Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 50541 

person will notify interested persons 

regarding their request to speak by 

October 14, 2021. 

Closed Committee Deliberations: On 

October 28, 2021, from 12:20 p.m.to 

1:20 p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigator’s 

research programs, along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kathleen 

Hayes (CBERVRBPAC@fda.hhs.gov) at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19436 Filed 9–8–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0951] 

Reconsidering Mandatory Opioid 

Prescriber Education Through a Risk 

Evaluation and Mitigation Strategy in 

an Evolving Opioid Crisis; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Reconsidering 

Mandatory Opioid Prescriber Education 

Through a Risk Evaluation and 

Mitigation Strategy (REMS) in an 

Evolving Opioid Crisis.’’ Convened by 

the Duke-Margolis Center for Health 

Policy and supported by a cooperative 

agreement between FDA and DukeMargolis, the purpose of the public 

workshop is to give stakeholders an 

opportunity to provide input on aspects 

of the current opioid crisis that could be 

mitigated in a measurable way by 

requiring mandatory prescriber 

education as part of a REMS. We expect 

interested stakeholders to include 

healthcare providers, healthcare 

professional associations, pharmacists, 

pharmacy benefit managers, public and 

private insurers, patient organizations, 

Federal and State Agencies, providers of 

continuing education for healthcare 

professionals, and the public. A second 

public workshop is being planned to 

solicit input on additional issues 

associated with a move to mandatory 

prescriber education under a REMS, 

such as operational and technical issues 

related to such a system and what 

should be included in potential 

mandatory prescriber education. 

DATES: The public workshop will be 

held on October 13, 2021, from 1 p.m. 

to 5 p.m. Eastern Time and October 14, 

2021, from 1 p.m. to 4:05 p.m. Eastern 

Time. Submit either electronic or 

written comments on this public 

workshop by December 3, 2021. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: Due to the impact of the 

COVID–19 pandemic, these meetings 

will be held virtually to help protect the 

public and limit the spread of the virus. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before December 3, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of December 3, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0951 for ‘‘Reconsidering 

Mandatory Opioid Prescriber Education 

Through a Risk Evaluation and 

Mitigation Strategy (REMS) in an 

Evolving Opioid Crisis.’’ Comments 

filed and received in a timely manner 

(see ADDRESSES) will be placed in the 

docket and, except for those submitted 

as ‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 


lotter on DSK11XQN23PROD with NOTICES1
50542 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 

1 Dowell, D., T.M. Haegerich, and R. Chou, ‘‘CDC 

Guideline for Prescribing Opioids for Chronic 

Pain—United States, 2016’’. JAMA, (2016) 

315(15):1624–1645. 

2 IQVIA Institute, ‘‘National Prescription Audit’’ 

extracted March 2021, U.S. Census Bureau. 

3Mallama, C.A., C. Greene, A.A. Alexandridis, et 

al. ‘‘Patient-Reported Opioid Analgesic Use After 

Discharge From Surgical Procedures: A Systematic 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Michie Hunt, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6153, Silver Spring, 

MD 20993, 301–796–3504, 

michie.hunt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As FDA continues to work to address 

the opioid crisis, we are reconsidering 

our current efforts to ensure prescriber 

education regarding opioids is being 

delivered in a way that is as efficient 

and effective as possible. As a part of 

this work, we are revisiting whether 

there is a need for a mandatory form of 

prescriber education linked to the 

prescribing of opioids. In 2012, FDA 

approved the Extended Release/Long 

Acting (ER/LA) Risk Evaluation and 

Mitigation Strategy (REMS), at the core 

of which was a requirement that 

sponsors of ER/LA opioid analgesics 

make an education program available 

for healthcare providers who prescribe 

ER/LA opioid analgesics (e.g., 

physicians, nurse practitioners, and 

physician assistants). The goal of the 

ER/LA opioid analgesic REMS was to 

reduce serious adverse outcomes 

resulting from inappropriate 

prescribing, misuse, and abuse of ER/LA 

opioid analgesics while maintaining 

patient access to pain medications. The 

adverse outcomes of concern included 

addiction, unintentional overdose, and 

death. 

While developing the REMS 

requirements, FDA considered whether 

the education should be made 

mandatory for prescribers but decided 

against making mandatory education a 

REMS requirement at the time. This was 

due to concerns about placing an undue 

burden on the healthcare delivery 

system, in part because the 

implementation of mandatory education 

through the REMS might have required 

a restricted distribution system. It is 

possible that given technological 

advances in the intervening years, 

including broader implementation of eprescribing for controlled substances, 

there might be ways to lessen the 

burden associated with a restricted 

distribution system, including potential 

negative impact on patients who need 

opioids for pain management. 

When the REMS was put in place in 

2012, instead of mandatory education, 

FDA required that ER/LA opioid 

manufacturers make the training 

available to prescribers at no or nominal 

cost and that the training be accessible 

in a variety of different formats. FDA 

also recommended that the training be 

offered for continuing education (CE) 

credit. The REMS as implemented 

requires the training to conform to a 

blueprint (available at https://

www.accessdata.fda.gov/drugsatfda_

docs/rems/Opioid_analgesic_2018_09_

18_FDA_Blueprint.pdf) developed by 

FDA that contains a high-level outline 

of the core educational messages to be 

included in the CE programs developed 

under the REMS. The initial education 

program included general and productspecific information about the ER/LA 

opioid analgesics; information on 

proper patient selection for use of these 

drugs; guidance for safely initiating 

therapy, modifying dosing, and 

discontinuing use of ER/LA opioid 

analgesics; guidance for monitoring 

patients; and information for counseling 

patients and caregivers about the safe 

use of these drugs. 

After reviewing existing requirements 

and considering Advisory Committee 

recommendations obtained in 2016 

about the ER/LA REMS, in 2018 FDA 

expanded the REMS to include both 

immediate release (IR) opioid analgesics 

and ER/LA opioid analgesics intended 

for use in an outpatient setting. The 

content of the blueprint was redesigned 

to contain principles of appropriate pain 

management, including the use of 

alternatives to opioids for the treatment 

of pain; the basic elements of addiction 

medicine; and the neurobiology, 

identification, and management of 

opioid use disorder. The blueprint 

currently does not include principles for 

managing opioid use disorder, including 

treatment with buprenorphine. The 

revised Opioid Analgesic (OA) REMS 

also expanded the prescriber audience 

and requires that the OA manufacturers 

make training available to all members 

of the healthcare team involved in the 

management of patients with pain, 

including nurses and pharmacists. As 

with the ER/LA REMS, training under 

the OA REMS is voluntary. 

Cumulatively, from February 28, 

2013, through May 15, 2021, there have 

been 354,949 completers of REMS CE 

from the ER/LA REMS and the OA 

REMS. For context, there were 

approximately 1 million prescribers of 

opioid analgesics in 2019. In addition, 

although many public and private 

entities have independently 

implemented their own education 

programs and other interventions to 

encourage safe and effective prescribing 

practices for opioid analgesics, there is 

no nationwide standard. Therefore, 

these programs likely differ with regard 

to content, focus, and duration. 

Following the creation and expansion 

of the REMS and other efforts, including 

the introduction of the Centers for 

Disease Control and Prevention (CDC) 

Guideline for Prescribing Opioids for 

Chronic Pain in 2016,1 the estimated 

number of opioid analgesic 

prescriptions dispensed per capita in 

the United States has been steadily 

declining from a peak of 84 

prescriptions per 100 residents in 2012 

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, reflecting levels not seen since 

the early 1990s (44 prescriptions per 

100 U.S. residents in 1992).2 Despite 

this decrease in dispensing, multiple 

studies have reported patients received 

more opioid analgesic tablets than 

needed following surgical procedures. 

FDA’s systematic review of studies 

published prior to 2019 showed that in 

articles reporting on the prescribing of 

excess tablets, 25 percent to 98 percent 

of the total tablets prescribed were 

reported to be excess, with most studies 

reporting that 50 percent to 70 percent 

of tablets went unused.3 There are also 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 50543 

Review.’’ (2021) Pain Medicine, doi: 10.1093/pm/ 

pnab244. 

4National Institute on Drug Abuse, ‘‘Overdose 

Death Rates.’’ (2021) (Available at: https://

www.drugabuse.gov/drug-topics/trends-statistics/ 

overdose-death-rates) (accessed August 20, 2021). 

5Mattson C.L., L.J. Tanz, K. Quinn, et al, ‘‘Trends 

and Geographic Patterns in Drug and Synthetic 

Opioid Overdose Deaths—United States, 2013– 

2019.’’ Morbidity and Mortality Weekly Report, 

(2021) 70(6):202–207. 

6Compton, W.M., C.M. Jones, and G.T. Baldwin, 

‘‘Relationship Between Nonmedical PrescriptionOpioid Use and Heroin Use.’’ New England Journal 

of Medicine, (2016) 374:154–163. 

7Ahmad, F.B., L.M. Rossen, and P. Sutton, 

‘‘Provisional Drug Overdose Death Counts.’’ 

National Center for Health Statistics, 2021. 

(Available at: https://www.cdc.gov/nchs/nvss/vsrr/ 

drug-overdose-data.htm) (accessed 8/20/2021). 

8National Institute on Drug Abuse, ‘‘Overdose 

Death Rates.’’ January 29, 2021. (Available at: 

https://www.drugabuse.gov/drug-topics/trendsstatistics/overdose-death-rates). 

concerns about continued opioid 

analgesic prescribing to vulnerable 

populations, such as children and 

adolescents following common dental 

and minor surgical procedures. 

Despite this decline in opioid 

analgesic dispensing, overall opioidinvolved overdose deaths have risen 

sharply since 2012, with opioids often 

seen in combination with other 

substances such as cocaine, 

methamphetamine, and 

benzodiazepines.4 5 This rise has been 

driven primarily by a surge in deaths 

initially involving heroin and then 

illicitly manufactured fentanyl and 

fentanyl analogues. Although these 

overdose deaths largely involve illicit 

substances, many users of illicit opioids 

are initially exposed to opioids through 

nonmedical use of prescription 

opioids.6 Moreover, as of 2020, 

prescription opioids were involved in 

more than 16,000 fatal overdoses per 

year,7 higher than the number seen at 

the peak of opioid analgesic dispensing 

in 2012.8

Against this background of a complex 

and intensifying crisis, FDA is 

reconsidering the need for mandatory 

prescriber training through a REMS and 

seeks input from stakeholders about the 

aspects of the opioid crisis that 

mandatory training through such a 

REMS could potentially mitigate. In 

light of the many available education 

programs and the lack of a nationwide 

standard, FDA is exploring the value of 

a single source for education on the 

appropriate use of opioids, on the risks 

of opioid abuse and misuse, and on the 

treatment of opioid use disorder to 

address multiple needs and reduce the 

burden on prescribers. 

II. Topics for Discussion at the Public 

Workshop 

1. How could mandatory prescriber 

education through a REMS improve 

appropriate opioid prescribing, pain 

management, and the treatment of 

opioid use disorder? 

a. Please specifically discuss the value 

of such a system in light of existing 

continuing education requirements, the 

wide array of available educational 

programs (including currently available 

OA REMS educational offerings), and 

other interventions by Federal Agencies, 

States, healthcare systems, retail 

pharmacies, payers, pharmacy benefit 

managers, and other public and private 

organizations. Could mandatory 

education under a REMS make 

prescriber education more consistent, 

efficient, and effective? 

b. Please specifically discuss how a 

mandatory REMS educational program 

could address the needs for prescriber 

education on the overprescribing of 

opioids for acute pain. 

c. Please specifically discuss how a 

mandatory REMS educational program 

could address the needs for prescriber 

education on the treatment of opioid use 

disorder. 

2. What are the important core 

competencies, knowledge gaps, clinical 

challenges, or misunderstandings 

among practitioners that could be 

addressed through mandatory education 

under a REMS to help improve patient 

outcomes and mitigate the current 

crisis? 

a. Please comment specifically on any 

key knowledge gaps or core 

competencies related to screening, 

diagnosis, or treatment of opioid use 

disorder or substance use disorder that 

should be incorporated into mandatory 

education for opioid prescribers. 

3. If FDA were to implement a 

mandatory prescriber education 

program, please discuss what 

appropriate program goals might be. 

How could we measure the impacts of 

such a program and determine whether 

it is meeting its goals? 

4. Regarding the implementation of 

such a mandatory REMS educational 

system: 

a. Please discuss challenges you 

foresee in the implementation of a 

mandatory REMS educational system. 

b. What can we learn about the 

implementation of prescriber education 

from existing educational programs in 

pain management, in opioid risk 

reduction, and in the treatment of 

opioid use disorder? 

5. What could be unintended 

consequences of mandatory opioid 

prescriber education through a REMS 

and are there ways to identify and 

address them? 

Although not specifically discussed at 

this Public Workshop, FDA is interested 

in obtaining input on additional issues, 

including: 

a. The continuing education delivery 

approaches, methods, and information 

technology platforms that should be 

considered to maximize the 

acceptability and effectiveness of 

mandatory prescriber education. 

b. Any technological advances since 

2012 that would make the delivery of 

mandatory training more efficient and 

reduce burden on the healthcare system. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: http://

events.constantcontact.com/register/ 

event?llr=4fyj4myab&oeidk=a07eifbycns

fd5b6b1f. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. 

Registration is free. Persons interested 

in attending this public workshop must 

register by 4:05 p.m. Eastern Time on 

October 14, 2021. Registrants will 

receive confirmation when they have 

been accepted. Registered participants 

will be sent technical system 

requirements in advance of the event. 

We recommend that you review these 

technical system requirements prior to 

joining the virtual public workshop. The 

workshop will be recorded, and the 

recording will be available after the 

workshop at https://

healthpolicy.duke.edu/events/fdapublic-workshop-opioid-prescribereducation. 

There will be live closed captioning 

for this event. If you need other special 

accommodations due to a disability, 

please contact Michie Hunt (see FOR

FURTHER INFORMATION CONTACT) no later 

than October 4, 2021, or the DukeMargolis Center for Health Policy at 

margolisevents@duke.edu. 

FDA has verified the website 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Dated: September 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19437 Filed 9–8–21; 8:45 am] 

BILLING CODE 4164–01–P 


lotter on DSK11XQN23PROD with NOTICES1