonathan", "commenter_lname": "Randall", "comment_length": 360}, {"text": "I am opposed to this rule because the VA is still expecting our veterans to pay more for their prescriptions medications than they would pay if purchasing them through a non VA pharmacy. It is time for us to be more generous to our veterans and live up to our duty to support them after they made an oath to give their life to defend our country. Lets offer them the same rate that they would receive in civilian pharmacies. ", "comment_id": "VA-2016-VHA-0003-0006", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0006", "comment_date": "2016-02-25", "comment_time": "05:00:00", "commenter_fname": "Tina", "commenter_lname": "Stockbridge", "comment_length": 430}, {"text": "BIO comments on Copayments for Medications Beginning January 1, 2017.", "comment_id": "VA-2016-VHA-0003-0010", "comment_url": "https://api.regulations.gov/v4/comments/VA-2016-VHA-0003-0010", "comment_date": "2016-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 81}]}, {"id": "SSA-2011-0035", "agency": "SSA", "title": "Agency Self-Evaluation Under Section 504 of the Rehabilitation Act of 1973", "update_date": "2016-09-27", "update_time": "01:01:59", "purpose": "Nonrulemaking", "keywords": ["Section 504", "Self-Evaluation", "Rehabilitation Act of 1973"], "comments": [{"text": "Letters from Social SEcurity to mentally disabled cllients shoud be in simple understandable English, not legalese.Their right to have an advocate should be clearly stated. A real telephone number (not a calling center), with  HUMAN being at the othere end should ber provideed.Obtuse regulations like the TRial Work Period should be adequately explained along with the necessary statutory authorization for such rules.", "comment_id": "SSA-2011-0035-0002", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2011-0035-0002", "comment_date": "2011-08-17", "comment_time": "04:00:00", "commenter_fname": "Ramon", "commenter_lname": "Joseph md", "comment_length": 429}, {"text": "The Disability Rights Education and Defense Fund (DREDF), founded in 1979, is a leading national cross-disability law and policy center that advances the civil and human rights of all people with disabilities through legal advocacy, training, education, and public policy and legislative development.  As an organization that protects the civil rights of individuals with disabilities in pursuit of benefits provided by SSA, we are aware that SSAs website is not fully accessible.  For example, SSA provides information about its online forms and publications, http://www.socialsecurity.gov/online/, and lists forms that can be submitted online, but does not separately list forms that are fillable, though some are.  SSA should provide all forms that are downloadable in fillable format and make it clear that the forms are available in this accessible format.  Notably, SSAs SSI application should be available online and in fillable format, like its application for social security benefits.  SSA has recently revamped its website and should take steps necessary to ensure that it meets accessibility requirements.  ", "comment_id": "SSA-2011-0035-0004", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2011-0035-0004", "comment_date": "2011-09-21", "comment_time": "04:00:00", "commenter_fname": "Larisa", "commenter_lname": "Cummings", "comment_length": 1139}, {"text": "As an independent federal agency committed to disability policy leadership since 1978, the National Council on Disability (NCD) is pleased to offer brief comments during the Social Security Section 504 Self-Evaluation. Participation in this opportunity is consistent with NCDs mission to be a trusted advisor to the President; Congress; federal entities, state, tribal, and local governments and community and private sector entities. NCD recognizes efforts that the Social Security Administration (SSA) has made to comply with Section 504 of the Rehabilitation Act of 1973 (Section 504), as amended. To continue positive steps under that law and promote nondiscriminatory practices in response to several areas of concerns highlighted by members of the public, NCD encourages SSA to include within its self-evaluation some actions that can be incorporated in SSAs strategic plan. At the same time, focus is needed on changing the fragmented nature of service and support delivery systems that also are plagues with uneven access for many people with disabilities. An earlier NCD report  highlights ongoing needs across federal agencies for program, service, support, and systems reform to address variables such as age, gender, ethnicity, disability category and use of federal programs. Reform efforts need to consider the countrys changing demographics, different eligibility criteria, rising need, and other diversity aspects of disability. In this vein and based on input from members of the public, three recommendations are offered to SSA during the Section 504 self-evaluation agency as follows.Recommendation 1: Developing Universal Standards. NCD suggests that SSA should give consideration to identifying and implementing steps that can lead to universal standards of conduct for application across all SSA locations. A thorough review of various SSA settlements, consent decrees, court orders and related complaint resolutions can be used as a starting point. Consideration ", "comment_id": "SSA-2011-0035-0008", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2011-0035-0008", "comment_date": "2011-11-17", "comment_time": "05:00:00", "commenter_fname": "Joan", "commenter_lname": "Durocher", "comment_length": 2066}]}, {"id": "FDA-2016-D-1273", "agency": "FDA", "title": "Osteoporosis:  Nonclinical Evaluation of Drugs Intended for Treatment", "update_date": "2019-10-23", "update_time": "10:31:23", "purpose": "Nonrulemaking", "keywords": ["2015-769", "Osteoporosis", "Nonclinical Evaluation of Drugs", "Intended for Treatment"], "comments": [{"text": "More information needs to occur on the role of nutrition in bone health. There should be less reliance on drugs and more on role of food that impacts the body. None of the drugs available have a positive impact on body. There are too many negative side effects.", "comment_id": "FDA-2016-D-1273-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-1273-0003", "comment_date": "2016-07-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 261}, {"text": "Radius Health, Inc. (Radius) is pleased to submit these comments in connection with the Food and Drug Administrations (FDAs) issuance of the draft guidance for industry entitled, Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment, released June 14, 2016.  ", "comment_id": "FDA-2016-D-1273-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-1273-0006", "comment_date": "2016-08-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 284}]}, {"id": "FDA-2010-P-0089", "agency": "FDA", "title": "Alter the Manner In Which the Agency Reviews Drug Approval Applications for & Regulates Nicotine Replacement Therapy Medications-CLOSED", "update_date": "2022-01-05", "update_time": "01:04:05", "purpose": "Nonrulemaking", "keywords": ["CDER", "tobacco", "medications", "regulates nicotine", "replacement therapy", "CLOSED"], "comments": [{"text": "As a nurse who has specialized in Tobacco Cessation Treatment for over 25 years, I implore the FDA to adopt all the provisions as stated in this petition.   All tobacco products contain nicotine which is unquestionably the most powerful of all addictions to overcome.   It is more difficult to control nicotine addiction than alcohol, heroin or cocaine.  The majority of tobacco users wish they could stop but do not have the tools to do so.   It is long overdue that the treatment of tobacco dependence and that the labeling on the NRT products reflect evidence based findings and recommendations.", "comment_id": "FDA-2010-P-0089-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0011", "comment_date": "2010-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 598}, {"text": "The use of medications such as nicotine replacement products is vital to helping millions of smokers quit.  As a primary care physician, I see the horrible consequences of smoking each and every day.  The proportion of smokers who use these medications to quit is woefully low.  There is a great deal of misinformation and misperception regarding them, and these are needless barriers.  Smokers should certainly have better access to life-saving medications (i.e. those that help people quit smoking) than the products that are killing them (tobacco).  Right now, you can buy a pack of Marlboros that carries minimal warnings as to how harmful it is in any convenience store, gas station, etc.  In order to get NRT, you need to usually go to a pharmacy, ask for them as they are often behind the counter, overpriced, and have warnings that are vastly out of proportion to the actual harms (consult your doctor if you have diabetes or ulcers for the gum/lozenge??? - who thought of that?).  Tobacco smoke contains HIGH levels of nictoine along with 4000 known txoins.  NRT contains low-dose nicotine in its safest form - with all products tested and available for 20 years in the general public.  Yet, it is harder to obrain these medications than cigarettes.  Something has to change.  Please meet your agencys mission and keep our citizens safe.", "comment_id": "FDA-2010-P-0089-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0007", "comment_date": "2010-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1351}, {"text": "To whom it may concern:As a member of ATTUD and a clinician who has been working in the trenches to help tobacco dependent patients quit, I would strongly urge you to follow through on the ATTUD/SNRT Citizen Petition, to lower barriers on NRT, so we can help more tobacco users successfully quit.Chris Kotsen, PsyD, CTTSProgram Manager, Tobacco QuitcenterSteeplechase Cancer CenterSomerset Medical CenterSomerville, NJ", "comment_id": "FDA-2010-P-0089-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0009", "comment_date": "2010-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 458}, {"text": "I  think the  nicotine  replacment therapy should  be  readily  avaliable in all  convient store  that  sell  tobacco  and I  support  the  efforts in getting this  done.", "comment_id": "FDA-2010-P-0089-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0006", "comment_date": "2010-03-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 170}, {"text": "Please do as New York State Health Commissioner Richard Daines asked through a petition to the FDA two years ago and make nicotine replacement therapy more readily available and encourage more quit attempts. Recently the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) submitted similar petitions. This petition allows FDA-approved over-the-counter NRT products (i.e. nicotine gums, patches and lozenges) to be sold in all stores that sell cigarettes. This petition also allows NRT products to be competitively priced with cigarettes and/or sold in less expensive daily dose units. It changes the labeling on NRT products to inform consumers of the health benefits of NRT compared to cigarettes/other tobacco products. When these changes are made the FDA will increase the percentage of tobacco users who successfully quit as well as move users beyond contemplation of quitting to their first real quit attempt.", "comment_id": "FDA-2010-P-0089-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0008", "comment_date": "2010-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 991}, {"text": "I agree with all statements of the ATTUD-SRNT petition.  Access to these products will be greatly increased with smaller trial size packages.  And combination therapy with muliple NRT therapies should be promoted, as it has been shown to be one of the mosst effective means to quit.", "comment_id": "FDA-2010-P-0089-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0010", "comment_date": "2010-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 282}, {"text": "I disagree with the section listed below:Availability of NRT at Retail Stores: NRT should be available as widely as possible . The FDA should explicitly remove any restrictions that discourage the sale of NRT at non-pharmacy retail locations ; NRT should be widely available at retail establishments, including all stores wherecigarettes are sold .I am a pharmacist and I treat many patients with tobbaco dependence. One of the reasons for treatment failure is improper use of NRT products. By removing the education compopnent from the use of the medication, will increase failure rates with NRT. By allowing NRT to be sold with tobacco products, smokers will no longer believe that these products are medictions to treat tobacco dependence and assume that it is just another form of tobacco. I would like to suggest that pharmacies continue to have NRT products with the option of the pharmacy keeping the products behind the counter, to encourage counseling of the product and discourage misuse by adolescents.Ideally, pharmacies should not sell tobacco products.", "comment_id": "FDA-2010-P-0089-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0012", "comment_date": "2010-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1128}]}, {"id": "HHSIG-2014-0002", "agency": "HHSIG", "title": "Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities", "update_date": "2021-10-16", "update_time": "01:00:53", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Please see uploaded file for Greater New York Hospital Association comments to OIG-403-P2: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector Generals Exclusions Authorities. Thank you for conisdering our comments.  ", "comment_id": "HHSIG-2014-0002-0014", "comment_url": "https://api.regulations.gov/v4/comments/HHSIG-2014-0002-0014", "comment_date": "2014-07-09", "comment_time": "04:00:00", "commenter_fname": "Brittany", "commenter_lname": "Allison", "comment_length": 267}, {"text": "PhRMA Comments ", "comment_id": "HHSIG-2014-0002-0019", "comment_url": "https://api.regulations.gov/v4/comments/HHSIG-2014-0002-0019", "comment_date": "2014-07-09", "comment_time": "04:00:00", "commenter_fname": "Lauren", "commenter_lname": "Roth", "comment_length": 15}, {"text": "See comments below.", "comment_id": "HHSIG-2014-0002-0003", "comment_url": "https://api.regulations.gov/v4/comments/HHSIG-2014-0002-0003", "comment_date": "2014-07-08", "comment_time": "04:00:00", "commenter_fname": "Wendy", "commenter_lname": "Krasner", "comment_length": 19}]}, {"id": "FDA-2010-D-0026", "agency": "FDA", "title": "Assessment of Abuse Potential of Drugs", "update_date": "2022-01-05", "update_time": "01:04:03", "purpose": "Nonrulemaking", "keywords": ["CDER", "2016-69", "Assessment of Abuse Potential of Drugs"], "comments": [{"text": "You all are the worst - yall are making the world suffer and causing people to commit suicide because of pain that goes untreated because you all insist of causing torment across the country due to 2% of problem users. I hope our families disown you all for you actions against our most vulnerable. Yall all no better than terrorist who pray on the weak. Punks. Im an inventor for our countrys citizens and I wish you all would wake up and start making rational, logical decisions. Dont punish pain, punish yourselves for the torment youve all caused to our most vulnerable Citizens. ", "comment_id": "FDA-2010-D-0026-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0031", "comment_date": "2020-06-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 624}, {"text": "The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to provide comments on the above-noted draft guidance.  PhRMA is a voluntary, non-profit trade organization representing the firms that discover, develop and produce prescription drugs and biologic products. In 2009, Americas pharmaceutical research and biotechnology companies invested $65.3 billion in the research and development of new life-changing medicines. PhRMA-member companies alone invested over $45 billion in research and development leading to new cures.  PhRMA appreciates FDAs efforts in drafting guidance for assessment of abuse potential of drugs.  This is a constructive step and will assist sponsors who are developing drugs and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act.The new draft guidance provides information on submitting an abuse potential assessment, including a proposal for scheduling and information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling.A PhRMA team with experience in abuse liability management was assembled and has reviewed the draft guidance and is pleased to take this opportunity to provide comments. Our intention is to assist the FDA in developing guidance that clearly outlines current expectations for assessing new medicines for abuse liability potential.  We believe the current draft guidance can be enhanced with additional details which help to address the complexities associated with this topic.  PhRMA believes that differing approaches to assessing drug abuse potential are appropriate given the variety of molecules (large and small) and pharmacological classes (known abuse; no known abuse; novel mechanism of action) which exist.", "comment_id": "FDA-2010-D-0026-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0011", "comment_date": "2010-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1949}, {"text": "Comments of The College on Problems of Drug Dependence (CPDD), submitted by Patrick M. Beardsley, Ph.D., on behalf of Linda Porrino, Ph.D., President of CPDD.", "comment_id": "FDA-2010-D-0026-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0005", "comment_date": "2010-03-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 158}, {"text": "This file contains our comments on the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs.", "comment_id": "FDA-2010-D-0026-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0018", "comment_date": "2010-03-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 109}, {"text": "Comments on the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs from Pinney Associates", "comment_id": "FDA-2010-D-0026-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0006", "comment_date": "2010-03-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 108}, {"text": "Let people make their own decisions, this is the job of us the citizenry, leave us alone and let us treat ourselves for the problems we have, not the FDA or DEA. its our lives, and we should have all choices available to us (even diamorphine). We need to follow  Portugal. we are failing our country by controlling people who are suffering. its cruel and unusual punishment. Im an inventor and want the best for our country and that starts by people making their own decisions, not have anouther human or organization make it for us. People are dying because of how you treat our country. ", "comment_id": "FDA-2010-D-0026-0032", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0032", "comment_date": "2020-06-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 614}, {"text": "My name is Dr. Elan Cohen and I work at a research site in the US where I am a PI. We conduct Human Abuse Liability / Potential (HAL/P) studies and I wanted to ask a few questions about our work on these clinical trials from someone in the FDA who reviews / approves these trials. Please, how do I talk or have an email exchange from someone at the FDA who reviews drugs using the Assessment of Abuse Potential of Drugs Guidance or who approves/reviews HAL/P studies? My email is ecohen@hritrials.com and my cell is 267-981-8911. My questions are not about reporting any maleficent behavior; just questions about the conduct of such trials. Thank you for any help you can provide in having such an FDA personnel contact me. Elan Cohen  ", "comment_id": "FDA-2010-D-0026-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0033", "comment_date": "2021-07-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 736}]}, {"id": "DEA-2023-0168", "agency": "DEA", "title": "Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I (DEA1156)", "update_date": "2024-02-12", "update_time": "10:28:38", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I do not support putting psychedelics in schedulenone classification. These drugs are powerfully healing for many people and need to be studied", "comment_id": "DEA-2023-0168-0042", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0042", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Kim", "commenter_lname": "Erickson", "comment_length": 143}, {"text": "Placing these compounds under Schedule I severely limits the ability of dedicated researches to research both these compounds and the serotonin system of the brain in general.  Scheduling compounds with largely no street presence, being already covered under the analogue act when used for human consumption, is a grave mistake. ", "comment_id": "DEA-2023-0168-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0039", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 329}, {"text": "Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I is a criminal act; a continuation of chronic long-term governmental abuse on ALL communities and families. In a Nation where war is the main GNP, it is imperative for the government to provide damage control to those who serve and to the family members and relatives of those who have. Every individual in our communities are left to clean up and tolerate the what and how these persons returning present.  These psychological messes have ended up in our streets since Reagan deinstitutionalized them and then we later jailed them. SHOW OUR COUNTRY YOU CARE ABOUT THE PEOPLE IN IT", "comment_id": "DEA-2023-0168-0046", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0046", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Thomas", "commenter_lname": "Miles", "comment_length": 694}, {"text": "These substances should not be schedule 1", "comment_id": "DEA-2023-0168-0056", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0056", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Andrew", "commenter_lname": "Luistro", "comment_length": 41}, {"text": "The above proposition is unscientific and shortsighted proposition on absolutely every level of analysis.  I am a medicinal chemist and a pharmacology Ph.D. student currently working on anti-Parkinsons drug development.  One of the compounds I am investigating as an anti-Parkinsons medication is in the same class of drugs as these compounds.  DOI, as Im sure the DEA is well aware, is THE standard serotonin 2A radioligand and a critical tool in serotonin pharmacology and in neuroimaging research more broadly. The field of neuroscience and the field of medicine both would not be where they are without DOI. A quick Google Scholar search yields 2,500 papers with the search term 2,5-dimethoxy 4-iodo amphetamine. It could not be more clear that the DEA does not care at all about science, research, or the development of drugs that can help ease the disease burden and concomitant suffering of the human race. These two drugs have almost zero recreational users, partially because their durations are intolerably long, their potency is great, and more enjoyable recreation drugs that are more easily available already exist. I, and I believe the DEA secretly agrees, do not expect either DOC or DOI to become drugs of abuse on any scale that matters, now or in the future. This move, rather, seems explicitly designed to impair basic scientific research rather than prevent some perceived illicit drug threat. These drugs (as I am also sure the DEA is aware) are also already covered under the Federal Analogue Act as analogues of 2C-B/Mescaline/and DOM.  There are already illegal for human consumption. How much more is the DEA willing to set back medicine, neuroscience, pharmacology, psychiatry, mental health treatment, veterans treatment, and basic sanity?  As far as I can tell this is the DEA showing their true colors; a vestigial and reactive church to puritanical prohibitionism, operating with absolutely no basis in science, fact, or rational discourse, willing to throw away the lives of fellow Americans, and the lives of others around the world by hampering the advancement of the medical sciences, all for the delusion that drug prohibition keeps society healthy. The scientific community can and will fight this proposal, and we can and will win.  ", "comment_id": "DEA-2023-0168-0101", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0101", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2297}, {"text": "DOi and DOc pose NO public health threat, and furthermore are incredibly important chemicals in neuroscientific research. Recreational use of these drugs is incredibly rare, and the research value certainly outweighs the threat they pose. Listen to the researchers, listen to the people who came forward in June July and August. Im disgusted that my government continues to act in such a foolish manner. Everyone that is involved in this effort to criminalize research should be ashamed of themselves.", "comment_id": "DEA-2023-0168-0082", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0082", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 508}, {"text": "We Americans no longer believe you make drugs illegal because you care about us or our well-being. I can legally buy most of the most dangerous neurotoxins in this country. If i did so, it would be legal and nobody would card unless i gave them to someone. You make molecules illegal when people WANT to take them, not because these molecules are dangerous. We never voted for the existence of the DEA, so please stop being tyrants and stop classifying molecules with your scheduling system ", "comment_id": "DEA-2023-0168-0074", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0074", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Robert", "commenter_lname": "Cassady", "comment_length": 501}, {"text": "NO I dont approve of this", "comment_id": "DEA-2023-0168-0064", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0064", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "John", "commenter_lname": "Rath", "comment_length": 30}, {"text": "These chemicals show the movement through the brain to track neurological pathways because they are slightly radioactive.  Chemists that are trying to unlock the secrets of the brain using these molecules and not a single reported death in 75 plus years since their creation has been found.  The United States public made a bunch of comments about this last year and is now brought up again is insulting to the people of this great nation.  A concerned citizen", "comment_id": "DEA-2023-0168-0072", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0072", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Jonathan", "commenter_lname": "Ross", "comment_length": 470}, {"text": "Despite what the DEA docket says, 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) are rarely drugs of abuse. The open sale of these novel psychoactive amphetamines is extremely rare, and the amount of overdose deaths from these agents in recent memory is zero. The main result of scheduling these novel psychoactives would be wasted time. Given the increased interest in medical research involving drugs with similar pharmacological method of action, such as 4-hydroxy-n,n-dimethyl-tryptamine (Psilocin), the chilling effect on scheduling these two drugs (and thus their structural analogs) would have on constructing novel medical drugs and reevaluating older substances previously only conceived of as recreational drugs for medical efficacy would be tremendous, and a massive setback to medical research in psychiatry and neurology.Since the previous motion in 2022 also failed, I imagine public opinion has not changed much. Thus, this is a waste at best and a disingenuous attempt to force something to happen at worst.", "comment_id": "DEA-2023-0168-0078", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0168-0078", "comment_date": "2024-01-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1090}]}, {"id": "FDA-2013-P-1711", "agency": "FDA", "title": "Refrain From Submitting the Stated Recommendation to HHS to Reclassify Hydrocodone Combination Products That Contain Hydrocodone Bitartrate in a Strength That is Lower Than 5 mg in Strength Into Schedule II", "update_date": "2017-03-21", "update_time": "09:22:03", "purpose": "Nonrulemaking", "keywords": ["cder", "citizen petition", "2013-10552", "open", "hydrocodone bitartrate", "5 mg", "7.5 mg", "10 mg", "Schedule II"], "comments": [{"text": "I represent The Hawaii academy of Physician Assistants, a constituent organization of the AAPA.  We work in a state where PAs are not yet authorized to prescribe Schedule II medications. The Drug Enforcement Administrations (DEAs) proposal (Docket No. DEA-389. ) to reclassify hydrocodone combination products from Schedule III to Schedule II will affect us and the patients we serve. If implemented, the proposed rule will restrict PAs from prescribing hydrocodone combination productions in states where they do not yet have prescribing authority for Schedule II drugs. Reclassifying the medications will impose additional burdens on all patients who need these medications to manage severe pain.We are opposed to this change and request that hydrocodone not be reclassified as a Schedule II drug.Fielding Mercer, PA-CPresidentHawaii Academy of Physician Assistants", "comment_id": "FDA-2013-P-1711-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-1711-0004", "comment_date": "2017-03-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 928}]}, {"id": "IRS-2021-0016", "agency": "IRS", "title": "Prescription Drug and Health Care Spending (REG-117575-21)", "update_date": "2023-01-05", "update_time": "11:26:22", "purpose": "Rulemaking", "keywords": ["password"], "comments": [{"text": "Transparency is always great- especially in a system as convoluted as the current health care system!", "comment_id": "IRS-2021-0016-0005", "comment_url": "https://api.regulations.gov/v4/comments/IRS-2021-0016-0005", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 101}, {"text": "Many employer groups (whether self-insured or fully-insured) may not have access to the information below in order to provide this to the Department of HHS, Labor and Treasury:1.  The 50 most frequently dispensed brand prescription drugs;2.  The 50 costliest prescription drugs by total annual spending;3.  The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year;4.  Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; For this reason, we strongly encourage the Departments of Labor, HHS and Treasury to include language in the final rule which stipulates that the employer groups pharmacy benefits manager (PBM) and third party administrators (TPAs) must provide this information directly to their clients fee free - whether they are an employer group or health plan administrator - so that their clients and health plans may report it directly to the HHS. Treasury and Labor in order to remain compliant each year.  Absent this requirement, many employer groups (ours, for example), may not have this information and our PBMs and TPAs may charge us exorbitant fees to obtain it, which we may not have the funds to pay, the mechanism to do so under our existing PBM and TPA contracts, and if we do then the costs may be passed on to plan members in the form of higher premiums for those of us who are self insured.  ", "comment_id": "IRS-2021-0016-0003", "comment_url": "https://api.regulations.gov/v4/comments/IRS-2021-0016-0003", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1579}, {"text": "Hello, I am a University of Virginia Batten student studying public policy. I am writing this public comment in support of the proposed rule to implement temporary transparency laws for group health plans and health insurance issuers. Making sure these health care providers report prescription drug spending will ensure that prescription drug prices will be lower. According to a study by Kaiser Family Foundation, nearly 25% of Americans who take prescription drugs struggle to afford their medication. Low-income families especially need to have lower medication prices to ensure that they do not have to make the impossible choice between food for their family or medication. Healthcare transparency is also important because it forces health care providers and professionals to take responsibility for their actions. With increased transparency and responsibility, these health care professionals are more likely to provide better care for their patients. Once patients know more about their health care themselves, they are also able to learn more about the medical and health care systems. This increased knowledge can also, hopefully, lead to better advocacy efforts on behalf of patients. If patients know more about their care, they are able to advocate for what they think may be best for their bodies along with medical advice. In conclusion, I support this proposed rule to increase transparency among group health plans and health insurance issuers. I appreciate the time set aside to read and consider this regulatory comment. ", "comment_id": "IRS-2021-0016-0004", "comment_url": "https://api.regulations.gov/v4/comments/IRS-2021-0016-0004", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Diana", "commenter_lname": "Gaiter", "comment_length": 1577}, {"text": "Drug prices have sky-rocketed across the United States, in turn increasing medical costs, premiums, and others. Several proposals focus on increasing visibility into how drug prices are set and decisions that lead to price increases; thus, potentially requiring drug companies to report price increases over a certain percentage and why that increase. Personally, I am in support of implementing transparency laws in order to ensure prescription drug prices are being regulated properly and efficiently.  One in ten brand drugs saw annual price increases of more than 20 percent (AHIP 2018). Additionally, from 2013-2017, 78% of drugs that saw a price increase were branded drugs (AHIP 2018).Generic prescription drugs during this period were also more likely to decrease in prices compared to branded prescription drugs (AHIP 2018). The IRS is issuing regulations that increase transparency by requiring group health plans and health insurance issuers in the group and individual markets to report information about prescription drugs and healthcare spending various departments. This regulation implements a reporting requirement for prescription drug costs and other medical expenses in order to better understand prescription drug pricing trends and impacts on premiums an out of pocket costs. Consumers could benefit from the reporting if plans and issuers are able to negotiate lower prescription drug prices. In turn, the reductions can result in a form of reduced premiums and out of pocket expenses. Transparency and lower drug prices not only hold companies accountable, but also can restore trust amongst patient in their healthcare providers. Lack of trust in the healthcare system is a large issue amongst minority communities. If patients trust that their healthcare providers are looking out for their best interests, they may be more likely to initiate or complete care and medications. Additionally, drug prices for medications are not provided through private insurers. Many Americans have private health insurance, so it is unclear the discrepancies they face. PBMs are well-intentioned but there are multiple negotiating prices with varying ranges of prices, thus there is little transparency in the supply chain about who gets what deal and how much of a deal another person receives. Oregon has implemented an Rx Drug Transparency that requires health plans to report the top 25 drugs responsible for the greatest increase in plan spending, top 25 most costly prescription drugs, as well as the top 25 most frequently prescribed drugs. The National Academy for State Health Policy (NASHP) proposed legislation includes minimizing reporting burden with a common data set for reporting across states, detailed reporting requirements across the entire supply chain; and strong penalties for pharmaceutical companies that fail to report or submit insufficient reports. This allows for a greater understanding regarding pharmaceutical drug price increases in addition to drug impacts on health insurance plans. Orphan drugs and specialty drugs will need to be evaluated differently due to reporting differences and higher prices from lower numbers of potential patients. Will transparency laws be effective and how large of a burden will they impose on pharmaceutical industry and regulatory agencies? Will transparency laws truly lower out of pocket costs and premiums? Overall, I support the proposed rule. There should be more studies should be done to determine the economic impact on various entities. I believe the transparency laws will allow for pharmaceutical companies, pharmacies, practices, and other businesses will provide clarity to patients in addition to reduced out of pocket costs. Additionally, the recordkeeping and reporting requirements will increase for plans and issuers subject to these regulations; such as developing, building and maintaining information technology systems to report the required data. So, it is important to take this into consideration when implementing such regulations and the economic impact on various companies. ", "comment_id": "IRS-2021-0016-0007", "comment_url": "https://api.regulations.gov/v4/comments/IRS-2021-0016-0007", "comment_date": "2021-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4106}, {"text": "Creating efficient and transparent record keeping initiatives around health care costs and expenses and the pharmaceutical industry are effective tools needed to mitigate excessive spending and drug cost within the health care market. These tools can offer new opportunities that would promote innovative responses to lowering medical and pharmaceutical drug costs for consumers while still administering high quality standards of care and fostering innovative pharmaceutical drug developments. Health care and pharmaceutical drug prices have been an ever-growing issue that many individuals would like to see policy changes to address the financial burden of seeking medical care coverage. The final rules included in the provisions of the Internal Revenue Code and the Public Health Service Act in part issued from the Consolidated Appropriations Act of 2021 will provide a new layer of record keeping for medical and pharmaceutical entities that will share information about prescription drugs and health care spending costs identical to that of group health plans and health insured individual coverages. These new rules will offer reporting on a multitude of categories, most notably on the 50 most frequently issued prescription drugs, as well as reporting on the 50 most costly prescription drugs given the timeframe of an entities yearly spending. The importance behind these new methods offers transparency within the health care market around both prescription drugs and health care spending, which will ultimately create new rules and regulations that will go as far as reporting the impact on premiums through rebates and fees supported by pharmaceutical companies. This level of record keeping is of high importance because it is necessary when trying to identify key problem areas within the health care and pharmaceutical industry that creates an overwhelming financial burden on the people of the United States. These efforts bolster a larger initiative supported by President Joe Biden through a recent executive order that promotes competition within the United States economy in an effort enacted to fight industry concentration and market power abuse by preventing industry specific monopolies. This move will not only aid in policy changes but will help identify key areas of excessive pricing within the pharmaceutical industry further creating transparency in a free market with the goal of lowering consumer costs of health care and prescription drugs. These rules and regulations will also bolster larger initiatives to lower cost when seeking pharmaceutical drugs and health care through the implementation of the new No Surprises Act. The No Surprises Act will provide new protections for individuals that receive medical care specifically from out of network providers through in network medical facilities as deemed through the consumers medical care provider. The new rules provide innovative approaches to making pharmaceutical drugs and seeking medical care more accessible and affordable while promoting competition in the marketplace and fueling innovative research in pharmaceutical drug development. The new reporting and record keeping structures will also allow for a deeper understanding of where medical and pharmaceutical drug cost accrue to better help target key problem areas to provide additional benefits and support when seeking care. By allowing for more transparency on how costs are accumulated and accounted for within the medical industry, policymakers and consumers will be granted information needed to better understand medical cost to avoid surprise billing, as well as mitigating the risk of avoiding needed medical care due to excessive spending. The newly implemented reporting structures through the Consolidated Appropriations Act also allow for deeper accountability from medical care providers and pharmaceutical drug manufacturers when creating prices for medical care and pharmaceutical drug cost by openly reporting on cost line items that allow for consumers to make more informed decisions based on spending data.", "comment_id": "IRS-2021-0016-0006", "comment_url": "https://api.regulations.gov/v4/comments/IRS-2021-0016-0006", "comment_date": "2021-12-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4188}]}, {"id": "FNS-2011-0008", "agency": "FNS", "title": "SNAP: Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation and Energy Act of 2008", "update_date": "2022-04-12", "update_time": "01:00:43", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "In regards to 273.11How should the DAA return a prorated share of the benefit to the client?  This question is two-fold:  The regulations do not require that DAAs be a SNAP retailer, they can also be authorized as a treatment facility by other means.  Indiana currently has a DAA who is authorized as a treatment facility but is not a SNAP retailer, they therefore do not have a way to debit a daily amount, nor to credit the individual with any amount upon leaving the facility.  In any case, how would a return of benefits be issued via an EBT transaction? The SNAP recipient would not be returning merchandise as one may do at a grocery store or other retailer.  How would this be processed as a credit to the individuals EBT account? Has FNS considered only allowing a prorate share to be deducted each day?  This seems to be a more effective way of managing, particularly with DAAs who are quick to withdraw all of the benefits at once.  The state agencies can set their own requirements for how this process should be carried out, however, State Agencies are not always notified when an agency is designated by FNS as a DAA.  The notification form from FNS contains information telling the DAA they can withdraw all of the funds at once from the EBT account.  (iv) If the household has already left the DAA treatment center, and as a result the treatment center is unable to refund the benefits in accordance with this paragraph, the DAA treatment center.....must effect the refund from the treatment centers bank account to the households EBT account within 5 days  How is this to occur? How would money be transferred from an agencys bank account to a clients EBT account?  What action is taken if the agency does not comply with this requirement?  How is the client refunded their SNAP benefit if the agency does not comply? Will the benefit be replaced and will FNS pursue a return of the benefit from the agency? Since the state agency, per the regulation,  the state must ensure that the EBT design or procedures for DAAs prohibit the DAA from obtaining more than one half of the households allotment prior to the 16th of the month.  Shouldnt then, the instructions for how to carry out the DAA process with state clients, be delivered by the state, and not by FNS?  It has been noted that FNS is providing info to facilities designated by FNS as DAAs. that they may debit a maximum of one months benefits, below is copied from such an FNS letter:oA maximum of 1 months benefits may be debited from a clients Electronic Benefit Transfer (EBT) card at any given time, regardless of the clients benefit balance. The center is not entitled to more than a single months food stamp benefit. The Food and Nutrition Service and the State SNAP agency will monitor EBT transaction history at your facility and you may be required to provide inventory records substantiating food purchases made with SNAP benefits. [SNAP regulations at 273.11(e)(5)(ii)(A)  (B)]", "comment_id": "FNS-2011-0008-0128", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0128", "comment_date": "2017-04-04", "comment_time": "04:00:00", "commenter_fname": "Suzanne", "commenter_lname": "Tryan", "comment_length": 3142}, {"text": "On behalf of Heartland Alliance, offering comments on UDSAs proposed SNAP regulation...", "comment_id": "FNS-2011-0008-0009", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0009", "comment_date": "2011-06-29", "comment_time": "04:00:00", "commenter_fname": "Gina", "commenter_lname": "Guillemette", "comment_length": 92}, {"text": "The USDAs proposed regulations to reform the asset limit test of the Supplemental Nutrition Assistance Program are strong and much appreciated. We worked with CFED to include these changes in the 2008 legislation and are glad to see the regulations published.  Excluding tax-preferred retirement accounts and education savings accounts from the SNAP asset limit test enables families that currently or could receive SNAP benefits to save and build wealth for the future and improve their financial security.In addition to releasing these rules, the USDA should swiftly release detailed guidance for implementing these new regulations so that state agencies and caseworkers may properly identify all tax-preferred retirement accounts and education savings accounts and avoid improperly denying eligible individuals or households.Thank you for helping low-income households become banked and build wealth.Sincerely, Evelyn Njoroge", "comment_id": "FNS-2011-0008-0060", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0060", "comment_date": "2011-07-05", "comment_time": "04:00:00", "commenter_fname": "Evelyn", "commenter_lname": "Njoroge", "comment_length": 933}, {"text": "in Massachusetts).Thank you for the opportunity to comment. Please contact Larry Goolsby at (202) 682-0100 ext. 239, lgoolsby@aphsa.org, with any questions.Tracy L. WareingKathie WrightExecutive Director, APHSAPresident, AASD ", "comment_id": "FNS-2011-0008-0067", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0067", "comment_date": "2011-07-06", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Goolsby", "comment_length": 386}, {"text": "I was awarded $16 a month in food stamps, just what can you purchase with .50 a day in food stamps?Why is there not a minimum of say $50 a month?How do I find out what whom or who is/are entitled to? As in a listed scale, other than the monthly income base that is on the back of the award letter.Thank you. ", "comment_id": "FNS-2011-0008-0002", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0002", "comment_date": "2011-06-21", "comment_time": "04:00:00", "commenter_fname": "Keith", "commenter_lname": "Angelety", "comment_length": 348}, {"text": "The federal government needs to raise the asset limit on all benefit program for the disabled including food stamps, SSI, ssdi AND medicaid, medicare to $5,700.  We need to be able to have savings and afford basic needs to 5000,7000. Many people with disabilties can only work part time and that is not enough to afford rent and basic needs to live indepently. It is hard.  Just getting a section 8 voucher is tough. Its a struggle for us to make ends meet on section 8 alone. ", "comment_id": "FNS-2011-0008-0023", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0023", "comment_date": "2011-07-05", "comment_time": "04:00:00", "commenter_fname": "Nicole", "commenter_lname": "Leblnac", "comment_length": 477}, {"text": "The USDAs proposed regulations to reform the asset limit test of the Supplemental Nutrition Assistance Program are strong and much appreciated. We worked with CFED to include these changes in the 2008 legislation and are glad to see the regulations published.  Excluding tax-preferred retirement accounts and education savings accounts from the SNAP asset limit test enables families that currently or could receive SNAP benefits to save and build wealth for the future and improve their financial security.In addition to releasing these rules, the USDA should swiftly release detailed guidance for implementing these new regulations so that state agencies and caseworkers may properly identify all tax-preferred retirement accounts and education savings accounts and avoid improperly denying eligible individuals or households.Thank you for helping low-income households become banked and build wealth.Sincerely,Nuria Y. Ortiz Vargas, Esq.", "comment_id": "FNS-2011-0008-0043", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0043", "comment_date": "2011-07-05", "comment_time": "04:00:00", "commenter_fname": "Nuria", "commenter_lname": "Ortiz-vargas", "comment_length": 980}, {"text": "July 5, 2011Lizbeth SilbermannDirectorProgram Development DivisionFood and Nutrition Service3101 Park Center Drive, Room 810Alexandria, VA 22302Dear Ms. Silbermann:Following are comments from the American Public Human Services Association in response to the proposed rule of May 4, 2011, Supplemental Nutrition Assistance Program: Eligibility, Certification, and Employment and Training Provisions. The rule would implement provisions of the Food, Conservation and Energy Act of 2008 (FCEA, the farm bill) affecting certain portions of the Supplemental Nutrition Assistance Program.Income Exclusions and Deductions: Eliminating the Cap on Dependent Care Expenses, Section 4103We have particular concerns with the allowance of transportation costs for dependent care. We agree with the allowance in principle, but believe that the great variety of possible arrangements opens the door to errors, and requires an unwarranted amount of effort by the worker.Rather than requiring states to calculate actual transportation costs on an individual basis, FNS should establish a standard amount that states may use if they choose. Alternatively, FNS could allow states to develop their own transportation standards, with FNS approval of the amount, but in either case allow states to mandate use of the standard. As with utility standards, uniform use of a standard is simple, quick, and holds little risk for error.States should be allowed to use actual expenses if they prefer, but the regulation should specify that no verification of costs is required. Rather, documentation of client-declared costs should be sufficient to establish the amount of allowance, unless verification is needed because the amount is questionable.  States should also be allowed to use a variety of activity fees.   State Options from the FCEA: Expansion of Simplified Reporting, Section 4105   Certain states have established broad-based categorical eligibility that uses higher asset limits for th", "comment_id": "FNS-2011-0008-0065", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0065", "comment_date": "2011-07-06", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Goolsby", "comment_length": 2116}, {"text": "PROVERBS 15-16    838   Proverb of SolomonKing JamesAmplified16:3  Committ:  thy works unto the Lord, and thy thoughts shall be established. 1h. I have a complaint against:  information in Title: Revised Medical Criteria for Evaluating Mental Disorders (886P) DENIAL OF ASSOCIATED ADMINI STRATION JUDGE FOLEY. In addition to direct payments to the care provider, we propose to permit households to deduct other out-of-pocket costs that are part of the total cost of dependent care incurred by SNAP households and necessary for the household to participate in or maintain the care arrange ment. The following types of dependent care expenses would be deductible under this proposal:Transportation costs to and from the care facility; Activity fees associated with structured care programs. Only those expenses that are separately identified, necessary to participate in the care arrangement, and not already paid by another source on behalf of the household would be deductible. Under current SNAP regulations at Sec.  273.2(f)(2) and Sec.  273.2(f)(3), State agencies may require households to verify any dependent careexpenses and must verify any questionable information.Parents Advocates J.L.S. Advocates2DCA-05-6151,Thank you for contacting the Attorney Generals Office regarding I filed a Complaint with A. S. Weiner 1a-1b-1c-1d-1e-1f-1g. Our staff will process it as soon as possible and, if nece ssary, respond appropriately. We appreciate hearing from concerned citizens such as yourself. If you wish to keep abreast of the activities of this office, you may wish to consider a subscription to our electroniThe advocate has a duty to use legal procedure for the fullest benefit of the clients cause, but also a duty not to abuse legal procedure. The law, both procedural and substantive, establishes the limits within which an advocate may proceed. However, the law is not always clear and never is static. Accordingly, in determining", "comment_id": "FNS-2011-0008-0039", "comment_url": "https://api.regulations.gov/v4/comments/FNS-2011-0008-0039", "comment_date": "2011-07-05", "comment_time": "04:00:00", "commenter_fname": "Lewis", "commenter_lname": "Scott", "comment_length": 2054}]}, {"id": "DEA-2020-0018", "agency": "DEA", "title": "Schedules of Controlled Substances: Exempt Anabolic Steroid Products", "update_date": "2021-12-02", "update_time": "01:00:57", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "A proposed rule in congress currently is the Schedules of Controlled Substances: Exempt Anabolic Steroid Products, which discusses the proposal to take esterified estrogens and methyltestosterone out of the schedule III-controlled substances. In 1990, congress passed the Anabolic Steroids Control Act which defined anabolic steroids as any drug or hormonal substance that promotes muscle growth in a manner pharmacologically similar to testosterone, including specified substances (Congress.gov, n.d.). According to the Mayo Clinic, esterified estrogens and methyltestosterone combined tablets are used as hormonal replacement for menopausal women (Mayo Clinic, 2020). The Mayo Clinic (2020) states that this medication helps women who are experiencing symptoms such as hot flashes, dryness, and itching in the vagina. The proposal states that there are substances with similar active substances that were exempted from controlled substances. Furthermore, reporting documents did not find recent evidence that there is abuse of the substances esterified estrogen and methyltestosterone (DEA, 2020). The substances are avoided for those trying to gain muscle because of the estrogen components, which cause negative symptoms, such as retaining water. Therefore, those who are abusing steroids will most likely not use esterified estrogens and methyltestosterone. From the information provided by the DEA in the proposal, I agree that esterified estrogens and methyltestosterone should be exempt from the controlled substances schedule III. Providers should be aware of prescribing patients with it and the possibility of abuse. However, most likely, menopausal women are using the esterified estrogen and methyltestosterone 0.625/1.25 mg or 1.25/2.5mg tablets. Therefore, esterified estrogens and methyltestosterone should not be controlled substances. ReferencesCongress.gov. (n.d.). H.R.4658-Anabolic steroids control act of 1990. https://www.congress.gov/bill/101st-congress/house-bill/4658 DEA. (2020). Schedules of controlled substances: Exempt anabolic steroid products. https://www.regulations.gov/document?D=DEA-2020-0018-0001 Mayo Clinic. (2020). Esterified estrogens and methyltestosterone (oral route). https://www.mayoclinic.org/drugs-supplements/esterified-estrogens-and-methyltestosterone-oral-route/description/drg-20073253 ", "comment_id": "DEA-2020-0018-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0018-0002", "comment_date": "2020-08-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2478}]}, {"id": "TTB-2016-0002", "agency": "TTB", "title": "Establishment of the Willcox Viticultural Area ", "update_date": "2016-09-12", "update_time": "11:33:55", "purpose": "Rulemaking", "keywords": ["alcohol", "wine", "American viticultural areas", "viticultural areas", "Arizona", "Cochise County", "Graham County", "Willcox"], "comments": [{"text": "I am writing in opposition to the establishment of an American Viticulture Area in the foothills of the Chiricahua Mountains, Arizona. An AVA is not in the benefit of the rural community in this area.The Chiricahua foothills have historically been cattle ranches, and the community wants to see it stay that way. Established agriculturalists in the area are not in favor of the current vineyards, and a designation for an AVA makes the area more desirable for other vineyards to establish.The Chiricahua Foothills area is desirable for vineyards because we still have unregulated ground water. Vintners come here for the resources but dont participate in the local community. This is not a new NAPA. Current vineyard owners are trying to grab surface water rights that were allocated in the 1800s, and are being met with great resistance.Vintners disregard local agriculture as well. They are opposed to historical range management practices local ranches have used for generations. This limits the tools ranchers can utilize to sustain the ecosystem. Vineyards fragment the open space that ranches provide, disrupt the watershed and block wildlife patterns. Ranchers work with the local Natural Resource Conservation Districts, the Natural Resource Conservation Service and the Farm Service Agency to prevent these things. Establishment of vineyards within the community counteracts these efforts. In addition to the ecological concerns, established vineyards in the Chiricahua Foothills bring economic concerns with them as well. These vineyard owners are retirees from high paying jobs. Their deep pockets allow them to subsidize their hobby vineyards, most of which are not sustainable economically. They therefore do not benefit the community economically.Well paid, technically trained employees are imported. Non-technical work is done by seasonal workers who are not from the immediate area either. Local contractors who have been employed by these vineyards in the past are wary of working for vineyard owners, due to unpaid bills.While wine tastings bring tourists, vineyards have tasting rooms in towns like Bisbee and Willcox, but do not bring money into the rural area where grapes are actually grown. In summary: I am strongly opposed to the establishment of an American Viticulture Area in the Chiricahua Foothills area. We are unhappy with the current vineyards and the ecological and economic hassles they bring with them. They are not a benefit to the rural community, and I do not support any decision that would make this area more appealing to other grape growers.", "comment_id": "TTB-2016-0002-0005", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0002-0005", "comment_date": "2016-02-29", "comment_time": "05:00:00", "commenter_fname": "Clay", "commenter_lname": "Riggs", "comment_length": 2630}, {"text": "As a resident in the proposed AVA region for over 15 years, I fully support the formation of the Willcox AVA. It is exciting to see the growth of the wine industry; vineyards; tasting rooms;  in the area and the official recognition of Willcox will be a great boon to this region.  It will provide much needed jobs for our citizens and a over all boost to our economy in this state.  This has been long over due and I am glad to see it come in our region.  As a widow and senior citizen it is vital to our economy to  generate revenue for our county and state.  Water and soil are unique; as are the climate.  These things contribute to wines that are truly different from those made anywhere else.", "comment_id": "TTB-2016-0002-0004", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2016-0002-0004", "comment_date": "2016-02-18", "comment_time": "05:00:00", "commenter_fname": "Narita", "commenter_lname": "Siegel", "comment_length": 698}]}, {"id": "DEA-2020-0029", "agency": "DEA", "title": "Registering Emergency Medical Services Agencies under the Protecting Patient Access to Emergency Medications Act of 2017", "update_date": "2023-01-05", "update_time": "11:22:06", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "1304.27 (a) Each emergency medical services agency registered pursuant to 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record:The use of the word dose should be heavily re-considered. EMS units often will administer multiple doses of a drug to a patient. For example, 25mcg of Fentanyl to a geriatric to ensure that they tolerate it well, before administering a second 25mcg dose.The use of the word dose could make each emergency run require multiple logs for controlled substance administration, adding significantly to the paperwork burden, while creating unseen incentives that impact how often paramedics administer medications that are clinically indicated. For example, as mentioned above, perhaps the paramedic will be incentivized to administer the full 100mcg vial of Fentanyl to the patient because they want to see the patients pain controlled, but do not want to make 4 duplicative records for each 25mcg administration. Now, the patient receives the 100mcg and the patient suffers a side effect of vomiting and respiratory depression. The paperwork burden of healthcare is already high enough. The use of the word dose should be removed, and record requirements should be based on the type of controlled substance per ambulance run. Redundancy as required by the word dose will negatively impact patient care without any significant impact to reducing diversion. I.E. if the paramedic has a standing order to administer up to 200mcg of Fentanyl for pain in doses of 25mcg-100mcg, and they administer 3 doses of 50mcg and wasted 50mcg. They should be required to create ONE record that indicates that they administered 150mcg of Fentanyl and wasted 50mcg. Not three to four duplicative records.1304.27 (a) (2) Finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);This provision should receive extra consideration. Is the intent to create duplicative records when a patient requires more than one unit dose (container/vial) of a medication? At times medications come in a variety of concentrations due to shortages. At times, patients require more than one unit dose (or container/vial) of the medication during the course of EMS treatment. Does tracking the finished form of each administration lend more positive impact on preventing diversion than it costs in paperwork burden? Im inclined to say that it does not.Again, as noted above in comments on dose this provision should be removed. 1304.27 (a) (7) Initials of the medical director or authorizing medical professional issuing the standing or verbal order;This provision should be altered as it will create a significant burden on both the EMS agency and medical professional. In relation to verbal orders under some medical control systems are from a physician that is located at a central location, or other location that the EMS unit will not be physically present at. To physically or electronically track down the medical professional giving the order, is impractical and problematic. In relation to standing orders, the medical professional has already signed the order. While a review of the controlled substance administration may be appropriate, a requirement that the medical director initial each administration record is problematic and redundant, as again, this medical director is infrequently physically present in the course of the duties of the paramedic who followed the standing order and administered the controlled substance. The purpose of standing orders is to allow the paramedic to follow the orders without the physical or verbal presence of the medical professional. Tracking an individual down after delivering a patient to the hospital or other location (as is starting to be allowed by billing practices and Medicare) negates the benefit of standing orders to patients and EMS systems who will now have to exert significant effort to obtain two to three letters on paper.Implementing this rule as written will cause undue burden on the EMS system and medical professionals overseeing them, and will be especially problematic in super rural, and highly busy urban systems; Possibly causing racial disparities in who actually receives these medications in times of need.I recommend that you replace this provision with a requirement that the paramedic document the name of the medical professional providing the standing or verbal order, with the last name being sufficient.", "comment_id": "DEA-2020-0029-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0007", "comment_date": "2020-10-08", "comment_time": "04:00:00", "commenter_fname": "Eric", "commenter_lname": "Wanta", "comment_length": 4951}, {"text": "EMS personnel should be required to report and be monitored on their use (patient administration) of scheduled medications to a registry board (much like Prescription Drug Monitoring Program) in hopes to minimize over use (administration) of medications. At this education level (medic) the overall whole person is not considered in patient care. Sadly, in my experience (from a medical perspective), medics tend to medicate and over medicate just for a smooth ride so to say. ", "comment_id": "DEA-2020-0029-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0006", "comment_date": "2020-10-08", "comment_time": "04:00:00", "commenter_fname": "G", "commenter_lname": "Caruso-hill", "comment_length": 497}, {"text": "How do these regulations impact those medical directors that are overseeing multiple agencies within their EMS System, such as in Illinois?  Illinois utilizes EMS Systems in which an agency must be a part of, according to the Illinois EMS Act.  The rules only state agency and does not seem to fit into the way EMS is ran in Illinois where there are multiple agencies in one system.    ", "comment_id": "DEA-2020-0029-0027", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0027", "comment_date": "2020-11-25", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 434}, {"text": "Regarding the security of controlled substances, the first option in proposed 1301.80(b)(1) would allow for an EMS agency to store controlled substances in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. This storage component must be located at a secured location, as stated in proposed 1301.80(i).  The second option in proposed 1301.80(b)(2) would allow an EMS agency to store controlled substances in an automated dispensing system (ADS) machine, under specific conditions.Under, WV state law (Policy Number: 4.12-082013), ALS providers may have medication stored in the ambulance jump bag. However the jump bag must be secured using a device such as a tamper detectable plastic lock. The bag must be stored in a secured locked location on the ambulance or in the Agency Station. ALS providers or the Registrants designated personnel (Power of Attorney as described above) must be in control of the bag at all times when not locked in a secure location.It appears that the proposed rule would eliminate the possibility of storing controlled substances in a jump bag in order for the EMS personnel to have quick access in an emergency situation.", "comment_id": "DEA-2020-0029-0026", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0026", "comment_date": "2020-11-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1283}, {"text": "Section (G)(1) related to standing orders: In Pennsylvania standing orders (statewide protocols) are issues by the Pennsylvania Department of Health. EMS Agency Medical Directors are not permitted to issue their own standing orders (protocols), nor are they permitted to alter a statewide protocol, except as may be permitted within a specific protocol.Section (G)(1), as currently drafted, creates a conflict with Pennsylvania EMS statute and regulation. The Pennsylvania Emergency Health Services Council, who is the Pennsylvania Department of Healths advisory board on EMS related matters, recommends consideration of the following amended language:Section (G)(1)Standing orders that are developed by a state authority may be issued and adopted by the medical director of an EMS Agency [OR BE AUTOMATICALLY ISSUED AND ADOPTED WHEN REQUIRED BY STATE STATUE OR REGULATION.]  Under the Act and proposed regulations, only the medical director of an EMS agency [OR STATE AUTHORITY] is given authority to issue and adopt a standing order In our opinion, the recommended language change would not diminish the effectiveness of the proposed regulations with regard to authority, accountability or security.", "comment_id": "DEA-2020-0029-0042", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0042", "comment_date": "2020-12-03", "comment_time": "05:00:00", "commenter_fname": "Donald", "commenter_lname": "Potter", "comment_length": 1275}, {"text": "1304.27(a) states that, any EMS personnel who disposes of or administers controlled substances to a patient in the course of providing emergency medical care must record the name of the controlled substance(s) and detailed information about the circumstances surrounding the administration of the controlled substance(s) (e.g., name of the substance, date dispensed, identification of the patient)... While sensible in theory, in reality EMS work is often chaotic with back-to-back calls and many distractions between patients, as in the case of a car wreck with multiple victims, or a mass casualty event such as a mass shooting or other accident. In such instances, it may be nearly impossible for an individual to collect and retain such detailed information as the names of those who are administered critical care involving controlled substances, beyond the timeframe of the event, to be recorded properly.  What protections will be put in place for EMS workers who are unable to provide this information due to extenuating circumstances, or who make mistakes in their record keeping after a mass casualty type event? ", "comment_id": "DEA-2020-0029-0036", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0036", "comment_date": "2020-12-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1230}, {"text": "1) Section 1300.06(b)(14)  Definition of StationhouseThe proposed definition of stationhouse will work well for some EMS systems and poorly for others. Particularly, many EMS systems will likely need to designate locations where EMS vehicles, equipment or personnel are housed understanding that such locations may or may not actually house vehicles inside. This is particularly true in urban systems that use central supply facilities, air ambulance bases and other arrangements where vehicles are not permanently housed or stored indoors. As such we recommend the following change to the definition:Stationhouse means an enclosed structure that houses one or more emergency medical services agency vehicles, equipment or personnel within a State in which that emergency medical services agency is registered, and that is actively and primarily being used for emergency response by that emergency medical services agency. (2) Section 1301.20 - Ability of an emergency medical services agency to register  We appreciate the statutory and regulatory changes that clarify that an EMS organization may register directly with the DEA. We believe this approach removes historic ambiguity where the agency registration may have been combined or confused with the registration of an individual physician or physicians. As such, we strongly support the ability of an EMS agency to be held accountable for compliance with these regulations separate from physicians who legally authorize the administration of controlled substances by standing or verbal order. We would further discourage the DEA from making any changes that obscure or diminish the ability of the EMS agency to develop and implement policies and procedures to comply with these regulations including but not limited to review or approval by third parties.  (3) Section 1304.27 - Additional recordkeeping requirements applicable to emergency medical services agencies.  The proposed rule would require the initials of the medical director or authorizing medical professional issuing the standing or verbal order in each record for each dose of controlled substances administered or disposed of in the course of providing emergency medical services.  As a practical matter, the standard electronic patient charts utilized for emergency medical services do not provide a means by which the medical director can initial the chart.  However, the National Emergency Medical Information System (NEMSIS) already includes as a data element in the record to indicate the standing order being utilized. For verbal orders, the name of the physician or authorizing medical professional is entered as well.  Accordingly, we urge the Attorney General to remove the requirement for the medical director or authorizing medical professional to provide initials in the record.  Instead, the final rule should simply require that the record specifically reference the standing order utilized to administered the controlled substance and the name of the medical director that issued the standing order.  For verbal orders, the record should specifically reference the name of medical director or authorizing medical professional that issued that particular verbal order for that particular patient. We further believe cross referencing a patient chart to the controlled substance log will add an additional level of accountability  (4) Allowance for security and chain of custody outside of a vehicle or building. The final rule should provide a section to recognize that day-to-day operational needs may require controlled substances be removed from a vehicle or station and kept with an accountable individual for some or all of a shift. This could include situations where providers are not assigned to an automobile and only have portable equipment, when temperatures prohibit safe storage in a vehicle, or when central supply stations issue a limited amount of controlled substances in a kit for use during their shift. We urge the Attorney General to recognize this practice exists and that the rule should require adequate security, chain of custody and inventory controls, much like those already in the proposed rule, for this practice when used.  ", "comment_id": "DEA-2020-0029-0056", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0056", "comment_date": "2020-12-07", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4299}, {"text": "1304.27 Additional record keeping requirements applicable to emergency medical services agencies.(a) Each emergency medical services agency registered pursuant to 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record: (7) Initials of the medical director or authorizing medical professional issuing the standing or verbal order;I respectfully request that item 7 is looked at for reconsideration. Many EMS agencies operate under very specific standing orders. A system that works very well for many obvious reasons. I do not believe that it is practical to obtain the initials of the medical director or authorizing medical professional for each dose.Thank you for your time and consideration. ", "comment_id": "DEA-2020-0029-0014", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0014", "comment_date": "2020-10-13", "comment_time": "04:00:00", "commenter_fname": "Darren", "commenter_lname": "Mooney", "comment_length": 1036}, {"text": "1304.03 Must have record keeping of the EMS personnel due to state laws having different requirements. (a) EMS personnel may not always return to the station house due to the fact that if an emergency response that is being acknowledged was done well they do not have to time to go back to restock their controlled substances. The Act allows EMS to receive controlled substance from a non hospital-base agency. This is important due to the fact that they are constantly receiving phone calls about an emergency that needs to be taken care of. 1301.80 (b) DEA wants to add more storage for EMS agencies so that they have more options of their controlled substances. EMS agencies require more options due to the fact that they never know what type of emergency theyre are responding to. They would be securely locked and safe so that no just anybody can break into the substances. The areas will be locations that are designated or registered. I, respectfully, ask for 1304.03 to be reconsidered since it makes sense why the EMS need their remote locations. They are the ones who try to keep people alive before getting to the hospital. ", "comment_id": "DEA-2020-0029-0018", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0018", "comment_date": "2020-10-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1165}, {"text": "As someone who worked as an EMT for quite some time, I support the 2017 act which allows EMTs and paramedics the ability to administer these controlled substances for primary two reasons. The first is that EMS personnel are expected to quickly and effectively respond to crisis  and for tens of millions of Americans annually, EMS personnel are the first point of healthcare treatment. As such, considering the need for EMS agencies to adequately treat medical conditions of huge variance, I am in support of these same agencies possessing the grounds to use medical tools and substances which help them treat the large spectrum of medical conditions encountered daily. Because of this, I find it especially important for the Attorney General to implement the Act to save for any uncertainty for emergency medical services agencies.", "comment_id": "DEA-2020-0029-0038", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0029-0038", "comment_date": "2020-12-03", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 839}]}, {"id": "EPA-HQ-UST-2010-0651", "agency": "EPA", "title": "Compatibility of Underground Storage Tank Systems with Biofuel Blends", "update_date": "2022-03-25", "update_time": "14:39:50", "purpose": "Nonrulemaking", "keywords": ["ethanol", "biodiesel", "underground storage tanks", "biofuel", "compatibility"], "comments": [{"text": "Fuel hoses as well as all dispensing equipment components, such as knozzles, valves and backflow preventers, should also undergo testing and inspection to ensure all seals, sufaces and product elements can withstand prolonged exposure to increased ethanol, and or bio diesel constituants.", "comment_id": "EPA-HQ-UST-2010-0651-0019", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-UST-2010-0651-0019", "comment_date": "2010-12-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 288}, {"text": "Submission of comment on Compatibility of Underground Storage Tank Systems With Biofuel Blends", "comment_id": "EPA-HQ-UST-2010-0651-0022", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-UST-2010-0651-0022", "comment_date": "2010-12-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 94}]}, {"id": "FDA-2015-D-2479", "agency": "FDA", "title": "Gastroparesis:  Clinical Evaluation of Drugs for Treatment", "update_date": "2019-10-22", "update_time": "12:26:03", "purpose": "Rulemaking", "keywords": ["cder", "2015-165", "Gastroparesis"], "comments": [{"text": "RE:  Docket No. FDA-2015-D-2479Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015Reference is made to the proposed Draft Guidance for Industry on Gastroparesis, published in the Federal Register notice referenced above. Ironwood Pharmaceuticals, Inc. is pleased and appreciative about the publication of this guidance document for development of drugs for gastroparesis and the opportunity to provide comments on this important guidance.", "comment_id": "FDA-2015-D-2479-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2479-0008", "comment_date": "2015-10-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 478}, {"text": "Hello,Please find our uploaded comments from the American Neurogastroenterology and Motility Society (non-profit) medical society.  I could not find under the list of categories one for Medical Societies, so chose Health Care Association if the definition of category is for our society the submitter.Thank you,", "comment_id": "FDA-2015-D-2479-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2479-0009", "comment_date": "2015-10-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 331}, {"text": "Comment from Vanda Pharmaceuticals, Inc. ", "comment_id": "FDA-2015-D-2479-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2479-0015", "comment_date": "2019-10-22", "comment_time": "04:00:00", "commenter_fname": "Vanda pharmaceuticals", "commenter_lname": "Carlin", "comment_length": 41}]}, {"id": "SSA-2009-0081", "agency": "SSA", "title": "Drug Addiction and Alcoholism", "update_date": "2015-10-23", "update_time": "01:00:47", "purpose": "Nonrulemaking", "keywords": ["Drug Addiction", "Alcoholism"], "comments": [{"text": "Honorable Ladies and Gentlemen:As an attorney regularly representing claimants in disability cases, it is my opinion that the laws and regulations as written are not being followed by a significant number of administrative law judges.  There appear to be a large percentage of ALJs and doctors who testify at hearings who will , because of mere references in the record to past D  A usage, either find that D  A is a material contributing factor or will be biased against the claimant in finding them capable of SGA.   This is decided without evidence that the D  A materially causes their current condition.These decision makers seem to be timid to find that someone with drug usage  in his or her record is disabled, almost regardless of what the diagnosis would be with abstension.  Sadly, persons with schizophrenia, bipolar disorder, and other mental conditions frequently have a history of D  A when trying to self-medicate.  Sometimes the doctors at the hearings will testify that a schizophrenics disability did not start until the date he proves he stopped using.  Obviously, if he or she is disabled now that he stopped using, he or she would have been disabled had he never used D  A.The bottom line is that there is an extreme bias against persons with D  A in their records.  The regulation should state that there should be no bias against the cliamant soley because of D  A in the record.  RECOMMENDATION:  A CLARIFICATION OF THE LAW SHOULD BE GIVEN IN WRITING BOTH TO THE DECISION MAKERS AND ALSO TO MEDICAL DOCTORS AIDING IN THE DECISION PROCESS.", "comment_id": "SSA-2009-0081-0063", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0063", "comment_date": "2010-04-02", "comment_time": "04:00:00", "commenter_fname": "Randall", "commenter_lname": "Simmon", "comment_length": 1658}, {"text": "THIS HAD TO BE RESUBMITTED: As an attorney who represents disability claimants before the SSA, I would like to endorse the comments already made by NOSSCR in its submission to you on March 24, 2010. In addition I recommend that any comprehnsive policy adopted by the SSA, including any new regulations, include the insights reflected in the answers to questions 27 and 29 in the emergency teletype dated August 30, 1996, EM-96200. Wherever the burdens of proof or coming forward with the evidence are placed, there should be proof in the record that drug addiction or alcoholism is a contributing factor material to the finding of disabiliity. And the proof should be clear and convincing, rather than a mere preponderance (a standard which permits calls which are closer than the evidence can bear and which are often questionable, but protected from correction on appeal as substantial). An increased standard of proof in this particular will reflect the inherent difficulty projecting or reliably predicting (1) what limitations would remain if the claimant stopped using drugs or alcohol or (2) how severe the remaining limitations would be. As the answer to question 29 notes, the answer is not automatic even when there is an actual period of abstinence. Questions of length, recency, and measurement remain. And the proof of the counterfactual (if the claimant were to stop, then . . .) is virtually impossible without research data upon which a prediction can be reliably placed. Most important, however, the requirement of clear and convincing evidence will protect the unrepresented claimant who is mentally impaired and unable to stop (and very great difficulty stopping or inability to stop is of course a characteristic of persons who are addicted and alcoholic). Most of those claimants will find the required proof to be beyond understanding, let alone a proof within the claimants ability.", "comment_id": "SSA-2009-0081-0079", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0079", "comment_date": "2010-04-05", "comment_time": "04:00:00", "commenter_fname": "John", "commenter_lname": "Ratcliff", "comment_length": 1930}, {"text": "There is a broad range of people with abuse problems from the casual user through the person who is surviving after rehab to the person who is addicted and actively abusing either alcohol or drugs.  You cant start denying benefits without undertaking a massive evaluation component that is beyond government ability.  Substance use is part of society and Substance abuse is quite simply a disease and should not make a person eligible for benefits.", "comment_id": "SSA-2009-0081-0024", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0024", "comment_date": "2010-03-17", "comment_time": "04:00:00", "commenter_fname": "Kris", "commenter_lname": "Prohl", "comment_length": 453}, {"text": "I am opposed to drug and alcohol abusers being eligible for Social Security benefits. They make their choice to abuse drugs and alcohol whereas people with actual disabilities have no choice. If the choice were to have a disability or not, a person with a disability would chose not to however, in the case of a bonafide disability, there is no choice.", "comment_id": "SSA-2009-0081-0033", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0033", "comment_date": "2010-03-18", "comment_time": "04:00:00", "commenter_fname": "Candace", "commenter_lname": "Lauber", "comment_length": 352}, {"text": "I am a recovering addict who has a bipolar disorder and is currently working as a Peer Support Specialist through Community Mental Health.  I need to be very blatant about who I am and where Ive come from.  Im not ashamed anymore.  Ive been clean almost a decade.  I used marajuana constantly for about 15 years (only marajuana and yes, I was addicted).  Before I became addicted, I had 3 psych hospitalizations.  I never received an accurate diagnosis or treatment.  Marajuana worked for many years but I was isolated and alone and very depressed.  When I stopped using (I found my own bottom) I became manic and my life spiraled out of control.  I finally was diagnosed and entered into treatment for this bipolar disorder that still very much affects my life.  So I do feel uniquely qualified to speak to these issues.  I have been a sponsor to many and Ive been to alot of funerals.  I firmly believe that until an addict hits that place in his/her life (we call it the bottom) where the pain of addiction is bigger than the fear of stepping off into the unknown, everyone that tries to cushion the blow or give support is just extending the pain.  I dont think that anyone who is actively using should be on SSD.  Id go one further and say I dont think that anyone who is using should be receiving DHS money (but thats a whole other issue).  Theres no way to get an accurate psych diagnosis when drugs and alcohol are on board.  So what would be done about the doctors who so freely are handing out the opiates and benzos?  Now Im really asking for eutopia.I am now a Peer Support Specialist.  I believe its the best thing thats ever happened to mental health.  Flexible hours and the ability to take time off as needed.  To be able to look in someone eyes and say with confidence, Ive been there and there really is hope!  AMAZING!", "comment_id": "SSA-2009-0081-0040", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0040", "comment_date": "2010-03-22", "comment_time": "04:00:00", "commenter_fname": "Deb", "commenter_lname": "Chandler", "comment_length": 1942}, {"text": "I have worked with people with severe mental illness and various addictions for over 20 years. There is no question that addictions, like severe mental illness, is a brain-based set of disorders. Addictions is not chosen. It has the characteristic of many other disorders of being experienced as chronic, remitting and relapsing. As with many with severe mental illness, requiring a person to have a representative payee (person or agency that handles the Social Security benefits), may be in the best interests of the affected person. In both categories of disorders, the person may have considerable difficutly managing their financial affairs. For too many years, addictions have been regarded in society as a moral failure. It is, in fact, a disorder of the brain that affects many in our society. It is time Social Security recognizes that fact in determining eligibility for disability payments.", "comment_id": "SSA-2009-0081-0034", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0034", "comment_date": "2010-03-18", "comment_time": "04:00:00", "commenter_fname": "Jim", "commenter_lname": "Matthews", "comment_length": 911}, {"text": "In my experience, many individuals take illegal drugs in order to self medicate,to feel normal if you will. When diagnosed and on appropriate prescription medications, they no longer need illegal drugs. In additon, many have no health insurance to address thier mental helath needs and turn to illegal means to obtain relief fro the symptoms of their disease. So, the answer is not an easy one. A policy that restricts all drug users from benefits will capture this group who is underserved,  in so many ways, and deny them critical benefits that may save their lives. In our state, the route to SSA benefits is so cumbersome and lenghty that many poor individuals resort to drugs to deal with the daily frustrations of their economic reality. They cannot work, due to disabilities, but may have to wait many years for benefits.", "comment_id": "SSA-2009-0081-0038", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0038", "comment_date": "2010-03-22", "comment_time": "04:00:00", "commenter_fname": "Shell", "commenter_lname": "Bowne", "comment_length": 850}, {"text": "Dr. Gitlows comment raises the important point of evidence.  I suggest that one source of important evidence that can help separate out the effects of substance abuse would be the claimants limitations during times of Uninterrupted abstinence [capitalization for emphasis].  This analysis, in turn, raises two other points:(1) Has Uninterrupted abstinence been established?  Again, the burden should be on the claimant to establish Uninterrupted abstinence.(2) How long has the Uninterrupted abstinence been?  Medical experts suggest there must be a minimum time before the effects of the substance abuse can clear the claimants system.  (I have heard doctors give time frames from six months to a year.)Once it has been established that the claimant has been abstinent long enough to reveal the substrate of underlying limitations, it would probably be fairly easy to determine materiality.I believe adjudicators would appreciate some form of guidance on these matters.", "comment_id": "SSA-2009-0081-0007", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0007", "comment_date": "2010-02-17", "comment_time": "05:00:00", "commenter_fname": "Doug", "commenter_lname": "Morrisson", "comment_length": 1025}, {"text": "Comments from the Disability Law Center and the Greater Boston Legal Services, Boston, MA", "comment_id": "SSA-2009-0081-0066", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0066", "comment_date": "2010-04-02", "comment_time": "04:00:00", "commenter_fname": "Svetlana", "commenter_lname": "Uimenkova", "comment_length": 89}, {"text": "I have represented clients seeking Social Security disability benefits for 38 years.  I find that many clients with mental impairments are A and/or D users because they are seeking comfort for the mental impairments.  Many are so mentally impaired that they qualify for benefits in spite of the A and/or D use.I feel that any regulation regarding A  D should express the requirement that claims of these mental A and/or D claimants should be specifically  evaluated regarding the severity of the mental impairment prior to any denial upon reconsideration to see if disability benefits can be awarded in spite of A and/or D.", "comment_id": "SSA-2009-0081-0046", "comment_url": "https://api.regulations.gov/v4/comments/SSA-2009-0081-0046", "comment_date": "2010-03-26", "comment_time": "04:00:00", "commenter_fname": "Jim", "commenter_lname": "Grennan", "comment_length": 638}]}, {"id": "SAMHSA-2022-0002", "agency": "SAMHSA", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) (Revised)", "update_date": "2022-06-14", "update_time": "14:07:49", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Federal workers should absolutely be allowed use medical marijuana with a doctors recommendation just as they can use any other controlled substance with a valid prescription. The a huge portion of federal employees are disabled veterans and should be allowed to use medical marijuana if their doctor deems it an appropriate treatment.The War on Marijuana is an ridiculous and its even more ridiculous that the federal government is proposing this language, as congress is moving towards completely removing cannabis from the controlled substance list. Stop discriminating against federal employees as the majority of states allow medical marijuana and it general direction is towards recreational legalization.", "comment_id": "SAMHSA-2022-0002-0003", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0003", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 728}, {"text": "Medical cannabis is legal in 37 states, there are many doctors and medical professionals that realize the benefits of cannabis. The federal government is completely out of touch with the American people on the benefits of medical cannabis, and it should be up to a doctor and their patient on its use. I find it disturbing that the Federal government wants to continue the use of urinalysis on their employees, current or prospective, to detect cannabis use when it does not detect intoxication. Continuing to test current or prospective federal employees for cannabis use limits the applicant pool, and will force current employees to retire early, or move to the private sector rather than continue this policy.", "comment_id": "SAMHSA-2022-0002-0004", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0004", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "John", "commenter_lname": "Wurm", "comment_length": 753}, {"text": "Please find comments from the Substance Abuse Program Administrators Association on UrMG, File code 2022-0001.", "comment_id": "SAMHSA-2022-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0008", "comment_date": "2022-06-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 110}, {"text": "The only constitutional use of drug testing is to find impairment.  It should not be used as an extrajudicial fishing expedition to identify and punish workers who use godsend medicines of which politicians disapprove, many of which have inspired the creation of entire religions!!! To do so is an affront to religious freedom and a violation of the natural law upon which America was founded. Thats why Thomas Jefferson rolled in his grave when the DEA stomped onto Monticello and confiscated the garden-loving presidents poppy plants.  Stop betraying everything that America stands for: end indiscriminate drug testing. PS  Its also cruel and unusual punishment to remove an American from the workforce without so much as a trial. ", "comment_id": "SAMHSA-2022-0002-0016", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0016", "comment_date": "2022-06-14", "comment_time": "04:00:00", "commenter_fname": "Brian", "commenter_lname": "Quass", "comment_length": 748}, {"text": "Request for Public Comment - Docket ID SAMHSA-2022-0002Federal drug testing guidelines were established in the 80s, at the same time that the American War on Drugs hit fever pitch. Panic surrounding less expensive, easily available street drugs like crack cocaine lead to mass arrests of low-income Americans, while the wealthy were able to bring vials of more expensive powder cocaine with them to parties with far less consequences. As a result of the treatment of drug use since the 80s, thousands of Americans are incarcerated on drug charges and drug testing has become commonplace for pre-employment and routine employment screening. But in 2022, times have changed. Routine drug use includes prescription drugs and medical marijuana. In fact, recreational marijuana use is legal in several states and generally socially acceptable in most circles. We have lived through two and a half years of a pandemic in social isolation not without consequence to public health. Gun violence rates are climbing, domestic violence trends are up, and substance use is increasing. Is now the right time to introduce stricter drug testing?The proposed rule to update the federal mandatory drug testing guidelines appears, at first glance, only to clarify previously established procedures for oral fluid and urinary specimens. The executive summary only mentions annual publication of drug panels, revised definitions and processes for collection, and guidelines for report submissions. However, upon further review there are some unexpected non-administrative changes proposed. Most interestingly, the proposed rule hopes to publish the drug panel annually in the Federal Register with any revisions (additions or removals of illicit substances) without providing option for public notification and comment (per the Administrative Procedures Act). However, even though a drug has been removed from the published drug panel, the proposed rule provides any federal department the agency to continue to test for said drug whether due to reasonable suspicion or internal routine policy.  The given reason for this overreach is to improve effectiveness of drug testing programs, but it reads to me like a cheap way to enforce a power dynamic by choosing what to test for on the whim of whoever is managing testing that go-around.There are other proposed updates including use of biomarkers to verify human specimens and MRO judgment calls on illegal opiate use, but most notably there were strange proposals regarding what constitutes a drug test refusal. Section 1.7 of the established guidelines details every potential action that could result in a refusal, and the current proposal includes arriving late, leaving before the end of the waiting period after collection, and not washing your hands before giving your sample. In general, it feels like over policing federal employees. The individual is already providing a sample for testing based on an ambiguous drug panel, subject to biomarker testing to determine if its a human specimen, and still have the potential to fail the drug test for stepping out early to take a phone call? Most of the proposals cite overall cost savings either in terms of actual cash or time spent performing the tasks related to the regulations. But what, if any, are the benefits to the federal employees? During a time of uncertainty as we recover from COVID and transition to an endemic response, is it the best use of our energy to increase regulatory compliance with federal drug testing? The federal government is a stable employer that Americans have trusted for decades. Perhaps its time for the federal government to trust their employees.  The drug campaigns of the 80s through the early 2000s portrayed marijuana as a highly addictive drug, like crack cocaine, amphetamines, and opioids. Millions of Americans use marijuana recreationally today, even police officers and teachers. Its not an appropriate use of federal funds to spend time writing further restrictive regulations for mandatory testing, holding federal employees to a pristine standard, nor is it an appropriate use of their time when there are more important things to regulate, such as highly addictive prescription opioids. ", "comment_id": "SAMHSA-2022-0002-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0015", "comment_date": "2022-06-14", "comment_time": "04:00:00", "commenter_fname": "Hilde", "commenter_lname": "Mckee", "comment_length": 4406}, {"text": "I am very concerned about the following section;Therefore, the Department proposes to publish the drug testing panel in the Federal Register on an annual basis, including any revisions to the panel, without the need (perceived or otherwise) to undergo notification and comment. Should the Department remove a drug from the drug testing panel, a Federal agency may test specimens for that drug in accordance with Section 3.2 (i.e., on a case-by-case basis for reasonable suspicion or post accident testing, or routinely with a waiver from the Secretary). This process is expected to improve the effectiveness of Federal agency drug testing programs in support of the Federal Drug-Free Workplace Program. The drug testing panel in Section 3.4 of the final OFMG will remain in effect until the effective date of a newly published drug testing panel.These proposed changes would be a nightmare for collectors and employers.  While the intent may be practical scientifically, I do not feel this would be viable in real world situations.  If a drug is removed, DOT will have to follow suit.  What will happen with the paper CCFs when they are incorrect.  There was a total fiasco at the last update which required adding the oral fluid.  Laboratories, collection sites, and employers were not able to get the new CCFs resulting in a plethora of MFRs and cancelled tests.  Then a reversal of the requirement to use the new CCF was issued to try to minimize the damage.  While I know the eCCF would be immediately updated to reflect changes, rural collection sites and onsite collections are generally always performed using a paper CCF for practical reasons.If drugs are added or removed, policies will have to be changed, employers and employees notified and collectors educated.  While it is noble to think this can happen by publishing a yearly Federal Register, again this is not at all feasible in real time drug and alcohol testing programs. As a third party administrator and collection site supervisor, I am very aware how challenging and detrimental to drug and alcohol testing programs this proposed change would be.  Despite blanket coverage and communications from many sources, there are still ", "comment_id": "SAMHSA-2022-0002-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0014", "comment_date": "2022-06-14", "comment_time": "04:00:00", "commenter_fname": "Helen", "commenter_lname": "White", "comment_length": 2282}, {"text": "Under the Authorized Biomarker Testing Panel section. If the assumption is that approved endogenous biomarkers are used; as the determinative readout of a positive, false, false positive, false negative, and invalid test for cannabinoid use. Then the test and result alone would highlight a clear defining indicator that only show if an individual has a medical condition, preexisting and not, and would expose knowledge of the possibility of a medical condition an individual may have, regardless of if symptoms are exhibited, including treatments for and of any conditions that could also be associated with cannabinoids use. A test, if ever required. Should be conducted by the individuals personal doctor of choice specifically if any request is made by an employer. To protect and enshrine an individuals right of private medical information so that the possibility of discrimination against an individual for any conditions, preexisting conditions included, does not occur. The indicator of a test using endogenous biomarkers for cannabinoids would easily show as the perimeter, an indication of a medical condition if a positive, false, false positive, false negative, and invalid test are given and read. ", "comment_id": "SAMHSA-2022-0002-0005", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0005", "comment_date": "2022-04-19", "comment_time": "04:00:00", "commenter_fname": "Timothy", "commenter_lname": "Barrett", "comment_length": 1243}]}, {"id": "FDA-2012-N-0067", "agency": "FDA", "title": "Assessment of Analgesic Treatment of Chronic Pain; A Public Workshop", "update_date": "2013-08-30", "update_time": "00:31:02", "purpose": "Nonrulemaking", "keywords": ["cder2011204", "CDER", "Public Workshop", "Analgesic Treatment"], "comments": [{"text": "It is my understanding that the FDA is doing everything in its power to make it more difficult and complex for patients, who genuinely suffer from chronic, severe pain syndromes, to access opiod medications.  Having undergone a catastrophic ureteroscopy procedure, seven years ago, which resulted in the loss of my left kidney, permanent paralysis of my left flank muscles, chronic, severe nerve damage pain, and Stage 4 right kidney failure, I object to these actions by the FDA.  The abrupt onset of severe kidney failure, following my surgeons decision to remove my healthy left kidney, rather than repair my left ureter, has left me forever on the brink of requiring kidney dialysis.  There are no pain medications, apart from major opiods, that can adequately control the intense nerve pain I will suffer from, the rest of my life.  All other known pain medications (apart from Tylenol), will damage my already impaired right kidney, so are prohibited.  The obstacles that are already in place, for me to obtain my doses of Fentanyl patches are  extraordinary.  They include: my MD cannot phone in nor fax my prescription to the pharmacy, my MDs DEA number must be on all Fentanyl prescription documents, I must physically sign for the patches if I order them from a mail order pharmacy, and I must hand-deliver the Fentanyl prescription to pharmacy staff during pharmacy business hours, rather than at a time that is convenient for me.Having been a professional RN for more than two decades, I am keenly aware that Im not the only legitimate patient whose sole option for pain control involves major opiods.  I have taken care of hundreds of ill  injured persons whose kidneys and/or other medical conditions or medications, prevented them from using NSAIDS or minor narcotics for pain control, on a long-term basis.  It is cruel  unethical to make our health burdens more difficult than they already are.  I didnt ask to be in this situation, nor did any of my former patients!", "comment_id": "FDA-2012-N-0067-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0009", "comment_date": "2012-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2034}, {"text": "I think it is wrong to change the rules of my pain medications. I am pusshing 50 years old. I have and still do work very hard manual labor. I am a state certified plumbing contractor. That was in a very bad car accident back in 1980. I have been onPain management successfully for the past three years. Before this i could no longer do my job properly. I now can suport my family and be a successfully bisiness professional. If you take away my pain medication i will loose everything. It is not right to hurt everyone for the actions of a few bad seeds. Please do not mess with my medcation anymore. I already havd a hard time filling my legal percriptions. Please stop this madness and let me and my family live the life we diserve", "comment_id": "FDA-2012-N-0067-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0013", "comment_date": "2012-08-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 739}, {"text": "Opioid pain medications are an essential treatment option for acute and chronic pain. I know of many individuals with Ehler-Danlos Syndrome (EDS) who suffer daily from chronic pain and it would be of tremendous benefit to them if they could obtain these medications from their physician. ", "comment_id": "FDA-2012-N-0067-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0006", "comment_date": "2012-07-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 288}, {"text": "I respectfully request that any decisions to be be made limiting pain medication be decided by a jury of my peers meaning people who have chronic pain. I contracted MRSA in 2006 on top of Pagets disease and I worked in the concrete swimming pool industry for 25 years as a nozzleman doing shotcrete thus all my joints are destroyed by osteoarthritis with bone spurs thruout my body. Honestly I tell you that without pain medication I cannot get out of bed.It enables me to help care for my grandchildren so please please in the name of God leave the prescribing and care up to my doctor, he is an honorable man.My bone marrow is swollen inside my bones. You can imagine the pain this creates. Again please, please I dont have cancer but my pain is great. Thank you for considering me and my family.Sincerely, Roger K. Cummings 501 S. Mccall Rd. Englewood, Florida 34223 Phone 9416811747 God Bless You", "comment_id": "FDA-2012-N-0067-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0012", "comment_date": "2012-08-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 910}, {"text": "I been on pain management since 2008,and finally was considered disabled in aug of 2011, and I currently take oxycodone since being on pm,I take 6 a day,was 7 but due to the problems in florida pharmacies wouldnt allow anymore,Ive been without meds for a few days and i cant even get outta bed,but while taking my medications it allows me to somewhat function as a normal human,shower cook shop and such.. There isnt any other medication out there that will allow me to do those things as Ive tried,I cant imagine life without these, If you take these away you be hurting me and hundreds and thousands of people that depend on them for a better quality of life,and to take that away,would be cruelty as in cruelty to animals, no one deserves to suffer....The dea has played a huge role in are problem in florida,were lucky now to get are legal scripts,but not with out a huge crawl to find them,all your gonna do is force us pain patients to the streets to find a dealer for relief,an as we already are being treated like criminals they mite as well arrest us now,my back has hernated disks,bulging disks one hip bone larger then the other and just gonna get worse, please dont take a away the quality of life we all deserve...", "comment_id": "FDA-2012-N-0067-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0005", "comment_date": "2012-07-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1262}, {"text": "Docket No. FDA-2012-N-0067Representatives of The Steve Rummler Memorial Foundation attended the May 30-31 workshop on Assessment of Analgesic Treatment of Chronic Pain.  We told Steves story, a tragic part of the epidemic of prescription drug overdose deaths that is plaguing our country today.  This epidemic is fueled by the tremendous increase in prescriptions of opioids for pain.  15,000 deaths per year are proof that opioids are not safe or effective in the treatment of chronic pain.Steve was a loving son, fianc, brother, uncle, cousin, nephew and friend.  He was smart and excelled in school and in sports.  He was a gifted musician and successful financial advisor.  He loved his family and was loved in return.  We miss him terribly, and our lives will never be the same.Chronic pain, caused by an injury in 1996, changed Steves life.  He immediately sought help from many healthcare professionals.  No treatable diagnosis was found, and he was prescribed antidepressants, benzodiazepines, and in 2005 opioids.  He became addicted and went the Mayo Clinic in Rochester, MN and to Hazelden in Center City, MN.  Until the night of his death, Steve had never taken an opioid that had not been prescribed to him.  After his accidental death we found a note among his belongings, referring to his treatment with opioids that said: At first it was a lifeline; now it is a noose around my neck.The mission of The Steve Rummler Memorial Foundation (www.rummlerfoundation.org) is to heighten awareness of the dilemma of chronic pain and the disease of addiction and to improve the associated care process.  We support change and urge the FDA to:Correct the labeling of opioid drugs to indicate their use for short-term severe pain onlyCorrect the classification of hydrocodone products from Class III to Class IIPlease hear the pleas of the many who have lost loved ones to this epidemic.Judy Rummler, President of The Steve Rummler Memorial Foundation", "comment_id": "FDA-2012-N-0067-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0003", "comment_date": "2012-07-03", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2168}]}, {"id": "FDA-2017-P-6692", "agency": "FDA", "title": "Requests that the FDA issue a Final Order adding to Title 21, Section 310, Subpart E, of the Code of Federal Regulations (C.F.R.) a provision in the form of a negative monograph that adds marijuana and THC to the current list contained therein and described in an FDA document\ntitled, \"Guidance for Industry: Marketed Unapproved Drugs - Compliance Policy Guide; CLOSED", "update_date": "2019-11-13", "update_time": "16:44:01", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Drug Watch International,  Inc.", "adds marijuana", "and THC to the current list contained", "Guidance for Industry", "Marketed Unapproved Drugs", "Compliance Policy Guide", "published on September 19, 2011", "therein and described in an FDA document", "Title 21, Section 310, Subpart E", "Code of Federal Regulations", "CLOSED"], "comments": [{"text": "Dear decision makers,I am a 53 year old woman, and I believe that the prohibition of cannabis has been against the best interest of the United States. I would like to see cannabis RESCHEDULED so that we can do the research necessary to finally discover the medical benefits of this wonder plant, see criminal justice reform, which has disproportionally affected African Americans, and allow ADULTS to decide for themselves if they want to use it in a responsible way. Thank you for your consideration,Jennifer KeatsLexington, Kentucky ", "comment_id": "FDA-2017-P-6692-0081", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0081", "comment_date": "2018-11-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 555}, {"text": "Mr. Colemans citizens petitions ultimate goal is the safety of the American people. The petition requests the Food and Drug Administration (FDA) to explicitly order a negative monograph which places marijuana and THC on the current list of unapproved drugs. This is particularly significant because it is the responsibility of the FDA to protect its citizens. Numerous states have bought into the manufacturers advertisements and endorsements that marijuana is the miracle drug for all diseases. Sadly, many individuals with cancer and seizures, for instance, have abandoned appropriate drug therapies in exchange for medical marijuana because they believe it will cure them. As Mr. Coleman stated, there is insufficient research and evidence on the efficacy of medical marijuana. In addition, some studies have shown success, however, long-term research on the side effects of these drugs have not been conducted. While rounding with physicians in the emergency department,  we observed three cases where patients presented with uncontrollable abdominal pain, vomiting, and diarrhea. After assessing the patients cases, we observed an interesting commonality between all three; these patients had recently begun self-medicating with marijuana. The attending physician informed me that unusual patient cases were showing up in Americas ERs after these patients began self-medicating with the drug. Patients are very susceptible to the false advertisement, especially when it states there is a cure for a condition they have been suffering from on a daily basis. Unfortunately, we have a zero tolerance for pain mentality within our social circles. Since patients desire immediate relief, they will try to alleviate their plan regardless of associated health risks. This further exacerbates the need to seek quick relief. This is where the FDA comes into play. With medical marijuana being advertised heavily and with an increase in the number of states legalizing its use, the FDA must place heavy regulations on this drug to protect the US citizens. Colorado is a prime example of what can result from marijuana legalization before adequate regulations and research have taken place. It was noted that medical marijuana licenses increased substantially from 4,819 to 116,287 licenses within the span of six years.1 Such drastic increases meant that the increased availability of marijuana and its exposure result in the exacerbation of chronic health conditions.1 Colorados EDs were presented with increased visits for marijuana intoxication; 1 to 2 patients presented with cases of marijuana intoxication and 10 to 15 for marijuana-related illnesses.1 With the increase of marijuana legalizations, there is evidence of harmful public health effects on children.2  Caretakers do not perceive marijuana as a dangerous substance and improperly store marijuana. Therefore, they expose the child to the drug by leaving marijuana containing products within the childs reach.2 Emergency Departments in Colorado concluded the most affected population appears to be children ages 0 to 5, specifically after ingesting edible THC products.1 Similarly, The University of Colorado burn center reported a rise in the number of marijuana-related burns, some of which involve over 70 percent of patients body surface area.1  Burns occur during the extraction process from the plants. Since the blind legalizing of marijuana, Colorado has faced a surplus of adverse health outcomes. Nevertheless, it is important to note that proper conversions of marijuana have yet to be established. Appropriate conversion formulations become exceptionally significant when individuals are utilizing both marijuana and opioids. According to recent studies, it was demonstrated that there is only about a 17 percent accuracy rate in 75 different marijuana-based product labels.3 This is quite alarming considering that more legalizations are happening. Unless accurate conversion data is established, states must steer away from marijuana legalizations to protect overall public safety.ReferencesBecker, W. and Tetrault, J. (2016). Medical Marijuana in Patients Prescribed Opioids. Mayo Clinic Proceedings, 91(7), pp.830-832.Monte, A., Zane, R. and Heard, K. (2015). The Implications of Marijuana Legalization in Colorado. JAMA, [online] 313(3), p.241. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ [Accessed 15 May 2018].Wang, G., Heard, K. and Roosevelt, G. (2017). The Unintended Consequences of Marijuana Legalization. The Journal of Pediatrics, [online] 190, pp.12-13. Available at: https://www.jpeds.com/article/S0022-3476(17)31081-8/fulltext [Accessed 16 May 2018].", "comment_id": "FDA-2017-P-6692-0041", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0041", "comment_date": "2018-05-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4764}, {"text": "Medical Marjiuana.Please make medicinal marijuana available to specific diseases like epilepsy, autism, cancer, etc.  It promises such hope for many of these families having to give their children dangerous pharmaceuticals.", "comment_id": "FDA-2017-P-6692-0027", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0027", "comment_date": "2018-04-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 233}, {"text": "As a nurse and a social worker who has worked in healthcare for 30 years, I must tell you that marijuana is not our problem. I have never assisted one person in getting treatment for marijuana addiction, never assisted anyone as a nurse or a social worker who was very ill or highly intoxicated from marijuana. All of the people I have helped have had addiction to alcohol, heroin, meth and/or crack as well as prescription pills. Marijuana has actually helped people with depression and PTSD, it has helped people function in the world who would otherwise need prescription medication that almost always includes some type of side effect.  It needs to be fully legalized for people to sell it, grow it and use it. I am not saying that there wont be people who do take it to another level but those same people are going to drink alcohol or use other drugs.  This ridiculous prohibition needs to stop. I feel it wont however, since the FDA and/or our pharmaceutical companies will not make the millions of dollars that they do from prescription drugs. ", "comment_id": "FDA-2017-P-6692-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0020", "comment_date": "2018-04-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1062}, {"text": "Presumably, a negative monograph as described herein, would not apply to products containing marijuana, THC, or any other constituent part of the marijuana plant, sold as food, cosmetics, or beverages - unless unsupported medical claims also are made for their use.Well thanks for that Mr. John Coleman. But let me tell you the FDA is trying to shut down all cannabis foods and dietary constituents (which are not making medical claims) against the will of the American People.  ", "comment_id": "FDA-2017-P-6692-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0012", "comment_date": "2018-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 501}, {"text": "The the hypothetical harm feared by drug war proponents has not materialized under the limited trials in medical and subsequently recreational states.  As conventional science has very slowly embraced the opportunity to study this once wholly forbidden plant, we are discovering the broad potential tied to the natural receptor system, built into the human body triggered by these natural compounds.  Common sense shows the madness has not met with the hype. As my hippie father told me back in the 1980s, the only truly common sense approach would be to legalize and regulate/tax cannabis like tobacco or alcohol. In the states where this method is being tested, the public benefits are clearly apparent.  Abundant public funds are being applied to deficiencies resulting from the recession... Can we honestly evaluate cannabis impact on the economic recovery and burgeoning prosperity of our country? From the local level I can vouch for its reality.  Time to replicate the success in every locality willing to accept the benefits.", "comment_id": "FDA-2017-P-6692-0076", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0076", "comment_date": "2018-11-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1048}, {"text": "The hypocrisy of cigarettes and alcohol being legal, without any medicinal uses (both resulting in addiction, permanent damage to the body, and death). while marijuana is considered a controlled substance and a gateway drug to opiod addiction is insane. Marijuana has many medicinal effects, including; pain control, help with appetite  nausea, anxiety and sleep disturbances. Refusing the medicinal use of marijuana equates to patients needing to take multiple medications that can cause horrible side effects and permanent damage to the body, and death. How many deaths have been reported due to marijuana use? *NONE*.  How many overdoses have been reported due to marijuana? *NONE*. WHY is it illegal? Because Big Pharma, lumber and cotton lobbyists will lose profits. If you truly cared about the health and well-being of people, cigarettes and alcohol would be illegal and marijuana would be allowed to help with the symptoms of injuries and illnesses. It would actually help to reduce the opiod epidemic.By denying medicinal marijuana and allowing other damaging  addictive substances shows that you really dont care about the health and well-being of people, only how much $ you can profit from special interest groups. Shame on you ", "comment_id": "FDA-2017-P-6692-0079", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0079", "comment_date": "2018-11-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1280}, {"text": "Dr. Coleman is completely correct in re his opposition to Big Pharma and the FDA should place more restraints on their trafficking in dangerous drugs, drugs that are making their way to School age. Please restrain those drug traffickers.", "comment_id": "FDA-2017-P-6692-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0008", "comment_date": "2017-12-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 237}, {"text": "I implore you to please whole heartedly reconsider this reclassification of this drug. Please think about your kids and your family members. This is not a cure all. Please understand that we know that. But please understand that we are looking for a solution. We are looking to help our country in more ways than one. We are trying for our mental health. We are wanting the chance to be better.  We think that this cannabis plant could help our children live normal lives when prescription drugs made them lifeless and somber. Its helping people heal. People who fought to save us. Please reschedule the cannabis plant.", "comment_id": "FDA-2017-P-6692-0054", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0054", "comment_date": "2018-11-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 629}, {"text": "According to the DEA, schedule I drugs are substances or chemicals that are defined as drugs with no currently accepted medical use and a high potential for abuse. Currently, cannabis is listed as schedule I. It is known that no amount of cannabis has ever caused overdose in any individual. It is also relatively well known that CBD can have several therapeutic properties when used for certain ailments. While the debate about recreational marijuana legalization is still very much an open topic, the rescheduling of cannabis will allow for further study of the drug and its influences on human health and behavior. Cannabis is currently scheduled higher than the often fatal and addictive drug fentanyl. If cannabis is rescheduled, it will allow researchers to gather data in order for the public and the nation to make an informed decision about medical and recreational cannabis in the future. I firmly support the rescheduling of cannabis in order to perform necessary health research. ", "comment_id": "FDA-2017-P-6692-0063", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0063", "comment_date": "2018-11-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 992}]}, {"id": "DEA-2013-0010", "agency": "DEA", "title": "Schedules of Controlled Substances:  Placement of Tramadol into Schedule IV", "update_date": "2021-12-02", "update_time": "01:01:29", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The reason this drug is being prescribed more is because the doctors dont fear the DEA breathing down their neck with a non scheduled prescription. I suffer chronic pain and this drug works for me. I cant imagine it having any abuse potential as you dont get High on it as you would taking the traditional schedule II and III narcotics. It doesnt even compare to pentazocine (Talwin) Sch IV. There is too much regulation of useful drugs in this country. I dont need my doctors scared to prescribe tramadol for me. I have been on it in excess of 7 years. My dose has remained the same for those seven years, 2 50mg tabs tid. Its not like the other narcotics and Ive been on them all in the past at one time or another. If people want to try to get high off something they will. Something else will just fill in that gap. There seems to be a never ending story of scheduling drugs to what end. I live in Washington State, legal pot is available to me if I want it. I cant use marijuana as it makes me sick and I dont think it would help anyhow. Tramadol does help though,  I do not want to see any scheduling decisions that scare my doctors off from prescribing a perfectly safe, effective, non escalating dose, necessary drug that I need to function . I have AIDS and severe peripheral neuropathy I have been on every drug from hydrocodone, morphine, and fentanyl and more not to mention all the amitrytylines and neurontins that dont work and cause bad side effects such as ticks, metallic taste, etc. This is the first one I have landed on that did not carry any of those drugs problems. All of those in Schedule II and III caused problems and the doses had to be escalated to keep my pain under control not to mention the addiction from them. I have finally found a non scheduled opiod where I dont have to escalate the dose that works for my pain (Ive been on it over 7 years). Tramadol needs to remain  unscheduled. This is not the first time this has been proposed and it needs to be overturned again. ", "comment_id": "DEA-2013-0010-0012", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0012", "comment_date": "2013-12-02", "comment_time": "05:00:00", "commenter_fname": "Daniel", "commenter_lname": "Anonymous", "comment_length": 2067}, {"text": " Docket No. DEA-351The Drug Enforcement Administration (DEA) proposes to place the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including tramadol (the term isomers includes the optical and geometric isomers) into Schedule IV of the Controlled Substances Act (CSA).Ok, for the United States of America to meet  or help meet the standards of Our treaty obligations under The Psychotropic Substances Act of 1978 as amended by the Controlled Substances Act proper regulation of the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including Tramadol (the term isomers includes the optical and geometric isomers) must be placed  into Schedule IV of the Controlled Substances Act (CSA) or subjected to certain defined uses only. Current research shows the above named substance aka Tramadol to affect Public Health in the United States; the substance Tramadol has from research caused Death, Sickness along with affecting Commerce by not being regulated enough to prevent Serotonin syndrome along with other symptoms. I find it troubling that proper action has not already reflected a change in the regulation of Tramadol, however now is the time. So the question proposed is to place Tramadol into either Schedule IV or III of the CSA. If Tramadol was to be placed into Schedule III of the CSA then what could occur is non use of the substance, now since there are reports of the drug working for some for Restless leg syndrome placement into Schedule IV should be considered. Further it would also be unethical not to a placement into the CSA. This substance is nothing compared to substances listed in Schedule III of the CSA so I believe action to place the substance into Schedule IV or V is warranted. I must note that there are similar substances that can be used that are much safer than Tramadol and those other substances have listings in Schedule IV and Schedules III along with Schedule II of the CSA.Tramadol and its similar substances of this listings remind myself of Libby Zion. I believe that to prevent Death along with illness caused by Tramadol we must accept previous similar occurrences and only allow combinations of Tramadol so in effect Schedule III placement could occur. Further notation should be noted that Death and Illnesses from using Tramadol are very different than substances listed in Schedule III of the CSA. We cannot compare Tramadol to Hydrocodone. Hydrocodone is an Opioid and Tramadol is Psychotropic in nature and very similar if not the same as a SNRI.  CodificationSection was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.Change of NameSecretary of Health and Human Services substituted for Secretary of Health, Education, and Welfare in par. (3) pursuant to section 509(b) ofPub. L. 9688, which is classified to section 3508 (b) of Title 20, Education.Effective DateSection 112 of title I of Pub. L. 95633provided that: This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States. [The Convention entered into force in respect to the United States on July 15, 1980.]", "comment_id": "DEA-2013-0010-0020", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0020", "comment_date": "2013-12-12", "comment_time": "05:00:00", "commenter_fname": "Thomas", "commenter_lname": "Thompson", "comment_length": 4155}, {"text": "Speaking and acting within ALL, ALL INCLUSIVE, his capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as the respective SOLE, PRO BONO Estate Administrator (abbreviated as SOLE Est. Adm.) of the Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) AND Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), ALL INCLUSIVE: I WANT MY OFFICIAL, FULLY-UPDATED, FULLY-AUTHENTICATED, FULLY-AUTHORIZED, FULLY-EMPOWERED ET AL., ALL INCLUSIVE, U.S. ET AL., ALL INCLUSIVE, DOD, USCG, NOAA (i.e., National Oceanic and Atmospheric Administration), CIA (i.e., United States Central Intelligence Agency), USDOJ (i.e., United States Department of Justice), HHS (i.e., United States Department of Health and Human Services), ODNI (i.e., Office of the United States Director of National Intelligence) ET AL., ALL INCLUSIVE, COMMON ACCESS CARDS (respectively one set for the aforementioned Delois Albert Brassell Estate and the other set for the aforementioned Robert James Brassell Estate, for now, for more sets WILL BE TIMELY AND CORRECTLY forthcoming) NOW, INCLUSIVE. Ever since I acquired the respective EINs (between Winter 2002 and Winter/Spring 2004) for the respective Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) and Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), INCLUSIVE, among many various other Estates, INCLUSIVE, I was LEGALLY REQUIRED AND ENTITLED to be FORMALLY, CORRECTLY, TIMELY AND OTHERWISE ON-THE-RECORD informed of the precursors to ALL, ALL INCLUSIVE, such all-in-one smart cards, INCLUSIVE, so as to continue the work et al., ALL INCLUSIVE, said respective decedents were conducting, had established et al., ALL INCLUSIVE, among many various other affirmative-to-and-for-me matters, concerns et al., ALL INCLUSIVE. These, ALONG WITH MANY VARIOUS OTHER MATTERS, CONCERNS ET AL., ALL INCLUSIVE, WERE NOT FORTHCOMING, INCLUSIVE, i.e., IT DID NOT OCCUR, ALL INCLUSIVE. Said all-in-one smart cards, i.e., Common Access Cards, were, upon my additionally and correctly acquiring the respective New York State Surrogate Court (Suffolk County)-issued Certificates of Letters of Administration (a/k/a Certificates of Appointment) respectively for said Delois Albert Brassell Estate (Court Index Number 176A2004 (original court certificate number 17268), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Friday, March 26, 2004 onward) and said Robert James Brassell Estate (Court Index Number 177A2004 (original court certificate number 17269), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Thursday, March 18, 2004 onward), acquiring the respective D-U-N-S Numbers for each said and respective Estate AND FINALLY THE RESPECTIVE AND LONG-OVERDUE CAGE CODES (said Delois Albert Brassell Estates respective CAGE Code actively issued on Tuesday, September 8, 2009 and said Robert James Brassell Estates respective CAGE Code actively issued on Tuesday, September 10, 2010), ALL INCLUSIVE, REQUIRED TO BE TIMELY, OFFICIALLY, CORRECTLY, ON-THE-RECORD ET AL., ALL INCLUSIVE, TURNED OVER TO ME FIRST AND FOREMOST AS THE SOLE EST. ADM. OF THE RESPECTIVE REGISTERED ENTITIES SAID ESTATES, ALL INCLUSIVE. SAID COMMON ACCESS CARDS AND THEIR RESPECTIVE PRIVILEGES ET AL., ALL INCLUSIVE, WERE ILLEGALLY AND WITHOUT ANY OFFICIAL NOTICE-MAILED-TO-ME-AT-MY-OFFICIAL-BUSINESS-MAILING-ADDRESS-AT-THE-UNITED-STATES-POSTAL-SERVICE-JAMES-A.-FARLEY-BUILDING WITHHELD FROM ME WITHOUT ANY CAUSE ET AL., ALL INCLUSIVE, FROM THE HIGHEST LEVELS, ESPECIALLY FROM WITHOUT DOD, CIA, NOAA AND THE REST OF USDOC (i.e., United States Department of Commerce), USCG AND THE REST OF USDHS, ODNI ET AL., ALL INCLUSIVE, resulting in me, among numerous various other actions, INCLUSIVE, manually (via the USPS First-Class Mail) using my authority to purge virtually all independent contractors and subcontractors (including Charles Ellis Schumer (New York State Office of Court Administration currently-registered Attorney Registration Number 1923804 (since 1976) and William Gerard Asher (New York State Office of Court Administration currently-registered Attorney Registration Number 1209329 (since 1966))) associated with and within said respective Estates except for several respective independent contractors and subcontractors. The purge is OVERDUE AND NECESSARY, ALL INCLUSIVE, despite the metaphorical ET AL., ALL INCLUSIVE, foot dragging ET AL., ALL INCLUSIVE, from the President (i.e., POTUS), the rest of the White House Office/EOP, the United States National Security Council (U.S. NSC), the United States Homeland Security Council (U.S. HSC) ET AL., ALL INCLUSIVE. I WANT ALL, ALL INCLUSIVE, MY COMMON ACCESS CARDS NOW, ALL INCLUSIVE. Thank you.", "comment_id": "DEA-2013-0010-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0007", "comment_date": "2013-11-22", "comment_time": "05:00:00", "commenter_fname": "Robert", "commenter_lname": "Brassell jr (c07673494)", "comment_length": 5012}, {"text": "On behalf of the Prescription Drug Abuse Medical Task force of San Diego, California we would like to strongly supportthe proposed Docket No. DEA regulation 351 to move Tramadol to a schedule IV medication. Tramadol is currently a loop hole drug which is addictive, abused, and diverted, yet many patient and prescriber do not realize this because it is not a controlled substance. Tramadol cannot currently be tracked in our state Prescription Drug Monitoring Program because it is not a scheduled medication.The morphine equivalents of the typical Tramadol dose of 50 mg contains 10 morphine equivalents compared to Hydrocodone 5mg which contains 5 Morphine equivalents and Oxycodone 5 mg which contain 7.5 morphine equivalents. This regulation is an important step in combating the prescription drug abuse epidemic.Roneet Lev, MD FACEPChair, Prescription Drug Abuse Medical Task ForceSan Diego, California", "comment_id": "DEA-2013-0010-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0006", "comment_date": "2013-11-18", "comment_time": "05:00:00", "commenter_fname": "Roneet", "commenter_lname": "Lev", "comment_length": 965}, {"text": "Society might not be as inept as believed to be by those in power. Leave the people alone. Let us decide what we ingest for pain or anxiety.Many of us elderly persons know by nowThat too many doctors turn away From pain treatment even though we Patients have read about our right to pain relief.IGNORE THE STIGMASOMEONE HAS BEEN CRYING AND WRITHING ATHOME, BED-RIDDEN FOR 3 WEEKS... RECLUSE..IN PAIN.. TRULY WISHING FOR DEATH, whenJust a block away, medicine sits guarded by our laws..Nurses and pharmacy assistants laugh us off And the whole of society sits judging without pity Or empathy. Control, control, and kill. Just wait until itHappens to your loved one. Its coming for you, and you areNot fighting hard enough for our liberty.Stop badgering Doctors. They want to help, but dare they?BUT THE DOCTOR SAYS IM FINE FINE? ID BE BETTER OFF DEAD.Its disgusting to witness someone hopeless, in pain ", "comment_id": "DEA-2013-0010-0024", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0024", "comment_date": "2014-01-06", "comment_time": "05:00:00", "commenter_fname": "Deborah", "commenter_lname": "Anonymous", "comment_length": 1084}, {"text": "My girlfriend was in horrible pain for along time barely able to get off the couch. She had surgery her stomach muscle was torn from hip bone. Ins paid for half. Now both sides are torn and she has no insurance, being able to take the tramadol does not take all of her pain away but it helps to lead a some what normal life. It brakes my heart to think  of  her going back to that miserable women on the couch. Before the injury she was a work horse even worked side by side with her husband to build their own house. I realize there are addicts that abuse things but they always find some thing to get high on, Robatussin  spray paint cans or whatever sick thing they find. The people that really need it and dont abuse it are the ones that will suffer. There not going to stop selling Robatussen or spray paint are they?", "comment_id": "DEA-2013-0010-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0010", "comment_date": "2013-11-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 827}, {"text": "I support the proposed Docket No. DEA-351, Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.  As a Certified Pharmacy Technician I see on a daily basis the abuse that Tramadol gets from patients.  It is a controlled substance in Mississippi and the stricter laws have seemed to lessen the abuse.  Since it is a controlled substance in this state, patients are only allowed to get this prescription at the max, two days early and a max of five refills per prescription.   Mississippi is one of the more stricter states when it comes to controlled substances and medications in general.  We are one of two states that has made pseudoephedrine a scheduled drug and we are also a state in which controlled medications cannot be transferred, even within the same state or even to the same chain pharmacy.  Tramadols opioid like actions makes it just as addicting as other opioids.  The known abuse of its pharmacology is a potential harm to patients and society.  Since becoming a controlled substance in Mississippi it has cut down on many issues that comes with dispensing addictive but non-controlled medications.  Instead of just refusing to fill it we can now go back to the state laws and their regulations regarding controlled substances.  This proposed docket would also make the penalties for illegal manufacturing, dispensing, distribution, export, import or any other illegal activity harsher in punishment. ", "comment_id": "DEA-2013-0010-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0008", "comment_date": "2013-11-25", "comment_time": "05:00:00", "commenter_fname": "M", "commenter_lname": "Williams", "comment_length": 1504}, {"text": "Tramadol is the only non-opiate analgesic that has any effect at all on my pain, caused by trigeminal neuralgia.  My doc will give me hundreds of oxy or hydro-codone, but these have activity only at high doses that most docs are reticent to prescribe.  If tramadol becomes unavailable, Ill be forced to go back to the streets to get effective pain killers.  With opiates, docs refuse to entertain the phenomenon of tolerance, requiring, on occasion, more than is prescribed.  Those of us with severe chronic pain that is refractory to most analgesics are once again, out on our own to find drugs on the street just to get enough pain relief to act like a living person.  This sucks.  This will make thousands of legitimate users out in the cold, again.  Oh well, back to the street corners with pockets full of cash.  Yall should be ashamed of yourselves when pain relief takes a back set to maybe catching a buzz.  Screw all of you.", "comment_id": "DEA-2013-0010-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0009", "comment_date": "2013-11-26", "comment_time": "05:00:00", "commenter_fname": "James", "commenter_lname": "Mone'", "comment_length": 943}, {"text": "December 30, 2013Michele Leonhart, AdministratorDrug Enforcement Agency (DEA)8701 Morrissette DriveSpringfield, Virginia 22152Attn: DEA Federal Register Representative/ODL RE: Docket No. DEA-351: Opposition to Upscheduling Tramadol Dear Administrator Leonhart: Thank you for the opportunity to provide input in consideration of the Drug Enforcement Administrations (DEA) November 4, 2013 proposal to schedule substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl) cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including tramadol (tramadol) into Schedule IV of the Controlled Substances Act (CSA). The American Society of Consultant Pharmacists (ASCP) appreciates the opportunity to assist DEA with the development of reasonable and practical regulations to impede the abuse and diversion of prescription medications while avoiding access issues for sick and injured patients who legitimately need these drugs for valid pain-related purposes.  Tramadol is a frequently dispensed medication in the long-term care (LTC) setting because it is indicated for moderate to moderately severe pain, including bone and cancer pain.  Making it a controlled substance would serve to limit access to needed pain medications for the frail and elderly patient population. Therefore, ASCP opposes the proposed upscheduling until a workable solution to ensure timely access for patients in LTC facilities can be reached. Prescribers who care for elderly patients in LTC facilities often are not full-time employees of the facility. Because the prescriber may not be on-site, he or she may not be able to examine a patient in-person as soon as the need for controlled pain medications arises.  This problem is exacerbated because controlled substances require an actual prescription from the prescriber. In the LTC setting, when a patient needs a new, non-controlled substance prescription a nurse can call-in or fax a chart order containing the prescribers recommendation for the needed drug directly to the pharmacy. This is a quick and seamless process for patients in nursing homes and other LTC facilities. However, this procedure is not possible when dealing with controlled substances. In LTC facilities, the prescriber must call, hand deliver, or fax the prescription. This involves LTC employees tracking down the non-employee prescriber no matter the day or time.This practice can severely impede the delivery of prescription medications to elderly patients in LTCs. For example, if a patient is discharged from a hospital on a Friday evening and requires unanticipated intensive pain management upon admission to the nursing home, that patients prescriber must be located and must write or call-in a controlled substance prescription. The patient may endure prolonged periods of pain and discomfort because LTC personnel must locate the off-site prescriber, a task that could take an extended period of time. In considering this hardship for patients, it cannot be forgotten that most patients who use tramadol do so legally. Further, this medication is a common component to many patients pain management regimens and overall health.  Access barriers create serious medical difficulties, and any program to prevent drug abuse should be narrowly tailored to protect legitimate users.  Accordingly, there are more appropriate options for handling prescription drug abuse that will avoid these access issues, like electronic prescription drug monitoring programs (PDMPs). PDMPs maintain statewide electronic databanks of prescriptions for controlled substance and facilitate the identification, tracking and investigation of potential abuse. The government should focus resources on practical programs, like PDMPs, instead of harmful and taxing regulations that will only serve to create barriers for those who legitimately need these medications for pain management. ASCP believes a more comprehensive and long-lasting solution is needed to ensure that patients have swift, responsible access to medically necessary pain medications. We would value the opportunity to work with DEA on finding a solution to the issue of the prescriber-agent status in long-term care facilities. Wed like to offer our assistance, experience, and knowledge in crafting an enduring resolution for this problem.  The American Society of Consultant Pharmacists shares DEAs concerns regarding the abuse of tramadol and other pain medication; however, upscheduling this drug will not adequately address this problem and will create serious obstacles for patients. ASCP members are committed to working with you and other stakeholders to develop viable preventative measures to discourage abuse and diversion and to ensure public safety. Sincerely,Bryan J. SoukupBryan J. Soukup, Esq. - Manager of Government AffairsAmerican Society of Consultant Pharmacists ", "comment_id": "DEA-2013-0010-0022", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0022", "comment_date": "2014-01-06", "comment_time": "05:00:00", "commenter_fname": "Bryan", "commenter_lname": "Soukup", "comment_length": 5113}, {"text": "My 25-year old daughter has Lupus and Fibromyalgia. Doctors started giving her Tramadol and kept increasing the dose. My daughter became addicted, as did her husband, and they have lost their jobs, their home, all of their belongings, and custody of their 4 1/2 year old daughter. Theyve stolen from family and friends,  went doctor and hospital shopping to get this pill, and even pretended to be me at a hospital so that she could be written more. Ive seen people addicted to Meth, and Heroin, and theyve done the EXACT same things to get their drugs. My daughter recently decided to attempt to take her own life.....all while on Tramadol. I HATE THIS DRUG. It shouldve been controlled long ago. Ive done my research: people have died on it...and continue to do so. Ive prayed this drug would be made to be a controlled substance. PLEASE DO BEFORE ANYONE ELSE DIES. THIS PILL HAS DESTROYED OUR FAMILY.", "comment_id": "DEA-2013-0010-0015", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0015", "comment_date": "2013-12-09", "comment_time": "05:00:00", "commenter_fname": "Melissa", "commenter_lname": "Almeida", "comment_length": 945}]}, {"id": "FDA-2012-N-0548", "agency": "FDA", "title": "Drug Safety and Risk Management Advisory Committee; Notice of Meeting", "update_date": "2013-06-17", "update_time": "15:42:17", "purpose": "Nonrulemaking", "keywords": ["oc", "oc2012142", "drug safety management", "October 29-30, 2012", "hydrocodone", "analgesics", "antitussive"], "comments": [{"text": "I am opposed to moving Hydrocodone substances to a Schedule 2 status.  This will impact the patients access to this medication in a timely fashion for proper pain contro as more restrictions to get proper prescription in hand of pharmacist from physician will take place.  Going about this in a different light by giving further education of physicians, better and further use of PDMPs and access, better controls and abilities for proper disposal of product with help and input of pharmacy all lend to better solutions to hinder the abuse issues surrounding the medication.  Tighter restrictions lend to higher abuse as noted by just looking at what has taken place with Oxycodone.I oppose the move to Schedule 2 status.  Believe their are better resolutions and solutions.Thank you", "comment_id": "FDA-2012-N-0548-0445", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0445", "comment_date": "2013-02-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 808}, {"text": "Dear Dr. Throckmorton: I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products. While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them. Rather than reschedule hydrocodone containing products, it is important for you to consider the following:  States Can Reschedule Controlled Substances: Under Federal law, states can act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances. As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens.  Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. In most instances there is a significant lag time that will often pass before the physician can be reached to provide the required written order. This means delays in properly caring for the patients needs.  Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunately on the rise. I have serious concerns that pharmacies may become even larger targets than we ", "comment_id": "FDA-2012-N-0548-0129", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0129", "comment_date": "2013-02-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2060}, {"text": "Regarding the change of hydrocodone to a class II drug: I believe we are chasing our tails in trying to regulate abuse out of out system. It cleary has not worked in the past and will not work in the future. However,  Oxycontin tablets were reformulated several years ago so that the tablets could not be crushed. This change in the tablet reduced the abuse potential of Oxycontin by 99%. My suggestion is to work in conjuction with manufactures to develope doseage forms that CAN NOT be abused.... ie smart tablets that check levels of medication and will not release any more medication after a certain level is reached. I know that this is a complicated issue but so were transdermal patches and insulin pumps 30 years ago...Lets get to work!Mike Cionci", "comment_id": "FDA-2012-N-0548-0131", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0131", "comment_date": "2013-02-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 783}, {"text": "Re-scheduling Oxycodone will only make it more difficult for patients in need.  More dollars should be allocated to the DEA to enforce laws and regulations already in place.  Physicians (where the Rx starts) must be better educated and overseen as their writing habits are already accessible to the DEA.  Heavy writers of narcotics should be visited and educated. Placing the burden on wholesalers and distributors is not working because there are no guidelines and these wholesalers and distributors are being asked to come up with formulas that are skewed and not working. A persons health and needs cannot be placed in a formula.  A Pharmacist is not a detective - They are already working behind bullet proof glass or have an armed guard ($$$) on hand in their facility.Set up sensible and understandable rules and guidelines.  When I have talked to the local DEA office, they admitted they do not have the personnel, nor do they have guidelines.  They are just an enforcement arm, again without any rules or guidelines.  Its a big problem - Handle it properly, not making healthcare more difficult.", "comment_id": "FDA-2012-N-0548-0135", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0135", "comment_date": "2013-02-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1123}, {"text": "February 1, 2013Douglas C. Throckmorton, M.D.Deputy Director for Regulatory ProgramsCenter for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 31, rm. 2417Silver Spring, MD 20993-0002Dear Dr. Throckmorton:I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products.While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them.Please consider: States Can Reschedule Controlled Substances: Under Federal law, states can act on theirown to place tougher restrictions on the prescribing and dispensing of controlled substances based upon the public health needs and experience of their citizens. Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. This means delays in properly caring for the patients needs. Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and this May lead to increased crimes in Pharmacies. I understand the concerns about diversion and abuse of these products and I share these concerns. Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products. Sincerely, Maureen Gallagher, RPh.", "comment_id": "FDA-2012-N-0548-0144", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0144", "comment_date": "2013-02-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2081}, {"text": "Dear Dr. Throckmorton: I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products. While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them. Rather than reschedule hydrocodone containing products, it is important for you to consider the following:  States Can Reschedule Controlled Substances: Under Federal law, states can act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances. As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens.  Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. In most instances there is a significant lag time that will often pass before the physician can be reached to provide the required written order. This means delays in properly caring for the patients needs.  Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunately on the rise. I have serious concerns that pharmacies may become even larger targets than we ", "comment_id": "FDA-2012-N-0548-0197", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0197", "comment_date": "2013-02-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2060}, {"text": "I would like for you to consider the implications of CII scheduling of hydrocodone products for all cancer and home hospice patients. We are in a very rural area with a high percentage of elderly patients. Unfortunately some of these will develop cancer, it is always easier on them to be treated at home, but if the Dr. from their oncology clinic (who is usually in a distant and larger town) cannot call these medicines in, then the patient either does without or has to travel 100 miles just to get a presciption. This just isnt feasible for most families and usually leads to  putting the patient in the hospital or nursing home (a much more expensive alternative). Thank you for your consideration. Ronny Hefner, P.D., SH Pharmacy, McCrory, AR 72101", "comment_id": "FDA-2012-N-0548-0206", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0206", "comment_date": "2013-02-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 764}, {"text": "The moving Hydrocodone products to Schedule C-II will deny many pts with acute as well as chronic pain access to this medication.. especially outside of normal docs office hours..  which will either increase the work load on ERs, increase medical expenses, or cause the acute pain pt to remain in pain or the chronic pain pt to be thrown into withdrawal.Who is going to accept responsibility for adding these unnecessary cost to a system that is already out of control.. or allowing pts to be left in pain/withdrawal... which is a form of torture. Maybe our country only finds it unacceptable to torture terrorists who wants to kill us., but not those in our society.Schedule C-II has not worked all that well to prevent diversion of Oxycodone, Opana and other C-II drugs.. Who believes that putting Hydrocodone in that schedule will alter much diversion?", "comment_id": "FDA-2012-N-0548-0209", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0209", "comment_date": "2013-02-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 875}, {"text": "My name is Joshua Favre, and I am a student pharmacist in Mississippi. I have worked in the pharmacy for a little over 5 years now. I do not believe drugs containing hydrocodone should be moved to a class II. I understand the need to control the distribution of the medication, but I do not think this is the way to go about it. Hydrocodone products are given to patients whom just come out of the dentist, the hospital, or for chronic pain. It would be much simpler for the dentist or doctor to be able to call in the prescription for these patients. The chronic users would then have a limited prescription for monthly periods. I have had many elderly patients who come in once every three months to get their three month supply because it ails them to get around on a day to day basis. If the drug was moved to a Class II, I believe the problem would still persist just as it is. ", "comment_id": "FDA-2012-N-0548-0211", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0211", "comment_date": "2013-02-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 883}, {"text": "January 30, 2013Douglas C. Throckmorton, M.D.Deputy Director for Regulatory ProgramsRe: FDA-2012-N-0548; Drug Safety and Risk Management Advisory Committee; Notice ofMeeting; Community pharmacy perspective regarding the public health benefits and risks ofdrugs containing hydrocodone either combined with other analgesics or as an antitussive.Dear Dr. Throckmorton:I am a community pharmacist and would like to present my views on the implications forpharmacies and impact on patients surrounding the rescheduling of hydrocodone containingproducts. While pharmacists share concerns regarding the abuse, misuse and diversion of theseprescription drugs, these concerns must be balanced with the impact on patients wholegitimately need access to them.Rather than reschedule hydrocodone containing products, it is important for you to consider the following:States Can Reschedule Controlled Substances: Under Federal law, states can act on theirown to place tougher restrictions on the prescribing and dispensing of controlled substances.As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens. I prectice in the state of Florida which has had the ledgon drug carisoprodol in a higher classification for many years. Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone inprescriptions to pharmacies for their patients. Schedule II drugs can only be filled after apharmacy receives a hard copy prescription signed by the prescriber except in an emergency. Rescheduling Would Likely I ncrease the V alue of I llicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunate.", "comment_id": "FDA-2012-N-0548-0212", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0212", "comment_date": "2013-02-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2053}]}, {"id": "CMS-2010-0231", "agency": "CMS", "title": "\"Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs\"", "update_date": "2021-04-21", "update_time": "01:00:35", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "October 4, 2010Centers for Medicare and Medicaid ServicesDepartment of Health and Human ServicesRoom 445-G Hubert H. Humphrey Building200 Independence Avenue, SWWashington, D.C. 20201Subject: Medicaid Program: Withdrawal of Determination of AMP, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (CMS 2238-P2; RIN 0938-AP67)To Whom It May Concern:The National Community Pharmacists Association (NCPA) is writing to support the proposed regulation to modify the final regulation Medicaid Program: Prescription Drugs that was published in the Federal Register on July 7, 2007. The sections that are proposed to be withdrawn are Section 447.504, Determination of AMP; Section 447.514, Upper Limits for Multiple Source Drugs; and the definition of multiple source drug in Section 447.502, as it was amended by the multiple source drug rule published on October 7, 2008.NCPA represents the owners and operators of approximately 23,000 independent community pharmacies in the United States.  We believe that it is appropriate that CMS withdraw these sections of the regulation, as Congress recently amended several sections of Section 1927 in the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148) that will require that CMS promulgate new proposed regulations regarding these particular issues. NCPA has long held that in the final 2007 regulation, CMS did not implement the provisions of the Deficit Reduction Act (DRA) of 2005 consistent with Congressional intent. Among our concerns were the inappropriate definition of AMP to include prices not paid by community retail pharmacies and the use of a definition of multiple source drug that was inconsistent with the statute.  Several independent economists certified that CMSs planned implementation of the original DRA law would have closed some 11,000 community retail pharmacies  some 20 percent of all pharmacies  and many independent pharmacies.  When issuing a new", "comment_id": "CMS-2010-0231-0006", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0231-0006", "comment_date": "2010-10-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2107}, {"text": "HDMA supports CMS efforts to withdraw provisions, which, as defined by the agency in the DRA final rule, are inconsistent with amendments to the Medicaid Drug Rebate Statute (Social Security Act section 1927) under healthcare reform and not reflective of Congressional intent to ensure that reimbursement to retail pharmacies is fair and accurate for generic medicines dispensed to Medicaid patients.  In promulgating new regulations implementing section 2503 of PPACA and to avoid future complications, HDMA urges CMS to seek stakeholder input to ensure those regulations are consistent, complete and provide necessary guidance for industry to comply with new requirements established in law. In our view, CMS should provide additional clarity on the treatment of bona fide services for purposes of AMP reporting.   In particular, we urge CMS to confirm that the list of bona fide services codified in PPACA is not exclusive and that payments for additional services such as marketing and sales services, financial management services and information and data services, provided by wholesalers on behalf of manufacturers must be excluded from the calculation of AMP, even if the payment amount is set as a percentage of goods purchased, whenever the payment is properly structured as a bona fide service fee.  Finally, in light of the significant impact AMP will have on the entire supply chain, and in light of previous litigation and new requirements established by PPACA, HDMA strongly urges CMS to delay publishing AMPs and implementing any FULs for purposes of Medicaid reimbursement of multiple source drugs until such time as the agency has promulgated and completed full rulemaking in accordance with the Administrative Procedures Act.", "comment_id": "CMS-2010-0231-0003", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0231-0003", "comment_date": "2010-10-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1771}, {"text": "In this rule, we are proposingto withdraw two provisions from theMedicaid Program; Prescription Drugsfinal rule (referred to hereafter as AMPfinal rule) published in the July 17,2007 Federal Register. The provisionswe are proposing to withdraw are asfollows: The determination of averagemanufacturer price (AMP), and theFederal upper limits (FULs) for multiplesource drugs. We are also proposing towithdraw the definition of multiplesource drug as it was revised in theMedicaid Program; Multiple SourceDrug Definition final rule published inthe October 7, 2008 Federal Register. The provisions of the AMP final ruleand the definition of multiple sourcedrug that we are proposing to withdrawwere challenged in a lawsuit that wasfiled in November 2007. The challengedregulations have been superseded insignificant part by the Patient Protectionand Affordable Care Act, as amended bythe Health Care and EducationReconciliation Act, and the FAA AirTransportation Modernization andSafety Improvement Act. This documentwould withdraw the regulatoryprovisions challenged in theaforementioned litigation.", "comment_id": "CMS-2010-0231-0015", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2010-0231-0015", "comment_date": "2010-10-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1353}]}, {"id": "HHS-OS-2009-0007", "agency": "HHS", "title": "Proposed Rule on Buprenorpine Dispensing In Opioid Treatment Programs", "update_date": "2019-01-11", "update_time": "01:04:12", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comment 4", "comment_id": "HHS-OS-2009-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0006", "comment_date": "2009-08-17", "comment_time": "04:00:00", "commenter_fname": "Ronald", "commenter_lname": "Pike", "comment_length": 9}, {"text": "see attatched file", "comment_id": "HHS-OS-2009-0007-0008", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0008", "comment_date": "2009-08-17", "comment_time": "04:00:00", "commenter_fname": "Elizabeth", "commenter_lname": "Stanton md", "comment_length": 18}, {"text": "Comment from Robert Newman, M.D.", "comment_id": "HHS-OS-2009-0007-0010", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0010", "comment_date": "2009-08-17", "comment_time": "04:00:00", "commenter_fname": "Robert", "commenter_lname": "Newman", "comment_length": 32}, {"text": "August 17, 2009 Re: Dockett No. CSAT 001, Proposed Rule Change for Buprenorphine Take Homes for Opioid Treatment Programs (OTPs)  At Texas Clinic, we started utilizing buprenorphine, specifically Suboxone, soon after it was approved for usage in our OTP.  We have had great success with this medication, as it seems to have reached a new population of individuals addicted to opiates. Our main problem from the very beginning in giving buprenorphine to our patients has been the cumbersome take home restrictions identical to those placed on methadone dispensing. We are constantly having to get exception requests for take homes while our colleagues in private practice were simply able to prescribe or dispense Suboxone with no such restrictions. The take home restrictions have definitely been a deterrent to successful treatment.  Over the years, we have had patients drop out of treatment while waiting for their take homes to be processed for approval or simply switch to a private practice (which actually cost them more) because they had freedom to work, go to school, or manage their household more easily. We would strongly be in favor of lifting any take home restrictions on buprenorphine in OTPs and, therefore, amending the Federal OTP regulations as soon as possible.  In this vain, we would further propose that an emergency order be issued, lifting such restrictions immediately, to avoid the possibility of any other patients leaving treatment, relapsing, and going back to a life of abusing opioids. Thank you for allowing us to comment on this proposed rule change. Sincerely,Farrukh Shamsi, MBAExecutive DirectorTexas Clinic Fulton6311 Fulton St.Houston, TX 77022(713) 694-8100", "comment_id": "HHS-OS-2009-0007-0009", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0009", "comment_date": "2009-08-17", "comment_time": "04:00:00", "commenter_fname": "Farrouk", "commenter_lname": "Shamsi", "comment_length": 1798}, {"text": "AATOD", "comment_id": "HHS-OS-2009-0007-0005", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0005", "comment_date": "2009-08-05", "comment_time": "04:00:00", "commenter_fname": "Mark", "commenter_lname": "Parrino", "comment_length": 5}, {"text": "From: Charles Walton Sent: Tuesday, July 21, 2009 4:03 PMTo: SAMHSA DPT_InterimruleSubject: Eliminaton of Buprenorphine takehome dispensing schedule under Section III I am pleased to support the Secretarys decision in this matter.  It will serve to increase access to a most successful treatment for opioid dependency.  I am the Medical Director of an opiate maintenance clinic and would suggest that physicians in this field, such as myself, are every bit as, or more, capable of determining which patients are safe to have multi-day or multi-week prescriptions of Suboxone as are the orthopods or internists or family physicians who have had only the 8 hour training in its OBOT use.  Opiate maintenance clinic staff focus on issues of diversion, actually do callbacks to count pills left, actually do provide counseling, and actually do random UA, all of which are poorly applied in community suboxone prescribing.  Mr. Secretary, thank you for taking this logical move.  It will make many patients lives better through easier access and genuine treatment resource availability.  Charles W. Walton, MDMedical Director DHUT, DHUC, DHTV, DHLT", "comment_id": "HHS-OS-2009-0007-0004", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0004", "comment_date": "2009-08-05", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Walton", "comment_length": 1298}]}, {"id": "FDA-2013-P-0703", "agency": "FDA", "title": "Request to Foster a Transition to Abuse-Deterrent Opioids and Promoting Greater Access to Treatment for Opioid Addiction and, More Specifically, Medication-Assisted Treatment (\"Mat\"), as set out in the Petition-CLOSED", "update_date": "2015-03-11", "update_time": "20:19:12", "purpose": "Nonrulemaking", "keywords": ["cder", "2013-4480", "medication-assisted treatment", "abuse-deterrent", "opioids", "ANDA", "abuse", "abstinence", "Epidemic", "Prescription Pills", "CDC", "closed"], "comments": [{"text": "I am very disturbed by a recent FDA decision to fail to approve Titan Pharmaceuticals new drug application for Probuphine, a novel implant to aid those who are addicted to opioids in eliminating their dependency and resuming normal and productive lives. With the current epidemic of opioid addiction in the United States and the current emphasis placed on finding ways to combat this addiction while reducing the extreme risk of diversion of these medications, this medication can be pivotal in the process of change.  Probuphine met the criteria for approval which the FDA themselves established for the drug to meet- the ADCOM on March 21st rendered a positive vote of 10 members For Approval, 4 Against, with 1 Abstaining- yet the drug was not approved by the FDA on April 30th. The reasons for non-approval make little to no sense, given what the FDA agreed to at the outset of Titans study in order for approval. Everything the FDA was asking for in their Complete Response Letter to Titan Pharmaceuticals could have been determined post-approval, and Titan could have proceeded forward in changing and saving peoples lives immediately. The decision on April 30th by the FDA would suggest something more than mere trepidation on their part. This is a huge step backwards in President Obamas pledge to combat and eradicate this scourge on the American people. I would urge the FDA to look into this matter at their earliest possible convenience. A delay of 6-30 months to gain approval on this drug could cost the lives of many more people who might otherwise be saved here and now by its approval. The opioid addiction epidemic has been well-documented and has become a focus of the current administration- right here, right now is a viable answer and alternative to what is woefully, inadequately available currently.", "comment_id": "FDA-2013-P-0703-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-0703-0003", "comment_date": "2013-08-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1843}]}, {"id": "SAMHSA-2023-0001", "agency": "SAMHSA", "title": "Medications for the Treatment of Opioid Use Disorder", "update_date": "2023-05-08", "update_time": "13:37:08", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think it would benefit greatly if Telemed appointments were permanently available for inductions/first visits.", "comment_id": "SAMHSA-2023-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0007", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Kennedy", "commenter_lname": "Powell", "comment_length": 112}, {"text": "As a public health professional, I strongly urge SAMSHA to adopt the proposed changes to medications for opioid use disorder (MOUD) regulations to increase access to these lifesaving medications and enable people with substance use disorder (SUD) to successfully discontinue illicit drug use and reclaim their lives. I currently serve as deputy director of Virginia Harm Reduction Coalition, a 501(c)(3) nonprofit providing harm reduction services to people who use drugs (PWUD) in Southwest Virginia. I have witnessed firsthand the struggles our clients face in accessing MOUD, including not being able to afford to take time off work for appointments and facing stigma at work when they do, difficulties with getting childcare to facilitate appointments, and difficulties obtaining transportation to access appointments. I have witnessed clients struggle mightily to remain in treatment only to finally succumb to the weight of these barriers and relapse. The closest Medicaid-accepting methadone clinic to Roanoke, Virginia, is located 50 miles away in Martinsville. Methadone is much more effective for many of our clients than buprenorphine (especially since Virginia law makes obtaining buprenorphine without a naloxone component impossible for most patients). The availability of telehealth appointments for methadone patients and the ability of patients to receive up to 4 weeks worth of medication enables many more of our clients to enter and remain compliant with treatment. It is an absolute game changer.  ", "comment_id": "SAMHSA-2023-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0014", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Barbie", "commenter_lname": "Zabielski", "comment_length": 1526}, {"text": "While I absolutely believe addiction and addiction issues are a significant problem, I wanted to make sure that my understanding (and my doctors understanding is correct as it was told to me, a pain patient). The proposals wording leaves no choice for someone taking opioids to NOT be dependent either physically or mentally. Meaning, it is appropriate to code all patients claims who use opioids as at least opioid dependence diagnosis. They have no choice to do this even if their doctors have zero dependency concerns documented in the medical chart. Even if the patient has no dependency issues with the opioid(s) being taken. And I am assuming there will be some sort of protections for the patients to ensure that there will be no denial of organ transplants, should they ever be needed in the future because of this coding. Because again, the patient and doctor had no choice.", "comment_id": "SAMHSA-2023-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0017", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 918}, {"text": "Anything to make buprenorphine more easily accessible. It is by far the safest opioid. Its use to treat pain and opioid overdose should be studied and encouraged. It is safe enough to be dispensed over the counter to competent adults. H B Edwards, MDAddiction PsychiatristBehaveNet, LLC", "comment_id": "SAMHSA-2023-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0019", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Howard", "commenter_lname": "Edwards", "comment_length": 306}, {"text": "I am an OTP methadone patient. Ive watched as federal and state laws have provided easier access to treatment. However, this means nothing if the OTP or Methadone clinic does not adopt these rules. I have 14 years 100% compliant in my treatment but my clinic will not allow me to have more than 6 take home doses. According to Samhsa and my state law I should be getting up to 27 doses. People at other clinics with less time clean can get more takehomes than me. But because you make these changes and do not require these opioid treatment programs to follow, nothing will change. Its a shame. You just let people suffer and die and do nothing about it. I am told by the people who run the clinic that they get paid more when we have to show up in person more. So its become about these companies money and bottom lines and not peoples lives and treatment. You all should be quite ashamed of yourselves.", "comment_id": "SAMHSA-2023-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0020", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 919}, {"text": "I am totally NOT in favor of SAMHSA adopting the Proposed Rule as is, in its entirety because it will create a huge financial hardship on the agencies that receive funding based on being CARF accredited if given one year or a non-accreditation outcome for more than a few recommendations that could be resolved within 60-90-days. Without a lot of details regarding why SAMHSA is moving into this direction, it is very difficult to really assess the pros and cons.  However, one thing that I know is that agencies work hard to comply with CARF standards as well as overall service delivery to consumers and to put these stricter expectations as well as time restraints on these agencies appears to be a setup for failure.  No agency is perfect and to say an agency can only have a hand full of recommendation is not reality because of the overall diversity within all agencies.  It is not a one size fit all type of situation.  The reason why agencies have chosen to comply with CARF standards as initially written is because we were want to provide a high level of care to our consumer based on surveyors overall feedback within a reasonable amount of time to correct issues, etc.  This is not a agency at large friendly proposal.   ", "comment_id": "SAMHSA-2023-0001-0042", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0042", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1238}, {"text": "I wanted to say that I think this is a good thing for MH  addicted patients, also think that MH patient for some if not most should not be taken away our rights to certain anxiety and panic attacks meds such as benzodiazepines. When I came to South Carolina from California I had to quit on my own wt benzodiazepines because no doctor here would refill it.I would like to suggest for more groups  resources for MH patients as is almost non existent here in SC. I dont think MH or addiction should be stigmatized anymore.!!! Thank you ", "comment_id": "SAMHSA-2023-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0027", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Rose", "commenter_lname": "Muniz", "comment_length": 551}, {"text": "To expect a treatment center to not have a singular standard (out of 1900) out of conformance seems like an unrealistic expectation.  If a surveyor finds one treatment plan out of all the charts that they look at and that treatment plan was completed a week after its due date.  Then that would be the one singular out of conformance that they are allowed to have for their entire survey (now they know they are only going to get a one year and they are stuck in compliance nightmares all year for every clinic they have).  This regulation would force surveyors to decide if they should make any recommendations to the clinic to help them improve or decide that it is crucial for the clinic to stay open to treat patients so they must ignore any issues and just issue a perfect 100% survey at every location to ensure access to treatment for patients.  It defeats the purpose of professional consultation and makes the survey process punitive.", "comment_id": "SAMHSA-2023-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0040", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Scott", "commenter_lname": "N", "comment_length": 943}, {"text": "The proposed post-survey process described in Proposal  8.4(b)(1)(iii) and (b)(2)  is unreasonable and unduly burdensome to Opioid Treatment Programs (OTPs). First, it is unreasonable to require full conformance to all standards in order to obtain a Three-Year Accreditation or to maintain accreditation following a One-Year Accreditation. Although all accreditation standards are meaningful and promote quality performance, the facts and circumstances of each OTP are unique; therefore, conformance to particular standards may not be appropriateor even possiblefor every OTP at all times. Second, it is unreasonable to expect OTPs to be able to develop and implement all quality improvement activities for all recommendations within a period as short as 60 days. In fact, the implementation period would need to be much shorter than 60 days, so that accreditation agencies could perform verification within the 60-day period. Third, it is unduly burdensome for OTPs to be subject to verification surveys shortly following prior surveys for what are often relatively minor recommendations that may have no direct impact on persons served. Moreover, the indirect and direct costs of preparing for and obtaining such verification surveys would also be unduly burdensome and totally unnecessary, as the current resurvey process demonstrates a quarter century of significant quality improvement by OTPs during each three-year survey cycle without the cost and inconvenience of mid-cycle verification.", "comment_id": "SAMHSA-2023-0001-0047", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0047", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Nichole", "commenter_lname": "Meyers", "comment_length": 1516}, {"text": "The proposed changes to the rules for accreditation for OTP facilities are not only unnecessary, but would be nearly impossible to implement in a meaningful fashion.  Absent a serious health and safety violation that creates unsafe conditions, there is no need for an organization to be re-surveyed within 60 days.  It is also foolish to think that any program could complete a survey with no recommendations.  This proposed change goes against the principles of quality improvement and does nothing to improve service delivery or patient care.  Furthermore, it also creates a financial burden for organizations that would have to pay for another survey within 60 days.  These funds are better spent on providing care to low-income patients.  Please reconsider this change.  ", "comment_id": "SAMHSA-2023-0001-0045", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0045", "comment_date": "2023-05-05", "comment_time": "04:00:00", "commenter_fname": "Carl", "commenter_lname": "Anderson", "comment_length": 775}]}, {"id": "BIA-2007-0053", "agency": "BIA", "title": "Law & Order on Indian Reservations", "update_date": "2022-03-25", "update_time": "01:03:41", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "We represent the Cheyenne and Arapaho Tribes Gaming Commission, which is currently involved in litigation in the courts of the Cheyenne and Arapaho Tribes (Tribe).  We provide the following comments on behalf of the Gaming Commission regarding the proposed rule titled Law and Order on Indian Reservations, 72 Fed. Reg. 71,835, because the rule could inhibit the Bureaus planned reassumption of the Tribes court program, and thereby impact tribal court litigants such as the Gaming Commission. Although the Tribe has operated a tribal court system for several years, the Bureau has continuously listed the Tribe in 25 C.F.R. ? 11.100(a) as a tribe with a Court of Indian Offenses.  Recently, the Bureau determined that the current tribal court system has significant structural defects.  A tribal court assessment commissioned by the Bureau and released in September 2007 recommended reassumption of the court program.  Due to the unacceptable rating, the court system should be taken over by the BIA under the CFR court system . . . .  The financial problems that created the high risk tribe have not been rectified.  Elbridge Coochise and Ramona Tsosie, Tribal Court Assessment, 16 (July 27, 2007) (emphasis added).  The Bureau requested a corrective action plan from the Tribe, but the Tribe has failed to provide such a plan.  Given the Bureaus pending establishment of a Court of Indian Offenses for the Tribe, it would be inappropriate to remove the Tribe from Section 11.100(a), and we request that the Bureau reinsert the Tribe into this section of the proposed rule. ", "comment_id": "BIA-2007-0053-0002", "comment_url": "https://api.regulations.gov/v4/comments/BIA-2007-0053-0002", "comment_date": "2008-01-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1750}]}, {"id": "FDA-2017-N-6924", "agency": "FDA", "title": "Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation", "update_date": "2020-01-03", "update_time": "14:40:05", "purpose": "Nonrulemaking", "keywords": ["Repeal of Regulation Requiring an Approved", "New Drug Application for Drugs Sterilized by", "Irradiation", "OPEN"], "comments": [{"text": "As a current quality contributor in the Pharmaceutical industry, I fully support the repeal of regulation 310.502(a)(11) requirements. As noted within the summary and conclusion, necessity for this provision was put into place in 1955 due to the lack of technological understanding / control of nuclear radiation for sterilization of OTC drugs in comparison to the current sterilization and cGMP practices. It is the responsibility of the government and its agencies to facilitate the elimination of outdated and unnecessary regulations bogging down the health care system resulting in, but not limited to, a positive impact on the public,  the market, achieve the cost savings the public desire, and possibly allow for greater ease access to medication needed. ", "comment_id": "FDA-2017-N-6924-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0013", "comment_date": "2018-10-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 774}, {"text": "As a member of the healthcare industry I am in full support of the repeal of the requirements in 310.502(a)(11) necessitating  an NDA for irradiated sterilization of drugs.  As highlighted in the summary, this requirement was put in place in the 1950s when radiation technology was still in its early stages.  As the technology has become more refined, research has shown many benefits to using this sterilization process with no adverse effects to the environment or to individual consumers.  It is the responsibility of the government and its agencies to serve people effectively and eliminating outdated regulations is an integral part of achieving that.  The cost savings will be significant and a safer product will reach consumers more consistently.  ", "comment_id": "FDA-2017-N-6924-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0011", "comment_date": "2018-10-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 757}, {"text": "I concur with the conclusion that technological understanding has advanced to the point where we realize that drugs sterilized through radiation are the same drugs and non-irradiated ones.Repealing this categorization would provide a positive economic impact, reduce paperwork, and speed the process with which this treatment can be used to get drugs to market faster.", "comment_id": "FDA-2017-N-6924-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0010", "comment_date": "2018-09-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 390}, {"text": "I support the deregulation of requiring a new drug application for drugs sterilized by irradiation.  As stated in the proposal, the regulations under which this pre-approval was created date back to 1955 when irradiation was not as understood as it is today.  Radiation of active ingredients in medications is very common and there have been extensive research studies supporting this method of sterilization, showing this method to be safe and effective (Abuhanglu  Ozer, 2014).  By removing the regulation requiring an approved new drug application for drugs sterilized by irradiation, medication can be more available to the public at a more cost effective rate.  This benefits the consumer of OTC drugs by increasing drug availability while reducing cost. Abuhanoglu G, Ozer AY. (2014). Radiation sterilization of new drug delivery systems. Interventional Medicine  Applied Science. 2014;6(2):51-60. doi:10.1556/IMAS.6.2014.2.1.", "comment_id": "FDA-2017-N-6924-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-6924-0012", "comment_date": "2018-10-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 957}]}, {"id": "FDA-1996-N-0006", "agency": "FDA", "title": "Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System", "update_date": "2022-01-05", "update_time": "01:01:55", "purpose": "Rulemaking", "keywords": ["Time and Extent Application", "TEA", "OTC 27PA001", "MENSTRAL DRUG", "IBUPROFEN", "OTC MONOGRAPH SYSTEM", "ELIGIBILITY CRITERIA", "1996N-0277"], "comments": [{"text": "I urge you to ban triclosan from all cosmetic products.  As a researcher and environmental toxicologist it is apparent that based on multiple lines of data in the scientific literature, triclosan presents a significant concern as an endocrine disruptor. Its breakdown to a dioxin, a much more potent and long lived endocrine disruptor is also a very great concern.", "comment_id": "FDA-1996-N-0006-0084", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1996-N-0006-0084", "comment_date": "2010-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 369}, {"text": "I would like to voice my opposition to including anymore additives into OTC items that are ingested, for whatever purpose. I am specifically commenting on the use of triclosan. We have enough things in our environment disrupting our bodies and chemistries (hormones) without adding another to the ever-growing list of inclusions. I would think as an agency dealing with public health and safety for consumers, you would consider approving anything else that is detrimental to the human species an atrocity, which I do. Please think of us little people when you are making these decisions. PLEASE DO NOT APPROVE TRICLOSAN AS AN ADDITIVE TO ANY MORE OTC ITEMS.Thank you.", "comment_id": "FDA-1996-N-0006-0080", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1996-N-0006-0080", "comment_date": "2010-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 700}, {"text": "I am opposed to allowing Triclosan in any additional products and feel we should be working toward removing the currents uses.  There is adequate evidence that it may be a hormone disruptor and we already have too many of those in our drinking water.  Triclosan and its byproducts are poorly removed from waste treatment water that is then released back into the environment", "comment_id": "FDA-1996-N-0006-0081", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1996-N-0006-0081", "comment_date": "2010-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 379}, {"text": "The National Park Service has no comments on this document. Thanks for the opportunity to comment.", "comment_id": "FDA-1996-N-0006-0093", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1996-N-0006-0093", "comment_date": "2010-05-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 98}, {"text": "As a consumer, I do not want triclosan in the products that I buy to use or consume.  Please regulate against the use of triclosan.", "comment_id": "FDA-1996-N-0006-0085", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1996-N-0006-0085", "comment_date": "2010-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 131}]}, {"id": "DEA-2009-0013", "agency": "DEA", "title": "Schedules of Controlled Substances:\r\nPlacement of 5-Methoxy-N,NDimethyltryptamine\r\nInto Schedule I of\r\nthe Controlled Substances Act", "update_date": "2021-12-02", "update_time": "01:00:49", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Objection to Scheduling 5-MeO-DMT addressing barrier to scientific research and other matters.", "comment_id": "DEA-2009-0013-0020", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0020", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Gerrard", "commenter_lname": "Winstanley", "comment_length": 94}, {"text": "Assuming something is bad without actually researching the subject has proven itself throughout history to later be a mistake. A classic example was the Vaticans fight against Galileo Galilei. They feared him bringing new knowledge to the people that the church could not itself provide. If we were to move this chemical to a schedule 1 substance, we would be agreeing that knowledge is unimportant. This is because the chemical would no longer be allowed to be researched. Further research could prove this chemical important to the US in future situations. If we were to ban it however, we could potentially miss out on a scientific opportunity.I hope you will not allow the US to be held back in its pursuit of knowledge. Stephen Tanner", "comment_id": "DEA-2009-0013-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0005", "comment_date": "2009-11-09", "comment_time": "05:00:00", "commenter_fname": "Stephen", "commenter_lname": "Tanner", "comment_length": 784}, {"text": "Six hospitalizations and one reported death over the span of a decade?  This is a serious threat to public safety?The reported death was an instance of poly-drug ingestion including MAOIs.  MAOIs in high concentrations are dangerous and can make taking relatively safe drugs such as Benadryl potentially deadly.  How is the DEA able to determine that the death was from 5-MeO-DMT and not the other drugs in the users concoction?The DEA also claims that 5-MeO-DMT is being sold as or as an adulterant to ecstasy/MDMA.  While I have no reason to dispute the authenticity of the drug seizure, it is a fact that 5-MeO-DMT is not orally active.  Putting 5-MeO-DMT into a pressed pill for human ingestion is pointless.  It is not clear why this seizure was referenced, but it should be made clear that 5-MeO-DMT is not active orally and is not at all related to ecstasy except in this bizarre seizure.In the reports the DEA has provided, 5-MeO-DMT is repeatedly likened to LSD and mescaline despite sharing few similarities.  5-MeO-DMT has a brief duration of effect in humans, and most recreational-minded users would find it entirely unpleasant.  It has been hypothesized that 5-MeO-DMT could be used in the treatment of alcoholism and depression.", "comment_id": "DEA-2009-0013-0016", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0016", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1288}, {"text": "The current comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. Regulation of Tobacco Products FDA-2009-N-0294 had a 90 day comment period which was extended by 90 days  to allow sufficient time to develop meaningful, thoughtful responses. Please extend the comment period  for DEA-2009-0013-0001 to 180 days.A 30 day period is so short it seems futile to comment.", "comment_id": "DEA-2009-0013-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0011", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 430}, {"text": "Docket # DEA-3315-MeO-DMT should not be placed in Schedule I and the period for public comment should be extended by 24 months so people can do the kind of research FDA should have done. We want scientists, not sockpuppets.Soma is being recommended for schedule IV and much more evidence of harm has been shown for that than 5-MeO-DMT. Schedule V would allow age restrictions and purity regulation. It would also allow research into psychiatric and other use. Doctors could prescriibe it for terminally ill patients if it would help people prepare for the transitition from this life to whatever follows.", "comment_id": "DEA-2009-0013-0012", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0012", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Bob", "commenter_lname": "Anonymous", "comment_length": 624}, {"text": "Appendix to Comment Tracking Number: 80a5e5ed Appendix C Entheogens  Sacramentals or Sacrilege? by Thomas B. Roberts, Ph.D. Used by permission. Submitted as a separate file/comment but incorporated by reference. I couldnt find a way to paste this in with no change resulting. Renamed Docket No. DEA331 --- Apendix C to Gerrard Winstanley Comment draft 009--- Entheogens-Sacramentals-or-Sacrilege-draft-11e by Thomas B. Roberts.doc to reference Docket No. DEA331 without making any change in the file. Including the full file with no changes in it was a condition of the permission (see below). ---- Original Message ----From: Thomas Roberts troberts@niu.eduTo: REDACTED EMAIL ADDRESS Cc:  REDACTED EMAIL ADDRESS Sent: Thursday, November 19, 2009 9:16 PMSubject: Re: Copyright permission request Dear Mr. Winstanley,  You have my permission to use this file as you propose provided you include the full file and make no changes in it.   Thomas B. Roberts   Tom Roberts  =============== We are all prisoners of our minds. This realization is the first step on the journey to freedom.   --- Ram Dass Gerrard Winstanley  REDACTED EMAIL ADDRESS  11/16/09 1:51 AM   Thomas B. Roberts, Ph.D., Professor Emeritus Dept. of Leadership, Educational Psychology and Foundations Northern Illinois University DeKalb, IL. 60115  I request permission to include Entheogens -- Sacramentals or Sacrilege?: Design for a course syllabus found at http://www.cedu.niu.edu/lepf/edpsych/faculty/roberts/Entheogens-Sacramentals-or-Sacrilege-draft-11e.doc as an appendix to a public comment on the Notice of Proposed Rulemaking,  Docket No. DEA-331.The deadline for comments is 11/27/2009. The comment  I would prefer to append this to should be ready for submission within a  few days although I can use this in a seperate comment as long as I get  permission to use it in ti", "comment_id": "DEA-2009-0013-0019", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0019", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Gerrard", "commenter_lname": "Winstanley", "comment_length": 2340}, {"text": "Docket No. DEA-3315-MeO-DMT should not be scheduled. If the CSA doesnt allow wine to be prohibited but allows sacraments of nonmainstream religions to be prohibited it violates the First Amendment and is unconstitutional. If its unconstitutional its not a valid law so nothing should or can be scheduled under the CSA. Thats easy to understand.I also request a 24 month extension of the period for public comment.", "comment_id": "DEA-2009-0013-0014", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0014", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Lynne", "commenter_lname": "Anonymous", "comment_length": 453}, {"text": "We are opposed to the rule based on the data and reports provided. The rulemaking would be improved by adding more scientific data on the effects of the drug.  Instead of relying on blogs and websites that do not have proper accreditation, perhaps the DEA should wait for human statistics before rulemaking, given the very limited use of this drug.  The DHHS report relied heavily in their recommendation on the drugs lack of a  currently accepted medical use, but that is not one of the 8 factors that the DEA and DHHS use for determining drug scheduling. Further, the DHHS did not mention this until the very end of the recommendation report, yet it was a pivotal point in their final recommendation. There should be consistency in the standards used by collaborating agencies.  In addition, since they have not done testing on humans yet, what is their basis for asserting there is no accepted medical use? Until these issues are addressed we would not support any rulemaking on this drug.", "comment_id": "DEA-2009-0013-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0009", "comment_date": "2009-11-16", "comment_time": "05:00:00", "commenter_fname": "Zachary", "commenter_lname": "Barrett", "comment_length": 1013}, {"text": "The controlled substance 5-MeO-DMT or 5-Methoxy-N,N-Dimethyltryptamine is a very serious psychedelic and powerful psychedelic. The Drug Enforcement Agency is right in proposing that this should be moved up on the Controlled Substance List into the Schedule 1 which is the most serious of categories in this act and warrants the most intense of punishments if found using, possessing, or selling these substances. This drug is similar to DMT another hallucinogen and is considered extremely dangerous. The government should place this higher up on the list along with other psychedelics due to its severity and dangerous reactions that users experience. As they explain that the government has repeatedly seized various amounts of this substance and has done numerous studies proving that there is no therapeutic or medicinal purpose of this drug. This drug is commonly used for recreational use primarily by young adults and teenagers. The only use outside of recreational use is for shamanistic purposes in South American countries where they are used as an entheogen which is a substance which has psychoactive effects. The use of this substance in the United States is however not for religious purposes and can be controlled by the government. I believe that they are doing the right thing by attempting to make it a Schedule 1 drug because there is no good that can come from it and people have had many negative side effects from the use of it. Your judgment is impaired and your senses are distorted which is similar to LSD (Lysergic Acid) or Psilocybin Mushrooms which are also schedule 1 substances on the list. If the effects are similar to one another and the uses are too recreational and have no proven medicinal or therapeutic purposes than it definitely should be considered a highly illegal drug and not allowed to be bought offline from chemical supply companies.  Few states so far have already declared this derivative of frog venom and tree bark as a Schedule 1 offense but the DEA has not yet made it mandatory for all states to place this drug that high up on the list. It is in the best interest of the government to make the use, possession, or distribution of 5-MeO-DMT illegal so that it is not out on the streets being used by people for the wrong purposes because there is not one scientific study that proves the use of this drug is beneficial in any way.", "comment_id": "DEA-2009-0013-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0006", "comment_date": "2009-11-09", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2384}, {"text": "Docket No. DEA-331As a practical matter5-MeO-DMT should not be placed in Schedule I. Ive looked at abstracts of some of the research its being used in and some of it seems important (and even suggests FDAs claims are outdated, not just dumbed down and biased). At least suspend this farce until a proper review of research can be made and dont tell FDA which schedule to recommend or pick another schedule that be a barrier to research. Schedule IV would allow research and medical use and theres no real risk of diversion from allowing that. People will just get it on the underground market or use something else.", "comment_id": "DEA-2009-0013-0017", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2009-0013-0017", "comment_date": "2009-11-30", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 645}]}, {"id": "FDA-2013-D-0045", "agency": "FDA", "title": "Abuse-Deterrent Opioids Evaluation and Labeling", "update_date": "2019-04-19", "update_time": "10:56:45", "purpose": "Nonrulemaking", "keywords": ["cder", "CDER2012192", "draft guidance", "abuse-deterrent opioids", "evaluation and labeling", "opioid analgesic", "2014-643"], "comments": [{"text": "I am a legitimate pain patient NOT an addict. Ochronosis/Alkaptonuria is what I am suffering with-this disease is definitely in the intractable pain category! The irreparable injury being done to me is, in equity, the type of harm which no monetary compensation can cure or put conditions back the way they were. What has been done to me is SHAMEFUL and I am going to find a lawyer so they can never do harm to disabled Americans again!! AM NOT SURE HOW MUCH LONGER I CAN GO ON LIKE THIS! For thirty-two years I only saw one doctor along with the surgeons he sent me to, in all that time ,I have tried and tried seeking a specialist for the genetic bone disease they diagnosed me with called Ochronosis/Alkaptonuria- a Rheumatologist who could also help me live with this disease. But, every doctor that my old doctor referred me to- rejected seeing me - saying they could not help, especially now, when they see my medical records and see there is no cure for this disease, that only treatment that is listed for my disease- is pain medication - they have expressed they do not want to risk their livelihoods by taking me on as a patient. THIS DISEASE IS INTRACTABLE PAIN, its turns my bones black, brittle and eats way all the cartilage and the disc between my bones -my body over-produces a homogentisic acid  that literally nukes my vertebra and makes them inoperable black bones that look like a Mummies bones , it causes the nerves down my arms to become paralyzed and eats away at the valves to my heart, attacks the kidneys etc etc etc, BUT beyond all that I was doing as well as a person could. I have to have a chore service person because I can not lift anything more than 10 pounds, and if I sleep wrong I wake wake not being able to use my arms - But I changed my diet I kept my body as strong as I can And most people would never know the pain I live with every day! The irreparable harm that has been done to me and STILL BEING DONE TO ME has NOW caused this disease to spread even further down my back and they only let me have half the medicine I was on, the pain of going without medication has done irreparable damage me!!ALL this is causing my nerves so much stress, that my disease gets worse and worse everyday. why is it they can not see a legitimate patient from a patient who just wants to abuse it. Dont my medical records mean anything?! PLEASE if you know of anyone who could or would help me - would you show them this letter - I do not want to die or end up committing suicide - like all those veterans shooting themselves in the head everyday from being denied their medicine! mahalo nui loa, Virginia Leigh", "comment_id": "FDA-2013-D-0045-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0038", "comment_date": "2019-04-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2659}, {"text": "FDA-2017-N-1094Guidelines need to address legitimate prescription of opioids to people with chronic pain disorders.  They SHOULD NOT bepenalized!  Any one of us at any time can have an illness or injury that puts us in this situation! It should not be made more difficult for anyone with legitimate reason to receive relief from pain to live a functioning life. The whys of abuse/addiction need to be addressed for the remaining population before any cure can be realized andadministered. Lower socio-economic, ethnicity, race are factors for all drug and alcohol abuse.The areas of the country where this is prevalent have seen extreme economic downturns in the last 8 years or more.People are in despair! We need MORE research on Marijuana and its chemical makeup as it shows promise to help chronic painwithout the THC high, we need STEM cell research to find a way to help cure people who have chronic pain.We also need to be screaming to have our tax dollars go to support these efforts at both State and Federal levelsRebuilding infrastructure that would create jobs for the ones lost due to factory closures etc.,would infuse life back into these communities, people WANT to work and support themselves.Health care needs to be available at a cost that is affordable!  A sliding scale based on ability to pay!Our country appears to be stifled in arguing over these important issues that will affect EVERYONE.We need to remember you cannot teach a closed mind!", "comment_id": "FDA-2013-D-0045-0037", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0037", "comment_date": "2017-05-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1595}, {"text": "I am a long time chronic pain patient and I am extremely concerned  afraid of what my future will be because of how the new prescribing laws  regulations have affected millions of chronic pain patients ability to get adequate care/medication treatment for their life altering pain conditions. How in the world do you plan to win the war on drugs by eliminating access to medication for people with horrible,  debilitating illnesses? Doctors no longer want to treat us because we are too hi a risk  its much easier to be pushed away or just not take the risk. Lets face it,  Doctors have plenty of patients!  If opioid medications can include a deterrent  to stop abuse and/or improper use, yet still be effective at controlling pain,  I believe everyone would support that.  But in the crusade to stop abuse,  you have successfully removed or significantly reduced, millions of chronic pain patients access to *effective* pain medication dosages that actually have a positive impact on patients lives.  Millions of chronic pain patients are on the opioid treatments were on as a *last line of defense!* Weve already had the treatment alternatives,  the NSAIDS, the injections, the holistic  even the surgeries! Isnt that in fact the definition of chronic pain,  pain that is ongoing, pain that persists in spite of treatment and there is no known cure ? While other treatment therapies may help  I encourage any treatments that are helpful,  I know that MOST chronic pain patients would NOT BE ABLE to get themselves washed, dressed  driven to their alternative treatment appointments without the help of their opioid medication!  If you want to make opioid medications safer...do it, if you want to provide education to Doctors  Clinicians. ..do it, if you want to improve the drug epidemic provide quality,  afforable help for those with abuse and addiction issues! However, limiting/removing patients access to opioid medications which is the only thing left for millions of people, that provide any true quality of life,  many of whom otherwise, would in all probability contemplate suicide, is beyond my ability to understand! My final comment, is that the approach to this so called drug epidemic will never be successful. The reason? The people whose lives this effects to their very core: It IS the people who suffer with daily, chronic pain issues  BUT, WE have been COMPLETELY left out of all of these discussions,  regulations, treatment protocols  the media! People who are legitimate chronic pain patients with life altering pain conditions, just want to have a life thats actually worth living! Believe it or not, that can mean having the ability to do the simplest things that are unattainable without the relief opioid medications provide !  Thank-you for allowing me to comment on this very important topic. ", "comment_id": "FDA-2013-D-0045-0035", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0035", "comment_date": "2016-07-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2999}, {"text": "I have Fibromyalgia.  Thus I am very concerned with the Opiods conversation and new regs.   The facts that doctors are pulling back from prescribing meds that worked for me and now I will be in pain again and pushed back into bed because of the pain.  I will go fighting to keep myself from that fate.  I spent almost ten years there and no longer wish to see that happen again.I am in support of changing the Opioids to not work propery if not used in the proper way.   I just want to use the meds the way the doc perscribe them.    Make the meds so you cant snort them or whatever those people do to them.  Im all for it.  This way my doc can perscribe my meds to me and I can live at least a life where I manage life carefully.  Please do this before you pull Opioids off the market. ", "comment_id": "FDA-2013-D-0045-0034", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0034", "comment_date": "2016-01-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 817}, {"text": "To whom it may concern.  After over 20 years of chronic unrelenting pain, I am now taking an opoid painkiller.  Since that going on this medication two months ago, I am able to get around better, exercise over two hours a week and attend church.  I have done physical therapy, cognitive behavioral therapy, meditation, tai chi, muscle relaxers, antidepressants and so forth with minimal results.  I am asking you to consider that some people need this type of medication in order to function.  If the FDA wants to help us, develop medication that is not addictive.", "comment_id": "FDA-2013-D-0045-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0002", "comment_date": "2013-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 564}, {"text": "While I totally understand the need for regulation on Opioids, I hope that there is much thought and consideration taken into the pact that chronic pain patients cant be placed in a one size fits all box. Addiction is a huge issue but so is not being able to live a somewhat normal life without pain medications. I have Chronic Pancreatitis due to a birth deformity. Im 27 years old. Even with proper pain management I cant live like a normal person. If access to pain medication was limited to less than what I need for my condition my quality of life would be hugely impacted. There would be days I ended up bedridden, ER trips and hospitalizations would be increased and I would lose any ability to have a somewhat stable life. Ive worked in the mental health field so I have seen addiction first hand and I totally understand how terrible it is for the patient and their loved ones. Im not sure there is going be ever be a great solution to this issue but I hope that a balance can be found. ", "comment_id": "FDA-2013-D-0045-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0003", "comment_date": "2013-03-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1053}]}, {"id": "DEA-2008-0009", "agency": "DEA", "title": "Electronic Prescriptions for Controlled Substances", "update_date": "2015-11-17", "update_time": "12:28:19", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think e-prescribing is wonderful and would eliminate forgeries. Pharmacies could email practices instead of calling them if there were any questions about the Rx or its authenticity as well.  It would move toward a paperless practice, and save money for everyone.  If banks can move money this way, then we can do prescribing this way!", "comment_id": "DEA-2008-0009-0081", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2008-0009-0081", "comment_date": "2008-09-23", "comment_time": "04:00:00", "commenter_fname": "Jonathan", "commenter_lname": "Daitch", "comment_length": 362}, {"text": "NCPDP is submitting the following 2 documents as response to DEA-218P Electronic Prescriptions for Controlled Substances.", "comment_id": "DEA-2008-0009-0065", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2008-0009-0065", "comment_date": "2008-09-18", "comment_time": "04:00:00", "commenter_fname": "Lynne", "commenter_lname": "Gilbertson", "comment_length": 126}, {"text": "Re: Docket No. DEA-218P: Electronic Prescriptions for Controlled SubstancesThe Pain  Policy Studies Group (PPSG) respectfully submits a series of comments to the United States Drug Enforcement Administration (DEA).  These comments are in response to the DEAs anticipated modification of the Code of Federal Regulations (CFR), which is outlined in the proposed rule for Electronic Prescriptions for Controlled Substances and the corresponding Solicitation of Comments of June 27, 2008 (Docket No. DEA-218P).We recognize the obligation of healthcare professionals to provide effective treatment for legitimate medical purposes while also avoiding knowingly contributing to diversion of prescription controlled substances.  Alternatively, law enforcement and regulatory officials should prevent prescription medications from becoming a source of harm or abuse while ensuring that they are available for patient care.  It is this principle that underlies the proposed rule; the DEA states that the planned electronic prescribing system is designed to reduce diversion through prescription forgeries and maintain a sufficient supply of controlled substances for legitimate purposes (p. 36722).Although the proposed rule is considered an addition to, rather than a replacement for, the existing rules for prescribing, and practitioners use of electronic prescribing is voluntary at this time, the DEA anticipates that all practitioners will eventually transition to electronic prescribing of controlled substances (p. 36761).  As a result, it is essential that the authority be adequate, and that the technical and procedural characteristics of an electronic prescribing system be carefully and thoroughly vetted not only by practitioners, regulators, and law enforcement officials, but also by healthcare facility and insurance administrators and, perhaps most importantly given the nature of this electronic system, computer security experts.  We do not have enough information or expertise to comment on the calculated fiscal impact or the technological appropriateness of the proposed electronic prescribing system.  However, it remains unclear whether increases in registration fees will be used to cover the costs of the new system.  In addition, it seems that the DEA is placing much of the responsibility for system security on practitioners and pharmacies, but does the DEA have sufficient statutory authority to do so?   Does such authority to require this new responsibility lie within the Controlled Substances Act (CSA) authority to register practitioners?  Further, with todays technology, would it not be more appropriate and efficient for this responsibility instead to be accomplished centrally and electronically?  We appreciate the DEAs requests throughout the proposed rule for multidisciplinary feedback on various aspects of the prescribing system.  Such feedback will help achieve a final electronic controlled substances prescribing system that is feasible and effective while sufficiently satisfying the DEAs objectives and concerns.We applaud the DEA for attempting to offer an electronic controlled substances prescribing system that is designed to minimize the risk of diversion of these prescription medications while ensuring their adequate supply for legitimate medical and scientific purposes.  However, there are a number of procedures and requirements within the proposed CFR regulations that demand further consideration, so that the ultimate implementation of an electronic prescribing system does not foster unintended practitioner concerns about potential federal, state, or local law enforcement oversight.The question of balance.  Despite the statement that the proposed regulations are designed to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes (p. 36722) the new rule does not seem to establish responsibility for monitoring and reporting of cases where legitimate electronic prescriptions cannot be filled in a reasonable period.  The DEA should consider what system safeguards are needed to ensure an adequate supply of medications to patients with legitimate prescriptions.  The obligation to ensure adequate medication availability and access should be reflected throughout the regulation, as it is in the CSA. 1311.100(c)  Eligibility to issue electronic prescriptions.  Under this provision, practitioners are given the broad responsibility to confirm whether an electronically-issued prescription for a controlled substance does not conform to all essential respects to the law and regulations (p. 36775).  This requirement clearly establishes an obligation for the practitioner to be responsible for the effectiveness of the security system established by this regulation, and for verifying third-party audit reports (as in  1311.155(f)).  Of course, practitioners must remain responsible for issuing electronic prescriptions only for a legitimate medical purpose and in the usual course of professional practice, as they are with paper or oral prescriptions.  However, the technological complexity of the electronic prescription system, and corresponding services, could establish for practitioners an onerous burden of oversight over a system for which they ultimately have little control.  Responsibility for the efficacy and accuracy of the electronic prescribing system and security services should reasonably fall to the hardware/software manufacturers and the computer security technicians. 1311.105(b)(2  3)  Electronic prescription system requirements: Identify proofing.  Among other requirements, practitioners who wish to prescribe controlled substances electronically must submit to in-person identify proofing conducted either by the state professional or licensing board, state controlled substances authority, or a state or local law enforcement agency.  This is a practice requirement that has few if any precedents with other, non-law enforcement, professionals, and the healthcare community likely will perceive this as a criminalization of medical practice.  Research and published reports demonstrate that healthcare practitioners historically have avoided engaging in prescribing practices associated with greater law enforcement scrutiny, such as with state triplicate prescription monitoring programs.  The prospect of practitioners acquiring identify proofing through local law enforcement agencies could significantly impede the widespread adoption of electronic prescribing.  Given these considerations, we recommend that the requirement of in-person identity proofing, if maintained, be satisfied solely through the use of non-law enforcement organizations. 1311.140(b)  Electronic prescription system requirements: Providing log of prescriptions to practitioner.  A practitioner using an electronic prescription system seems required to review, and indicate review of, monthly logs of all electronic prescriptions issued by the practitioner during the previous month using that system.  When describing this provision in the Section-By-Section Discussion of the Proposed Rule (p. 36754), the DEA does not detail the practitioners ultimate responsibility to review and approve the information in the logs, the manner and timeframe in which the review must be completed, or the practitioners liability for failing to review the log.  This obligation, as well as the other requirements detailed above, seems to create a new practice standard that places more responsibility, and thus increased liability, for proper implementation of the law on practitioners.  In addition, there is a need to specify the confidentiality of all such records, including who has access and under what circumstances. 1311.165(a)  Pharmacy system requirements: Prescription processing.  Pharmacists have a corresponding responsibility for the proper prescribing and dispensing of controlled substances ( 1306.04(a)).  This proposed provision requires the pharmacy, or the prescribing practitioners service provider or one of the intermediaries to verify the validity of a practitioners DEA registration prior to dispensing; if the prescription is not determined to be valid for any reason, the pharmacy must reject the prescription  A pharmacy that fails to check the validity of controlled substance prescription before dispensing is legally responsible if the prescription is invalid (p. 36740).  Under current federal law, pharmacists are not required to verify a practitioners DEA registration before every controlled substance prescription, paper or oral, is dispensed, but are given guidance about how to verify practitioner registration, when there is a reason to do so, in the DEAs Pharmacist Manual (April, 2004).  Although this new requirement could be considered simply an extension of the corresponding responsibility requirement of  1306.04(a), the language could be viewed as creating an additional legal and practice standard which may an additional compliance burden for pharmacies and may even become part of state pharmacy boards requirements .Again, we agree with the DEAs objective of proposing an electronic controlled substances prescribing system that reduces medication harm and risk of diversion while maintaining availability for legitimate medical and scientific purposes; given this objective, the new regulation should require the DEA to submit an annual report concerning various aspects of the system operation, including the prevalence of system errors that reduce patient access and how these are corrected.  However, the proposed system of checks and balances seems likely to create a cumbersome and overly strict system that, if implemented as currently designed, would result in an enormous burden of oversight for practitioners and pharmacies.  We anticipate that concern about law enforcement actions resulting from failure to comply with the complex regulatory requirements will be a substantial reason for practitioners and pharmacies deciding against voluntarily engaging in these procedures.  Since practitioners currently have the option of issuing electronic prescriptions, such profound disincentives would argue against electronic prescribing becoming a feasible practice, thereby undermining the program intent.  We urge the DEA to consider the issues above, as well as those involving sufficiency of authority, fiscal impact, and system and security technology, when modifying the proposed rule before issuing the final regulations.Sincerely,Aaron M. Gilson, MS, MSSW, PhDDirector of U.S. Program, Senior ScientistDavid E. Joranson, MSSWFounder, Distinguished Scientist", "comment_id": "DEA-2008-0009-0117", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2008-0009-0117", "comment_date": "2008-09-25", "comment_time": "04:00:00", "commenter_fname": "Aaron", "commenter_lname": "Gilson", "comment_length": 11677}, {"text": "In the proposed rules and regulations for Electronic prescriptions for controlled substances needs to be a provision for if when the Electronic prescription is received at the pharmacy, and the patient decides to actually fill the prescription at another pharmacy, that the original receiving pharmacist may print out the electronic prescription and hand it to the patient to take elsewhere. Often times when a hand written controlled prescription is presented at the pharmacy we can not fill it for a full amount, or do not have the product in stock. If the patient can not wait for the product to be specially ordered a provision needs to be in place to allow the patient to have the prescription filled at another pharmacy. Since the prescriber might not be available to contact by the alternate pharmacy for a new electronic prescription then the first one sent must be able to be printed out, handed to the patient or their representative, and then brought to another pharmacy. In lieu of this, the electronic prescription might be electronically forwarded un-altered to another pharmacy that accepts electronic prescriptions. Hopefully this situation will be addressed in the upcoming rules. ", "comment_id": "DEA-2008-0009-0045", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2008-0009-0045", "comment_date": "2008-09-08", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Saija", "comment_length": 1268}]}, {"id": "VA-2009-VHA-0018", "agency": "VA", "title": "AN15 - Final Rule - Charges Billed to Third Parties for Prescription Drugs Furnished by VA to a Veteran for a Nonservice-Connected Disability", "update_date": "2018-07-11", "update_time": "01:04:10", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Im covered under a Medicare Part D plan, but I am also covered on my wifes insurance plan.  I know VA doesnt bill Medicare, but why do I always get charged a full copay for my drugs at VA?  When I ask aty the VA Im told the insurance company wont pay for my drugs, why is that?", "comment_id": "VA-2009-VHA-0018-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2009-VHA-0018-0003", "comment_date": "2009-08-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 302}, {"text": "August 10, 2009DirectorRegulations Management (02REG)Department of Veterans Affairs810 Vermont Avenue, NWRoom 1068Washington, D.C.  20420RE:  RIN 2900-AN15 Charges Billed to Third Parties for Prescription Drugs Furnished by the VA to a Veteran for Nonservice-Connected DisabilityDear Director:Thank you for the opportunity to comment on the proposed rule regarding Charges Billed to Third Parties for Prescription Drugs Furnished by the VA to a Veteran for Nonservice-Connected Disability.Express Scripts, Inc. is one of the largest pharmacy benefit management (PBM) companies in North America, providing PBM services to millions of consumers.  PBMs manage prescription drug benefits for thousands of client groups, including managed-care organizations, insurance carriers, third-party administrators, employers and union-sponsored benefit plans.  Specifically, we administer benefits on behalf of various payers and health plans for the VA program.   In the proposed rule, the Department of Veterans Affairs would move from a flat $51 average drug charge amount to an actually drug ingredient cost incurred by the VA plus a $11.17 dispensing fee.  While we understand the Departments desire to bill third parties for a more accurate prescription drug amount, we have serious concerns about the proposed rule and its impact the rule could have on the prescription drug market.The proposed rule would require third party plan sponsors to reimburse the Department of Veterans Affairs for its actual acquisition costregardless of whether that cost is what the private plan would have paid.  While the VA clearly has a favored purchase price on single source prescription drugs, that is not necessarily the case with generics.  For example, many PBMs purchase generics in bulk and repackage them.  This can result in the plan sponsor actually paying less for a generic drug than what the VA would bill for.The proposed $11.17 dispensing fee does not comport with average private sector dispensing fee.  In the commercial market, a PBM fiercely negotiates dispensing fees and our industry has been successful in negotiating such fees to a range of $1.50-2.00.  To require private plan sponsors to pay the VAs administrative fee would require a plan sponsor to pay a much higher fee than if they had paid the claim according to their own terms and conditions.In addition to the serious policy concerns we have with the Departments proposed rule, we also have several concerns with how the VA might go about implementing such a policy.  Specifically:What is the proposed timeline to make system changes and under what timeline will changes be applied?  Under current law claims can be submitted up to four years after the date of service.  It would be our strong recommendation that the VA clarify that any such proposed rule apply prospectively, from the date of service, so as to distinguish between reimbursement under the new system and reimbursement under the old system. How will the Department determine the price point within the Drug File and how will this information be communicated to plan sponsors?  What field will the Department use to submit cost information? While we understand the Departments desire to pay more accurately for prescription drugs, the proposed rule will substantially raise private plan sponsors VA responsibility.  Some sort of graduated or phased implementation should be considered so that plan sponsors have time to absorb these increased costs.In summary, we have serious policy and technical concerns with the Departments proposed rule.  We particularly are concerned with the extremely high mandated dispensing fee.  We urge the Department to take our concerns into account when promulgating any final rule.Thank you for the opportunity to comment.  If you have questions you can contact me directly at 952-949-3868 or cjones@express-scripts.com. Sincerely,Carolyn JonesSenior Director PolicyExpress Scripts, Inc.", "comment_id": "VA-2009-VHA-0018-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2009-VHA-0018-0004", "comment_date": "2009-08-18", "comment_time": "04:00:00", "commenter_fname": "Carolyn", "commenter_lname": "Jones", "comment_length": 4501}, {"text": "How will this make certain that as a veteran my prescriptions for 90 days are paid by my insurance company so that I am not charged a copay?", "comment_id": "VA-2009-VHA-0018-0002", "comment_url": "https://api.regulations.gov/v4/comments/VA-2009-VHA-0018-0002", "comment_date": "2009-07-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 140}]}, {"id": "CDC-2020-0091", "agency": "CDC", "title": "Medication-Assisted Treatment (MAT) for Opioid Use Disorders Study 0920-1218 Revision ", "update_date": "2020-10-29", "update_time": "08:07:41", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "Regarding the Department of Health and Human Services/Centers for Disease Control and Prevention (hereinafter the agency) request for additional time to collect patient data regarding opioid addiction, there are a few things to consider. First, the patient recruitment period for this project was extended so it should have been expected that the processing of the collected data would also require some extensions in response. Also, there is practical utility in the information being requested by the agency because without treatment information to battle opioid addiction, we wont know what works and what doesnt. This information is necessary to the functions of the agency in their pursuit to enhance the health and well-being of all Americans. While we are currently in the midst of a global COVID pandemic, we cannot set aside the opioid epidemic that has been ravaging this country for years now. Gathering this information is necessary to continue the fight against addiction in this country. While many Americans are currently out of work and facing economic difficulties due to the COVID pandemic, many may be turning to their addictions to cope. Now more than ever we need as much information as possible to assist in battling this debilitating addiction to opioids be it through medication-assisted treatment, or otherwise. It is imperative to obtain this information to find out what treatment is working and what is not, and what factors can contribute to a successful recovery. The agency has estimated a straightforward and minimal cost to obtaining this information but there are not many details on how this information will be obtained. The questionnaire to be submitted by the patients seems a minimal inconvenience to the patient and of a minimal cost to the agency to process. Due to a lack of details, it could be assumed that this questionnaire would be obtained through electronic means, through the mail, and possibly an in-person pick up or drop off site. An electronic portal would be the most convenient, but not all patients may have access to the technology needed to return the information requested. Having a secure address for each patient and including a self-addressed stamped envelope could go a long way in receiving the information back but also having a site for information pick up and drop off - possibly at the local health department or their treatment site, could all contribute to receiving the information from each patient participant with minimal inconvenience. The information collection costs cited by the agency are extremely low in comparison to the value of the information. When you contrast the costs of the estimated 300 hours it would take to process the returned information versus the recent $8 billion settlement against Purdue Pharma, it could even be argued that these efforts could be increased. Deaths have been on the rise since approximately 2014 and efforts need to be increased in understanding the addiction and what utilities we have available to battle the addiction. This request by the agency should be considered a low cost, inconvenient starting point.", "comment_id": "CDC-2020-0091-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0091-0003", "comment_date": "2020-10-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3151}, {"text": "Medication Assisted Treatment (MAT) has been a wonderful option for those in need. I firmly believe that primary care providers should be not only Able to prescribe, but ENCOURAGED TO PROVIDE this option for their patients. In so many areas the access to clinics that utilize MAT becomes more than another barrier to treatment- but a giant HURDLE that many folks cannot physically, economically, mentally, emotionally, and quite LITERALLY overcome. We need to end the stigma of being on medications to treat patients. Can you imagine...if everytime that you needed the medication to manage your blood pressure or high cholesterol... you had to drive 120 miles round trip, DAILY for 90 days, attend groups that inform you about the stuff that you already KNOW- or could simply GOOGLE  find out about your medical issue, possibly LOSE ACCESS to the medication because of human error that was made in a routine mandatory lab that you had no control over,  then had to deal with others who dont understand high blood pressure JUDGING YOU CONSTANTLY  shaming you for having it?Or, can we simply let primary care providers DO THEIR JOBS, TREAT THEIR PATIENTS, encourage those who seek treatment,  DEFEND THEIR RIGHT TO ACCESS OF MEDICATION?! One more thing.... the idea that a human being needs to choose which debilitating illness- Acid Reflux (treated effectively with omeprazole) or Hypothyroidism (treated effectively with Synthroid) is insane! Oops....wait..that IS NOT THE CASE! Both of those diagnoses are JUST FINE TO HAVE TOGETHER. I meant these- PTSD/ANXIETY disorder (treated effectively with benzodiazepines) and chronic pain (treated Effectively with opiates). Humans who have established treatment regimens that are effective shouldnt have to suffer because of a non-healthcare provider gets to decide what is best for their health. ", "comment_id": "CDC-2020-0091-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2020-0091-0002", "comment_date": "2020-10-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1936}]}, {"id": "FDA-2012-P-0818", "agency": "FDA", "title": "Regulate Labeling of Opioid Analgesics - CLOSED", "update_date": "2016-08-31", "update_time": "11:20:37", "purpose": "Nonrulemaking", "keywords": ["cder", "closed"], "comments": [{"text": "na", "comment_id": "FDA-2012-P-0818-0789", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0789", "comment_date": "2013-07-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2}, {"text": "With all of the news hype about the number of overdose deaths, which as a researcher I have evaluated by actually reading the documents cited rather than merely accepting a citation as supporting a contention, the lost truth is the never decreasing number of people in chronic pain whose suffering underpins this ongoing and not particularly scientific debate.  That some patients develop hyperalgesia does not speak to the multitudes who do not. That some people misuse and abuse opioid and other medications does not address the multitude who do not.  Lost in this controversy of vested interests and fear, of prosecution or ignorance or regulatory overload, are the multiple thousands of people who benefit from chronic opioid therapy, and beyond benefiting are able to live functional and productive lives.  This proposal ignores the reality that different people have profoundly different tolerances to medications. Pain, in its daily reality is vastly different than it is in theory to some faceless person miles if not thousands of miles away. It is not an imagined event but, rather, a neurobiological cascade with damaging long term consequences which are as dangerous as this now uncontrolled fear of overdose so reminiscent of the fears of Prohibition and the ever escalating war on drugs which we have long since lost.  Quite frankly, it fits well with managed care with guidelines determined by non-healthcare professionals. However, that is not medicine. It is time to return some autonomy to the doctors who have spent the necessary years in learning to treat suffering, as well it is time to stop reacting and start thinking. It is time to stop twisting statistics to meet the needs of biased arguments and instead start being honest about what is the underlying problem. Surely, there are very few doctors truly acting as the diversion to the streets that everyone from law enforcement to professional licensing boards claims exist. This is too important for the game of act-react.", "comment_id": "FDA-2012-P-0818-0784", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0784", "comment_date": "2013-05-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2010}, {"text": "I emphatically support PROPs petition. Opioid label changes are needed so that FDA can prevent drug companies from making false claims that opioids are proven safe and effective for chronic, non-malignant pain.  Label changes will also reduce overprescribing by sending a clear message to the medical community that benefits may not outweigh risks when opioids are prescribed long-term and in high doses.As an emergency physician, I feel the medical community has been falsely informed for the last 2 decades.  We have created a culture of pain and disability prompted by the drug makers and by pain societies.  Because of this we are in the midst of an epidemic of opioid dependency which is leading to alarming numbers of deaths and social disruption.  Please change the labeling so we can reverse this most disturbing trend.  We owe it to our patients and their families. Gratefully,Aaron Wohl, MDPracticing Emergency PhysicianLee Memorial Health SystemFort Myers, FL", "comment_id": "FDA-2012-P-0818-0774", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0774", "comment_date": "2013-04-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1024}, {"text": "I DO NOT support the PROP petition. I have worked as a nurse practitioner in pain management for almost 15 years. I have seen countness patients improve their quality of life with the multidisciplinary treatment options we offer. I have also seen countless patients continue to work that would have ended up on disability. Pain medications are not evil. The evil is the greed of some physicians who see pain management as a profit making business. Physicians who do not have training in pain management (GYN MDs, general surgeons, etc) who have no business doing pain management just like the physicians I work (board certified in anesthesia and pain mgmt) for have no business doing brain surgery. Pain medications are beneficial when done correctly with the right screening, the right degree of monitoring and the right degree of follow-up. Some of these practices are just pill mills and have not real f/u or assessment of risk to prescribe meds. And not every patient is addicted, which is the position addictionologists take with this issue. They have always thought pain meds were evil and shouldnt be used but they see the negative part of opiate abuse and not the positive benefits that it offers. Saying opiates can only be used for 90 days is going to hurt many innocent patients who a benefitting from pain management. The answer is not stopping prescribing but allowing only trained pain management physicians to practice this specialty--not anyone who wants to say they are pain management and to only allow physician owners of pain management practices to ensure that they are not just for profit centers. Taking away a viable treatment option for legitimate patients is cruel. How will these people feel if they need chronic pain management for a legitimate diagnosis in the future and they are limited to 90 days worth of medications. This is a cutting off the nose to spit the face reaction to this public health problem.", "comment_id": "FDA-2012-P-0818-0759", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0759", "comment_date": "2013-02-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1955}, {"text": "Given the huge number of addicts who innocently just wanted to be rid of physical pain, intelligent, professionals including medical professionals, something has to be done. I believe the changes in prescribing suggested will help. Ultimately, the docs and nurses need to be much more aware of the long term ramifications to their patients as they write the prescriptions and give appropriate guidance as as the hand over that piece of paper.", "comment_id": "FDA-2012-P-0818-0715", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0715", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 442}, {"text": "I completely support PROPs petition.  Over prescribing is a major problem in our area and done by good doctors who are not given full information by the drug companies.I am a pain physician and now spend most of my time trying to get patients off of narcotics prescribed by well meaning physicians.  Re labeling is the minimum we can do.John Hart, DO ", "comment_id": "FDA-2012-P-0818-0758", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0758", "comment_date": "2013-02-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 376}, {"text": "I am a Nurse, Hospital Administrator of over 26 years in the military where I served as an Auditor making sure medical contracts from medical supplies, Doctor care, prescriptions, medications and Manufacture contracts were in compliance with JACHO and the terms of the contract and laws were upheld.In my limited duty, I found over six million dollars in error in contracts, Nursing contracts, and medication charges from manufacture.NOW why does this petition effect me ? I am disabled by a severe disease requiring a three level spinal fusion (taking three discs out of my vertabrae replacing with BAK cages) and I have two rods and seven long screws sticking me.An approved procedure, Spinal Injections which the FDA does not  approve for spinal injection was used on me over twenty times along with eight myelograms and I acquired arachnoiditits from the multiple procedures with an unapproved medication in the epidural spaces. Recently this medication was shown to get fungi, and I was told that I had to have those injections first before I could be on medication management !!! I am sorry for the loss of lives of overdoses but these people should have intervention no Physicians.Some of the staff of this petition knew their family was mentally sick, being a physician she could have him commited, not blame opoid dosing. So DO I SUFFER with decreased dosageto account for the deaths of people who knew better and will get it somewhere and kill themselves. There are warnings on the medication inserts. Realize that you are taking pain relief away from Millions to pacify your inadequecy to have programs to assist addicts. Free Pot laws, Death laws for people to kill themselves while you are supposedly wanting responsible opoid dosages (less than manufacturerdoses/PDR dosages) does not make sense. So the uncontrolled pain patients come to Oregon and Washington State and ask for assisted suicide, Nice Policy-You are a death sentence for me.", "comment_id": "FDA-2012-P-0818-0771", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0771", "comment_date": "2013-02-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1995}, {"text": "I am deeply concerned about changing the wording of this document to delete the word moderate and add caps nto the amount of medication a patient may have and the amount of time they may take a medication.  A person is the best judge of their pain and they have the right to excellent treatment.  We should not deny them treatment because their pain is moderate.  It is already difficult enough for the to procure their medication without making it more difficult.I urge you not to change this rule.Thank you for your time. ", "comment_id": "FDA-2012-P-0818-0775", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0775", "comment_date": "2013-04-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 534}, {"text": "I am against this change for these reasons:1.  Not everyone can take the same dose, our bodies are not all the same.2.  Chronic Intractable pain never goes away, we live with it for life.3.  Addiction and dependency are two different things, we are not drug addicts, we have no quality of life without the medication.4.  Without medication, most of us can no longer work or take care of our families, we are confined to beds or chairs, unable to have quality life.5.  It is a provable fact that untreated or under treated chronic intractable pain patients often end up divorced, unable to work, have trouble interacting with their children and do commit suicide.6.  To see what a person can accomplish with the right medications, please read this:  http://www.foresttennant.com/pdfs/905-Feature-JFK-Tennant.pdf7.  Most patients who take opioids only take them because other medication does NOT work for them.8.  How can physicians decide what is right for a patient when they have never seen or treated them?9.  Do you consider it to be humane to let people suffer in terrible pain because some can not follow directions or blame innocents for their family member taking medication illegally? 10. Do we blame a gun when someone uses it to kill someone?11. Do we blame the car when the driver is drunk and kills a family while driving that car?12. There are NO new studies on this matter,  Physicians for Responsible Opioid Prescribing are using data that is old and incomplete.  They are not concerned about chronic intractable pain patients, their spokesman has publicly said we are not important.13. I agree with PROMPT (Professionals for Rational Opioid Monitoring  Pharmaco Therapy)  You received a petition from them on this matter as well.14. Chronic intractable pain is not a picnic to live with, in many ways it is like a baby, you have to live your life around it.  Some days we cant even get out of bed because the pain is so bad, others we are moving around barely.  ", "comment_id": "FDA-2012-P-0818-0697", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0697", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2070}, {"text": "I strongly support the petition submitted by the Physicians for Responsible Opioid Prescribing.  As a physician who has provided treatment for opioid dependence for the last 4 years, I can attest from first hand experience that ever greater numbers of patients are coming to treatment after becoming dependent on pills that were originally prescribed by a physician.  Label changes will raise provider awareness that we have no data to support long term or high dose opioids for chronic pain, which should reduce the number of people exposed to these powerful chemicals.More important, as a physician who provides primary care to patients with chronic pain, I believe that our patients have a right to know that no data supports the use of long term or high dose opioids.  Label changes, and the consequent public announcements surrounding them, will facilitate this in a way that simple provider education cannot.  FDA regulations allow direct to consumer advertising on behalf of pharmaceutical companies selling their wares, they should do more to promote direct to consumer messages about what the scientific evidence for the use of these drugs really states.", "comment_id": "FDA-2012-P-0818-0719", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0719", "comment_date": "2013-02-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1168}]}, {"id": "DEA-2020-0035", "agency": "DEA", "title": "Partial Filling of Prescriptions for Schedule II Controlled Substances", "update_date": "2023-07-21", "update_time": "08:48:17", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I live with a person who suffers from chronic pain and takes her prescription as directed by her pain management doctor. Even with the help of her prescription, she is not fully pain free and often can not leave the house to take care of her personal needs. Having to make multiple trips to her pharmacy would put her in a situation where she may have to travel while in a great deal of pain; this would be unfair to her. The amount of medication prescribed to a patient should be made at the discretion of treating doctors. Furthermore, enough medication should be prescribed to a responsible patient to minimize the financial burden and health risks associated with multiple trips to a pharmacy. The potential abuse of schedule II medication by some irresponsible individuals should not negatively impact patients who use their prescriptions responsibly and rely on them to help them live as close to a normal life as possible. ", "comment_id": "DEA-2020-0035-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0006", "comment_date": "2020-12-16", "comment_time": "05:00:00", "commenter_fname": "Eric", "commenter_lname": "Parks", "comment_length": 945}, {"text": "Proposal Comment: Docket No. DEA-469Under the proposed rules for Partial Filling of Prescriptions for Schedule II Controlled Substances-Proposed Rule by DEA on 12/04/2020  ID: DEA-2020-0035, the DEA must take steps to provide alternatives to the opioid crisis by creating partial refill options that can be opted by the provider or client in order to better customize legitimate opioid prescriptions to minimize deterrence and burdensomeness on providers, clients and our society, given the opioid epidemic plaguing our country. Between 2006 and 2016, average days of supply per prescription increased from 13.3 to 18.3 days, an overall relative increase of 37.6% (CDC, 2018). Although this is a steady decrease in gradual reductions of average days of supply per prescription since 2006, the progress has been slow. This trend could be greatly impacted by this proposal with the potential reduction of excess in-home opioids which this proposed rule would cultivate.At a minimum, a patient should be able to direct their decision to obtain fewer opioids than the full prescription in order to mitigate concerns for opioid overuse by themselves, family or other community aspect. Consuming opioids beyond the experienced management period for which they are intended can set up a patient to have beginnings of new dependence issues. Furthermore, this practice would parallel the inpatients prerogative when they choose the minimum level of pain medication for adequate pain management. In regard to provider notification by the pharmacist, as a DNP graduate student I believe that the potential increase in costs and clinicians time do not warrant this action. I do agree that a partial refill upon dispensation does warrant an electronic pharmacy record depicting the controlled substance dispensation quantity and the requesting party be it the provider or patient. ReferenceCenters for Disease Control and Prevention (2018). 2018 Annual surveillance report of drug-related risks and outcomes. https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf", "comment_id": "DEA-2020-0035-0021", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0021", "comment_date": "2021-01-28", "comment_time": "05:00:00", "commenter_fname": "Madonna", "commenter_lname": "Reece", "comment_length": 2120}, {"text": "I am in support of Docket No. DEA-469 for Partial Filling of Prescriptions for Schedule II-Controlled Substances for several reasons.  One, this proposal should have a positive economic impact on individuals.  I suggest partial fillings should result in lower copay with the additional partial filling copay, if needed, to not exceed the amount of one full prescription fill.  Unused prescriptions drive demand for opioids and the reduction of such medications could presumably decrease drug prices.  Secondly, allowing the individual the opportunity to opt for a partially filed prescription promotes patient-centered care allowing them to contribute to their own treatment plan.  Partially-filled prescriptions will decrease the number of unused medications diminishing the opportunity for drug diversion and misuse.  Increased prescribing practices from providers has contributed to the growing epidemic (AAFP, 2020).  With limited data to support the effectiveness of long-term opioid analgesic use for pain management, limiting the supply for potential abuse should be promoted.  In response, to the alternative approaches I believe allowing the pharmacist to dispense the partial fill as requested without consent or notification to the prescribing practitioner is the most appropriate and cost-effective approach.  Agreeably, a situation arising in which a provider refusing a partial fill seems nonexistent.  As we attempt to confront the opioid epidemic plaguing our country, we must find effective, evidence-based alternatives to adequately manage pain and not consequently create more opioid abusers in the process.  American Academy of Family Physicians (2020). Chronic pain management and opioid misuse. A public health concern (position paper).  https://www.aafp.org/about/policies/all/chronic-pain-management-opiod-misuse.html", "comment_id": "DEA-2020-0035-0022", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0022", "comment_date": "2021-02-01", "comment_time": "05:00:00", "commenter_fname": "Connor", "commenter_lname": "Rezzonico", "comment_length": 1851}, {"text": "Partial Filling of Prescriptions for Schedule II Controlled Substances, Docket No. DEA-469Although the Drug Enforcement Agency (DEA) regulations provide three exceptions, generally speaking, a pharmacist cannot partially fill a controlled-II prescription for a patient (Heesters, 2020). The DEA is, however, proposing to amend the regulations where a pharmacist would be able to partially fill a controlled-II prescription as authorized under the Comprehensive Addiction and Recovery Act (CARA). According to the Wyoming Department of Health (2021), 65 people died in Wyoming from an opioid overdose in the year 2018. An estimated 10.3 million people aged 12 and older misused opioids in the year 2018 (HHS, 2020). Misuse of prescription drugs is a problem both nationally and state-wide. If permitted, this will expand opportunities for a partial filling of schedule II-controlled substances in certain instances which will ultimately reduce waste, lower the use of controlled substances, and reduce the potential for addiction, overdose, and diversion. Thus, I support the DEAs proposed rule for partial filling of prescriptions for schedule II-controlled substances. ReferencesHeesters, M. (2020). DEA proposes rule to expand partial filling of schedule II prescriptions; Will the benefit be cost-effective. https://www.fdalawblog.net/2020/12/dea-proposes-rule-to-expand-partial-filling-of-schedule-ii-prescriptions-will-the-benefit-be-cost-effective/U.S. Department of Health and Human Services (HHS). (2020). Opioid crisis statistics. https://www.hhs.gov/opioids/about-the-epidemic/opioid-crisis-statistics/index.html#:~:text=In%202018%2C%20an%20estimated%2010.3,and%20808%2C000%20people%20used%20heroin.Wyoming Department of Health. (2021). Opioids. https://health.wyo.gov/publichealth/prevention/substanceabuseandsuicide/opioid-information-wyoming/", "comment_id": "DEA-2020-0035-0025", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0025", "comment_date": "2021-02-01", "comment_time": "05:00:00", "commenter_fname": "Raegan", "commenter_lname": "Kartupelis", "comment_length": 1902}, {"text": "After reviewing the proposed rule for Partial Filling of Scheduled II Controlled Substances, from the patient perspective I agree with the cost savings and safety aspects of partially filling. The patient may only wish to fill part of a prescription based on monetary and/or safety factors. This gives the patient an option regarding their own health care and outcomes, and can lend to patient empowerment and engagement. The partial filling option may also increase community safety, decrease waste, and potentially decrease abuse of schedule II prescriptions. However, these choices are often left to the patient and proper education will be required to reap benefits from such a rule. From the providers perspective, I question if this additional option results in time, cost and waste savings. It is difficult to estimate how many unused medications are currently in homes, therefore estimating safety, cost, and waste benefits is not exact. Further, how likely will patients choose to utilize a partial fill when they are suffering from an acute problem that would require two trips to the pharmacy in 72 hours versus one trip. How often will a patient choose to fill one week at at time or 3 days at time, within a 30 day fill period. There are some instances in which a patient might choose this route, though I believe it is the exception not the rule. From the providers perspective, I believe this rule increases the amount of time a provider will spend writing and sending prescriptions, and it increases the amount of education required for the patient to properly understand the available options regarding schedule II substances. Visit time required for the provider to understand the patients circumstances and needs if the patient is willing to utilize the partial fill option should be considered and calculated. I believe the majority of providers have the patients best interests and health at heart. I also believe most providers will do what they can to facilitate best practices and patient safety, with or without the proposed rule. The proposed ruling embodies these concepts; however, ultimately this rule relies on patient understanding and compliance. The DEA is estimating over $640 million in costs savings with this propsed rule. While economics are always a driving factor, time is at a premium. I question if this rule will facilitate the desired change and cost savings.  ", "comment_id": "DEA-2020-0035-0028", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0028", "comment_date": "2021-02-01", "comment_time": "05:00:00", "commenter_fname": "Sonia", "commenter_lname": "Klein", "comment_length": 2425}, {"text": "Being a nurse and student, I see people come in every day who are addicted to schedule II substances.  Many of these patients were seen by an older family practice MD who would prescribe these medications without assessing other options first.  Practitioners who I have recently worked with have attempted discontinuance of these schedule II substances, but patients have not tolerated the change well, requiring the need for a renewed prescription.  Allowing partial fill of medications eliminates the possibility of extra medication be stored for potential future use.  Preuss, Kalava,  King (2020) report that 55-65% of people obtain schedule II-controlled substances from a friend or relative that received the prescription in the past.  In hopes of making changes in the future, assessing the new proposed rule of partial filling of prescriptions for schedule II-controlled substances would allow patients the option of lower cost prescriptions, decrease chances of medication dependence or overdose, and reduce the frequency of medication use from people other than the individual prescribed. One question I do have is if the patient fills a partial prescription and then fills the other portion of the prescription at a later date, would the patient be charged two separate co-pays?Preuss, C., Kalava, A.,  King, K. (2020). Prescription of controlled substances: Benefits and risks. StatPearls. https://www. ncbi.nlm.nih.gov/books/NBK537318", "comment_id": "DEA-2020-0035-0012", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0012", "comment_date": "2021-01-25", "comment_time": "05:00:00", "commenter_fname": "Caitlyn", "commenter_lname": "Nitsch", "comment_length": 1487}, {"text": "Docket No. DEA-469 Partial Filling of Prescriptions for Schedule II Controlled SubstancesAs a registered nurse of 15 years and current APRN student I support the proposal of partial filling for schedule II prescription medications as requested by the practitioner OR the patient in accordance with state law. There are many reasons a practitioner or patient may request a partial fill including cost, need, and effort to limit exposure. For these reasons it is vital that the patient have the ability to request a partial fill with or without written permission from the practitioner. This process poses little to no risk given that the patient will not receive a number of pills beyond what the original prescription indicates, they will only have 30 days to fulfil the remainder of the prescription, and the practitioner will have access to information regarding the dispensed medication. Allowing the patient to request a partial fill is an excellent example of empowering the patient to participate in shared decision making regarding their use and need of schedule II controlled substances.  ", "comment_id": "DEA-2020-0035-0016", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0016", "comment_date": "2021-01-26", "comment_time": "05:00:00", "commenter_fname": "Brittany", "commenter_lname": "Cox", "comment_length": 1107}, {"text": "Partial Filling of Prescriptions for Schedule II Controlled SubstancesDocket No. DEA-469The proposed rule to conform and delineate DEA regulatory requirements for partial filling of prescription for schedule II controlled substances in the Comprehensive Addiction and Recovery Act of 2016 is necessary for proper auditing by the DEA and clear guidance for practitioners and pharmacists. I support the proposed rule to specify the quantity to be dispensed for partial filling of a prescription and allow the patient to request a partial filling through alternative means. Firstly, as a nurse practitioner student, I can appreciate the clear guidance and communication when prescribing a schedule II controlled substance for my patients safety and sustaining compliance with the DEA. Secondly, allowing a patient to partially fill a prescription by way of phone or written request is necessary for an acute condition where the patient is unable to be physically present. By passing the proposed rule, accurate dispensing and recording of schedule II controlled substances are supported and the patients access to their prescription is more easily attained.", "comment_id": "DEA-2020-0035-0013", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0013", "comment_date": "2021-01-25", "comment_time": "05:00:00", "commenter_fname": "Amanda", "commenter_lname": "Hirz", "comment_length": 1174}, {"text": "Docket No. DEA-469, Partial Filling of Prescriptions for Schedule II Controlled Substances. Thank you for the opportunity to comment. My name is Rebecca M Tharp. I have been a registered nurse for nearly 13 years and am presently a doctoral family nurse practitioner student. As a future provider, I believe the partial filling of schedule II-controlled substances will help reduce unnecessary waste, avert risky disposal of unused narcotics, prevent theft of unused portions for illegal use or sale of narcotics, allow for reduced prescription costs for patients, and empower patients in greater shared decision-making. The need for pain relief and the use of opioid analgesics has been a double-edged sword as practitioners walk the fine line between undertreatment and overtreatment, especially amid todays opioid state of crisis (Preuss et al, 2020). Addiction to opioids has been extremely problematic in our society for decades and is the very reason the Controlled Substance Act of 1970 exists. Preuss et al (2020) noted that extreme risk of addiction and further substance use is a known factor for schedule II-controlled substance use. Therefore, partial filling of schedule II-controlled substances will help to alleviate this crisis and should be implemented. References: Preuss, C.V., Kalava, A.,  King, K.C. (2020). Prescription of Controlled Substances: Benefits and Risks. Treasure Island, FL: StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK537318/", "comment_id": "DEA-2020-0035-0023", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0023", "comment_date": "2021-02-01", "comment_time": "05:00:00", "commenter_fname": "Rebecca", "commenter_lname": "Tharp", "comment_length": 1519}, {"text": "Partial Filling of Prescriptions for Schedule II Controlled Substances, Docket No. DEA-469 My name is Kaleh Owen and I have practiced as a registered nurse (RN) for eight years. I am currently attaining a graduate degree through the family nurse practitioner (FNP) program at the University of Wyoming with the intention to impact the health and wellness of my community and all individuals I encounter during my practice. I appreciate the aim of the DEAs proposed rule for partial filling of prescriptions for schedule II controlled substances. While the rule may address diversion and improper disposal of such medications, I believe there is a potential for harm in implementing the rule. First, without parameters enacting criteria for consideration of prescribing schedule II medications, practitioners implicit biases may dictate the selection of the option for partial filling. Racial and ethnic disparities exist in healthcare of the United States. To illustrate, black patients are less likely to be prescribed pain medications, and if they do receive a prescription, they receive lower quantities (Hoffman et al., 2016).  Next, a patients socioeconomic factors must be considered, which may impact the ability to fill the remainder of the prescription, including access to healthcare, affordability of medications, and transportation means. With fear of the unknown, I believe patients will be less likely to request partial filling on their own. The prescribing of such substances must include shared decision making between the practitioner and patient to achieve the best outcome. Discussion should consist of potential risks, proper disposal, and address patients fears. The proposed rule does not take the place of shared decision making and informed care. Kaleh Owen, BSN, RN, CMSRNReferenceHoffman, K.M., Trawalter, S., Axt, J.R.,  Oliver, M.N. (2016). Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proceedings of the National Academy of Sciences of the United States of America, 113(16), 4296-4301. https://doi.org/10.1073/pnas.1516047113", "comment_id": "DEA-2020-0035-0030", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0035-0030", "comment_date": "2021-02-01", "comment_time": "05:00:00", "commenter_fname": "Kaleh", "commenter_lname": "Owen", "comment_length": 2236}]}, {"id": "CMS-2015-0063", "agency": "CMS", "title": "Medicare Program; Changes to the\nRequirements for Part D Prescribers (CMS-6107-IFC)", "update_date": "2021-04-21", "update_time": "01:00:33", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Catamaran appreciates the opportunity to comment on the interim final rule with comment period, Medicare Program; Changes to the Requirements for Part D Subscribers, as published in the Federal Register on May 6, 2015.  Catamaran, the industrys fastest-growing pharmacy benefits manager, helps organizations and the communities they serve to take control of prescription drug costs. We manage more than 400 million prescriptions each year on behalf of 35 million members. Our flexible, holistic solutions improve patient care and empower individuals to take charge of their health. In addition, Catamarans skill and scale deliver compelling results and sustainable improvements in the overall health of our members. After a careful review of the proposed guidance, and discussion with other industry and Medicare Part D stakeholders, Catamaran is supportive of the comments provided by the Pharmaceutical Care Management Association. We appreciate the opportunity to comment and look forward to your feedback regarding this matter.", "comment_id": "CMS-2015-0063-0006", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2015-0063-0006", "comment_date": "2015-07-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1061}, {"text": "RelayHealth Prospective Health Services appreciates the opportunity to comment on CMS-6107-IFC.  Prospective Health Services is an active member of NCPDP and fully supports the comments that they are submitting.  Our main concerns mirror what is detailed in the NCPDP letter and include the following:1.There needs to be a publically available listing of Other Authorized Providers to ensure consistency within the industry and less interruptions in service. 2.The provisional fill will create more confusion and there is not sufficient time to implement the logic effectively by 6/1/2016.  3.There is insufficient time to implement all of the new logic necessary by 6/1/2016.  There are still too many outstanding questions on many pieces of the logic including the Other Authorized Providers, the provisional fills, the member notifications, and PDE Edits.  In addition the timeframe is insufficient to implement new NCPDP code values.", "comment_id": "CMS-2015-0063-0010", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2015-0063-0010", "comment_date": "2015-07-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1087}, {"text": "CMS-6107-IFCDoes CMS intend to provide model letters that plans will use to notify beneficiaries and prescribers when the prescriber is not enrolled with Medicare?", "comment_id": "CMS-2015-0063-0012", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2015-0063-0012", "comment_date": "2015-07-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 183}]}, {"id": "CDC-2021-0101", "agency": "CDC", "title": "Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S.", "update_date": "2021-11-29", "update_time": "08:33:13", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I am writing as a Master of Public Policy Students from the University of Virginias Frank Batten School of Leadership and Public Policy. Thank you for taking the time to consider my thoughts regarding the Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U. S. As things such as electronic cigarettes have increased the prevalence of nicotine usage in society, it is important to ensure that the government is also keeping track of smokeless tobacco and the harmful effects it has. I am in support of this regulation as it would make people more aware of the harm smokeless tobacco can do.When looking at numbers provided by the CDC (link provided after this paragraph), almost 6 million adults say they use a form of smokeless tobaccomost of them use it daily. This number is likely the lower bounds as people have incentives to be dishonest when asked about their use of smokeless tobacco. In addition, almost 5% of high school students are estimated to use smokeless tobacco. As the CDC themselves say Smokeless tobacco is not a safe alternative to smoking. I would also like to add that as a college student, I have seen many of my peers use some form of smokeless tobacco, this is a real problem.https://www.cdc.gov/tobacco/data_statistics/fact_sheets/smokeless/use_us/index.htmI think this program will be helpful because it will provide the government with more information about the public health problem they are facing. In order for the government to come up with adequate solutions to the problem, they must have as much information as possible; they cannot fight against something they do not know. This regulation would lead to an increase in information possessed by the government and allow for better decision making. I think this policy should be adopted and a framework should be set in place for how this information can then help inform future policy decisions. Thanks for taking the time to read my public comment!", "comment_id": "CDC-2021-0101-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2021-0101-0002", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Daniel", "commenter_lname": "Nakasone", "comment_length": 2094}]}, {"id": "FDA-2019-P-1783", "agency": "FDA", "title": "Requests that the FDA immediately impose a moratorium on all future approvals of new drug applications (NDAs) for new opioids or new opioid formulations.", "update_date": "2019-09-16", "update_time": "08:56:20", "purpose": "Nonrulemaking", "keywords": ["CDER", "petition", "citizen petition", "Public Citizen", "opioids", "opioid formulations", "NDAs", "open"], "comments": [{"text": "Everyone deserves fresh healthy produces on both both rich and poor communities on the city the people are living. Like in Atlanta neither youre living in Bankhead or Buckhead, both of them deserve equal fresh clean healthy produce and much more on their communities.", "comment_id": "FDA-2019-P-1783-0160", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0160", "comment_date": "2019-09-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 272}, {"text": "To see how it was that the republicans in Pennsylvania dropped all information on opiate drugs overdose potential and physical addiction potential shows how this is all about the money, selling the drug to uneducated parties in order to deceive them about the drugs nature and dangers. Then in Ohio, a republican leader proposed to limit how many times addicts were to be brought back after an overdose to two times. See? They sell killer dope to us, then limit how many times we are to be brought back after an overdose; in an active addiction. And then plan on a person relapsing 7-10 times if a person has an abuse history. So clearly bringing back a person so affected parasuicidally a couple of times is certainly NOT getting the job that needs to be done, done; the services to accomplish that are not substantially out there adequate to the growing need(s). See also article The Mega Group, Maxwells, and the Mossad on guns for drugs ops (1 of a four part series), child trafficking ops, black market body parts trade (UC-Berkeley Dept. of Anthropology-Organswatch). at www.mintpressnews.com, and large scale secret drug fueled mass murder operations carried out inside war crimes, like Operations Phoenix and Condor. See book The Phoenix Program, by Douglas Valentine and books by Alex Constantine. The first step in these programs is to cut the anti-poverty budgets, creating the original crisis, then lie yuge and say the economic crisis is caused by drug abusers and the homeless in a deliberate big lie program based on what is termed projective Inversion;blaming the victim/survivors for what the nazi budget cutters, eerrr republicans actually did. Then too, see how opiate drug producers targeted areas that had a lot of consumption and overdoses for greater supplies when it was not used for medical purposes. Kentucky, West Virginia, Ohio, etc..This is clearly a slow death program; one of many run by the nazis, eerrr republicans. Harass, cut back benefits, cut benefits off completely-dead client. Just what the nazi doctor ordered. . . . Lyle Courtsal  www.3mpub.com-Kissinger wants to reduce population by 2/5ths any means necessary. . . See also Gary Kohls at www.duluthreader.com and Peter Breggin on warehousing, rather than receiving care for conditions humanely. . .PS What we also see is rather than an individual patient specific, patient centered interactive approach to pain management, etc., is instead a swinging between one professional sub-cultural extreme, enough pain pills for the pain and the addiction-no effective support then professional subculture swings to a complete cutoff of access to opiate pain pills that actually did work for the majority of patients out there; opiate medicine cut off completely (by Sessions); patients situations much worse for those using opiates successfully than before. No more pain meds-patient in new much nastier crisis medically and is probably not getting adequate medical support with or without pain meds-next visit doctor 2 months away?!! ", "comment_id": "FDA-2019-P-1783-0381", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0381", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3099}, {"text": "I urge the FDA to impose an immediate, temporary moratorium on new opioid approvals. The National Academies of Sciences, Engineering, and Medicine issued detailed recommendations for an improved opioid regulatory framework more than two years ago, but the FDA has failed to put this new public health framework in place. Until it does, the moratorium is urgently needed.", "comment_id": "FDA-2019-P-1783-0382", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0382", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 370}, {"text": "I absolutely support this petition.", "comment_id": "FDA-2019-P-1783-0364", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0364", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 35}, {"text": "Im tired of having to worry about whether people are selling their opioid products instead of disposing of them properly.  The whole problem needs to be controlled.", "comment_id": "FDA-2019-P-1783-0369", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0369", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 169}, {"text": "I completely support Public Citizens petition concerning this critical public safety issue.", "comment_id": "FDA-2019-P-1783-0383", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0383", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 96}, {"text": "I am calling on the FDA to stop approving new opioids until it has adopted the public health opioid regulatory framework recommended in 2017 by the National Academies.The FDA has recklessly approved dozens of new opioids without adequately assessing either their effectiveness or the likelihood that new products will be diverted into illegal trade and make the opioid addiction crisis still worse. Its up to us to demand the agency impose a freeze on opioid approvals until it adopts a safer approval process.I am urging the FDA to impose an immediate, temporary moratorium on new opioid approvals. The National Academies of Sciences, Engineering, and Medicine issued detailed recommendations for an improved opioid regulatory framework more than two years ago, but the FDA has failed to put this new public health framework in place. Until it does, the moratorium is urgently needed.", "comment_id": "FDA-2019-P-1783-0385", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0385", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 905}, {"text": "There are enough drugs already that can KILL and maim people. STOP with the quick release of new ways to get addicted ", "comment_id": "FDA-2019-P-1783-0386", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0386", "comment_date": "2019-09-16", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 118}, {"text": "I support the Citizen Petition from Public Citizen to restrict the sale of opioids.", "comment_id": "FDA-2019-P-1783-0090", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0090", "comment_date": "2019-09-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 83}, {"text": "I support this petition.", "comment_id": "FDA-2019-P-1783-0117", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0117", "comment_date": "2019-09-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 24}]}, {"id": "EPA-HQ-OAR-2006-0089", "agency": "EPA", "title": "Prevention of Significant Deterioration, Nonattainment New Source Review,  and Title V:  Treatment of Corn Milling Facilities Under the  \"Major Emitting Facility\" Definition", "update_date": "2022-03-08", "update_time": "01:01:59", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I write to oppose proposed changes to New Source Review regulations that wouldencourage greater levels of pollution by ethanol plants.", "comment_id": "EPA-HQ-OAR-2006-0089-0031", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2006-0089-0031", "comment_date": "2006-03-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 144}, {"text": "April 25, 2006Attn: Docket ID No. EPA-HQ-OAR-2006-0089U.S. Environmental Protection AgencyEPA West (Air Docket) 1200 Pennsylvania Avenue, Northwest B102, Mail code 6102TWashington, DC 20460I am writing to strongly oppose the proposed changes to Treatment of Corn Milling Facilities Under Clean Air Act Permitting Programs. I oppose these changes for ethanol manufacturing facilities based on my own experiences.  The emissions from these plants are know to make people sick as the USEPA had discovered with the Minnesota 2002 enforcements and the events that have taken place in Lena, Illinois with Adkins Energy, LLC, enforcement. Increasing the levels for PSD from 100 to 250 tpy allows fuel-ethanol producers to emit more conventional pollutants than they are presently allowed under minor status. PSD applies to all pollutants that do not exceed the National Ambient Air Quality Standards (NAAQS) in an area. The NAAQS establish maximum pollution concentration levels to protect public health and welfare from harmful levels of pollutants. Placing a 250 tpy threshold on criteria pollutants emitted by industrial chemical ethanol plants would not allow citizens due process to protest. They will not have any say on a minor source permit with this proposed increased volume of emissions from ethanol manufacturing that will be emitted into their community. Minor source permit applications do not allow citizen envolvement. Their is no requirement for public notice or a comment period on minor source permitting. Any documents submitted by citizens do not become part of the record for a pollution control boards? review and decision on permit applications.I have experienced first hand the effects of polluting emissions from the Adkins Energy, LLC, ethanol plant located 2 miles from my home. I have included photos of this plant in operation. When these photos were taken, the officials of the Adkins Ethanol plant were telling the public that they meet and beat all Federal and State emission standards. Your own environmental scientist Sara Dauk acquired documents in November, 2002, that were to the contrary. Many people were experiencing symptoms of nauseau, vomiting, headaches, asthma attacks, burning eyes  throats, aches in their sides, and the inability to breathe. Precursors to serious health problems.I understand the Adkins plant is another isolated case in the many ethanol cases, but the pollutants remain the same when manufacturing ethanol and what I also know is how these combinations of pollutants can affect a person?s health when they are encountered. Illinois EPA stated in a meeting with a Lena trustee that they DO NOT KNOW what the potential long term health effects can be from breathing the combination of pollutants from a ethanol manufacturing plant. There have been no studies to determine long term effects. Currently the Lena Adkins plant is regulated under a FESOP with emission limits under 100 tpy. I can tell you that there are still people in close proximity that continue to experience some of the before mentioned symptoms with limits under 100 tpy. Increasing the threshold limits would increase the harmful affects inflicted on these people, myself included. My air is not the sewer and dumping site for emissions that can and should be eliminated with the proper controls to protect our health. Raising the threshold would allow these plants to install and run pollution controls at a less stringent level.The air pollutant emissions from ethanol manufacturing begin to occur at the very first process. Grain is delivered to the plant, handled, and milled, tiny particles are released into the air referred to as particulate matter (PM). It is well known that PM is very harmful to human respiratory systems. During fermentation, distillation and drying, volatile organic compounds (VOCs), such as ethanol, and HAPs, such as acetaldehyde, acrolein, formaldehyde, and methanol are released. Many VOCs cause serious harm and even cancer in humans. Carbon monoxide, nitrogen oxides, and sulfur oxides may be generated in one of several combustion operations at an ethanol facility. These oxides can be leathal to humans.VOCs are a group of chemicals that evaporate easily into the air. VOCs react with nitrogen oxides, other contaminants, and sunlight. VOCs are known to directly and indirectly cause health effects in humans. Certain VOCs such as benzene are know carcinogens. VOCs also can react with ozone depleting the protective ozone layer. Reducing VOCs react with carbon monoxide, nitrogen oxides and sunlight to form smog. Smog has damaging effects on plants and causes respiratory problems in humans. The ethanol production process gives off a complex mixture of VOCs, carbon monoxide, nitrogen oxide and sulfur oxide. VOCs come from the Distillers Dried Grain dryer, cooling cyclones, centrifuges, and fermentation and distillation scrubbers, and are emitted into the air to mix with the combustion oxides from an ethanol plant. It was our experience that when you were downwind of the ethanol plant these emissions did not dilute readily in the air. We would experience many symptoms very shortly after exposure. Our only recourse was to remove ourselves from the area. Our homes were volunerable if we had windows open. During high heat seasons a citizens? right to have windows open was eliminated when they were downwind from the plant.Ethanol plants locate themselves in close proximity to residents, schools, and nursing homes. Young children and the elderly are more at risk from harmful effects from the pollutants generated from these plants. I have included pictures showing how close the Adkin?s plant is to the school?s athletic fields and nursing home property.It would be better for the environment if all ethanol plants continued to meet the more stringent criteria, i.e., 100 tons/year. Fuel ethanol is possibly going to continue to be a growing industry with the potential of having a plant as often as every 20 miles in the cornbelt. The 100 tpy thresholds would protect the air humans require to sustain healthy lives. In?the Lena?case, to be considered a FESOP source with 100 tpy threshold, Adkins was required to install a thermal oxidizer, which helped address emissions.?Although, we still experience emissions when we are downwind and still have ill symptoms.On the other matter in the proposal, eliminating fugitive releases from the definition is a concern - all emissions should be counted. Road dust (particulate emissions), leaking pipe valves (VOCs) and the storage of the wet distillers grain are potentially significant sources of fugitive pollutants. Many of the neighbors can tell when there is large quantities of wet distillers grain on hand. Loading and unloading of grain stock also produces large quantities of particulate. I request the fugitive emissions remain counted when determining an ethanol plant?s total emissions for title V, PSD or NSR permitting programs.?One more problem in Illinois is that?no specific air modeling is required so that emissions at a certain levels are not limited to prevent down-wind issues from occurring. Some states, like Iowa do require certain new sources to perform modeling to minimize these types of issues. I would also like to comment that air modeling should be required of all new ethanol manufacturing construction projects to enable the EPA and state EPAs to accurately assess downwind issues before a permit is issued.?The criteria pollutants covered by the NAAQS are nitrogen oxides, volatile organic compounds (which are precursors to ground-level ozone), sulfur dioxide, fine particulate, carbon monoxide, and lead (all harmful to humans). Ethanol plants produce large amounts of nitrogen oxides, volatile organic compounds, sulfur dioxide, fine particulate, carbon monoxide and HAPS. All are proven harmful to humans. The role the public is assuming the USEPA is performing, is to make sure their health is protected and is foremost when the decisions are made in permitting. The public?s health will be protected if you do not revise the definition of ?chemical process plants? as it applies to ethanol manufacturing, continue to count fugitive emissions, and do not change the minimum threshold to 250 tpy for the PSD permitting program.We only have one Earth were we can sustain life. Pollutants are harmful. We have technology to eliminate pollutants, that should be the end of the discussions.Sincerely,Heidi Thorp2273 N. Schlegel RoadLena, Illinois 61048heidithorp@yahoo.com", "comment_id": "EPA-HQ-OAR-2006-0089-0035", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2006-0089-0035", "comment_date": "2006-04-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 9148}, {"text": "Letter regarding EPAs preferred Option 1 to the air permitting classifications for fuel ethanol plants", "comment_id": "EPA-HQ-OAR-2006-0089-0051", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2006-0089-0051", "comment_date": "2006-05-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 107}]}, {"id": "DEA-2023-0058", "agency": "DEA", "title": "Placement of Nine Specific Fentanyl Related Substances in Schedule I (DEA1036)", "update_date": "2023-12-07", "update_time": "08:20:24", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "When looking at the schedule requirements, and the eight different factors going into what places a drug into a schedule, I believe that fentanyl should be placed in schedule 1. The fact that marijuana is classified as a schedule 1 drug, but not fentanyl blows my mind. Marijuana deaths are extremely low and not as likely to happen, whereas fentanyl deaths are on the rise, and thousands have suffered from it. Loved ones have lost family members to this drug which is why it should be classified as a schedule 1 drug. The risk to the public health, the potential for abuse, and dependency alone should classify it as a schedule 1 drug. Instead of extending the rule to December 31, 2024, put fentanyl as a schedule 1 drug today.", "comment_id": "DEA-2023-0058-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0005", "comment_date": "2023-04-18", "comment_time": "04:00:00", "commenter_fname": "Dazi", "commenter_lname": "Psurny", "comment_length": 730}, {"text": "The Drug Enforcement Administration (DEA proposes to permanently schedule the following nine controlled substances in schedule I of the Controlled Substances Act (CSA). The nine specific fentanyl-related substances are: (1) Meta-fluorofentanyl, (2) Meta-fluoroisobutyryl fentanyl, (3) Para-methoxyfuranyl fentanyl, (4) 3-furanyl fentanyl, (5) 2,5-dimethoxyfentanyl, (6) isovaleryl fentanyl, (7) ortho-fluorofuranyl fentanyl, (8) alpha-methyl butyryl fentanyl, and (9) andpara-methylcyclopropyl fentanyl. I agree that Drug Enforcement Administration should make the nine Fentanyl-related substance listed under the category of Schedule I drugs permanent instead of constantly extending the temporary order multiple times. First it started on February 6, 2018, then two years later February 6, 2020. Then the Congress extended until May 6, 2021, after it was extended on December 29, 2021, and now the order was extended until December 31, 2024. After the extended order expires on December 31, 2024, this order should be made permanent, honestly, it shouldve been made permanent already. By finalized this rule, the federal law can act against the people who are handling these nine specifics fentanyl substance. Over 150 people die every day from fentanyl-related drug overdoses. I think it is time to take action against this fatal drug. ", "comment_id": "DEA-2023-0058-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0011", "comment_date": "2023-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1422}, {"text": "The designation of Nine specific Fentanyl related substances to Schedule I of the Controlled Substance Act should be made permanent after the temporary scheduling order expires on December 31, 2024. Fentanyl-related drug overdoses have been increasing throughout the US according to the National Institute on Drug Abuse. The Proposed rule states in the background information that these substances pose an imminent hazard to public safety, as citizens we see this news daily about the effects of fentanyl in communities across the country. In section 1 (a) the criteria for the potential of abuse is described through evidence that taking the drug will create a hazard to their health or to the safety of others in the community, it is clearly a hazard because of all the deaths that have been occurring due to Fentanyl overdose and the destruction it is causing in communities. Fentanyl and the list of related substances listed in the Rule being in a category of Schedule I drugs would allow for regulation of the substances and improve the Publics Health from the negative effects of this drug.", "comment_id": "DEA-2023-0058-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0006", "comment_date": "2023-05-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1104}, {"text": "DiscussionNine drugs are being suggested to be added to Schedule I of the Controlled Substances Act by the Drug Enforcement Administration (DEA). These substances are stated in the suggested regulation. The nine drugs all fulfill the criteria for fentanyl-related compounds defined in the interim scheduling directive from February 6, 2018. The Temporary Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues Act stretched the power until December 31, 2024, and the Consolidated Appropriations Act of 2023 expanded it. If adopted, the proposed measure would irrevocably limit the nine particular compounds and impose punishments on any person found in the ownership of, manufacturing, importing, exporting, engaging in academic study, conducting chemical examinations, importing, or managing them in any other manner.Direct and indirect effects on federal-state healthcare would result from the policy as mentioned above. Directly stated, it would boost federal oversight of manufacturing and disseminating possibly harmful chemicals, limiting their availability and expected abuse (Pardo et al., 2023). Furthermore, it would keep these drugs off the black market, giving the federal level greater assurance to administer and utilize drugs. By demonstrating the federal governments commitment to ensuring the well-being and protection of its residents, the policy move would help significantly increase public confidence in the medical field.I support the suggested regulation in its entirety. The federal level must have a role in reducing the consumption of such drugs in a society where opioids are putting an ever-increasing strain on medical care. Rigorous regulatory oversight and criminal penalties for perpetrators will guarantee that authorities can effectively administer the law. It is critical to restrict the utilization of fentanyl replicates to people who need them for serious medical needs. Establishing a regular schedule, I classification for these medicines aids in ensuring that they are applied prudence and remain accessible for recognized medical purposes. Furthermore, raising public knowledge of the risks of abusing these drugs benefits their prevention. The suggestion is in line with this requirement and ought to be accepted.ReferencePardo, B., Kilmer, B.,  Taylor, J. (2023). Illegal Supply and Supply Control. AMERICAS OPIOID ECOSYSTEM, 273. https://www.jcoinctc.org/wp-content/uploads/RAND_Americas-Opioid-Ecosystem_2023.pdf#page=295", "comment_id": "DEA-2023-0058-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0008", "comment_date": "2023-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2531}, {"text": "The proposed regulation by the Drug Enforcement Agency (DEA) would permanently classify nine fentanyl-related substances as schedule 1 drugs. These substances were placed on a temporary schedule since February 6, 2018, and since then has been extended multiple times by Congress. However, this temporary order will expire on December 31, 2024, but the DEA is hoping to classify it as schedule 1 permanently thereafter. This would keep in place all regulations and law pertaining to how schedule 1 substances are handled, distributed, manufactured, or sold by anyone who handles the drug whether for illegal purposes or not.This will affect healthcare on a federal level because the ongoing opioid crisis has seen multiple agencies across the government trying to bring this public health crisis under control. There were about 1,550 pediatric deaths from fentanyl in 2021  over 30 times more than in 2013, when the wave of overdose deaths involving synthetic opioids started in the US. A surge that began in 2018 led to a nearly 3-fold increase in deaths among older adolescents and a nearly 6-fold increase among children younger than 5. In 2021, 40 infants and 93 children ages 1 to 4 died from a fentanyl overdose (McPhillips, 2023). There are no reasons that children or anyone should be exposed to this drug because even a small amount can be deadly.I would have to agree with this proposed regulation of classifying fentanyl-related substances as a schedule 1 drug with the ongoing epidemic of the opioid crisis that has grip the nation. Fentanyl is highly addictive being 50 to 100 times more potent than morphine (Fentanyl Drugfacts, 2023). While prescription fentanyl is given to some patients who have chronic pain or have had major surgery other alternative medications should be prescribed first leaving fentanyl as a last resort. While theres an understanding that we will probably never get rid of substances such as fentanyl at least people might think twice about distributing it to others because it is such a highly addictive drug.ReferenceMcPhillips, D. (2023, May 8). Fentanyl-related deaths among children increased more than 30-fold between 2013 and 2021. CNN. https://www.cnn.com/2023/05/08/health/fentanyl-overdose-deaths-children/index.html U.S. Department of Health and Human Services. (2023, March 3). Fentanyl drugfacts. National Institutes of Health. https://nida.nih.gov/publications/drugfacts/fentanyl ", "comment_id": "DEA-2023-0058-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0009", "comment_date": "2023-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2489}, {"text": "The topic being proposed is the placement of nine fentanyl-related substances into Schedule I of the Controlled Substances Act. This proposal aims to combat the growing opioid epidemic in the United States by making it more difficult to produce and distribute these dangerous substances.According to a news article by NPR, these nine fentanyl-related substances are not currently classified as controlled substances, which makes it easier for manufacturers to produce and distribute them without facing legal consequences. However, the proposed ruling would add these substances to Schedule I, which is reserved for drugs with a high potential for abuse and no accepted medical use.At the federal level, this proposal could have significant impacts on the healthcare industry. It could lead to increased regulation and oversight of fentanyl-related substances, which could help prevent the misuse and abuse of these drugs. However, it could also make it more difficult for medical professionals to access these substances for legitimate medical purposes, which could potentially harm patients in need of pain management.Overall, I agree with the proposed ruling to add these nine fentanyl-related substances to Schedule I. The opioid epidemic in the United States has had devastating effects on communities across the country, and it is important to take strong measures to combat it. While there may be some challenges associated with increased regulation of these substances, I believe the potential benefits outweigh the potential drawbacks.", "comment_id": "DEA-2023-0058-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0007", "comment_date": "2023-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1584}, {"text": "The Drug Enforcement Administration (DEA proposes to permanently schedule the following nine controlled substances in schedule I of the Controlled Substances Act (CSA). The nine specific fentanyl-related substances are: (1) Meta-fluorofentanyl, (2) Meta-fluoroisobutyryl fentanyl, (3) Para-methoxyfuranyl fentanyl, (4) 3-furanyl fentanyl, (5) 2,5-dimethoxyfentanyl, (6) isovaleryl fentanyl, (7) ortho-fluorofuranyl fentanyl, (8) alpha-methyl butyryl fentanyl, and (9) andpara-methylcyclopropyl fentanyl. I agree that Drug Enforcement Administration should make the nine Fentanyl-related substance listed under the category of Schedule I drugs permanent instead of constantly extending the temporary order multiple times. First it started on February 6, 2018, then two years later February 6, 2020. Then the Congress extended until May 6, 2021, after it was extended on December 29, 2021, and now the order was extended until December 31, 2024. After the extended order expires on December 31, 2024, this order should be made permanent, honestly, it shouldve been made permanent already. By finalized this rule, the federal law can act against the people who are handling these nine specifics fentanyl substance. Over 150 people die every day from fentanyl-related drug overdoses. I think it is time to take action against this fatal drug. ", "comment_id": "DEA-2023-0058-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0058-0010", "comment_date": "2023-05-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1422}]}, {"id": "SAMHSA-2016-0004", "agency": "SAMHSA", "title": "Protecting Our Infants Act Report to Congress ", "update_date": "2021-05-04", "update_time": "01:00:35", "purpose": "Nonrulemaking", "keywords": ["Protecting Our Infants Act", "Neonatal Abstinence Syndrome", "Noenatal Opioid Withdrawal", "Opioid Use Disorder", "Pregnancy", "Prenatal Opioid Exposure"], "comments": [{"text": "Stop infant circumcision. ", "comment_id": "SAMHSA-2016-0004-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0007", "comment_date": "2017-01-27", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 26}, {"text": "Women need supports in addition to services, while pregnant and after their child is born.  Babies exposed to drugs in utero are often fussy, difficult to soothe infants and children.  It would be wonderful if the administration could find a way to tap into the compassionate individuals who are Pro-Life to volunteer their services to these families in need.  Perhaps hospitals, clinics and treatment programs could be funded to advertise for volunteers and pay for child abuse and other appropriate clearances and provide training to the volunteers.  Magee-Womens Hospital in Pittsburgh, PA has a program in their neonatal unit for volunteers to hold and rock babies.  The waiting list is so long they no longer take names for volunteers.  Programs like this across the country would be wonderful.", "comment_id": "SAMHSA-2016-0004-0009", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0009", "comment_date": "2017-01-31", "comment_time": "05:00:00", "commenter_fname": "Janice", "commenter_lname": "Meinert", "comment_length": 799}, {"text": "As a former methadone patient who gave birth to 3 children while in treatment, I would like to see national standards advocating the use of split dosing upon confirmation of pregnancy.  Maintaining an even level of medication in the system is essential to avoid learned withdrawal response in infants and can reduce symptom severity or prevent neonatal abstinence syndrome. There was no document or public study available concerning pregnancy while in methadone treatment.  I had to do the research myself and present the studies to the clinic doctor in order to Split dose for the duration of my pregnancy and while breastfeeding.  None of my children experienced NAS due to my diligence and willingness to fight for the healthiest outcome for them. Not all clinics are willing to allow for split dose.  In my time as an advocate for patients, there were multiple occasions where despite the research, the clinic refused the patient split dose simply due to inconvenience, which is not a proper response in an evidence-based setting. Setting national standards, giving a clinic the proper method for administering medication during pregnancy, would benefit both mother and child and would reduce the severity of NAS in this population. Additionally, having a website where patients could easily read the potential complications and outcomes of opioid use in pregnancy is necessary.  There is no one place where these women could read the studies, learn the potential for NAS symptoms in babies, and educate themselves on the effect of use and ways to lessen the potential for these effects on their children.  Knowledge is instrumental in assisting these women. ", "comment_id": "SAMHSA-2016-0004-0010", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0010", "comment_date": "2017-02-06", "comment_time": "05:00:00", "commenter_fname": "Ericka", "commenter_lname": "Lear", "comment_length": 1683}, {"text": "Part 4 Section 2(b) of the Act:I believe a strong emphasis should be encouraged for the rooming in interventions and others that would allow the mother and infant bonding time.  This would allow for practical education for the mother with the child at the oversee of the medical staff.  I support the development of family friendly relapse prevention and recovery strategies and feel that there should be some thought put into the most appropriate community based program that is not driven by each states Division of Child and Family Services.  In a rural area, this will send a message of criminalization to the affected childs family. Under education, a wider societal educational role needs to be placed with more preventative attempts with the childbearing population. It would be beneficial going forward to encourage further research specifically into Suboxone and Subutex  management. In the field results are indicating much better long term results than methadone for both baby and mother.", "comment_id": "SAMHSA-2016-0004-0004", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0004", "comment_date": "2017-01-23", "comment_time": "05:00:00", "commenter_fname": "Dawn", "commenter_lname": "Goodman-martin", "comment_length": 1014}, {"text": "I live in Massachusetts, and have been volunteering in a special care nursery as a cuddler for more than seven years. Almost all of the newborns I have cuddled are drug exposed in utero, and are in the special care nursery going through withdrawal, experiencing Newborn Abstinence Syndrome (NAS). After spending hundreds of hours holding babies who are suffering with the challenging symptoms associated with newborn withdrawal, observing how caregivers and families interact, and on my own time, learning about newborn brain development, I believe the process of caring for and protecting our infants born drug exposed begins by investing in and using a model of care in our hospital nicus and special care nurseries, and beyond, that supports healthy newborn brain development...what I have come to think of as brain sensitive care.Science teaches that immediately following birth, rapid brain development occurs, and the way a newborn brain develops is closely connected to environment. If NAS newborns going through withdrawal are cared for in nicus and/or special care environments designed to support healthy newborn brain development, along with doctors, nurses, caregivers, and families, educated in developmental care, with their focus on the baby first, there may be tremendous opportunity for positive, lifelong outcomes for this population of infants, and their families.Over the past several years, as I have looked for professional direction and validation around what I have observed in my volunteer role, I have reached out to a handful of medical pioneers and leaders in the field of newborn behavior and developmental care, several of whom are based in Boston, MA. In 2014, I have had the privilege of attending a training workshop at The Brazelton Institute in Boston to learn about a specific model of newborn care. The workshop, entitled, The Newborn Behavioral Obseravtion (NBO) System for At-Risk Infants introduced an approach to me that I have come to believe could be key in the long-term health of this population of babies and their families. Located in Boston, based in the division of Developmental Medicine, Boston Childrens Hospital, the Institute is founded on the ground-breaking work of Dr. T. Berry Brazelton. I think that those reporting to Congress, advising on public policy and best practices around caring for these infants, have a responsibility to consult with the Institutes leaders, including Dr. Joshua Sparrow, Director, Brazelton Touchpoints Center, Boston Childrens Hospital and President Brazelton Touchpoints Foundation, to learn how the Institutes developmental care research and this model of care may create an important and much needed stance within hospitals, and beyond, for supporting the well-being of NAS babies, parents, and families dealing with the disease of addiction.", "comment_id": "SAMHSA-2016-0004-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0014", "comment_date": "2017-02-14", "comment_time": "05:00:00", "commenter_fname": "Dara", "commenter_lname": "Fruchter", "comment_length": 2895}, {"text": "Dear Panel,My hope is that, in addressing the problems of opiate dependent children, we will begin to address the much larger problem of opiate dependent parents. My feeling is hat this has to be addressed in conjunction with any attempt to reduce the incidence of opiate dependency in pre- and post-natal infants. Lack of insurance is probably the largest institutional limitation to access to care. Education of children through adolescents about the dangers of drugs is also important.A genuine attempt by society to understand the drug addicts poverty, upbringing, and lack of education will go a long way towards restoring these people to functioning members of our communities.I hope you can address some of these concerns, as I dont hold out much hope for your initiative without them.Thank you, Richard Fein, D.O.", "comment_id": "SAMHSA-2016-0004-0008", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0008", "comment_date": "2017-01-27", "comment_time": "05:00:00", "commenter_fname": "Richard", "commenter_lname": "Fein", "comment_length": 901}, {"text": "Nearly 7 million people in the U.S. had used OUD related to prescription opioids or heroin in the last 30 days.  This number is not only shocking but unacceptable. I do not personally associate myself with anyone that does drugs, but I know people that I went to high school with that used opioids while pregnant and I have family members who adopted a child that was born with NAS.  It is not beyond reach that everyone knows or knows of someone who had a baby that was exposed to opioids. This is a trend that must be stopped. I know this act focuses on the impact that holds for unborn babies and the impact once they are born but to me it seems the recommendations provided to congress have a major blind spot. As a law student whos area of interest is education law, it seems most of your recommendations are to educate women about the best options for the child once they become pregnant and the fetus is exposed to the drugs. Education should start in middle school health class. Students are educated about drugs and the process of reproduction. An in depth analysis of what happens when the two are mixed should be provided. The actual effects are not portrayed in a way that provides the gruesome reality. Women who are prescribed opioids as a form of pain management should be educated about the risks of becoming pregnant while using opioids when they begin their treatment instead of when they become pregnant. Prescribing doctors should also prescribe a contraceptive.  Opioid use should never be a choice that is made without knowing the impact it could hold on the future of the user and that includes their future children. More emphasis needs to be placed on providing a comfortable forum for a woman who becomes pregnant while using opioids to disclose this and provide proper medical assessment.  It is in recommendations from the report, but still no specific plan has been made to overcome the deterrents. In 2012 with nearly 5.8 per 1,000 hospital births having an incidence of NAS, it is essential that the proper treatment be given from the first time a woman visits her doctor. The education of medical professionals should go beyond understanding what to do if your patient is using opioids while carrying a baby. There should be specialized doctors. We have specialists for every body part and most diseases. With the dramatic amount of infants born with NAS, there should be OBGYNs that these women can go to and know that they will receive the best care for their situation. If all of the women seeing this specialized OBGYN were dealing with the same issues associated with opioid use, it would provide a comfortable environment for them to seek help and not feel singled out as the bad woman on drugs while pregnant.   Additionally, the report continuously mentions the needs for collective data to avoid overlaps and receive more conclusive statistics. There is no direct plan suggested of how to accomplish this. Defining the specific data that would be the most beneficial, will further the plan drastically.  Without data, it is hard to figure out the exact problem and viable solutions. Having specialized OBGYNs would provide a much easier way to establish accurate statistics without invasion of privacy from the patients.  Having a support group for women going through the same thing as described in the report is of immense value. It is remarkable that these groups continue even after the children are born, and it is likely an essential reason to help prevent these women from falling into the same situation in the future. Formulating a plan to make these groups more organized and readily available to those in need is indispensable. Having a specialized OBGYN would provide an environment that would stimulate the creation of these groups. Having women all dealing with the same issue in one place makes the creation of these groups extremely easy, and with their success already proven it should be contribution towards finding a solution. These women can become mentors for others.  They should use their experience to educate others not just that are in the same situation but before they get there. It is essential that these women who have experienced the pain of carrying a baby while using opioids and having a baby suffering from NAS use their experience to discourage others from enduring the same suffering. In general, the solution will be found in education of children, women and health care professionals. Bringing about awareness of the problem and its frequency as well as specifics as to what infants exposed to opioids experience will be a strong starting point. Specializing medical professionals to address the growing issue will be the ultimate force that can produce change in the future outcome. Support from peers and those who have grown through the same experience will empower women to stop the trend. Finally, continued education and support after childbirth will be essential to avoiding recurrence. ", "comment_id": "SAMHSA-2016-0004-0021", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0021", "comment_date": "2017-02-21", "comment_time": "05:00:00", "commenter_fname": "Regan", "commenter_lname": "Ward-allen", "comment_length": 5063}, {"text": "As was said, women are often on treatment plans that use opioids and are advised to continue said treatments. But whether they obtain opioids medically or recreationally, their access to the drugs cannot and will not be prevented as it is unethical to force someone to not treat him/herself for the good of a fetus, nor will the illegal drug trade stop functioning. The most practical solution to prevent fetal exposure to harmful drugs, such as opioids, and the limit the costs and burdens of treatment is to provide women with effective birth control. Preventing often unwanted pregnancies will dramatically reduce the strain on the government to provide or assist the mothers who experience prenatal complications due to their opioid usage as well as the strain to provide and treat damaged infants who, might possibly, suffer from disabilities due to their prenatal exposure throughout their lives.", "comment_id": "SAMHSA-2016-0004-0006", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0006", "comment_date": "2017-01-25", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 902}, {"text": "During a SOAR event in Somerset, KY; I learned the troubling statistics given by a representative of Pikeville Medical Center who presented that 30% of the babies being born in their facility were diagnosed with Neonatal Abstinence Syndrome.  A representative from Louisville suggested that the statistics are more like 50% in Louisville of babies being born with Neonatal Abstinence Syndrome. This troubling data has given me the recognition that Neonatal Abstinence Syndrome is an epidemic and really needs to be acted on.I have provided some resources below that I do not claim to be my own, but data that I have researched to find.The American College of Obstetrics and Gynecologistshttp://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/Opioid-Abuse-Dependence-and-Addiction-in-PregnancyAn excerpt from this article:Long-Term Infant OutcomeRecent data on long-term outcomes of infants with in utero opioid exposure are limited. For the most part, earlier studies have not found significant differences in cognitive development between children up to 5 years of age exposed to methadone in utero and control groups matched for age, race, and socioeconomic status, although scores were often lower in both groups compared with population data . Preventive interventions that focus on enriching the early experiences of such children and improving the quality of the home environment are likely to be beneficial.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2989871/ This is an excerpt from the article:For opioid-dependent pregnant and postpartum women in treatment, methadone maintenance is the treatment of choice in the United States. In contrast to other substances, concentrations of methadone in human milk and the effects on the infant have been studied, and the concentrations of methadone found in human milk are low; therefore women stable on methadone maintenance should be permitted to breastfeed if desired, and irrespective of maternal methadone dose. There are no apparent short-term or long-term effects of methadone in human milk on neurodevelopment. However, infants chronically exposed to opiates in utero typically experience neonatal abstinence syndrome (NAS), a constellation of signs and symptoms that includes neurologic excitability (tremors, irritability, increased wakefulness, high-pitched crying, increased muscle tone, hyperactive reflexes, seizures, frequent yawning and sneezing), gastrointestinal dysfunction (poor feeding, uncoordinated and constant sucking, vomiting, diarrhea, dehydration, poor weight gain), and autonomic signs (increased sweating, nasal stuffiness, fever, mottling of skin). Withdrawal signs and symptoms typically present within 48-72 hours of birth following in utero opioid exposure, but these can manifest up to 4 weeks later in some infants. Infants with significant NAS symptoms can have difficulties with breastfeeding mechanics, which can impact their ability to breastfeed. Despite this, there is increasing evidence to support that methadone-exposed infants may benefit from breastfeeding and/or breast milk; infants who are breastfed are less likely to have severe NAShttp://pediatrics.aappublications.org/content/129/3/e827.fullThis is an excerpt from this article:Maternal substance abuse is not a categorical contraindication to breastfeeding. Adequately nourished narcotic-dependent mothers can be encouraged to breastfeed if they are enrolled in a supervised methadone maintenance program and have negative screening for HIV and illicit drugs. Street drugs such as PCP (phencyclidine), cocaine, and cannabis can be detected in human milk, and their use by breastfeeding mothers is of concern, particularly with regard to the infants long-term neurobehavioral development and thus are contraindicated. Alcohol is not a galactogogue; it may blunt prolactin response to suckling and negatively affects infant motor development. Thus, ingestion of alcoholic beverages should be minimized and limited to an occasional intake but no more than 0.5 g alcohol per kg body weight, which for a 60 kg mother is approximately 2 oz liquor, 8 oz wine, or 2 beers. Nursing should take place 2 hours or longer after the alcohol intake to minimize its concentration in the ingested milk.101 Maternal smoking is not an absolute contraindication to breastfeeding but should be strongly discouraged, because it is associated with an increased incidence in infant respiratory allergy and SIDS. Smoking should not occur in the presence of the infant so as to minimize the negative effect of secondary passive smoke inhalation. Smoking is also a risk factor for low milk supply and poor weight gain.The research appears to suggest that withdrawal during pregnancy may be harmful to the infant in utero and breastfeeding may be of benefit to ease withdrawal.  ", "comment_id": "SAMHSA-2016-0004-0005", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0005", "comment_date": "2017-01-25", "comment_time": "05:00:00", "commenter_fname": "Joyeal", "commenter_lname": "Hunter", "comment_length": 4976}, {"text": "I think this is a great bill that NEEDS to be passed! So many children are being exposed to drugs at such a young age and there are not enough consequences for this crime. The law needs to crack down on these awful people that are ruining childrens lives. I support this bill 100% ", "comment_id": "SAMHSA-2016-0004-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0015", "comment_date": "2017-02-16", "comment_time": "05:00:00", "commenter_fname": "Sierra", "commenter_lname": "Lacivita", "comment_length": 286}]}, {"id": "VA-2010-VACO-0032", "agency": "VA", "title": "AN73 - Final Rule - Health Care for Homeless Veterans\r\nProgram", "update_date": "2018-07-11", "update_time": "01:02:24", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I support this proposed rule as I feel that our country owes a debt to our veterans that is not being fully paid. They are struggling with substance use as the proposed regulation states and mental illnesses because of what they were exposed to when serving our country, including post-traumatic stress disorder and traumatic brain injury. This program has a solid foundation on which it plans to operate that should be successful in finding and helping these veterans in need. If more programs like this were in place, we may not have the issues we do today with homeless veterans. They didnt leave our country out in the cold when needed in both peace and war time, so why would we leave them out in the cold now?", "comment_id": "VA-2010-VACO-0032-0002", "comment_url": "https://api.regulations.gov/v4/comments/VA-2010-VACO-0032-0002", "comment_date": "2010-12-22", "comment_time": "05:00:00", "commenter_fname": "Caroline", "commenter_lname": "Anonymous", "comment_length": 730}, {"text": "Under eligibility requirements, it is required that the veterans serious mental illness or substance abuse must be caused by their homeless.  What about those veterans whose serious mental illness or substance abuse problem cannot be clinically proven to be caused by their homeless?  Are they not eligible for the program or its services? Any veteran regardless of the reason why they have a mental illness or substance problem should be eligible for services provided by the HCHV.  It can be inferred that veterans with serious mental illnesses or substances abuse problems will need more than 6-months to put their lives back in order.  By accepting those veterans without any mental illness or substances problems, those veterans may have a better advantage of getting stable within a 6-month period.  This could also lead to a higher rehabilitative rate within the HCHV.  In my opinion it would take individual with a mental illness or substance abuse problem longer to improve their quality of life thus lengthening their services and adding to the financial assistance needed to care for that individual.  Veterans without any serious mental or substance problems might not require the additional financial assistance needed for a veteran with those particular issues.  In order to improve this proposed rule, I suggest opening up the health care to all homeless veterans, so any individual wishing to use the services offered.However, I do think that health care for homeless veterans is a very good idea.  Statistics have shown that a high number of veterans make up the homeless population especially in downtown metropolitan type areas.  It is commendable that the VA is supporting this legislation to help those whom served our country that are no longer able to care for themselves.   ", "comment_id": "VA-2010-VACO-0032-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2010-VACO-0032-0005", "comment_date": "2011-01-24", "comment_time": "05:00:00", "commenter_fname": "Derrick", "commenter_lname": "Womble", "comment_length": 1841}]}, {"id": "FDA-2012-N-1172", "agency": "FDA", "title": "Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments", "update_date": "2013-04-23", "update_time": "11:24:53", "purpose": "Nonrulemaking", "keywords": ["cder", "cder2012179", "labeling ", "opioid", "public hearing", "drugs", "chronic pain", "extended-release ", "long-acting ", "ER/LA opioid ", "REMS", "abuse"], "comments": [{"text": "Created in 2009, the Chronic Pain Research Alliance (CPRA)  led by the National Vulvodynia Association, Chronic Fatigue and Immune Deficiency Syndrome Association of America, Endometriosis Association and The TMJ Association  has served as the first and only collaborative advocacy effort dedicated to advancing both disorder-specific and collective federal research efforts on eight prevalent, but longtime neglected disorders that frequently co-occur and disproportionately affect women. They include: vulvodynia, temporomandibular disorders (TMD), fibromyalgia, endometriosis, chronic fatigue syndrome (CFS), chronic headache, interstitial cystitis/painful bladder syndrome and irritable bowel syndrome. As highlighted in the landmark 2011 Institute of Medicine Report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research, millions of Americans suffer from one or more of these disorders at an enormous cost to both the U.S. economy and to the individual sufferer. Only a handful of treatments have been approved by the FDA for the treatment of five of these disorders, and despite their widespread prevalence, cost and life-altering impact, no FDA-approved therapies exist for vulvodynia, TMD and CFS. In addition, the federal governments investment in researching these disorders is poor  averaging just a couple of dollars per affected individual, and only a handful of clinical trials are currently studying the effectiveness of treatments to manage these conditions. The result is that sufferers are routinely misdiagnosed and shuffled from office-to-office in search of a diagnosis and effective treatment; when a diagnosis is made, very little scientific evidence exists to inform treatment recommendations, and the afflicted are left to try to gain some semblance of quality of life by stumbling upon an effective treatment(s) through the only option available to them  many months (and often times years) of trial-and-error. An expanded", "comment_id": "FDA-2012-N-1172-0248", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0248", "comment_date": "2013-04-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2038}, {"text": "I have RSD. the only thing that allows me to live as normal a life, raise the last 2 of the 4 children I have, coach their teams, go to PTA, Hold down a full time critical Gov job and get thru the day without crying too much is because I have NORCO. would i choose to take this? NO. I would much prefer to live a normal life. Some days I take what is prescribed, some days i take 1 or none. It depends, but let me ask you something. If someone you loved, God forbid as I wouldnt wish RSD on The worst people in the world, your Mom, Dad, Wife, sister, brother or child had RSD and it felt, on a daily bases and even while sleeping, that their bones were being stabbed from the inside with a hot poker, their muscles were being eaten by fire ants while getting the worst indian burn ever, to the point their skin felt as if it would tear, would you want them to have relief from that? That is what I go through daily and some have it worse. But Im guessing as Doctors or FDA employees, no one in your family would have to suffer needlesly that way. Please, Please dont let the A-Hole celebrities and recreational drug users put us back into dispare. There is a reason they call RSD the suicide disease. thank you for your time.....mary", "comment_id": "FDA-2012-N-1172-0210", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0210", "comment_date": "2013-04-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1243}, {"text": "The NFMCPA understands reasonable and necessary safety measures, but we believe the recommendations for severely restricting opioids (hydrocodone  oxycodone): 1) to a maximum daily dose equivalent to 100 mg for non- cancer pain ans 2) a maximum durations of 90 days for continuous daily use are EXTREME MEASURES! I have been living with chronic, unrelenting pain for the past 20 years and will suffer severe  consequences from such restrictions. No alternative treatments are being offered. I object to the FDA changes for more stricter hydrocodone product prescribing by changing them from Schedule III to Schedule II classification of drugs. My doctor    prescribes medications to treat my chronic pain. He is the one who should decide what his patient needs, and not the government. Thank you.", "comment_id": "FDA-2012-N-1172-0189", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0189", "comment_date": "2013-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 801}, {"text": "I am a sufferer of Chronic severe pain due to Fibromyalgia. I have pain that on the 1-10 pain scale is a 25.I have been on the narcotic Oxycontin 80 mg twice a day for about 15 years.I take it as prescribed only.Even with this strong pain med.I still have to take Nucenta for breakthrough pain and I take Ibuprofen 600mg three times a day.I certainly did not ask for this horrid pain which is frequently worse than some cancers.I do work a part time job and have a small home business but if my dose is lowered or my pain med.taken away I will be non-functional and then need to be on government disability.Also,the pain would be so severe that either I would die from the pain or I would have to take my life.This I am sure goes for many pain sufferers that legitimately need pain control.We are not addicts.We need our legitimate pain controlled.I am sure you want me and other pain suffered to be productive members of society.Thank You for reading this. Jodi M.", "comment_id": "FDA-2012-N-1172-0195", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0195", "comment_date": "2013-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 965}, {"text": "I have RSD for 10 years now. 8 months ago my husband and I moved to Spokane WA. We moved from Nevada were I finally was starting to able to things like walking my dog. It took 2 long years changing my meds. I have RSD in my left shoulder all the way into my hand also have it is my left foot. Now I am worse than I first got it. I have been to 12 damn different doctors in Spokane. They just take me off all meds.It people like you that can live a normal life and dont care that people do have chronic pain. You will never go to bed at night crying yourself and people around get anger cause they cant help. Just because some parents are keep there an eye on their own kids. You will be leaving people like me no way out but suicide!!!!!! We are people that abuse these type of meds!!!!!YOU PEOPLE SHOULD START THINKING ABOUT OTHER PEOPLE THAT DONT KNOW IFTHEY CAN GO ON DAY WITH FOR THE REST THEIR LIVES WITH PAIN!!!!!!!!!!!!!!", "comment_id": "FDA-2012-N-1172-0207", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0207", "comment_date": "2013-04-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 948}, {"text": "I am writing to comment on the FDA regulating use of opioid drugs.  For people, including myself, who are in chronic pain, the use of opioid drugs is not an option.  There are days when it might not be necessary but most days and especially a flare-up of the conditions I have the only way to function is with these drugs.  If I had a choice, I would not take them or be in pain everyday of my life.  I would not miss family gatherings, work, getting together with friends, lose friends who no longer can understand why I cant go anywhere.  For some of us there is no option and whether or not we like it this is our reality.  Opioid drugs make us feel somewhat normal and somewhat able to function.  It does not make things go away just manageable for a while.  If you or someone in your family suffered from a chronic, life-long pain condition, I wonder if this would be an issue.  Please consider the millions of people this would affect.  We are not drug addicts, we are drug users that go through our doctors to get the help we need.  Thank you for your consideration.  ", "comment_id": "FDA-2012-N-1172-0202", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0202", "comment_date": "2013-04-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1080}, {"text": "Impact of Approved Drug Labeling on Chronic Opioid Therapy.  I would like to comment on this because I do have Fibromyalgia and if it were not for the Hydrocodone that I take, I would be in terrible, excruciating pain. My doctor has already told me that I am the worse case of Fibromyalgia that he has seen. The Hydrocodone doesnt even take away all of the pain, but it does take off the edge so it isnt so intense. This is why I do not believe in this new drug labeling. No, I am not an addict, I can go without the Hydrocodone, but it would be quite painful to do so. Please do not approve this new drug labeling. Im sure I am not the only one out here dealing with this problem. ", "comment_id": "FDA-2012-N-1172-0091", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0091", "comment_date": "2013-03-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 707}, {"text": "Pain medications can be and in most cases is necessary for a person to have a nomal life.  Every persons pain level and tolorence is different and WHO has the right to say what you should and should not take.  If there is a medication that helps you control and frees you of pain (which if one has never had a cronic condition requiring this) then it should be allow for ANYONE to be able to get the medication when prescribed by a Physcian or Nurse.Not all medications work the same way for everyone I was on a medication for years that helped me lead a normal life under controlled pain medication and now because of someone or a group of someones I am in constant pain and have been since my Doctor can no longer prescribe the medication I need to live a semi normal life.  My pain will never be totally gone but the difference between being completely bed ridden and living a semi normal life that allows a person to function should be a choice that my Doctor and myself make, Not a group of people who have never been in a situation where pain is a everyday problem to having a life that most people live.  Contast pain causes severe depression and in my case not moving my body helps prevent the pain to a small degree compared to being on the pain medication which helped me and allowed me to move about more freely and enjoy life as much as possible.  Until you are in a situation yourself where you experience this I dont believe that anyone should have the right to say whether a medication of any kind should be limited or not be allowed.  Spend a day in the shoes of someone in chronic pain for just one day and experience the suffering and depression that it causes then think again about whether medication should be allowed to help make a major change in a persons life.Thank you for the chance to express my opinion in hope of concideration and a chance to once again have a major life change, to start living again and to love again.SincerelyMary Beams", "comment_id": "FDA-2012-N-1172-0130", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0130", "comment_date": "2013-03-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2004}, {"text": "The PROPs recommendation of a maximum duration for continuous opioid treatment is a serious concern to those who legitimately suffer from chronic pain. I am a young adult living with Trigeminal Neuralgia (TN), also referred to as the Suicide Disease. Living the past 17 years with TN has stripped away my dreams and ruined my quality of life. I have been prescribed over 45 non-narcotic meds in attempt to manage my pain. These meds have resulted in the most awful side-effects.I have found on-going treatment with narcotic pain meds to be a life-saver for me. I have been taking narcotic pain meds for 10 years with mild side effects and little negative impact on my life. I have never taken them at a different dose or method than my doctor has instructed. I only take them to treat my constant and debilitating nerve pain in order to achieve more out of life  including maintaining my career, my independence, some quality of life, and basic survival. TN is a disease that becomes progressively worse over time. The last time my treatment did not include pain medication, I was so disabled that I could not work, care for myself independently, or perform basic ADLs. I could not eat, talk, brush my teeth, smile, or withstand a summer breeze without excruciating pain. I fully believe that I would NOT BE ALIVE TODAY if it hadnt been for the narcotic pain management treatment my doctor began a decade ago. What is 90 days of pain relief out of a lifetime of constant, debilitating pain? How can the PROP be allowed to decide who must suffer to death and who can be relieved of their pain? Why make the chronic pain patient who has a chance to live, succeed, and participate in life again, suffer needlessly when there are reliable treatments that work? Setting a maximum duration for opioid treatment will prevent chronic pain sufferers from receiving the medical care they need to survive.   ", "comment_id": "FDA-2012-N-1172-0145", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0145", "comment_date": "2013-03-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1936}]}, {"id": "FDA-2017-P-1359", "agency": "FDA", "title": "Request that the FDA the following actions:  Revoke approval of OxyContin's indication for the management of pain, approval of all extended-release opioids indicated for the management of pain and approval of all immediate-release opioid drug product labeling supporting use for the treatment of chronic pain", "update_date": "2017-08-31", "update_time": "16:42:01", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Pharmaceutical  Manufacturing Research Services", "PMRS", "Revoke approval of OxyContin", "approval of all extended-release opioids", "approval of all immediate-release opioid", "management of pain", "chronic pain", "2017-1067"], "comments": [{"text": "I look at the reports on how the opioid epidemic, has got to be stopped and addressed.  I am, along with millions of other Americans, are on the other end of opioids. I am on the end of the chronic pain disease epidemic.   As the CDC, DEA and Medicaid and medicare,  and numerous other government associates, are blaming Doctors for the over prescribing of medication,  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about not addressing these drugs as dangerous and addictive.  Lets look at them as lifesaving and medically necessary for the million of Americans in chronic pain.  Chronic pain is a disease.   It is now becoming an epidemic. No other disease medication is scrutinized.  Chronic pain is a disease.   We as patients are being denied,  dismissed and overlooked by our drs due to all the scrutiny associated with treating chronic pain disease.   Our doctors are afraid to treat us adequately.   We have a disease that medication is readily accessible to us and we are being denied.   We pain patients are truly being discriminated against, due to people who use heroin,  illegal fentanyl,  and placed a blame on anyone but themselves.   This is a witch hunt for drs who prescribe life saving medication and pain disease patients who benefit from this medication.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible,  but without access to our, potentially, life saving medications,  we are unable to do so.  We want to live not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.We need help.  With all the headlines, topics and stories on how opioids are bad, lets look at what good they do for our disease of chronic pain and the million of Americans they help.", "comment_id": "FDA-2017-P-1359-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-1359-0025", "comment_date": "2017-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1901}]}, {"id": "DOC-2014-0002", "agency": "DOC", "title": "Implementation of OMB Guidance on\r\nDrug-Free Workplace Requirements", "update_date": "2020-12-09", "update_time": "01:03:13", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "If those that are working have to be tested, then why shouldnt those wanting financial assistance be tested. This way the government could be somewhat sure these people arent spending tax dollars on dope.", "comment_id": "DOC-2014-0002-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOC-2014-0002-0002", "comment_date": "2014-04-08", "comment_time": "04:00:00", "commenter_fname": "David", "commenter_lname": "Delong", "comment_length": 214}]}, {"id": "CMS-2021-0167", "agency": "CMS", "title": "Opioid Treatment Program (OTP): CY 2022 Methadone Payment Exception (CMS-1751-IFC)", "update_date": "2022-06-22", "update_time": "12:14:07", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "It would be irresponsible of CMS to reduce OTP (Opioid Treatment Program) reimbursement for methadone while the current PHE is exacerbating opioid use disorders in the Medicare population. We need more, not less, support for medication-assisted treatment providers, and reducing reimbursement rates for methadone would likely make this drug less available to those who need it most. This is critical to avoid further opioid-related deaths. Given the growing crisis, CMS should seek options to make methadone treatment more widely available by authorizing it to be dispensed in a pharmacy setting and/or increasing reimbursement rates to existing treatment providers. Given the abundance of pharmacies in most communities, this would capitalize on the existing pharmacy infrastructure and enable Medicare beneficiaries who are otherwise limited in treatment options to pursue medication-assisted treatment such as methadone. ", "comment_id": "CMS-2021-0167-0008", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0008", "comment_date": "2021-12-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 939}, {"text": "With the nation in the grips of both the COVID-19 pandemic and the enduring opioid epidemic, it is critical to ensure continued access to recovery from opioid use disorder (OUD) for Medicare beneficiaries. The proposed rule to freeze payment to Opioid Treatment Programs (OTPs) for methadone in calendar year 2022 at the current calendar year 2021 rate should be implemented to protect access to methadone treatment. Over 1.2 million individuals over the age of 65 struggled with substance use disorder (SUD) in 2019.  However, only 23.6 percent received treatment.  The number of older adults seeking treatment for OUD specifically increased nearly 54 percent between 2013-2015, as the opioid epidemic began to accelerate, affecting individuals regardless of age, race, income, and other demographics.  More than 200,000 Medicare beneficiaries nationwide have died due to opioid overdoses since 2015.   Additionally, SUD is associated with many negative outcomes including health complications, accidents due to impairment, and decreased productivity. Individuals ages 65 and over are especially vulnerable during the pandemic. According to the National Institute on Drug Abuse (NIDA), the effects of many substances, including opioids, such as impaired judgement or coordination, can lead to falls and motor vehicle accidents, which pose a much greater risk for older adults. Additionally, NIDA research shows that older adults are more likely to suffer from mood disorders, heart conditions, and cognitive disorders, all of which can worsen due to SUD, increasing negative health outcomes.  Though rates of opioid use and overdoses were increasing as the pandemic began, they have surged to new highs, with a 28.5 percent increase over the first 12 months of the pandemic.  Older adults are more likely to be isolated due to the pandemic and more likely to have access to prescription opioids. Overdoses among Medicare beneficiaries rose by roughly 200 per month during the second half of 2020, during the heights of the pandemic.   With the rates of overdose and OUD rising among Medicare beneficiaries, it is necessary to ensure continued access to OUD treatment. Medication-assisted treatment (MAT), which combines medications such as methadone and Suboxone with individual and group therapy, has proven to be the most effective treatment for OUD, and therefore it is critical to protect and expand access to MAT, especially as the pandemic continues.  Many individuals struggle to find openings in existing MAT programs. Others are in communities without access to MAT at all.  A 2019 University of Michigan study identified the biggest barriers to MAT treatment, according to providers, are state regulations and reimbursement rates.  Additionally, as the opioid epidemic has spread, public support for prevention and treatment of OUD has significantly increase, decreasing stigma, a significant barrier to treatment. The addition of methadone treatment as a Medicare Part B benefit in January 2020 expanded access to MAT to a large portion of older adults struggling to find recovery.  However, a sharp and dramatic decrease in the reimbursement rate for methadone could upend that progress. As stated above, providers have identified reimbursement rates and costs as one of the top barriers to MAT. Slashing the reimbursement rate for methadone, especially with so little data available, could lead to financial impacts for clinics providing methadone treatment, significant cost sharing for Medicare beneficiaries, and other barriers to treatment at a time when the pandemic is fanning the flames of the opioid epidemic. It is possible that freezing the rate at the current level will still result in some of these negative outcomes, as supply chain and logistics issues have driven up prices across the country and the globe. It is possible an increase is necessary. However, freezing the rate at the current level is a prudent solution for the moment. As stated in the proposed rule, a year will allow CMS additional time to study methadone use among Medicare beneficiaries, the prevalence of the two available methadone formulations, as well as potential alternative reimbursement formulas, given the unique nature of methadone. Though it is concerning, given widespread inflation, that the rate will remain static in calendar year 2022, CMS rationale for this proposed rule is sound, and allows for additional time to study methadone treatment in general, a new benefit for Medicare. The proposed rule prevents a sharp decrease in the reimbursement rate, which could have injected chaos into the already fragile MAT infrastructure. Upon implementation of the proposed rule, it is critical that CMS dedicate significant time and resources to studying methadone treatment and reimbursement, as well as additional MAT options, particularly as the pandemic and opioid epidemic endure. ", "comment_id": "CMS-2021-0167-0009", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0009", "comment_date": "2021-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4978}, {"text": "Please continue to keep current payment rates. We struggle as it is to have enough providers to provide these services. Decreasing would greatly impact them.", "comment_id": "CMS-2021-0167-0004", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0004", "comment_date": "2021-12-01", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 157}, {"text": "PCMA appreciates the opportunity to comment on the U.S. Centers for Medicare  Medicaid Services interim final rule related to Opioid Treatment Programs: CY 2022 Methadone Payment Exception (interim final rule).  ", "comment_id": "CMS-2021-0167-0012", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0012", "comment_date": "2022-01-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 224}, {"text": "This is a very important issue and the action that is being taken is a step in the right direction. Addiction is a ruthless disease and it can happen to anyone.", "comment_id": "CMS-2021-0167-0007", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0007", "comment_date": "2021-12-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 160}, {"text": "Thank you for the opportunity to comment.  I am a disabled physician.  Please maintain or increase rates for reimbursement for treatment of pain and addiction such as with methadone.  Lack of access is driving the overdose deaths.  Lack of reimbursement and difficulty of practice is driving providers out. ", "comment_id": "CMS-2021-0167-0010", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0010", "comment_date": "2021-12-15", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 307}, {"text": "Eliminating the annual process to review methadone coverage treatment for CY 2022 to avoid implementing a possible decrease in the payment amounts for methadone for Medicare beneficiaries has been welcoming news for many who are indirectly or directly affected. I fully support maintaining the CY 2021 payment rate for methadone to treat opioid use disorders into CY 2022. While many people might agree simply because it feels like the right thing to do, data across states indicate that this measure is critical for the fight against opioid overdose during the Coronavirus Disease 2019 (COVID-19)  pandemic. The Centers for Disease Control and Prevention reported an increase in the use of opioids as the COVID-19 brought about lockdowns and quarantines. Prior to COVID- 19 opioid overdose cases consistently increased, but between May 2019 to May 2020, the United States saw 81,000 overdose deaths, the largest ever recorded. While some data suggest that steps taken have improved prescription opioid misuse and fatalities, there have been increases with synthetic opioids such as Fentanyl, which is 50 to 100 times more potent than morphine. Prescription opioid misuse among medicare beneficiaries tends to come from chronic pain as they age.The report states that nearly one million adults age 65 and older live with Substance Use Disorders (SUD). This number is almost certain to have increased over the years, following the increasing trend and the effects of the pandemic. It emphasizes the need to increase OTPs and expand the services offered across all states. Opioid use among older adults can result in excessive sedation, respiratory depression, impairment in vision, attention, coordination, and falls. Currently, falls are the leading cause of injury-related death among adults age 65 and older.Decreasing the payment rate to Opioid treatment programs from $37.38  to $17.64 would have grave consequences, limiting access to  SAMSHA certified and Medicare/Medicaid enrolled  Opioid Treatment Programs (OTP). Many programs may choose not to participate due to inadequate funding. These OTPs also provide psychosocial services. Most of these services have been transitioned to Telemedicine, thereby improving access. Data studying a clinicians perspective on methadone service delivery indicate that 85 % of OTPs offered Telemedicine for medication management, psychosocial services, or both. These services might not be provided if payment rates are reduced.Another factor to consider is that a decreased rate may hinder the enthusiasm and motivation of employees at OTPs. Compensation and benefits are directly related to employee motivation. Low employee morale can adversely affect attracting and retaining the best employees and negatively affect productivity.While this interim final rule (IFC) freezes the payment to OTPs for methadone in CY 2022 at the CY 2021 rate, the annual update to the non-drug component of HCPCS G2067 for CY 2022 as required under 410.67(d)(4)(iii) will be applied. It is worth noting that the effects of the pandemic on opioid use disorders will be long-lasting, possibly several years. Much of the data required for evidence-based decision-making has been undermined by poor data collection, tracking, and COVID-19 restrictions. Opioid overdose is a public health crisis requiring increasing public awareness about prescription misuse, overdose, and making safe choices while providing both drug treatments and non-drug therapy.According to the  Centers for Disease Control and Prevention, the U.S. economic cost of opioid use disorder was 471 billion and fatal opioid overdose $550 billion during 2017, a total cost of $1,021 billion The combined costs varied from $985 million in Wyoming to $1,204 in Hawaii. Federal and state public health agencies can use these data to help guide research, prevention, and resource allocation decisions. ", "comment_id": "CMS-2021-0167-0006", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0006", "comment_date": "2021-12-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3971}, {"text": "Washington State supports the proposed retention of the current Medicare payment rates for Methadone used for Opioid Use Disorder in SAMSHA certified and Medicare enrolled Opioid Treatment Providers (OTP).", "comment_id": "CMS-2021-0167-0003", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0003", "comment_date": "2021-11-29", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 219}]}, {"id": "DEA-2015-0018", "agency": "DEA", "title": "Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler", "update_date": "2021-12-02", "update_time": "01:00:51", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "The main reason for our federal agencies is to help the legislature regulate specific things that help protect the public from harm. In this case, the Drug Enforcement Administration (DEA) was created in order to help protect the public in terms of drugs and their usage. The DEA has the responsibility to interpret, prescribe, and implement rules for our protection.In this particular case, they are amending the table of excluded nonnarcotic products. This is important because this list identifies any  nonnarcotic drugs that are legally able to be purchased as over-the-counter drugs. This table is reviewed and put together by the DEA. More specifically, the Deputy Assistant Administrator of the Office of Diversion Control, is in charge of determining the schedule of the drug. This means that this person determines how harmful the drug is to the public. In this case, it involves a drug that is of the same compound of the illegal drug Methamphetamine. I find this to be important because I had never thought of a Vicks Vapor Rub/Inhaler as being linked to Methamphetamine. As I have educated myself on the subject, it makes sense. Although there has been no positive data linking the use of this drug to create the same affect, it is good to be educated on the subject.I find that I am indeed for this amendment. It helps to keep the public informed and up to speed on what is and is not deemed legal for use. This amendment will also inform the public on the ins and outs of how the agency operates and what it takes to create or amend a rule.", "comment_id": "DEA-2015-0018-0002", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2015-0018-0002", "comment_date": "2015-11-23", "comment_time": "05:00:00", "commenter_fname": "Bethany", "commenter_lname": "Pearson", "comment_length": 1611}]}, {"id": "VA-2014-VHA-0009", "agency": "VA", "title": "AO71 - Proposed Rule - Health Care for Homeless Veterans Program", "update_date": "2018-07-11", "update_time": "01:04:12", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Yes.  Please make these changes.  Lets provide resources for our homeless vets, regardless of whether or not they have a mental illness.", "comment_id": "VA-2014-VHA-0009-0006", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0006", "comment_date": "2014-05-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 141}, {"text": "Individuals from all walks of life regardless of their sex, ethnicity and age, have answered the call in times when this great nation has called.  They go selfishly without argument or judgment and lay their lives in order to preserve our way of life.  Since after the Vietnam war this has been an all-volunteer military.  These individuals come back home and ask for nothing but a chance to be accepted back into society. It is shameful that our government want them to be diagnosed with certain illness before be afford benefits that they have earned.", "comment_id": "VA-2014-VHA-0009-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0004", "comment_date": "2014-05-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 553}, {"text": "These proposed changes to the policies governing eligibility of homeless veterans need to be passed. I am in favor of the proposed changes of the Health Care for Homeless Veterans (HCHV) program. This revision of current policy is near and dear to my heart. Serving 6 years active duty in the United States Navy, I know from firsthand experience what our service-members are exposed to. Men and women who write a blank check, up to and including their own lives for our country, do not deserve to be on the streets without proper shelter. Veterans who have put their lives on the line for our country need to be able to turn to the Veterans Administration (VA) for help. Homeless veterans should be provided governmental assistance without undergoing prior medical evaluation first. Homeless veterans without debilitating mental illnesses should not be excluded from this program. Removing the requirement of diagnosis of a serious mental illness or substance use disorder to qualify for the HCHV program is the right call. Also, the addition of the VA providing case management services, including non-clinical case management, are services which can be of genuine use for those in need. If this policy change is approved, not only will these newly eligible homeless veterans have an honest chance with integration back in to society, these homeless veterans will become less dependent of VA assistance. The expansion of the breadth of the HCHV program can ease the burden of other governmental agencies and community efforts. Providing help, treatment, and guidance to our nations heroes is an ethical obligation for their service.", "comment_id": "VA-2014-VHA-0009-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0005", "comment_date": "2014-05-27", "comment_time": "04:00:00", "commenter_fname": "Andrew", "commenter_lname": "Akers", "comment_length": 1643}, {"text": " Removing the requirement of diagnosis of a serious mental illness or substance use disorder to qualify for the HCHV program allows the VA and HVHC to assist the significant population of homeless veterans who do not have substance abuse or serious mental health issues but are still in need of housing.  Additionally, removing the diagnosis requirement will allow the VA and HVHC to reach an even larger percentage of homeless veterans WITH mental illness, because homeless veterans who are not yet ready to address their mental illness will be able to bypass the sometimes stressful and painful process of clinical assessment that the current law mandates and still receive HVHC support. An estimated 131,000 veterans are homeless on any given night (NAMI.org), if HVHC and the VA can assist a greater portion of this deserving population by removing barriers to obtaining housing then the agency should support this. ", "comment_id": "VA-2014-VHA-0009-0007", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0007", "comment_date": "2014-06-18", "comment_time": "04:00:00", "commenter_fname": "Director erica borggren", "commenter_lname": "Il dept. veterans affairs", "comment_length": 920}, {"text": "I support this rule. According to the Department of Veterans Affair, there are an estimated 50,000 Iraq and Afghanistan veterans currently homeless or in a program to assist them (www.usatoday.com/story/news/nation/2014/01/16). According to the HCHV, 85% of the homeless VAs have a mental/abuse disorder but 15% do not. That 15% of homeless represents a large amount of Veterans. Coming back from a war where the economy is still recovering, these VAs who risked their lives for the US, many who have served in 2 wars, deserve all the assistance we can offer. It could eliminate the social stigma many homeless VAs who do dont suffer from a disorder may feel and enable them to seek assistance.", "comment_id": "VA-2014-VHA-0009-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0008", "comment_date": "2014-06-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 718}, {"text": "Veterans of all ages come home to the United States after fighting our wars on our behalf to protect our freedoms and rights as American citizens that we so often take for granted.  It is my opinion that these men and women, who have many times laid their lives on the line for our country, should be supported and taken care of in their times of need.  I presonally feel it is sad that before this proposal, if a veteran fell homeless on their return to the states, that our Country would need a diagnosis of substance abuse or serious mental health disorder to step up and take care of the people who have afforded us our very own freedom.  I stand behind this proposed amendment wholeheartedly.", "comment_id": "VA-2014-VHA-0009-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2014-VHA-0009-0003", "comment_date": "2014-05-20", "comment_time": "04:00:00", "commenter_fname": "Nicole", "commenter_lname": "Dudley", "comment_length": 711}]}, {"id": "DEA-2020-0008", "agency": "DEA", "title": "Controls To Enhance the Cultivation of Marihuana for Research in the United States", "update_date": "2021-06-11", "update_time": "13:31:18", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Using the cannabis that is already available to consumers through dispensaries makes common sense. This ensures that the research is relevant to those who are using it. This would also help provide the kind of insight required to make responsible legislation.", "comment_id": "DEA-2020-0008-0179", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0179", "comment_date": "2020-05-21", "comment_time": "04:00:00", "commenter_fname": "Charlie", "commenter_lname": "Mann", "comment_length": 259}, {"text": "I believe that scientists should be able to access cannabis from any state licensed businesses the same way consumers do.", "comment_id": "DEA-2020-0008-0178", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0178", "comment_date": "2020-05-21", "comment_time": "04:00:00", "commenter_fname": "Laurie", "commenter_lname": "Finkelstein", "comment_length": 121}, {"text": "The production of and research into medicinal cannabis should not be governed by the DEA, a law enforcement agency, but shifted to a public health and/or science-based institution.  It is imperative that regulations on medical cannabis research be significantly reduced and institutionally reorganized to promote the health and well-being of millions of AmericansNumerous studies have investigated the Endocannabinoid system and its documented potential to manage many diseases and its invaluable aid in the treatment of chronic pain, PTSD, Epilepsy, glaucoma, movement disorders, and cancer, among others.  Further, research and clinical applications indicate that the medicinal properties of cannabis may well protect the body against some types of malignant tumors.  Indeed, we have a friend whose ovarian cancer tumors were noticeably shrunk once she began regular, careful use of cannabis. Such significant benefit can no longer be ignored!The federal government should be facilitating wide and varied medicinal cannabis research, NOT discouraging it through restrictive regulations and bureaucracy.  It is long overdue that a major public health agency like the National Institutes of Health should be responsible for oversight of domestic cannabis production for research purposes and expand the research program eligibility of cannabis growers who operate in compliance with state laws and regulations. Millions of Americans will benefit from the approval by the FDA of cannabis based medicine.  The United States must act expeditiously to implement this life-saving science", "comment_id": "DEA-2020-0008-0192", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0192", "comment_date": "2020-05-21", "comment_time": "04:00:00", "commenter_fname": "Joan", "commenter_lname": "Ariel", "comment_length": 1607}, {"text": "Why should the DEA whose actions are responsible for stiffling the medical research in the first place now be given the power to regulate and control the very thing they opposed.Not only should the dea be defunded all together but new agencies staffed by americans who listen and hear the voice of the people should be put in its place to ensure progress and success for the american way of life.We have become worse than the tyrants my forefathers rebelled against.  This is a chance to change the course of history and progress the values we signed up to defend 243 years ago. All the best,", "comment_id": "DEA-2020-0008-0190", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0190", "comment_date": "2020-05-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 627}, {"text": "I believe marijuana should have never been passed in any state as there has been more and more studies leading to against marijuana use.", "comment_id": "DEA-2020-0008-0024", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0024", "comment_date": "2020-04-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 136}, {"text": "The highest quality product is in the state programs. Why would researchers have to go through an organization that supplied bunk medicine to the research community for decades when state-level growers are readily providing the goods?", "comment_id": "DEA-2020-0008-0082", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0082", "comment_date": "2020-05-14", "comment_time": "04:00:00", "commenter_fname": "David", "commenter_lname": "Lucito", "comment_length": 234}, {"text": "The DEA is not the appropriate body to be overseeing or regulating cannabis research. Instead of facilitating research, this proposed rulemaking will serve only to further hinder research  indefinitely delay any potential positive outcomes. Most significantly, a law enforcement agency like the DEA should not be in charge of any aspect of this process. One of the many qualified public health agencies in the federal government (i.e. Health and Human Services, National Institutes of Health, etc.) should manage all of the processes related to research, including making decisions about who qualifies to grow and sell to researchers. Furthermore, the US should adopt a regulatory framework that encourages and facilitates further research, rather than chilling it (as these proposed rulemaking would). The American public has repeatedly made clear its desire for greater unimpeded, evidence-based research to be conducted on the public health benefits of cannabis. Voters across the political spectrum overwhelmingly support medical cannabis legalization. In 2017, a Quinnipiac Poll showed 94% approval for medical cannabis, including 96% of Democrats and 90% of Republicans. On more comprehensive reform, a 2019 Gallup News Poll showed two-thirds (66%) of Americans support legalizing cannabis for adult use. There is no putting the genie back in the bottle; it is clear the American public wants regulated, tested and safe cannabis. It is time for the federal government to facilitate and not hinder research into these popular products. Evidence-based medicinal research guides practicing clinicians on medications use, dosing, and monitoring. These decisions combine anecdotal evidence supported by unbiased empirical data in the form of clinical research. Despite the fact that over 3 million patients in the US use cannabis legally as medicine to treat a variety of conditions and symptoms (chronic pain being the most prevalent), key research is stifled due to its current Schedule I status. The high-risk demographics of some patients like the elderly and veterans who use medical cannabis demand that research-based evidence guide cannabis use for these populations. High-quality research supports informed and safe decision-making in medicine. This is absolutely essential in all fields of medicine, including cannabis. Expanding research capability is of critical importance for Americans across the nation and who have a vested interest in knowing as much as possible about the medicinal properties of the cannabis plant. I share the DEAs stated goal to facilitate the cultivation of cannabis for research purposes, but strongly disagree that the DEAs proposed rulemaking will best accomplish that stated goal. The cannabis industry has been waiting for three years for the release of this Federal Register Notice with the hope that the proposed regulations were drafted to advance the goal of facilitating much-needed research. If adopted in its current form, however, this proposal would have just the opposite effect; it would impose another level of unnecessary regulatory and bureaucratic obstacles in the path of valid medical-cannabis science. Most significantly, DEA is not the proper agency to act as gatekeeper for such important public health research. Indeed, this mandate is entirely outside the agencys expertise. Reminder: DEA is a law enforcement agency, not a public health agency. It is my view that one of the many qualified public health agencies in the federal government like HHS or NIH can more effectively manage all of the processes related to research into the medicinal benefits of cannabis. I believe that the DEA should withdraw its rulemaking. Instead, Congress should modify the CSA to allow for a public health agency to license the production of cannabis for medical and scientific research purposes. I do not believe that such a narrow reading of our treaty obligations is warranted, given the reality that 33 states currently regulate commercial supply chains to safely produce, store and transport any cannabis needed for medical or scientific research. This threatens to exclude many of the nations most qualified applicants, namely, state-compliant grow operations. I assume that the DEA will assert that those operating in compliance with current state law are violating federal law. The US needs to leverage the expertise of growers with 20-30 years of experience, rather than relying on growers with limited experience growing cannabis. I would prefer to see a greater emphasis on other factors, like compliance with state laws and demonstrated ability to grow research-grade cannabis. Strict reliance on past compliance would naturally tend to abdicate US leadership on these issues in favor of foreign operators. The fed gov. should be incentivizing research, not discouraging it.", "comment_id": "DEA-2020-0008-0055", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0055", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Brad", "commenter_lname": "Bogus", "comment_length": 4841}, {"text": "More positive changes for a plant...yes", "comment_id": "DEA-2020-0008-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0039", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 39}, {"text": "Limiting the supply of research cannabis is ridiculous when there is such a plentiful supply of diverse strains available under state sanctioned programs. If federal law is going to continue to be behind the curve, then decentralize the research and allow science to access the strains available within their legal state research locations. The entourage effect of phytocannabinoids, terpenes, flavinoids, etc. is not well understood, but likely to play a major role in treatment response. By limiting availability of supply to a small number of commercially sanctioned growers under DEA guidelines, we are doing the science a grave disservice.", "comment_id": "DEA-2020-0008-0051", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0051", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Peter", "commenter_lname": "Shaw", "comment_length": 644}, {"text": "RIN 1117-AB54/Docket No. DEA-506If for individual research use, under 1301.32(a) of Action on applications for research in Schedule I substances:(a) In the case of an application for registration to conduct research with controlled substances listed in Schedule I, the Administrator shall process the application and protocol and forward a copy of each to the Secretary of Health and Human Services (Secretary) within 7 days after receipt. The Secretary shall determine the qualifications and competency of the applicant...And under the first half of (3) in 1303.12(e)(3) of AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS: (e) The following persons need not obtain a procurement quota:(3) Any person who is registered to conduct research with a basic class of controlled substance listed in Schedule I or II (this is the second half of the sentence: and who is authorized to manufacture a quantity of such class pursuant to Sec. 1301.13 of this chapter. Which reads; 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.)Why, if the Administrator and the Secretary both review patients and caregivers state registrations, which are a research based program, hence issuing registered patient IDs. And it would be unlawful without said registration. Are we as patients and caregivers, required to submit a secondary application reviewing the same qualifications already approved and registered by and for use by the state as referenced in (3)? The state should be mandated to include both requirements in one application with one set of fees. If requirements are automatic. Then allocate fees accordingly to the partnered governmental departments from one application who receive the benefits of fees. ", "comment_id": "DEA-2020-0008-0052", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0008-0052", "comment_date": "2020-05-13", "comment_time": "04:00:00", "commenter_fname": "Timothy", "commenter_lname": "Barrett sr.", "comment_length": 2292}]}, {"id": "CDC-2022-0024", "agency": "CDC", "title": "Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids", "update_date": "2022-11-29", "update_time": "11:59:11", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "I am begging you to change these guidelines.  Thanks to a NY Times article on 3/13/22, The Other Victims of the Opioid Crisis, I finally had the information I needed to ask the right questions about why I cannot get the relief from chronic pain that would enable me to live my life.  I do not remember the date but have a clear memory of the day my pain management doctor said he could not give me the level of medication I needed because of this guideline.  He said the government apparently only understood black and white.  And, yes, this was a period of time that it was scandalous that there were doctors who opened offices just to hand out opioid prescriptions.  Just a few months before my husband were in my hospital room talking to my spine surgeon after my 7th spinal fusion about the problem.  None of us foresaw the horrible swing of the pendulum.  I hope you caught that it was the 7th fusion.  Except for vertebrae C3, which is filled with stenosis, my entire spine has been surgically or auto-fused.  I assume that whoever reading this knows what these means in terms of pressure on nerves and blood vessels coming from the spine.I was in my early 30s (now 75) when told I had arthritis in my lower spine.  For years doctors tested me for rheumatoid arthritis because my osteoarthritis is so extensive and bilateral.  My first orthopedic surgery was my carpal tunnels in my early 40s.  In my 50s, the surgeries alternated between my knees (4 replacements) and my spine.  When my spine has been opened, if the surgery was near a previous one where bone material had filled in, the earlier hardware was removed to prevent a possible infection site.  One of those was attacked again by arthritis and was done again.  About a year ago I would sometimes get shooting pains in my feet. At my next appointment with my spine surgeon (every 3 months), I was told that when I bent my back L3 and L4 were sliding over the nerves to my feet.  Fortunately my surgeon is not only highly skilled but very conservative, so there was no immediate scheduling of a surgery that would have involved removing the hardware from the last fusion at T10 through L2, replacing it and continuing the fusion down through my pelvis (both sides of my sacrum are eroded by arthritis; after years of steroid shots, it became too painful to get in position for the shots).  Within 6 months L3  4 self- fused. Good.  The good news was that there would be no surgery.  The bad news is that the nerve is under constant pressure which means constant pain.  Unfortunately I do not tolerate the medications used for nerve pain.  From what I have read on the web from NIH, Mayo, and Cleveland, the treatment that remains is opioids.For the last 3-4 years, I have been taking a generic hydrocodone 10mg-acetaminophen 325 and used a Fentanyl 25 mcg duragesic patch. I dont think the patch does much of anything except for maybe the middle 24 hrs.  I also take one 100mg of Celebrex per day.The pain in my feet is most intense when I try to sleep.  Before I try to sleep I take a Tizanidine tablet and a Zolpidem tablet.  At most I sleep for 2 hrs. before pain awakens me; sometimes I can fall asleep for another hour or two.  Pain takes away any desire to eat; I make myself do it to keep glucose levels even (insulin resistant).  As often as not I am in tears which is not the person I am.  I havent seen my family in months because I dont want my beloved grandchildren to see me in this condition.  I dont go anywhere and I dont do anything because it means more movement and more pain.  Books have been a mainstay of my life, but pain even keeps me from reading.  I want my life back.My pain management doctor will not increase my dosage.  I dont know if this is really his choice or the policy of the much-vaunted health service for which he works.While you change this guideline, I am also begging you to change who is allowed to do the prescribing.  It is beyond belief that anyone would think that an anesthesiologist should prescribe these medications rather than a primary care physician who would know the patient best or even a specialist such as an endocrinologist, rheumatologist who the patient sees regularly.Unlike the man in The NY Times article, suicide is not an option for my beliefs about life, but that doesnt mean I havent thought about the relief it might bring.  I am begging you to give me and the thousand like me our lives back.", "comment_id": "CDC-2022-0024-5098", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5098", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4595}, {"text": "As a patient and advocate for adequate analgesia for the chronic disease and disability communities, I have witnessed and experienced the barriers to pain management and healthcare caused by CDC 2016 Guidelines. The harms patients suffer include experiencing severely increased high impact pain, forced tapers, patient abandonment, mental health crises, and suicide. Patients have lost access to adequate and appropriate pain care. CDC Guidelines also facilitate patient loss of access to the general healthcare system including primary care and mental healthcare. Healthcare providers now make decisions not based on their best clinical judgement, but through a lens of liability, fear, and stigmatization. This expanded clinical guideline will significantly increase the harms to all patients in all clinical settings in need of appropriate pain management. As evidenced by the harmful outcomes of the 2016 Guidelines and lack of any action to reverse these harms, terms such as unintended consequences and wide misapplication are now moot. Patients and providers are aware any issuance of federal guidance will be interpreted as standard of care, mandate, policy, and law, as federal guidance is designed to accomplish. This underscores the lack of forethought and understanding CDC demonstrates in its guidance issuance effects on providers and patient populations.   CDC Injury Prevention Center does not have the professional experience, expertise, or stakeholder input necessary to develop guidance on the appropriate treatment of pain in all clinical settings. The influence of special interest groups is obvious in the failure to address serious conflicts of interest of authors and blatant violations of the Federal Advisory Committee Act. The updated guidelines make painfully evident CDC Injury Prevention Center is insufficient and unqualified to provide guidance on treatment of acute, subacute, or chronic pain through the exclusion of new relevant evidence, data, and research, continued use of the scientifically invalidated metric of Morphine Milligram Equivalent (MME), as well as exclusion of input from stakeholders who possess the expertise and experience to contribute to best practice guidance for pain treatment including the crucial tool of appropriate opioid prescribing. The harms to patients caused by the 2016 Guidelines are still occurring in vast numbers of patients. The 2022 updated Guidelines do not address reversal of these harms and will further cause increased harms to expanded patient populations without any viable plan to track patient outcomes from implementation. As a patient with lived experience, a disabled person, and an advocate for pro-patient care, to prevent continued and increased patient harms, it is imperative CDC withdrawal and rescind both the 2016 Guidelines and the 2022 updated Guidelines immediately. Thank you for your time,[name redacted], Ambassador, Chronic Disease Coalition", "comment_id": "CDC-2022-0024-5101", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5101", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Koa", "commenter_lname": "Kai", "comment_length": 3002}, {"text": "You need to let doctors prescribe medicine as they see fit. If someone has an injury,  there is often no way of knowing whether pain will be acute or chronic. I used to have chronic pain. At the time, my  hospital was discouraging opioid use. That led to me not getting the proper pain treatment. My primary doctor kept trying to get me to stop taking Percocet even though I was in constant pain. Evevtually the Percocet didnt work as well. And you know what? My doctor refused to up my dose. She was worried that I would become a junkie in 10 years. I promised her that I would commit suicide long before that happened. I had to double my dose of Percocet and take it once every other day just to get four hours of relief in a 48 hour period. I researched pain treatments to try. Massage therapy? Tried it. It didnt fix my pain. Trigger point therapy? I tried both the pressure kind (worked a little at first, but eventually not) and the injection kind. An anesthesiologist injected a steroid and lidocaine near one of my nerves. The 20 minutes of relief was amazing! I thought I found a fix. But the steroid irritated the nerve. I have never been in so much pain in my life! Percocet did nothing for that pain. I spent a day and night crying and wishing I was dead. I wanted to go to a hospital for help, but was afraid that I would be accused of doctor shopping and would no longer be allowed to have any Percocet. You would think that by the way my doctor acted, that I was on a lot of Percocet. Nope. I got 10 mg/day. Other women with a similar issue were on 3 times that amount. To get further help with pain management, I wanted to try physical therapy. I made an appointment. The therapist told me I wouldnt get drugs from her. Who hoes to a physical therapist for drugs? Then she wanted to know about pain and drug use in my family members. Crazy right? I was there to find out if there was something I could physically try to get rid of my pain, but here this therapist was trying to see if Im doctor shopping and if Ive got drug addicts in my family.  She didnt recommended no physical therapy. Instead, I was told to do enjoyable things like spend time with friends. I told her I was in too much pain to enjoy friends plus the shear act of pretending to not be in pain when with friends was mentally and emotionally exhausting. I was told to relax with a hot bath or learn meditation. Thats when I knew something was was wrong in this hospital. I could tell the hospital had given directives to discourage pain medicine use. I was right. About a year later. I found an article about Group Health that stated the insurance carrier/hospital told doctors to encourage their patients to stop taking prescription pain medicine. I tried meditation for pain management. Hated it. I found that the hospital had an online group meeting to help with chronic illness. Listening to people worried about losing their jobs or marriages made my depression sooooo much worse. Plus, the class gave the same crappy advice that the physical therapist gave. I dropped the class. At some point I tried a salve I bought on the internet. Didnt work. I bought a tens unit. Didnt work. I was pissed. I tried so hard to find non opioid ways to deal with my pain, but there was no help. The one thing that did help, I  couldnt get a higher dose of. At the time, I had a coworker who had a bad fall. She got strong meds, physical therapy, AND water therapy. I couldnt wait to switch insurance companies.  I finally understood why people called Group Health Group Death.My situation was made worse because I was the one trying to find alternative treatments. My doctors insisted nothing could be done without more medicine which they would give me. I was suicidal. I mean neither my gynecologist or primary doctor recommended that I seek treatment elsewhere. In fact, I was told that if I doctor shopped, my pain management treatment would end. Once I switched insurance, what a difference! I was in so much pain that I couldnt wait to see my new doctor. I went to an urgent clinic to see if I could get muscle relaxers to help. I told the doctor everything that I had tried. I even told him how badly the trigger point injection was. I forgot to mention in my previous stated here that, on top of the excruciating pain. I urinated like a horse for days which caused severe leg cramps for weeks. You wouldnt think trying to stop pain would cause me to be in even more pain. That doctor got me on a non opioid and my new doctor added a different non opioid to that. He also told me Group Health didnt have a pain specialist, so they were limited in what they could prescribe. I should have been sent to a specialist!My new doctor recommended physical therapy. My new physical therapist was very familiar with my problem and gave me exercises that were very helpful. My pain decreased significantly. Still, it took over two years before I wasnt in pain 24/7. ", "comment_id": "CDC-2022-0024-5109", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5109", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Monica", "commenter_lname": "Turner", "comment_length": 5087}, {"text": "The CDC guidelines are based on noble motives-to improve health care, protect doctors from malicious prosecution,  and patients from side effects of opioid prescriptions.Unfortunately, they fail at all three, because the goals are impossible in our current legal and social environment.The great hollowing out of the middle class, driven by federal tax policy, has increased deaths of despair starting at least in 1979. Physician prescribing certainly hasnt increased deaths from alcohol or suicide. Neither was it the cause of increased use of drugs of all sorts.The Epidemic of Despair Among White Americans: Trends in the Leading Causes of Premature Death, 19992015  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5607670/Why Deaths of Despair Are Increasing in the US and Not Other Industrial Nations Deaths of Despair Rise Steeply in the US vs Western Europe, Canada, Australia, and Japan https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2788767#ysc210003f1 Deaths of Despair article w graphs How Working-Class Life Is Killing Americans, in Charts https://www.nytimes.com/interactive/2020/03/06/opinion/working-class-death-rate.html  Opioid/Overdose Crisis as a Dialectics of Pain, Despair, and One-Sided Struggle - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676222/Americas 1% Has Taken $50 Trillion From the Bottom 90%  https://time.com/5888024/50-trillion-income-inequality-america/ Deaths from overdoses of all sorts have been increasing smoothly since 1979.https://science.sciencemag.org/content/361/6408/eaau1184/tab-figures-data Actions based on misunderstanding the problem cannot solve the problem.In fact, the physicians task is simply impossible. Prescribing opioids comes with a high risk of felony prosecution; even if the prescribing is perfect, that is irrelevant if prosecutors show anomalies in the business or operations side of the practice. And we know that no one prescribes perfectly 100% of the time. When the price for this is 20 years in prison, doctors simply refuse to prescribe.The problem is the 1970 CSA that criminalizes use and possession of medications. The US prohibited use and sale of alcohol for 13 years, then wisely decided this was bad policy. Weve had drug prohibition for 50 years, and all thats done is waste money, kill Americans and put minority men in jail.The best CDC could do would be to recognize the epidemic of deaths of despair its causes, and advocate social policy to reverse them.The least CDC could do would be to not make the situation worse by prescribing bleeding and purging. ", "comment_id": "CDC-2022-0024-5106", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5106", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Peter", "commenter_lname": "Liepmann md faafp", "comment_length": 2734}, {"text": "Thank you for the opportunity to comment on the proposed CDC Guideline for Prescribing Opioids for Chronic Pain. While the proposed guidelines are an improvement from the 2016 guidelines, they do not represent a significant enough change to allow patients with legitimate chronic pain disorders who depend on opioid therapy to reduce their pain and improve their quality of life. It is understandable that the CDC is hoping to reduce drug overdose deaths. However, while opioid prescriptions have decreased by over 40% in the last decade (likely caused in part by the 2016 guidelines), annual drug overdose deaths in the U.S. have increased. The problem is clearly not with the prescribing of opioidsillicit street drugs are primarily driving the increase. There is therefore no reason to unfairly target chronic pain patients who are trying to treat their pain with the medical recommendations of their doctors. We do know that as legal prescriptions have decreased, suffering, disability, and suicide among those who suffer with chronic pain have risen steadily. The CDCs 2016 guidelines have unfortunately led to extremely harmful unintended consequences for patients with chronic pain. Many states adopted laws and regulations that limited opioid prescribing. Similarly, many health insurances based policies on those guidelines.  Many doctors have stopped prescribing opioids at all or minimize what they will prescribe, despite patients documented needs, because it is seen as such a huge risk to their license. Some doctors will not take on new patients who have been prescribed opioids. Many pharmacies will not fill patients prescriptions due to the increasing regulatory burden.  As a result of this, patients with chronic pain who have legitimately and safely taken opioids to control their pain for years now have to jump through herculean obstacles to obtain their prescriptions.The proposed guidelines do not balance discussing the known risks of opioids with the benefits of continuing opioids for chronic pain when a patient has failed other treatment options. The guidelines also do not take into account the incredible harms of poorly managed chronic pain, which include physical distress, mental agony, inability to hold a steady job, disability, and suicide. The guidelines must include strong language discouraging physicians from abandoning patients who depend on opioids for their pain. Additionally, citing specific doses can be interpreted (as it was in the 2016 guidelines) as giving a hard ceiling. Physicians need to be trusted to use their judgement to decide which medications are safe and beneficial for their patients, and at what doses.These guidelines matter deeply to me because I have a close friend in her early 40s who suffers from chronic pain and who currently spends the majority of her productive hours simply trying to obtain the medications that her doctor feels are most beneficial and safe for her. She has tried multiple other treatment methods to manage her pain, such as numerous non-opioid medications, procedures, injections, implanted spinal stimulators, complementary/ alternative medication modalities, mind-body strategies, etc. Her doctor agrees with her current treatment plan and has been prescribing opioids to her safely for many years. She is at low risk for overdose and would never dream of selling or giving away her medications. She does not get high from her medicationsshe simply has a reduction in pain that allows her to function on a daily basis. Most months out of the year, the red tape is so incredibly obstructive that she ends up running out of her needed medication, leading to dangerous sudden tapering, extreme pain, and inability to function. If her current doctor were to retire, it would be virtually impossible for her to find another doctor willing to take her on as a new patient and continue the medications that she has safely used to attain a minimum quality of life. My friend, like thousands of other chronic pain patients around the country, is depending on the CDC to take back much of the harmful language from the 2016 guidance. The CDC needs to replace the prior language with more appropriate statements that respect the benefits that many chronic pain patients receive from taking opioids and that acknowledges the incredible harms that come from limiting dosing, suggesting medically unnecessary tapers and making it incredibly difficult for patients to obtain the medication that their doctor has decided is best for them. One set of proposed changes that takes the needs of chronic pain patients into account was written by [name redacted], PhD and [name redacted], MD (https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/commentary-how-fill-holes-cdc-opioid-prescribing-guideline-revisi). These proposed revisions should be strongly considered by the CDC.", "comment_id": "CDC-2022-0024-5107", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5107", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Marisa", "commenter_lname": "Harford", "comment_length": 4941}, {"text": "6 years ago CDC issued Guidelines for opiod prescription and use. They have been a foreseeable disaster. Illegal fentanyl heroin cocaine meth are killing more Americans then ever. People with injuries surgery child birth are denied or get limited safe pain relief medication. ChronicPainPatients have their opiod prescription canceled or severely limited. Some seek Illegal drugs which have unknown ingredients, quality  amounts.The CDC Guidelines should be totally rescinded. If not, then substantially limited.", "comment_id": "CDC-2022-0024-5132", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5132", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 527}, {"text": "I have MS, congential spinal stenosis, degenerative disc disease, and need a knee replacement I cant get until next year. Because of all my issues I developed drop foot. The drop foot causes me to fall a lot. I never get pain meds even though I fractured my knee and footand had had bulging discs from my many falls. I basically sit on the couch most of the day because trying to do things or stand longer than 15 min I feel like my back is going to break. I have never abused my medication so I should not be treated like I have. These guidelines have poisoned the entire healthcare industry. Doctors and nurses are not treating pain even while patients lie in hospital. Pharmacists are making decisions about whether you deserve to fill the prescription or decide not to give you the full prescription. Its absolutely Ridiculous. My brother had multiple surgeries in a short period of time to clean out staph infection that has spread to bone throughout his body including 2 operations on his spine. He spent weeks lying in bed in agony. They were stingy with the morphine and oxy. They didnt try other options finally at week 5 he got Dilaudid which helped so much. He was actually able to carry a conversation and not be groaning in pain. He should have been given more medication. He should have gotten other medications tried. Instead he was in agony for weeks. Not only are these measures not a step in the right direction the intention behind these guidelines is positioning all aspects of healthcare. ", "comment_id": "CDC-2022-0024-5129", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5129", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Elizabeth", "commenter_lname": "Galicia-pigg", "comment_length": 1535}, {"text": "I have been a chronic pain patient for 12 years. My pain was being controlled by pain medication up until 2018 when I was force cutoff of 385 MME with no taper. I went from working full time to not being able to get out of bed.  My quality of life is next to nothing now compared to when I was properly medicated. Please help me and millions of others in ridding the 2016 opioid prescribing guidelines. Please do not put a MME cap on our medications. This will only continue to dissuade Drs. from being comfortable enough to prescribe the medication I need to survive and work as a functional member of society. I deserve a quality of life which has been taken from me and my family.Thank you.", "comment_id": "CDC-2022-0024-5265", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5265", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Nika", "commenter_lname": "M.", "comment_length": 698}, {"text": "DONT FORGET THE CURSE!!!!!!!", "comment_id": "CDC-2022-0024-5263", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5263", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Keith", "commenter_lname": "Brown", "comment_length": 33}, {"text": "I have been living with severe chronic pain for decades. This pain has negatively impacted every facet of my life. I have tried countless treatments for pain, including: OTC medication, prescription medication (non-pain medications, non-opioid pain medications, and opioids), injections, physical therapy, minimally invasive procedures, and major surgeries. The ONLY treatment that has given me relief and afforded me an acceptable quality of life is a combination of one long-acting and one short-acting opioid. Now, my insurance company, FEP BC BS, is taking me off opioids completely. This is  against my will and over the strong objections of my long-time physicians. FEP BC BS is using the CDCs strict 2016 opioid guidelines to justify their decision. The CDCs follow-up clarification statement on these guidelines has been ignored. This has caused great harm to me and to many others. The CDC must issue new, flexible guidelines that INCLUDE the clarifications, thereby making it more difficult for insurance companies to cherry-pick the official advice. I am physically dependent on, NOT addicted to or abusing, opioids. I have been on these two opioids for at least five years. I am a responsible and compliant pain management patient. I adhere to the strict terms of my patient contract and I have never given my physicians cause for concern. My condition has not changed. My behavior has not changed. What has changed is FEP BC BS opioid policy. This new policy is based on the CDC 2016 opioid guidelines and it completely dismisses the CDC, FDA, and HHS clarification statements that were issued later, in response to serious concerns over misapplication of the guidelines. FEP BC BS is misapplying the guidelines in the exact ways they have been explicitly told not to. For example:-FEP BC BS has instituted a rigid MME/day allotment and refuses to consider a prescribers informed opinion or a patients individual situation. The CDCs clarification paper states POLICIES THAT MANDATE HARD LIMITS CONFLICT WITH THE GUIDELINES EMPHASIS ON INDIVIDUALIZED ASSESSMENT OF THE BENEFITS AND RISKS OF OPIOIDS GIVEN THE SPECIFIC CIRCUMSTANCES AND UNIQUE NEEDS OF EACH PATIENT. -FEP BC BS has rejected explicit safety warnings from the CDC, such as, SERIOUS HARM IN PATIENTS WHO ARE PHYSICALLY DEPENDENT ON OPIOID PAIN MEDICINES SUDDENLY HAVING THESE MEDICINES DISCONTINUED OR THE DOSE RAPIDLY DECREASED. THESE INCLUDE SERIOUS WITHDRAWAL SYMPTOMS, UNCONTROLLED PAIN, PSYCHOLOGICAL DISTRESS, AND SUICIDE. The FDA agrees, stating, SHOULD NOT ABRUPTLY DISCONTINUE OPIOIDS IN A PATIENT WHO IS PHYSICALLY DEPENDENT.-FEP BC BS ignores the CDCs assertion that, THE RECOMMENDATION STATEMENT DOES NOT SUGGEST DISCONTINUATION OF OPIOIDS ALREADY PRESCRIBED AT HIGHER DOSAGES. This insurance company has inappropriately seized total control of my treatment. They have taken on the role of doctor and regulator. They have imposed hard limits. They have not considered my specific situation. They have not listened to my physicians. They have not listened to me. They have not listened to the CDC, FDA, or HHS. They have rapidly decreased my medications by a weekly 50% (a far cry from HHS advice to, WHEN tapering or discontinuation is appropriate, decrease opioids by no more than 10% per month). FEP has done this though I am physically dependent on these medications and have been for years, and despite the extreme physical and psychological effects I have and will continue to experience.Since their drastic cuts, I have been unable to sleep and have suffered with intense anxiety and panic attacks (at one point, I thought I was having a heart attack). I have headaches, joint and muscle pain, nausea, diarrhea, exhaustion, irritability, and more. I cannot complete necessary tasks. I feel worthless. And I know none of this is going to get better. It is only going to get worse. I have no more appeals and my only recourse is to take my insurance company to court. This will cost $30,000. I feel powerless, desperate, and hopeless. The life that awaits me is one of agonizing, daily pain and scant functionality. It is not a life worth living and I dont know what Im going to do. The CDC MUST incorporate these clarifications into the new guidelines, otherwise their sound, patient-centered advice will continue to be ignored and people with pain will continue to suffer. While the 2016 guidelines were created with good intent, they led to dramatic overcorrections and knee-jerk reactions that have resulted in serious negative repercussions. Pain is not being adequately treated and is often completely ignored. Doctors, nurses, pharmacists, and insurance companies feel free to openly engage in patient-profiling and discrimination. People in pain are resorting to desperate measures as their options for relief dwindle to nothing. Please take steps to fix these and other unintended consequences. ", "comment_id": "CDC-2022-0024-5274", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2022-0024-5274", "comment_date": "2022-04-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5075}]}, {"id": "CMS-2019-0090", "agency": "CMS", "title": "Secure Electronic Prior Authorization for Part D Drugs\nCMS-4189-P", "update_date": "2021-06-11", "update_time": "13:26:49", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "On behalf of McKesson, I am pleased to submit comments on the proposed rule Medicare Program: Secure Electronic Prior Authorization for Medicare Part D (CMS-4189-P).", "comment_id": "CMS-2019-0090-0042", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0042", "comment_date": "2019-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 177}, {"text": "Prior authorizations (PAs) were implemented as cost saving measure, to ensure that expensive medications were truly needed and that no less costly alternative was an option. Currently, prescribers and their staff spend an inordinate amount of time on PAs, sometimes nearly two workdays cumulatively (Robeznieks, 2018), putting the cost saving benefit into question. As electronic prescribing and electronic health records become the rule rather than the exception, it makes sense to tie the acts of prescribing and authorizing together. It is difficult to justify the upfront costs without looking at the bigger picture, because the entities subject to the upfront costs of converting to an electronic PA platform may not be the same entities benefiting from the cost saving. As both a healthcare consumer and a registered nurse, I can see clear benefit to this proposed change. From the provider standpoint, I have personally seen the snowball effect that the hassle associated with PA leads to. Patients can be deterred by the PA process, causing decreased medication compliance which ultimately causes larger health problems and increased cost. Research by CoverMyMeds, a company that produces electronic PA software, discovered that nearly 30 percent of these prescriptions are abandoned by patients(Beaton, 2018). As a person prescribed a medication that required a PA, it was frustrating to learn that often the prescriber was unaware of the PA requirement, since they can vary with insurance providers or the indication for the prescription. Having built-in alerts that inform the provider of the requirement, while prompting for the PA in real time simply makes good sense. Beaton, T. (2018). 96% of payers are committed to electronic prior authorization. Health Payer Intelligence. Retrieved from https://healthpayerintelligence.com/news/96-of-payers-are-committed-to-electronic-prior-authorization.Robeznieks, A. (2018). Cut prior authorization hassles through automation, EHR integration. American Medical Association. Retrieved from https://www.ama-assn.org/practice-management/sustainability/cut-prior-authorization-hassles-through-automation-ehr", "comment_id": "CMS-2019-0090-0002", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0002", "comment_date": "2019-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2189}, {"text": "THIS PROPOSED RULE IS YET ANOTHER DEMAND ON  NONREIMBURSED PHYSICIAN TIME.  IF PASSED, IT MUST INCLUDE A FEE SCHEDULE, SUCH AS A  $25 FLAT REIMBURSEMENT PER GENERATED PAR.", "comment_id": "CMS-2019-0090-0004", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0004", "comment_date": "2019-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 171}, {"text": "On behalf of the 32 member companies of the Electronic Health Record (EHR) Association, we are pleased to offer our comments to the Centers for Medicare  Medicaid Services (CMS) on the proposed rule for the Medicare Program; Secure Electronic Prior Authorization for Medicare Part D (CMS-4189-P.). We appreciate CMS objective to align the standards for e-prescribing with those used for prior authorization through Medicare Part D.  ", "comment_id": "CMS-2019-0090-0029", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0029", "comment_date": "2019-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 438}, {"text": "Dear Administrator Verma:On behalf of Dr. Saul Levin, M.D., M.P.H., the CEO and Medical Director of The American Psychiatric Association, please find our letter for CMS Proposed Rule: Medicare Program: Secure Electronic Prior Authorization for Medicare Part D CMS-4189-P. If you have any questions, please do not hesitate to contact me.Sincerely,Nathan A. Tatro, M.A.Associate Director of Digital HealthAmerican Psychiatric Association", "comment_id": "CMS-2019-0090-0041", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0041", "comment_date": "2019-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 480}, {"text": "Amazing Charts LLC, a leading provider of Electronic Health Records and Practice Management solution for small independent practices, is supportive of the Secretary and the Administrations efforts to comply with the provisions of HR 6 SUPPORT for Patients and Communities Act (Act). Additionally, Amazing Charts is supportive of the NCPDP SCRIPT standard which was called out in the proposed rulemaking for Medicare Part D ePA; however, HR 6 permits the Secretary to call out the use of standard(s) vs. one standard; therefore we strongly encourage the Secretary to permit the use of other, existing standards and technology such as HL7, APIs and applications for electronic prior authorization when finalizing this rule-making.  Because other standard technology is currently available and implemented, should SCRIPT be the only standard permitted in final CMS rulemaking, we would see forward innovation in the industry hampered.  Additionally, the exclusive naming of the NCPDP SCRIPT standard runs contrary to the efforts of ONC in their Information Blocking Rule and the CMS Interoperability rule.  The naming of multiple standards in rulemaking would be conducive to the needs of the industry and would also support the language found in Section 6062 of the Act. Sincerely,Chris ConradProduct Manager, Amazing Charts LLC", "comment_id": "CMS-2019-0090-0008", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0090-0008", "comment_date": "2019-08-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1351}]}, {"id": "HHS-OCR-2022-0018", "agency": "HHS", "title": "Confidentiality of Substance Use Disorder (SUD) Patient Records", "update_date": "2024-02-05", "update_time": "14:21:26", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "*", "comment_id": "HHS-OCR-2022-0018-0005", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OCR-2022-0018-0005", "comment_date": "2023-03-07", "comment_time": "05:00:00", "commenter_fname": "Matthew", "commenter_lname": "Defraia", "comment_length": 1}, {"text": "Oracle Cerner Comment Letter", "comment_id": "HHS-OCR-2022-0018-0058", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OCR-2022-0018-0058", "comment_date": "2023-02-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 28}, {"text": "Aloha, The Alcoholic Rehabilitation Services of Hawaii Inc., dba Hina Mauka submits its comments for the LAC-Part-2-January-2023-NPRM", "comment_id": "HHS-OCR-2022-0018-0034", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OCR-2022-0018-0034", "comment_date": "2023-02-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 133}, {"text": "On behalf of the American Society of Addiction Medicine (ASAM), please find enclosed ASAMs comment letter.", "comment_id": "HHS-OCR-2022-0018-0107", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OCR-2022-0018-0107", "comment_date": "2023-02-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 111}]}, {"id": "EPA-HQ-ORD-2020-0182", "agency": "EPA", "title": "IRIS Toxicological Review of Vanadium and Compounds (Inhalation)", "update_date": "2023-09-29", "update_time": "14:03:31", "purpose": "Nonrulemaking", "keywords": ["Vanadium, IRIS assessment"], "comments": [{"text": "Inaccuracies in the IRIS document", "comment_id": "EPA-HQ-ORD-2020-0182-0020", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2020-0182-0020", "comment_date": "2023-09-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 33}, {"text": "Comments of Judith A. MacGregor, Ph.D., D.A.B.T.", "comment_id": "EPA-HQ-ORD-2020-0182-0017", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2020-0182-0017", "comment_date": "2023-09-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 48}, {"text": "Presentation by VPRA for Vanadium Compounds Public Meeting", "comment_id": "EPA-HQ-ORD-2020-0182-0013", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2020-0182-0013", "comment_date": "2021-07-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 58}]}, {"id": "FDA-2019-P-2945", "agency": "FDA", "title": "Requests that the FDA enforce the laws and regulations with regards to cannabis (plant family of Cannabaceae excluding Humulus), cannabis-derived products, delta9-tetrahydrocannabinol, and cannabidiol.", "update_date": "2020-08-17", "update_time": "12:48:35", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "enforce the laws and regulations", "with regards to cannabis", "(plant family of Cannabaceae", "excluding Humulus), cannabis-derived", "products, deltaO- tetrahydrocannabinol", "and cannabidiol", "OPEN"], "comments": [{"text": "There is a need for HHS, Surgeon General, FDA, and CDC to educate the medical community about the appropriate usage of cannabis medications (yes, the FDA approved drugs) and the facts about street grade cannabis medication (ie not FDA approved drugs)..To provide some patient identity privacy I am using her/him to cover the patients identity:  Shortly after Colorado began allowing the sales of recreational cannabis in 2014,  my spouse was hospitalized in a Colorado hospital on the Front Range.   My spouse was admitted on a Sunday afternoon,  had major chest surgery on Monday afternoon, and Tuesday AM while in ICU recovering, the hospital physical therapist came to the room to tell her/him that physical therapy had been ordered and would be set up for him/her over the next day or so.   It took me a bit of time to figure out what was wrong with the PT -- she couldnt not get three words out without giggling.  At first, I thought this poor woman must be so timid and then....it dawned on me.....at 8 A.M. this physical therapist was stoned.   I was grateful that she apparently was too stoned to attempt any future doctor ordered physical therapy for my spouse.   THAT was my wake up call to the crisis of Colorados legalizing cannabis that adversely affected medical services in May 2014.Several days later the patient was moved to a regular floor.  As the nurse was dispensing medications to the patient,  I asked what the patient was being given.  The patient was still to sedated to be able to ask such questions for him/her self.At about this time the hospitalist physician arrived and told me that one of the medications was Marinol which he prescribed to increase the patients appetite.  WHOA!!!!   I knew that this was not the appropriate usage of Marinol to prescribe to a patient post surgery!   Marinol is supposed to be a last resort medication for persons with a wasting disease not someone still working off the sedation from major surgery.   The patient was eating because I was placing the food orders and feeding the patient who was tethered to all sorts of monitors and IVs at the time.  Furthermore, the patient had several health issues that made prescribing Marinol contra-indicated.    The physician did not seem interested in suspending his prescribing Marinol -- I finally had to tell the doctor that This patient is exercising his/her Patients Bill of Rights and refusing Marinol.I dont know how many other physicians are as ill-informed as this hospitalist but the FDA et al needs to educate the physicians about prescribing this drug of last resort ---its purpose and when it is contra-indicated etc.  I dont know if this hospitalist physician was dumber than a rock -- or if he was doing a Marinol study and not telling the patients (ie no informed consent) --- but for whatever reason this hospitalist was prescribing medication that was contra-indicated and for which no appetite stimulating medications were even needed.   I couldnt agree more with the Citizens Petition nine action steps including the dire need for the Food and DRUG Administration to educate physicians, nurses, hospital administrators, medical schools, and veterinarians on the cannabis derived products be they FDA approved or not.  Sign me as a Colorado resident who has had adverse experiences with weed impaired hospital staff and ill-informed physician prescribing Marinol.", "comment_id": "FDA-2019-P-2945-0049", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0049", "comment_date": "2019-10-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3590}, {"text": "To Food and Drug Administration ---- there are many cases of violence in the USA and abroad where the bad actor had a history of using cannabis and some news reports that the bad actor was high on cannabis during their violent acts upon others.  Below are just a few stories of such violent acts where the bad actor was linked to cannabis consumption.  When is the FDA going to respond to this known crisis and work with other law enforcement agencies to stop  or at least reduce a contributing factor to these violent and often deadly events?   The FDA is supposed to oversee drugs and the FDA has classified CBD and/or THC under its oversight and enforcement authority.The ads for using seat belts used to state If it saves ONE life, it is worth it.   Well,  there are thousands of lives that could be saved if the FDA would enforce the laws regarding cannabis -- surely if it saves ONE life from addiction, ONE life from being killed by someone who consumes marijuana,  ONE life from a completed suicide while using cannabis, ONE life from vaping THC/CBD products....it is worth it.  How many lives will be damaged or destroyed as the public waits for the federal governments help to arrive?I live in the heartland of America and I fully support the Citizen Petition from Jesse J. LeBlanc III.  The public needs the FDA to protect us from the harmful effects of the irresponsible states that have legalized recreational and medical-cannabis.Please, come to the rescue of the nation.....~~~~~~~~https://www.thelocal.fr/20190902/lyon-knife-attacker-smoked-cannabis-and-heard-the-voice-of-godInvestigators said the killer appeared to have psychological problems and had smoked large quantities of cannabis before stabbing the 19-year-old man to death and injuring eight others on Saturday afternoon at a bus station. He was found in public records with two identities and three different dates of birth, making him either 33, 31 or 27-years-old, prosecutor Nicolas Jacquet told a news conference in Lyon.~~~~~~~~https://dailycaller.com/2019/08/12/ohio-gunman-friend-arrested/[Betts is the Ohio man who killed numerous persons; Kollie was a friend of Betts.]The charges stem from Kollies confession that he regularly smoked marijuana and used mushrooms with Betts.~~~~~~~https://www.cbsnews.com/news/warrant-denver-man-ate-pot-candy-before-killing-wife/DENVER - Authorities say a Denver man accused of killing his wife while she was on the phone with 911 bought marijuana-infused candy and a pre-rolled joint in the hours before he allegedly shot and killed her.A copy of a search warrant sent to CBS News Crimesider on Thursday by the Denver Department of Public Safety alleges Kristine Kirk, 44, told dispatchers her husband ate the candy before he started hallucinating and frightening the couples three children. The warrant says 47-year-old Richard Kirk also may have taken prescription pain medication before he began acting erratically.~~~~~~~https://www.denverpost.com/2015/12/07/planned-parenthood-gunman-was-a-marijuana-newcomer-say-rural-neighbors/HARTSEL  Robert Dear Jr.s arrival here was part of a frenetic migration some locals derisively call the green rush.Just as people rushed haphazardly into the Rockies for gold in 1858, many of Hartsels newcomers moved here from across the country after recreational marijuana was legalized in 2012, rancher Keith Wells said.Locals identify Dear, the man accused of killing three people at a Planned Parenthood clinic in Colorado Springs, with the marijuana migration because he and they often live in squalid, makeshift homes on the high plains.", "comment_id": "FDA-2019-P-2945-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0030", "comment_date": "2019-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3939}, {"text": "This story below is a story of a woman who bought legal nocotine and cannabis to vape and it put her in ICU.The FDA is charged with protecting the public health and safety -- these products present a clear danger and harm to the publics health and safety.  There is a solution to this national crisis....enforced the federal laws over THC.  (This citizens petition is addressing THC/CBD and cannabis products -- and the FDA is already aware of its special duties regarding nicotine which is a known carcinogen.  Tobacco products has its own FDA portal to report adverse events such as the story below.)I urge the FDA to adopt the 9 Action Steps listed in the Citizens Petition.  The public clearly is in dire need of federal intervention to protect the public from these products such as discussed in the story below from harm to their health and safety.   The FDA has the ability to protect the nations health.  https://wgntv.com/2019/12/03/it-was-all-legal-then-i-got-sick-woman-warns-of-vaping-dangers-after-lung-illness-sends-her-to-icu/[snipped]It was all legal ... then I got sick: Woman warns of vaping dangers after lung illness sends her to ICUPosted 5:22 PM, December 3, 2019, by Dina Bair and Katharin CzinkAllison Herger thought she was bettering her health. After 28 years of smoking regular cigarettes, a habit she tried to quit four times, Herger made the switch to vaping last year.I loved the buzz and I loved smoking, she said. But I hated the smell and the taste.Her product of choice was flavored Juul cartridges.I was like, Im in love and this is what everybody was doing, she said. Honestly it seemed like it was working it was great. My skin got better, my teeth got better, my cough went away. All signs were pointing to it was a good idea for me.And she vaped marijuana about once a week purchased from dispensaries, not on the streets, in states where recreational use is legal.Buying everything over the counter, whether it was nicotine or marijuana vaping, it was all legal, she said. So I didnt match the statistic. And then I got sick.At first, she said, it felt like the flu - chills, a fever, she was achy and tired.Herger visited her doctor, who sent her to the emergency room concerned Herger was suffering with pneumonia.But within 24 hours, Hergers oxygen levels plummeted.[snipped]", "comment_id": "FDA-2019-P-2945-0063", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0063", "comment_date": "2019-12-16", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2598}, {"text": " The National Safety Council just released this paper regarding cannabis consumption and worker safety / absenteeism (October, 2019)Yet ANOTHER  concern over the problems of the federal government not enforcing the federal cannabis laws.  View Full Report at this Link:National Safety Council just issued a statement.  https://www.nsc.org/Portals/0/Documents/NSCDocuments_Corporate/Policy-Positions/Workplace/W-Cannabis%20Impairment%20in%20Safety%20Sensitive%20Positions%20-%20153.pdf#153NATIONAL SAFETY COUNCIL Position/Policy Statement Cannabis Impairment in Safety Sensitive PositionsNSC Policy/Position The National Safety Council (NSC) supports policies to mitigate and eliminate the risks of cannabis (marijuana) and other products containing delta-9-tetrahydrocannabinol (THC), the impairing component in cannabis.Safety concerns are paramount as legalization and decriminalization continues.NSC believes it is unsafe to be under the influence of cannabis while working in a safety sensitive position1due to the increased risk of injury or death to the operator and others. Research is clear that cannabis impacts psychomotor skills and cognitive ability. However, the amount of THC detectable in the body does not directly correlate to a degree of impairment.At this time, NSC believes there is no level of cannabis use that is safe or acceptable for employees who work in safety sensitive positions.Need for Policy Position By adopting this position, NSC will be able to increase involvement in the policy discussion about cannabis impairment, and provide guidance for employers as they navigate changing cannabis laws.Cannabis is the most widely consumed illicit substance worldwide.2In 2015, the World Drug Report estimated over 200 million people between the ages of 15-64 have ingested cannabis. According to a study reported by the National Institute on Drug Abuse, employees who tested positive for cannabis had:55% more industrial incidents85% more injuries75% greater absenteeism compared to those who tested negative.3", "comment_id": "FDA-2019-P-2945-0051", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0051", "comment_date": "2019-10-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2151}, {"text": "As this article indicates by this alleged interview of a woman who has been illegally growing, transporting, and selling weed for decades there is an attitude of being above the laws.  The article is linked below and the statements below are extracted from the article.  I thought we were supposed to be a nation of laws -- and when those laws are not enforced we have chaos. https://www.vice.com/en_us/article/ywa4xm/im-a-mom-i-sell-huge-amounts-of-weed-and-i-dont-give-a-fuckA lot of people think selling cannabis is really easy. It takes a lot of focus when youre working with stoned people.by Seth FerrantiNov 1 2019, 8:12amWhat do you sell and where?I sell organic cannabis grown in California, preferably outdoor sun and soil cannabis. It gets sealed up, mailed to me and we ship it all over the country. Some of it I sell legally and some illegally.You move large amounts of weed around. Ever come close to a big bust?I have had multiple sketchy moments, like 12 pounds being shipped to my previous rental address. I had to wait three weeks for it to be rerouted to my current address. I would look out the window every day wondering if they were going to come and get me with big charges. It did show up, but I learned a big lesson. Thats when I went down to two pounds at a time if the customers were choosing to go through USPS.Who are your wholesale customers?Mostly incredibly talented musicians and artists who want to send their children to private school. There are multiple people who have spent decades selling my cannabis and not worked a real job and sent their kids to private school. There are huge numbers of people in our community that do not buy into the nine-to-five, sell your soul for health insurance lifestyle. We enjoy working together and building each other up. Its a really sweet kind of hippie mafia based on organic food and non-governmental lifestyle.As long as there are people in prison for the cannabis plant I will stand firm in believing that we do not pay taxes, we do not support the government, and fund their incarceration nation. Ive never paid taxes and Im 48.", "comment_id": "FDA-2019-P-2945-0053", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0053", "comment_date": "2019-11-05", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2233}, {"text": "This story appeared in USA Today with the quote below from Donald Ashley, Director of the Office of Compliance at FDA.I could not agree more with the statement that Americans EXPECT and DESERVE DRUGS that are SAFE, EFFECTIVE and meet our standards for QUALITY ----  yet today across America cannabis products are being produced, marketed, transported, and sold to the naive public who believe that cannabis from non-FDA approved sources is medication.  The public deserves and expects products marketed as drugs, medication, dietary supplements,  pet drugs or supplements to have met the FDA standards and controls but these state-only legalized products do not met the high standards developed over the decades by the Food and Drug Administration.   People --- infants, children, youth, young adults, and elderly are being harmed by these unregulated and non-FDA approved products marketed as safe, healthy, and effective by an industry whose sole desire appears to be get a few people rich at the cost of the health and safety of the general public.   Recently, a young man in Detroit, Michigan whose lungs were damaged by supposedly vaping THC -- a devise that the FDA has regulated for nicotine only usage --- and THC a controlled FDA/DEA substance had a lung transplant.   Short of death -- how much more severe can this become before bold steps are taken to intervene on this entire cannabis industry in the USA?Vaping devises as used in the medical cannabis industry are medical devises used to deliver medical cannabis.  The FDA has federal, plenary authority to enforce the laws on harmful medical devises.  FDA please adopt the Nine Action Steps submitted in the Citizens Petition.   The public is in dire need of federal intervention-- NOWAmericans expect and deserve drugs that are safe, effective and that meet our standards for quality, Donald D. Ashley, director of the Office of Compliance in the FDAs Center for Drug Evaluation and Research, said in the release. In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.https://www.usatoday.com/story/money/2019/11/14/dollar-tree-otc-drugs-fda-warning-letter-assured-brand/4199656002/", "comment_id": "FDA-2019-P-2945-0054", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0054", "comment_date": "2019-11-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2394}, {"text": "My youngest has bad hayfever and cannabis is a high pollen plant.  She has extreme reactions when people smoke around us.    So we made sure that we obtained non-smoking housing.  Ha.  Like that helped.  It being a matter of basic survival and life and death we made sure that marijuana smokers were prosecuted.  One moved out and shortly after another would move in.  The landlord would warn them that their neighbors were allergic to cannabis and they just didnt care.  They just puffed away.I have so many friends with small children that cry on their social media on the internet, every day, about a neighbor smoking pot and how it makes their children so upset and miserable.  The babies and moms both crying because they can barely breathe.  There really needs to be a way to keep smoking out of public places and housing. :(", "comment_id": "FDA-2019-P-2945-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0024", "comment_date": "2019-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 846}, {"text": "The public is in dire need of the Food and Drug Administration boldly stepping forward to protect the public from the now clearly known harms from the foolish states that have legalized cannabis as medicine and as a recreational drug.  Currently, there are federal laws to prohibit the cultivation, processing, sells, and consumption of cannabis please exercise the plenary powers of the federal government to protect our children, our families, and our communities from those who are aggressively marketing what has been commonly known as snake oil or patent medicine.  As is clearly stated in the Citizens Petition which I fully support,  no single substance can cure diseases or health problems yet that is how many states have claimed when they have legalized cannabis.  I am adding this recent article for your review from the FreeBeacon.   Dr. Karen Randall is quoted about the harms she is seeing in the state of Colorado that has legalized cannabis for medicine and for recreational usage.   The fall out from this disaster is clear.   PLEASE work with the DEA,  FBI,  CDC,  DoJ,  Surgeon Generals Office and others to end this disaster brought on by persons with special interests desiring to simply make money off of the ill-informed who have foisted and deceived these bad laws upon the public that cannabis is a safe, harmless, and useful medicine or recreational drug.   It is NOT compassionate to lie to the public that cannabis is a cure-all substance for cancers, seizures, diabetes, etc.   Sound scientific principles and reviews should and must be applied prior to permitting such substances into the stream of medicine.   The FDA has approved four drugs that contain or are derived from cannabis products.  They control for dosage and purity.   This is what the public is entitled to have -- clean, pure, safe, appropriate dosages for modern medicine.  We are already seeing the disaster of the lies that vaping is safe.  Hundreds of people -- mostly young people because they are typically the people who vape -- are hospitalized and now several reported deaths.  They are vaping nicotine AND THC or a combination of them.   The data is already there that this is an alarmingly dangerous activity.   Vaping is one of the delivery tools for medical cannabis --- ban vaping devices as an unregulated medical device.https://freebeacon.com/issues/colorado-doctor-sounds-alarm-on-marijuana-legalization/Randall said the state government has not only ignored scientific findings about marijuanas effects to push sales, but failed in the regulatory responsibility it promised would accompany legalization. The surgeon generals report noted that marijuana use during pregnancy is linked to adverse outcomes, including lower birth weight. A recent study of Colorado dispensaries found that 69 percent recommended women use marijuana anyway, with some actually discouraging mothers from telling their doctors about their drug use.Randall pointed to other commonly cited effects of legalization, including a historic increase in homelessness and a growing population of chronic, marijuana-dependent users. All of these, she suggested, have gone unreported in spite of the toll they are taking on her community.The glittering image of post-legalization Coloradowith billions in tax revenue and a happy populaceruns up against the uncomfortable reality of poor regulation and patients dangerously misguided about the risks and benefits of marijuana use. ---I am a concerned citizen and asking for the FDA to help save our nation from the clearly known problems from failed cannabis legalization.   ", "comment_id": "FDA-2019-P-2945-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0031", "comment_date": "2019-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3824}, {"text": "You have been issuing warnings about inappropriate therapies/treatments from CBD products, but everywhere I look, there is now CBD, under the guise of hemp in products.  I took a cannabis in science  medicine course so I could find the benefits, but the reality is that the literature supporting any of these claims is paltry at best.   I work in an ED.  I see the side effects of this industry (on a daily basis).  The harms of THC are profound.  It is sad when I can look at a 15 y/o with cannabis induced hyperemesis and know that this will keep happening.  There are now case reports of deaths related to this.  https://onlinelibrary.wiley.com/doi/abs/10.1111/1556-4029.13819https://journals.lww.com/ajg/Fulltext/2016/10001/Cases_of_Death_Secondary_to_Cannabinoid.2217.aspxThis has become one of the most frequent diagnoses seen in the ED on a consistent basis.  As you know, in addition to CHS, there are numerous other harms.  We have not done enough to protect our teens/young adults from the false advertising that is occurring all the time.Please contact me for questions", "comment_id": "FDA-2019-P-2945-0069", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0069", "comment_date": "2020-07-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1144}, {"text": "Dr. Sharpless prepared testimony to the US Congress is linked below with several statements noted for their importance. I note that Dr. Sharpless has called the vaping issues an epidemic of youth use of ENDS products -- surely the rise of youth consuming illicit cannabis IS AN EVEN LARGER NATIONAL EPIDEMIC!  I am not at all dismissing the crisis of youth vaping THC, CBD, and/or nicotine products or ENDS but rather that if vaping among children and young people qualifies as an epidemic than most certainly the broader consumption of THC and CBD products qualifies for an even large concern of an epidemic.   If this qualifies for the FDA to exercise its emergency powers through the Emergency Operations unit of the FDA than this call to action --- yes, action by the FDA itself --- should be mobilized regarding the cannabis epidemic of children, youth, young adults, and all society consuming cannabis products.   With crime up, hospitalizations up,  emergency room visits up,  neglected children cases up, traffic deaths from cannabis impaired drivers is up,  children being given cannabis by parents is up -- than surely this should qualify for the FDA to place this crisis with the Emergency Operations unit of the FDA.The FDA has authorized the sale of vaping devices for tobacco products (nicotine).  It would appear that this was approved without adequate scientific evidence as to the safety of a nicotine delivery devise but, be that as may be,  the vaping devises have not been approved to vape THC nor CBD products.  Thus any sales of a vaping device for the vaping of THC and/or CBD or combined with nicotine would appear to be a violation of federal law and such transactions would appear to be outside the FDA regulated approval of vaping devises for nicotine products. As noted in the testimony,  the FDA would consider the sale of an altered vaping devise .... if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. Because many of the products associated with cases contain THC oils, we have engaged the DEA to help with our investigation....   To be clear the pursuit of criminal behavior should be if anyone is selling an unapproved usage of a vaping devise (ie FDA has regulated it only for nicotine consumption) for a drug under the FDA authority i.e.CBD and/or THC then upon a criminal investigation, charges should be brought, and prosecuted working with the DEA and the US Department of Justice.   In fact, it should not just be for personal profit but if anyone is manufacturing and/or distributing vaping devises that are done for the consumption of CBD and/or THC drugs that are under the FDA regulations as controlled drugs that there should be prosecutions of such cases.   The purpose of the FDA is to provide oversight and enforcement of products and devices to protect the public health and safety. The FDA needs to invoke emergency protocols to address the cannabis epidemic in the USA that includes the vaping crisis but all forms of cannabis consumption as well.   States have placed vaping of medical cannabis into their state constitutions by a grossly uninformed voting public, and into state law by uninformed state legislatures.   September 25, 2019    Acting Commissioner of Food and Drugs - Food and Drug Administration Norman E. Ned Sharpless MDhttps://www.fda.gov/news-events/press-announcements/remarks-prepared-testimony-us-house-energy-and-commerce-subcommittee-fda-regulation-electronicSecond, FDAs ongoing efforts to address an epidemic of youth use of ENDS products; including the Administrations recent announcement about our intention to issue a policy that would address ongoing marketing of flavored ENDS products.Working with state partners, FDA and CDC have been investigating an outbreak of severe lung injury associated with the use of vaping products. Most cases have reported recent use of vaping products containing THC, the psychoactive ingredient in marijuana. Although these cases seem similar, it is not clear if they have a common cause, or if they have differing pathogenesis with similar presentation. The investigation has not identified any specific substance or product that is linked to all cases.Let me outline the main components of our investigation. FDAs Office of Emergency Operations has activated an Incident Management Group to coordinate across the agency and works alongside CDCs Incident Management System.But to be clear, if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. Because many of the products associated with cases contain THC oils, we have engaged the DEA to help with our investigation.", "comment_id": "FDA-2019-P-2945-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0043", "comment_date": "2019-09-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5070}]}, {"id": "SAMHSA-2016-0001", "agency": "SAMHSA", "title": "Medication Assisted Treatment for Opioid Use Disorders", "update_date": "2020-12-09", "update_time": "01:15:23", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am a physician who has run an outpatient buprenorphine-naloxone treatment program for 5 years now, limited to a maximum of 100 patients at a time, so welcome the increased access proposed.  Since you are seeking comments primarily related to the reporting requirements for those that choose to treat up to 275 patients, one comment I have is that the burden of reporting has less to do with the questions being asked than with the reporting method.  If there is a 15 page paper form to complete each month, that would be burdensome. I would not consider it burdensome, though to complete a one page on-line form with blanks to fill in for: 1) Numbers of patients seen per month; 2) Number who are currently in or have completed outpatient drug counseling; 3) Number who have left the program and reason.Other comments:1)Part of your proposed rule is unmanageably vague:b. Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to:1. Treatment initiation2. Change in clinical status--What does psychosocial or case management service include?  If you mean group outpatient drug treatment or individual counseling, it should say that.--What does change in clinical status mean?--When you are looking for percentages, is there a certain benchmark we are being required to meet?2)Another part of your proposed rule is also vague and burdensome the way it is worded:c. Percentage of patients who had a prescription drug monitoring program query in the past month--We query the PDMP for every single controlled substance prescription, so I am not sure how writing 100% every month is going to help you.  If we were to accidentally miss someone, I am not sure how we would know it.  It would seem to me the PDMP for each state would have a better handle on that information.3)There should be some oversight of HOW patients are being treated with buprenorphine and none of this data gathering includes that.  The makers of Suboxone, for instance, recommend no more than two 8-2mg films daily as the usual maintenance dose, and that up to three a day can be given for extenuating circumstances, yet many doctors in New York City are well known for prescribing three a day consistently, for months, if not years, and giving 30 days of medication at a time. Most opioid addicts know they do not need three a day, so the extra medication is just a source of income to them.  Where is the oversight on that?4)One of the biggest burdens likely to keep some providers from wanting to see more than 100 patients is the prior authorizations required by most insurance companies (particularly all versions of Medicaid) prior to starting buprenorphine and, for some companies, quarterly.  Some will only pay for the generic buprenorphine pill, which is difficult to split in order to taper someone down over time, and will not pay for Suboxone or its competitors. Others will stop paying for buprenorphine altogether if someone tests positive on a urine drug screen for marijuana (which is not even treated with buprenorphine). Yet others have a 3 to 5 day wait for approval for a new patient we have just seen who has stopped the heroin and wants their buprenorphine that first day.  What are they supposed to do for 3-5 days, continue heroin?  The insurance companies need oversight as wellor at least we providers should have a 24 hour hotline phone number to call to have SAMHSA intervene with the insurance company.", "comment_id": "SAMHSA-2016-0001-0511", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0511", "comment_date": "2016-07-26", "comment_time": "04:00:00", "commenter_fname": "G", "commenter_lname": "Thibault", "comment_length": 3872}, {"text": "This is a good start but it does not go far enough. As an Addiction Specialist I am capable of providing significant services to a large number of patients. When I was a Family Practitioner I use to manage more than 5000 patients. There is no limit on the number of patients that any other type of specialist can treat. Endocrinologists are not limited in the amount of insulin dependent patients that they can treat. Addiction is a medical disease and it needs to be treated by medical specialists. I can treat more people and provide fantastic care. I can provide full time counseling services, 24 hour phone coverage, evening, weekend, and holiday coverage, integrated electronic medical records with real time following of prescriptions that patients are filling, etc. However, I cannot expand to provide these services if my ability to see patients is limited to only 200.  Please allow me to practice to my full potential and to be able to provide the services that patients need and are entitled to at a reasonable cost. I can only do this if I have the ability to increase the volume of my practice thus dispersing the cost of services across more patients. I would urge you to consider eliminating a treatment limit all together for appropriately certified physicians, or at the very least increasing to number permitted to be treated to a more significant 500 or 1000 patients. Note that Senate bill S.1455 (TREAT Act) was recently amended to allow a 500 patient limit. Perhaps this rule could be changed to be consistent with that initiative.   ", "comment_id": "SAMHSA-2016-0001-0012", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0012", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Lee", "commenter_lname": "Tannenbaum", "comment_length": 1566}, {"text": "Persons suffering from Opioid Use Disorder have a difficult time finding treatment in the current system. Not only are Medication Assisted Treatment locations few and far between, they also have enormous waiting lists leaving those who want treatment, unable to secure it. The current limit of 100 patients per prescriber is not enough to handle the amount of persons affected. Please support increasing this limit to 200 and also continue to look into other ways we can make treatment easily accessible.", "comment_id": "SAMHSA-2016-0001-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0015", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Angie", "commenter_lname": "Geren", "comment_length": 504}, {"text": "Thanks so much for sending this out and furthering efforts to increase access to medication assisted treatment. I was a Suboxone prescriber for over seven years, though I currently work as a medical administrator for a multi-site mental health and substance abuse agency in CT. We do offer Suboxone in one of our outpatient clinics; this is a part of a program that includes Intensive Outpatient, relapse prevention, and much co-occurring behavioral health treatment.I am in total support of raising the limit from 100 to 200. I also think the added requirements for prescribers are reasonable, though I would want a crisp definition of what constitutes an acceptable setting. I am board certified but have never pursued additional certification from ASAM or in addiction medicine or psychiatry. I have however always prescribed in a clinic setting where counseling, at various levels of intensity, are provided. This also includes diversion strategies, lots of urine collection, and focus on treating co-occurring mental health problems, which are rampant in this population.As a final comment, where the need is greatest, is among the Medicaid population. Im hopeful that this increase in the limit will allow those few clinics that take Medicaid reimbursement, help meet this tremendous unmet need.", "comment_id": "SAMHSA-2016-0001-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0022", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Charles", "commenter_lname": "Atkins", "comment_length": 1326}, {"text": "With the shortage of prescribing physicians and the overwhelming opioid crisis, this would seem to be a rule change that is long overdue.", "comment_id": "SAMHSA-2016-0001-0024", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0024", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Thomas", "commenter_lname": "Grinley", "comment_length": 137}, {"text": "I support the rule to change to the highest patient limit from 100 to 200 patients per qualified doctor.I am employed as a chemical health intake coordinator, a common call from an opiate user seeking help is frustration of trying to find an outpatient provider of bupronorphine thiat is accepting new patients. There is not enough providers to meet the needs of this community. Increasing the volume of allowed patients per provider will assist with opening more doors for this population to get they initial help they need so they can begin a recovery process.  ", "comment_id": "SAMHSA-2016-0001-0035", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0035", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "James", "commenter_lname": "Murray", "comment_length": 574}, {"text": "I am a Board Certified Addiction Specialist and this bill is essential to helping the large numbers of opioid addicted patients who do not have access to MAT. Every patient who calls my office to get in my Suboxone program is asking for help and to save their lives. When I have to refuse treatment w Suboxone because of the current patient limit, I am depriving a life saving medication to a patient who may return to the street and overdose on heroin. PLEASE AT A MINIMUM RAISE THE CAP to 500 patients.Dr. Rick CampanaDiplomate ABAM, FASAM", "comment_id": "SAMHSA-2016-0001-0098", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0098", "comment_date": "2016-04-22", "comment_time": "04:00:00", "commenter_fname": "Rick", "commenter_lname": "Campana", "comment_length": 556}, {"text": "I am a board certified psychiatrist with added Qualifications in Addiction Medicine. I have treated patients suffering from addiction for over 25 years and have trained many future clinicians in this field.  Currently I treat United States veterans exclusively in a VA substance abuse program in the tri-state area of Kentucky, Ohio and West Virginia. This VA is one of two VA hospitals with highest percentage of prescription drug abuse.  We are trying to correct the poor prescribing practices of our predecessors.  Also the tri-state area tops the nation in drug overdoses. Unlike the private sector we cannot close admissions to our opiate treatment program to veterans suffering from opiate dependence when I reach my 100 limit.  We also cannot hire physicians willing to prescribe Suboxone to our veterans since they have lucrative private practices where they charge an average of $300 monthly just for their service (does not include cost of medication and $25 toxicology screen.) We cannot outsource these veterans to the private community because the government pays Medicare rates which are much lower than the $300/month.  The private doctors can easily  fill their 100 slots with folks willing to pay $300/month in cash.  I have not been able to convince my administration to apply for SAMSHA official OTP program with institutional license which would allow us to expand services. The same lack of knowledge in this area which lead to the problem seems to be impeding the solution.  So I am chronically frustrated and worry about welfare of our veteran population. Some of the pressure has been alleviated by outsourcing of patients to local methadone programs.  I applaud President Obamas push to expand training of pain management in medical schools.  I would favor increasing the limit to 200 for clinicians board certified in addiction and for VA hospital programs.  I do have some concerns about private clinicians with little experience in treating addiction profiting from those addicted to pain medications without providing appropriate care. ", "comment_id": "SAMHSA-2016-0001-0009", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0009", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Nancy", "commenter_lname": "Rubio", "comment_length": 2090}, {"text": "Increasing the number of prescriptions doctors can write for medication used to treat opioid addiction  is extremely good news. I just wish the door would open even more. The use of these medications has proven to be extremely effective.  I am at a loss as to why we are moving so slowly in changing our culture around drug treatment and am saddened by the amount of unnecessary deaths. I just hope that this MAT rule moves forward.  Thank you for your advocacy for doing the right thing! ", "comment_id": "SAMHSA-2016-0001-0013", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0013", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Hallie", "commenter_lname": "Marcotte", "comment_length": 489}, {"text": "As someone who works with the addiction community and sees the impact of the shortage of providers able to prescribe suboxone and take on new patients, I fully support expanding the ability of these much needed providers to take on additional patients. This is a small step to start helping reduce the amount of heroin/opiate overdose deaths that are so prevalent in our community due to the lack of help/assistance with people suffering from addiction who are unable to find the help they need. ", "comment_id": "SAMHSA-2016-0001-0028", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0028", "comment_date": "2016-04-17", "comment_time": "04:00:00", "commenter_fname": "Brianna", "commenter_lname": "Anonymous", "comment_length": 496}]}, {"id": "FDA-2015-D-0152", "agency": "FDA", "title": "Alcoholism: Developing Drugs for Treatment", "update_date": "2015-07-23", "update_time": "15:38:24", "purpose": "Rulemaking", "keywords": ["4164-01-P", "CDER"], "comments": [{"text": "I have been a psychiatrist for 25 years. Prior to the article in The Atlantic, April 2015, I had never heard of The Sinclair Method. I have watched the movie One Little Pill.Please, please consider The Sinclair Method of using naltrexone to reduce  the number of heavy drinking days.It is the same paradigm as Chantix.  With Chantix people smoke but they dont get the nicotine buzz so they are statistically more likely to give up smoking.With The Sinclair Method they drink but are statistically more likely to give up drinking.Will Finland be the only country to really look at this?Thank you,Jean J. Dansereau, M.D.", "comment_id": "FDA-2015-D-0152-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-0152-0007", "comment_date": "2015-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 719}, {"text": "Dear Food and Drug Administration:RE: Alcoholism: Developing Drugs for Treatment; Draft Guidance for Industry; AvailabilityAnthem agrees there is a strong need for additional pharmacologic treatments for alcoholism and applauds the Agencys commitment to examining this important issue. However, we have fundamental concerns relating to the draft guidance, namely, the shift in therapeutic endpoint for the treatment of alcohol use disorders. Our particular concern is that endpoints based on patterns of drinking be considered appropriate measures of clinical benefit. Unlike abstinence, the clinical and social implications of reduced-use remains unproven, with major potential consequences should the Agency shift accepted study endpoints. Anthem is aware that the concept of reduced use is a clinically useful endpoint in other substance use disorders. For example: reduced smoking associated with varenicline (Chantix) leads to quitting in some (Ebbert et al, JAMA 2015; 313:687-694); however, the value of reduced smoking is more certain at this time than reduced drinking or reduction in use of other illicit substances.  Absence of alcohol and drug use (abstinence) remains an important endpoint for members, families, and others. For example, members with alcohol use disorder and employed in the transportation industry as operators of vehicles are expected to remain abstinent from alcohol and illicit drugs to retain employment and for public safety.  Likewise, medical professionals, policeman and fireman with alcohol use disorders are expected to sustain abstinence for similar reasons. Social implications resulting from reduced alcohol and substance use (vs. abstinence) also remain largely unknown and poorly elucidated based on current data. Anthem suggests that the critical concept is trial endpoints (page 4, lines 155 and 156). The varenicline trial indicates that there appear to be trial designs that make abstinence and reduced drinking meaningful and feasible endpoints within the same trial and, at least potentially, as part of clinical practice.The shift in the Agencys use of clinically useful endpoints for alcohol use disorders is analogous to the Agencys accepted use of imaging-based disease free progression as an outcome for terminal malignancies. This paradigm shift occurred even though there was a paucity of data  demonstrating that imaging-based endpoints represented a clinically significant outcome for the patient; a shift, we should note, that remains incompletely supported by subsequent data. Before the Agency adopts a shift in its approach to evaluating the therapeutic endpoint for the treatment of alcohol use disorders, Anthem recommends that the Agency more fully assess the significance of clinical and social outcomes of reduced alcohol use and related outcomes for clinical and social impact as compared to the generally accepted measure of abstinence. ", "comment_id": "FDA-2015-D-0152-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-0152-0004", "comment_date": "2015-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2964}, {"text": "As a clinical researcher in addictions, I applaud your change in broadening the definition of successful treatments for substance use disorders. The notion of total abstinence as the best and only marker of a successful outcome was always arbitrary and not consistent with empirical research.With respect to medications specifically, the primary outcome of RCTs of naltrexone has always been the reduction of heavy drinking. And with reduced heavy drinking comes a concomitant reduction in alcohol related problems. And alcohol-related problems are the primary reasons heavy drinkers decide to change their drinking. So your expansion of the definition of a successful outcome can not only encourage research into new medications but also encourage many heavy drinkers to consider changing their drinking if success is not considered a yes/no proposition (e.g., abstinence or failure).", "comment_id": "FDA-2015-D-0152-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-0152-0003", "comment_date": "2015-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 895}]}, {"id": "FDA-2016-D-0236", "agency": "FDA", "title": "Nonallergic Rhinitis:  Developing Drug Products for Treatment", "update_date": "2018-09-06", "update_time": "14:24:24", "purpose": "Nonrulemaking", "keywords": ["2015-393", "CDER", "Sofia Chaudhry", "Nonallergic Rhinitis", "Developing Drug Products for Treatment", "Draft Guidance for Industry", "Availability", "NAR", "OPEN"], "comments": [{"text": "The FDA making a draft guidance to help assist development of products to treat NAR is a great idea. Even some of the recommended treatments like nasal spray, whether it being a home remedy version or over the counter, can actually cause symptoms to get worse. To prevent symptoms, one would basically have to isolate themselves from the word for the reason that the environment, foods, weather change, home cleaner, perfume, and even stress can cause the symptoms. Developing a product/drug to treat NAR could help a lot of people live their lives in a much more comfortable manner.", "comment_id": "FDA-2016-D-0236-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0236-0003", "comment_date": "2016-04-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 595}]}, {"id": "FDA-2020-P-1582", "agency": "FDA", "title": "Requests that the FDA to Establish a Regulatory Pathway to Legally Market\nDietary Supplements Containing Hemp-Derived Cannabidiol (CBD)", "update_date": "2023-01-26", "update_time": "09:56:36", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "The Council for Responsible Nutrition", "hemp-derived CBD", "lawful dietary ingredient", "guidance", "clarifying when a substance", "\"an article\"", "promulgated", "FDCA", "Title 21", "Code of Federal Regulations", "dietary supplements", "CFSAN", "CLOSED"], "comments": [{"text": "Due to the racist reasons why cannabis was made a schedule 1 drug I think we should decriminalize cannabis use. ", "comment_id": "FDA-2020-P-1582-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2020-P-1582-0003", "comment_date": "2020-11-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 112}]}, {"id": "HHS-OS-2019-0010", "agency": "HHS", "title": "Confidentiality of Substance Use Disorder Patient Records", "update_date": "2024-03-11", "update_time": "10:35:29", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I disagree with this proposal. It violates CFR and is being implemented without consent of Congress.I am afraid to sign my name because of the discrimination Ive experienced.", "comment_id": "HHS-OS-2019-0010-0112", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0112", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 184}, {"text": "This rule is so important to keep in place. Save lives by keeping 42CFR as it is.", "comment_id": "HHS-OS-2019-0010-0054", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0054", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Lisa", "commenter_lname": "Schultz", "comment_length": 81}, {"text": "I do not agree with the changes to Section 2.63 in this NPRM and ask that SAMHSA does not change this section or finalize this proposal. This statue was put in place to protect the rights of people who have sought drug treatment and allowing this change will deter people from seeking treatment during an opioid epidemic- when treatment is literally life and death for so many. I have been on methadone maintenance for 17 years. Being on treatment has evened the playing field and has given me the ability to fight and overcome my addiction to heroin. Even after over a decade and a half of sobriety, of hard work, of growth, of progress and contributing to society, as soon as someone finds out I am on treatment- Im labeled a junkie. My credibility becomes non- existent, my opinion worthless, Im automatically the guilty party in any dispute and all the good Ive done for society and in life becomes irrelevant. All of who I am- a medical and health writer, a loving wife, a Silversmith, President and Co- Founder of a non- profit that builds water wells in Uganda, an artist, an entrapuener, a leader, a GOOD influence on children as well as adults, an animal rescuer, an activist, a critical thinker- is replaced by one singular thing- a junkie. I am not to be trusted or believed. Im weak and worthless, a liar and a burden on society. And thats what this change will do- in the eyes of the world, turn someone like me back in to the addict I once was. It takes away everything Ive fought so hard for. We need people to seek treatment, not to be afraid of it because they will forever be labeled, defined and judged by the worst part of them and nothing more. Seeking treatment will become feared because the negative consequences of it will be life long. People will hesitate to seek treatment, people will decide not to seek treatment and instead try it on their own and people will die because of that decision. People will die because of this change of statue. ", "comment_id": "HHS-OS-2019-0010-0080", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0080", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2011}, {"text": "I strongly oppose this. I am alive today thanks to medication assisted treatment taking methadone daily for the past three years. My personal medical treatment information must be kept in the highest privacy and protection. Stigma and ignorance especially amongst the medical professional community as well as law enforcement can and will negattively impact interactions amongst people with substance use disorder. I have peraonally experienced negative treatment from doctors and nurses once they became aware I was a patient on methadone. I was immediately treated cold, less-than, and even with eye rolls and sighs. If the medical community is treating mmt patients this way, imagine what law enforcement will do with this information where stigma prevails and lack of knowledge regarding mat is the norm. Stigma is killing our generation. Stigmatized languange is still used even amongst doctors and mesical professionals. Once stigma is completely eradicated then we can loudly and proudly tell the world we take methadone. Unfortunately, many, do not even have basic knowledge of what methadone even is let alone get to know someone that is maintained successfully with it. Again, Stigma is just too prevalent to risk peoples recovery over it. I have had friends get off of their maintenance medications before they were ready due to pressures from family, friends, and even society and they relapsed within a month and overdosed and died. Stigma is killing an entire generation of my peers and I can not sit by and let more people die. I will fight stigma in anyway i can in every way i can. Please protect our privacy and protect our need for treatment without fear of being stigmatized by everyone we encounter. Our interactions with doctors and law enforcement shouldnt revolve around their feelings and knowledge of medication assisted therapy but unfortunately it does where stigma always prevails. ", "comment_id": "HHS-OS-2019-0010-0038", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0038", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Jacqueline", "commenter_lname": "Lebel", "comment_length": 1916}, {"text": "I am appalled by this suggested change to substance treatment patients confidentiality rights. This would allow my personal health information to be shared with law enforcement, exacerbating the costs of the disastrously failed War on Drugs and creating a chilling effect when it comes to treatment access in the middle of an overdose/opioid crisis. I am heartbroken that a government agency would even consider such a rule change motivated by Big Data lobby greed. As both a substance treatment patient and a harm reduction activist of many years experience, I feel that this rule change would have horrific consequences. ", "comment_id": "HHS-OS-2019-0010-0037", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0037", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Catherine m", "commenter_lname": "Simon", "comment_length": 633}, {"text": "With all we have and are learning about addiction, it is disheartening and appalling that this change is being proposed.  The only shame in seeking treatment for a mental health disorder will be with authorities for using the treatment against them if this is passed. Yet again, the sick will be forced to decide if they should die in hiding.  We never learn.    I do not agree with the changes to Section 2.63 in this NPRM and ask that SAMHSA does not change this section or finalize this proposal. This change is a fundamental and substantive change to privacy regulations that will allow personal health information to be shared outside the healthcare system for criminal justice purposes. This regulations purpose is to protect patients and their health data, this proposed change is not in line with the best interests of patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma. SAMHSA should also extend the comment period immediately, as this change is significant, the citizenry needs more than 30 days to analyze and respond to this NPRM.", "comment_id": "HHS-OS-2019-0010-0018", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0018", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1365}, {"text": "Dear Department of Health and Human Services:This comment is in response to the proposed amendment to the Confidentiality of Substance Use Disorder Patient Records regulation that intends to remove allegedly committed by the patient from Section 2.63. This amendment is premised on the theory that the phrase allegedly committed by the patient was erroneously added to the rule in the 2017 final rule. I disagree with this proposition. Although the Rule does not explicitly define communications, it is evidence that patient communications are distinct from patient records. I bring this issue to your attention for two reasons: 1. there are no safeguards in place to protect patients against public disclosure of such information following the disclosure of  confidential communications where such safeguards do exist following the disclosure of records (Sec. 2.66 (d)); and 2. this amendment is unnecessary to achieve the alleged purpose proposed and will hinder open communication. Despite some overlap, records and communications are two distinct sets of information. This proposition is supported by the fact that the words appear in separate sections covering essentially the same issue, whereas if the two were the same these sections would be redundant and futile (see Sec. 2.63 confidential communications disclosed for criminal investigation against patient and Sec. 2.65 patient records disclosed for criminal investigation against patient). Including the phrase allegedly committed by the patient authorizes confidential communication to be disclosed only when the patient is suspected of a crime--directly in line with general doctor-patient confidentiality rules. Furthermore, communications made by the patient will contain much broader personal information than what is generally recorded for medical files. While disclosing these communications in criminal proceedings against the patient him/herself may sometimes be in their favor and thus, acceptable, disclosing such information in proceedings against doctors or other employees will serve little to no purpose, but will expose the personal details of an individuals life to the public (as trials are open to the public). On the other hand, when patient records are disclosed for the purposes of investigating or convicting an employee holding the records, steps are taken to remove identifying information, securing patient privacy. It is much more difficult to make unidentifiable confidential communication because the patient will likely have to testify to such statements, and thus subject him/herself to public scrutiny.  Finally, the proposed purpose for this amendment is to aid law enforcement in eradicating the opioid crisis. It is unclear how patient communications will help investigation any more so than simply obtaining patient records pursuant to Section 2.66. The purpose of confidentiality rules, in general, is to encourage open communication with ones doctor, attorney, spouse, etc., authorizing disclose of confidential communication will stunt open communication and thus impede treatment efforts. If law enforcement need information regarding the frequency opioids are being prescribed by rogue doctors, that information may be gathered from pharmacy records or medical records with safeguards in place to protect privacy interests of the patient.For the foregoing reasons, I respectfully disagree with the proposition that the phrase allegedly committed by the patient was erroneous and recommend that the phrase be kept as is, due to patient privacy and open communication concerns. ", "comment_id": "HHS-OS-2019-0010-0050", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0050", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Najla", "commenter_lname": "Hasic", "comment_length": 3709}, {"text": "I do not agree with the changes to Section 2.63 in this NPRM and ask that SAMHSA does not change this section or finalize this proposal. This change is a fundamental and substantive change to privacy regulations that will allow (my) personal health information to be shared outside the healthcare system for criminal justice purposes. This regulations purpose is to protect patients and their health data, this proposed change is not in line with the best interests of patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma. SAMHSA should also extend the comment period immediately, as this change is significant, the citizenry needs more than 30 days to analyze and respond to this NPRM. ", "comment_id": "HHS-OS-2019-0010-0055", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0055", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1004}, {"text": "I do not agree with the changes to Section 2.63 in this NPRM and ask that SAMHSA does not change this section or finalize this proposal. This change is a fundamental and substantive change to privacy regulations that will allow my personal health information to be shared outside the healthcare system for criminal justice purposes. This regulations purpose is to protect patients and their health data, this proposed change is not in line with the best interests of patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma. SAMHSA should also extend the comment period immediately, as this change is significant, the citizenry needs more than 30 days to analyze and respond to this NPRM. As a person in recovery and an outreach worker advocating to connect vulnerable people to treatment, I know that they last thing we need to do in this time of crisis is to make treatment less accessible and safe for those who seek it. Thank you.", "comment_id": "HHS-OS-2019-0010-0012", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0012", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Loftin", "commenter_lname": "Wilson", "comment_length": 1241}, {"text": "I do not agree with the changes to Section 2.63 in this NPRM and ask that SAMHSA does not change this section or finalize this proposal. This change is a fundamental and substantive change to privacy regulations that will allow personal health information to be shared outside the healthcare system for criminal justice purposes. This regulations purpose is to protect patients and their health data, this proposed change is not in line with the best interests of patients seeking treatment for substance use disorders and their families. A change of this nature will deter people in need of treatment from seeking care out of fear of law enforcement involvement, which goes against the fundamental purpose of 42 CFR part 2. Part 2 was created to encourage people to seek care without fear of legal repercussions or stigma. SAMHSA should also extend the comment period immediately, as this change is significant, the citizenry needs more than 30 days to analyze and respond to this NPRM.I have helped people seek treatment in the past, and if there was any fear of their privacy being violated, I believe they would have not sought treatment.  As an attorney, I view this as an abomination and against everything the United States and the Constitution stands for.  It is more in line with a country like China or Russia than the USA.", "comment_id": "HHS-OS-2019-0010-0040", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2019-0010-0040", "comment_date": "2019-09-19", "comment_time": "04:00:00", "commenter_fname": "Michael", "commenter_lname": "Mccartney", "comment_length": 1348}]}, {"id": "FTA-2006-24592", "agency": "FTA", "title": "Controlled Substances and Alcohol Misused Testing", "update_date": "2022-11-04", "update_time": "01:08:35", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "There are three areas where the Ohio Department of Transportation, Office of Transit requests clarification on the June 5, NPRM, Docket Number FTA-2006-24592 on Controlled Substances and Alcohol Misuse Testing.The first clarification needed is what entities are covered by the NPRM.  Is this regulation for private and/or nonprofit carriers who are contract providers?   Are direct recipients, subrecipients, or designated recipients such as community action organizations that receive Section 5311 funding directly from the state exempt from this NPRM?   Should the direct recipients, subrecipients, or designated recipients still be covered the same as they have always been under the Federal Transit Administration drug and alcohol regulations (drug and alcohol testing based on the percentage of work performed per employee, FTA vs FMCSA)? We would also like clarification on how national contractors, such as First Transit, Laidlaw, MV, determine which type of DOT test is conducted.   If this is determined based on the overall type of operation at the national level, these entities could end up testing all of their employees under FMCSA instead of FTA.   Ohio suggests using a location by location basis.   For example, if MV is the Section 5311 contract provider at a specific location, all of the employees at that location be tested under FTA, regardless of category of testing (FTA or FMCSA) that the company falls under when looking at the number of employees at the national level.The third area where we would like clarification concerns full time employees versus part time employees.  Ohio suggests the type of test (FTA or FMCSA) should be determined based on full time equivalent employees versus total number of employees at either the national or specific local location.  For example, if Laidlaw has 100 employees and 30 drive full time, year round for a Section 5311 subgrantee and the other 70 drive a school bus 4 hours a day during a school year, the type of test should be based on the full time equivalent number of employees and not the total number of employees.Thank you for the opportunity to comment on the NPRM.    ", "comment_id": "FTA-2006-24592-0002", "comment_url": "https://api.regulations.gov/v4/comments/FTA-2006-24592-0002", "comment_date": "2006-07-14", "comment_time": "04:00:00", "commenter_fname": "Marianne", "commenter_lname": "Freed", "comment_length": 2200}]}, {"id": "CMS-2008-0073", "agency": "CMS", "title": "Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E Prescribing Exemption for Computer Generated Facsimile Transmissions", "update_date": "2022-01-09", "update_time": "19:05:38", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "OTHER ISSUES-SLEEP TESTConsumers are provided a listing of CPAP providers to meet the Patient Choice requirement.  By taking the listing and allowing non-afilliated healthcare systems that have both the sleep lab and a DME is restricting access. The physician ordering the test should not provide the CPAP because an accredited DME provider should provide the equipment.  Physicians diagnose, suppliers provide the education on the use and monitor compliance, this is written in the supplier standards that is distributed.The population is growing and the diagnosis is not simple. There are many criteria which must be met prior to the decision to treat with a CPAP.  This is scientific protocal and not based on a biased opinion. Maybe this proposed regulation is just that-a biased opinion to keep the most qualified locally based health care systems who also have a sleep lab and a DME  from providing the much needed services to the Medicare beneficiary. This is restrictive care.I oppose this proposed regulation.", "comment_id": "CMS-2008-0073-0321", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0321", "comment_date": "2008-08-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1115}, {"text": "I vote for option #2 of the Proposed Changes to Enrollment and Billing Rights change.", "comment_id": "CMS-2008-0073-0327", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0327", "comment_date": "2008-08-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 107}, {"text": "INDEPENDENT DIAGNOSTIC TESTING FACILITIESPlease refer to file code CMS-1403-P.I am writing to comment on the proposed rule change regarding diagnostic imagingfacilities referenced above.  Although I am not opposed to applying standards toensure patient safety and improve quality of care, I feel that there are severalimplications of the proposed rule that are unnecessary and will instead decreaseaccess to care by Medicare beneficiaries and increase costs.  Here are my concerns:1. IDTF designation is not appropriate or necessary for office-based imaging. As an orthopaedic surgeon, diagnostic imaging is essential to my medicaldecision-making process for my patients.  If I am restricted from obtainingx-rays, MRI studies, or other studies by the new regulations, then it willnegatively impact my ability to provide care to Medicare patients by delayingaccess to these studies.  Furthermore, it will increase costs by requiringmultiple office visits to order and then review studies.  Finally, I am likelyto choose to see fewer Medicare patients if obtaining the studies I need fortheir treatment requires cutting through red-tape and jumping over hurdles.  Theend result is less access to care for Medicare beneficiaries.2. Supervision of diagnostic imaging facilities should not be limited toradiologists.  As an orthopaedic surgeon, I am trained and able to interpret thediagnostic studies that I order.  Any attempt to limit the physicians who cansupervise diagnostic imaging must include a mechanism for non-radiologists toobtain certification to perform the imaging that they need.  Limitingsupervision to radiologists will increase the cost of studies by decreasingcompetition between imaging providers.  It is also unnecessary as anon-radiologist physician can be just as proficient at interpreting imagingstudies as a radiologist.3. Requiring general supervision by a radiologist can also decrease the qualityof studies performed.  In my practice, we choose to have our studies interpretedby remote radiologists who have subspecialty training in reading musculoskeletalimaging.  Radiologists with these qualifications are not readily available inour local market.  If we were required to have supervision of our imaging by alocal radiologist, the quality of interpretation could decrease.4. Direct supervision of contrast administration by a radiologist isunnecessary.  As a surgeon with clinical experience dealing with contrastextravasation and reactions, I am at least as qualified, if not more qualified,as a radiologist to supervise the administration of contrast for imagingstudies.  Limiting these studies to direct supervision by a radiologist willincrease the cost of these studies by decreasing competition, and will notimprove the safety or quality of these procedures for Medicare beneficiaries.In summary, I urge you not to adopt the proposed rule change without makingchanges to ensure available access to quality imaging and interpretation forMedicare beneficiaries.Thank you.", "comment_id": "CMS-2008-0073-0339", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0339", "comment_date": "2008-08-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3249}, {"text": "RE:  CMS-1403-PI am writing to comment on the propsed changes to the ENROLLMENT RULES.  Currently, a physician is enrolled retroactively to the first date of service.  The propsoed rules would delay the enrollment to the date Medicare approves the application or either the date of filing or the date an enrolled supplier started rendering services.  Either of these approaches would be difficult for anesthesia.  As you are aware, there is a serious shortage of anesthesiologists and recruiting a new physician can be very difficult and time consuming.  A delay in credentialing a physician for Medicare would be a serious problem for our group because Medicare comprises 25% of our patient population.  Our physicians choose to not look at a patients insurance when providing care in order to be totally objective.  If one of these changes is implemented we might be forced to look at insurance and delay a surgery until a Medicare credentialed physician was available.  This does not provide quality care for the patient, surgeon or hospital.  We do not want to begin looking at insurance before providing service.  And we certainly do not want to be placed in the position of delaying surgery simply because the Medicare credentialing is not complete.  We do not have the luxury of starting a physician after all insurance credentialing is completed.The second approach would be the preferred approach if a change is inevitable.  If the change is implemented, I would suggest part of the change be that Medicare carriers be required to process applications in a timely manner, with a resonable time frame spelled out, and penalties imposed if they cannot meet the time frame.  It is unfair for physicians to be penalized for the delayed action of the carriers.", "comment_id": "CMS-2008-0073-0358", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0358", "comment_date": "2008-08-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1894}, {"text": "The burden of hiring a supervising radiologist for in-office x-rays would only add another layer of cost and oversight, negatively impacting patient care.", "comment_id": "CMS-2008-0073-0373", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0373", "comment_date": "2008-08-25", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 159}, {"text": "WEST COUNTY HEART ALLIANCE2335 DOUGHERTY FERRY RD.ST. LOUIS, MO 63122August 25, 2008Kerry N. Weems, AdministratorCenters for Medicare and Medicaid ServicesDepartment of Health and Human ServicesAttention:  CMS-1403-PMail Stop:  C4-26-057500 Security BoulevardBaltimore, MD 21244-1850Re:Revisions to Payment Policies Under the Physicians Fee Schedule and Other Revisions to Part B for CY 2009; Proposed RuleDear Mr. Weems:On behalf of the West County Heart Alliance and our 18 individual practicing cardiologists and 15 staff, we appreciate the opportunity to submit comments to the Centers for Medicare  Medicaid Services (CMS) regarding the Resource-Based PE RVUs section of the above referenced July 7, 2008 Proposed Rule.  We are specifically concerned with the 2009-2010 PE RVUs established for non-facility outpatient cardiac catheterization procedure codes and the significant negative impact that could result for our practice and our Medicare patients if these values are finalized for the 2009 Physicians Fee Schedule.  The West County Heart Alliance is a Physician owned outpatient cardiac catheterization lab servicing 2000 cardiac patient annually with a service area covering East Central and Southern Missouri.The West County Heart Alliance is a member of the Cardiovascular Outpatient Center Alliance (COCA) and as such we have actively been involved in the effort that COCA made in 2007-2008 to collect and submit direct and indirect cost data to the CMS Center for Medicare Management in response to their specific November 2007 request.   Unfortunately, the Center senior staff chose not to share the results of their analysis with COCA or the Congressional offices that requested this information and instead returned the issue to the AMA PERC/RUC for reconsideration.  The AMA PERC/RUC declined to reconsider their 2007 recommendations without contacting COCA for any information or comments.  As a result, CMS states in the July 7, 2008 Federal Register, page 38512: We are in agreement with RUC recommendations, (including the recommendation that no change be made to the direct inputs for CPT 93510, a cardiac cath code).  We are disheartened that CMS chose not to use or even share its own analysis of COCAs complete cost data; once again resulting in PE RVU recommendations that severely undervalue the direct and indirect costs associated with providing these procedures to our patients.  The PE RVU values published in the July 7, 2008 Proposed Rule would result in additional draconian cuts in reimbursement for cardiac catheterizations performed in physician practice or IDTF locations.  For example, the 2008 reimbursement for the technical components of the primary three CPT codes for a Left Heart Cath (93510TC, 93555TC, and 93556TC) were cut by 23.33% in 2008, would be cut by an additional 14.38% in 2009, and cut another 18.29% in 2010 for a total reduction of 46.36% from 2007 levels.  At the same time, the outpatient hospital APC payments for the exact same procedure were increased by 8.56% in 2008 and are proposed to increase by another 4.84% in 2009.  Since the APC reimbursement was already 6.35% higher than the PFS rates in 2007, this means that as of January 1, 2009 the reimbursement for this procedure in a non-hospital outpatient cath lab (OPCL) will have dropped from 93.65% of the APC rate to 54.02%.These severe and unsupported reductions have already resulted in the closing (or sale to hospitals) of several OPCLs and if not reversed will more than likely result in the closure of the majority of OPCLs in the country.  This result would force thousands of Medicare patients who now benefit from improved access and lower costs into more acute hospital settings where their copayments will cost each of them several hundred dollars more than the same procedure in an OPCL.  Even comparing the original 2007 Physician Fee Schedule payment with the proposed 2009 APC rate, the increased cost to the Medicare Trust Fund and Medicare beneficiaries from this shift would conservatively add up to $28.5 million.  If the current 2008 PFS payment is compared to the 2009 APC rate, the additional cost to the Medicare program increases to $59.5 million.COCA is on record in their April 30, 2008 meeting with Dr. Jeffery Rich requesting that CMS reconsider the complete cost data provided to them by COCA in December 2007 and establish PE RVUs for non-facility outpatient cardiac catheterization procedures that more reasonably reflect the direct and indirect costs of providing these procedures.  In addition, the American College of Cardiology is on record in their June 11, 2008 letter to Dr. Rich requesting that CMS at least freeze the 2009 reimbursement at 2008 levels until an additional review of OPCL indirect costs can be conducted.We request that CMS listen to the recommendations of COCA and ACC and develop fair and reasonable reimbursement for non-facility outpatient cardiac cath procedures for 2009 before it is too late and we are forced to close or sell our OPCL to a local hospital.  The ultimate severe negative impact on the Medicare program, our Medicare patients, and our practice is unnecessary if CMS would only utilize the data that they have already analyzed.Thank you for the opportunity to comment on this critical issue.  Please contact me at 314-570-3312 if you are interested in the specific details of our request.Sincerely, Scott W. Hylton R.N.Manager West County Heart Alliance", "comment_id": "CMS-2008-0073-0384", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0384", "comment_date": "2008-08-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 6282}, {"text": "I am writing to comment on proposed changes to ENROLLMENT RULES for providers.Starting a new Anesthesiologist in a new practice typically takes 3-6 months from interviews to Hospital privileges. Quite often privileges are obtained mere hours before starting to work in the OR. Only then can a new provider apply for enrollment as a Medicare provider. Current rules allow retroactive enrollment to day of application. Proposed changes would delay our ability to bill for the new Anesthesiologists services for up to a couple of months.Our choices are then all bad: do we try to have the new physician avoid Medicare cases, nearly impossible when call is taken into account. Or are we put in a position of providing his/her uncompensated services for a time? We simply do not have the luxury of waiting for an Anesthesiologist to have all enrollments in hand to start work in a new practice. Enrollment works as is, do not change it.", "comment_id": "CMS-2008-0073-0378", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0378", "comment_date": "2008-08-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1016}, {"text": "CMS 1403-P once again illustrates the lack of understanding and lack of awareness present with CMS officials today, as demonstrated in the Competitive Bidding Debacle. The definition and rule change that will not allow an individual or a company to own a Sleep Lab and a seperate Medical Equipment company entity not only infringes once again upon free enterprise, but quite frankly misses the mark if the target idea is to curb abuse.These DME entities still must receive referrals and orders from physicians; the Sleep lab cannot order a CPAP, nor can the DME company initiate the therpay without the physicians order. There is no danger of self gratification because the ordering physician decides where the referral will go. The Sleep Lab performs the sleep study, the study is interpreted by a doctor, the final report is then sent to the ordering physician, who them refers the CPAP to a qualified provider.It should also be noted that many DME companies that are seperate entities and owned by the same owenr as a Sleep Lab arer also accrediited companies.The real targets should be Labs and DME operations jointly owned by physicians or Labs and DME operations owned by hospitals. In those cases, the entities can benefit from self referral. The fact that that has occurred for years has created an unstable playing field for many honest privately owned companies.As written, this change will only hurt small companies, while directing more business to larger national companies, once again limiting patient choice and free enterprise.as i have stated before, the real target should be limiting physician and hospital ownership in such realted entities, not private ownership that cannot and do not write the ordrs necessary for self referral.", "comment_id": "CMS-2008-0073-0016", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0016", "comment_date": "2008-07-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1895}, {"text": "CMS should be applauded for recognizing the need for inpatient telemedicine subsequent visit codes for consults provdided via telemedicine. Further, they should be applauded for recognizing the value of this service and the injustice of seeking to avoid compensating physicians for this service, now being provided for free via telemedicine, when it is a billable service in person.  There are not too many things that I have been involved with that I can honestly say everyone is happy with but telemedicine is one of them.  Referring physicians are happy, patients are happy and consulting physicians are happy.  Not to mention that it is far better care than that provided by the telephone which is likely to be inadequate, leave no one particularly happy and end up costing more in the long run.  Thank you for acting on this important and pressing issue!!!", "comment_id": "CMS-2008-0073-0019", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0019", "comment_date": "2008-07-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 911}, {"text": "I agree with the proposed regulations which would not allow any entity to provide a sleep test and to also provide any equipment to a patient who has been tested by that that same entity.As physicians and physician groups are being bought by hospitals, the physician is coming under more pressure by hospital administrations to administer more test and to prescribe more services and equipment to patients being tested. There can also be a bias in the interpretation of sleep studies by a physician who is employed by a hospital. This could be especially possible when his salary and/or bonus is directly related to the income generated by the test and prescription of equipment which will also be supplied by a hospital owned medical equipment company. We have also seen in the Charlotte community, the monopolization of referrals for equipment by hospital owned sleep labs. Patients are not always offered a choice of providers. The result is that there is no competition and thus no reason for a hospital owned company to offer quality service or competitive pricing. Physicians who are employed by a hospital should not be allowed to refer patients to a hospital owned medical equipment company!Another respondent has suggested that a company not owned by the sleep lab may not provide the same mask as used in the sleep test. This is doubtful as most homecare companies carry a wide variety of mask for existing customers. It is in the best interest of the company and the patient to provide the patient with a mask that will best ensure compliance by the patient. Homecare companies also have more time to spend with the patient in the home environment fitting the most appropriate mask for the patient to use in his own sleeping environment. The sleep environment of a diagnostic lab and that of the patients home are completely different. Also not all sleep labs send the mask home used in the test. Additonally, private physicians who own sleep labs are currently not allowed to refer Medicare or Medicaid patients to medical equipment companies in which they have ownership. Thus, there is no incentive to prescribe equipment that the patient may not need.I strongly urge the adoption of this regulation. It will surely result in more choice of providers to Medicare patients. It will also result in a higher quality of service to the Medicare patient and can help to keep competitve pricing in the marketplace.My final argument for this regulation is the positive effect it will have on the tax payer in general. No longer will tax paying private companies have to unfairly compete with not for profit hospitals. This will allow private companies to continue in business, grow as they provide quality service and continue to pay taxes to local governments. As not for profit hospitals gobble up the business, the profits they generate are used to buy more and more property which becomes nontaxable. This is not good for the community and places an additional burden on local taxpayers.Respectfully,H. Edward Eubanks23 Washington LaneConcord, NC 28025", "comment_id": "CMS-2008-0073-0020", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0073-0020", "comment_date": "2008-07-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3304}]}, {"id": "EPA-HQ-OPPT-2006-0795", "agency": "EPA", "title": "2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4dione; Proposed Significant New Use of a Chemical Substance", "update_date": "2022-03-25", "update_time": "13:17:13", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "publi comment on federal register of 12/18/06 vol 71 #242 pg 75703 40 cfr part 721docket 2006-0795 frl 8102-3 rin 2070-aj3l 2,3,5,6 tetrachloro...i think this new use should be totally banned. i see no reason to allow the new use of this dangerous chemical. that is my opinion. america simply does not need any more dangerous chemicals, we already have tens of thousands in full use and this agency is far too much in bed with chemical profiteers. and not fully protecting american citizens.b. sachau15 elm stflorham park nj 07932", "comment_id": "EPA-HQ-OPPT-2006-0795-0013", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OPPT-2006-0795-0013", "comment_date": "2006-12-20", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 585}]}, {"id": "CMS-2022-0191", "agency": "CMS", "title": "Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024", "update_date": "2024-03-04", "update_time": "08:43:35", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am writing as a concerned Independent Agent, who cares about my clients and the means to which I can help them find the best Medicare Supplement option for their specific needs. Adding more and more regulations to agents AS A WHOLE will only be to the detriment of my clients and potential clients. Independent Agents are not the same categorically, as those at a large call center who are simply badgering Medicare Beneficiaries. They certainly dont care about the individuals they are calling. They just want to convince them to sign up for their product. These are the agencies  you need to be regulating. NOT the Independent Agencies who actually HELP their clients. Adding more regulations, such as recording phone calls (2023 regulation) and 48 hour Scope of Appointments (proposed for 2024) will only hinder our ability to help our current clients and potential clients. We actually know our clients in most cases. We knew them when they were  our clients for the Marketplace or an employee for one of our group clients. We know their health history and we take the time to go over what medications they take, to be sure they get the best supplements for their specific needs. We will no longer be able to do that with our hands tied! Please take these concerns into consideration for the current and proposed regulations. Please consider separating the regulations imposed on Independent Agencies vs the Large Call Centers who are cold calling beneficiaries without consent. They are the big bad wolf you are looking to tie up, not me!", "comment_id": "CMS-2022-0191-0253", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0253", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Sara", "commenter_lname": "Dean", "comment_length": 1550}, {"text": "Prior authorization policies should only be used to confirm the presence of diagnoses. They should not be used to predetermine the necessary length of stay or for preadmission coding. ", "comment_id": "CMS-2022-0191-0301", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0301", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Cindy", "commenter_lname": "Thomas", "comment_length": 230}, {"text": "MTM Eligibility - We oppose lowering the cost threshold to the average annual cost of 5 generic drugs. Decreasing the cost threshold to one fifth of what the 2023 threshold is, will greatly increase the number of MTM eligible members, which again, is a significant financial impact to plans. The increased administrative cost will result in increased member premiums, copays and deductibles and will not result in more robust plan benefits to offer members.We request some additional clarification and details on the proposed updated annual cost threshold methodology to fully understand the impact of this change. Will the methodology utilize the top 5 utilized generic drugs by prescription volume? Or the top 5 generic drugs by cost (i.e., plan paid amount)? Will this include/exclude generic specialty medications, that may be outliers in terms of cost compared to other non-specialty generic medications? Will there be a process to detect outlier NDCs to ensure they are not included in the average AWP calculation? Is the cost per 30-day supply of medication? ", "comment_id": "CMS-2022-0191-0287", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0287", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1076}, {"text": "We would like clarification on how the adherence measures will be excluded from the CAI adjustment. Our understanding is that the CAI adjustment looks at the total population of the plan and calculates the percentage of low income, dual eligible, and disabled members. It is unclear how excluding the adherence measures would be applied to the calculation. Furthermore, we are concerned with the impact of implementing risk adjustment to the adherence measures. For the diabetes adherence measures, the change had an adverse effect on the rating.", "comment_id": "CMS-2022-0191-0280", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0280", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 546}, {"text": "I support you efforts to make MA plans more closely align their coverage decisions with traditional Medicare.  ", "comment_id": "CMS-2022-0191-0327", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0327", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Russell", "commenter_lname": "Jackson", "comment_length": 111}, {"text": "Regarding Guardrails - We feel that removing the guardrails will lead to unpredictability which will hurt plans ability to budget and plan. While we understand that Tukey is meant to remove outliers and limit large swings, we feel keeping the guardrails in place will act as a guarantee.", "comment_id": "CMS-2022-0191-0282", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0282", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 292}, {"text": "Page 58, Section H. Review of Medical Necessity Decisions by a Physician or Other Health Care Professional With Expertise in the Field of Medicine Appropriate to the Requested Service and Technical Correction to Effectuation Requirements for Standard Payment Reconsiderations ( 422.566, 422.590, and 422.629)Adverse Decision  appropriate expertise to deny  Is there more objective direction that can be provided to define this as it feels slightly subjective? ", "comment_id": "CMS-2022-0191-0319", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0319", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 547}, {"text": "If you think direct mail during an election year is bad, you should see the volume of mail during Medicare Open Enrollment.  Just like a political campaign, it can be difficult at times for knowledgeable professionals to figure out the best health insurance product let alone a single, 85 year-old, childless widow with chronic health conditions.  Our hospital, Neosho Memorial, sponsored an unbiased educational program this year using SHICK counselors through the Area Agency on Aging. The attendees stories were desprate and heartbreaking.  CMSs policy and technical changes to Medicare Advantage Program is good for our elderly and their healthcare providers.  Please continue, you cannot underestimate the difference they will make in helping our patients simply make better choices AND receive the health services they believe they are paying for.   ", "comment_id": "CMS-2022-0191-0240", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0240", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Patricia", "commenter_lname": "Morris", "comment_length": 878}, {"text": "I am an agent and mentor I teach agents how to own their own Medicare business. I read the deceptive marketing practices flourish in Medicare advantage Report by the finance committee. If you really look at the organizations that have the majority of complaints to CMS. You will find it is the robocallers, telemarketing, Television Advertising, radio advertising, and direct mail campaigns. These are the Third party organizations (TPMO), the problem is CMS and Ron Wyden Committee has lumped the above with Field agents and brokers. They are not the same and agents and Agencys do not advertise nor act to deceive consumers. You need to separate these bad actors from independent agents and Agencys. Independent agents are helping consumers understand Medicare and are local in their area helping consumers understand Medical Group Networks, Formularies, and how the plan works. We do not call without a permission to call or SOA. Independent agents should not be lumped into these bad actors that you talk about in your deceptive marketing report, you know who is to blame yet you are punishing agents and agency owners who are not part of these deceptive practices. Agents and Agency owners follow the rules set forth by CMS. We only help those who we meet in person who request our help. Agents and Agencies would be good with getting rid of TV advertising, radio, direct mail campaigns, telemarketing bait and switch. Please do not get rid of educational Events, permission to call and SOA we are out here helping not hurting our seniors. We want you to get rid of these people who blow up our customers phone promising the unrealistic freebies that dont exist. But please know it is not the independent agent or agencies. Your problem is people who dont even hold a license in the insurance industry the robocallers, telemarketers, TV ads and deceptive direct mail. Stop those and your complaints will end. Remember agents were the good guys!", "comment_id": "CMS-2022-0191-0248", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0248", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1979}, {"text": "Patient advocacy letter", "comment_id": "CMS-2022-0191-0345", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0345", "comment_date": "2023-02-13", "comment_time": "05:00:00", "commenter_fname": "Karen", "commenter_lname": "Polacheck standifer", "comment_length": 23}]}, {"id": "DEA-2020-0002", "agency": "DEA", "title": "Schedules of Controlled Substances:  Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl into Schedule I", "update_date": "2021-12-02", "update_time": "01:00:58", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "In light of growing number of opioid overdose deaths in America (more than 70,000 people died of opioid overdose in 2017 according to the CDC), I support the permanent addition of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl to list of Schedule 1 drugs. These drugs are structurally similar to the opioid fentanyl but are not FDA-approved drug products. As a result, users of these drugs are not protected by the FDAs quality standards. According to the CDC, abusing unregulated opioids of unknown quality and potency represents a significant risk of opioid overdose to users. Opioid overdose has been estimated to cost the United States more than 400 billion dollars annually (according the White House Council of Economic Advisors). Additionally, I argue that the social and emotional damage done to American communities caused by the opioid overdose epidemic cannot be presented solely financial terms. In an effort to minimize the presence of unregulated opioid substances of unknown quality and potency in illicit drug markets, I support the listing of these subtances as Schedule 1 drugs, as they meet the DEAs requirements for Schedule 1 subtances. ", "comment_id": "DEA-2020-0002-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0011", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "Brian", "commenter_lname": "Rogers", "comment_length": 1287}, {"text": "Why dont you get a chemist to make a list of all the chemical pictures that cause drug addicts who are using fentanyl to feel satisfied so that we dont do this stupid add five chemicals and China imports four hundred variants. The solution is to list every fentanyl variant as schedule 1.", "comment_id": "DEA-2020-0002-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0009", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 298}, {"text": "The proposal to reschedule fentanyl to schedule one under the Controlled Substances Act though honorable in intent, may potentially do more harm than good. A large portion of our population relies on controlled substances, such has fentanyl, to relieve their chronic pain. While these drugs were never meant to be a long-term solution, that has become the reality we must deal with. Rendering fentanyl illegal would leave many patients in a lurch, unable to access the care they were previously receiving. These patients would no doubt either receive a prescription for a different opioid or worse, obtain illicit substances to fill the void they are now left with. While prescription drugs make up a great portion of the opioid epidemic and I agree that alternative therapies need to be established, it would be foolish to forget the schedule one substances that are already contributing to this nation-wide crisis. The majority of fentanyl related deaths are due to its mixture with other substances that are already classified as schedule one. Creating more illegal substances will not solve the issue, rather add fuel to the fire that is the illegal drugs trade. ", "comment_id": "DEA-2020-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0006", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1167}, {"text": "Heres a article reported by CNNs Madeline Holcombe which explains everything we need to know about the fentanyl crisis that we are dealing with here in central Ohio: This Ohio county (Franklin) may need a second morgue to handle the number of fentanyl overdoses. [1] In her article, Holcome discusses the opioid scourge that is heavily affecting my home state. The article stated that [Franklin] county has seen 23 overdose deaths from January 31 to February 7, Dr. Anahi Ortiz, the countys coroner, said in a statement on her Facebook page. The next day, the county had five more. Dr. Ortiz also stated that [fentanyl] is the deadliest drug in the US, according to the Centers for Disease Control. It is up to 100 times more powerful than morphine, and just .025 milligrams can be deadly.While Franklin County usually has one or two overdose deaths in a day, Ortiz said on Facebook, one 26-hour period in September 2019 saw 10 people dying of overdoses.That year, overdose deaths in the county were up 15% from the year before, and 90% were opiate related.Fentanyl is a drug that affects everyone and is not limited to race, income, social class, age, education level, etc. It is a killer and can be fatal on someones first dose because of its potency and the chemicals it is mixed with for the purpose of cutting it for sale on the street and larger profits for the dealers. I have never had a friend or relative killed or had their lives destroyed by it, but I believe that I am in the minority. Almost everyone has been impacted by these drugs. We have all watched the news reports, watched documentaries, seen the impacts of the drugs in TV shows or movies... everyone knows it is a problem which needs a solution ASAP! We need to make it a schedule 1 narcotic and take every legal step to eliminate fentanyl from our streets, or neighborhoods, our schools, and our homes. Fortunately we are in the process of closing/controlling entry on our southern border where most of this lethal drug is being smuggled in from central and southern America. There is no simple, single solution to combating this fentanyl plague, all possible solutions need to be taken, and reclassifying fentanyl to a schedule 1 drug is a necessary step to take.[1]  Madeline Holcombe, This Ohio county may need a second morgue to handle the number of fentanyl overdoses, CNN, (February 13, 2020), https://www.cnn.com/2020/02/13/us/ohio-fentanyl-overdose-second-morgue/index.html.Thank you for considering my comments and concerns.Respectfully,James E. Yerian   ", "comment_id": "DEA-2020-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0008", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "James", "commenter_lname": "Yerian", "comment_length": 2663}, {"text": "This is a drug I think is abused by people by age and it is terrible to see it get worse year by year. I am glad that people will be punished at a higher degree of law if they are using these drugs to ruins the lives of others by providing a source for this drug. I hope that this reclassification will prevent further deaths and addiction.", "comment_id": "DEA-2020-0002-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0010", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "Jose", "commenter_lname": "Vargas", "comment_length": 340}, {"text": "Yes, this is good because the drug dealers are the words and much worse than the users.", "comment_id": "DEA-2020-0002-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0007", "comment_date": "2020-03-04", "comment_time": "05:00:00", "commenter_fname": "Lily", "commenter_lname": "Grant", "comment_length": 87}]}, {"id": "FDA-2017-D-2232", "agency": "FDA", "title": "Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy", "update_date": "2018-09-20", "update_time": "10:23:39", "purpose": "Nonrulemaking", "keywords": ["2016-1234", "Product Identifier Requirements Under the Drug", "Supply Chain Security Act"], "comments": [{"text": "Apotex acknowledges the efforts of the agency on the notice in the Federal Register soliciting public comments on the Draft Guidance for Industry Product Identifier Requirements under the Drug Supply Chain Security Act- Compliance Policy DocketNo- FDA-2017 -D-2232. We appreciate the opportunity to comment on this notice and would like to provide recommendations for your consideration in a separate attachment. ", "comment_id": "FDA-2017-D-2232-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2232-0009", "comment_date": "2017-09-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 418}, {"text": "Comments from The Association for Accessible Medicines (AAM) regarding Docket FDA-2017-D-2232: Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy.", "comment_id": "FDA-2017-D-2232-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2232-0017", "comment_date": "2017-09-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 186}, {"text": "On behalf of McKesson, I am pleased to submit comments on the draft guidance for industry, Product Identifier Requirements Under the DSCSA - Compliance Policy.", "comment_id": "FDA-2017-D-2232-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2232-0020", "comment_date": "2017-09-06", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 171}]}, {"id": "DOD-2012-HA-0049", "agency": "DOD", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\r\nTRICARE:  TRICARE Retail Pharmacy Program", "update_date": "2020-10-22", "update_time": "01:32:52", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "My comment is that the change has benefits and disadvantages, not only to the military personnel but to those that service them.  In particular the proposal to automatically place newly approved drugs by the FDA into tier 3 category without prior review from the PT committee will not only cause a financial hardship to those paying the exorbitant cost sharing to pharmacies but it also delays intended prescribers from any new medications.  As an associate in the pharmaceutical industry this change affects how our case managers conduct pharmacy benefit investigations for drug coverage, and how we train our associates to manage prescriber and patient expectations when reporting benefits. This change in regulation will also affect our manufacturers and their ability to provide financial assistance to families that cannot afford to pay their copayments.  I wish to have them reconsider this portion of the new rule or to allow manufactures the option of providing support to families that cannot afford their copayments. ", "comment_id": "DOD-2012-HA-0049-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0049-0004", "comment_date": "2012-07-26", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1037}, {"text": "I think that this action is good but it will cause a financial burden with patients on certain medicines that may be changed by a physicain due to a need to control the illness or disease with new medications. This may cause more out-pocket expenses. How will a patients interest be protected by having a medication left over and purchasing a new prescription? This will be a out-pocket expenses that they accrude will cause even more problems when facing coverage gap.", "comment_id": "DOD-2012-HA-0049-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0049-0002", "comment_date": "2012-07-10", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 474}, {"text": "Although not the intended subject of this proposed rule, the status of reimbursement for compounded drugs under TRICARE is currently a topic under review.  With that in mind, I am commenting on the proposed revisions to 32 CFR 199.21(h)(3)(i).  If compounded drugs are classified as Third Tier, or non-formulary drugs, retail pharmacies could be precluded from providing such drugs to TRICARE beneficiaries and such patients could be required to obtain these drugs from the TRICARE mail order pharmacy if the Department of Defense Pharmacy and Therapeutics Committee recommends limiting access to compounded drugs to the TRICARE mail order pharmacy only.  That recommendation would have to be based on determinations that there is no significant clinical need and there is a significant additional government cost for access in both mail order and retail pharmacies, and such recommendation must be approved by the Director of DHA.I am concerned that the ability to eliminate retail pharmacies from providing allowed compounded drugs would significantly restrict, and perhaps eliminate, the access of TRICARE beneficiaries to compounded medications.  Such a determination would leave the TRICARE mail order pharmacy as the sole source for compounded drugs.  It is unlikely that such a pharmacy has the expertise to safely prepare the wide variety and complexity of all compounded drugs prescribed.  If a prescribed compounded drug is covered under TRICARE, the TRICARE beneficiary should not be prohibited from receiving that drug due to limitations imposed based on the inability of the TRICARE mail order pharmacy to safely prepare such compounded medication.  For this reason, if the regulation must be revised to allow designation of a single point of service in order to comply with the statute, that access point should be the retail pharmacies.    ", "comment_id": "DOD-2012-HA-0049-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0049-0007", "comment_date": "2014-11-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1870}]}, {"id": "FDA-2017-P-6307", "agency": "FDA", "title": "Request that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes pharmaceuticals LP (ANDA# A074769) as reference standard (RS) for the subject drug product to conduct in vivo bioequivalence studies.", "update_date": "2019-03-14", "update_time": "16:22:32", "purpose": "Nonrulemaking", "keywords": ["CITIZEN PETITION", "CDER", "Aurolife Pharma LLC", "Reference listed drug (MSCONTIN", "NDA # 019516)", "Purdue Pharma LP", "discontinued", "MS CONTIN", "Referencing Approved Drug Products in ANDA", "Morphine Sulfate Extended Release Tablets", "100 mg", "Rhodes Pharmaceuticals LP (ANDA# A074769)"], "comments": [{"text": "Goals  for Chronic Pain Patients to receive adequate pain relief; * For correct misinformation online and in Media about chronic pain patients and opioid therapy be amended and corrected!* * institute a Chronic Pain Patients Bill Of Rights. -We all have a right to relief from our debilitating  pain and discomfort. * United Nations policy states PAIN MANAGEMENT IS A FUNDAMENTAL HUMAN RIGHT, under treatment or not treating is a crime against humanity and considered torture! That is what is being done to chronic pain patients all over this country right now! I being one of them as I am experiencing abandonment of care from my doctor. who has refused to treat me. Thus, I am in a very precarious state right now! I looking for a doctor. However, all pain management specialist are booked for at least a four month window! My pain is chronic 24/7, 365 days a year. I cant wait that four months. I do not want to end up as a statistic on the suicide list!Since the narrative of the opioid epidemic has taken hold, some/ many doctors are refusing pain relief, in fear of retribution, imprisonment or loss of livelihood!Many hospitals are implementing after surgery a spinal block and Tylenol, many patients are dying attributing it to cardiac arrest which is not the case!#2 Collateral damage Because of the innumerable, severe, and long lasting effects of constant pain, I believe that treatment for chronic pain is a human right. It impairs every part of a persons entire life, career, family, mind, body, spirit and soul. From financial hardships due to being unable to work and the family issues as we cannot be the parents, grandparents  partners  that we  would have and should be. Many chronic pain patients are hypo metabolizers or hyper-metabolizer ... I suffer with malabsorption I had a surgically inserted port in my chest.I had tpn pumped into to my body for 12 to 24 hours a day for 8 + years. I could not absorb the proteins in my food this is the way I sustained my life. It makes sense since food did not absorb either did my medication that is why I had to have higher doses For it to work. We are not a one-size-fits-all society.This creates, a lot of collateral damage to the family  because  we are not able to function  in a fashion  that our family needs us to !  It also  starts to deteriorate  our childrens  mindset  as they are continually worried  as to our health, expectancy of life/  longevity of life ! I know this first-hand has changed who my four children could have been !  It put too much weight  on them while trying to go through school  and life in general !Because of all the family issues in addition to other health issues like brain and organ damage from lack of sleep, medications, and the rewiring of your brain from constant stress. Air condition, heating our sensory capabilities are all screwed up we need to help chronic pain patients get better treatment, education of the public on the complexities of chronic pain, lobby the government to make changes that will benefit chronic pain patients, and to foster a better understanding of chronic pain patients struggles day in Day Out with daily life. After reading so many frustrating stories of chronic pain patients dealings with the healthcare industry, I decided to create a foundation that would serve the needs of chronic pain patients everywhere. By first educating the public on what chronic pain really is, how it affects us and our families, and what is missing in our treatment. Then I would like to focus on changing how government views chronic pain patients and writes guidelines and legislation that affects them. For those of us who suffer day in and day out 24/7, 365 days a year Relentless, cruel, aching, affliction, agony, burn, catch, convulsive, cramping, crick, discomfort, distressing, fever, gripping, hurting, illness, injury, irritation, laceration, malady, misery, pang, paroxysm, prickling, sickness, smarting, soreness, spasm, stinging, stitching, straining, tenderness, thro, tingling , tormentous, torturous, troubling, twinging, wounding always present, horrendous, debilitating pain sharp, exacerbating,There is a need in the chronic pain community and it is not being addressed, please we need to reduce the suffering as much as possible, of people suffering from chronic pain.Suicidedue2pain Malabsorbtion -TPNMusic therapy Massage Behavior therapy Physical therapy Biofeedback Acupuncture etcThree options - reform of opioid guidelines3. Campaign/Organizational Goal and Key ObjectivesEducating the public about chronic pain and how it affects chronic pain patients.-Fight preconceived notions on pain medication and those who need it.-What is missing from treatment of chronic pain?-Changing governmental views-Get new guidelines on pain medication created for chronic pain sufferers.-Explain how the war on opioids is killing chronic pain sufferers!", "comment_id": "FDA-2017-P-6307-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0006", "comment_date": "2018-05-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5172}, {"text": "Dear Readers,I am not certain how to write this letter, but I feel I must respond and comment on these regulations and have a voice in federal making of decisions.I have been in chronic pain since 1984. In all these years since a respiratory infection ended with widespread body pain, I have not had one day without pain. The original disease has increased from musculoskeletal to inflammatory and degenerative arthritis throughout all my joints. Every X-ray is filled with arthritis and bone spurs, even bone in locations bone should not be. An MRI of my spine sent me to a neurosurgeon who said the only surgery that might work would never permit me to bend over again. I take both diazepam and hydrocodone, in addition to medications you might not consider opioids or narcotics. These two are not high dosage, but they have worked and allowed me an active life. Daily I take care of horses, my own home, animals, and I work. I work as a writer and have had 16 books published while taking these medications. My main publisher has been WW Norton in NY. And for poetry, I have used a smaller, independent press. I also travel frequently to read my work, do workshops, and lecture on a variety of topics. This is with my medications.Without them, I am unable to get out of bed. I have had screams that are involuntary. I cannot bend or do any movement or work. My hands do not work, will not type, nor can I walk without severe pain. Without these medications, I will have no life, orat least not one worth living. The Dr. has changed. Even he has fear. He does not wish to prescribe medications like the ones I take, swears they would kill anyone else, all the exact same stories as the numerous other pain patients say they have heard. I feel sorry for those of us in pain, but I also feel sorry for those in the medical profession who are unable to really help their patients.Many pain patients have been committing suicide rather than living a life suffering. These deaths are worse than the ones of addicts who are shooting up because they are created by the governments regulations and fear tactics. They are going after the wrong people.Most of us are taking our meds at the right times, not asking for larger doses, and are responsible with our meds. We do not misuse our medicines. For us they are not addictive drugs, but healing agents that allow us to live full lives.Please consider this in your Regulations. We do want to live. We do not overdose. We are not the criminals. We want to be free from pain, as anyone else also would.Sincerely,Linda HoganProfessor EmeritaU of Colorado, Boulderwww.lindahoganwriter.com", "comment_id": "FDA-2017-P-6307-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0003", "comment_date": "2018-03-28", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2763}, {"text": "Id like to start out by saying Im a 39 yr old mother of 6. And have had chronic pain for over half my life.I was 11 yrs old when I first started having back pain and then went on to knee pain. I was cative throughout school I was involved in track n field, volleyball, cheerleading  basketball. I had to wear 2 knee braces and was on a very high does of anti-inflammatory prescription from my knee doctor at age 12. After giving birth to my 3rd child at age 20 I had my 1st knee surgery, every year after that 1st surgery i had knee surgery after another for 5 years... I had been sent to neurologists and physical therapy chiropractor and differant doctors ect.Finally at age 28 i found my dr and he referred me to a spine specialist and he diagnosed me with Schumanns disease which is very painful my spine was 69% curved on top and 69% curved on the bottom. They did surgery October15th 2010 and it was a very long recovery.Ive been on Percocet for 7 yrs and dont abuse it. I cant even get out of bed, walk or do basic self care without it. Ive seen what drug addiction has done to our community and people i love.But dont punish us that need our medication to live our basic daily lives.", "comment_id": "FDA-2017-P-6307-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0005", "comment_date": "2018-04-17", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1261}]}, {"id": "FDA-2022-N-2393", "agency": "FDA", "title": "Public Workshops - Diagnostic and Monitoring Medical Devices for Opioid Use and Risk Prediction Devices of Opioid Use and Opioid Use Disorder - Opportunities and Challenges", "update_date": "2022-12-08", "update_time": "14:48:59", "purpose": "Nonrulemaking", "keywords": ["CDRH", "Notice", "Public Workshops", "Diagnostic and Monitoring Medical Devices", "for Opioid Use and Risk Prediction Devices of", "Opioid Use and Opioid Use Disorder", "Opportunities and Challenges", "Open"], "comments": [{"text": "This is a hard no for me. Let Drs do what they think is best, not some machine telling them. Anti-opoiod rhetoric and targeting has killed many. People are left with death as the only option to escape chronic pain. Stay out of our Drs appointments..this machine will inadvertently cause even more deaths..", "comment_id": "FDA-2022-N-2393-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0008", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 315}, {"text": "I was told in April of 2019 the pain management practice I was seeing that I was being cut off meds. I remembered very well the pain I will have until I die would be back. Said stimulator was only thing could help. I saw doctor Id not seen before in the over 4 years of being there. They made sure I got the meds for that, and in Aug of 2019 I got the permanent one and they were cutting my meds off. It was a domino effect. I know need helpers. I dont see where a device that can tell what your pain is useless. When I gave birth to my 2nd son they used a device to keep track of contractions. Didnt work, kept telling them I was having closer pain and they looked at machine and said I was fine. Finally they looked and my son was on his way out. I believe only the patient can tell you how much pain you have. A new gadget that can tell is just another medical expense that isnt necessary. We are human and places have seem to forgot that. Insurance spent thousands on the stimulator, which I believe is a waste of money. Since so many doctors have turned to them, rate of success isnt as good. Any extra equipment to put us through that doctors need to use is just another insurance waste like my stimulator was. Would be a lot better to go back to what works for us. And keeping our records private as well. It is fast become inhumane treatment as it is. I feel its a waste of money for insurance companies have to pay. Are doctors allowed to listen to patient anymore. I know what my pain is. Please stop trying more fixer uppers and technology. Insurance paid to get stimulator out. Please no more trusting a machine to tell us about our pain. Its ridiculous.", "comment_id": "FDA-2022-N-2393-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0006", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1706}, {"text": "So let me get this straight: you want to subject me to a surgical procedure to prove that my pain is real? Who pays for this device? Who monitors it? What happens if this device breaks or malfunctions? As a person who suffers from chronic pain on a daily basis all because someone at the insurance company didnt feel my fractured spine was important enough to do a spinal fusion, do you really think I would trust anyone else doing unnecessary procedures to my body? After three tries with the insurance company, I finally had my fusion and guess what? My spine was in 2 pieces and my nerves were exposed and flapping. This is not a life I would wish on anyone.  To push CPPs to do monthly drug tests, pill counts, sign contracts, and be treated like criminals; only to now be pushed to get a medical devise  just to prove Im in pain is never going to happen. This is just another get rich quick scam the medical community will push, but it wont work. We are not criminals. Enough is enough.", "comment_id": "FDA-2022-N-2393-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0015", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1001}, {"text": "I am appalled at the lack of diversity of pain patients that were used. Valuable time was wasted playing prerecorded statement. There was a significant amount of duplicity.  I am even more disturbed that there was not more discussion about how patients on LTOT are profiled and denied opioids even in acute pain while in hospital from Narxcare. A score that is shielded by privacy under argument that its a proprietary algorithm. Yet FDA is testing the water to add more computer driven apparatus without transparency. DEA shouldnt be able to troll PDMPs an then use parallel construction to create cases against Drs. FDA needs to address the elephant in the room that opioids are FDA approved but not allowed under DEA scrutiny. ", "comment_id": "FDA-2022-N-2393-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0010", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 766}, {"text": "We (experts in statistical and psychiatric genetics, including substance use disorders) wish to raise important issues related both to the general topic and to a specific test that was described during the workshop. We highlight the expert consensus on 2 general issues about genetics of psychiatric and substance use disorders most relevant to the workshop and to potential approval of devices for risk prediction.First, while genetic variations contribute to the risk for psychiatric and substance use disorders (SUD), the genetic contribution accounts for only about half of the variation in risk, and that portion is distributed among hundreds to thousands of genes. The idea that a small set of genetic variants, however combined, can distinguish those at elevated risk for an SUD simply does not align with accepted scientific fact regarding the genetics of SUD and other psychiatric disorders.Second, there needs to be control for the participants genetic ancestry in any test for a trait or disorder that is complex (i.e., due to the effects of many genes). Groups of people differ in the frequencies of many genetic variants, and differences often track with recent ancestry. If these differences are not accounted for, they result in spurious findings where genetic variants that are actually indicators of the ancestry of a group can show up as false positive associations with the trait (e.g. the chopstick gene, PMID: 10673763). This is a major risk, because if a medical test preferentially confounds ancestry with OUD risk, it can contribute to biased treatment. During the workshop, one particular test that is being evaluated by the FDA was described: the AvertD(TM) genetic test for Opioid Use Disorder (OUD) risk, from SOLVD Health. We think that it is an example of a flawed test that could generate harm, and serves as an example of issues that should be considered in evaluating any such test.The AvertD(TM) test purports to predict who is at risk for becoming opioid dependent if prescribed opioids. The company proposes that a practitioner could test patients to determine risk before prescribing opioids, and use the information to guide his/her prescribing. The test uses 15 variants (PMID: 34452883); a prior version (PMID: 28801372) used those plus one additional. Based on the largest genome-wide studies to date (samples range from approx. 80,000 to 400,000; e.g. PMID: 35879402; PMID: 36171425; PMID: 34728798), even a full genomes worth of markers is not currently able to predict an individuals risk for OUD in a clinically useful way.One group evaluated how ignoring the scientific consensus noted above results in bias (PMID: 34710714), with examples using the exact genetic markers used previously by the creators of the test. The proposed SNPs differed significantly in allele frequency among different populations, a major problem. Although the companys particular machine-learning algorithm is not public, the group tested 5 major types of machine learning algorithms with the SNPs the company chose, as well as with 8 random sets of SNPs that were matched to theirs on allele frequency. These SNPs and algorithms were tested in a large number of carefully evaluated and ethnically matched individuals: half of European American and half of African American genetic ancestry, and within each group half of the participants met criteria for strictly defined OUD (DSM-IV) and half did not. The paper showed there was no predictive utility for OUD attributable to these SNPs. When done incorrectly the prediction could appear to exceed 90% accuracy but also  alarmingly  the prediction by this set of variants was highly confounded by ancestry such that it predicted subpopulations of minorities rather than OUD. This is particularly problematic, because it could exacerbate current biases in pain treatment. That paper also tested simulated data and another complex phenotype, tobacco smoking, and our results generalized. These analyses serve as a cautionary note when evaluating any genetic test for an SUD.We urge your panel to carefully review the consensus on the genetics of OUD and the published work on algorithmic bias in genetic prediction of opioid use disorder in any decisions on such a predictive test.A bibliography is appended as a pdf, due to space limitations.", "comment_id": "FDA-2022-N-2393-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0016", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4427}, {"text": "This device to tell doctors if a patient needs pain medication is asinine. Its a horrible idea.  Ive been on long term opiate therapy for 30 years. Opiates have saved my life. Without them I was unable to get out of bed without great pain and difficulty.  When I was forced off opiate therapy because of the anti opiate hysteria it almost killed me. I ended up in the ER and a stay in the hospital for a week to stabilize my heart. This should never happen to another patient. Ever and putting a device on someone to measure how much pain they are in instead of just listening to the patient is ridiculous. Same with spinal cord stimulators. Another piece of medical quackery ", "comment_id": "FDA-2022-N-2393-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0004", "comment_date": "2022-11-23", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 697}, {"text": "I am a data scientist with over 20 years of experience and have been affected by addiction.  The presentations of A. Haotum claiming there is scientific consensus that his approach is correct is demonstrably incorrect.  I reviewed the entirety of his published work including the papers he referred two in his short presentation.   None of the papers follow best practices in our space. All papers contain numerous flaws in study design that have been shown to lead to invalid modeling and incorrect results. For example, the in the study he spent the most time discussing, the inter-rater Cohen kappa coefficients the study data for the survey instrument (Semi-Structured Assessment for Drug Dependence and Alcoholism) used to classify opioid dependency range from ~0.1 to 0.4. This is important, because in electronically derived predictive classification modeling, we need to understand the noise in our data.  It is a reasonable assumption that the Cohen kappas contribute to the class noise and therefore set the minimal amount of class noise in opioid dependency of the dataset within this range (i.e. the minimal amount of class noise in opioid dependency in your study would be ~10-40%).  Whereas the empirically defined ancestry classification he used would not have equal class noise levels (although as you know the use of the 1000 genome data to assign ancestry and the under-specification issues with the genetic attributes (MAFs) in this approach is concerning especially for the AA groups).  Given that the approaches used will degrade with as little as 5% class noise, and that the differences in class noise of at least 10-40%, the comparative analysis using the unadjusted/uncleaned data with the differences in class noise between the two classes studied in invalid and uninterpretable.  Numerous independent studies have shown using uncleaned/unadjusted data across apparently large difference in class noise between classes (opioid dependency and ancestry in this case) makes the modeling, comparisons, and the conclusions unsupported. In addition, I also have a significant concern in the way the study is designed to test hypotheses within a dataset across classes and then generalized externally.  A reasonable interpretation of the results is that this dataset is not adequate to use for modeling opioid dependency, but that all that would be needed for this interpretation is to look at the inter-rater kappas for the class (it took me literally 10 min). Trying to generalize the limitations of the dataset to attributes or studies outside this dataset is utter nonsense.", "comment_id": "FDA-2022-N-2393-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0002", "comment_date": "2022-11-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2627}, {"text": "Please read the attachment from the Oregon Pain Action Group which contains our comment. Thank you. ", "comment_id": "FDA-2022-N-2393-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0005", "comment_date": "2022-12-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 100}, {"text": "I writing this today to voice my concerns about the manner chronic pain patients are treated nowadays. Since the DEA has been threatening our Doctors, we have been forced into pain clinics where the Doctors have really no knowledge of of our history or any condition that our PCP would know right off the top of his head! Its criminal that they are allowed to over ride our Doctors and in some cases put them in jail for only prescribing medication to their patients! In fact they are using this so called opioid crisis to do this! If truth be told 87% of deaths are from fentanyl that flows In across our Southrren border. Something must be done to help my community of chronic pain patients and deal with the illegal drugs pooring in", "comment_id": "FDA-2022-N-2393-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2393-0009", "comment_date": "2022-12-08", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 742}]}, {"id": "FDA-2019-N-0767", "agency": "FDA", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Cannabis and cannabis resin; Dronabinol (delta-9-tetrahydrocannabinol); Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol); Extracts and tinctures of cannabis; Cannabidiol preparations; Pharmaceutical preparations produced eit", "update_date": "2019-10-03", "update_time": "10:20:07", "purpose": "Nonrulemaking", "keywords": ["2019-113", "CDER", "International Drug Scheduling", "Convention on", "Psychotropic Substances", "Single Convention on", "Narcotic Drugs", "World Health Organization", "Scheduling Recommendations", "Cannabis and", "cannabis resin", "Dronabinol", "(delta-9-tetrahydrocannabinol)", "Tetrahydrocannabinol (Isomers of", "delta-9-tetrahydrocannabinol)", "Extracts", "and tinctures of cannabis", "Cannabidiol", "preparations", "Pharmaceutical preparations", "produced either by chemical", "synthesis or as preparation of cannabis", "Request for Comments", "OPEN"], "comments": [{"text": "I strongly recommend rescheduling cannabis from a class 1 to schedule 3 or 4, the least restrictive. Imposing more restrictions on manufacturing and distribution will only strengthen the Black Market More restrictions will only result in more incarcerations and cause the continued use and demand of even more psychotropic substances such as it is the case today.The benefits, facts, science, and statistics can all be found on your computer. Any restrictions of cannabis has always resulted in terrible consequences for the people.", "comment_id": "FDA-2019-N-0767-1767", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1767", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 549}, {"text": "As 9-THC is liable to similar abuse as cannabis and has similar ill-effects, it meets the criteria for inclusion in Schedule I of the 1961 Single Convention on Narcotic Drugs.Currently, approved medicines with 9-THC as the only active compound use synthetically produced 9-THC, e.g., Marinol, Syndros, although it is possible in the future that medicines with equivalent amounts of 9-THC could be prepared from cannabis. There is no difference in the therapeutic effects or adverse effects of synthetic 9-THC compared to 9-THC from the cannabis plant.If there is no difference between synthetic and plant-derived 9-THC, as acknowledged by WHO, then they should be scheduled the same.  Schedule I drugs have no therapeutic usefulness.  That cannot possibly true if There is no difference in the therapeutic effects or adverse effects of synthetic 9-THC compared to 9-THC from the cannabis plant.  Medical marijuana (containing 9-THC) is approved in many states in the US for some of the same uses as synthetic dronabinol like decreased appetite and nausea for cancer and HIV patients.  There is therapeutic benefit for all of the cannabinoids in the cannabis plant and it should not be scheduled any lower than Schedule III.", "comment_id": "FDA-2019-N-0767-1763", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1763", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1289}, {"text": "March 13, 2019Dear Food and Drug Administration,As Chairman of the Health Committee of the House of Representatives of Tennessee, and a practicing physician, I am contacting you in support of rescheduling, or descheduling, the cannabis plant and all its chemicals.Though cannabis and its derivatives are considered to be Schedule 1 chemicals, recently, the surgeon general has recommended removing cannabis from this status, claiming this status hinders scientists ability to conduct research on the plants effects and potential benefits. Likewise, after an extensive analyzation of completed cannabis studies, the World Health Organization (WHO) also recommended removing cannabis from its current restrictive status. I would concur with these sentiments.Studies have shown that the chemicals in cannabis have medicinal properties and, if used properly, they have low risk of morbidity and mortality. Currently, thirty-three states have passed legislation permitting the use of cannabis for medicinal purposes, leaving most of the country at odds with the federal governments longstanding prohibition. Despite this prohibition, the recently signed federal spending bill prevents the Department of Justice from spending money against states who have enacted a medical cannabis program.As a Chairman, physician, parent, and patient advocate, I am urging the FDA to reschedule or deschedule cannabis and its chemicals for the research and medical benefits of Tennesseans, and all Americans.Regards:Rep. Bryan Terry, M.D.", "comment_id": "FDA-2019-N-0767-1772", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1772", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1733}, {"text": "I am a Professor of Neurology and researcher on cannabis.  Researchers need better access to good quality cannabis products in the US.  My patients, most have Parkinson disease, are experimenting and some hallucinate and others have better sleep.  the various components of cannabis may have great benefit and risk - we need to be able to do the research, especially since our fragile patients have access to it!  presently there is little choice of products and little available.  we need more than the U of Miss as a source of cannabis for research.", "comment_id": "FDA-2019-N-0767-1789", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1789", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 551}, {"text": "  Please make my medicine legal. At least drop the schedule 1 to a 3 or 4.  We dont see over dosing like a schedule 1 drug.  It has multiple health benefits.  I suffer from crippling anxiety and delta- 9 tetrahydrocannabinol is the only thing that works for me.  In the past I was addicted to my pills I was given for anxiety and I had to up the dosage often (under a Dr. care).  Insomnia is practically cured with delta-9THC.  I also suffer from an eating disorder and the only way I am able to eat a full meal is with delta-9THC.  I am an Autistic person and have three Autistic children I know could benefit, yet without govt approval we will suffer in silence, waiting.  Thank you for your time,  Anna", "comment_id": "FDA-2019-N-0767-1838", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1838", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 715}, {"text": "I submit the following video evidence in favor of ending all forms of cannabis prohibition:Endocannabinoid Systemhttps://youtu.be/M8S2nfotTR8Understanding the Endocannabinoid Systemhttps://youtu.be/3sEwoJv_NRcDr. William Courtney and the dietary benefits of raw cannabishttps://youtu.be/eRLVyGfGcZs The Scientists : The story of Raphael Mechoulam and the Endocannabinoid Systemhttps://youtu.be/oQDJi6Jb8d4Medical cannabis and its Impact on Human Health https://youtu.be/2u5TpN_vGTE Cancer Killed by Cannabis -https://youtu.be/iksA-DD3990 Leafhttps://youtu.be/7xPmR8j4plw Prof. Raphael Mechoulam - Medical Cannabis- Complete Doctors Interviewhttps://youtu.be/sD1ZF0dE5nw Canna Tech 2016 welcome and keynotehttps://youtu.be/AeFn13R6ujsCannabis and cannabinoids - dr. Jeffrey Hergenrather, MDhttps://youtu.be/M8ieS2ICHME Dr. Mercola and Dr Getty on Medical Marijuana Full Interviewhttps://youtu.be/qerjjVVFVaQ CNN Documentary Weed 4 with Sanjay Guptahttps://youtu.be/R90JW1fTw8U ", "comment_id": "FDA-2019-N-0767-1834", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1834", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1181}, {"text": "We urge strongly that all cannabis products are declassified. THC should not be considered a harmful substance and instead regulated, as it has been, to enable a thriving industry that also helps individuals with a myriad of physical, emotional and mental issues that are well treated by cannabis. In addition, cannabis is a safe option for recreation and is less harmful than alcohol and tobacco, both of which have been part of the fabric of society for as long as most of us can recall. The regulated, recreational and medicinal cannabis industries for products that contain THC have also created countless jobs, created small businesses, and brought economic opportunity to towns larger and small. Studies have also shown that states with a regulated cannabis market have seen opioid deaths decrease, another major reason to encourage this plant to be made more accessible. In terms of CBD, this is a harmless substance as well which should be declassified. Limiting CBD use in tinctures, capsules, edibles and topicals at a level only achievable by pharmaceutical organizations would be a great loss to those who use it as a health aid in their lives, many of whom have been able to remove harmful substances from their daily routine, and who have found better lives with the use of the product. Keeping it accessible, affordable and in varying forms to suit the consumer is key. This is an industry as well that has created jobs, businesses and opportunities in every part of the country and the world. Attention to quality, testing, avoidance of the use of pesticides or herbicides, or other harmful ingredients, should be considered as a requirement for labeling CBD products so that consumers can choose for themselves the brands and companies that are creating products that are good for them at the level that they desire, much like the natural health and wellness sector vs. the lower grade food and product sectors. Consumers should have the options to choose for the themselves. In addition, banking laws need to be amended so that businesses in this sector, whether wholesale, retail, consulting, or peripheral, can work in the industry without financial repercussions like being robbed, having business accounts shut down, or not being able to secure loans or mortgages, like every other hard working person is able to do. Thank you for reviewing these comments. ", "comment_id": "FDA-2019-N-0767-1801", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1801", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2424}, {"text": "Former Minnesota Gov. Jesse Ventura tweeted, I truly feel sorry for South Dakota. @govkristinoem denied the state a great opportunity. #Hemp is a food-source for plant based protein, its jobs for farmers, its FEDERALLY LEGAL. She clearly did ZERO research before vetoing this bill.", "comment_id": "FDA-2019-N-0767-1837", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1837", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 303}, {"text": "Cannabis is a sacred, healing plant that has been used by peoples all over the world for millennia. It is a generally safe drug, and no one has EVER died from a cannabis overdose. Other drugs cannot claim this. I have heard of many people, including children, who have found relief from seizures with cannabis, where they have not had success with pharmaceuticals. These folks experience none of the side effects that pharmaceuticals give them, and now rely on cannabis to live their lives again. I feel it would be a crime to not allow these people easy access to something that is so helpful, and that has given them their lives back. For myself, being a strong, healthy person, I find that when I have puffs of cannabis before I go to sleep, I sleep much better, have better dreams and wake in the morning refreshed. I know others have this experience as well. This is just one of the many benefits of this plant.Cannabis is a natural plant that is easily grown. It may be a threat to the pharmaceutical giants because of this and because of its healing and calming effects on the human body, and that is exactly why it needs to be decriminalized and rescheduled. It is not addictive, despite what some say, and generally has no harmful side effects. It certainly does not deserve to be in the same category as cocaine or heroin. Seriously. This is so very wrong. Like I said before, no one has ever died of a cannabis overdose. Check the research on this.Please, please, please use your common sense and your sense of right and wrong and do the right thing here for cannabis. Thank you for doing the right thing for those who need this plant.", "comment_id": "FDA-2019-N-0767-1790", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1790", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1676}, {"text": "To Whom This May Concern:Hi, I would like to provide my support for the national decriminalization and rescheduling of marijuana and CBD derivatives. I am a practicing, board certified, and licensed Psychiatric Mental Health Nurse Practitioner in the state of TN. I have seen in practice and clinical rotations I had as a student many different individuals that use marijuana to help with anxiety, insomnia, pain relief, and mood regulation. Marijuana should not be classified as an illegal substance any longer. It has positive results in all realms of healthcare and I have seen this personally with my own patients I care for each and everyday. I support this as a way to provide better care to the people I see and their families. Some of these patients have replaced a highly addictive and highly abused class of medications- benzodiazepines- used in the realm of psych for anxiety and insomnia with marijuana use. Marijuana is a much safer alternative to benzodiazepines, it is cleaner, does not show to interfere with any other prescription drugs that they may be required to take, and does not come with a listing of side effects that can occur as is true for numerous prescription drugs that are written everyday. Another reason I support marijuana rescheduling and decriminalization, is due to the elimination of the concern of apnea- defined as the cessation of breathing- when marijuana is used in place of benzodiazepines. Apnea can occur with benzodiazepine use, as well as, muscle relaxers and pain medications. This adverse reaction is potentiated with the use of several of these classes of medications when they are prescribed together or in combination with one another. As a prescriber, seeing patients and families suffer from addiction, addiction recovery, and legal concerns, combined with mental health disorders, it is very hard to then have to turn to the use of medications- one stated above benzodiazepines- to help with symptoms of their disorders as there are not many choices of prescription drugs used to treat anxiety and insomnia adequately. Anxiety and insomnia are both disorders that many people suffer from and usually receive minimal coverage treatment at best for these disorders. Marijuana has been proven to treat these conditions among many others with great efficacy and ignoring these facts would be negligent and erroneous of our national leaders.  Thanks for your time and attention! ", "comment_id": "FDA-2019-N-0767-1771", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-0767-1771", "comment_date": "2019-03-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2481}]}, {"id": "TTB-2009-0002", "agency": "TTB", "title": "Implementation of Statutory Amendments Requiring the Qualification of Manufacturers and Importers of Processed Tobacco and Other Amendments Related to Permit Requirements, and the Expanded Definition of Roll-Your-Own Tobacco", "update_date": "2015-02-24", "update_time": "12:14:59", "purpose": "Rulemaking", "keywords": ["tobacco", "cigarettes", "cigars", "pipe tobacco", "chewing tobacco", "snuff", "excise taxes", "imports", "tobacco products", "roll-your-own", "CHIPRA"], "comments": [{"text": "Increase the tax on all tobacco products and use at least part of the tax to help pay for subsidies for the poor for buying the newly required health insurance.  Tobacco users should have to pay at least part of the expected cost of their nasty habit.  Since they will have to buy health insurance, unless they are too rich to qualify for the health insurance subsidy they will be getting at least some return from their tobacco tax in the form of the low income subsidy for health insurance.", "comment_id": "TTB-2009-0002-0007", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0007", "comment_date": "2009-08-18", "comment_time": "04:00:00", "commenter_fname": "Grace", "commenter_lname": "Adams", "comment_length": 492}, {"text": "South Dakota and several other states urge the TTB to continue to evaluate methods and standards to differentiate between roll-your-own tobacco and pipe tobacco and to publish rulemaking proposals on this subject for public comment in the near future.", "comment_id": "TTB-2009-0002-0016", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0016", "comment_date": "2009-09-23", "comment_time": "04:00:00", "commenter_fname": "Bobbi", "commenter_lname": "Rank", "comment_length": 251}, {"text": "Comments filed on behalf of Altadis USA, Inc.", "comment_id": "TTB-2009-0002-0021", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0021", "comment_date": "2009-10-29", "comment_time": "04:00:00", "commenter_fname": "Barry", "commenter_lname": "Schaevitz", "comment_length": 45}, {"text": "Comment regarding Notice No. 95 filed on behalf of John Middleton, Co., maker of pipe tobacco and cigars, by its counsel, Harold N. Bynum of the Smith Moore Leatherwood law firm in Greensboro, NC.", "comment_id": "TTB-2009-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0006", "comment_date": "2009-08-17", "comment_time": "04:00:00", "commenter_fname": "Harold", "commenter_lname": "Bynum", "comment_length": 206}, {"text": "National Tobacco comments on proposed CHIPRA regulations", "comment_id": "TTB-2009-0002-0015", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0015", "comment_date": "2009-09-15", "comment_time": "04:00:00", "commenter_fname": "James", "commenter_lname": "Horgan", "comment_length": 56}, {"text": "Comment from Venable, LLP, regarding Notice No. 95 proposed rules regarding tobacco processors.", "comment_id": "TTB-2009-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0008", "comment_date": "2009-08-18", "comment_time": "04:00:00", "commenter_fname": "Andrew", "commenter_lname": "Bigart", "comment_length": 100}, {"text": "Comment from Altadis USA, Inc. submitted by Peter Buck Feller, Esq., Bethesda, Maryland", "comment_id": "TTB-2009-0002-0025", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0025", "comment_date": "2009-12-07", "comment_time": "05:00:00", "commenter_fname": "Pe", "commenter_lname": "Feller", "comment_length": 87}, {"text": "I have smoked a pack a day for 35 years. I purchased an e-cig and have not had a cigarette in 87 days, and as long as I have my e-cig, I will never go back to smoking. The e-cig is a life saver for thousands of people and me. I am grateful every day for this new thing. I purchased it as a way to cut down on the expense of cigarettes, and ended up just giving tobacco up.The e-cig consists of a battery, an atomizer, and a cartridge which gets filled with juice made from propylene glycol-a common consumer product, water, flavoring, and different strengths of nicotine including 0 mg. It does not kill 400,000+ people a year, or create the thousands of cancer causing toxins produced by burning tobacco. There is no second hand smoke, and the initial cost of the e-cig kit of $50.00-$100.00 makes it unattractive to kids. Its a costly investment, one most likely made by a serious adult smoker who would like to cut down or quit.By banning this product, it will be back to using cancer causing cigarettes for many who have finally found a method that will get them away from tobacco. Doesnt everyone want smokers to quit smoking? I dont know of anyone who wants me or anyone to smoke. I hope that the FDA doesnt want anyone to smoke either.", "comment_id": "TTB-2009-0002-0004", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2009-0002-0004", "comment_date": "2009-08-05", "comment_time": "04:00:00", "commenter_fname": "Karen", "commenter_lname": "Fletcher", "comment_length": 1367}]}, {"id": "DEA-2023-0028", "agency": "DEA", "title": "Expansion of Induction of Buprenorphine via Telemedicine Encounter (DEA948)", "update_date": "2023-07-27", "update_time": "17:37:58", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "As a telemedicine OUD provider, I strongly oppose the DEAs proposal to require an in-person visit for buprenorphine prescription. This is a high-barrier imposition in an era when primary care is increasingly hard to find. There is a complete lack of evidence for in-person visits improving patient outcomes or preventing diversion. This rule will do an immense amount of harm for patients who are most vulnerable as those are the patients who are least able to complete this unneeded task. ", "comment_id": "DEA-2023-0028-2693", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2693", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "J", "commenter_lname": "Craig", "comment_length": 495}, {"text": "Bicycle Health has changed my life. I abused pain pills since I was 16 yrs old due to a dysfunctional home environment. I am now 38 years old with a 6 yr old autistic son. During Covid and due to my sond behavior I couldnt take the stress and emotional pain anymore and had no where to turn. I started taking Norcos again to help me cope, well sooner than later I needed more and more and it was killing my budget. Mind you all of my immediate family has passed away except for my 67 yr old mother who is not equipped to take my son for me. I cried out to God what do I do!??? I dont want to be on pain pills and I have no way to rehab because no one can take my son (he is nonverbal and Im a single mom) Bicycle Health Team saved my life. I was able to communicate and get help via video and get kind and compassionate help. Please do not enforce a rule or law that would cost so many their lives. ", "comment_id": "DEA-2023-0028-2696", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2696", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Rebecca", "commenter_lname": "Devilbiss", "comment_length": 914}, {"text": "With a medication like buprenorphine, access should be limited as little as possible. Because of the unprecedented rise in opioid related overdoses, drug users should have as much access to regulated safer options like buprenorphine at all times. One should not need a prescription to access this medication. Its not unreasonable for distribution to be monitored, however, especially when considering the ultra-potent opioids that currently keep the illicit market afloat, excessive purchasing of buprenorphine might not indicate illicit redistribution; but the necessary regimen for someone with OUD and an unreasonably high tolerance to live unimpaired. One might argue that increasing access to this extent would increase use among individuals who arent dealing with OUD, however, even in the case that someone who hasnt previously used opioids becomes dependent on buprenorphine, it is a far safer alternative to opioids available from the illicit market. That is ignoring the fact that in many areas, opioids are already available over the counter; like loperamide and tianeptine. Opioids are already readily available to people who dont have a prescription (or a reason to have one), thus more ready access to a reasonably potent opioid like buprenorphine would only serve as a means of harm reduction; allowing anybody who wishes to use an opioid for whatever reason, to do so with a safe, reliable product that is produced within legal regulations, it would slow down the production of novel synthetic opioids created to replace holes in the illicit market, due to a lower demand because of safer access. there are far more benefits to having a legal, easily obtainable substance than one that is prohibited. Looking at alcohol, the situation is almost entirely identical. During prohibition, the purchase of alcohol was made more dangerous because users had to participate in an unregulated market, alcohol that was available was often produced under poor/no regulations and often contained harmful substances like methanol which would result in a deadlier product for users. People can drink themselves to death; and will, whether alcohol is legal, or illegal. The same situation exists with a drug like heroin. People have used opioids for thousands of years, and according to statistics, will continue to do so despite prohibition. If heroin is illegal, the product on the market will be tainted and more dangerous; causing more deaths by overdose. If heroin is legal, the dea can regulate the production of the drug and make sure anyone who uses it is doing so in a far safer environment with a far safer product. legalize and regulate drugs. drug prohibition was created with racist intent and kills people. bye", "comment_id": "DEA-2023-0028-2697", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2697", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Patrick", "commenter_lname": "Blount", "comment_length": 2725}, {"text": "In reference to Docket No. DEA-948, please do not restrict access to treatment for opioid use disorder. Peoples lives depend on this assistance. Thank you!", "comment_id": "DEA-2023-0028-2701", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2701", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 155}, {"text": "Please do not take telehealth away!!!  The impact that it will have on the elderly, people without transportation, folks scared to leave their homes, etc.  PLEASE THINK ABOUT THE WRONG DECISION YOU ARE MAKING!!!!!!!!!!!!", "comment_id": "DEA-2023-0028-2709", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2709", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 220}, {"text": "Ive been on a telehealth plan for approximately two years, which has greatly improved my quality of living.  They took baseline bloodtests, prescribed TRT, gonadotropin and an antiestrogen.  Approximately 6 months later we ran blood tests again, made a few small adjustments and everything has been stable the past year.This has led to a much improved quality of life while not requiring monthly, or even quarterly, visits as the prescription is working as planned.  No different than thyroid and many, many other prescriptions.  Once blood markers and the body are in a stable state, there is no reason to meet with a Doctor on a monthly, or even quarterly, basis unless I am feeling off, or a blood test shows an adjustment is necessary.The requirement to see a Doctor every month for TRT is an unnecessary pressure on the medical system and an unnecessary cost to many insurance plans.  ", "comment_id": "DEA-2023-0028-2723", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2723", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Chad", "commenter_lname": "Anderson", "comment_length": 915}, {"text": "To Whom it May Concern:I am a registered nurse in New York State and I work at a clinic that practices Harm Reduction and prescribes buprenorphine products to individuals with opioid dependence all over the state. Being able to treat these patients via telemedicine has allowed us to help not only individuals in our county but those across the entire state. Many people with OUD face other challenges, such as having low to no income, making transportation access very difficult. Some of our patients live several hours away and would not be able to make it to our clinic for an in-person appointment. Being able to complete these appointments exclusively over telemedicine allows us to prescribe buprenorphine, a life-saving medication, to hundreds of individuals who otherwise would not have access. I strongly encourage you to not mandate in-person appointments for individuals receiving MAT for OUD as this would cause many of our patients to loose access to this medication that has the ability to transform someones life for the better.Thank you for considering this comment.", "comment_id": "DEA-2023-0028-2726", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2726", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1102}, {"text": "Hello, my name is Chris Baker and I was addicted to opioids over 25 years, I had my Dr. help get me off them and he prescribed Methadone, and I overdosed on that drug too even though I took it as prescribed. Im an American Indian and my body doesnt like hard drugs but I have a chronic pain condition so I need something for the pain. I moved to Florida around 6 years ago and heard about Suboxone to get you off the opiate drugs, I have now been on it for 5 years and in the last year been getting it via video conference with my Doc, there is no doctor near me that can prescribe Suboxone and I need it to stay off the opiate addiction that I have. This is the only way I can get my Suboxone and I am disabled and this is way more convenient for me as I have health issues now, please dont take this away from me, I dont know what I would do without it. I would probably go get some pills and get addicted all over again, I cannot take a second round of this, it almost killed me several times!! If you have any questions just contact me. Thank You for your time!!Chris Baker ", "comment_id": "DEA-2023-0028-2741", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2741", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Chris", "commenter_lname": "Baker", "comment_length": 1143}, {"text": "Ive been prescribed pain meds for 24 year Ive done a two year sentence and a 7 year sentence because of my addiction I found tele health the very day I got released from doing 7 years in prison clean for those 7 years I still had cravings tele health has saved my life and job because I dont have to chose my job or taking a 2 hour round trip to got to a clinic to get dosed before I go to work its very hard and you end up losing one or both. Tele health makes it easy and has support groups to attend please dont change the way tele health is going it saves peoples lives and I am one of those people thank you", "comment_id": "DEA-2023-0028-2742", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2742", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 654}, {"text": "I am writing to advocate amending Docket No. DEA-948, which would add an in-person requirement to all telehealth prescriptions of buprenorphine for opioid use disorder (OUD). As written, this rule defies evidence-based practice and will prevent critical medical care to those who need it most. Telemedicine delivered by appropriately licensed addiction treatment professionals is one of our best -- and only -- safe, affordable, available tools for fighting the worsening national overdose crisis.As an employee at a telemedicine company providing evidence-based care for individuals suffering from opioid use disorder, Ive seen first-hand the challenges our patients face accessing care. A requirement for an in-person visit would not serve to protect these patients, but rather to prevent them from accessing life-saving treatment. The vast majority of our patients have Medicaid, and they experience wait times well above 6 weeks  sometimes as much as 6 months  to access in person care. In addition, these patients already face barriers such as income or inability to take time off work, geography, lack of transportation, and lack of childcare. These patients  those that face the biggest challenges  have been the ones least considered in formulating this rule.It is imperative that the DEA reconsider its position. If it does not, the consequences will be catastrophic for these patients.", "comment_id": "DEA-2023-0028-2743", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2743", "comment_date": "2023-03-31", "comment_time": "04:00:00", "commenter_fname": "Pia", "commenter_lname": "S", "comment_length": 1455}]}, {"id": "FDA-2015-N-1514", "agency": "FDA", "title": "Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products", "update_date": "2023-01-05", "update_time": "11:27:36", "purpose": "Rulemaking", "keywords": ["2015-196", "Nicotine Exposure Warnings", "Child-Resistant Packaging", "Liquid Nicotine, Nicotine-Containing E-Liquid(s)", "Other Tobacco Products", "Request for Comments", "open", "Advance notice of proposed rulemaking", "FD&C Act", "2015-723", "Bryant M. Godfrey or Courtney S. Smith,", "Center for Tobacco Products", "extension of comment period"], "comments": [{"text": "RAI Services Company (RAIS) Comments: Docket No. FDA-2015-N-1514, 80 Fed. Reg. 37,555 (Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments) ", "comment_id": "FDA-2015-N-1514-0274", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0274", "comment_date": "2015-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 272}, {"text": "I am commenting on ANPRM Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products (Docket No. FDA-2015-N-1514)I am opposed to this FDA over-regulation of life saving products intended for adults only that wish to enjoy a facsimili of smoking without the harm associated with it. Ecigarettes are a consumer product, not a tobacco or drug product.  Created as an alternative way for consumers to enjoy their vices without the known dangers of other products that have been on the market.  The freedom to choose is my number one priority. I believe in the fair market, private property rights, business owners rights  individual rights to choose whats right for the individual.  The regulatory agency is repugnant to our Constitution.  I support the industrys mandates on child resistant caps, proper labels, use at your own risk warnings, and I respect their innovations that improve their products.  These are common sense rules, which are easily implanted state by state through the leadership of the industry  consumers.  Innovation should remain free and unimpeded by government over-reach such as this regulatory agency. Thank you for your conscience and concern. ", "comment_id": "FDA-2015-N-1514-0434", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0434", "comment_date": "2015-10-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1340}, {"text": "As a pediatrician, I am writing to urge the U.S. Food and Drug Administration (FDA) to quickly develop and implement new regulations on e-cigarettes and their liquid nicotine refills.  I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.  If you go to stores liquid nicotine for e-cigarettes is seen in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.  It is often within arms reach of young children.  It is often shelved close to other more child friendly products.   When these materials come home they become even more available to young children.  Currently there is  no federal requirement that liquid nicotine containers have child-resistant packaging.  We know that child-resistant packaging is among the most effective methods for protecting children, and especially small children, from poisoning hazards.  The FDA has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning.   So please protect children by requiring child-resistant packaging, the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Robert Gunther, MD MPH FAAP", "comment_id": "FDA-2015-N-1514-0320", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0320", "comment_date": "2015-09-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1877}, {"text": "Unfortunately as we have seen the teen smoking rates in the US decline in the last few years, we have watched the significant increase in teen use of e-cigarettes.  Teen usage rates tripled between 2013 (4.5%) and 2014 (13.4%).  Despite the hard work of programs like the one I work with, Reality Check (anti-tobacco youth program in New York State) to raise awareness about the harms of smoking and tobacco use, with few regulations on e-cigarettes our youth see these products as a safer and less harmful alternative than traditional tobacco products.It is unfortunate that the e-cigarette makers can use the same aggressive and targeted tactics that traditional tobacco companies used for years to target our youth, without the regulations that have been placed on the big tobacco companies.Tobacco related illness is the leading cause of preventable death in the United States, tobacco control programs across the country have gotten so close to helping end this public health epidemic with smoking rates at an all-time low, our fight continues as we now have to tackle the unregulated e-cigarettes.  It would be due diligence to our youth and children to protect them through nicotine exposure warnings and child-resistant packaging and to treat these products in the same way as any other tobacco product, a hazard to public health.", "comment_id": "FDA-2015-N-1514-0376", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0376", "comment_date": "2015-09-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1363}, {"text": "Has I long term smoker I found that quitting was hard to do until I started vaping. I work with a lot of people on a daily basis and when they ask if I smoke I tell them I quit and started vaping. Is it safer in the long run yes since I quit I have noticed that its easier to do things that was hard when I was smoking cigarettes. Now my question  is would you sit in front of a fog machine filled with all the chemicals in a cigarette or something that smells good, safer for everyone around you? Personally I cant stand the smell from a cigarette anymore!!! I know a couple of different makers of fluid and they are the safer then the tobacco industry.", "comment_id": "FDA-2015-N-1514-0435", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0435", "comment_date": "2015-10-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 664}, {"text": "As a pediatrician, I urge the FDA to take swift action to protect children from liquid nicotine poisoning.I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.Liquid nicotine for e-cigarettes comes in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.E-cigarette use continues to increase dramatically, exposing more and more children to this alarming poisoning hazard. A recent study of people who use e-cigarettes and live in households with children showed just how ubiquitous these products have become and how easily accessible they are to children. 36% of those surveyed did not use child-resistant packaging or otherwise lock up liquid nicotine in containers that were difficult for children to access, and 13% reported storing liquid nicotine on an open counter. There is currently no federal requirement that liquid nicotine containers have child-resistant packaging.Child-resistant packaging is among the most effective and time-tested methods for protecting children, and especially small children, from poisoning hazards.The Food and Drug Administration (FDA) has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning. The FDA must publish a proposed rule as soon as possible requiring child-resistant packaging, including flow restrictors, and nicotine exposure warnings that specifically highlight the risk of harm to children on liquid nicotine containers. The FDA should also consider other measures to protect children from the harms of liquid nicotine poisoning, including the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Please act quickly to prevent further harm to children.", "comment_id": "FDA-2015-N-1514-0278", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0278", "comment_date": "2015-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2900}, {"text": "As an advocate for child health and well-being, I wholeheartedly support the potential FDA regulation of liquid nicotine packaging. Liquid nicotine is highly toxic; one 36 mg/mL bottle could kill four toddlers. The bright colors and flavors attract the young children to accidentally ingest the harmful substance. As liquid nicotine and e-cigarettes become more popular to adults trying to quit smoking, children will be at more risk. Support those who aim to quit smoking by protecting children from a new kind of harm. ", "comment_id": "FDA-2015-N-1514-0408", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0408", "comment_date": "2015-09-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 521}, {"text": "I am commenting on ANPRM Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products (Docket No. FDA-2015-N-1514).  I am an ecigarette user, and this has allowed me to stay tobacco free since 12/31/2011.  This is the longest that I have not used tobacco since I was an adolescent (Age 11).  I am currently 47.  I do not consider myself a smoker any longer, and believe that it is a mistake by those that want to categorize me as a tobacco user.  I feel better, breathe better, and have maintained a healthy weight since stopping tobacco.  I tried several times to kick the habit before, and had not been successful until I tried ecigarettes.  It is unfortunate that much of what is said concerning these devices appears to have its origins from those that stand to lose money as a result of their use rather than relying upon evidence that is not slanted. Since I began, I have discovered a community of vapers and organizations that successfully advocate for safety.  CASAA (The Consumer Advocates for Smoke-free Alternatives Association) is an organization that also helps in not only advocating for our rights, but insist on safety.  Most every company I know (I do not belong, nor have I belonged to an ecig company) has warnings and has child resistant packaging.  These companies (Vapor Stores {I do not buy from convenience stores only vapor stores} also do not allow purchases by minors.Thank You", "comment_id": "FDA-2015-N-1514-0392", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0392", "comment_date": "2015-09-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1504}, {"text": "As a pediatrician, I urge the FDA to take swift action to protect children from liquid nicotine poisoning.I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.Liquid nicotine for e-cigarettes comes in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.E-cigarette use continues to increase dramatically, exposing more and more children to this alarming poisoning hazard. A recent study of people who use e-cigarettes and live in households with children showed just how ubiquitous these products have become and how easily accessible they are to children. 36% of those surveyed did not use child-resistant packaging or otherwise lock up liquid nicotine in containers that were difficult for children to access, and 13% reported storing liquid nicotine on an open counter. There is currently no federal requirement that liquid nicotine containers have child-resistant packaging.Child-resistant packaging is among the most effective and time-tested methods for protecting children, and especially small children, from poisoning hazards.The Food and Drug Administration (FDA) has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning. The FDA must publish a proposed rule as soon as possible requiring child-resistant packaging, including flow restrictors, and nicotine exposure warnings that specifically highlight the risk of harm to children on liquid nicotine containers. The FDA should also consider other measures to protect children from the harms of liquid nicotine poisoning, including the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Please act quickly to prevent further harm to children.", "comment_id": "FDA-2015-N-1514-0336", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0336", "comment_date": "2015-09-30", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2905}, {"text": "No need for  child proof packaging . Been vaping for 5 months now. And never been more healthier. Bottles cone with a childproof cap already with warning labels. Just people need to be 18 years of age. Thats it", "comment_id": "FDA-2015-N-1514-0439", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0439", "comment_date": "2015-10-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 215}]}, {"id": "DEA-2016-0019", "agency": "DEA", "title": "Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical", "update_date": "2021-12-02", "update_time": "01:00:57", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "As a public health practitioner who does work on drug addiction and treatment, I support the DEAs pending regulation to designate alpha-phenylacetoacetonitrile and its isomers and salts as List I chemicals.Drug abuse and addiction in America has reached such epidemic proportions that the Surgeon General recently released a report titled Facing Addiction in America1. The year 2014 saw 27,100,000 current drug users and 47,055 drug overdose deaths, more than any previous year on record1. As the Surgeon General report so candidly, and correctly, states about drug addiction, the accumulated costs to the individual, the family, and the community are staggering...1. Simply trying to decrease addiction by treating those addicted is not enough. We need to prevent people from becoming addicted in the first place. The best way to achieve this is by decreasing drug supply.Alpha-phenylacetoacetonitrile (APAAN) is a chemical compound that is a non-scheduled precursor chemical pre-precursor to manufacture methamphetamine2. As other precursors around the world become more regulated and harder to supply, APAAN has become the replacement of choice among many criminal organizations2. Currently, APAAN has no recognized legitimate use outside of small quantities used in research and development and laboratory analytical purposes3.  Authorities now believe that traffickers in the Americas are turning to non-scheduled precursor chemicals to manufacture methamphetamine through alternative methods2. In fact, APAAN as a methamphetamine pre-precursor has become so popular that a Google search for alpha-phenylacetoacetonitrile uses returns multiple results on the very first page for how to use APAAN to manufacture phenyl-2-propanone, a precursor for manufacture of methamphetamine. Clearly something has to be done to decrease the illicit supply of APAAN in order to decrease the supply of methamphetamine in the US.The DEAs category of List I chemicals was established by the Chemical Diversion and Trafficking Act in 1988. These laws provide a system of regulatory controls and criminal sanctions to address both domestic and international diversion of important chemicals without interrupting access to chemicals destined for legitimate commerce4. While burdensome regulations can cause harm to the economy, this proposed rule regarding APAAN regulation would carry only minimal economic risks due to the low number of licit uses for APAAN. For those small numbers of institutions and personnel burdened by this regulation, it would be a small price to pay in return for decreasing rates of drug addiction in the US. Criminals and drug traffickers are creative, albeit misguided, people. You only have to look as far as the introduction of the shake and bake method of methamphetamine manufacture to understand how creative some drug manufacturers are. The only way to stay one step ahead of them is being creative ourselves about how to decrease the supply of illicit drugs. A great way to do that is by cutting off their precursors and pre-precursors for their drug manufacturing operations. You cannot make drugs if you do not have any of the ingredients. Its as simple as that.Drug addiction in the US has reached epidemic proportions. It kills people, destroys lives, wrecks families, and burdens society with the costs of increased law enforcement and health care expenditures1. A primary function of government is to protect the health and well-being of its citizens. Therefore the government has a role to play in fighting this battle against this addiction epidemic ravaging large swaths of America. Preventing people from becoming addicted in the first place would be far more effective at achieving this goal than treating people after the fact. In order to do that, the illicit drug supply must be decreased, and restricting the ingredients has been shown to make it harder for drug manufacturers to keep up supply. To that end, and as a public health professional, I support the DEAs proposed regulation to designate alpha-phenylacetoacetonitrile as List I Chemical.", "comment_id": "DEA-2016-0019-0003", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0019-0003", "comment_date": "2016-12-20", "comment_time": "05:00:00", "commenter_fname": "M. kyle", "commenter_lname": "Graham", "comment_length": 4342}]}, {"id": "FDA-2014-N-0374", "agency": "FDA", "title": "Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics; Public Meeting; Request for Comments", "update_date": "2017-03-24", "update_time": "11:37:47", "purpose": "Nonrulemaking", "keywords": ["cder", "cder201424"], "comments": [{"text": "I want to thank the FDA for inviting me to this important stakeholders meeting.  My 2 cents in no particular order:1. I commend the FDA and the industry partners for tackling this issue.  We all recognize the critical issues we are discussed.  Id like to acknowledge the tremendous amount of work already done and left to do.2. If I ask myself the fundamental question, do I believe these studies will move the field forward?  The answer is an emphatic YES!.  3. Do I believe these studies will provide the definitive answers to all the questions in this area?  The answer is a resounding NO!  However, this gives us researchers and funders reason to continue to address the questions raised.  4. My concerns were articulated beautifully by other stakeholders/meeting participants.  The philosophical bent of these studies was an almost exclusive focus on the harms of these medications.  And very limited attention to the potential benefits.  While this leaning towards harms really addresses important questions, there is the wonderful opportunity to address more questions.  In the current framing, the answers will likely help the FDA from a regulatory standpoint and industry to meet the postmarketing requirements.  But have limited influence on clinical decision making and possibly unintended consequences by focusing exclusively on harms.  I worry that the current environment were become even more opioiphobic among prescribers and lead to restricted access to opioids for pain sufferers that benefit from them.  5. question:  I may have missed it, but I did not hear the rationale for the ambitious timelines to conduct the studies.6. An opportunity to triagulate data sources and incorporate qualitative data might be considered especially for the doctor/pharmacy shopping study.  A better understanding of drug seeking could benefit from talking with patients (qualitative data collection).  What is the patients view of this concept?  ", "comment_id": "FDA-2014-N-0374-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0374-0009", "comment_date": "2017-03-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2043}, {"text": "Subject: Marketing and discussion of home-brew (i.e., non-approved) urine testing on FDA property without any discussion of severe limitations.I watched the public meeting via the webcast feature.  Dr. Passik  an employee of a urine lab  touted the use of expensive mass spectrometry-based urine testing without revealing its severe limitations. Others, perhaps ignorant of these limitations, made statements that cannot be supported with evidence. In order to protect FDAs reputation as an evidence-based institution, I provide the information that follows. While I could provide an exhaustive and lengthy summary of the medical literature, the federal court case noted below is succinct and accurate.In a case called Millennium Laboratories, Inc. v. Ameritox, Ltd., 924 F. Supp. 2d 594 (D. Md. 2013), between two of the largest laboratories in the United States performing urine drug testing, Millennium Laboratories, Inc. and Ameritox, Ltd., the Court noted that:By processing patients urine samples through sophisticated laboratory equipment, Millennium and Ameritox can provide doctors with considerable information.  Their tests can determine the presence (and, by necessary implication, absence) of the prescribed pain mediation and a wide variety of other drugs, whether prescription, non-prescription, legal, or illegal. The test can also quantify the amount of pain medication or its metabolite present in the urine.Even using this advanced technology, however, UDT [urine drug testing] has its limitations.  First, it provides only a snapshot of current drug use; drugs and their metabolites remain in a persons urine only for so long.  Additionally, because individuals metabolize drugs at different rates, UDT cannot determine the dosage taken by the patient or when he took the dosage.  During the litigation, Millennium and Ameritox agreed that UDT can determine whether certain drugs are present or absent, but it cannot determine prescription compliance.Id. at 597-598.", "comment_id": "FDA-2014-N-0374-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0374-0005", "comment_date": "2017-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2071}]}, {"id": "FDA-2010-P-0093", "agency": "FDA", "title": "Follow-Up the July 22, 2009 Press Release and Press Conference Regarding E-cigarettes or Electronic Cigarettes", "update_date": "2022-01-05", "update_time": "01:03:55", "purpose": "Nonrulemaking", "keywords": ["E-cigarettes", "electronic cigarettes", "tobacco product", "nicotine", "vaporizers", "CTP"], "comments": [{"text": "The FDAs July 22, 2009 press conference about e-cigarettes was construed by many to be strongly negative and misleading; however, nearly seven years later, it appears that the expressed concerns about the safety of e-cigarettes and their ability to attract large numbers of teens to nicotine use were valid after-all. The FDA needs to classify e-cigarettes as tobacco products and not cessation devices. FDA has regulatory authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. We urge the FDA to finalize the rule to bring additional tobacco products such as e-cigarettes, hookahs, and some or all cigars under that same authority.Data from the 2015 National Youth Tobacco Survey show that 3 million middle and high school students were current users of e-cigarettes in 2015, up from 2.46 million in 2014. The National Youth tobacco survey is a school-based, self-administered questionnaire given to more than 22,000 middle and high school students in 2014.  In 2014, e-cigarettes became the most commonly used tobacco product among youth surpassing conventional cigarettes. Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year. During 2011 through 2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.Staff with Advancing Tobacco-Free Communities in Delaware, Otsego and Schoharie Counties (ATFC-DOS) in New York State have also seen and been told about an increase in local youth use e-cigarettes as they pursue Reality Check youth engagement initiatives in area communities. We are disturbed by the dramatic increase in e-cigarette use among our rural youth populations whether it be at the middle school, high school or college level. We know that no form of youth tobacco use is safe.E-cigarettes are now the most commonly used tobacco product among youth, and use continues to climb, according to CDC Director Tom Frieden, M.D., M.P.H. Nicotine is an addictive drug and use during adolescence may cause lasting harm to brain development.The increase in the use of e-cigarettes by U.S. youth in recent years has gone hand-in-hand with a corresponding increase in e-cigarette advertising expenditures. During 2011 to 2014, current e-cigarette use among high school students soared from 1.5% to 13.4%, and among middle school students from 0.6% to 3.9%. Spending on e-cigarette advertising rose from $6.4 million in 2011 to an estimated $115 million in 2014.The FDA remains deeply concerned about the overall high rate at which children and adolescents use tobacco products, including novel products such as e-cigarettes and hookah, said Mitch Zeller, J.D., director of the FDAs Center for Tobacco Products. Finalizing the rule to bring additional products under the agencys tobacco authority is one of our highest priorities, and we look forward to a day in the near future when such products are properly regulated and responsibly marketed.Corinne Graffunder, Dr.P.H., M.P.H., director of CDCs Office on Smoking and Health said We know about 90 percent of all adult smokers first try cigarettes as teens. Fully implementing proven tobacco control strategies could prevent another generation of Americans from suffering from tobacco-related diseases and premature deaths.Brian King, Ph.D., deputy director for research translation in the CDCs Office on Smoking and Health asserts that The unrestricted marketing of e-cigarettes and dramatic increases in their use by youth could reverse decades of progress in preventing tobacco use among youth.", "comment_id": "FDA-2010-P-0093-0053", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0053", "comment_date": "2016-08-31", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3947}, {"text": "Ecigarettes have given me a new lease on life - plain and simple. It doesnt get much better than that. 37 years on tobacco and finally stopped entirely by switching to ecigs over a period of 2 months from first ecig to last tobacco cig. I will not restate all the political, legal and moral issues behind the government crusade to stamp out ecigs other than to say it is rooted in ignorance and based on power, money and protecting the status quo. The result of the government using the FDA to systematically eliminate ecigarettes from the marketplace while leaving tobacco product sales untouched is at best criminally negligent and at worst, murder in the first degree. I remain, an enthusiastic and vocal advocate for the widespread use of electronic cigarettes as an alternative to tobacco for the millions of long term committed smokers such as myself who have choosen this alternative. Ralph Woodin", "comment_id": "FDA-2010-P-0093-0045", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0045", "comment_date": "2010-09-24", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 914}, {"text": "I am a 55 year old female who has been smoking cigarettes for over 35 years. I have tried to quit using cigarettes since experiencing shortness of breath, asthma, and numerous respiratory diseases over the last 10 years.  Of all the ways I have tried - hypnosis, gums, patches, accupuncture, lozenges - the electronic cigarette is the FIRST time I have been able to comfortable and successfully quit inhaling tar, chemicals, and particulate matter into my lungs.  I can breath easier, sleep, the asthma is much less severe, and the shortness of breath is going away.Please, I need these devices to be easily available, affordable, and without hindrance to my personal choice to quit smoking tobacco.  If the FDA is being purchased by the tobacco and cigarette industry, I implore you to refuse the corporate influence and instead think of people like me - those who have been enslaved for years and finally have a chance to quit.", "comment_id": "FDA-2010-P-0093-0027", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0027", "comment_date": "2010-03-29", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 939}, {"text": "I have been a smoker for 25 years.  I have tried every available NRT and pharmaceutical method of quitting on the market.  Not one of them worked for more than a few weeks, with some of them having EXTREME side effects.  The personal vaporizer (electronic cigarette) worked INCREDIBLY well and has kept me off of cigarettes with almost no discomfort for over 6 months now.", "comment_id": "FDA-2010-P-0093-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0022", "comment_date": "2010-03-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 372}, {"text": "FDA: Correct your misleading press statements from last year about electronic cigarettes.", "comment_id": "FDA-2010-P-0093-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0021", "comment_date": "2010-03-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 89}, {"text": "In my six months of Vaping Ive NOT smoked 7,920 regular cigarettes.  Not a single one, havnt touched them since the day I purchased a e-cig. Should I continue using an e-cig the Joye 510 specifically, and I have Every intention of doing so I will NOT smoke 15,840 cigarettes in 2010.  At the age of 26 if I live to be 90, I will NOT smoke 1,013,760 cancer causing filled with tar nasty smelling cigarettes. I will NOT smoke 1,013,760 cigarettes. Not because of the pill or the patch or the gum nor cold turkey, Ive tried all of those several times and failed each and every time.  I will NOT smoke 1,013,760 cigarettes because of the life saving E-cig.  AND I FEEL BETTER ALREADY!", "comment_id": "FDA-2010-P-0093-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0031", "comment_date": "2010-04-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 735}, {"text": "Please classify e-cigarettes as a tobacco product!!!!!", "comment_id": "FDA-2010-P-0093-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0046", "comment_date": "2010-11-18", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 54}, {"text": "I have been smoking for over 50 years and never believed that I could quit.  I purchased V4L e cigarettes and have successfully stopped smoking tobacco cigarettes, as well as having a diminished need to smoke even the e cigarettes.  I see a point in the future that I will no longer even use the electronic cigarettes.   This has been a God send for me, health wise and socially acceptable.  It would be a crime to do anything to discourage the sale and use of e cigarettes ... my health and interaction with non smokers has dramatically improved.Jo-An Torres", "comment_id": "FDA-2010-P-0093-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0019", "comment_date": "2010-03-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 584}, {"text": "signed", "comment_id": "FDA-2010-P-0093-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0024", "comment_date": "2010-03-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 6}, {"text": "The FDA lab report (http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf) has been cited in numerous news stories as proof that smoking tobacco cigarettes is less hazardous than using an electornic cigarette.As a result, countless smokers who were considering substituting vaporized nicotine for inhaling tobacco smoke decided to continuing inhaling tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens along with their nicotine.  I sincerely hope that this was an unintended consequence.   The harm that has been done is incalculable.  Do the right thing.  If it is too embarassaing to print the truth about the study conducted in May 2009, then conduct a new study.  Compare the output from an electronic cigarette to the smoke from an equivalent number of tobacco cigarettes.  Provide what was missing in the May 2009 toxicology report:  quantitative analysis.  Smokers should be told that 20 cigarettes deliver 5,500 to 11,000 ng/g of TSNAs, compared to 8 ng/g in a 16 mg. cartridge from an e-cigarette.  Smokers should be told the substances (and quantities) delivered by smoke that are absent in the vaporized nicotine.Tell the public that although this product cannot be declared safe in an absolute sense, it is thousands of times less hazardous than continued smoking.", "comment_id": "FDA-2010-P-0093-0035", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2010-P-0093-0035", "comment_date": "2010-04-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1386}]}, {"id": "CMS-2008-0122", "agency": "CMS", "title": "Revisions to the\r\nMedicare Advantage and Prescription\r\nDrug Benefit Programs", "update_date": "2021-04-21", "update_time": "01:00:55", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I was placed into a Medicare Advantage program (Medicare Blue Plus PFFS)by my ex-employer on Jan1, 2008.  I am 70 years old and was on plain Medicare with BCBSM Medigap provided by my ex-employer (BCBS Michigan) upon my retirement.I had no choice in the matter. I see that permanent residence is required to be enrolled in a Medicare Advantage program.  I have not resided in the Michigan area for 10 years.  I am currently residing in St. Marys,GA and received most of my medical care in Jacksonville, Florida.I have read these regulations fairly thoroughly, and no where do I find that I could be forced into an MA program.  All that I read states that enrollment must be initiated or at least confirmed by the potential enrollee.There are very few providers in Jacksonville who accept MA.  Only 2 hospitals (one of which is the local emergency/charity hospital).  BCBSM cant provide me with a list of providers who will accept this MA insurance. I could spend days trying to find a provider of a specific speciality, if I have to call them all myself, explain the program and see if they will accept it.It seems that if permanent residence in the state (Michigan) is required to enroll in their program is required, how could I be forced into the program when my permanent residence is St. Marys, GA and has been for 10 years.I have had cancer 4 times, and have had cardiac problems. I was being treated by oncologists and cardiologists in Jacksonville.  All that changed on Jan. 1, 2008.  I had to find a new oncologist, a new hospital (Shands) and a surgeon for the CA related surgery I needed in April.  Now I am searching for a dermatologist, since the one I have had for 6 years will not accept the MA insurance.  BCBSM cannot tell me who will accept the insurance.I strongly suggest that you add something to the regulations which prohibits forcing enrollment into the program. It should be strictly voluntary and only for residents of the state where the program is initiated.  And that the opportunity to disenroll  will not depend on the threat of dropping the Medigap coverage by an ex-employer.  That would be blackmail and what was told would happen if I disenrolled in the MA program.You may contact me by replying to this e-mail, or a white pages search", "comment_id": "CMS-2008-0122-0059", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0059", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2472}, {"text": "I am a long time agent in my mid forties, having worked in the insurance business for nearly 20 years.  I have ALWAYS had my clients best interest at heart, and it has ALWAYS been a struggle to do the right thing when you see unscrupulous agents making hundreds of thousands of dollars by doing the wrong thing.  But now with these new regulations, especially the fact that all 1st year commissions are going to be paid ONLY for new enrollees, and all others will be paid at renewal rates, it is going to run honest hard working agents like me out of the business.Lets take a specific example: I sell all of the leading companies (Humana, United HC, Aetna, AARP, BCBS, etc.) and a client who takes 12 different medicines that change often needs a prescription plan.  I spend more than 2 hours researching the literally 56 drug plans availabe in Texas for 2008 and he buys a Humana PDP.  I got paid a whopping $50 commission and continue to have to help my client whenever there is a prescription problem, so I have a service issue all the time, making my phone ring off of the wall.  Add to that, that when 2009 offerings come out, I need to re shop his list, and make the tweaks of the changes in his medicines, and reshop it with the literally 50 PDP plans available for 2009.  So if I were to sell him Humana again (or just leave him with them) I was making a whole $15. for the 2nd year renewal commission.  That $15 doesnt even pay the gas to drive round trip to many of these clients home, let alone pay me to be able to take the time it deserves to shop the case properly for the client.  Now Im told that if I take an existing client from one PDP to another, Ill get only renewal commissions, which are by far too small to make a living. Inocent clients will be suffering because you have taken away all of the good agents by cutting commissions to a level that makes it not a feasable what to make a living.  I feel betrayed by CMS and think that this whole business is messed up and that the regulators have little care about whats best for the whole lot of us.  I can NOT STAY IN BUSINESS with pay structures as horrible as these, and dont think that Im the only one.  This whole country will be suffering from no one being able to help them figure out the maze of options, because the CMS decided to over regulate.  FOR GODs SAKE, an agent working a booth at a Walmart cant even ask the prospect that comes up to them if anyone has helped them figure out their Medicare options for the following year, how messed up is that?  Seniors need proding, they often have no idea how to ask.  Thats another example of how ridiculous this mess is.  I only wish there were more I could say to bring through my feelings of disgust for the whole mess.  Ive no idea how you all can sleep at night dealing with matters such as this with such a dis incentive to agents.  Did you all not even get the a broad spectrum of agents from the real world involved in your research to figure better what to stay in the Medicare segment to help people who need help?  I pity the United States if this is where we are headed. ", "comment_id": "CMS-2008-0122-0085", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0085", "comment_date": "2008-11-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3362}, {"text": "Response to Medicare Marketing GuidelinesWe are writing to express our concern about the recent Medicare Marketing Guidelines.  Our organization, DaVita VillageHealth, operates Medicare Advantage Chronic Special Needs Plans for beneficiaries with End Stage Renal Disease.  In addition, we operate a Medicare demonstration program for ESRD which also utilizes the Chronic Special Needs Plan business model.  When Medicare Advantage Special Needs Plans (SNPs) were authorized by the Congress, they were intended to provide specialized, tailored care to beneficiaries with severe and disabling chronic conditions.  CMS intent was to have these plans focus on specific high-needs populations and provide benefits and care management services not available through traditional Medicare.  In the case of Chronic Special Needs Plans, there was further hope that these targeted plans could facilitate greater integration between providers, filling the gaps in care that are commonly experienced by beneficiaries with one or more chronic illnesses.  The goal for SNPs was improved clinical outcomes and lower total costs through their highly targeted approaches.  The recent Medicare Marketing Guidelines reflect a desire to protect beneficiaries from inappropriate behavior by MA plans, which we appreciate and applaud.  However, these guidelines run directly counter to the founding principles for Chronic SNPs, which are fundamentally different from other MA plans.  Under the guidelines, Chronic SNPs face unique challenges to successfully expanding participation in their high-value programs. At DaVita VillageHealth, we specifically focus on beneficiaries with ESRD, who have even more unique and urgent needs.  ESRD patients need to receive life-saving dialysis treatments three times per week, and usually spend up to four hours in the dialysis facility during each treatment.  Their needs and experiences are different from those of other Medicare beneficiaries, and as a result, only Chronic Special Needs Plans with specifically approved waivers may enroll ESRD patients.  Our comment addresses the following aspects of the Medicare Marketing Guidelines: \uf0a7Marketing Through Unsolicited Contacts\uf0a7Scope of Appointments\uf0a7Sales/Marketing in Health Care SettingsMarketing through Unsolicited Contacts 42 CFR 422.2268(d) and 423.2268(d) -- CMS 4131-F The prohibition on marketing through unsolicited contacts is particularly challenging to the operations of our Chronic Special Needs Plans.  There are only 350,000 Medicare dialysis patients in the United States.  Our marketing efforts must therefore be highly targeted  it is not efficient for us to participate in mass advertising, given the low number of eligible patients in any one geography.  If we are unable to conduct targeted telemarketing activities, the only avenue available to let potential enrollees know about the plan is through direct mail. However, we desire to ensure patients fully understand the components of a Special Needs Plan, and do not feel that mail is the best forum for such a communication.  The demographics of dialysis patients also make targeted telemarketing especially critical for ESRD SNPs.  Many of our potential enrollees face literacy difficulties, and many others speak a primary language other than English.  In addition, many beneficiaries do not have permanent addresses, making it difficult for us to reach them by mail.  For the majority of ESRD beneficiaries, brief contact by phone enables us to provide clearer, more comprehensive information and more effectively reach those who could benefit from the program.    Therefore, we request that Chronic Special Needs Plans be able to contact potential enrollees by phone.  In order to ensure beneficiary protection, we will submit a script to CMS for approval and use this script for all outgoing calls.  Scope of Appointments 42 CFR 422.2268(g) and (h); 423.2268(g) and (h) -- CMS 4138-IFC The Medicare marketing guidelines also require that plans document the potential enrollees agreement to the scope of any marketing appointment.  The guidelines emphasize that no lines of business other than that agreed to by the beneficiary may be discussed at the appointment.  However, our offer ESRD patients only our Chronic Special Needs Plans; there is no risk of cross-selling.  This guideline will therefore only result in unneeded administrative activities given how few beneficiaries we typically seek to enroll, the relative impact of this guidelines associated administrative costs (particularly the installation of recording software) is significant.Therefore, we request that Chronic Special Needs Plans that offer only one product or line of business be exempted from the requirement to document the scope of marketing appointments.  We believe that such a change would not decrease the level of beneficiary protection that CMS has intended to provide, but would eliminate unnecessary administrative burden upon single-product organizations. Sales/Marketing in Health Care Settings 42 CFR 422.2268 (k) and 423.2268(k) -- CMS 4131-F Dialysis patients are unique even among those with severe chronic conditions.  In order to sustain life, they must undergo dialysis treatments three times per week, and typically spend up to four hours in a dialysis facility at each treatment.  The dialysis facility is a source of information to patients about their treatment, lifestyle and nutritional behaviors, and insurance.  Therefore, the dialysis facility, where ESRD patients spend the vast majority of their time, is where they seek critical, reliable information.In addition, dialysis facilities themselves are unlike many other health care settings.  In order to be accessible to beneficiaries, they are frequently located in low-income areas and are generally modest stand-alone facilities that do not have lobbies or common cafeterias.  Dialysis clinics usually consist of treatment floors, waiting rooms, offices, and a break room for staff.  Most do not contain patient-accessible conference rooms or other common areas.  According to Section 42 CFR 422.2268 (k) and 423.2268(k) of CMS 4131-F, Chronic Special Needs Plans are unable to market to potential beneficiaries in the waiting rooms of dialysis facilities.  Since dialysis facilities are unlike other health care settings and often do not have patient-accessible common areas, this would greatly restrict beneficiaries ability to learn about or participate in the new special needs programs now available to them.   We thank CMS for understanding the special nature of dialysis facilities and for thus providing flexibility to our ESRD Chronic Special Needs Plans with respect to conducting marketing activities at dialysis facilities. *********ESRD is severe and debilitating, has high mortality and risk of hospitalization, and is usually accompanied by multiple co-morbidities.  Because of the tremendous needs of ESRD patients and their potential to benefit from care management, this is exactly the kind of condition for which Special Needs Plans were intended.   We appreciate the support CMS has consistently provides to our ESRD Chronic Special Needs Plans, and hope that CMS will again take our comments above into consideration before finalizing its regulations.Sincerely, Jess ParksGeneral Manager, VillageHealth ", "comment_id": "CMS-2008-0122-0088", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0088", "comment_date": "2008-11-21", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 8170}, {"text": "This note goes to CMS. I can see by the Catagory above that as a health insurance agent you dont consider my opinion worthy enough to give us a seperate catagory. Maybe if you did, you wouldnt have the mess you have created involving the Medicare Advantage plans that you do. I applaud the attempt to levelize commissions to stop the churning. But just once, have you stopped to consider what is written in the Medicare and You handbook? You know, the part that tells the medicare recipients that they should review their plans each and every year? Well, as an agent who is true blue to his clients thats my job! If I find a better plan for my client then its my job to change them or churn them as you want to label it. I do understand there have been many agents doing this but Im not one of them. The mess you have created trying to solve another mess is not getting the job done. Maybe you should get the insurance companies to stop changing the plans every time you turn around and we wouldnt have to jump through hoops each and every year trying to help them. Standardize the plans just like the Medicare Supplements are if you want to stop this mess. And now, Representative Stark wants to limit my commissions? Get real! I wish someone from CMS would come down and work in the trenches with us then you might begin to understand what you put us through with no consideration that we are the ones that have to help these seniors in the way they need it! We are the ones that have to figure out from all of the possibilities what plans suit thier needs. And on top of that you give us just a very few days to figure it out! Not only that, but you do it near to the biggest holiday time of the year! Does this not seem a little ignorant to you? Please, Im begging, stop the insanity!", "comment_id": "CMS-2008-0122-0037", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0037", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1981}, {"text": "I am very glad to see that CMS is getting stricter with us, the producers of PDP and MAPD Plans.  However, there might still be an element out there that is disregarding all of the rules imposed by both the Federal as well as the State Government Regulatory entities.  There are still agents who are bringing in people from across the border from El Paso, Texas and getting them to market these plans by phone.  These people are unlicensed.  I believe that more secret shoppers are needed all over the country to be able to catch the law breakers.Thank You for getting stricter.I believe that eventually all of these plans will have to be standardize just like the medicare supplements were standardize several years ago.Who knows, if Obama gets in office we might just have the comrades from the kremlin take care of us.  What do you think?", "comment_id": "CMS-2008-0122-0045", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0045", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 921}, {"text": "This new Scope of Appointment form is not being well received by Medicare recipients.  Mostly I am hearing this is the most ridiculous thing Ive ever heard.  Dont they have something better to worry about than this.  I can understand filling one out for people that are not current clients but the ones that are clients already are counting on us to help them with all their options.  You really need to reevaluate this before 11/15 and quite worrying about commissions.  Believe it or not Insurance Agents also have families, utilities, gas bills, etc. just like everyone else.  We have 6 weeks to help anywhere from 300-700 clients, we sure dont need more paperwork.  You are only hurting the Medicare recipients because Agents do not have time for all these additional requirements and alot of them are going to be left without help.  ", "comment_id": "CMS-2008-0122-0055", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0055", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 943}, {"text": "As a life and health  insurance agent for 28 plus years, and a member of the National Association of Health Underwriters and also the National Association of Insurance and Financial Advisors, I feel that the most recent regulations imposed on health insurance agents marketing Medicare Part D and Medicare Advantange products are heavy handed at best and oppressive at worst.Members of the two professional insurance agent associations have very specific codes of ethics that all members thereof are expected to fulfill very seriously and conscientiously.  It appears to me that CMS is trying to make it so difficult to market the Medicare senior products of Medicare Part C and D that many agents will just chose to not go through the hastle involving time, money and long hours to jump through the hoops being imposed.  This will eventually lead to a bureacratic takeover of a national health insurance system that fails to provide qualified professional agents to advise their clients.  Telling an agent that he/she must wait 48 hours before a clients question can be answered or discussed because it hasnt been previously submitted as a subject to be discussed in the interview is pure foolishness.  This whole thing is a case of using a sledge hammer to kill a fly instead of a fly swatter!Walter J. Sexton,  LUTCF; Agent  OwnerSexton Insurance AgencyP. O. Box 445Franklin, KY 42135(270) 586-7746", "comment_id": "CMS-2008-0122-0061", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0061", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1575}, {"text": "Your Scope of Agreement Form is another brick wall for Seniors seeking help with their Medicare Options and gaining information about Medicare from agents that specialize in Medicare. You people make harder and harder for seniors to get help. Why do you keep making things harder for our Seniors? WHY? Isnt life complicated enough for them. STOP with your rules!!!!", "comment_id": "CMS-2008-0122-0065", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0065", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 412}, {"text": "Get off the insusrance agents back.  We are intitled to make a living.  We are not all crooks.  The same cannot be said about the congress. If you are going to cap agents commission, then are you going to cap the profits of the insurance companies?  How much did the BIG companies contribute to your campaigns?I know that AARP wields a lot of weight because of their contributions.", "comment_id": "CMS-2008-0122-0030", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0030", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 411}, {"text": "THE  SCOPE  OF  APPOINTMENT  FORM  IS  UNNECESSARY  BECAUSE  WE  ARE  COVERED  BY  THE  FREE  LOOK  PERIOD  ACCORDING  TO  WHAT  I  SEE..  YOU  ARE  MAKING  THINGS  TOO  DIFFICULT  FOR  THE  AVERAGE  CITIZEN  ...  YOU  MUST  BE  LISTENING  TO  THE  COMPLAINTS  OF  MAYBE  1%  AND  PUTTING  THE  REST  OF  US  THROUGH  MORE  TIME  SPENT  JUST  TRYING  TO  APPLY  FOR  THE  COVERAGE ...", "comment_id": "CMS-2008-0122-0046", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2008-0122-0046", "comment_date": "2008-11-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 421}]}, {"id": "TTB-2014-0006", "agency": "TTB", "title": "Establishment of the Fountaingrove District Viticultural Area", "update_date": "2015-02-24", "update_time": "14:53:25", "purpose": "Rulemaking", "keywords": ["alcohol", "wine", "American viticultural areas", "viticultural areas", "labeling", "Fountaingrove District", "Sonoma County", "California"], "comments": [{"text": "I support this new AVA.  This area of Sonoma County is quite distinctive as a wine growing region and has a lot of history, including wine history, behind the Fountaingrove name.   ", "comment_id": "TTB-2014-0006-0004", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2014-0006-0004", "comment_date": "2014-07-09", "comment_time": "04:00:00", "commenter_fname": "George", "commenter_lname": "Marek", "comment_length": 181}, {"text": "I support the Fountaingrove AVA. Im Japanese, and I admire what Kanaye Nagasawa had done in California.But his name is still unknown for most of the Japanese people, and only a few traces of his work remain in Sonoma now.I believe this new AVA will help his name to be known to more people, and also help Sonomas popularity for Japanese.", "comment_id": "TTB-2014-0006-0007", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2014-0006-0007", "comment_date": "2014-07-29", "comment_time": "04:00:00", "commenter_fname": "Andy", "commenter_lname": "Matsubara", "comment_length": 357}, {"text": "We are strongly supportive of establishing the new Fountaingrove District Viticultural Area.  This part of eastern Sonoma County is unique in its volcanic roots, elevation and influence by the Pacific Ocean. Wine grapes were grown on our property before prohibition. After rotating through prunes and walnuts, the land was once again planted to wine grapes in the mid 1990s.  We are very supportive of the new Fountaingrove District Viticultural Area both as growers and wine makers.Sincerely,Steve and Joan HellerHeller Family VineyardsHLR Cellars", "comment_id": "TTB-2014-0006-0006", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2014-0006-0006", "comment_date": "2014-07-29", "comment_time": "04:00:00", "commenter_fname": "Steven", "commenter_lname": "Heller", "comment_length": 595}, {"text": "Gentlemen:   We live at 1825 Riebli Rd., Santa Rosa, within the area of the proposed appelation.   This site has had grapes on it for over 125 years.  We have been growing wine grapes on it since 1989, and definitely think it would be appropriate for the area to have its own appelation.  It has a unique micro-climate that deserves to be identified separately from surrounding areas.   We support the proposal to designate the area as the Fountaingrove District Viticulture Area.Peter and Kathryn Boeck", "comment_id": "TTB-2014-0006-0005", "comment_url": "https://api.regulations.gov/v4/comments/TTB-2014-0006-0005", "comment_date": "2014-07-15", "comment_time": "04:00:00", "commenter_fname": "Peter", "commenter_lname": "Boeck", "comment_length": 548}]}, {"id": "DOT-OST-1996-1533", "agency": "DOT", "title": "Final Rule - Amendment to Definition of \"Substance Abuse Professional\"", "update_date": "2015-07-29", "update_time": "08:33:47", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am a licensed LPC and would like to see LPCs added to the list of eligible providers to conduct SAP assessments. MFTs have been added. Licensed professional counselors are licensed in all 50 states, have a minimum of a masters degree in psychology or counseling or a related field, and meet educational and experiential requirements. I conduct non-DOT assessments currently, and would like to be able to join the SAP provider pool.I have extensive experience treating clients with substance abuse issues. ", "comment_id": "DOT-OST-1996-1533-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-1996-1533-0002", "comment_date": "2015-07-29", "comment_time": "04:00:00", "commenter_fname": "Marion", "commenter_lname": "Hecht", "comment_length": 522}]}, {"id": "EPA-HQ-OARM-2018-0065", "agency": "EPA", "title": "Drug Testing for Contractor Employees (Renewal)", "update_date": "2022-10-14", "update_time": "11:37:46", "purpose": "Nonrulemaking", "keywords": ["Drug testing for contractor employees"], "comments": [{"text": "I support the passing of the regulation to make Drug Testing for Contractor Employee.  Working under influence can be hazardous and even deadly.  It is not only to the publics safety and also for the protection of the employees themselves.  Furthermore, since the contract has direct working relationship with government employees, the standard should be matching to ensure the quality of the employee is matching.", "comment_id": "EPA-HQ-OARM-2018-0065-0008", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OARM-2018-0065-0008", "comment_date": "2021-08-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 419}, {"text": "Im glad that EPA contractors will be tested for marijuana, cocaine, opiates, amphetamines, PCP, etc. But Im not sure that this goes far enough. It would also be good to drug test the EPA Administrator and his boss, President Tiny Hands. Now I know what youre thinking. President Tiny Hands doesnt even drink, so why should anyone suspect him of drug use? Well, perhaps the fact that he babbles like a deranged squirrel:I think Puerto Rico was incredibly successful. It was one of the best jobs thats ever been done with respect to what this is all about. - President Tiny Hands, September 11, 2018Riiiight. Incredibly successful = supplies dropped off on a runway but never used, a major electrical contact being given to one of Zinkes acquaintances, the power grid down for months, thousands of deaths, etc. The GAO found a long list of mistakes or problems. But President Tiny Hands looked at the same situation and saw nothing but good. Lets get the lab results and find out whether his problem is chemical or just garden variety imbecility.", "comment_id": "EPA-HQ-OARM-2018-0065-0004", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OARM-2018-0065-0004", "comment_date": "2018-09-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1128}]}, {"id": "FDA-2017-P-6918", "agency": "FDA", "title": "Requests that the FDA amend the FDA contraindication of codeine in children younger than 12 years old.; CLOSED", "update_date": "2023-08-14", "update_time": "08:50:58", "purpose": "Nonrulemaking", "keywords": ["CItizen Petition", "CDER", "St. Jude Children\u2019s Research Hospital", "amend the FDA contraindication of", "codeine in children younger than 12 years old", "CLOSED"], "comments": [{"text": "How is this possible? Why would the FDA deny cough medicine to children? They are very ill, some terminal. This is ludicrous! Codeine has been around for approximately 80 years. Are you going after the sick, disabled children now? Do you realize how this makes you look? You appear to be monsters! Monsters of the type I have never encountered in my 60 years on this planet. CHILDREN!!!", "comment_id": "FDA-2017-P-6918-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0020", "comment_date": "2018-07-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 386}, {"text": "This petition is well thought out and expressed.  Please note that the persons signing this, for the most part, are not affiliated with a pharmaceutical company, thereby avoiding conflicts of interest.The goal is simple:  to allow physicians to prescribe codeine to pediatric patients under certain conditions.Please consider these two points when evaluating this petition.", "comment_id": "FDA-2017-P-6918-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0019", "comment_date": "2018-07-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 393}, {"text": "When used in the correct patient populations, codeine with acetaminophen is a highly effective scheduled 3 agent. It would be a  serious detriment to lose this drug in our arsenal when treating sickle cell patients. ", "comment_id": "FDA-2017-P-6918-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0018", "comment_date": "2018-07-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 216}, {"text": "I support this citizen petition.", "comment_id": "FDA-2017-P-6918-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0017", "comment_date": "2018-07-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 32}, {"text": "Why are the children being forced to suffer, its bad enough the government has tortured millions with the  CDC GUIDELINES. Why do these precious children have to suffer more. I beg you please change the  way pain Is Treated today and let these children have some relief. Ive lost all hope in humanity now I beg you change these  awful rules.its the only way and the right thing to do. TY for your time", "comment_id": "FDA-2017-P-6918-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0021", "comment_date": "2018-07-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 428}]}, {"id": "DEA-2016-0003", "agency": "DEA", "title": "Temporary Placement of the Synthetic Cannabinoid MAB-CHMINACA into Schedule I", "update_date": "2021-12-02", "update_time": "01:00:56", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "The unrest , anxiety , apprehension and activists in our children is a failure of Teachers not educating the children Activist and bullies are pushing the unrest in our children by increase use of Online devices.  Teens users of social media sites and apps. 76%) of teens use social media. 92% of teens report going online daily, three-quarters (73%) of teens have a smartphone, African-American and Hispanic youth report going online with greater frequency than white teens. nearly all (93%) teens from homes earning more than $30,000 annually go online daily, 91% of teen cell owners use text messaging, (33%) of teens with cell phones use messaging apps, 46% of Hispanic teens and 47% of African-American teens using messaging apps, girls ages 15 to 17 are the most likely to pin, with 38% using online boards. (72%) of teens play video games online, 47% of teens talk with others over video connections.Some Asia nations are now restrict the use of online phone during school hour. America should do the same. Suspend teachers not educating the children. College should pay back the children if they can not find job. To get fire there needs to be a spark, the children spark has become online device. They are being target of activists. Bullys have gone from playgrounds to online.Restrict the use of online. Restrict the use of backpacks, to stop drugs, online devices and harm. American has laws for under age for drinking, driving, working, American should extend these laws to online use until the child are able to understand.", "comment_id": "DEA-2016-0003-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0007", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1571}, {"text": "More help must be given  to the Board Patrol.....    The Federal government spends a net amount of $45.8 billion on illegal aliens and their U.S.-born children. This amount includes expenditures for public education, medical care, justice enforcement initiatives, welfare programs and other miscellaneous costs. It also factors in the meager amount illegal aliens pay to the federal government in income, social security, Medicare and excise taxes.   The total cost of illegal immigration to U.S. taxpayers is both staggering and crippling. In 2013,  estimated the total cost to be approximately $113 billion. So, in under four years, the cost has risen nearly $3 billion. This is a disturbing and unsustainable trend. At the federal, state, and local levels, taxpayers shell out approximately $134.9 billion to cover the costs incurred by the presence of more than 12.5 million illegal aliens, and about 4.2 million citizen children of illegal aliens. That amounts to a tax burden of approximately $8,075 per illegal alien family member and a total of $116,000,000,000.   Demonstration Authorization Act of 1978,  Federal Advisory Committee Act of 1972 (FACA).  The national government should be deferential to the States when taking action that affects the policymaking discretion of the States and should act only with the greatest caution where State or local governments have identified uncertainties regarding the constitutional or statutory authority of the national government. With respect to Federal statutes and regulations administered by the States, the national government shall grant the States the maximum administrative discretion possible. Intrusive Federal oversight of State administration is neither necessary nor desirable. Required federal agencies must consult with state and local officials early in the process of developing proposed regulation where the regulation will impose substantial direct compliance costs on State and local governments and that is not required by statute.", "comment_id": "DEA-2016-0003-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0008", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2007}, {"text": "Redact all PERSONAL IDENTIFYING INFORMATIONTo quote the data provided from the DEA Proposed Rule on Placement of MAB-CHMINACA into Schedule 1, MAB-CHMINACA was associated with a cluster of 125 subjects who presented to emergency facilities within the Baton Rouge and Shreveport, Louisiana areas in October 2014...From October 2014 to the present, multiple clusters of overdoses involving MAB-CHMINACA and at least eight deaths attributed to the abuse of MAB-CHMINACA have been reported. Adverse health effects associated with these incidents involving MAB-CHMINACA have included: Seizures, coma, severe agitation, loss of motor control, loss of consciousness, difficulty breathing, altered mental status, and convulsions that in some cases resulted in death. One case report noted the presence of MAB-CHMINACA within the body fluids and tissue samples of a recently deceased individual. A subsequent case report concluded that synergistic toxicity of MAB-CHMINACA and another SC, 5-fluoro-ADB, led to death.  With this in mind, the National Institute for Drug Abuse mentions that manufacturers who create these synthetic cannabinoids try to side step the law by changing the chemical formula of them. How does the DEA plan on staying ahead of the manufacturing of synthetic cannabis? ", "comment_id": "DEA-2016-0003-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0009", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1344}, {"text": "The DEAs findings ignore the underlying issue revolving the substance which is the subject of the proposed rule. The abuse of the drug in question is not representative of the danger of the drug, as its use is a symptom of the Schedule 1 status of THC. The high potential of abuse that the DEA has found is a symptom of the Schedule 1 status of THC rather than a representation of the true abuse potential. The statistics cited by state public health entities are not compelling because they look at a two month time period in 2015. This is not a long enough time period to demonstrate a reliable factual finding. Further, public perception of THC and marijuana have significantly changed since 2015. As the DEA notes, the majority of the users of the drug at hand use it to circumvent the illegality of THC. As the use of THC is more acceptable now than in 2015, the rates of the use of this drug are likely to have dropped and thus these numbers do not relay the current potential for abuse. While there may be no current accepted medical use in treatment for the drug at hand, there has been a rapid increase in possible medical treatments involving THC. The drug here is so similar to THC that most medical treatments involving one can be substituted with the other. The rise of medicinal THC use demonstrates the possibility of a need for an alternative synthetic option. While there is a lack of accepted safety for the use of this drug under medical supervision, this is again not representative of the danger of the drug. The lack of accepted safe medical applications is a symptom of the fact that medical research of THC has been forbidden by the DEAs placement of THC on Schedule 1. Any possible medically supervised use will not come to light if this drug is similarly labelled Schedule 1. The DEA has incentive to label this drug Schedule 1 in an attempt to secure more funding for the agency in the future by stifling possible accepted medical uses.", "comment_id": "DEA-2016-0003-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0010", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Kyle", "commenter_lname": "Mclean", "comment_length": 2003}, {"text": "Ed dept. schools, agencies; should consider banning Backpacks of children in schools. Put all books online, and each student could have electronic pad or computer to access online subject. 1. the teachers would know no one is carrying anything that might harm our children. 2.reduces the high costs of books that a school or child pay.3. back packs are too heavy for most children.", "comment_id": "DEA-2016-0003-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0006", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 396}, {"text": "I sought out Red Lawhern once I learned he is trying to help Chronic Pain Patients continue our medicine regimen involving opioid products.You are doing us harm by restricting our Doctors from treating us with the most effective methods available. I am a person who is extremely sensitive to most medications. I have terrible side effects that sometimes last months. I would have to write a novel here if I were to accurately describe here all the medicines I have tried and the terrible side effects they produce. Always have been willing to try what the doctor orders, until the side effects caused harm to my body, also the stress it put on my family. I was a very successful insurance agency owner with multiple employees for 25 years. During that time I basically was used a guinea pig for different meds many, many times. One cannot imagine what my business days/family life were like during these trial and error efforts. Finally after about 20 years my doctors and I found a combination of medications that allow me to function, and even participate in life.I had a right hip replacement in 2011, everything went great. I was the model patient, I breezed through physical therapy....then about 7-8 months later things began to go awry. In the end my Rheumtlgst diagnosed me with osteo arthritis, and Fibromyalgia. The Fibro was likely brought on by the trauma to my body of the hip surgery. I went for over a year just sitting because every medication they threw at me caused terrible side effects. It just hurt too much I could not bring myself to do much of any thing. Then my pain mgmt doctor prescribed oxy, small dose of 5-325 4 times a day. The difference this made in my life waslife saving. I had been growing weaker and weaker.....THEN the oxy took enough of the pain away I actually started moving again after many months of just sitting.. Doing housework, some yard work, going out to see friends and relatives etc. I was able to begin aquatic therapy and graduated to using resistance tools in the water which has made me stronger, allows me to participate in life. A God send. I have never abused my meds, I am like the poster child for following the pain med. agreement my doctor had me sign. If ever I had a question about certain meds being prescribed to me by another doctor I always called pain mgmt. and either got permission or didnt to fill the script, and I followed the instructions from the pain mgmt doctor. I recently had a routine 6 mos. appt. with my primary care. I had hurt my neck/shoulder area and he prescribed Soma for a muscle spasm that was very painful and had not gone away with traditional treatments of ice and heat, and Nsaids over a period of 2 weeks. I am not supposed to take Nsaids due to Chronic Kidney disease, but I did because I was in a lot of pain. Mind you....I NEVER increased the amount of oxy prescribed to me during this time or ever. When the nurse handed me the script for Soma she said it was a controlled substance. We dropped it off at our pharmacy but told them to hold up on filling it until I could talk to pain mgmt. Pain mgmt. told me not to fill the script and I did not. I had to wait 5 days to get into see pain mgmt. When the PA walked in the first thing he said was they were discharging me because my urine specimen did not show the presence of oxy. I couldnt believe what I was hearing. I did not believe that to be the reason. In the past the PA had told me my urine sample failed to show the presence of oxy, but he just said it happens sometimes, not to worry about it. Since I take a low dose, and every once in a while I will not take oxy for a day or two that could very well explain the test results. I had a feeling he was upset that I accepted the Soma script even tho I did not fill it. He said he knew I did not fill it, however he told me rather abruptly my primary care doctor should have known better. I showed him the summary of my primary care visit that shows the primary care dr. knows about all the meds I take including pain mgmt. meds. He didnt care. My primary tried calling them twice but no return calls. My primary says he cant take over the script due to the climate on the opioid crisis. So, this is so difficult and depressing that I am back to sitting. This is not healthy, however the pain keeps me down. With meds my pain doesnt go away, however it does decrease it enough that I can tolerate activity. I am not a drug seeker. I worked 2 and 3 jobs in my twenties until I went into insurance, then that was just as hard on me as I was working many many hours to make sure my clients were treated properly. My business credo was Honesty above all else...and still is. I studied TaeKwonDo for 4 years. My husband and I raised our son who is now 27 who is successful in his endeavors and business. I am not a lazy drug seeker! Please stop to consider people like me, there are many. We are harmed by your irresponsible grouping us into the same category as drug addicts. HELP US!", "comment_id": "DEA-2016-0003-0005", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0003-0005", "comment_date": "2018-03-20", "comment_time": "04:00:00", "commenter_fname": "Cindy j", "commenter_lname": "Colbert-hock", "comment_length": 5052}]}, {"id": "FDA-2015-D-0404", "agency": "FDA", "title": "Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order", "update_date": "2015-08-28", "update_time": "13:10:11", "purpose": "Nonrulemaking", "keywords": ["No-Tobacco-Sale Order", "Compliance With an Order", "Tobacco Retailers", "open", "CTP", "2015-280", "Colleen Maschal", "Determination of the Period Covered by a", "Guidance for Tobacco Retailers", "Availability", "NTSOs"], "comments": [{"text": "These regulations are an important step towards curbing the sale of tobacco products to minors and ensuring compliance by retailers of tobacco products.   We support these regulations with slight amendments. Under these regulations, a retailer would be able to continue to sell electronic products containing nicotine, without repercussion, despite a no-tobacco-sale order.  Data collected by the State of Alaska has shown a four-fold increase in Alaskan adult use of e-cigarettes between 2010-2013.  Recent studies have also shown the dramatic rise in youth use of e-cigarettes and Alaska is no exception.  Many Alaskan youth have stories of their peers using e-cigarettes in class when their teachers are not looking and exhaling the aerosol down their shirts.  Without including e-products in the NTSO, the proposed regulations will not be as effective as needed.The proposed regulations also fall short by not requiring retailers to either cover tobacco products or remove them from the shelves.  There is also no requirement to inform customers of the NTSO.  Finally, The State of Alaska Synar program provides for stiffer penalties and more immediate enforcement of tobacco sale violations than these proposed regulations.  The FDAs proposed five violations before issuing a NTSO is too lenient.  Alaska imposes a NTSO of 30 days after a single violation during Synar compliance checks.  This will likely create confusion among retailers and may create miseducation that repeated violations are allowed prior to a consequence occurring, such as is proposed by these FDA regulations.", "comment_id": "FDA-2015-D-0404-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-0404-0003", "comment_date": "2015-07-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1603}]}, {"id": "NPS-2017-0001", "agency": "NPS", "title": "General Provisions, Electronic Cigarettes", "update_date": "2021-02-10", "update_time": "01:00:42", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "With all due respect it is past time for denying the science behind the safe factors surrounding vaping and second-hand vape.  This is not burning tobacco nor is it smoke.  The Royal College of Physicians are the latest peer reviewed, scientific study that states clearly there is zero harm, no harm to bystanders.  This backs up the 2015 findings from Public Health England, the Onasis Cancer Center, and many other scientific studies conducted over the past 9+ years.  We must quit overreacting and overregulating vaping, it is saving lives across this country and it saved my life 3.5 years ago.  It is time our government shares the actual truth about the real harms.  At least 95% safer than smoking and no harm to bystanders.  Beyond the millions of people living and breathing better thanks to switching the science is insurmountable at this point.  Smoking kills and vaping is helping drive the lowest smoking rates in the U.S. and around the globe.  Please stop treating us like smoking, it is VERY different and does not deserve or need the type of regulatory control smoking does. ", "comment_id": "NPS-2017-0001-0009", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0009", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1092}, {"text": "This is absolutely ridiculous! The reports by the FDA and Surgeon General have been debunked multiple times and criticized by Public Health Organizations, Advocated, Researchers, Scientists, etc from both the US and over seas. It has been proven that vaping is 95% safer than smoking cigarettes. There is absolutely no evidence of negative effects of second hand vaping, and vaping is not a public health threat to anyone! It has saved millions of lives worldwide! I really wish our government agencies would do some real research of the effects of vaping to see what the truth is! Watch the documentary A Billion Lives. Read some blogs and information about vaping and its effects. Here are a few sites you should check out for some true information! www.vapingwithmatt.comwww.lizardjuice.com/blogwww.churnmag.comwww.vaping360.comand many more! LEARN THE TRUTH ABOUT VAPING AND STOP THE STUPIDITY! ", "comment_id": "NPS-2017-0001-0013", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0013", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 946}, {"text": "I believe this is a smart policy. I have experienced negative side effects from second hand vape smoke including asthma and pain in my lungs. I support this.", "comment_id": "NPS-2017-0001-0002", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0002", "comment_date": "2017-01-06", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 157}, {"text": "Vapers are trying to better their lives and the lives they/we impact because of our smoking cigarettes (to include wildlife from discarded butts.)Banning Vape devices will lend to the use of cigarettes again, thus increasing the likelyhood of more fires and debris being discarded throughout the parks that you are surely used to seeing in the past. You jumping on the cigarette manufacturers bandwagon will only help them to complete their ultimate goal(s) of the progression of cigarette distribution and destruction of human and animal life alike.", "comment_id": "NPS-2017-0001-0010", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0010", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 575}, {"text": "Can we ban perfumes well we are at it?  They smell bad, trigger migraines and send me into an allergic fit.  Sound absurd?  So does this proposed rule.  We are talking about the great outdoors, are we not?  These are not combustible products that will cause forrest fires, nor leave unsightly butts littered across the landscape of our nations great parks.  These are alternatives to traditional tobacco that people use to keep from smoking; a product the Royal College of Physicians have embraced as being 95% safer than combustible tobacco.  ", "comment_id": "NPS-2017-0001-0012", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0012", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 549}, {"text": "As someone who uses these parks often, I cannot believe this. Vaping has done nothing but help keep our parks clean! Cigarette butts in our parks are huge problems, vaping is helping this greatly! Please oppose this bill and allow vaping to help keep our parks clean!", "comment_id": "NPS-2017-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0017", "comment_date": "2017-01-18", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 267}, {"text": "The vaping community needs to stop making claims that vaping and or use of nicotine is safe. As a public health professional I see  no evidence to support that vaping is safe, and to the contrary, every month there is more evidence that shows that burning flavored products creates ultrafine particles that are hazardous and that there is little to no research on the safety of burning the flavors added to these products.Use of them by the public (or employees) is not as safe as breathing clean air.  Isnt breathing clean air one of the reasons we visit National Parks?", "comment_id": "NPS-2017-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0019", "comment_date": "2017-01-23", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 586}, {"text": "I am a 46 year old mother of 4. I started smoking roughly 36 years ago! I stopped smoking 3 years ago in favor of vaping. I felt so strongly about the benefits of these devices that i quit my job and started working for our local vape shop to help educate traditional smokers on the things that big tobacco and government dont want them to know....that these devices work and are WAY safer than traditional cigs. The FDA has made a call (a seriously BAD one) that jeopardizes the lives of MILLIONS of its American citizens! As vapors, we pray that the new administration will look at these devices in a more scientific, serious and fair way! I propose there be NO FURTHER REGULATIONS ON VAPING UNTIL THE NEW ADMINISTRATION HAS TIME TO MAKE THEIR OWN EVALUATION THAT IS NOT TAINTED BY BAD SCIENCE AND/OR BAD POLITICS! Telling people they can not vape in a National park or anywhere else for that matter is the same as not allowing people to drink coffee in those same places! Nicotine is in the same class and schedule as caffeine and ***NEWS FLASH*** Nicotine in cigs is NOT what can kill you! The carcinogens do that along with all the other chemicals that the combustion causes! Our government officials need to get a clue, do their own research and stop giving INCORRECT and BIASED information to its citizens in the name of public health and safety!", "comment_id": "NPS-2017-0001-0003", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0003", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1373}, {"text": "Tobacco poses a known, severe public health hazard, killing hundreds of thousands of people in the US every year, tens of thousands of whom dont even smoke. Electronic cigarettes are not known to present the same hazardwhile studies continue, theres already reason to think they do not. They dont emit the same products of combustion, and even where they do emit known harmful substances, the concentrations are orders of magnitude lower than from tobaccoconcentrations not known to be harmful.They are not in the same risk category, and should not be treated the same. Im not arguing electronic cigarette usage should be completely unrestrainedjust that restrictions should be proportionate to known problems, not moral panic.Other side effects of electronic cigarettes:1. Less odor, which doesnt glue itself to skin, hair, and clothes the way tobacco smoke does.2. Less litter, since electronic cigarettes dont produce ash or leave filters to be tossed on the ground.3. No fire, under normal circumstances. (Under abnormal circumstances, lots of things become fire hazards.)Lumping them in with tobacco is a mistake.", "comment_id": "NPS-2017-0001-0016", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0016", "comment_date": "2017-01-18", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1198}, {"text": "As a public health professional it is encouraging to see that the National Park Service is proposing to include e-cigarettes in its smoking policy. The current policy on smoking is one that I welcomed as someone who visits National Parks every year. Our Parks are sanctuaries that preserve and protect the natural beauty that America is renowned for. Visitors come from all over the world to experience the many wonders our parks have to offer, and to breathe in the fresh, clean air of our grasslands, forests, mountains, coastlines, and deserts. Because they are relatively new, we cannot, yet, fully understand what the long-term effects of electronic cigarettes will be; however, preliminary reports have shown them to contain toxic ingredients which cause illness. Studies of e-cigarettes have found chemical substances and ultrafine particles (known to be toxic, carcinogenic, and/or to cause respiratory and heart distress) in e-cigarette aerosols, cartridges, refill liquids and environmental emissions (Williams et al., 2013). Furthermore, there have been many instances of these devices exploding, causing grave injury and property damage.  As a mother who loves to visit the parks with my children I am concerned that if electronic cigarette use is permitted, my children and others will be involuntarily exposed to potentially dangerous emissions. There is also a danger that the nicotine liquid and e-cigarette aerosols could pose a threat to our protected wildlife and waterways. And finally, I am concerned that the widespread use of e-cigarettes at National Parks will renormalize tobacco use, and reverse the progress that has been made by reducing public tobacco use. When tobacco use is seen as normal it leads to more children smoking (Gilpin, 2004; Bauer, 2005).  Diane MooreBauer JE, Hyland A, Li Q, Steger C, Cummings KM. A longitudinal assessment of the impact of smoke-free worksite policies on tobacco use. American Journal of Public Health 2005;95(6):1024-9.  Gilpin EA, Lee L, Pierce JP. Changes in population attitudes about where smoking should not be allowed: California versus the rest of the U.S.A. Tobacco Control 2004;13(1):38-44.  Monique Williams et al., Metal and Silicate Particles Including NanoparticlesAre Present in Electronic Cigarette Cartomizer Fluid and Aerosol, 8 PLOS ONE e57987 (2013); TobaccoProduct Deeming Rule, supra note 2, at 29029.", "comment_id": "NPS-2017-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/NPS-2017-0001-0007", "comment_date": "2017-01-12", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2465}]}, {"id": "FAA-2022-0098", "agency": "FAA", "title": "MCAI-2021-01084-T Airbus SAS Model A350-941 and -1041 airplanes. Correct adjustment and locking of load sensing drive struts (LSDS) and drive struts (DS).", "update_date": "2022-06-22", "update_time": "12:28:32", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "This proposed Airworthiness Directive submitted by the FAA is crucial in ensuring the integrity of Airbus SAS Model A350-941 and -1041 load-sensing drive struts. This directive will facilitate more effective inspections for both types throughout their time of service and will ensure that no drive struts are left in a condition that could lead to further complications. The establishment of this AD also establishes more consistency throughout the industry as it will support the respective EASA AD. With the presence of Delta A350 aircraft based out of American hubs, it is crucial that this Airworthiness Directive be existent for American inspectors and air carriers. The absence of this proposal would lead to a pertinent risk in aviation safety. It is also important to note the applicability of this inspection process on other Airbus production lines with a similar type to the A350 such as the A330neo. ", "comment_id": "FAA-2022-0098-0002", "comment_url": "https://api.regulations.gov/v4/comments/FAA-2022-0098-0002", "comment_date": "2022-02-10", "comment_time": "05:00:00", "commenter_fname": "James", "commenter_lname": "Miramontes", "comment_length": 912}]}, {"id": "FDA-2019-N-5973", "agency": "FDA", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Providers\u2019 Understanding of Opioid Analgesic Abuse Deterrent Formulations", "update_date": "2020-09-15", "update_time": "09:27:20", "purpose": "Nonrulemaking", "keywords": ["2019-958", "OO", "Notice", "Agency Information Collection Activities", "Proposed Collection", "Comment Request", "Health Care Providers\u2019 Understanding of Opioid", "Analgesic Abuse Deterrent Formulations", "OPEN"], "comments": [{"text": "I believe Phase 2 should include more pharmacists than 10% ratio. Also practitioners chosen should be based on greater prescribing habits. Those practitioners who are the larger rate of treating Chronic Non-Cancer pain with ADF Opioid should be the target of information gathering.", "comment_id": "FDA-2019-N-5973-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-N-5973-0004", "comment_date": "2020-02-28", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 281}]}, {"id": "CDC-2008-0002", "agency": "CDC", "title": "Medical Examination of Aliens \u2013 Revisions to Medical Screening Process", "update_date": "2014-01-10", "update_time": "20:36:31", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I am writing to comment on the proposed changes to the medical screeningrequirements for admittance to the United States.  I urge you to remove therequirement that aliens be negative for HIV for short-term visits to the UnitedStates.  The current policy, refusing entry even for short visits for peoplewith HIV, does not make sense in todays world.  It is known that HIV hasspecific methods of transmission, and the likelihood that an HIV-positiveforeign visitor would present an unusual risk of disease is extremely low.  Inan economy that is currently struggling, it is not a good idea to refusevisitors who present a low risk, or to discourage visitors who are HIV-negative,but visit other places that do not place harsh restrictions.Additionally, it is extremely close to the change in administration, and I urgeyou to postpone the publication of the final rule until after the newadministration is in place in late January, 2009.  Because this issue is of asensitive and foreign relations matter, the new administration should weigh inon it.Thank you.", "comment_id": "CDC-2008-0002-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2008-0002-0004", "comment_date": "2009-02-10", "comment_time": "05:00:00", "commenter_fname": "Susan", "commenter_lname": "Debardeleben", "comment_length": 1146}, {"text": "The CDC has indicated that this rule will not affect medical examinations of aliens in the U.S.  A plain language reading of section 212(a)(1) of the Immigration and Nationality Act, and 42 C.F.R. 34.1, 34.3(a)(1), do not support this conclusion.  Even so, this rule would create a dangerous precedent, perhaps one that the CDC did not intend to happen.   The CDC is creating a double standard: an alien in the U.S. with a newly identified disease would not be found inadmissible but an alien overseas with the same disease would be found inadmissible.  Such a conclusion does not support the intent of the immigration and public health laws.  Aliens in the U.S. are no less of a danger to the public health.  Rather, they are more of a danger as they are already in the U.S.  This rule would, among other things, encourage aliens to avoid overseas medical examinations and to find ways to illegally enter the U.S.  This rule does not address the issue of what the CDC and USCIS could or would do if an alien in the U.S. had a newly identified disease.  The CDC and USCIS must be ready, able and willing to deal with such a consequence.  Avoidance of the issue would threaten public health.The best approach to this issue would be to apply the same standards to medical examinations performed overseas and those in the U.S.  Whether aliens are overseas or in the U.S., the threat to public health is no different.  If the CDC truly intends to limit this rule to overseas medical examinations, then it should revise 42 C.F.R. 34 to clearly differentiate between overseas medical examinations and to those in the U.S.  Currently, 42 C.F.R. 34.3(c) contradicts the Immigration and Nationality Act and 42 C.F.R. 34.1, 34.3(a)(1).   For medical examinations in the U.S., the CDC should include an additional regulation to allow civil surgeons to discretionarily screen for newly identified diseases.  If this is not feasible, then the additional regulation should provide guidance if an alien in the U.S. has a newly identified disease.  While it may not be a common scenario now, it could be common in the future.", "comment_id": "CDC-2008-0002-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2008-0002-0002", "comment_date": "2009-02-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2239}]}, {"id": "FDA-2019-D-1536", "agency": "FDA", "title": "Opioid Analgesic Drugs:  Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability ", "update_date": "2020-02-26", "update_time": "15:13:28", "purpose": "Nonrulemaking", "keywords": ["2018-551", "CDER", "Guidance for Industry", "Opioid Analgesic Drugs", "Considerations for", "Benefit-Risk Assessment Framework", "Open"], "comments": [{"text": "Hello,I am another chronic pain patient who is paying the price for people who recreationally use opioids and become addicted. By now you know it is not those of us who are prescribed pain medicine and take it as directed by our physicians who become addicted. There is a very small chance of that, and it is not that the opioid is addictive, it is the persons genetics and social, economic, and personal history factors that determine this. This is why denying pain medicine for the population in general does not defeat addiction. The addict will find a replacement drug on the black market, meanwhile law abiding citizens are left to suffer.What I am asking the FDA to do, please emphasize that opioids are essential medicines, that the benefits outweigh the risks for most patients. The so called opioid epidemic has spread the false narrative that opioids only have risks but no benefits, this needs to be made clear that this is an overdose epidemic involving illicit substances, and polypharmacy. It is reckless use of taking opioids with alcohol, sedatives, cocaine, and multiple other substances that are killing people. Responsible people are paying the price for the recklessness of others. Opioids are valuable, and desperately needed, extremely beneficial medications for the majority of citizens. Again, please emphasize this!Sincerely, Donna Johnson", "comment_id": "FDA-2019-D-1536-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0022", "comment_date": "2019-08-20", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1399}, {"text": "Collegium written response to June 2019 FDA draft guidance Opioid Analgesic Drugs Considerations for Benefit-Risk Assessment FrameworkCollegium Pharmaceutical is a specialty pharmaceutical company committed to being the leader in responsible pain management. For nearly two decades, Collegium has been focused on developing and commercializing new medicines for pain management that reflect our core values and our commitment to people suffering from pain, providers and our communities.  As an integral part of our overall strategy we strongly believe in leading with science.  The result of those efforts is a portfolio consisting of Xtampza ER, Nucynta and Nucynta ER, three meaningfully differentiated medications to treat moderate to severe pain.  Collegium Pharmaceutical appreciates the FDAs recent actions in relation to the opioid crisis. These included the recent issuance of Draft Guidance to describe the benefit-risk assessment framework that the Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.  In particular, we agree with the Agency that, in light of the ongoing opioid crisis in the U.S., an assessment of opioid analgesic drugs should take into account the broader public health impact of such drugs, including consideration of risks related to misuse, abuse, opioid use disorder, accidental exposure, and overdose.  In doing so, it is equally important that the Agency take into consideration the legitimate need of millions of Americans for meaningful relief for their moderate to severe pain when alternative treatments are inadequate.  Collegium understands that opioid analgesics carry substantial risks.  We are dedicated to supporting responsible pain management that meets the needs of patients, healthcare professionals, and society.  We support FDAs conclusion that it is appropriate when making drug approval decisions to consider the benefits and risks of a product relative to other available analgesic therapies indicated for a specific condition.  We acknowledge that FDA has not historically required a showing of superiority to available therapies as a condition of approval under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.  355.  Although such superiority is not an express requirement for approval under section 505 and would not in most cases necessarily be warranted, we believe the language of the Act provides the Agency with adequate authority to require that sponsors of New Drug Applications (NDAs) for opioid drug products include comparative data in appropriate cases.  Specifically, Section 355(d) of the Act provides that FDA should deny approval of any NDA when the application does not include reports of investigations that establish whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.  It is well established that the term safe does not refer to absolute safety but rather requires the Agency to determine that the benefits of a drug product outweigh its known risks.  This determination cannot be made in a vacuum but implicitly requires consideration of, among other things, the public health landscape into which every proposed product will be launched.  Because of the substantial risks that opioid medications present not only to individual patients but also to their household members and their larger communities, it is reasonable for the Agency to conclude that new opioid medications that do not provide a meaningful clinical improvement over existing therapies cannot be viewed as sufficiently safe to merit approval.  Such a position would be entirely in keeping with FDAs mission to protect the public health.  Adopting such a position would strengthen the Draft Guidance (i.e., lines 155-157), enable the application of the benefit-risk framework, and provide clarity to sponsors. Collegium Pharmaceutical welcomes the opportunity to discuss these issues regarding the new Draft Guidance further with the FDA.  In closing, and as an organization dedicated to leading in responsible pain management, we strongly support the Draft Guidance and we believe that it will provide direction to industry in relation to the development of meaningfully differentiated opioid analgesic drugs.   ", "comment_id": "FDA-2019-D-1536-0026", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0026", "comment_date": "2019-08-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4420}, {"text": "Guidance to industry on criteria for risk-benefit assessment certainly seems called for in the review and approval process for opioid analgesic drugs.  But several fundamental problems are evident in the present draft phrasing of that guidance. The following issues require reconsideration in light of emerging knowledge.For existing opioid analgesics, todays medical patient is rarely tomorrows non-medical abuser. [1] Risk of opioid use disorder among actively managed medical patients is so low as to be difficult to measure.  Large scale studies of post-surgical patients prescribed opioids for the first time reveal incidence of Opioid Use Disorder (OUD) diagnoses of 0.6% or less for follow-up periods averaging 2.5 years. [2] This number is likely a maximum, since many diagnoses are recorded by GPs who lack current training in evaluating patient behaviors that define OUD.  Incidence of protracted opioid prescribing for 13 weeks or longer in post-surgical patients is also less than 1%.  Such prescribing may be more closely related to procedure failure than to properties of opioid analgesics per se.  Procedures where chronic prescribing is most often observed are also among those in which procedure failures and emergence of chronic pain are highest (e.g. total knee replacement).[3]There is no reliable relationship between rates of opioid prescribing by physicians versus rates of opioid overdose-related mortality from all sources (legal prescriptions, diversion of prescriptions, or illegal street drugs).  There has never been a relationship during the past 20 years.  CDC prescribing and demographics directly contradict any such relationship.  People over age 55 are prescribed opioids for pain two to three times more often than youth and young adults under age 25; but, age-adjusted overdose related mortality in seniors is the lowest of any age group and has been mostly stable for 20 years, while mortality in youth and young adults has skyrocketed to levels now six times higher than in seniors. [4],[5]A major missing dimension in the draft Framework must be addressed substantively if drug approvals are to be safe and reliable for the public.  Due to naturally occurring genetic polymorphism in six key liver enzymes, there can be no one size fits all minimum dose or risk threshold that applies to all patients. Some patients are natural hyper metabolizers of specific opioids, while others are poor metabolizers.  Thus there may be a broad natural range in minimum effective dose levels. [6]Finally, medical practice and ongoing drug approvals for both established and new opioid formulations must come to grips with emerging evidence that risks of opioid use disorder on short term exposure may be elevated among a small fraction of patients due to effects of an abnormality in the A118G gene.  [7]Emerging evidence of genetic factors in metabolism and mu-receptor response to all opioids has clear implications for the drug approval process.  To ensure patient safety, larger and longer trials are clearly needed, with more rigorous documentation of the variations in patient outcomes.  Approval of drugs based on 90 day trials in populations of less than 200 patients must become a thing of the past.  This change in policy must become explicit in Benefit Risk Frameworks which drive Industry investment in trials. References:[1] Singer JA, Sullum JZ, Shatman ME,  Todays nonmedical opioid users are not yesterdays patients; implications of data indicating stable rates of nonmedical use and pain reliever use disorder, Journal of Pain Research 2019:12 617620[2] Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018;360:j5790.[3] Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and risk factors for chronic opioid use among opioid-naive patients in the postoperative period. JAMA Intern Med. 2016;176(9):1286-1293.[4] Lawhern RA.Over Prescribing Did Not Cause the Opioid Crisis. Blog of Dr. Lynn Webster. Last updated April 5, 2019. http://www.lynnwebstermd.com/over-prescribing/.[5] Lawhern RA, Tucker JA. Analysis of US Opioid Mortality and ER Visit Data. Last updated April 2019. Available at: http://face-facts.org/atip/analysis-of-us-opioid-mortality-and-er-visit-data-v15-april-2019/. [6] Richeimer SH, Lee JJ,  Genetic Testing in Pain Medicine  The Future Is Coming , Practical Pain Management, Volume 16, Issue #8, August 8, 2017. Available at:  https://www.practicalpainmanagement.com/treatments/genetic-testing-pain-medicine-future-coming [7] Kline T, Opioid Facts  Are We Getting the Whole Picture?  - A Physicians Perspective,   Medium, June 14, 2019, https://medium.com/@ThomasKlineMD/opioid-facts-are-we-getting-the-whole-picture-a-physicians-perspective-67cc7e3b0d2e?fbclid=IwAR1uYeo1OXS2lVo0--IKFx5fP_BwmytUExjI65ZbJ2tfqGMvbjLHzHboDsc ", "comment_id": "FDA-2019-D-1536-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0004", "comment_date": "2019-07-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5054}, {"text": "Patients with intractable pain are careful with their meds or else they have no pain relief. Thats what gives us a life, not euphoria. We must sign a lengthy contract and if we violate it, we have no pain doctor. The addiction rate is proven to be 1%. The people overdosing on opioids are using heroin and illicit fentanyl. Thats been proven too. How do you explain the major decrease in prescriptions and continued increase in opioid overdose deaths? Its been found patients with chronic/intractable pain who are undertreated or not treated adequately with pain medication will eventually get so desperate due to the pain that they will seek out some type of pain relief whether prescription meds or street drugs. They are then labeled as drug seekers or addicts when they are not. They exhibit symptoms similar such as doctor shopping, stealing others prescriptions, lying or buying illegal street drugs. Even if these patients are prescribed medication in dosages that dont provide them adequate relief, they will still seek out relief. Many patients have had their lives ruined because doctors either dont believe them or dont treat their pain adequately with an appropriate dosage. It happened to me after my first cervical fusion surgery. My surgeon didnt believe me that my pain was worse after the surgery and documented in my medical records that I was a drug seeker even though I was his patient 8 months and never abused my medication. He never mentioned anything about addiction until I told him the pain was worse. I was accused of drug addiction for five years and forced into a detox/rehab program in order to save my RN/Nurse Practitioner license. However, once I completed it, I still wasnt believed and my pain wasnt treated at all. So for seven years , I was either untreated or under treated and I started doctor shopping. Finally a pharmacist intervened and recommended a physician who literally saved my life. I was started on a compounded pain medication with 40mg hydrocodone plus naloxone every six hours. I had adequate pain relief for the first time in eight years. I was finally able to go back to work. I eventually had three more neck surgeries and now have three fusions and another bulging disc. All the years of the rest of my spine working extra hard led to spinal arachnoiditis down my entire spine. My pain gradually increased over the years as did my medication dosages. I now have two neurostimulators and three years ago I had a fentanyl pain pump implanted. Ive also taken tizanidine, a muscle relaxant, it has ruined my teeth. I also had to quit working in 2007 which was devastating. I loved my career and I was one of the first Neonatal Nurse Practitioners licensed in the state of Texas. Anyone who truly knows about intractable pain knows that our brain works different than a drug addict in that we DO NOT experience euphoria, our pain receptors are busy concentrating on pain relief from the pain medication and not euphoria. The last comment about me Ill add is that Im pretty certain if my pain meds were stopped, I would definitely have a heart attack or a stroke because my blood pressure elevates to stroke level anytime my pain is excessive. Either that or Im sure Id consider suicide because I know I cant live like that....pain has already taken everything I ever loved. With intractable higher doses allow us to at least have a life, nothing compared to what we used to have though. Its better than laying in bed in extreme pain all the time. FDA states that they hear frequently from patients and providers about the need for higher doses. The patients need it for a decent life and the doctors feel like they cant do their job and treat their patients adequately. Statistics show complications in intractable pain patients is extremely low. There is a small amount of diversion, but we are very careful about our medication. The past three years of the patients horrific suffering, deaths and suicides should be enough to answer your questions. A lot of patients feel the CDC and DEA both are responsible with blood on their hands. Im including two short articles written by Red Lawhern PhD. He has dedicated his life to advocating for us. Please read them. https://www.statnews.com/2019/06/28/stop-persecuting-doctors-legitimately-prescribing-opioids-chronic-pain/ http://face-facts.org/lawhern/congress-clean-up-this-mess/", "comment_id": "FDA-2019-D-1536-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0013", "comment_date": "2019-07-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4416}, {"text": "Heres my story, short-version:I first started having chronic pain when I was 4 months pregnant with my son back in 2007. I toughed it out at first but I ended up seeing my PCP and rheumatologist  getting some treatment for RA  fibromyalgia.Then in 2009-2010, things got REALLY bad: it was eventually discovered that I had a 9-inch long benign hemangioma tumor going from the spinous process of T4 to my left shoulder blade, which was unbearably painful, but only one neurosurgeon believed me and did a T4 laminectomy  tumor resection. He said this tumor ended up eating away part of this protective coating around my spinal cord and that I would always be in pain from it. Well, the surgery was a success because it took care of most of the pain.Anyway, fast-forward to today:Ive got another aggressive vertebral hemangioma at T10, but once again, no doctor will believe that Im one of the rare 1% of patients with symptomatic vertebral hemangiomas! Ive been red-flagged, black-listed, called many different names (besides the usual drug-seeker  addict). Ive been screamed at by ER nurses (among other verbal abuse), verbally and even physically abused by EMTs (cant prove it, so theyve told me...), etc. The forced tapering off of very effective high dose opioid medications caused me to have a stroke in my early 30s. Afterwards, I lost my successful career and my life has spiraled downhill ever since this started 3-4 years ago.Today Ive got an OK pain doctor, but hes injection  procedure happy and has expressed fear of going to jail and such to me in the past. Hes reduced my meds to the point they barely touch the pain. 2 of my former pain doctors left pain management out of fear of DEA persecution and I dont blame them.Like Ive said before, I could write a book! This is just a basic outline of my story. If it werent for Kratom, I would already be dead because the constant pain I would feel without it just isnt compatible with life!I left out a lot, but I didnt want a ridiculously long post. My basic diagnoses not listed above: OA, DDD, possible CRPS/RSD (disputed by current PM doc), seizure disorder, hx of mild strokes, PE  other blood clots.It also took doctors 2 years to realize I needed a hysterectomy and a cholecystectomy...but they were too busy accusing me of drug-seeking to actually diagnose the real problems I was having. I almost died of sepsis from my gallbladder as they were wheeling me into an emergency cholecystectomy!No one deserves to be in unbearable pain, especially when patients like me were stable on them (opioids) for a very long time. Its inhumane and it directly goes against my Constitutional rights to life, liberty, and the pursuit of happiness.We desperately need to find a middle ground in which to prescribe and take opioids, and without government overreach and interference. Our physicians know what theyre doing!Thank you for listening!Sincerely,Christina Leann Nunn7108 Hardwood TrlDallas, TX 75249214-402-3319jarednunn10@gmail.com", "comment_id": "FDA-2019-D-1536-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0010", "comment_date": "2019-07-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3277}, {"text": "Can the FDA please compile a list of FDA approved drugs that are approved for the treatment of pain, especially post-surgical pain, that are NON-opioids and make this available to both physicians and patients so that informed decisions can be made regarding options for treating pain? A useful list would be one that lists all non-opioid FDA approved drugs that have an indication for the treatment of pain and a short explanation of what type of pain they can be used to treat. ", "comment_id": "FDA-2019-D-1536-0036", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0036", "comment_date": "2020-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 479}, {"text": "Ladies and gentlemen,Thank you for taking my comments, Im a pain patient dad has almost committed suicide four times because of the misapplication of the CDC guidelines.I think we must ask ourselves some questions when considering benefit risk assessment. Heres my take.Q. Is there an epidemic of opioid overdose death?A. Not really. They actually increase from 2014 to 2015 was in the line with years past a 0.001% increase. These are street overdose deaths in addiction communities, not in the general public. No particular year was significantly higher than the other.Q. Is addiction rare?A. Yes, the rate for the last hundred years has been steady at 0.5% ( today CDC reports 1 million heroin-addicted/320 million u.s. population = 0.5%).Q. Why are addiction rate staying the same with so many prescriptions we hear about?A. Opiate addiction ( not addiction to marijuana, cocaine or amphetaminesl) needs two things to trigger it: an opioid and the gene for addiction. No genes, no genes, no addiction.Q. Can a person become addicted by taking too much pain medication or for taking it for a long time?A. No, FDA scientist ruled both of these fears as being unfounded. Google FDA 2011-P-0818 to see the report. Once on the pain medicine, without becoming addicted immediately, you have virtually no chance of addiction from then on. No cases have been reported of addiction occurring in patients already taking opioid pain medication.Q. Do doctors prescribe too much opioid medicine per patient?   Shouldnt the number of prescriptions be limited? NoA. No, the concern is, higher doses cause more overdose deaths and addiction. The FDA has already ruled that this is not true (FDA 2012-P-0818).Q. Opioids given longer than 90 days dont work and can cause more pain, addiction and overdose.A. Not true. FDA review these arguments and found all three faults in 2013 (FDA 2012-P-0818) these scary assumptions are made up by Lunatic Fringe groups, such as Physicians for Responsible (reduction) of Opioid Prescriptions, commonly known as PROP, a group with the goal to stop the use of opioid pain medications as both ineffective and dangerous, are not true. *** in the words of an ex FDA senior official.Q. Are prescription opioid deaths increasing at an alarming rate?A.NO (False) they have been the same for six years. Heroin deaths have been increasing, and important difference thats conveniently forgotten in many reports thank you. Google (NIH overdose deaths September 2017) and see the graphs for yourself. Prescription opioid deaths or not increasing, just more FOA thinking and actions.With all due respect, the FDA has already investigated all the things you are talking about, there is no reason to reinvent the prescription opioid wheel. It is well known that the CDC guideline has no reliable scientific data in it.The bottom line is prescription opioids are safe for 99.5% of the population. If you want to stop addiction, then test people for the gene that makes them addicted.Please consider making chronic / intractable pain patients a endangered species as we are dropping like flies in a bug spray Factory. All of these rules and regulations for pain patients are doing nothing to help addiction. As you know we have the lowest prescription rate in 25 years, however we have the highest drug related deaths in 25 years. That should tell you everything that were doing to stop addiction is doing nothing.Please, for god sakes stop making it hard on pain patients oh, were dying.Thank you for your time I know this is going to be a difficult task.Sincerely,David Cole", "comment_id": "FDA-2019-D-1536-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0011", "comment_date": "2019-07-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3862}, {"text": "Yes, I am a chronic pain patient living in Florida. As a disabled senior, I have been adversely affected by the CDC guidelines. Even though there has been a retraction, most doctors here have made no adjustment to their their new practices of prescribing an insuficent amount of pain medications. I was doing as well as could be expected on a regime that addressed my intractable pain by a regular dosage, that exceeded the 90MME with my doctor of 20 years. As of January, I lost my doctor and, after going to several pain management doctors, realized that there was not much hope that I would be treated with an appropriate dosage and, dare I say compassion. My dosage has been decreased by 2/3rds- my mobility so compromised that I am bed ridden. I must go to the store occasionally and that, has become a nightmare. These draconian methods are absurd.I have severe cervical and lumbar degenerative disc disease, inoperable , along with a myriad of other physical problems associated. I have tried all modalities, massage, chiropractic, injections, accupuncture, and more. (these were when I was ambulatory) The only thing that gives me relief is my narcotic medication which is being lowered each month, according to my present doctors theory. I find it deplorable that a citizen of these united states is being subjected to  inadequate treatment going along with a one size fits all  idea of treatment.I was led to this forum by a piece written by Red Lawhern, a blessed advocate for chronic pain patients. He has done extensive research into this problem and statistically and humanely written a draft that is comprehensive and unflinching in the truth.. The AMA, Human Rights Watch, and others, which Im sure you are  aware,  agrees with his assesment of the wrongs being inflicted on people who are already suffering, without having their care disrupted and medication reduced.Please address this situation. There are so many who have been abused from withdrawral of comprehensive treatment and many have resorted to suicide, a number of our veterans among them. This is not a case of kids getting high from the street dealer, but a unacceptable epidemic full of fallacies that has been spoon fed to the general public, while those of us who suffer are miscategorized and ignored! Please dont punish pain!!", "comment_id": "FDA-2019-D-1536-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0017", "comment_date": "2019-08-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2369}, {"text": "August 15, 2019Ned Sharpless, MDActing CommissionerFood and Drug Administration U.S. Department of Health  Human Services 5630 Fishers Lane, Rm. 1061Rockville, MD 20852RE: Docket No. FDA-2019-D-1536Dear Dr. Sharpless, On behalf of over 34,000 orthopaedic surgeons and residents represented by the American Association of Orthopaedic Surgeons (AAOS), we are pleased to have the opportunity to offer the U.S. Food and Drug Administration (FDA) comments on the draft guidance, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry. The AAOS has observed the implementation of the benefit-risk framework within the Centers for Devices and Radiological Health. We are struck by the deliberate and thoughtful process of the FDA in expanding their understanding of safety and effectiveness to include a more individualized consideration of how patients evaluate the risks and benefits of treatments. The AAOS supports the Agencys continued efforts to incorporate these factors in the regulatory schema of its centers.Benefit-Risk AssessmentThe AAOS wishes to share our approbation of the FDAs expressed intent to give greater scrutiny to key questions regarding the benefits and risks of opioid analgesic drugs. We are pleased to note the clear emphasis placed on the provision of evidence in support of efficacy claims, as those claims apply to specific populations and duration of use. The AAOS is further encouraged by the Agencys request for information about risks associated with abuse-deterrent properties and any indications that new compounds or formulations may increase the risk and/or severity of adverse events.The AAOS recognizes that addressing the questions outlined in this guidance may require larger, longer studies to satisfy the FDAs requirements for safety and effectiveness data. Given the economic, social, and health consequences of placing a higher priority on pain alleviation that supports public wellness, we believe the cost and inconvenience of any delays to market are far outweighed by the benefits of a more deliberate regulatory approach. To ease these potential regulatory burdens, we suggest the FDA assess the appropriateness preapproval incentives to better support and encourage development of all therapeutics  opioid or non-opioid drugs, biological products or devices  intended to treat pain or addiction. Access to alternative pain alleviation modalities should lead to a reduced reliance on opioid analgesics.Broader Public Health Effects and Risk ManagementWe share the FDAs interest in receiving information from both traditional and non-traditional data sources from applicants in support of their descriptions of the ways in which their product might be misused or abused in the post-market setting. We believe those data and considerations of how abuse deterrent formulations may influence routes of abuse will provide the Agency and clinicians with a broader picture of the potential harm a product may pose to certain patients. A greater understanding of factors impacting misuse and abuse, as well as populations that could be at increased risk of diversion and abuse, will support shared decision-making and may reduce adverse events related to those practices.The AAOS supports the FDAs Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain. In reviewing the contents of this resource during the preparation of these comments, we noted the lack of educational goals related to transitioning patients from opioid to non-opioid pain alleviation strategies in the required education. We encourage the FDA to revisit this document and consider amending it to include this material.ConclusionThe AAOS thanks the FDA for describing the benefit-risk assessment framework that they intend to use in the evaluation of opioid analgesic drugs. We hope that the comments we have provided will be useful to the Agency in the finalization of their recommendations. If you have any questions or comments, please do not hesitate to contact William Shaffer, MD, FAAOS, AAOS Medical Director, by email at shaffer@aaos.org.Sincerely, Kristy L. Weber, MDPresident, American Association of Orthopaedic Surgeonscc:  Joseph A. Bosco III, MD, First Vice-President, AAOS Daniel K. Guy, MD, Second Vice-President, AAOSThomas E. Arend, Jr., Esq., CAE, CEO, AAOS William O. Shaffer, MD, FAAOS, Medical Director, AAOS", "comment_id": "FDA-2019-D-1536-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0021", "comment_date": "2019-08-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4788}, {"text": "Ive been a pain patient for over 36 years with the last 25 of those years as a chronic pain patient. In 1991 I had my 5th and 6th surgeries on my spine, until that time I had 4 previous surgeries that started in 1982 from a work related injury. I did not think of myself as a chronic pain patient because I was able to manage my pain and function using alternative methods of pain management such as Physical Therapy, Pool Therapy, TNS unit, NSAIDS, Meditation, exercise and diet. After my 5th and 6th surgeries I spent 2 years trying to get well enough to return to work, or at least part time work. I was told by 3 doctors I was not going to get better from my injury and I could expect to get worse over time, at the same time I was told I should not return to my previous type of work and to retrain into something that did not require physical labor. After trying to retrain for a different career I noticed I was unable to function nor able to concentrate due to pain. I told my doctors what was going on so they suggested opioid therapy and I was warned of the possibility of addiction. Only after I had exhausted all other means of pain management available to me, I decided to try opioid therapy. That was not something I wanted to do, for a lot of reasons. In fact I spent a year soul searching and trying to make up my mind if opioid therapy was the right direction to go in. Things got to the point where I needed to at least try opioid therapy and see if it would work out. I ended up trying the opioid therapy and I was put on a low dose but had to up the dose a couple of times to get to the point I could function better and concentrate more. I was able to start a new career. I started training and was hired on as a State Employee. I thrived the first year, and earned an Employee of the year certificate, along with several certificates of achievement over five and a half years, until 2003 when I needed another surgery on my spine. I was unable to return to work due to pain, however in 2014, and after years of hard work from my doctors and myself and the aid of exercise, diet and complimentary alternative pain management and opioid therapy,  I felt well enough to try to return back to work.  In July, 2014 I was excited about a doctor appointment I had that day because I was finally going to tell my pain specialist that all of the hard work he, my PC doctor and myself had done was going to pay of after such a long time of being off work.  Well, the time came for me to tell my pain specialist of my plans, at the moment I informed him of my plans, and at that instant, he informed my that he is cutting my pain medication in half! I was shocked, especially after telling him I felt as if I was ready to return back to work. Thats when it all came to a huge, screeching halt and ended with a crash to a brick wall. I asked why would he was dong that to me. He replied, he is following the new CDC Opioid Guidelines and every doctor and health insurance company including State Accident Industrial Insurance are going to be on board by the end of Sept 2014. He said his hands were tied and didnt have a choice! I have never misused my pain medication, have never had any problems with my doctor, have always passed every U.A. screening done, always had the right amount of pain meds at the end of the month. Never a problem to justify my doctor cutting my medication. After a couple of months of tapering, I found out my doctor lied to my when he said he was cutting my meds in half, he tapered me down by eighty five percent of what I was getting for pain. Now, I am in intractable pain, home ridden, in more pain than I have been in, in over 36 years and trying to live on Social Security. What a waste! I could have been working over the last 5 years. I could have had a functional life and not just existing in a shell of pain. I could have been a functioning contributing member of my community. If you dont think opioid pain therapy works for long term chronic and intractable pain patients, then you really need to start doing research on long term chronic and intractable pain patients. Start working with us, beside us, start asking us what is happening with us and the opioid pain medication. One of the many problems with this issue is, no one has asked the chronic/intractable pain patients how they are dealing with the so-called opioid crisis. We are under the assumption no wants to hear or see the truth were it comes to the disabled chronic pain patients in this country. It appears everyone (FDA, DEA, Lawmakers) have closed off all communication with the AMA, Pain Advocacy Groups, and most of all the disabled pain patients in this country. Lets be clear, opioid pain medication is the last resort to a functioning life most of the pain community has and by taking away the medicine, you have literally taken away the lives of Disabled Chronic Pain Patients. You need to start listening to your Disabled American Citizens in pain!  Wake up!    ", "comment_id": "FDA-2019-D-1536-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0019", "comment_date": "2019-08-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 5024}]}, {"id": "FDA-2019-P-1364", "agency": "FDA", "title": "Request that the FDA impose a moratorium on approval of all NDAs for new opioids or new opioid formulations-WITHDRAWN 4/5/19", "update_date": "2019-08-05", "update_time": "12:03:41", "purpose": "Nonrulemaking", "keywords": ["Public Citizen\u2019s Health Research Group", "Approval of New Drug Applications for New", "Opioids or New Opioid Formulations", "non-existent opioid regulatory framework", "opioid crisis in the U.S.", "National Academies of Sciences, Engineering,", "and Medicine (the National Academies),", "OPEN", "CDER"], "comments": [{"text": "The FDAs continued approval of new potent opioids, which are known to threaten the public health, without first significantly improving the review process by creating and finalizing an opioid regulatory framework recommended by the National Academies, represents a clear and present continuing danger to the health and safety of people in this country.", "comment_id": "FDA-2019-P-1364-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0007", "comment_date": "2019-08-02", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 352}, {"text": "The Nations opioid epidemic / crisis is far from over. The time has long past that we try to deal with it using a band-aid approach. The pharmacutical companies are not evil, but they have apparently chosen to not address this epidemic which is well documented and keep manufacturing far more of the varous opioid drugs than this country needs. Responsible government and private sector management should dictate a focus on developing sound opertional strategies to solve the current epidemic before we should be approving additional new opioid drugs. If this were a contagious disease there would be a mandated containment effort. Why do we think this isnt the same type of problem?", "comment_id": "FDA-2019-P-1364-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0006", "comment_date": "2019-08-01", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 693}, {"text": "I support the fight against addiction, overdose and the import of illicit drugs into the United States. While FED UP fights for these causes however, you leave in your wake millions of chronically ill patients who suffer with severe pain as they are being denied appropriate opioid pain management. These are people who were on a long term managed and monitored regimen of opioid pain medication while adhering to every clause in their physician/patient contract. Both the New England Journal of Medicine and the Substance Abuse and Mental Health Services Administration (SAMHSA) released studies showing that less than 1% of those prescribed opioids for the purpose of managing chronic pain became addicted. Likewise, the study below explains that prescription opioid use to manage acute pain almost never results in addiction. Researchers note that despite a documented doubling of opioid analgesic use from 2000 to 2010, they cannot find evidence that prescribing opioids for chronic pain is the principal driver of rising addiction rates in adults. OUD develops in only a small percentage of adults who are prescribed opioids for acute pain. In a large study of 640,000 opioid-naive patients in which chronic opioid use was examined one year after surgery for 11 surgical conditions, the prevalence was found to range from 0.12% for cesarean section deliveries to 1.4% for total knee replacement surgeries. In another study in which chronic opioid use was examined in approximately 18 million people with acute pain who had not undergone surgery and had never taken opioids, only 0.14% of those who were prescribed opioids were found to still use the medications a year later.I hold no ill will toward those fighting addiction. They were a community stigmatized by those who hold office, the news media and the public at large. This has and continues to change but the fight must continue. In their place however are now those who suffer with intractable, chronic illness and resulting pain. This is now a community stigmatized by the same people who are coming to realize that it is far more effective and far more humane to offer treatment to those fighting addiction. But now those who live with debilitating pain become the lepers, refused treatment by the very same people who once turned a blind eye to those addicted. I would ask that those involved in creating the message FED UP uses to reach out to the masses PLEASE adjust your language to highlight that pain patients must not be made the new target. Please take this request into consideration. ", "comment_id": "FDA-2019-P-1364-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0008", "comment_date": "2019-08-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2592}]}, {"id": "HHS-OS-2016-0005", "agency": "HHS", "title": "Confidentiality of Substance Use Disorder Patient Records", "update_date": "2019-01-11", "update_time": "01:04:20", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Based on my understanding of the updated rule I read I was very disappointed to see the rules for coordination of care with other health care providers, the sharing information in provision of integrated care and sharing information with health information exchanges was not streamlined - the regulations not reduced or changed for ease in these areas.  We continue to need specific permission from the patient to share this very critical medical information.  Withholding the information from coordination, from health information exchanges, and from the integrated care model causes care for the individual to be compromised.  The rules, from my perspective (someone who has worked with organizations servicing patients for over 30 years) continues to stigmatize the illness of addiction and continues to stigmatize addiction treatment.  Please consider eliminating the rules that require  authorization form the patient to share their treatment information with the providers who are providing treatment and care for the individual - we are providing treatment for the whole individual, not the individual minus the addiction.  This sort of restriction of information sometimes puts the patient at risk, they (the patient) choose not to share their addiction information so their providers or other aspects of their care are not aware of the treatment for addiction or their addiction and are then unable to include that variable in the treatment plan, sometime resulting in contra indicated treatments for the patient.", "comment_id": "HHS-OS-2016-0005-0379", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0379", "comment_date": "2017-02-07", "comment_time": "05:00:00", "commenter_fname": "Margaretq", "commenter_lname": "Chappell", "comment_length": 1522}, {"text": "Comments on 42 CFR Part 2: Proposed RuleFile Code SAMHSA 4162-20Section 2.52: Research2.52(a). I support SAMHSAs expansion of authority to disclose patient identifying information for the purpose of conducting scientific research to include other lawful holders of part 2 data.  Data for scientific studies is usually obtained from payer rather than providers.  The proposed language permits continuation of necessary and important scientific research on the effects of alcohol and drug use disorders and the value of treatment for the disorders. SAMHSAs interpretation of the current language as restricting the release to part 2 programs was too narrow and inhibited health services and health economics research.  The standards (2.52(a) (1 - 3)) for releasing data to qualified researchers appear to be reasonable.The restrictions on the use of the data (2.52 (b) (1 - 6) also appear to be reasonable.  SAMHSAs discussion of the proposed revisions to section 2.52 (p. 65 - 72), requests comments on restricting data linkage to federal data repositories. This proposed restriction is much too narrow.  Researchers working with a local drug court, for example, could seek to link part 2 data to criminal justice records.  There is no need to engage a federal data repository if local arrest and court records are sufficient for the investigation.  A university based investigator could readily meet the expected confidentiality, privacy and security safeguards.  Similarly, some health plans place part 2 data in a separate database and data linkages are required to assess associations with healthcare utilization and access.  A commercial health plan, private health care system, or a state agency should be permitted to link their part 2 data for purposes of research and evaluation. The eight standards proposed (page 69  70) are reasonable.  A necessary safeguard could require the data to be de-identified prior to release to an investigator.  As an investigator, I do not want to receive identified data.  It is easier to protect the data from a court order if there is insufficient identifying information in the data set.", "comment_id": "HHS-OS-2016-0005-0030", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0030", "comment_date": "2016-03-03", "comment_time": "05:00:00", "commenter_fname": "Dennis", "commenter_lname": "Mccarty", "comment_length": 2223}, {"text": "I know that under the current rule anyone outside of my agency that I refer them to as part of my program (e.g a psychologist) must agree to the same level of protection as they have here. Under the revision, can I reassure my patients that a simple court order signed by a judge is not enough to force the psychologist release information? How must I communicate this to the psychologist? ", "comment_id": "HHS-OS-2016-0005-0392", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0392", "comment_date": "2017-02-16", "comment_time": "05:00:00", "commenter_fname": "Fr. jack", "commenter_lname": "Kearney", "comment_length": 390}, {"text": " By not addressing the PDMP issue you are no longer protecting patients who are by lawIn a Protected group. Bupernorphine patients treated by data 2000 waived doctors should he afforded the same protection as a patient being seen in an OTP. This leaves this issue open to law suits by 42 CFR part 2 patients. Who are having anyone look them up and then possibly being descimated in getting a job or Heath care. ", "comment_id": "HHS-OS-2016-0005-0035", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0035", "comment_date": "2016-03-04", "comment_time": "05:00:00", "commenter_fname": "Paul", "commenter_lname": "Bowman", "comment_length": 416}, {"text": "Please expand the  SAMHSA  comment period for a period of one year for a more open process.I oppose the changes to 42 CFR PART 2 as currently proposed by SAMHSA. Confidentiality is key to people getting treatment that works!", "comment_id": "HHS-OS-2016-0005-0075", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0075", "comment_date": "2016-03-29", "comment_time": "04:00:00", "commenter_fname": "Louise", "commenter_lname": "Foote", "comment_length": 234}, {"text": "I write on behalf of the American Statistical Association to support the proposed rule change, Confidentiality of Substance Use Disorder Patient Records. As documented in the March 15, 2016 JAMA article, Suppression of Substance Abuse Claims in Medicaid Data and Rates of Diagnoses for NonSubstance Abuse Conditions, the suppression of claims with diagnoses that indicate substance use disorders also suppresses data on conditions that are comorbid with substance use disorders. Thus, suppression adversely affects researchers and policy makers ability to examine not only substance use disorders but several other conditions as well.  The implications of the proposed rule change for data linkage are also important, given the increase in alternative payment models, such as Accountable Care Organizations, and the need to effectively evaluate them. We strongly support the proposed rule be adopted to reverse the deleterious impact of the current suppression of substance abuse-related claims. ", "comment_id": "HHS-OS-2016-0005-0121", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0121", "comment_date": "2016-04-06", "comment_time": "04:00:00", "commenter_fname": "Steve", "commenter_lname": "Pierson", "comment_length": 1011}, {"text": "I strongly support the proposed rule", "comment_id": "HHS-OS-2016-0005-0187", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2016-0005-0187", "comment_date": "2016-04-10", "comment_time": "04:00:00", "commenter_fname": "William", "commenter_lname": "Rogers", "comment_length": 36}]}, {"id": "FDA-2015-P-0059", "agency": "FDA", "title": "Requests that the FDA ban the retail distribution of pure and highly concentrated caffeine as a dietary supplement. CSPI also requests that FDA limit the form in which caffeine is sold to prevent unreasonable risks to adolescents and others from overdoses of caffeine.", "update_date": "2018-04-19", "update_time": "14:29:20", "purpose": "Nonrulemaking", "keywords": ["2015-51", "Caffeine", "Powdered Caffeine", "Dietary Supplement", "Overdose", "Ban"], "comments": [{"text": "October 6, 2015Dr. Stephen Ostroff, M.D., Acting CommissionerFood and Drug Administration (FDA) 10903 New Hampshire AvenueSilver Spring, MD   20993Re:  Petition to Ban the Retail Distribution of Pure and Highly Concentrated Caffeine Sold in Powder Form as a Dietary Supplement, FDA-2015-P-0059-0003Dear Acting Commissioner:We applaud FDA for issuing warning letters to five companies distributing pure powdered caffeine.  On September 1, 2015, FDA found that the products presented a significant or unreasonable risk of illness or injury to consumers, and directed recipients of the letters to cease distribution of these products  FDA indicated that a reason powdered caffeine is dangerous is the concentration of the product, making the difference between a safe amount and a toxic dose exceedingly small.  The agency also wrote that safe quantities are nearly impossible to measure accurately with common kitchen measuring tools.  FDA stated that it will continue to aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.  We appreciate these preliminary efforts and FDAs clear commitment to ongoing oversight and action on this issue.  However, we urge FDA to press forward on a ban on the sale of caffeine powder in bulk for the reasons presented below.  We also write to alert FDA that one company that did not receive an enforcement letter is still selling powdered caffeine in the United States, that a company that did receive a letter is still selling a related and risky product, and to raise concerns about related products that remain unaddressed by the agencys actions.  ", "comment_id": "FDA-2015-P-0059-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-P-0059-0009", "comment_date": "2015-12-10", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1747}]}, {"id": "FDA-2017-N-2903", "agency": "FDA", "title": "Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments", "update_date": "2017-09-15", "update_time": "11:56:53", "purpose": "Nonrulemaking", "keywords": ["CDER", "2017-77", "Data and Methods for Evaluating the Impact of", "Opioid Formulations with Properties Designed", "to Deter Abuse in the Postmarket Setting", "A Scientific Discussion of Present and Future", "Capabilities", "Public Workshop", "Issues Paper", "Request for Comments", "OPEN"], "comments": [{"text": "1) NomenclatureTo call tamper-resistant opioids Abuse Deterrent Formulations (ADFs) substantially misstates what these technologies can accomplish even if and when they work as intended.  The Food and Drug Administration (FDA) is a scientific agency that should subscribe to maintain standards of accuracy, especially when communicating with the public and with stakeholders on issue of such grave importance.  Accordingly, the term ADFs should be abandoned in favor of a more accurate terminology.2) Vaccines  MeasurementAs was discussed during the public meeting, the appropriate analogy to draw when discussing the effort to elevate all licit opioid-prescribing is to vaccination, which must prove safe and effective for the recipient, and must also provide a herd immunity or substantial public health benefits in outcomes of interest. In order to judge tamper-resistant technology, two separate scales should be considered.3) Scale 1Considering the denominator all prescription pain pill users (adherent patients as well as misusing patients and recreational misuse), the FDA should itself sponsor prospective studies of tamper-resistant technologies based on categories of type (not a particular brand).  Particular brands should then be asked to match or outperform those results.  Entirely new innovations should be judged against similar products with proven results.  Any brand that agrees to place its product in the bucket study should be rewarded, if the technology is proven effective, with increased market penetration.  The outcome of interest here is: in this community of users, does the technology thwart attempts to manipulate it without incurring new or exacerbating existing hazards?4) Scale 2The denominators of interest here are all adverse outcomes: overdose death totals; overdose totals; Hep C or HIV infection rates; etc.  The buckets of technology-types and/or individual brands supply the numerator.  If these technologies successfully deter manipulation but do not meaningfully affect outcomes vital to abatement of the opioid crisis, then there is a limit to the kinds of vaccination or public health claims that can be made on their behalf.  On the other hand, if they can be shown as effective, it is important to seize on that knowledge and advance their market penetration.Kathleen J. Frydl", "comment_id": "FDA-2017-N-2903-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0004", "comment_date": "2017-07-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2383}, {"text": "Inflexxion, Inc. - Comments re: Data and Methods for Evaluating the Impact of Abuse-Deterrent Opioid Formulations", "comment_id": "FDA-2017-N-2903-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0014", "comment_date": "2017-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 113}, {"text": "On behalf of McKesson, I am pleased to submit comments on FDAs notice, Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments.", "comment_id": "FDA-2017-N-2903-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0013", "comment_date": "2017-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 333}, {"text": "Preventing Prescription Opioid Addiction Reduces Reliance on Abuse Deterrent Formulations  while Treating Chronic PainWhile the focus of this initiative is to evaluate opioid formulations that are identified as abuse deterrent, the fact is that the recreational  abuse of opioids is proceeded by addiction to the opioids. It is just common sense: As with most diseases, preventing opioid addiction is a lot better than needing to  treat it or, for that matter,  trying to avoid ways those addicted can administer it to achieve a greater high .In May, Dr. Scott Gottlieb, the new FDA Commissioner, declared that addressing the opioid epidemic is his first and highest priority. In his FDA VOICE blog, he cites data unequivocally establishing prescription opioids as the major cause of opioid addiction. These medications are also gateway drugs: Some 75 percent of heroin users in treatment began their addiction with prescription opioids. Prescription opioids are responsible for the majority of opioid-overdose deaths, responsible for about 22,000 of the 33,091 fatalities in 2015. The Agency for Healthcare Research and Quality reported 1.27-million emergency-room visits or inpatient stays for opioid-related issues in 2014 (the most recent year for which data is available). The public debates over legal and regulatory policies to combat this epidemic are ongoing, with opinions continuing to evolve. Yet discussions mainly fail to consider another vital concern: the medically legitimate needs of people who require prescription opioids to help live with chronic pain. The inconvenient truth is that moderate-to-severe chronic pain typically cannot be adequately controlled with non-opioids. One highly promising solution to this dilemma focuses on an underutilized treatment for chronic pain called buprenorphine (bu-pren-or-fin). It is the only opioid in the CIII schedule of drugs, a category recognized by the FDA as representing a reduced risk of addiction. All other opioids for pain are grouped in the riskier CII class. Until recently, buprenorphine was only available as a once-a-week transdermal (skin) patch, which limited its efficacy and caused some doctors to eschew it. Early last year, however, the FDA approved a twice-daily formulation of buprenorphine that provides significant pain relief: a small, transparent film resembling a Listerine breath strip that dissolves against the inside of the cheek.In this new form, buprenorphine may play a key role in fighting the prescription-opioid epidemic. It is the least addicting of all the opioids. It typically does not lead to withdrawal symptoms when stopped. Importantly, it reduces the risk of death due to overdose because it doesnt shut down respiration the way other opioids can.Buprenorphine is not immune to abuse, especially by people whove never before taken prescription-opioid medicationthe so-called opioid-nave. But it poses much less risk than CII opioids because it doesnt produce the same kind of potentially addictive euphoria. People living with chronic pain can get relief from buprenorphine but addicts looking for a high dont like the drug very much, according to studies.The FDA has approved high-dose buprenorphine (generally, over ten times the amount approved for pain management) as a treatment for opioid addiction. The advantage of buprenorphine is that it can eliminate withdrawal symptoms without triggering euphoria. This is in stark contrast to the use of methadone to treat heroin addiction. The dual ability of buprenorphine to both manage pain and also addiction underscores its uniqueness.The danger posed by CII opioids is real and immediate. In an analysis by the Centers for Disease Control and Prevention, the longer the exposure of opioid-nave patients to CII opioids, the greater the risk of becoming a chronic user. A one-day supply is associated with a 6 percent risk of continuing the opioid for at least a year; a 30-day supply is associated with about a 35-percent risk of becoming a chronic user. There are common-sense conclusions to be drawn here. For chronic-pain patients who are not getting adequate relief from non-opioids, prescribers should be required to offer buprenorphine as a first-line therapy before resorting to a CII opioid.  For patients who have been on a CII-opioid long-term, the mandate should be to gradually replace the medication with buprenorphine. The quickest and most effective way to encourage this change is for pharmacy benefit-management companies to adopt these requirements nationally. In addition, the FDA should mandate labelling changes for all CII opioids, requiring that prescribers try buprenorphine first as a treatment for chronic pain.", "comment_id": "FDA-2017-N-2903-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0003", "comment_date": "2017-07-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4856}, {"text": "I look at the reports on how the opioid epidemic, has got to be stopped and addressed.  I am, along with millions of other Americans, are on the other end of opioids. I am on the end of the chronic pain disease epidemic.   As the CDC, DEA and Medicaid and medicare,  and numerous other government associates, are blaming Doctors for the over prescribing of medication,  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about not addressing these drugs as dangerous and addictive.  Lets look at them as lifesaving and medically necessary for the million of Americans in chronic pain.  Chronic pain is a disease.   It is now becoming an epidemic. No other disease medication is scrutinized.  Chronic pain is a disease.   We as patients are being denied,  dismissed and overlooked by our drs due to all the scrutiny associated with treating chronic pain disease.   Our doctors are afraid to treat us adequately.   We have a disease that medication is readily accessible to us and we are being denied.   We pain patients are truly being discriminated against, due to people who use heroin,  illegal fentanyl,  and placed a blame on anyone but themselves.   This is a witch hunt for drs who prescribe life saving medication and pain disease patients who benefit from this medication.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible,  but without access to our, potentially, life saving medications,  we are unable to do so.  We want to live not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.We need help.  With all the headlines, topics and stories on how opioids are bad, lets look at what good they do for our disease of chronic pain and the million of Americans they help.", "comment_id": "FDA-2017-N-2903-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0006", "comment_date": "2017-08-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1901}, {"text": "Comments provided by RADARS System", "comment_id": "FDA-2017-N-2903-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0015", "comment_date": "2017-09-12", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 34}, {"text": "The Association for Accessible Medicines (AAM) acknowledges the efforts of the Food and Drug Administration (FDA, or the Agency) on Docket Number FDA-2017-N-2903 regarding exploring present and future capabilities to evaluate the effectiveness of abuse deterrent opioids in the post market setting. As discussed further below, AAM commends the Agency for its ongoing efforts in mitigating the risk of misuse and abuse of prescription opioids, and offers several suggestions regarding this important public health issue. ", "comment_id": "FDA-2017-N-2903-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0008", "comment_date": "2017-09-11", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 520}, {"text": "This war on opioids is actually a war on  chronic incurable diseases.  A war on chronic pain disease patients who benefit from opioid medications.  Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases. The fiction, widespread hysteria and distorted truths about this opioid epidemic, is killing legitimate chronic pain disease patients who use their medications responsibly.  We are patients.100 million Americans have one or more chronic incurable pain Diseases.  As the CDC, DEA, FDA, Medicaid and Medicare,  and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication.  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about NOT addressing these drugs as dangerous and addictive.  When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication.   Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease.   Chronic pain disease patients are now the epidemic.   The addiction rate of chronic pain disease patients is .02-.6 %.  We do not misuse or abuse our medications.No other disease medication is scrutinized.  We, as patients, are being denied,  dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications.   Our Drs are afraid to treat us humanely and adequately.   We have a disease that medication is readily accessible and beneficial to us and we are being denied.   We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl.  This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them.  We have our privacy invaded, we no longer are able to have doctor/patient confidentiality.  We now have insurance agencies,  pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians. Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.  The specific causes of deaths also needs to be closely investigated.  The opioid in the persons system needs to be specified.  Was it an illegal opioid,  was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out.  These Government agencies do not want that information out, due to the fact that this opioid epidemic, would then be debunked.Lets put the shoe on the other foot.  Restricting or taking away our medications is like FORCING people who do not want this medication to take it.  One day those against these medications will need them but they will be denied.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible,  but without access to these life saving medications,  we are unable to do so.  We want to live, not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.  These agencies are not physicians.   They are trying to doctor us, patients, without a medical license.   They are also trying to police our physicians.  This is a war on a disease, medications, physicians and patients. We chronic pain disease patients need help.  All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them.  We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief. The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl,  illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS.  Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications. WE ARE PATIENTS NOT ADDICTS! !", "comment_id": "FDA-2017-N-2903-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0005", "comment_date": "2017-07-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4624}]}, {"id": "FDA-2015-D-2496", "agency": "FDA", "title": "Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems", "update_date": "2022-02-17", "update_time": "09:27:30", "purpose": "Nonrulemaking", "keywords": ["2015-381", "Colleen Maschal", "CTP"], "comments": [{"text": "Do not take away flavors that is the only thing making it so I can vape and quit smoking and Im former cancer patient so this is saving my life it has made me stop coughing up stuff every day every time I cough amd everything ", "comment_id": "FDA-2015-D-2496-0048", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0048", "comment_date": "2018-03-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 231}, {"text": "Currently the FDA allows for 510k clearance for devices, additives, equipment, and packaging of transfusion approved biologics, such as packed red blood cells, plasma, platelets, etc.The process, application, and regulation of these products allows for substantial equivalency to be awarded based on products already approved for use regardless of their initial premarket evaluation and approved application. For example, a material used in the creation of bags approved for packed red blood cells can be deemed substantially equivalent in function and safety if used to hold cryoprecipitate or used as tubing in the transport of biologics from one container to another.  This process is also applied many times in other regulated categories such as pharmaceuticals, medical equipment, food additives, preservatives, and processing techniques for dairy and meat. When it comes to the application process for END liquid/juice production the FDA should justify the requirement of separate PMTP applications for base compounds that are produced in the same facility, with the same ingredients following cGMP as outlined by the FDA, and bottled, marketed, and sold by the same company due to greater or lesser contents of nicotine.Nicotine amount in varying concentrations (mg/mL or %vol.) cannot, under any reasonable or scientifically founded circumstances, be considered unequivocal  to itself. That is to say that any standardized solution with varying concentration cannot be promulgated as substantially unequivocal without unwinding decades of regulated solutions and concentrations sold for consumption being approved without premarket evaluation costs. As such, guidance released by the FDA for the PMTP application process should include a clearly defined route with which varying nicotine levels can be established as substantially equivalent after a flag or initial product is submitted and approved via the PMTP application process. An example of this would be artificial sweeteners with varying levels of their active ingredient below the limiting threshold established by the FDA and the ADI as calculated by the FDA.For clarity, a limit for the highest concentration of nicotine allowed in these products is not at question and is a reasonable variable in the production of e-liquid/juice to regulate. However, any concentration below that upper limit should be considered the same product and waived from additional applications and approval by the very concrete and undeniable rules of physics and chemistry.Additionally the use of flavorings in the creation of these e-liquid/juices that are currently considered GRAS or unregulated for use in perfumes, deodorants, candles, air fresheners, or any other inhaled product not currently under scrutiny for adverse health effects, must have a reasonable or scientifically justifiable premise for submission as a PMTP.As such if a common use of these chemicals is in fact inhalation, the requirement that they be regulated by the FDA via PMTP applications rather than a substantial equivalence raises deep concerns about the FDAs scope of regulation versus the FDAs mandate by law. Guidance in the PMTP application process should in fact include a multitude of options for meeting the regulatory threshold without compromising the value of the FDA as a consumer health and regulation agency rather than a private laboratory or corporation.", "comment_id": "FDA-2015-D-2496-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0012", "comment_date": "2016-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 3523}, {"text": "I file a dissent to the new rule governing e-cigarette sale and manufacture.1. I personally smoked cigarettes for over 30 years and quit with the help of e-cigarettes and with no ill effects.2. A U.K. medical study cites this nicotine delivery system is up to 95% safer than cigarettes.3. Theres no proof they are a gateway to smoking cigarettes by the young.  Theyre having the opposite effect for current smokers.4. Theres no solid proof e-cigs are harmful.5. The cost of compliance will put many companies out of business and employees out of work.6. Only big tobacco can afford the price of admission.  The fact that R.J. Reynolds was even involved with the process is suspect. This gives the appearance of their powerful lobby getting to the right people in government, to get this regulation pushed through.  Their traditional sales have plummeted and its well known they wish to gain access to this new lucrative industry. Its also well known, while we condemn smoking, the government has subsidized tobacco growers.", "comment_id": "FDA-2015-D-2496-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0005", "comment_date": "2016-06-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1108}, {"text": "As an American adult, I choose to enjoy premium tobacco products. Many of those products have been introduced in recent years. I oppose setting an arbitrary date after which those products would be required to undergo lengthy and costly testing. Some, if not all of the items I currently enjoy would disappear or become ridiculously expensive, even though theyve been sold for a number of years.", "comment_id": "FDA-2015-D-2496-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0021", "comment_date": "2016-07-07", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 405}, {"text": "Please allow adults to make decisions for themselves.   Stop killing business adults support.   I dont need a nanny.  I need you to enforce the laws requiring people be 18 or 21 to purchase tobacco or nicotine delivery devices.   Enough is enough.  If you want i would be happy to bring someone from your office to a real vape store and show you that these are adults purchasing these products and they are a positive social situation.   Not kids doing inappropriate things for their age.  Punish people doing wrong, like selling to underage poeple.   Not arbitrarily punish business and people doing something new or different.   Kids in my area can find stores to buy actual tobacco products, but vape stores keep them out completely.  Or is this the goal?  Keep getting kids to use cigarettes so taxes keep rolling in?  Thanks for listening to my rant....   :)", "comment_id": "FDA-2015-D-2496-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0025", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 868}, {"text": "Dear FDA, as a former smoker of 20 years and current vaper of over 3 years I am ashamed to live in a country where corrupt, selfish, bureaucrats like yourselves can take peoples freedoms and spit upon them just to stuff more cash in their pockets. Your deeming regulations are unconstitutional and you deserve to be imprisoned for your corrupt methods of business. I will not comply and the fact that you want to implement a process that only tobacco companies can comply with and consider a product to be tobacco when it is not made from nor contain any tobacco just because it contains nicotine yet do not consider the same for other products that do, such as NRT products shows that you have a particular agenda to carry out for vested interests. What you are trying to do is wrong, poses extreme risks to public health and will be fought everywhere.", "comment_id": "FDA-2015-D-2496-0037", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0037", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 853}, {"text": "As a small eliquid manufacturing company and long time advocate for vaping, I can assure you that this will effectively stifle and could even shut down many small business owners in this community. Thousands of jobs will be lost. Millions of people will convert back to smoking because they will not be able to get eliquid. All due to the draconian regulations being introduced. ", "comment_id": "FDA-2015-D-2496-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0028", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 379}, {"text": "For me electronic cigarettes were a God send. My doctor told me 6 years ago (when I started using them) that for the first time in all the years hes treated me my lungs and bronchial tubes were clear. They have remained clear and Ive gotten healthier.However it looks like thats all coming to an end. With the FDAs new rules Ill be forced back to smoking as they have left us with no options.Most other leading countries are legalizing them because their medical institutions have proven the benefits in using electronic cigarettes. But their contrives value their citizens more than money.Its pretty plain that money, or the loss of is whats causing our governments agencies to make such an idiotic rule. It gives control for the electronic cigarette industry to big tobacco as they are the only ones with enough money to compete in the industryLastly it locks out all the devices that deliver enough vapor to satisfy a nicotine consumers needs.I would like to thank the FDA for sending me back to smoking and the unhealthy life it carries. But really I dont think they care as Im just a US citizen and not a US dollar.", "comment_id": "FDA-2015-D-2496-0038", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0038", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1190}, {"text": "The FDA has overstepped their boundaries as I and others cannot get straight answers to our questions about the unfounded assault on the pipe and pipe tobacco industry. If the powers that be truly did their research into said industry, they would realize that it is the cigarette tobacco companies that take floor sweepings and package them in bags and label them as pipe tobaccos to skirt taxes and rules they should be going after. Pipe tobacco has none of the additives and carcinogens that are in cigarettes. As a study by the U.S. Surgeon General (No. 1103 page 112 and 92) found that the death rates for pipe smokers were little if at all higher than nonsmokers. In the same report, it also came to the conclusion that pipe smokers on whole lived three years longer than nonsmokers.As the vast majorities of pipe smokers do not inhale, the dangers that cigarette smokers face are not present. As our country is rebuilding our economy, with miles to go, there is no logical reasoning for this attack on small artisan pipe makers, retailers and pipe tobacco blenders. It was the commerce from tobacco that help establish and fund our country in the first place. Lets not turn our backs on history.", "comment_id": "FDA-2015-D-2496-0024", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0024", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1241}, {"text": "Ecigs and juice have NO TOBACCO in them, so how can they be considered a tobacco product?  The FDA is pissed because big tobacco is losing billions of dollars every year because people are vaping instead of smoking.  I hope you get sued and go bankrupt!  We as vapers are united and will NOT conform to your greed!", "comment_id": "FDA-2015-D-2496-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0031", "comment_date": "2016-07-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 314}]}, {"id": "EPA-HQ-ORD-2022-0833", "agency": "EPA", "title": "IRIS Toxicological Review of Cobalt and Compounds (Inhalation)", "update_date": "2022-12-16", "update_time": "11:22:31", "purpose": "Nonrulemaking", "keywords": ["Toxicological Review", "IRIS Assessment", "Coblt"], "comments": [{"text": "1) Section 2.2. Scoping Summary indicates that all cobalt containing substances are considered for this assessment with the exception of radioactive cobalt (60Co) and vitamin B12. This suggests that all cobalt containing substances including alloys with varying physical properties are within the scope of this assessment. The assessment appears to be relying largely on prior assessments in addition to a literature review of newer studies published 2019-2021. Key prior reviews contained language that specifically excluded cobalt alloys from their evaluation including NTP (2016) and OEHHA (2020). Therefore, relying exclusively on the references  of these prior reviews to evaluate mechanism and ADME of all cobalt containing substances inclduing diverse alloys might have flaws. As a single example, one study on the disposition of inhaled CoCr grinding dust from dental alloys was not referenced in OEHHA (2020) and NTP (2016) [Brune, D., Kjserheim, A., Paulsen, G.  Beltesbrekke, H.: Pulmooar,  Deposition following inhalation of chromium-cobalt grinding dust in rats and distribution in other tissues. Scand, J. Dent. Res. 1980: 88: 543^551].  Please consider whether a new literature search for additional studies related to the disposition and toxicity for cobalt containing alloys may be appropriate.2) Section 3,2 Specific Aims discusses the possibility of developing separate inhlation unit risk factors for water soluble and insoluble compounds as was done in OEHHA (2020). The Assessment Plan under Section 2.4 Key Scientific Issues also discusses the importance of the dissolution of low water soluble or insoluble compounds in biological fluids inclduing the lower pH of the lysosome. Some cobalt alloys are highly corrosion resistant and are not only water insoluble but may also have very low solubility in lysosomal fluids. Such particles may have greatly different ADME properties and toxicity compared with the cobalt metal powder used in the NTP study. A single inhalation unit risk factor for all water insoluble substances may not be scientifically justifiable. I would like to urge EPA IRIS to consider the rate of dissolution as proposed in section 2.4 and the physical clearance from the lung of different alloy particulates in the Assessment rather than assuming that all cobalt containing water insoluble substances are the same with a single dose-response assessment. A separate unit risk factor for cobalt alloy that have low solubility in lysosomal fluid, if supportable, would be a benefit to the regulatory community since there are facilities which release alloy grinding dust into the environment. Alternatively, limitations on the application of the URFs developed for different water insoluble particulates should be included in the Assessment.", "comment_id": "EPA-HQ-ORD-2022-0833-0002", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2022-0833-0002", "comment_date": "2022-11-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2808}, {"text": "The Cobalt Institute is submitting detailed comments on the EPA IRIS assessment plan and protocol for Co and Co compounds in the two attachments to this submission (i.e. CI response into IRIS PC 2022Dec13 and Stantec ChemRisk Cobalt Comments IRIS). We have provided the Executive Summary of the CI response below.Executive SummaryCobalt and cobalt compounds were nominated by the EPAs Office of Air and Radiation (OAR), in June 2022 for a cancer assessment under the US EPA IRIS Program due to potential carcinogenic risks arising from emissions to air of cobalt compounds during industrial processes. The Cobalt Institute (CI) is submitting comments in December 2022, relating to the consultation on the IRIS Assessment Plan (IAP) and protocol for Co and Co compounds.  The CI recently published a series of papers containing data on the cobalt mode-of-action (MOA) relating to longer-term inhalation toxicity and carcinogenicity of cobalt and cobalt compounds. In these publications, the CI has performed a tiered, mode-of-action based read-across approach, detailing the distinct differences in the release of the Co ion in artificial lung fluids, upregulation of in vitro biomarkers for hypoxia, inflammation, oxidative stress and acute toxicity/persistent inflammatory responses and sub-acute toxicity, between the reactive Co substances (represented by Co metal and Co sulfate) and the poorly reactive / poorly soluble Co substances (represented by tricobalt tetraoxide). Based on this and other extensive datasets, Co metal is not considered as part of the poorly soluble group of substances. In contrast, tricobalt tetraoxide is poorly soluble in all lung fluids and high quality, mode-of-action data indicates a lower potency and potential alternative cancer MOA for poorly soluble cobalt substances. The existence of different groups of cobalt substances, and the grouping of Co metal with the reactive substances, is supported by the recent IARC review of Co and Co compounds. In addition, mutagenic responses (i.e. direct genotoxicity) have not been detected in guideline-compliant studies with any cobalt substance, including the substances that were positive for cancer by inhalation exposure in rodent studies.The CI proposes that the EPA uses a weight-of-evidence approach to assess the dose-response for reactive, bioavailable cobalt substances taking into account MOA, animal and epidemiological (workplace) data. A multi-year testing program has been provisionally approved and will inform on the MOA, dose-response and tissue deposition of poorly soluble/ poorly reactive Co substances and in vivo site of contact genotoxicity and inflammatory responses induced by reactive Co substances. Combined, all evidence on the carcinogenicity of cobalt can be reconciled into one mode-of-action paradigm and into one continuous exposure response with a good estimation of a threshold in the dose response curve. The essential biological role of cobalt and its extensive mechanistic, genotoxicity and toxicity data fit the overall profile of a carcinogen with a threshold mode-of-action and this is consistent with the available epidemiological data. In contrast, current linear approaches based solely on animal data yield a predicted excess cancer risk that cannot be reconciled with the lack of excess cancer cases observed in the epidemiology studies. In both NTP cancer bioassays (cobalt sulfate and cobalt metal powder), adrenal pheochromocytoma were observed. These tumors are a well-known secondary response to respiratory distress of any origin (not just lung cancer) and should not be interpreted as independent cobalt-related tumors. Further systemic tumors were only seen in one sex of rats (not in mice) in the cobalt metal powder study. The rat strain and colony used in this inhalation study does not have a historical control database against which these tumors can be compared, making the interpretation of these findings extremely difficult. Further, there was no exposure-response in any of these findings. The conclusion of independence of these tumors appears implausible. The CI promotes the responsible and sustainable production and use of cobalt in all its forms and applications. The Institute aims to protect and grow the market for cobalt and compounds by promoting a proportionate regulatory environment. We welcome any additional requests or clarifications from the US EPA regarding the current submission and would appreciate the opportunity for cooperation and communication to lead to the appropriate risk management measures and limit values applied to cobalt and cobalt substances. ", "comment_id": "EPA-HQ-ORD-2022-0833-0006", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-ORD-2022-0833-0006", "comment_date": "2022-12-16", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 4708}]}, {"id": "DEA-2016-0020", "agency": "DEA", "title": "Schedules of Controlled Substances: Temporary Placement of six synthetic cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) into Schedule I", "update_date": "2021-12-02", "update_time": "01:00:52", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I believe the DEA should add the six synthetic cannabinoids listed in the document to the list of Schedule 1 drugs. The document states that these drugs are highly addictive, contain severe safety concerns and serve no health benefits. Additionally the document states that there have already been several fatalities where this drug was found in the victims blood. Given these facts, it is evident these drugs are dangerous and should therefore be prohibited from use.", "comment_id": "DEA-2016-0020-0012", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2016-0020-0012", "comment_date": "2019-04-15", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 468}]}, {"id": "EPA-HQ-OAR-2009-0211", "agency": "EPA", "title": "Notice of Receipt of a Request for a Clean Air Act Waiver to Increase the Allowable Ethanol Content of Gasoline to 15 Percent\r\n", "update_date": "2022-03-08", "update_time": "01:04:01", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "As the owner of a boat powered by an outboard engine, I engourage you to reject the waiver.  There is already sufficient evidence that the E10 fuels now are quite damaging to these engines.  I am a supporter of the research and testing for renewable fuels, but it is too early to allow for wide use of these fuels in engines that were not designed to handle it.  E15 fuel would lead to higher maintenance costs, loss of use, and potential safety problems for boat owners like me.Sincerely,C. Dickinson", "comment_id": "EPA-HQ-OAR-2009-0211-1575", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-1575", "comment_date": "2009-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 546}, {"text": "My 2001 Toyota only gets 20 mpg now.  If you allow for E15 to go into effect I will not be able to afford to drive my car to my $8.00 an hour job..  Lets get real,  We dont even know about the long term damage being done to my car with E10.  Lord knows I cant afford to buy another car!!!!", "comment_id": "EPA-HQ-OAR-2009-0211-1580", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-1580", "comment_date": "2009-06-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 314}, {"text": "I believe it is unfortunate many oil companies think they are in the petroleum industry when they should be in the energy business.  Instead of trying to stop ethanol they should embrace it and encourage its use.  We should not only have 15% ethanol blends but should have 100% ethanol vehicles", "comment_id": "EPA-HQ-OAR-2009-0211-0535", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-0535", "comment_date": "2009-05-13", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 309}, {"text": "Not only will increased use of ethanol further reduce my gas mileage, butaccording to my owner manual, anything higher than 10% ethanol will void thewarranty on my vehicle.The reduced mileage flies in the face of the nations desire to reduce carbonemissions.  Perhaps ethanol reduces the carbon emissions per gallon, but we haveto use more gallons so there is no noticeable reduction.  The increased usage of ethanol can cause corrosion that will cost a lot of moneyto repair.  Please consider all aspects before causing Americans to spend more money thatthey dont have.", "comment_id": "EPA-HQ-OAR-2009-0211-1552", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-1552", "comment_date": "2009-06-05", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 635}, {"text": "Please increase the ethanol content to at least E15.  All vehicles built sincethe early 1980s are tolerant of the oxygen that is a part of the ethanolmolecule.  Ethanol provides a boost to the octane without being a health threat(like Lead, Benzene or MTBE).Ethanol is a clean burning, high octane, renewable fuel in and of itself and theperfect additive to help dirty gasoline burn cleaner and help us wean ourselvesfrom our addiction to oil.", "comment_id": "EPA-HQ-OAR-2009-0211-1689", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-1689", "comment_date": "2009-06-09", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 473}, {"text": "Why do we have a mandate for 90% gasoline?  To me, thats what the E10 restriction really is.  Do we owe the future of our transportation energy complex to the oil companies?  I think not.  Theyve helped build it over the past century and were rewarded handsomely for it.  Now its time to break the technical and economic monopoly that they and OPEC have evolved into.E15 will increase competition in the market and bring prices down at the pump, helping every one of us.  I have a blender pump nearby and frequently find myself waiting in line for it while regular gas pumps sit idle.  Choice is good and people will buy what makes sense for them.  As ethanol production gets more efficient and markets open, making it more competitive, people will move our country away from oil.  The best thing government can do is clear the way for open competition.Yes, there have been concerns about engine wear.  And without data, all concerns are legitimate; but now we have the data.  I have read the conclusions and data of many studies.  The overwhelming majority say E15 does not negatively effect engines and, in fact, may have a positive impact.Next, the stability of our economy depends on making products here on U.S. soil.  Ethanol provides a strong, diverse and sustainable base for agriculture, fuel production, machinery, and support services.  As we advance competitive renewable fuels, many jobs and communities will continue to turn the corner from a steady decline to rebuilding and thriving as we put U.S. citizens to work.And last.  If we really want to clean up our environment, the best effort is one that we can control, here at home.  If we continue to import such a large portion of our oil and support the use of gasoline globally, we have very little control over the pollution generated by those countries.  As a leader, the U.S. can help turn the corner away from carbon-heavy fossil fuels to cleaner energy that is produced in environmentally controlled facilities right here.Thank you.", "comment_id": "EPA-HQ-OAR-2009-0211-0012", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-0012", "comment_date": "2009-04-21", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2175}, {"text": " The increase to E15 from E10, will damage fuel systems, componets, and void car/truck warranties...if approved the government much ensure those warranties...this is not a comsumer choice. This proposal does simply smack more of politics and is wrongheaded...to support the farm states and big-arga-busnesses. This will further decrease MPGs, damage systems not designed to handle E15. It seems clear that the ethanol plans are being shut down for lack of demand vis a vis lower oil prices worldwide have plunged to $50/bbl from $140/bbl. This is just a bad idea that trys to bail out producers who have tried to benefit from government directed solutions instead of allowing the marketplace to determine the best alternatives to become less oil dependant.  The USA should address in part the situation with already proven technologies, eg neclear power plants that successful provide eletrical engery to 75 percent of all of France. This doable, safe, and clean...no carbon whatsoever!In closing, do not mandate solutions such as raising E10 to E15...Just tax gasoline inversely to the cost oil per bbl, ie oil goes up,the the tax goes down...this would,if the tax were sufficent to reduce demand, mileage, improve the enviorment, and result in smaller more effecient auto/trucks to boot. As proposed mandating E15, is a bad ideal!", "comment_id": "EPA-HQ-OAR-2009-0211-0051", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-0051", "comment_date": "2009-04-22", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1431}, {"text": "This is simply a bad idea. Our equipment will not run on the mandated 10% Ethanol. Increasing to15% makes a bad idea worse.", "comment_id": "EPA-HQ-OAR-2009-0211-0081", "comment_url": "https://api.regulations.gov/v4/comments/EPA-HQ-OAR-2009-0211-0081", "comment_date": "2009-04-23", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 128}]}, {"id": "DOD-2012-HA-0146", "agency": "DOD", "title": "TRICARE; Reimbursement of Long Term Care Hospitals", "update_date": "2020-10-22", "update_time": "01:33:07", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "When CMS adopted the site-neutral payment method in the 2015 IPPS Final Rule, CMS-1607-R, they set one requirement for a preceding 3 day ICU stay at an acute care hospital. CMS then issued MLN Matters 9015 which changed that requirement to IPPS hospital. As a result, civilian long term acute care hospitals are rejecting patients from a VA or military hospital because the preceding ICU stay was not at an IPPS hospital. This is depriving military and veteran patients access to LTACH because of that small change. Can you clarify this?", "comment_id": "DOD-2012-HA-0146-0006", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0146-0006", "comment_date": "2016-09-27", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 585}, {"text": "Because of the low number of inpatient cases to LTCHs, we can conclude that the change of payment methods would do very little to affect the amount that Medicare pays and therefore the proposed rule should not be implemented. The LTCHs do not rely on the payments of TRICARE at all. Based off of average amounts per year, less than four TRICARE beneficiaries are served at LTCHs. Furthermore, 73% of billed charges were people not affiliated with the TRICARE program which proves that a change in reimbursement is completely unnecessary because of the lack of utilization by TRICARE beneficiaries. If we were to adopt this rule, the reimbursement system would need to change completely which could potentially create confusion for both the patients and hospitals. Also, the system has not already been created and would be different than Medicares reimbursement system because they would have to recalculate how to charge for short term stays. In conclusion, the low number of cases that would benefit from this reimbursement should not completely change the program simply because it would just be too impractical. ", "comment_id": "DOD-2012-HA-0146-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0146-0002", "comment_date": "2015-03-18", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1126}, {"text": "As an active duty service member, I can understand the need to decrease costs related to long term stays in long term care hospitals and inpatient rehabilitation units.  My opinion is that if there is to be a cost-share that the service member will be required to pay out of pocket, then an alternate means of insurance should be made available for purchase to the service member or retiree to cover these costs even though they are considered to be minimal utilizing catastrophic caps.  I believe this is important because it is not unrealistic that many service members injured either during training or down range will require these services.  It is not something that can be based solely on age related injuries or illnesses alone.  Also, if utilization of VA services are an option that will not require the service member to pay out of pocket costs, they should be made aware and these services should be comparable to services provided at a private/civilian facility.  This is simply because these service members have put their life in danger for this country and for that, they have earned the right to the best possible care they can receive without putting their family in debt.", "comment_id": "DOD-2012-HA-0146-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2012-HA-0146-0005", "comment_date": "2016-09-08", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1189}]}, {"id": "DOD-2013-HA-0085", "agency": "DOD", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\r\nTRICARE:  Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries through the TRICARE Mail Order Program", "update_date": "2020-10-22", "update_time": "01:33:13", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "i BELIEVE THE EFFECTIVE DATE OF THE RULE FOR OPTING OUT SHOULD BE EARLY IN 2013 AS MANY OF US BEGIN USING MAIL ORDER AT THAT TIME IN ACCORDANCE WITH THE LAW.....NOW YOU BACK IT OFF UNTIL February 14, 2014. IT WAS NOT THE BENEFICIARY FAULT THAT THE PHARMACY BENEFIT MANAGER WAS NOT READY TO IMPLEMENT THE LAW....ITS A FIVE YEAR PROGRAM AND SOME OF US PLAYED BY THE RULES AND NOW FIND WE ARE PENALIZED. AFTER WELL OVER A YEAR IN THE PROGRAM, THE MAJOR PROBLEM IS THE LACK OF ABILITY TO COMMUNICATE WITH EXPRESS SCRIPTS....IN WELL OVER A YEAR, WE HAVE NOT COMMUNICATED WITH A PHARMACIST OR EVEN A TECHNICIAN. WE HAVE NO IDEA THE QUALIFICATION OF THE SO CALLED ADVOCATES IN PHARMACOLOGY. THE RULES FOR OPTING OUT AND FOR A WAIVER SHOULD BE MUCH MORE SPECIFIC. EXPRESS SCRIPTS WORKS HARD ON KEEPING THE MEDICATIONS ON TIME....BUT GOD FORBID IF THE PHYSICIAN CHANGES THE mg OR THE DRUG....IMPOSSIBLE TO COMMUNICATE THE ISSUE WITH THEM IN TIME TO MEET THE DEMANDS OF THE MEDICATION. I ALSO QUESTION YOUR SAVINGS FROM THE PROGRAM...IN A RECENT DOD/IG REPORT THEY SAY THE PROGRAM IS A WASTE OF MONEY......WHEN AND WHERE WILL THE LIST OF SELECTED MEDICATION FOR MAIL ORDER BE POSTED? .THANK YOU FOR LETTING ME COMMENT.   ", "comment_id": "DOD-2013-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0002", "comment_date": "2014-01-17", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1211}]}, {"id": "FDA-2011-N-0467", "agency": "FDA", "title": "Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products", "update_date": "2012-02-23", "update_time": "13:51:22", "purpose": "Rulemaking", "keywords": ["ctp20117", "CTP", "0910-AG43", "Non-Face-to-Face Sale", "Tobacco Products"], "comments": [{"text": "Docket # FDA 2011 N 0467I would like to comment on the U.S. Food and Drug Administration proposed rule of Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products. As a legal citizen of the United States I strongly agree with the proposed ruling, regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face or exchanged between a retailer and a consumer (FDA 2011-n-0467). Far too often children are finding ways to get their hands on tobacco products. I dont think they understand the significant of what tobacco product can do to their bodies. Under the FDA 2010-n-0568 Required Warning for Cigarettes and Advertisement stresses their concern on how smoking causes death. I think the Food and Drug Administration should have strict guidance to control the promotion and marketing of tobacco products that are sold or distributed through a non-face-to-face exchange to protect our children from getting their hands on tobacco products who have not reached the legal age to purchase those items. By law it is required that the nine warning must appear on cigarette advertisement and packaging but who is monitoring those non face to face exchange and ensuring they are checking to see if young adults are at the legal age to purchase tobacco products. It worries me that the Center for Disease Control and Prevention says tobacco use is the single biggest cause of preventable death in the United States  killing more than 443,000 user and victims of secondhand smoke and causing serious illness in 8.6 million Americans (FDA Wants your input on Cigarette Warning). I suffer from asthma and I know how it feels to be around someone who smokes and I immediately have to leave the area because it triggers my asthma. Smoking is a big health risk we face in our society. Please protect us and our children from those non - face - to - face exchange. Im for the propose rule", "comment_id": "FDA-2011-N-0467-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0009", "comment_date": "2011-12-19", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2041}, {"text": "I work for a small business owner writing to comment on the FDAs review of non-face-to-face sales of tobacco products. Specifically, my comments address electronic cigarettes.The emerging market for electronic cigarettes represents a possible new revenue stream for businesses like mine.  Adult tobacco users who seek alternatives to traditional tobacco can purchase electronic cigarettes at a growing number of retails stores in cities across the nation.Unfortunately, a few shadowy companies - located who knows where  are making big profits by selling electronic cigarettes on the Internet.  Those companies dont invest in their communities and create jobs they way mine does.Why would the federal government allow this to happen?Its not fair for the federal government to favor out of state retailers over local businesses by making it easier to sell on the Internet than from a bricks and mortar retailer.And what about keeping harmful products away from kids?  Age verification on the Internet is unreliable.I urge the FDA to implement an outright ban on electronic cigarette sales on the Internet or, at a minimum, to increase the regulations covering non-face-to-face sales.  This could include requiring online retailers of electronic cigarettes to comply with the many state and local regulations Ive got to deal with.  And to pay all the taxes Ive got to pay!Thank you for your consideration of my comments.", "comment_id": "FDA-2011-N-0467-0075", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0075", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1535}, {"text": "I work for a wholesale distributer.  Included in our product line are electronic cigarettes.  I believe that the FDA should ban sale of electronic cigarettes as well as all tobacco products from sale over the internet. Tobacco products should be sold only on a face to face basis from a local retailer to insure age verification. Internet sales companies do not support local communities the way that we and our retail customers do. Please protect our children and support local business by banning these cigarettes from internet sales. ", "comment_id": "FDA-2011-N-0467-0087", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0087", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 732}, {"text": "To Whom It May Concern: Regarding non-face-to-face sales of tobacco and tobacco derivative products, please strengthen the regulations related to Internet sales.  Whether people use these products to stop smoking or for simple enjoyment, they have a right to buy them through their local retailer, or perhaps with reasonable restrictions, even on the Internet.  Lets just keep kids from dodging the age verification requirements and maybe help out the bricks and mortar retailers in my neighborhood.", "comment_id": "FDA-2011-N-0467-0091", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0091", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 506}, {"text": "I believe Ecigs should be regulated so minors cannot purchase on the internet.", "comment_id": "FDA-2011-N-0467-0097", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0097", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 78}, {"text": "I am writing to ask the FDA to protect the children of our nation by banning the Internet sale of electronic cigarettes, or to at least regulate their availability on the web in some form or fashion. Its not that I oppose the idea of e-cigarettes. In fact, I know several people have been using them. THey feel better than ever and have been off of traditional cigarettes for months now. Many of these people have tried other cessation methods in past. But, e-cigarettes were the answer for them. However, such tobacco products should be purchased at their local retailer in a face-to-face transaction because age verification on the Internet is too easily manipulated by children.Lets keep tobacco products out of the hands of children!Thank you.", "comment_id": "FDA-2011-N-0467-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0071", "comment_date": "2012-02-13", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 786}, {"text": "To Whom It May Concern,My name is Rebecca Maisel, and I am a partial owner and full-time employee of a company that manufactures and imports electronic cigarettes. I am writing to respectfully urge FDA to impose regulations requiring face-to-face sales of electronic cigarettes. Based on various studies published world-wide, there is no question that electronic cigarettes pose a safer alternative to traditional cigarettes. With that said, even a cursory review of available retail outlets on the web reveals a clear lack of regard for the safety of minors under the age of 18 (or 19 in some states) with respect to electronic cigarette purchases. Although e-cigs are a safer alternative, they still contain nicotine. It is well-known that age verification methods online are ineffective. Thus, currently minors can easily attain electronic cigarettes containing nicotine online. Being involved in the electronic cigarette industry, I can personally attest to the fact that the race to brick-and-mortar retailers is well underway. There currently exists abundant availability of a wide range of e-cig brands at retail outlets throughout the U.S. Indeed, adults of majority age who choose to purchase electronic cigarettes will continue to have the opportunity to do so should FDA ban remote or online sales of these products. In the alternative, if FDA chooses not to outright ban online sales of electronic cigarettes, FDA should at a minimum heavily regulate the online sale of electronic cigarettes, requiring online retailers to have strict age verification policies, among other regulations intended to deter and prevent minors from purchasing e-cigs online. In addition to increasing the safety of minors, a ban of online sales would show FDAs support for traditional retail business, many of which are run by small business owners who are employing Americans in their stores nationwide. As I see it, there is no downside to removing or heavily regulating online sales of e-cigs. Thank you.", "comment_id": "FDA-2011-N-0467-0073", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0073", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2008}, {"text": "Its not fair for the federal government to favor out of state retailers over local businesses by making it easier to sell on the Internet than from a bricks and mortar retailer.", "comment_id": "FDA-2011-N-0467-0074", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0074", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 230}, {"text": "Speaking and acting with ALL, ALL, ALL, ALL, ALL, ALL, ALL the power and plural, ALL INCLUSIVE, ALL, ALL, ALL, ALL, ALL, ALL, ALL the influence and plural, ALL INCLUSIVE, ALL, ALL, ALL, ALL, ALL, ALL, ALL the authority and plural et al., ALL INCLUSIVE, within ALL, ALL, ALL, ALL, ALL, ALL, ALL my capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as and for myself per se, ALL INCLUSIVE, a duly-sworn/affirmed and duly-commissioned New York State Notary Public (registration number 01BR6014922, via and based in Suffolk County, since October 19, 1998, hereinafter abbreviated as N.P.), ALL INCLUSIVE, the Delois Albert Brassell Estate Administrator (via New York State Surrogate Court (Suffolk County) index number 176A2004 (Certificate of Letters of Administration, court certificate number 17268, issued and court appointment granted on March 26, 2004), D-U-N-S Number 831823948 and U.S. CAGE Code 5PAZ8), ALL INCLUSIVE, and the Robert James Brassell Estate Administrator (via New York State Surrogate Court (Suffolk County) index number 177A2004 (Certificate of Letters of Administration, court certificate number 17269, issued and court appointment granted on March 18, 2004), D-U-N-S Number 962019514 and U.S. CAGE Code 64WJ9), ALL INCLUSIVE: ANY AND ALL tobacco producers, retailers, harvesters et al., ALL INCLUSIVE, WITHOUT EXCEPTION, ALL INCLUSIVE, better make sure all of you, ALL, INCLUSIVE, get your lies straight, ALL INCLUSIVE, ESPECIALLY on such matters, concerns et al., ALL INCLUSIVE, as non-Face-to-Face Sale and distribution of your various products and advertising, promotion, marketing et al., ALL INCLUSIVE, via et al., ALL INCLUSIVE, your operations et al., ALL INCLUSIVE.", "comment_id": "FDA-2011-N-0467-0098", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0098", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1735}, {"text": "Ok, So we are going to let anyone buy e cigs over the Internet? How will this be monitored? Does this mean that my 15 year old can go online and order cigarettes now? When they show up atthe house say I have no clue? How do we know that the people are legal smoking age? We dont. If there is one thing that we have learned and preached about the internet, it is that you never know who is on the other end. Avaliablty needs to be regulated.", "comment_id": "FDA-2011-N-0467-0084", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0467-0084", "comment_date": "2012-02-14", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 450}]}, {"id": "CMS-2020-0060", "agency": "CMS", "title": "Value in Opioid Use Disorder Treatment Demonstration (CMS-10728)", "update_date": "2021-04-04", "update_time": "01:05:32", "purpose": "Nonrulemaking", "keywords": null, "comments": [{"text": "How do an FQHC sign up to participate. Please advise.Thanks,", "comment_id": "CMS-2020-0060-0002", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0002", "comment_date": "2020-07-14", "comment_time": "04:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 80}]}, {"id": "CISA-2020-0014", "agency": "CISA", "title": "Removal of Certain Explosive Chemicals from the Chemical Facility Anti-Terrorism Standards", "update_date": "2024-01-19", "update_time": "15:41:17", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "On behalf of Owen Oil Tool, I am writing to support this Advanced Notice of Proposed Rulemaking (ANPRM) and urge you to move forward with the solutions outlined without delay.  As Corporate Sales of Owen Oil Tool I am acutely aware of the burden the Chemical Facility Anti-Terrorism Standards (CFATS) program places on the commercial explosives industry and the absence of any data indicating the program has made the 49 chemicals identified in this ANPRM more secure. The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has overseen the manufacture, sale, possession and use of all commercial explosives since 1970.  The CFATS programs additional oversight of these 49 chemicals represents clear-cut regulatory duplication.  Based on data from the U.S. Bomb Data Centers (USBDC) annual Explosive Incident Report, thefts of explosives have seen a steady decrease over the last 30 years due to ATF regulation and industry best practices.  Since the beginning of the CFATS program in 2007, that historical rate of decline has not seen a significant change.  The CFATS program plays a pivotal role in securing previously unregulated chemicals.  However, according to all available government data, no benefit is seen when stacked on top of preexisting ATF regulations. On January 21, 2021, the Government Accountability Office (GAO) released a study reviewing the CFATS program and its overlap with other chemical security programs .  The study found that most CFATS Risk-Based Performance Standards directly overlap with ATF regulatory requirements for commercial explosives.  COMPANY NAME strongly supports all government efforts to bolster explosive security; however, directly overlapping regulation without commensurate benefit does not fulfill that goal.The removal of these chemicals from CFATS Appendix A is both an exercise in regulatory rightsizing and good government.  This ANPRM should move forward with haste to free up government and industry resources towards efforts that show tangible impacts on national security.  Respectfully Submitted,Richard CarterCorporate Sales", "comment_id": "CISA-2020-0014-0024", "comment_url": "https://api.regulations.gov/v4/comments/CISA-2020-0014-0024", "comment_date": "2021-03-02", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2153}, {"text": "Dear Acting Director Wales:I commend you for considering removing all 49 Division 1.1 explosive chemicals of interest from Appendix A of the Chemical Facility Anti-Terrorism Standards (CFATS) regulations. Removing these chemicals of interest from coverage under CFATS would reduce regulatory requirements for facilities currently covered by both CFATS and ATFs regulatory frameworks and relieve compliance burdens for affected facilities.The commercial explosives industry has been subject to duplication in security oversight since the introduction of the Chemical Security Anti-Terrorism Standards (CFATS) program. This rulemaking will remedy a long overdue and unnecessary burden on our industry that shows no commensurate benefit to national security. The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) oversight of commercial explosives has resulted in a steady decrease in thefts of explosives over the last 30 years, according to statistics from the U.S. Bomb Data Center. The added layer of CFATS oversight on these chemicals has not shown a statistical improvement in their security.On January 21, 2021, the Government Accountability Office (GAO) released their study reviewing the CFATS program and overlap with other chemical security programs . The study found that most CFATS Risk-Based Performance Standards (RBPS) directly overlap with ATF regulatory requirements for commercial explosives. In 1998, while developing the Risk Management Plan (RMP) regulations, the Environmental Protection Agency (EPA) issued a final rule removing Division 1.1 explosives from its list of regulated substances for accidental release prevention, coming to the conclusion that the explosives industry practices promote safety and accident prevention in storage, handling, transportation and use of explosives.Thank you for this opportunity to submit my comments. I support this Advanced Notice of Proposed Rulemaking and urge you to move forward with prudent and financially responsible regulations.", "comment_id": "CISA-2020-0014-0014", "comment_url": "https://api.regulations.gov/v4/comments/CISA-2020-0014-0014", "comment_date": "2021-02-26", "comment_time": "05:00:00", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 2064}]}]