Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10097 

Dated: February 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03244 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0165] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization; Scheduling 

Recommendations; Isotonitazene; 

MDMB-4en-PINACA; CUMYLPEGACLONE; Flubromazolam; 

Clonazolam; Diclazepam; 3- 

Methoxyphencyclidine; Diphenidine; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

interested persons with the opportunity 

to submit written comments concerning 

recommendations by the World Health 

Organization (WHO) to impose 

international manufacturing and 

distributing restrictions, under 

international treaties, on certain drug 

substances. The comments received in 

response to this notice will be 

considered in preparing the United 

States’ position on these proposals for a 

meeting of the United Nations 

Commission on Narcotic Drugs (CND) in 

Vienna, Austria, in April 2021. This 

notice is issued under the Controlled 

Substances Act (CSA). 

DATES: Submit either electronic or 

written comments by March 22, 2021. 

ADDRESSES: You may submit comments 

as follows: 

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–0165 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; World 

Health Organization; Scheduling 

Recommendations; Isotonitazene; 

MDMB-4en-PINACA; CUMYLPEGACLONE; Flubromazolam; 

Clonazolam; Diclazepam; 3- 

Methoxyphencyclidine; Diphenidine; 

Request for Comments.’’ Received 

comments 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 

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: 

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, 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (1971 Convention). Section 

201(d)(2)(B) of the CSA (21 U.S.C. 

811(d)(2)(B)) provides that when the 

United States is notified under Article 2 

of the 1971 Convention that the CND 

proposes to decide whether to add a 

drug or other substance to one of the 

schedules of the 1971 Convention, 

transfer a drug or substance from one 

schedule to another, or delete it from 

the schedules, the Secretary of State 

must transmit notice of such 

information to the Secretary of Health 

and Human Services (Secretary of HHS). 

The Secretary of HHS must then publish 

a summary of such information in the 

Federal Register and provide 

opportunity for interested persons to 

submit comments. The Secretary of HHS 

must then evaluate the proposal and 

furnish a recommendation to the 

Secretary of State that shall be binding 

on the representative of the United 

States in discussions and negotiations 

relating to the proposal. 


jbell on DSKJLSW7X2PROD with NOTICES
10098 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

As detailed in the following 

paragraphs, the Secretary of State has 

received notification from the SecretaryGeneral of the United Nations (the 

Secretary-General) regarding seven 

substances to be considered for control 

under the 1971 Convention. This 

notification reflects the 

recommendation from the 43rd WHO 

Expert Committee for Drug Dependence 

(ECDD), which met in October 2020. In 

the Federal Register of August 4, 2020 

(85 FR 47217), FDA announced the 

WHO ECDD review and invited 

interested persons to submit 

information for WHO’s consideration. 

The full text of the notification from 

the Secretary-General is provided in 

section II. Section 201(d)(2)(B) of the 

CSA requires the Secretary of HHS, after 

receiving a notification proposing 

scheduling, to publish a notice in the 

Federal Register to provide the 

opportunity for interested persons to 

submit information and comments on 

the proposed scheduling action. 

The United States is also a party to 

the 1961 Single Convention on Narcotic 

Drugs (1961 Convention). The Secretary 

of State has received a notification from 

the Secretary-General regarding one 

substance to be considered for control 

under this convention. The CSA does 

not require HHS to publish a summary 

of such information in the Federal 

Register. Nevertheless, to provide 

interested and affected persons an 

opportunity to submit comments 

regarding the WHO recommendations 

for drugs under the 1961 Convention, 

the notification regarding these 

substances is also included in this 

Federal Register notice. The comments 

will be shared with other relevant 

Agencies to assist the Secretary of State 

in formulating the position of the 

United States on the control of these 

substances. The HHS recommendations 

are not binding on the representative of 

the United States in discussions and 

negotiations relating to the proposal 

regarding control of substances under 

the 1961 Convention. 

II. United Nations Notification 

The formal notification from the 

United Nations that identifies the drug 

substances and explains the basis for the 

scheduling recommendations is 

reproduced as follows (non-relevant text 

removed): 

Reference: 

NAR/CL.1/2020 

WHO/ECDD43; 1961C–Art.3, 1971C–Art.2 

CU 2021/7(A)/DTA/SGB 

The Secretariat of the United Nations 

presents its compliments to the Permanent 

Mission of the United States of America and 

has the honour to inform the Government 

that in a letter dated 30 November 2020, the 

Director-General of the World Health 

Organization (WHO), pursuant to article 3, 

paragraphs 1 and 3 of the Single Convention 

on Narcotic Drugs of 1961 as amended by the 

1972 Protocol (1961 Convention), and article 

2, paragraphs 1 and 4 of the Convention on 

Psychotropic Substances of 1971 (1971 

Convention), notified the Secretary-General 

of the following recommendations of the 

forty-third Meeting of the WHO’s Expert 

Committee on Drug Dependence (ECDD): 

Substance recommended to be added to 

Schedule I of the 1961 Convention: 

—Isotonitazene 

chemical name: N,N-diethyl-2-(2-(4- 

isopropoxybenzyl)-5-nitro-1Hbenzo[d]imidazol-1-yl)ethan-1-amine 

Substances recommended to be added to 

Schedule II of the 1971 Convention: 

—CUMYL-PEGACLONE 

chemical name: 5-pentyl-2-(2-phenylpropan2-yl)-2,5-dihydro-1H-pyrido[4,3-b]indol-1- 

one 

—MDMB-4en-PINACA 

chemical name: methyl 3,3-dimethyl-2-(1- 

(pent-4-en-1-yl)-1H-indazole-3- 

carboxamido)butanoate 

—3-Methoxyphencyclidine 

chemical name: 1-(1-(3- 

methoxyphenyl)cyclohexyl)piperidine 

—Diphenidine 

chemical name: 1-(1,2- 

diphenylethyl)piperidine 

Substances recommended to be added to 

Schedule IV of the 1971 Convention: 

—Clonazolam 

chemical name: 6-(2-chlorophenyl)-1-methyl8-nitro-4H-benzo[f][1,2,4]triazolo[4,3- 

a][1,4]diazepine 

—Diclazepam 

chemical name: 7-chloro-5-(2-chlorophenyl)- 

1- methyl-1,3-dihydro-2Hbenzo[e][1,4]diazepin2-one 

—Flubromazolam 

chemical name: 8-bromo-6-(2-fluorophenyl)- 

1-methyl-4H-benzo[f][1,2,4]triazolo[4,3- 

a][1,4]diazepine 

In accordance with the provisions of article 

3, paragraph 2 of the 1961 Convention and 

article 2, paragraph 2 of the 1971 Convention, 

the Secretary-General hereby transmits the 

notification as annex I to the present note. In 

connection with the notification, WHO also 

submitted an extract of the report of the fortythird meeting of the WHO Expert Committee 

on Drug Dependence, which provides a 

summary of the assessment and 

recommendations made by the Expert 

Committee on Drug Dependence (attached as 

annex II). 

Also in accordance with the same 

provisions, the notification from WHO will 

be brought to the attention of the sixty-fourth 

session of the Commission on Narcotic Drugs 

(12–16 April 2021) in a pre-session document 

that will be made available in the six official 

languages of the United Nations on the 

website of the 64th session of the CND: 

https://www.unodc.org/unodc/en/ 

commissions/CND/session/64_Session_

2021/session-64-of-the-commission-onnarcotic-drugs.html 

In order to assist the Commission in 

reaching a decision, it would be appreciated 

if the Government could communicate any 

comments it considers relevant to the 

possible scheduling of substances 

recommended by WHO to be placed under 

international control under the 1961 

Convention, namely: 

—Isotonitazene 

as well as any economic, social, legal, 

administrative or other factors that it 

considers relevant to the possible scheduling 

of substances recommended by WHO to be 

placed under international control under the 

1971 Convention, namely: 

—CUMYL-PEGACLONE 

—MDMB-4en-PINACA 

—3-Methoxyphencyclidine 

—Diphenidine 

—Clonazolam 

—Diclazepam 

—Flubromazolam 

The Secretariat of the United Nations 

avails itself of this opportunity to renew to 

the Permanent Mission of the United States 

of America to the United Nations (Vienna) 

the assurances of its highest consideration. 

12 January 2012 

Annex I 

Letter addressed to the Secretary-General of 

the United Nations From the DirectorGeneral of the World Health Organization, 

dated 30 November 2020 

‘‘The Forty-third meeting of the WHO 

Expert Committee on Drug Dependence was 

convened in a virtual format from 12 to 16 

October 2020 and was coordinated from the 

WHO headquarters in Geneva. The objective 

of this meeting was to carry out an in-depth 

evaluation of the abuse and dependenceproducing capacity of psychoactive 

substances in order to make 

recommendations on appropriate 

international scheduling measures. 

The Forty-third WHO ECDD Meeting 

critically reviewed eleven psychoactive 

substances, including one synthetic opioid, 

one hallucinogen, one synthetic stimulant, 

two synthetic cannabinoid receptor agonists, 

three dissociative-type drugs, and three 

benzodiazepines. These substances had not 

previously been formally reviewed by WHO 

and are currently not under international 

control. Information was brought to WHO’s 

attention that these substances are 

clandestinely manufactured, of especially 

serious risk to public health and society, and 

of no recognised therapeutic use by any 

Party. Therefore, a critical review to consider 

international scheduling measures was 

undertaken for each substance. 

With reference to Article 3, paragraphs 1 

and 3 of the Single Convention on Narcotic 

Drugs (1961), as amended by the 1972 

Protocol, and Article 2, paragraphs 1 and 4 

of the Convention on Psychotropic 

Substances (1971), WHO is pleased to submit 

recommendations of the Forty-second 

Meeting of ECDD as follows: 

To be added to Schedule I of the Single 

Convention on Narcotic Drugs (1961): 

—Isotonitazene 

chemical name: N,N-diethyl-2-(2-(4- 

isopropoxybenzyl)-5-nitro-1Hbenzo[d]imidazol-1-yl)ethan-1-amine 


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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10099 

To be added to Schedule II of the 

Convention on Psychotropic Substances 

(1971): 

—CUMYL-PEGACLONE 

chemical name: 5-pentyl-2-(2-phenylpropan2-yl)-2,5-dihydro-1H-pyrido[4,3-b]indol-1- 

one 

—MDMB-4en-PINACA 

chemical name: methyl 3,3-dimethyl-2-(1- 

(pent-4-en-1-yl)-1H-indazole-3- 

carboxamido)butanoate 

—3-methoxyphencyclidine 

chemical name: 1-(1-(3- 

methoxyphenyl)cyclohexyl)piperidine 

—Diphenidine 

chemical name: 1-(1,2- 

diphenylethyl)piperidine 

To be added to Schedule IV of the 

Convention on Psychotropic Substances 

(1971): 

—Clonazolam 

chemical name: 6-(2-chlorophenyl)-1-methyl8-nitro-4H-benzo[f][1,2,4]triazolo[4,3- 

a][1,4]diazepine 

—Diclazepam 

chemical name: 7-chloro-5-(2-chlorophenyl)- 

1-methyl-1,3-dihydro-2Hbenzo[e][1,4]diazepin2-one 

—Flubromazolam 

chemical name: 8-bromo-6-(2-fluorophenyl)- 

1-methyl-4H-benzo[f][1,2,4]triazolo[4,3- 

a][1,4]diazepine 

The assessments and findings on which 

these recommendations are based are set out 

in detail in the forty-third meeting report of 

the WHO Expert Committee on Drug 

Dependence. An extract of this report, 

providing a summary of the assessment and 

recommendations made by the ECDD, is 

contained in Annex 1 to this letter. 

I am very pleased with the ongoing 

collaboration between WHO, the United 

Nations Office on Drugs and Crime (UNODC) 

and the International Narcotics Control Board 

(INCB) and in particular, how this 

collaboration has benefited the work of the 

WHO Expert Committee on Drug Dependence 

and more generally, the implementation of 

the operational recommendations of the 

United Nations General Assembly Special 

Session 2016. 

Annex II 

Summary Assessment and Recommendations 

of the 43rd Expert Committee on Drug 

Dependence, 12–16 October 2020 

To be added to Schedule I of the Single 

Convention on Narcotic Drugs (1961): 

Isotonitazene 

Substance identification 

Isotonitazene (Chemical name: N,Ndiethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1Hbenzo[d]imidazol-1-yl)ethan-1-amine) 

belongs to the 2-benzylbenzimidazole group 

of compounds, which includes the closely 

related opioids etonitazene, metonitazene, 

and clonitazene. It is found in yellow, brown, 

or off-white powder forms. 

WHO Review History 

Isotonitazene has never been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is clandestinely manufactured, 

poses a risk to public health, and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

Isotonitazene is a chemical analogue of 

etonitazene and clonitazene, both of which 

are Schedule I compounds under the Single 

Convention on Narcotic Drugs, 1961. 

Isotonitazene is a potent opioid analgesic 

with a rapid onset of action. Preclinical 

studies have demonstrated that isotonitazene 

is more potent than fentanyl and 

hydromorphone, and substantially more 

potent than morphine. There is limited 

research on the effects of this compound on 

the central nervous system, but given its 

demonstrated potency at the m-opioid 

receptor, it would be expected to produce 

analgesia, respiratory depression and 

sedation. 

Dependence Potential 

No controlled animal or human studies 

have assessed the dependence potential of 

isotonitazene. As a potent m-opioid agonist, it 

would be expected to produce dependence. 

An unverified online report described 

dependent use and withdrawal symptoms, 

including flu-like symptoms and anxiety. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

There are no controlled studies of the 

abuse potential of isotonitazene, but as a 

potent m-opioid receptor agonist, it would be 

expected to produce euphoria and other 

effects predictive of high abuse liability. 

Due to its relatively recent appearance on 

the illicit drug market, there is limited 

information on the prevalence of use of 

isotonitazene or its associated harms. 

Seizures have been reported in multiple 

countries and regions. It is noted to be used 

via a range of routes including sublingually, 

vaping and intravenously. 

The number of deaths involving 

isotonitazene has increased in a short time 

span. Deaths commonly occur in 

combination with other opioids or 

benzodiazepines. Isotonitazene deaths share 

common features with heroin deaths, 

including evidence of injection, and signs 

consistent with opioid overdose such as 

pulmonary and/or cerebral oedema. Deaths 

are likely to be underreported due to its 

recent and rapid appearance. 

Recommendation 

Isotonitazene (Chemical name: N,Ndiethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1Hbenzo[d]imidazol-1-yl)ethan-1-amine) has a 

mechanism of action such that it is liable to 

similar abuse and productive of similar ill 

effects as other opioids which are controlled 

under Schedule I of the 1961 Single 

Convention on Narcotic Drugs. Its use has 

been reported in a number of countries and 

has been associated with adverse effects 

including deaths. It has no known 

therapeutic use and is likely to cause 

substantial harm. 

Therapeutic Usefulness 

Isotonitazene is not known to have any 

therapeutic use. 

To be added to Schedule II of the 

Convention on Psychotropic Substances 

(1971): 

CUMYL-PEGACLONE 

Substance Identification 

CUMYL-PEGACLONE (Chemical name: 5- 

pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro1H-pyrido[4,3-b]indol-1-one) is a synthetic 

cannabinoid. It has been found in seized 

material formulated for smoking and vaping. 

WHO Review History 

CUMYL-PEGACLONE has never been 

formally reviewed by WHO and is not 

currently under international control. 

Information was brought to WHO’s attention 

that this substance is clandestinely 

manufactured, poses a risk to public health, 

and has no recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

CUMYL-PEGACLONE is a synthetic 

cannabinoid with a mechanism of action 

similar to that of other synthetic 

cannabinoids. It is a potent full agonist at 

CB1 receptors. 

There are no controlled studies of its 

effects, but there are online user reports 

describing euphoria, dissociation, red eyes, 

dry mouth and appetite stimulation. These 

effects are consistent with known 

cannabinoid agonist effects. 

Dependence Potential 

There are no controlled animal or human 

studies that address the dependence 

potential of CUMYL-PEGACLONE. However, 

CUMYL-PEGACLONE has been shown to be 

a full and potent agonist at the CB1 receptor 

and therefore would be expected to produce 

dependence consistent with other CB1 

receptor agonists. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

There are no controlled animal or human 

studies that address the abuse potential of 

CUMYL-PEGACLONE. 

A number of countries across several 

regions have reported that CUMYLPEGACLONE is being used for its 

psychoactive properties. 

There are reports of adverse effects such as 

seizures and of fatalities involving CUMYLPEGACLONE. While other drugs were 

present, CUMYL-PEGACLONE was deemed 

to be a causal or contributory factor in a 

number of these deaths. 

Therapeutic Usefulness 

CUMYL-PEGACLONE is not known to 

have any therapeutic use. 

Recommendation 

CUMYL-PEGACLONE (Chemical name: 5- 

pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro1H-pyrido[4,3-b]indol-1-one) is a synthetic 

cannabinoid receptor agonist with a mode of 

action that suggests a likelihood of 

dependence and abuse, and similar ill-effects 

to other synthetic cannabinoids. Its use has 

been associated with severe adverse effects 

and fatalities. The effects of 

CUMYL-PEGACLONE are similar to those of 

other synthetic cannabinoids that are 

controlled under Schedule II of the 


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10100 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Convention on Psychotropic Substances of 

1971. CUMYL-PEGACLONE has no 

therapeutic use, and its use constitutes a 

substantial risk to public health. 

• The committee recommended that 

CUMYL-PEGACLONE (Chemical name: 5- 

pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro1H-pyrido[4,3-b]indol-1-one), be added to 

Schedule II of the Convention on 

Psychotropic Substances of 1971. 

MDMB-4en-PINACA 

Substance Identification 

MDMB-4en-PINACA (Chemical name: 

methyl (S)-3,3-dimethyl-2-(1-(pent-4-en-1-yl)- 

1H-indazole-3-carboxamido)butanoate) is a 

synthetic cannabinoid. It has been identified 

in seized material formulated for smoking, 

and found as white to yellow/brown powder. 

WHO Review History 

MDMB-4en-PINACA has never been 

formally reviewed by WHO and is not 

currently under international control. 

Information was brought to WHO’s attention 

that this substance is clandestinely 

manufactured, poses a risk to public health, 

and has no recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

MDMB-4en-PINACA is a synthetic 

cannabinoid that binds to CB1 cannabinoid 

receptors as a full and potent agonist. It is 

structurally similar to 5F-MDMB-PINACA 

(5F-ADB) which is controlled under 

Schedule II of the Convention on 

Psychotropic Substances of 1971. A report 

from an unpublished animal study indicates 

that MDMB-4en-PINACA can produce the 

characteristic effects of CB1 cannabinoid 

agonists such as hypothermia and lethargy. 

Reports from online user forums describe 

cannabis-like euphoria at moderate levels of 

intake, with dissociation described at higher 

doses. Both sedation and stimulation have 

been reported, in addition to memory loss, 

confusion and agitation. 

Dependence Potential 

No animal or human studies were 

identified that described the dependence 

potential of MDMB-4en-PINACA. As a full 

CB1 agonist, it would be expected to produce 

dependence similar to other CB1 receptor 

agonists. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No animal or human studies have been 

conducted to provide an indication of the 

likelihood of abuse of MDMB-4en-PINACA, 

though CB1 receptor agonists have known 

abuse potential. A number of countries across 

different regions have reported MDMB-4enPINACA use. Its use has been associated with 

cases of impaired driving and death. 

Therapeutic Usefulness 

MDMB-4en-PINACA is not known to have 

any therapeutic use. 

Recommendation 

MDMB-4en-PINACA (Chemical name: 

methyl (S)-3,3-dimethyl-2-(1-(pent-4-en-1-yl)- 

1H-indazole-3-carboxamido)butanoate) is a 

potent synthetic cannabinoid receptor 

agonist with a similar mechanism of action, 

and similar effects to a number of other 

synthetic cannabinoids that are controlled 

under Schedule II of the Convention on 

Psychotropic Substances of 1971. Use of 

MDMB-4en-PINACA has been associated 

with severe adverse effects, including fatal 

intoxications, and cases of impaired driving. 

MDMB-4en-PINACA has no therapeutic use. 

• The Committee recommended that 

MDMB-4en-PINACA (Chemical name: 

methyl (S)-3,3-dimethyl-2-(1-(pent-4-en-1-yl)- 

1H-indazole-3-carboxamido)butanoate) be 

added to Schedule II of the Convention on 

Psychotropic Substances of 1971. 

3-methoxyphencyclidine (3-MeO-PCP) 

Substance Identification 

3-methoxyphencyclidine (3-MeO-PCP), 

(Chemical name: 1-[1-(3- 

methoxyphenyl)cyclohexyl]piperidine) is an 

arylcyclohexylamine and 3-methoxy 

derivative of phencyclidine (PCP) which is 

controlled under Schedule II of the 

Convention on Psychotropic Substances of 

1971. It appears as powder and tablets. 

WHO Review History 

3-methoxyphencyclidine has never been 

formally reviewed by WHO and is not 

currently under international control. 

Information was brought to WHO’s attention 

that this substance is clandestinely 

manufactured, poses a risk to public health, 

and has no recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

3-methoxyphencyclidine is an N-methyl-Daspartate (NMDA) receptor antagonist with a 

similar mechanism of action and effects to 

phencyclidine. These effects include an 

altered mental state characterized by 

confusion, disorientation and out of body 

experiences as well as hallucinations and 

other psychotic symptoms. 

Dependence Potential 

No human or animal studies have 

examined the dependence potential of 3- 

methoxyphencyclidine. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

As an NMDA receptor antagonist, 3- 

methoxyphencyclidine would be expected to 

produce similar effects, and have abuse 

potential similar to that of phencyclidine. 

Adverse effects include cardiovascular 

effects (such as hypertension and 

tachycardia) and cognitive effects including 

psychosis, confusion and agitation. There 

may be a greater risk of psychosis in those 

with a history of, or vulnerability to 

psychotic illness. Cases of severe and fatal 

intoxication are reported from several 

countries and regions. 

Seizures have been reported in a number 

of countries from several different regions. 

Therapeutic Usefulness 

3-methoxyphencyclidine is not known to 

have any therapeutic use. 

Recommendation 

3-methoxyphencyclidine (Chemical name: 

1-[1-(3-methoxyphenyl)cyclohexyl] 

piperidine) is an analogue of, and has similar 

effects to phencyclidine (PCP), which is 

controlled under Schedule II of the 1971 

Convention on Psychotropic Substances. Its 

mode of action suggests a likelihood of abuse. 

There is evidence of use of this substance in 

a number of countries across different 

regions. 3-methoxyphencyclidine causes 

substantial harm, including severe adverse 

events such as hallucinations, other 

psychotic symptoms, and fatal intoxications. 

It has no therapeutic use. 

• The Committee recommended that 3- 

methoxyphencyclidine (Chemical name: 1-[1- 

(3-methoxyphenyl)cyclohexyl]piperidine) be 

added to Schedule II of the Convention on 

Psychotropic Substances of 1971. 

Diphenidine 

Substance Identification 

Diphenidine (Chemical name: 1-(1,2- 

diphenylethyl)piperidine) is a dissociative 

and hallucinogenic substance of the 1,2- 

diarylethylamine class. It appears as powder 

and tablets. 

WHO Review History 

Diphenidine has never been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is clandestinely manufactured, 

poses a risk to public health, and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

Diphenidine is known to produce 

hallucinogenic and dissociative effects 

through its action as an N-methyl-D-aspartate 

(NMDA) receptor antagonist. This 

mechanism of action as well as its effects are 

similar to those of phencyclidine (PCP) 

which is controlled under Schedule II of the 

1971 Convention on Psychotropic 

Substances. 

Dependence Potential 

No animal or human studies have 

determined the dependence potential for 

diphenidine. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

As an NMDA receptor antagonist, 

diphenidine would be expected to have 

abuse potential similar to that of 

phencyclidine. In addition, diphenidine 

causes dopamine release, in a manner similar 

to, but to a lesser degree, than cocaine. This 

effect may also contribute to its abuse 

potential. 

Cases of intoxication requiring 

hospitalization are reported. Adverse effects 

include cardiovascular effects (such as 

tachycardia and hypertension) and central 

nervous system effects including 

hallucinations, depersonalization, delusions, 

paranoia, dissociation, confusion, nystagmus 

and muscle rigidity. These effects have 

resulted in cases of acute intoxication leading 

to emergency department admissions. A 

small number of fatal intoxications involving 

diphenidine have been documented. All 

deaths involved multiple drug toxicity, 

though cardiovascular and hallucinogenic 

symptoms described in the cases are 

consistent with the effects of diphenidine. 

Seizures have been reported in a number 

of countries from several different regions. 


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Therapeutic Usefulness 

Diphenidine is not known to have any 

therapeutic use. 

Recommendation 

The available evidence indicates that 

diphenidine (Chemical name: 1-(1,2- 

diphenylethyl)piperidine) has a mechanism 

of action and effects that are similar to those 

of phencyclidine (PCP), which is controlled 

under Schedule II of the 1971 Convention on 

Psychotropic Substances. Its mode of action 

suggests a likelihood of abuse. There is 

evidence of significant harm due to 

diphenidine, including psychosis and 

cardiovascular effects, which represents a 

substantial risk to public health. Diphenidine 

has no therapeutic use. 

• The Committee recommended that 

diphenidine (Chemical name: 1-(1,2- 

diphenylethyl)piperidine) be added to 

Schedule II of the Convention on 

Psychotropic Substances of 1971. 

Substances recommended to be scheduled 

in Schedule IV of the Convention on 

Psychotropic Substances (1971): 

Clonazolam 

Substance Identification 

Clonazolam (Chemical name: 6-(2- 

chlorophenyl)-1-methyl-8-nitro-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is 

1-4 triazolobenzodiazepine similar to 

clonazepam, triazolam and alprazolam. It is 

sold in powder, blotter, liquid and tablet 

form. 

WHO Review History 

Clonazolam has never been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is clandestinely manufactured, 

poses a risk to public health, and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

Clonazolam enhances the effects of the 

inhibitory neurotransmitter gammaaminobutyric acid (GABA) through binding 

at the benzodiazepine site of the GABA-A 

receptor. This mechanism of action, as well 

as its effects (sedation, muscle relaxation, 

slurred speech and loss of motor control, 

amnesia) are similar to those of the 

benzodiazepines (such as diazepam, 

triazolam and alprazolam) which are 

controlled under Schedule IV of the 1971 

Convention on Psychotropic Substances. 

In cases of clonazolam poisoning, the 

effects have been reversed with the 

benzodiazepine antagonist flumazenil, 

confirming that its action is mediated via the 

benzodiazepine receptor in the GABA-A 

receptor complex. 

Dependence Potential 

No controlled animal or human studies 

have examined the dependence potential of 

clonazolam, though based on its 

pharmacological effects, and similarity to 

other benzodiazepines, it would be expected 

to have potential to produce dependence. 

The development of tolerance to the effects 

of clonazolam following repeated use and the 

onset of withdrawal symptoms after cessation 

of use have been reported on online forums. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No human or animal studies have 

examined abuse liability. Online forums 

describe its recreational use and consistently 

report its strong anxiolytic effects. 

A number of published reports describe the 

management of cases of intoxication 

involving clonazolam in emergency 

departments or intensive care. Clonazolam 

use has been analytically confirmed in cases 

of impaired driving, in combination with 

other substances. Clonazolam has the 

potential to increase the effects of other 

drugs, including opioids, and on its own can 

cause severe central nervous system 

depression, including somnolence, 

confusion, sedation and unconsciousness. 

There are reports of its identification in 

multiple countries representing all regions, 

indicating that its use may be increasing. 

Clonazolam is increasingly sold as falsified 

pharmaceutical benzodiazepines. 

Therapeutic Usefulness 

Clonazolam is not known to have any 

therapeutic use, is not listed on the WHO 

Model List of Essential Medicines, and has 

never been marketed as a medicinal product. 

Recommendation 

Clonazolam (Chemical name: 6-(2- 

chlorophenyl)-1-methyl-8-nitro-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is 

a 1-4 triazolobenzodiazepine that has actions 

and effects very similar to those of 

benzodiazepines listed under Schedule IV in 

the Convention on Psychotropic Substances 

of 1971. Like other benzodiazepines, 

clonazolam can produce a state of 

dependence and central nervous system 

depression. There have been a number of 

reports of abuse, impaired driving and nonfatal intoxications. There is sufficient 

evidence of its abuse so as to constitute a 

public health problem, and it has no known 

therapeutic use. 

• The Committee recommended that 

clonazolam (Chemical name: 6-(2- 

chlorophenyl)-1-methyl-8-nitro-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) 

be added to Schedule IV of the 1971 

Convention on Psychotropic Substances. 

Diclazepam 

Substance Identification 

Diclazepam (Chemical name: 7-chloro-5-(2- 

chlorophenyl)-1-methyl-1,3-dihydro-2Hbenzo[e][1,4]diazepin2-one) is a 2-chloro 

derivative of the benzodiazepine diazepam. It 

appears as a white powder, and is commonly 

sold as tablets, pellets and liquid. 

WHO Review History 

Diclazepam has never been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is clandestinely manufactured, 

poses a risk to public health, and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

Diclazepam is an agonist at the 

benzodiazepine site of the GABA-A receptor, 

acting to increase the effect of the inhibitory 

neurotransmitter gamma amino butyric acid 

(GABA). Diclazepam has similar effects to the 

benzodiazepine diazepam, which is currently 

controlled under the Convention on 

Psychotropic Substances of 1971. It is 

metabolized to the benzodiazepines 

delorazepam, lorazepam and lormetazepam. 

These metabolites are active and are also 

pharmaceuticals that are included in 

Schedule IV of the Convention on 

Psychotropic Substances of 1971. 

Diclazepam has been demonstrated to 

cause sedation and muscle relaxation in 

animals. Central nervous systems depressant 

effects are also described in humans. 

Dependence Potential 

No controlled animal or human studies 

have examined the dependence potential of 

diclazepam. 

Online user reports describe crosstolerance with other benzodiazepines and 

use to self-manage benzodiazepine 

withdrawal. This evidence, along with its 

mechanism of action, suggests that 

diclazepam has the capacity to produce 

dependence similar to other 

benzodiazepines. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No controlled animal or human studies 

have examined the abuse liability of 

diclazepam. However, based on its 

mechanism of action and effects, it would be 

expected to have abuse liability similar to 

other benzodiazepines. 

Diclazepam has the potential to increase 

unintentional opioid overdoses. Its long halflife may increase the risk of accumulation 

and interactions when combined with other 

drugs. Fatal intoxications with diclazepam 

have been reported. 

Seizures of diclazepam have been reported 

from multiple countries across different 

regions. Diclazepam is increasingly sold as 

falsified benzodiazepines, commonly as 

diazepam. 

Diclazepam has been implicated in cases of 

impaired driving, including cases where 

diclazepam was identified as the main 

contributor to impairment. It also has been 

involved in cases of drug-facilitated sexual 

assault. 

Therapeutic Usefulness 

Diclazepam is not known to have any 

therapeutic use, is not listed on the WHO 

Model List of Essential Medicines and has 

never been marketed as a medicinal product. 

Recommendation 

Diclazepam (Chemical name: 7-chloro-5-(2- 

chlorophenyl)-1-methyl-1,3-dihydro-2Hbenzo[e][1,4]diazepin2-one) is a 2-chloro 

analogue of the benzodiazepine diazepam 

that has actions and effects very similar to 

those of benzodiazepines listed under 

Schedule IV of the Convention on 

Psychotropic Substances of 1971. It can 

produce a state of dependence and central 

nervous system depression, like other 


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benzodiazepines. There have been reports of 

abuse, impaired driving and fatal and 

nonfatal intoxications. There is sufficient 

evidence of its abuse so as to constitute a 

significant risk to public health, and it has no 

known therapeutic use. 

• The Committee recommended that 

diclazepam (Chemical name: 7-chloro-5-(2- 

chlorophenyl)-1-methyl-1,3-dihydro-2Hbenzo[e][1,4]diazepin2-one) be added to 

Schedule IV of the 1971 Convention on 

Psychotropic Substances. 

Flubromazolam 

Substance Identification 

Flubromazolam (Chemical name: 8-bromo6-(2-fluorophenyl)-1-methyl-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is 

a 1-4 triazolobenzodiazepine. Flubromazolam 

is a white powder, often sold as a liquid or 

as tablets. 

WHO Review History 

Flubromazolam has never been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is clandestinely manufactured, 

poses a risk to public health and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on Central Nervous System 

Flubromazolam is a highly potent 

benzodiazepine with long lasting depressant 

effects on the central nervous system. 

Flubromazolam enhances the effects of the 

inhibitory neurotransmitter gammaaminobutyric acid (GABA) through binding 

at the benzodiazepine site of the GABA-A 

receptor. This mechanism of action, as well 

as its effects, are similar to those of the 

benzodiazepines triazolam and alprazolam 

which are controlled under Schedule IV of 

the 1971 Convention on Psychotropic 

Substances. 

A single pharmacokinetic study showed 

that a 0.5 mg flubromazolam dose induced 

strong sedative effects that lasted more than 

10 hours, and caused partial amnesia for 

more than 24 hours. The effects of 

flubromazolam have been effectively 

reversed by the benzodiazepine antagonist 

flumazenil. 

Reports from online user forums describe 

benzodiazepine-like effects including 

anxiolytic, euphoric and sedative effects. 

Dependence Potential 

No controlled animal or human studies 

describe the dependence potential of 

flubromazolam, although multiple reports 

from online sources describe severe 

withdrawal symptoms, such as muscle aches, 

sleeping disorders, severe anxiety and panic 

attacks, dissociative symptoms, perceptual 

distortions, cramping, chills, vomiting and 

risk of seizures. There are also descriptions 

of loss of control over use, and rapid onset 

of tolerance. The latter suggests that taking 

increased doses and developing physical 

dependence is likely. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No controlled animal or human studies 

have assessed the abuse potential of 

flubromazolam. Impaired driving with 

flubromazolam as the sole intoxicant is 

reported. Non-fatal intoxications requiring 

hospital admission, and fatal intoxications 

due to flubromazolam use are documented. 

In these cases, central nervous system 

depression and severe sedation were clinical 

features of presentation. Flubromazolam has 

the potential to increase unintentional opioid 

overdoses. Its long half-life may increase the 

risk of accumulation and interactions when 

combined with other drugs. 

Nonmedical use and seizures of 

flubromazolam have been documented in 

multiple countries across different regions. It 

is increasingly sold as falsified 

pharmaceutical benzodiazepines. 

Therapeutic Usefulness 

Flubromazolam is not known to have any 

therapeutic uses, is not listed on the WHO 

Model List of Essential Medicines and has 

never been marketed as a medicinal product. 

Recommendation 

Flubromazolam (Chemical name: 8-bromo6-(2-fluorophenyl)-1-methyl-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) is 

a 1-4 triazolobenzodiazepine that has actions 

and effects very similar to those of 

benzodiazepines listed under Schedule IV in 

the Convention on Psychotropic Substances 

of 1971. It can produce a state of dependence 

and central nervous system depression, like 

other benzodiazepines. There have been 

increasing reports of abuse, impaired driving 

and fatal and non-fatal intoxications. There is 

sufficient evidence of its abuse to constitute 

a significant risk to public health, and it has 

no known therapeutic use. 

The Committee recommended that 

flubromazolam (Chemical name: 8-bromo-6- 

(2-fluorophenyl)-1-methyl-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) 

be added to Schedule IV of the 1971 

Convention on Psychotropic Substances. 

III. Discussion 

Although WHO has made specific 

scheduling recommendations for each of 

the drug substances, the CND is not 

obliged to follow the WHO 

recommendations. Options available to 

the CND for substances considered for 

control under the 1971 Convention 

include the following: (1) Accept the 

WHO recommendations; (2) accept the 

recommendations to control but control 

the drug substance in a schedule other 

than that recommended; or (3) reject the 

recommendations entirely. 

Isotonitazene (chemical name: N,Ndiethyl-2-(2-(4-isopropoxybenzyl)-5- 

nitro-1H-benzimidazol-1-yl)ethan-1- 

amine) is a potent synthetic opioid that 

is abused similar to other synthetic 

opioids. Its use has resulted in adverse 

health effects, including positively 

identified in 49 death investigation 

cases in the United States between 

August 2019 and April 2020. Law 

enforcement data indicate that 

isotonitazene has appeared in the 

United States’ illicit drug market. 

According to the National Forensic 

Laboratory Information System (NFLIS) 

database, there have been 53 encounters 

of isotonitazene in the United States (as 

of June 2020). There are no commercial 

or approved medical uses for 

isotonitazene. On August 20, 2020, the 

Drug Enforcement Administration 

issued an order to temporarily control 

isotonitazene as a Schedule I substance 

under the CSA. As such, additional 

permanent controls will be necessary to 

fulfill U.S. obligations if isotonitazene is 

placed in Schedule I of the 1961 

Convention. 

CUMYL-PEGACLONE is a synthetic 

cannabinoid that has been sold online 

and used to mimic the biological effects 

of tetrahydrocannabinol (THC), the 

main psychoactive constituent in 

marijuana. Research and clinical reports 

have demonstrated that synthetic 

cannabinoids are applied onto plant 

material so that the material may be 

smoked as users attempt to obtain a 

euphoric and psychoactive ‘‘high’’. 

Synthetic cannabinoids have been 

marketed under the guise of ‘‘herbal 

incense’’, and promoted by drug 

traffickers as legal alternatives to 

marijuana. In vitro studies demonstrate 

that CUMYL-PEGALCONE binds to and 

activates the cannabinoid one receptor. 

CUMYL-PEGALCONE has not been 

encountered within the United States 

according to the NFLIS database (as of 

January 14, 2021). There are no 

commercial or approved medical uses 

for CUMYL-PEGALCONE and it is not a 

controlled substance under the CSA. As 

such, additional permanent controls 

will be necessary to fulfill U.S. 

obligations if CUMYL-PEGALCONE is 

controlled under Schedule II of the 1971 

Convention. 

MDMB-4en-PINACA is a synthetic 

cannabinoid that has been sold online 

and used to mimic the biological effects 

of THC, the main psychoactive 

constituent in marijuana. Research and 

clinical reports have demonstrated that 

synthetic cannabinoids are applied onto 

plant material so that the material may 

be smoked as users attempt to obtain a 

euphoric and psychoactive ‘‘high’’. 

Synthetic cannabinoids have been 

marketed under the guise of ‘‘herbal 

incense’’, and promoted by drug 

traffickers as legal alternatives to 

marijuana. According to the NFLIS 

database, MDMB-4en-PINACA was first 

encountered in the United States in 

January 2019. There have been 3,331 

encounters of MDMB-4en-PINACA in 

the United States (as of January 14, 

2021). MDMB-4en-PINACA has also 

been encountered mixed with opioids 

including heroin and fentanyl, with 

some incidents resulting in violent 


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behaviors, tachycardia, and 

hypertension. There are no commercial 

or approved medical uses for MDMB4en-PINACA and it is not a controlled 

substance under the CSA. As such, 

additional permanent controls will be 

necessary to fulfill U.S. obligations if 

MDMB-4en-PINACA is controlled under 

Schedule II of the 1971 Convention. 

3-Methoxyphencyclidine; chemical 

name: 1-(1-(3-methoxyphenyl)

cyclohexyl)piperidine) is a novel Nmethyl-D-aspartate (NMDA) receptor 

antagonist with structural and 

biochemical similarities to 

phencyclcycidine (PCP) and other 

arylcyclohexylamines. 3- 

Methoxyphencyclidine is classified as 

an arylcyclohexylamine and produces 

dissociative anesthetic and 

hallucinogenic effects. Use of this 

substance is associated with 

intoxication and published case reports 

of both fatal and non-fatal overdose. 3- 

Methoxyphencyclidine is encountered 

by law enforcement in drug seizure 

reports. 3-Methoxyphencyclidine is an 

analogue of the Schedule II 

hallucinogen PCP. There is no approved 

medical use for 3- 

Methoxyphencyclidine in the United 

States and is not a controlled substance 

under the CSA. If intended for human 

consumption, 3-Methoxyphencyclidine 

may be treated as a ‘‘controlled 

substance analogue’’ under the CSA 

pursuant to 21 U.S.C. 802(32)(A) and 

813. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if 3-Methoxyphencyclidine 

is controlled under Schedule II of the 

1971 Convention. 

Diphenidine (chemical name: 1-(1,2- 

diphenylethyl) piperidine) is a noncompetitive NMDA receptor antagonist 

classified as a diarylethylamine and 

produces dissociative anesthetic and 

hallucinogenic effects. It was originally 

synthesized in the 1920s but reports of 

abuse started in the last decade. Use of 

this substance is associated with 

intoxication and published case reports 

of both fatal and non-fatal overdose 

outside of the United States. 

Diphenidine is encountered by law 

enforcement in drug seizure reports. 

Diphenidine is not approved for 

medical use in the United States and is 

not a controlled substance under the 

CSA. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if diphenidine is controlled 

under Schedule II of the 1971 

Convention. 

Flubromazolam, clonazolam, and 

diclazepam belong 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. 

Flubromazolam is a triazole analogue of 

the designer benzodiazepine, 

flubromazepam. Flubromazolam can be 

purchased on the internet and is used as 

a recreational substance in the United 

States. Flubromazolam has been 

identified in an increasing number of 

law enforcement seizures and has been 

associated with an increasing number of 

drug overdose deaths. According to the 

NFLIS database, in 2020 there were 

1,446 clonazolam encounters (as of 

December 2020). It is abused by a broad 

range of groups including youths, young 

adults, and older adults. Clonazolam 

has been involved in an increasing 

number of drug seizure events as well 

as drug overdose deaths, alone and in 

combination with alcohol. As such, the 

NFLIS database reported 249 encounters 

in 2020 (as of December 2020). 

Diclazepam is a designer 

benzodiazepine sold on the internet and 

most often found as a liquid solution, 

but it may be sold as a powder, tablet, 

blotter paper, or pellet. In 2020, the 

NFLIS database reported 113 encounters 

of diclazepam (as of December 2020). In 

2018, flubromazolam, clonazolam, and 

dicalazepam were all identified by law 

enforcement in driving under the 

influence of drugs cases in the United 

States. Flubromazolam, clonazolam, and 

diclazepam are not approved for 

medical use in the United States and are 

not controlled substances under the 

CSA. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if flubromazolam, 

clonazolam, and dicalazepam are 

controlled under Schedule IV of the 

1971 Convention. 

FDA, on behalf of the Secretary of 

HHS, invites interested persons to 

submit comments on the notifications 

from the United Nations concerning 

these drug substances. FDA, in 

cooperation with the National Institute 

on Drug Abuse, will consider the 

comments on behalf of HHS in 

evaluating the WHO scheduling 

recommendations. Then, under section 

201(d)(2)(B) of the CSA, HHS will 

recommend to the Secretary of State 

what position the United States should 

take when voting on the 

recommendations for control of 

substances under the 1971 Convention 

at the CND meeting in April 2021. 

Comments regarding the WHO 

recommendations for control of 

isotonitazene under the 1961 Single 

Convention will also be forwarded to 

the relevant Agencies for consideration 

in developing the U.S. position 

regarding narcotic substances at the 

CND meeting. 

Dated: February 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03268 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

SIP21–008, Examining Approaches to 

Improve Care and Management of 

People with Lupus. 

Date: May 13, 2021. 

Time: 11:00 a.m.–6:00 p.m., EDT. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

FOR FURTHER INFORMATION CONTACT: Jaya 

Raman, Ph.D., Scientific Review Officer, 

National Center for Chronic Disease 

Prevention and Health Promotion, CDC, 

4770 Buford Highway, Mailstop S107–8, 

Atlanta, Georgia 30341, Telephone (770) 

488–6511, JRaman@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 


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