37866 Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices 

the Commonwealth of Northern Mariana 

Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Post-Expenditure Reporting Form ................................................................... 56 1 110 6,160 

Use of Post-Expenditure Reporting Form as Part of the Intended Use Plan 56 1 2 112 

Estimated Total Annual Burden 

Hours: 6,272. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW., Washington, DC 20201. 

Attention Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–17098 Filed 8–11–17; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4515] 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

interested persons to submit comments 

concerning abuse potential, actual 

abuse, medical usefulness, trafficking, 

and impact of scheduling changes on 

availability for medical use of 17 drug 

substances. These comments will be 

considered in preparing a response from 

the United States to the World Health 

Organization (WHO) regarding the abuse 

liability and diversion of these drugs. 

WHO will use this information to 

consider whether to recommend that 

certain international restrictions be 

placed on these drugs. This notice 

requesting comments is required by the 

Controlled Substances Act (the CSA). 

DATES: Submit either electronic or 

written comments by September 13, 

2017. 

ADDRESSES: 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 September 13, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 13, 2017. 

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– 

2017–N–4515 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; 

Ocfentanil; Furanyl fentanyl (Fu-F); 

Acryloylfentanyl (Acrylfentanyl); 

Carfentanil; 4-fluoroisobutyrfentanyl (4– 

FIBF); Tetrahydrofuranylfentanyl (THF– 

F); 4-fluoroamphetamine (4–FA); AB– 

PINACA; AB–CHMINACA; 5F–PB–22; 

UR–144; 5F–ADB; Etizolam; Pregabalin; 

Tramadol; Cannabidiol; Ketamine; 

Request for Comments.’’ Received 

comments, those filed 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. 

• 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices 37867 

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 

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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, email: 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (Psychotropic Convention). 

Article 2 of the Psychotropic 

Convention provides that if a party to 

the convention or WHO has information 

about a substance, which in its opinion 

may require international control or 

change in such control, it shall so notify 

the Secretary-General of the United 

Nations (the U.N. Secretary-General) 

and provide the U.N. Secretary-General 

with information in support of its 

opinion. 

Section 201 of the CSA (21 U.S.C. 

811) (Title II of the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970) provides that when WHO notifies 

the United States under Article 2 of the 

Psychotropic Convention that it has 

information that may justify adding a 

drug or other substances to one of the 

schedules of the Psychotropic 

Convention, transferring a drug or 

substance from one schedule to another, 

or deleting it from the schedules, the 

Secretary of State must transmit the 

notice to the Secretary of Health and 

Human Services (Secretary of HHS). The 

Secretary of HHS must then publish the 

notice in the Federal Register and 

provide opportunity for interested 

persons to submit comments that will be 

considered by HHS in its preparation of 

the scientific and medical evaluations of 

the drug or substance. 

II. WHO Notification 

The Secretary of HHS received the 

following notice from WHO (nonrelevant text removed): 

Ref.: C.L.xx.2017 

The World Health Organization (WHO) 

presents its compliments to Member States 

and Associate Members and has the pleasure 

of informing that the Thirty-ninth Expert 

Committee on Drug Dependence (ECDD) will 

meet in Geneva from 6 to 10 November 2017 

to review a number of substances with 

potential for dependence, abuse and harm to 

health, and will make recommendations to 

the U.N. Secretary-General, on the need for 

and level of international control of these 

substances. 

At its 126th session in January 2010, the 

Executive Board approved the publication 

‘‘Guidance on the WHO review of 

psychoactive substances for international 

control’’ (EB126/2010/REC1, Annex 6) which 

requires the Secretariat to request relevant 

information from Ministers of Health in 

Member States to prepare a report for 

submission to the ECDD. For this purpose, a 

questionnaire was designed to gather 

information on the legitimate use, harmful 

use, status of national control and potential 

impact of international control for each 

substance under evaluation. Member States 

are invited to collaborate, as in the past, in 

this process by providing pertinent 

information as requested in the questionnaire 

and concerning substances under review. 

It would be appreciated if a person from 

the Ministry of Health could be designated as 

the focal point responsible for coordinating 

and answering the questionnaire. (non 

relevant information from letter not shown, 

see letter for text not shown here) The 

designated focal point, and only this person, 

should access and complete the 

questionnaires: 

1. Ocfentanil 

2. Furanyl fentanyl (Fu-F) 

3. Acryloylfentanyl (Acrylfentanyl) 

4. Carfentanil 

5. 4-fluoroisobutyrfentanyl (4–FIBF) 

6. Tetrahydrofuranylfentanyl (THF–F) 

7. 4-fluoroamphetamine (4–FA) 

8. AB–PINACA 

9. AB–CHMINACA 

10. 5F–PB–22 

11. UR–144 

12. 5F–ADB 

13. Etizolam 

14. Pregabalin 

15. Tramadol 

16. Cannabidiol 

17. Ketamine 

PDF versions of the questionnaire in 

English, French and Spanish may be 

downloaded from the link http://

www.who.int/medicines/access/controlledsubstances/ecdd/en/. Please note that these 

versions are for reference only and all 

questionnaires must be answered through the 

online system. Further clarification regarding 

the questionnaire may be obtained from the 

Secretariat by emailing: ecddsecretariat@

who.int. 

Replies to the questionnaire must reach the 

Secretariat by 30 September 2017 in order to 

facilitate analyses and preparation of the 

report before the planned meeting. Where 

there is a competent National Authority 

under the International Drug Control 

Treaties, it is kindly requested that the 

questionnaire be completed in collaboration 

with such body. 

The summary information from the 

questionnaire will be published online as 

part of the report on the Web site for the 

Thirty-ninth ECDD linked to the Department 

of Essential Medicines and Health Products 

(EMP). The provisional agenda of the Thirtyninth ECDD and the list of psychoactive 

substances under review are also published 

on Thirty-ninth ECDD Web page: http://

www.who.int/medicines/access/controlledsubstances/ecdd/en/. 

Member States are also encouraged to 

provide any additional relevant information 

(unpublished or published) that is available 

on these substances to: ecddsecretariat@

who.int. This information will be an 

invaluable contribution to the ECDD and all 

submissions will be treated as confidential. 

The World Health Organization takes this 

opportunity to renew to Member States and 

Associate Members the assurance of its 

highest consideration. 

GENEVA, 7 July 2017 

FDA has verified the Web site 

addresses contained in the WHO notice, 

as of the date this document publishes 

in the Federal Register, but Web sites 

are subject to change over time. 

III. Substances Under WHO Review 

Ocfentanil is a synthetically produced 

opioid that is structurally related to 

fentanyl and approximately equipotent 

in effect. Reported risks associated with 

use of ocfentanil include development 

of opioid use disorder, overdose, and 

fatal overdose. It has no approved 

medical use in the United States and is 

not a controlled substance in the United 

States under the CSA. 

Furanyl fentanyl (Fu-F) is a potent 

clandestinely produced synthetic opioid 

that is an analog of fentanyl. Evidence 

suggests that the pattern of abuse of 

fentanyl analogues, including furanyl 

fentanyl, parallels that of heroin and 


sradovich on DSK3GMQ082PROD with NOTICES
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prescription opioid analgesics. Fu-F 

produces the typical opioid effects that 

include respiratory depression and loss 

of consciousness. Seizures of Fu-F have 

been encountered in powder form. FuF has been connected to fatal overdoses, 

in which intravenous routes of 

administration are documented. It has 

no approved medical use in the United 

States. On November 29, 2016, the Drug 

Enforcement Administration (DEA) 

issued a final order to temporarily 

schedule Fu-F and its isomers, esters, 

ethers, salts and salts of isomers, esters 

and ethers, into Schedule I pursuant to 

the temporary scheduling provisions of 

the CSA. 

Acryloylfentanyl (Acrylfentanyl) 

belongs to the 4-anilidopiperidine class 

of synthetic opioids and is similar in 

structure to fentanyl. Acryloylfentanyl 

is a clandestinely produced analog of 

fentanyl and sold illegally as a research 

chemical on several Web sites. 

Acryloylfentanyl has also been 

associated with adverse events typically 

associated with opioid use such as 

respiratory depression, anxiety, 

constipation, tiredness, hallucinations, 

and withdrawal. The use of 

acryloylfentanyl has also been linked to 

the development of opioid use disorder, 

overdose, and fatal overdose. 

Acryloylfentanyl has no commercial or 

medical uses. On July 14, 2017, the DEA 

issued a temporary order to temporarily 

schedule acryloylfentanyl, its isomers, 

esters, ethers, salts and salts of isomers, 

esters, and ethers, into Schedule I 

pursuant to the temporary scheduling 

provisions of the CSA. 

Carfentanil, also known as 4- 

carbomethoxyfentanyl, is an extremely 

potent synthetic opioid that is similar in 

structure to and approximately 100 

times more potent than fentanyl as an 

analgesic. At one time legitimately 

produced, carfentanil is no longer 

manufactured, marketed, or used in the 

United States; it is approved by FDA for 

use under restricted conditions by 

veterinarians as a immobilizing agent 

for certain large animals. Illicitly 

produced carfentanil is a particularly 

harmful fentanyl analogue that is also 

being laced into heroin or sold by itself 

and trafficked in the United States. It is 

not approved for human use. Drug 

seizure data indicate that carfentanil is 

typically used in small doses to cut 

heroin and other illicitly abused drugs. 

The significant risk to public health 

associated with carfentanil use stems 

from its respiratory depressive effects 

with very small amounts. Several 

fatalities have been reported as the 

result of carfentanil overdoses. On 

October 28, 1988, the DEA placed 

carfentanil in Schedule II of the CSA. 

4-fluoroisobutyrfentanyl is a 

clandestinely produced synthetic opioid 

that is an analog of fentanyl. It has mreceptor agonist activity similar to that 

of fentanyl. This would result in effects 

associated with opioid agonists such as 

analgesia, respiratory depression, 

anxiety, constipation, tiredness, 

hallucinations, withdrawal, the 

development of opioid use disorder, 

overdose, and fatal overdose. The use of 

4-fluoroisobutyrfentanyl has been 

implicated in several cases of overdose 

and fatal overdoses. 4- 

fluoroisobutyrfentanyl has not been 

approved for medical use in the U.S. On 

May 3, 2017, the DEA issued a 

temporary order to temporarily schedule 

4-fluoroisobutyrfentanyl, its isomers, 

esters, ethers, salts and salts of isomers, 

esters and ethers, into Schedule I 

pursuant to the temporary scheduling 

provisions of the CSA. 

Tetrahydrofuranylfentanyl (THF–F) is 

a synthetic opioid that is an analog of 

fentanyl. It has m-receptor agonist 

activity similar to that of fentanyl, 

resulting in effects associated with 

opioid agonists such as analgesia, 

respiratory depression, anxiety, 

constipation, tiredness, hallucinations, 

withdrawal, the development of opioid 

use disorder, overdose, and fatal 

overdose. THF–F is not approved for 

medical use or controlled in the United 

States under the CSA. 

4-Fluoroamphetamine (4–FA) is a 

psychoactive substance of the 

phenethylamine and substituted 

amphetamine chemical classes and 

produces stimulant effects. WHO 

reports that 4–FA is clandestinely 

produced, and its use is associated with 

fatal and non-fatal intoxications. 4–FA 

was reviewed at the 37th ECDD (2015) 

and, while not placed under 

international control due to insufficient 

data, was kept under surveillance. 4–FA 

is not approved for medical use in the 

United States and it is not controlled 

under the CSA. 

AB–PINACA is a clandestinely 

produced synthetic cannabinoid agonist 

approximately 1.5 times as potent as 

delta-9-tetrahydrocannabinol. Adverse 

effects produced by cannabinoid 

agonists include tachycardia, agitation, 

hallucination, chest pain, seizure, 

anxiety, acute psychosis, and death. 

AB–PINACA has been detected in illicit 

synthetic cannabinoid substances, and 

reported in cases of overdose and 

hospitalizations. It has not been 

approved for medical use in the United 

States. On January 27, 2017, the DEA 

published a Notice of Proposed 

Rulemaking to permanently control AB– 

PINACA as a Schedule I substance 

under the CSA. 

AB–CHMINACA is a clandestinely 

produced synthetic cannabinoid agonist 

that is approximately 16 times more 

potent than delta-9- 

tetrahydrocannabinol. Adverse effects 

produced by cannabinoid agonists 

include tachycardia, agitation, 

hallucination, chest pain, seizure, 

anxiety, acute psychosis, and death. 

AB–CHMINACA has been detected in 

illicit synthetic cannabinoid substances 

and found in cases of overdose and 

hospitalizations. AB–CHMINACA has 

not been pre-reviewed or critically 

reviewed by the WHO. On January 27, 

2017, the DEA published a Notice of 

Proposed Rulemaking to permanently 

control AB–CHMINACA as a Schedule 

I substance under the CSA. 

5F–PB–22 is a synthetic cannabinoid 

agonist with similar effects to delta-9- 

tetrahydrocannabinol, one of the main 

psychoactive components of cannabis. 

Adverse effects produced by 

cannabinoid agonists include 

tachycardia, agitation, hallucination, 

chest pain, seizure, anxiety, acute 

psychosis, and death. 5F–PB–22 is 

clandestinely produced. It has been 

found laced on plant material and 

marketed as herbal products, and is 

smoked for its psychoactive effects. 

According to the WHO, 5F–PB–22 has 

been associated with fatal intoxications. 

On September 6, 2016, the DEA issued 

a final rule to permanently place 5F– 

PB–22 into Schedule I of the CSA. 

UR–144 is a clandestinely produced 

synthetic cannabinoid agonist. In 

general, adverse effects produced by 

cannabinoid agonists include 

tachycardia, agitation, hallucination, 

chest pain, seizure, anxiety, and acute 

psychosis. UR–144 has been detected in 

herbal smoking blends that are sold as 

herbal incense. In June 2014, the 36th 

(2014) ECDD reviewed UR–144 and 

recommended that it be placed under 

surveillance. On May 11, 2016, the DEA 

issued a final rule to permanently 

schedule UR–144 into Schedule I of the 

CSA. 

5F–ADB is a clandestinely produced 

synthetic cannabinoid agonist. In 

general, adverse effects produced by 

cannabinoid agonists include 

tachycardia, agitation, hallucination, 

chest pain, seizure, anxiety, and acute 

psychosis. 5F–ADB has been identified 

in overdose and/or cases involving 

death attributed to their abuse. Adverse 

health effects reported from incidents 

involving 5F–ADB and other synthetic 

cannabinoids have included: Nausea, 

persistent vomiting, agitation, altered 

mental status, seizures, convulsions, 

loss of consciousness, and/or cardio 

toxicity. On April 10, 2017, the DEA 

issued a temporary scheduling order to 


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Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices 37869 

temporarily schedule 5F–ADB, its 

isomers, esters, ethers, salts and salts of 

isomers, esters, and ethers into 

Schedule I pursuant to the temporary 

scheduling provisions of the CSA. 

Etizolam belongs to a class of 

substances known as benzodiazepines. 

Benzodiazepines produce central 

nervous system depression and are 

commonly used to treat insomnia, 

anxiety, and seizure disorders. Etizolam 

is currently prescribed in some 

countries to treat generalized anxiety 

disorder with depressive symptoms, but 

is not approved for medical use or 

controlled in the United States under 

the CSA. WHO reported that non-fatal 

intoxications that include cases of 

driving under the influence of drugs 

have been linked to etizolam. The ECDD 

at its 37th (2015 meeting reviewed 

etizolam and recommended that a 

critical review of etizolam is warranted. 

Pregabalin is an anticonvulsant-type 

drug used to treat pain generated from 

the nervous system. It is available as an 

oral capsule and oral solution and 

approved for medical use in the United 

States for the management of 

neuropathic pain associated with 

diabetic peripheral neuropathy, postherpetic neuralgia, and adjunctive 

therapy for partial onset seizures, 

fibromyalgia, and neuropathic pain 

associated with spinal cord injury. 

Although the mechanism of action of 

pregabalin is unknown, studies in 

animals suggest that binding to the 

nervous system tissues may be involved 

in its pain-relieving and anti-seizure 

effects. Pregabalin binds with high 

affinity to the alpha 2-delta receptor site 

(a subunit of voltage-gated calcium 

channels) in the central nervous system. 

The binding of pregabalin at this site is 

thought to be responsible for its 

therapeutic effect on neuropathic pain. 

Reports indicate that patients are selfadministering higher than 

recommended doses to achieve 

euphoria, especially patients who have 

a history of substance abuse, 

particularly opioids, and psychiatric 

illness. While effects of excessively high 

doses are generally non-lethal, 

gabapentinoids such as pregabalin are 

increasingly being identified in postmortem toxicology analyses. Pregabalin 

is a Schedule V controlled substance in 

the United States under the CSA. 

Tramadol is an opioid analgesic that 

produces its primary opioid-like action 

through an active metabolite referred to 

as the M1 metabolite (Odesmethyltramadol). Tramadol was first 

approved for marketing in the United 

States in 1995 and is available as 

immediate-release, extended-release, 

and combination products for the 

treatment of moderate to moderately 

severe pain. On July 2, 2014, the DEA 

published a final rule in the Federal 

Register controlling tramadol as a 

Schedule IV substance of the CSA 

effective from August 18, 2014. 

Tramadol was pre-reviewed by the 

ECDD at its 28th (1992) and 32nd (2000) 

meetings, and critically reviewed at the 

33rd (2002) meeting and not 

recommended for international control 

but placed on surveillance. Tramadol 

was pre-reviewed again by the ECDD at 

its 34th (2006) meeting; however, the 

ECDD concluded that there was not 

sufficient evidence to justify a critical 

review. At the 36th (2014) meeting, the 

ECDD considered updated information 

on tramadol, but again concluded that 

there was insufficient evidence to 

warrant a critical review. 

Cannabidiol (CBD) is one of the active 

cannabinoids identified in cannabis. 

CBD has been shown to be beneficial in 

experimental models of several 

neurological disorders, including those 

of seizure and epilepsy. In the United 

States, CBD-containing products are in 

human clinical testing in three 

therapeutic areas, but no such products 

are approved by FDA for marketing for 

medical purposes in the United States. 

CBD is a Schedule I controlled 

substance under the CSA. At the 37th 

(2015) meeting of the ECDD, the 

committee requested that the Secretariat 

prepare relevant documentation to 

conduct pre-reviews for several 

substances, including CBD. 

Ketamine is classified as a rapidacting general anesthetic agent used for 

short diagnostic and surgical procedures 

that do not require skeletal muscle 

relaxation. It is marketed in the United 

States as a solution for injection. 

Ketamine is controlled in Schedule III of 

the CSA in the United States. It is not 

controlled internationally under the 

Convention on Psychotropic Substances 

or the Single Convention on Narcotic 

Drugs. The ECDD reviewed ketamine at 

its 34th (2006), 35th (2012), and 36th 

(2014) meetings. On March 13, 2015, the 

Commission on Narcotic Drugs (CND) 

decided by consensus to postpone the 

consideration of a proposal concerning 

the recommendation to place ketamine 

in Schedule IV of the Psychotropic 

Convention. The CND requested 

additional information from the WHO. 

The ECDD reviewed updated 

information at its 37th (2015) meeting 

and found no reason to recommend a 

new pre-review or critical review of 

ketamine that could potentially change 

its standing 2014 recommendation that 

ketamine should not be placed under 

international control. 

IV. Opportunity To Submit Domestic 

Information 

As required by section 201(d)(2)(A) of 

the CSA, FDA, on behalf of HHS, invites 

interested persons to submit comments 

regarding the 17 named drug 

substances. Any comments received 

will be considered by HHS when it 

prepares a scientific and medical 

evaluation of these drug substances. 

HHS will forward a scientific and 

medical evaluation of these drug 

substances to WHO, through the 

Secretary of State, for WHO’s 

consideration in deciding whether to 

recommend international control/ 

decontrol of any of these drug 

substances. Such control could limit, 

among other things, the manufacture 

and distribution (import/export) of these 

drug substances and could impose 

certain recordkeeping requirements on 

them. 

Although FDA is, through this notice, 

requesting comments from interested 

persons, which will be considered by 

HHS when it prepares an evaluation of 

these drug substances, HHS will not 

now make any recommendations to 

WHO regarding whether any of these 

drugs should be subjected to 

international controls. Instead, HHS will 

defer such consideration until WHO has 

made official recommendations to the 

Commission on Narcotic Drugs, which 

are expected to be made in early 2018. 

Any HHS position regarding 

international control of these drug 

substances will be preceded by another 

Federal Register notice soliciting public 

comments, as required by section 

201(d)(2)(B) of the CSA. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://www.

regulations.gov. 

Dated: August 9, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17119 Filed 8–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Behavioral Health; Office of 

Clinical and Preventive Services; 

Behavioral Health Integration Initiative 

(BH2I) 

Announcement Type: New. 


sradovich on DSK3GMQ082PROD with NOTICES