Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 8683 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0105] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization; Scheduling 

Recommendations; Butonitazene; 3- 

Chloromethcathinone; Dipentylone; 2- 

Fluorodeschloroketamine; 

Bromazolam; 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 March 2024. This 

notice is issued under the Controlled 

Substances Act (CSA). 

DATES: Submit either electronic or 

written comments by February 27, 2024. 

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 February 27, 

2024. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 27, 2024. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received 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– 

2022–N–0105 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; World 

Health Organization; Scheduling 

Recommendations; Butonitazene; 3- 

Chloromethcathinone; Dipentylone; 2- 

Fluorodeschloroketamine; Bromazolam; 

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, 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: 

Edward (Greg) Hawkins, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5110, Silver Spring, 

MD 20993–0002, 301–796–0727, 

Edward.hawkins@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 


lotter on DSK11XQN23PROD with NOTICES1
8684 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 

States in discussions and negotiations 

relating to the proposal. 

As detailed in the following 

paragraphs, the Secretary of State has 

received notification from the SecretaryGeneral of the United Nations (the 

Secretary-General) regarding four 

substances to be considered for control 

under the 1971 Convention. This 

notification reflects the 

recommendation from the 46th WHO 

Expert Committee for Drug Dependence 

(ECDD), which met in October 2023. In 

the Federal Register of August 24, 2023 

(88 FR 52179), 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 of this document. 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.18/2023 

WHO/ECDD46; 1961C-Art.3, 1971C-Art.2 

CU 2023/403/DTA/SGB 

The Secretariat of the United Nations 

presents its compliments to the Permanent 

Mission of the United States of America to 

the United Nations (Vienna) and has the 

honour to inform the Permanent Mission 

that, in a letter dated 15 November 2023, 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-sixth Meeting of the WHO’s Expert 

Committee on Drug Dependence (ECDD): 

Substance recommended to be added to 

Schedule I of the 1961 Convention: 

—Butonitazene 

IUPAC (International Union of Pure and 

Applied Chemistry) name: N,N-diethyl2-[(4-butoxyphenyl)methyl]-5-nitro-1Hbenzimidazole-1-ethanamine 

Substances recommended to be added to 

Schedule II of the 1971 Convention: 

—3-chloromethcathinone or 3-CMC 

IUPAC name: 1-(3-chlorophenyl)-2- 

(methylamino)propan-1-one 

—Dipentylone 

IUPAC name: 1-(1,3-benzodioxol-5-yl)-2- 

(dimethylamino)pentan-1-one 

—2-fluorodeschloroketamine 

IUPAC name: 2-(2-fluorophenyl)-2- 

(methylamino)cyclohexan-1-one 

Substance recommended to be added to 

Schedule IV of the 1971 Convention: 

—Bromazolam 

IUPAC name: 8-bromo-1-methyl-6-phenyl4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine 

Substance recommended to proceed to 

critical review at a future ECDD meeting: 

In the letter from the Director-General of 

WHO to the Secretary-General, reference is 

also made to the recommendation made by 

the WHO Expert Committee on Drug 

Dependence (ECDD), at its forty-sixth 

meeting, to conduct a critical review of the 

following substance: 

—Carisoprodol 

IUPAC name: 2-[(carbamoyloxy)methyl]-2- 

methylpentyl(1-methylethyl)carbamate 

Substances to be kept under surveillance: 

In the letter from the Director-General of 

WHO to the Secretary-General, reference is 

also made to the recommendation made by 

the WHO Expert Committee on Drug 

Dependence (ECDD), at its forty-sixth 

meeting, to keep the following substances 

under surveillance: 

—Flubromazepam 

IUPAC name: 7-bromo-5-(2-fluorophenyl)- 

1,3-dihydro-2H-1,4-benzodiazepin-2-one 

—Nitrous oxide 

IUPAC name: nitrous oxide 

In accordance with the provisions of article 

3, paragraph 2, of the 1961 Convention and 

article 2, paragraph 2, of the 1971 

Convention, the notification is hereby 

transmitted as NAR/CL.18/2023—Annex I to 

the present note. In connection with the 

notification, WHO also submitted a summary 

of the assessments and findings for these 

recommendations made by ECDD in Annex 

1 to the letter to the Secretary-General, 

hereby transmitted in NAR/CL.18/2023— 

Annex II. 

Also, in accordance with the same 

provisions, the notification from WHO will 

be brought to the attention of the sixtyseventh session of the Commission on 

Narcotic Drugs (14–22 March 2024) in a presession document that will be made available 

in the six official languages of the United 

Nations on the website of the sixty-seventh 

session of the Commission on Narcotic 

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

commissions/CND/session/67_Session_2024/ 

67CND_Main.html. 

In order to assist the Commission in 

reaching a decision, it would be appreciated 

if the Permanent Mission 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: 

—Butonitazene 

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: 

—3-chloromethcathinone or 3-CMC 

—Dipentylone 

—2-fluorodeschloroketamine 

—Bromazolam 

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 December 2023 

Annex I 

Letter Addressed to the Secretary-General of 

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

Dated 15 November 2023 

I have the honour to refer to the Forty-sixth 

Meeting of the World Health Organization 

(WHO) Expert Committee on Drug 

Dependence (ECDD), which was convened in 

Geneva, Switzerland, from 16 to 19 October 

2023. 

WHO is mandated by the 1961 and 1971 

International Drug Control Conventions to 

make recommendations to the SecretaryGeneral of the United Nations on the need for 

a level of international control of 

psychoactive substances based on the advice 

of its independent scientific advisory body, 

the ECDD. To assess the appropriate control 

of a psychoactive substance, WHO convenes 

ECDD annually to review the potential of a 

substance to cause dependence, abuse and 

harm to health, as well as any therapeutic 

applications. 

The Forty-sixth WHO ECDD Meeting 

critically reviewed six new psychoactive 

substances: one novel synthetic opioid 

(butonitazene), two cathinones/stimulants (3- 

chloromethcathinone or 3-CMC, 

dipentylone), one dissociative substance (2- 

fluorodeschloroketamine) and two 

benzodiazepines (bromazolam, 

flubromazepam). These substances, with the 

exception of bromazolam, had previously not 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 8685 

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 risk to public 

health and society, and of no recognized 

therapeutic use by any party. Therefore, a 

critical review to consider international 

scheduling measures was undertaken for 

each substance so that the Expert Committee 

could consider whether information about 

these substances may justify the scheduling 

of a substance in the 1961 or 1971 

Conventions. 

In addition, the Forty-sixth ECDD carried 

out pre-reviews of the medications nitrous 

oxide and carisoprodol to consider whether 

current information justified a critical 

review. 

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 

endorse and submit the following 

recommendations of the Forty-sixth Meeting 

of ECDD: 

Substance recommended to be added to 

Schedule I of the 1961 Convention: 

—Butonitazene 

IUPAC (International Union of Pure and 

Applied Chemistry) name: N,N-diethyl2-[(4-butoxyphenyl)methyl]-5-nitro-1Hbenzimidazole-1-ethanamine 

Substances recommended to be added to 

Schedule II of the 1971 Convention: 

—3-chloromethcathinone or 3-CMC 

IUPAC name: 1-(3-chlorophenyl)-2- 

(methylamino)propan-1-one 

—Dipentylone 

IUPAC name: 1-(1,3-benzodioxol-5-yl)-2- 

(dimethylamino)pentan-1-one 

—2-fluorodeschloroketamine 

IUPAC name: 2-(2-fluorophenyl)-2- 

(methylamino)cyclohexan-1-one 

Substance recommended to be added to 

Schedule IV of the 1971 Convention: 

—Bromazolam 

IUPAC name: 8-bromo-1-methyl-6-phenyl4H-[1,2,4]triazolo[4,3- 

a][1,4]benzodiazepine 

Substance recommended to proceed to 

critical review at a future ECDD meeting: 

—Carisoprodol 

IUPAC name: 2-[(carbamoyloxy)methyl]-2- 

methylpentyl(1-methylethyl)carbamate 

Substances to be kept under surveillance: 

—Flubromazepam 

IUPAC name: 7-bromo-5-(2-fluorophenyl)- 

1,3-dihydro-2H–1,4-benzodiazepin-2-one 

—Nitrous oxide 

IUPAC name: nitrous oxide 

The assessments and findings on which 

these recommendations are based are set out 

in detail in the forty-sixth meeting report of 

the WHO Expert Committee on Drug 

Dependence. A summary of the assessment 

and recommendations made by the Fortysixth ECDD is contained in Annex I to this 

letter. 

I am pleased with the ongoing 

collaboration between WHO, the United 

Nations Office on Drugs and Crime, and the 

International Narcotics Control Board, 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 46th Expert Committee on Drug 

Dependence, 16–19 October 2023 

Substance to be added to Schedule I of the 

Single Convention on Narcotic Drugs (1961): 

Butonitazene 

Substance Identification 

Butonitazene (IUPAC name: N,N-diethyl-2- 

[(4-butoxyphenyl)methyl]-5-nitro-1Hbenzimidazole-1-ethanamine), also known as 

butoxynitazene, is a benzimidazole-derived 

synthetic opioid. Butonitazene is found as a 

crystalline solid and a white or yellow-brown 

powder. 

WHO Review History 

Butonitazene has not been reviewed 

formally by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is manufactured clandestinely, 

poses a risk to public health, and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

The chemical structure and 

pharmacological effects of butonitazene are 

similar to those of opioid drugs such as 

etonitazene and isotonitazene that are 

controlled under Schedule I of the United 

Nations Conventions on Narcotic Drugs of 

1961. Butonitazene is an agonist at m-opioid 

receptors and has similar analgesic effects as 

morphine and fentanyl. 

Dependence Potential 

No studies in experimental animal or 

humans were found on the dependence 

potential of butonitazene; however, as it is a 

m-opioid receptor agonist, it would be 

expected to produce dependence. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No studies on the abuse potential of 

butonitazene in humans were found. In an 

animal model predictive of abuse potential, 

butonitazene had morphine-like effects, 

which were blocked by the opioid antagonist 

naltrexone. As it is a m-opioid receptor 

agonist, it would be expected to produce 

euphoria and other effects predictive of high 

abuse liability. Butonitazene is reported to be 

administered by various routes, including 

smoking, intranasally and by injection. Nonfatal intoxications that involved butonitazene 

and required hospitalization have been 

reported. Seizures of butonitazene have been 

reported in multiple countries in two regions. 

Therapeutic Use 

Butonitazene is not known to have any 

therapeutic use and has never been marketed 

as a medicinal product. 

Rationale and Recommendation 

Butonitazene, also known as 

butoxynitazene, is a synthetic opioid that is 

liable to abuse and to production of ill effects 

similar to those of other opioids that are 

controlled under Schedule I of the Single 

Convention on Narcotic Drugs, 1961. Its use 

has been reported in a number of countries. 

It has no known therapeutic use and is likely 

to cause substantial harm. The Committee 

recommended that butonitazene (IUPAC 

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

butoxyphenyl)methyl]-5-nitro-1Hbenzimidazole-1-ethanamine), also known as 

butoxynitazene, be added to Schedule I of the 

Single Convention on Narcotic Drugs, 1961. 

Substances to be added to Schedule II of 

the Convention on Psychotropic Substance 

(1971): 

3-Chloromethcathinone (3-CMC) 

Substance Identification 

3-Chloromethcathinone or 3-CMC (IUPAC 

name: 1-(3-chlorophenyl)-2- 

(methylamino)propan-1- one), is a synthetic 

cathinone. 3-CMC has been described as a 

grey or white solid and as a white powder. 

It has been identified in capsule, tablet, and 

liquid forms. 

WHO Review History 

3-CMC has not been reviewed formally by 

WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is manufactured clandestinely, 

poses a risk to public health and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

3-CMC is a chemical analogue of 

methcathinone, which is controlled under 

Schedule I of the United Nations Convention 

on Psychotropic Substances of 1971. Its 

structural isomer, 4-CMC, is controlled under 

Schedule II of the United Nations Convention 

on Psychotropic Substances of 1971. In 

common with other cathinone 

psychostimulants, 3-CMC has been shown to 

act via dopamine, serotonin and 

norepinephrine transporters in the central 

nervous system to increase the 

concentrations of these neurotransmitters. 

Dependence Potential 

No controlled experimental studies of the 

dependence potential of 3-CMC in 

experimental animals or humans were 

available; however, clinical admissions 

associated with dependence to 3-CMC have 

been reported. Given its action in the central 

nervous system, 3-CMC would be expected to 

produce a state of dependence similar to that 

produced by amphetamine and other 

psychostimulants. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No controlled studies of the abuse 

potential of 3-CMC in experimental animals 

or humans were available. In experimental 

animals, 3-CMC produced locomotor effects 

consistent with a psychostimulant. Cases of 

intoxication with 3-CMC alone and with 

other drugs requiring hospitalization have 

been reported. The adverse effects included 


lotter on DSK11XQN23PROD with NOTICES1
8686 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 

agitation, restlessness, seizures, high blood 

pressure, sweating, and chest pain. These 

adverse effects are similar to those of other 

psychostimulants, such as amphetamine and 

various cathinones. Fatal intoxications 

involving 3-CMC have been documented, 

including in cases in which 3-CMC was the 

only substance identified. It is reported to be 

administered by various routes, including 

smoking, intranasally and by injection. 3- 

CMC has been detected in an increasing 

number of countries in most regions of the 

world. Seizures of 3-CMC have been reported 

in multiple countries and regions, with 

recent increases coinciding with 

international control of 4-CMC. 

Therapeutic Use 

3-CMC is not known to have any 

therapeutic uses and has never been 

marketed as a medicinal product. 

Rationale and Recommendation 

3-Chloromethcathinone or 3-CMC is a 

synthetic cathinone with effects similar to 

those of other synthetic cathinones, such as 

mephedrone and 4-CMC, which are listed as 

Schedule II substances under the Convention 

on Psychotropic Substances of 1971. Its mode 

of action and effects are similar to those of 

other cathinones. There is evidence of use of 

3-CMC in a number of countries and regions, 

where it has resulted in fatal and non-fatal 

intoxications. The substance causes 

substantial harm, constitutes a substantial 

risk to public health and has no therapeutic 

use. The Committee recommended that 3- 

chloromethcathinone or 3-CMC (IUPAC 

name: 1(3-chlorophenyl)-2- 

(methylamino)propan-1-one) be added to 

Schedule II of the Convention on 

Psychotropic Substances of 1971. 

Dipentylone 

Substance Identification 

Dipentylone or N-methylpentylone (IUPAC 

name: 1-(1,3-benzodioxol-5-yl)-2- 

(dimethylamino)pentan-1-one, also known as 

N,N-dimethylpentylone, dimethylpentylone 

or bk-DMBDP) is a synthetic cathinone. It is 

distributed mainly as crystals or tablets. 

WHO Review History 

Dipentylone has not been reviewed 

formally by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is manufactured clandestinely, 

poses a risk to public health and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

In common with other cathinone 

psychostimulants, dipentylone has been 

shown to act via dopamine, serotonin, and 

norepinephrine transporters in the central 

nervous system to increase the 

concentrations of these neurotransmitters. 

Online self-reports describe insomnia, 

hallucinations, paranoia and confusion after 

its use. Adverse effects documented in 

clinical presentations include agitation and 

tachycardia. These effects are consistent with 

a psychostimulant mechanism of action. 

Dependence Potential 

No controlled experimental studies of the 

dependence potential of dipentylone in 

experimental animals or humans were 

available. In view of its action in the central 

nervous system, however, dipentylone would 

be expected to produce a state of dependence 

similar to that produced by amphetamine 

and other psychostimulants. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

Studies in experimental animals 

demonstrate that dipentylone has an abuse 

potential similar to that of 

methamphetamine, which is listed under 

Schedule II of the Convention on 

Psychotropic Substances of 1971, and 

cocaine, which is listed under Schedule I of 

the Convention on Narcotic Drugs of 1961. 

Dipentylone has been shown to produce 

locomotor stimulant effects in animal 

models. No controlled studies on the abuse 

potential of dipentylone in humans were 

identified. Non-fatal intoxication involving 

dipentylone that required hospitalization has 

been reported, and fatal intoxications have 

been reported by a number of countries, in 

which no other substance was involved in at 

least one case. Cases of driving under the 

influence of dipentylone have reported by 

some countries. Seizures of dipentylone have 

been reported in a number of countries and 

regions. Dipentylone appears to be 

commonly sold as cocaine or MDMA. 

Therapeutic Use 

Dipentylone is not known to have any 

therapeutic uses and has never been 

marketed as a medicinal product. 

Rationale and Recommendation 

Dipentylone or N-methylpentylone is a 

synthetic cathinone with effects similar to 

those of other synthetic cathinones and other 

psychostimulants, such as methamphetamine 

that are listed under Schedule II of the 

Convention on Psychotropic Substances of 

1971. Its mode of action suggests the 

likelihood of abuse, and it poses a substantial 

risk to public health. It has no known 

therapeutic use. The Committee 

recommended that dipentylone or Nmethylpentylone (IUPAC name: 1-(1,3- 

benzodioxol-5-yl)-2-(dimethylamino)pentan1-one) be added to Schedule II of the 

Convention on Psychotropic Substances of 

1971. 

2-Fluorodeschloroketamine 

Substance Identification 

2-Fluorodeschloroketamine (IUPAC name: 

2-(2-fluorophenyl)-2- 

(methylamino)cyclohexan-1-one) is an 

arylcyclohexylamine that is chemically 

related to the dissociative anaesthetic 

ketamine. It has been described as a brown 

oil in its free base form or as a crystalline 

solid or white powder as a salt. It has been 

identified in some food products 

(chocolates). 

WHO Review History 

2-Fluorodeschloroketamine has not been 

reviewed formally by WHO and is not 

currently under international control. 

Information was brought to WHO’s attention 

that this substance is manufactured 

clandestinely, poses a risk to public health 

and has no recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

The mechanism of action of 2- 

fluorodeschloroketamine is uncertain, but it 

has effects similar to those of N-methyl-Daspartate receptor antagonists such as 

phencyclidine, which are controlled under 

Schedule II of the Convention on 

Psychotropic Substances of 1971. Effects 

documented during clinical admissions due 

to 2-fluorodeschloroketamine intoxication 

include dissociation, confusion, agitation, 

tachycardia and hypertension. Unverified 

reports from people who use 2- 

fluorodeschloroketamine describe 

hallucinogenic and dissociative effects. The 

clinical and self-reported effects of 2- 

fluorodeschloroketamine are consistent with 

the effects of phencyclidine. 

Dependence Potential 

No controlled studies in experimental 

animal or humans were found on the 

dependence potential of 2- 

fluorodeschloroketamine; however, clinical 

admissions for dependence on 2- 

fluorodeschloroketamine have been reported 

in various countries and regions. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

Studies in experimental animals indicate 

that 2-fluorodeschloroketamine has 

behavioural (locomotor) effects consistent 

with central nervous system stimulation. 

Such studies confirm that it has rewarding 

properties and effects predictive of abuse 

liability. Cases of intoxication that involved 

2-fluorodeschloroketamine and required 

hospitalization have been reported. The 

adverse effects included central nervous 

system effects such as dissociation, 

confusion, agitation, combativeness, 

nystagmus, hallucinations and impaired 

consciousness, loss of consciousness and 

cardiovascular effects such as tachycardia 

and hypertension. Fatal intoxications 

involving 2-fluorodeschloroketamine have 

been documented, including at least one case 

in which no other substance was involved. 2- 

Fluorodeschloroketamine has been 

analytically confirmed in people driving 

under the influence of drugs and in clinical 

admissions due to drug intoxication. It is 

reported to be administered by various routes 

including orally, intranasally and by 

injection. Seizures have been reported in a 

number of countries in several regions. 

Therapeutic Use 

2-Fluorodeschloroketamine is not known 

to have any therapeutic use, is not listed on 

the WHO Model Lists of Essential Medicines 

and has never been marketed as a medicinal 

product. 

Rationale and Recommendation 

2-Fluorodeschloroketamine has effects 

similar to those of dissociative substances 

such as phencyclidine, which are controlled 

under Schedule II of the Convention on 

Psychotropic Substances of 1971. The results 

of studies in experimental animals indicate a 

high likelihood of abuse. There is evidence 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 8687 

that this substance is used in a number of 

countries in several regions. 2- 

Fluorodeschloroketamine causes substantial 

harm, including impaired driving, emergency 

department presentations and deaths. It has 

no known therapeutic use. The Committee 

recommended that 2- 

fluorodeschloroketamine (IUPAC name: 2-(2- 

fluorophenyl)-2-(methylamino)cyclohexan-1- 

one) be added to Schedule II of the 

Convention on Psychotropic Substances of 

1971. 

Substance to be added to Schedule IV of 

the Convention on Psychotropic Substances 

(1971): 

Bromazolam 

Substance Identification 

Bromazolam (IUPAC name: 8-bromo-1- 

methyl-6-phenyl-4H-[1,2,4]triazolo[4,3- 

a][1,4]benzodiazepine) is a 

triazolobenzodiazepine. Bromazolam has 

been described as a white or crystalline solid 

and has been identified in tablets, capsules, 

powders, solutions and chewable candy 

products (‘‘gummies’’). Bromazolam has been 

identified in falsified pharmaceutical 

benzodiazepine products. 

WHO Review History 

Bromazolam was critically reviewed at the 

45th ECDD meeting. Because of lack of 

information on its pharmacological effects, it 

was not recommended for international 

control but was placed under surveillance. 

New information on such effects was brought 

to WHO’s attention, in addition to ongoing 

evidence that this substance is manufactured 

clandestinely, poses a risk to public health 

and has no recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

Bromazolam is a benzodiazepine with 

relatively high potency and a shortintermediate duration of action. It is 

structurally related to alprazolam. Like other 

benzodiazepines, bromazolam binds to gaminobutyric acid (GABAA) receptors, and its 

effects can be reversed by administration of 

the benzodiazepine receptor antagonist 

flumazenil. Unconfirmed online reports by 

people who use bromazolam describe 

benzodiazepine-like effects, including 

hypnotic, sedative, muscle relaxant and 

euphoric effects. 

Dependence Potential 

No controlled studies in experimental 

animals or in humans have examined the 

dependence potential of bromazolam. In 

view of its pharmacological effects and 

similarity to other benzodiazepines, however, 

it would be expected to produce dependence. 

Online self-reports describe withdrawal 

symptoms after cessation of chronic use. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No studies in humans were found of the 

abuse liability of bromazolam. In an animal 

model predictive of abuse liability, 

bromazolam had effects similar to those of 

midazolam and diazepam, which are 

controlled under Schedule IV of the 

Convention on Psychotropic Substances of 

1971. The effects were attenuated by preadministration of the benzodiazepine 

receptor antagonist flumazenil, confirming 

bromazolam’s action as a benzodiazepine. 

Seizures of bromazolam have been reported 

increasingly in many countries in various 

regions. Bromazolam has been analytically 

confirmed as a causal or contributory agent 

in several deaths and non-fatal intoxications, 

and its presence has been confirmed in 

instances of driving under the influence of 

drugs. These harms have been reported in 

multiple countries and regions. 

Therapeutic Use 

Bromazolam is not known to have any 

therapeutic use, is not listed on the WHO 

Model Lists of Essential Medicines and has 

never been marketed as a medicinal product. 

Rationale and Recommendation 

The mechanism of action and ill effects of 

bromazolam are similar to those of other 

benzodiazepines, such as alprazolam and 

diazepam, that are listed under Schedule IV 

of the Convention on Psychotropic 

Substances of 1971. Reports of seizures and 

detection in fatal and non-fatal intoxications 

have increased over time. There is sufficient 

evidence of its abuse to conclude that it 

constitutes a significant risk to public health 

and has no known therapeutic use. The 

Committee recommended that bromazolam 

(IUPAC name: 8-bromo-1-methyl-6-phenyl4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) 

be added to Schedule IV of the Convention 

on Psychotropic Substances of 1971. 

Substances to be recommended for critical 

review: 

Carisoprodol 

Substance Identification 

Carisoprodol (IUPAC name: 2- 

[(carbamoyloxy)methyl]-2-methylpentyl(1- 

ethylethyl)carbamate) is a centrally-acting 

skeletal muscle relaxant sold as a singleingredient preparation and in combination 

products. Carisoprodol is available as a 

pharmaceutical product in tablet form, has 

been detected in falsified pharmaceuticals 

and is also found as a white powder. 

WHO Review History 

Carisoprodol was pre-reviewed at the 32nd 

ECDD meeting in 2000. The Committee did 

not recommend critical review of 

carisoprodol at that time, noting that 

sporadic nonmedical use of carisoprodol was 

not a new phenomenon and there was no 

indication of significantly increasing 

nonmedical use. A new pre-review was 

initiated in 2023 after information received 

from an international agency that suggested 

a significant increase in the reported number 

of trafficking cases and seizures involving 

carisoprodol. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

Carisoprodol is an analogue of 

meprobamate and has effects similar to those 

of other central nervous system depressants 

such as meprobamate, pentobarbital, 

diazepam and chlordiazepoxide that are 

listed under schedules III and IV of the 

Convention on Psychotropic Substances of 

1971. Meprobamate is also a metabolite of 

carisoprodol. Although its exact mechanism 

of action is not known, the therapeutic effects 

of carisoprodol appear to be due to 

modulation of GABAA receptors similar to 

the action of barbiturates. The sedative 

effects of carisoprodol can be potentiated 

when it is combined with benzodiazepines, 

opioids or alcohol. 

Dependence Potential 

Tolerance and withdrawal have been 

documented in experimental animals, and 

the potential for dependence on carisoprodol 

is considered to be similar to that of 

barbiturates and benzodiazepines. Tolerance, 

withdrawal and craving have been 

documented in humans, and increasing 

numbers of cases of carisoprodol dependence 

have been documented in pharmacovigilance 

reporting systems. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

In animal models indicative of abuse 

liability, the effects of carisoprodol were 

similar to those of pentobarbital, 

chlordiazepoxide and meprobamate in a 

dose-dependent manner. In humans, 

carisoprodol produces central nervous 

system depressant effects, including 

drowsiness, sedation, confusion and coma. 

Public health harm associated with use of 

carisoprodol has included cases of driving 

under the influence of the drug. Nonmedical 

use of carisoprodol is widely documented in 

multiple countries and regions, including in 

combination with opioids and/or 

benzodiazepines. The incidence of poisoning 

and other public health harm has been 

reported to have decreased in some countries 

after increased restrictions on carisoprodol 

prescription or removal of the drug from the 

market. 

Therapeutic Use 

Carisoprodol is a centrally acting muscle 

relaxant used in some countries in the short 

term as an adjunct in symptomatic treatment 

of acute musculoskeletal disorders associated 

with painful muscle spasms. It is not on the 

2023 WHO Essential Medicines List or the 

WHO Essential Medicines List for Children. 

It has been withdrawn from use in some 

countries because of concern about increased 

rates of diversion, nonmedical use, 

dependence, intoxication and psychomotor 

impairment. 

Rationale and Recommendation 

The increasing evidence of misuse and 

abuse of carisoprodol in a number of 

countries is a growing cause for concern. 

Carisoprodol has been shown to produce a 

state of dependence and central nervous 

system depression. It has only limited 

medical use. The Committee recommended 

that carisoprodol be subject to a future 

critical review. 

Substances to be kept under surveillance: 

Flubromazepam 

Substance Identification 

Flubromazepam (IUPAC name: 7-bromo-5- 

(2-fluorophenyl)-1,3-dihydro-2H-1,4- 

benzodiazepin-2-one) is a 1,4- 

benzodiazepine. Flubromazepam is described 

as a white powder or a crystalline solid and 

has been found in infused paper forms. 


lotter on DSK11XQN23PROD with NOTICES1
8688 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 

WHO Review History 

Flubromazepam has not been formally 

reviewed by WHO and is not currently under 

international control. Information was 

brought to WHO’s attention that this 

substance is manufactured clandestinely, 

poses a risk to public health and has no 

recognized therapeutic use. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

The chemical structure of flubromazepam 

is similar to that of other benzodiazepines, 

including phenazepam. Currently, there is 

insufficient information on the 

pharmacological profile of flubromazepam 

from controlled studies in experimental 

animals or humans to conclude that it has 

effects that are similar to those of 

benzodiazepines that are controlled under 

the Convention on Psychotropic Substances 

of 1971. Online self-reports by people who 

claim to have used flubromazepam describe 

sedative, muscle relaxant and euphoric 

effects and its use to self-manage 

benzodiazepine withdrawal. There are, 

however, no clinical reports to confirm such 

effects. 

Dependence Potential 

No controlled study in experimental 

animals or humans have addressed the 

dependence potential of flubromazepam. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

No studies in humans were found of the 

abuse liability of flubromazepam. People 

who self-report flubromazepam use describe 

euphoric effects and other benzodiazepinelike effects that would suggest it has a similar 

likelihood of abuse, but their use of 

flubromazepam cannot be confirmed. Results 

from limited studies in experimental animals 

suggest abuse liability. Seizures have been 

reported in multiple countries across a 

number of regions. Although flubromazepam 

has been detected in several deaths and cases 

of driving under the influence of drugs, other 

drugs were also detected, and the 

contribution of flubromazepam was unclear. 

Therapeutic Use 

Flubromazepam is not known to have any 

therapeutic use, is not listed on the WHO 

Model Lists of Essential Medicines and has 

never been marketed as a medicinal product. 

Rationale and Recommendation 

Flubromazepam is a 1,4-benzodiazepine. 

Although it is chemically similar to other 

benzodiazepines listed under Schedule IV of 

the Convention on Psychotropic Substances 

of 1971, little information is available on its 

effects. Few studies in experimental animals 

and no studies in humans were found on its 

effects or abuse potential. The limited 

information on its effects provides 

insufficient evidence to justify the placement 

of flubromazepam under international 

control. The Committee recommended that 

flubromazepam (IUPAC name: 7-bromo-5-(2- 

fluorophenyl)-1,3-dihydro-2H-1,4- 

benzodiazepin-2-one) be kept under 

surveillance by the WHO ECDD secretariat. 

Nitrous Oxide 

Substance Identification 

Nitrous oxide (IUPAC name: Nitrous oxide, 

N2O) is an inhalational anaesthetic marketed 

under a range of trade names as both a single 

ingredient gas and in multi-ingredient 

preparations. It is also manufactured for 

industrial use, including in food production, 

as small metal canisters, bulbs and larger 

cylinders. It is described as a colourless gas. 

WHO Review History 

Nitrous oxide is not currently under 

international control and has never been 

reviewed by the ECDD. Information was 

brought to WHO’s attention by a Member 

State of increased nonmedical use, such that 

it presented a risk to public health. 

Similarity to Known Substances and Effects 

on the Central Nervous System 

Nitrous oxide appears to have multiple 

mechanisms of action that are not entirely 

understood. There is some evidence for 

effects on opioid, GABAergic, glutamatergic 

and other neurotransmitter systems. Nitrous 

oxide produces anaesthesia, analgesia and, in 

laboratory studies with humans, subjective 

effects such as perceptual distortion, 

paranoia, delusions, anhedonia and cognitive 

disorganization. 

Dependence Potential 

Acute and chronic tolerance to the effects 

of nitrous oxide have been documented in 

experimental animals, with signs of 

withdrawal when exposure was ended 

abruptly. Animals that were tolerant to 

nitrous oxide were partially cross-tolerant to 

ethanol but not to barbiturates or morphine. 

Laboratory studies in humans provide 

evidence of tolerance to some effects of 

nitrous oxide, but the degree of tolerance 

varied according to the effect and between 

individuals. Epidemiological and clinical 

studies provide evidence of dependence. 

Actual Abuse and/or Evidence of Likelihood 

of Abuse 

The evidence from studies in experimental 

animals on the likelihood of abuse of nitrous 

oxide is inconsistent. The abuse potential of 

nitrous oxide has been reported since the 

19th century, including its euphoric effects 

and ability to cause auditory and visual 

distortions. Nitrous oxide was originally 

promoted for recreational use as ‘‘laughing 

gas’’; however, laboratory studies with 

humans have produced inconsistent results 

on abuse liability. The global prevalence of 

non-medical use of nitrous oxide is 

unknown. Reports from several countries 

indicate that nonmedical use is highest 

among adolescents and young adults, and 

evidence from some countries indicates an 

increase in use in recent years. Nitrous oxide 

used nonmedically is typically obtained from 

legal manufacturers, with no evidence of 

illicit manufacture and minimal evidence of 

cross-border trading. Nitrous oxide use has 

been implicated in cases of impaired driving. 

Deaths directly related to nonmedical use of 

nitrous oxide appear to be rare and to be due 

to intended or unintended asphyxia. Longterm exposure can result in neurological and 

haematological toxicity. 

Therapeutic Use 

Nitrous oxide is widely used globally for 

analgesia and sedation during childbirth and 

in painful short procedures in dentistry and 

emergency medicine. It is used commonly as 

a supplementary agent in anaesthesia. 

Nitrous oxide is listed on the 2023 WHO 

Model List of Essential Medicines and the 

Essential Medicines List for Children as an 

inhalational anaesthetic. Clinical trials of 

nitrous oxide are being conducted to explore 

its value as a medication for other indications 

such as treatment-resistant depression and 

management of alcohol withdrawal 

symptoms. 

Rationale and Recommendation 

Nitrous oxide is a widely used inhalation 

anaesthetic and is listed on the 2023 WHO 

Model List of Essential Medicines and 

Essential Medicines List for Children. While 

the Committee acknowledged the concerns 

raised by some countries, it recommended 

that nitrous oxide not proceed to critical 

review because of the absence of evidence of 

illicit manufacture and of common trading 

across borders, and in recognition of its 

global therapeutic value. The Committee 

recommended that nitrous oxide not proceed 

to critical review but be kept under 

surveillance by the WHO Secretariat. 

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. 

Butonitazene (chemical name: N,Ndiethyl-2-[(4-butoxyphenyl)methyl]-5- 

nitro-1H-benzimidazole-1-ethanamine) 

is a benzimidazole synthetic opioid that 

functions as an agonist of the m-opioid 

receptor and has similar psychoactive 

effects as morphine and fentanyl. 

Butonitazene is reported to produce 

euphoria after administration through 

various routes including smoking, oral, 

intranasal, and injection. It was first 

identified in law enforcement seizures 

in the United States in 2021 and has 

since (i.e., 2021 to 2023) been identified 

in 63 different drug seizures. 

Butonitazene has also been identified in 

drug toxicology screens and is 

confirmed to have been responsible for 

at least one fatality in the United States. 

There are no commercial or approved 

medical uses for butonitazene. 

Butonitazene is controlled in schedule I 

of the CSA and will not require 

additional permanent controls if it is 

placed in Schedule I of the 1961 Single 

Convention. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 8689 

3-Chloromethcathinone (3-CMC) 

(chemical name: 1-(3-chlorophenyl)-2- 

(methylamino)propan-1-one) is a 

synthetic cathinone that functions to 

inhibit reuptake of the dopamine, 

serotonin, and norepinephrine 

transporters in the central nervous 

system. Functionally this increases the 

concentration of these neurotransmitters 

which leads to psychostimulatory 

effects. Humans and animals have 

demonstrated clinical signs of agitation, 

restlessness, seizures, high blood 

pressure, and increased locomotor 

activity. The appearance of 3-CMC on 

the illicit drug market is similar to other 

designer drugs trafficked for their 

psychoactive effects. There are no 

commercial or approved medical uses 

for 3-CMC in the United States. 

Methcathinone was controlled in 

Schedule I of the CSA on October 15, 

1993. As a positional isomer of 

methcathinone, 3-CMC is controlled in 

Schedule I of the CSA. As such, 

additional permanent controls will not 

be needed if 3-CMC is placed in 

Schedule II of the Convention on 

Psychotropic Substances, 1971. 

Dipentylone (chemical name: 1-(1,3- 

benzodioxol-5-yl)-2- 

(dimethylamino)pentan-1-one, also 

known as N,N-dimethylpentylone, 

dimethylpentylone or bk-DMBDP) is a 

synthetic cathinone that produces 

psychostimulant effects similar to 

cathinone. Dipentylone functions by 

increasing the concentration of 

dopamine, serotonin, and 

norepinephrine in the central nervous 

system similar to amphetamines. 

Anecdotal reports indicate that 

dipentylone produces clinical effects of 

insomnia, hallucinations, paranoia, and 

confusion. As of 2021, dipentylone was 

identified in 8,368 drug seizures, and 

was confirmed as the cause of death in 

at least nine fatalities in 2023. There are 

no commercial or approved medical 

uses for dipentylone in the United 

States. Pentylone was controlled in 

Schedule I of the CSA on March 4, 2016. 

As a positional isomer of pentylone, 

dipentylone is controlled in Schedule I 

of the CSA. As such, additional 

permanent controls will not be needed 

if dipentylone is placed in Schedule II 

of the Convention on Psychotropic 

Substances, 1971. 

2-Fluorodeschloroketamine (chemical 

name: 2-(2-fluorophenyl)-2- 

(methylamino)cyclohexan-1-one), 

fluoroketamine, or 2-FDCK) is an 

arylcyclohexylamine that is related to 

ketamine and phencyclidine (PCP). 2- 

FDCK is thought to function as an Nmethyl-D-aspartate receptor antagonist 

and produce effects similar to other 

dissociative anesthetics (e.g., ketamine). 

According to anecdotal reports, these 

effects include dissociation, 

hallucination, confusion, agitation, 

stimulation, and tachycardia and 

hypertension. Studies in animals 

indicate that 2-FDCK was selfadministered (i.e., produced reinforcing 

effects) and produced a drug cue similar 

to that of ketamine. As a result, animal 

data suggests that 2-FDCK has an abuse 

potential similar to ketamine. 2-FDCK 

has not been detected in law 

enforcement seizures, or in toxicology 

screens in the United States. There are 

no commercial or approved medical 

uses for 2-FDCK, and it is not a 

controlled substance under the CSA. As 

such, additional permanent controls 

will be necessary to fulfill U.S. 

obligations if 2-FDCK is controlled 

under Schedule II of the Convention on 

Psychotropic Substances, 1971. 

Bromazolam (chemical name: 8- 

bromo-1-methyl-6-phenyl-4H- 

[1,2,4]triazolo[4,3- 

a][1,4]benzodiazepine) is a 

triazolobenzodiazepine that functions as 

a positive allosteric modulator of gaminobutyric acid A (GABAA) channels 

thereby decreasing neuronal activity. 

Similar to other benzodiazepines, such 

as alprazolam, it produces sedative and 

anxiolytic effects typically taken after 

oral administration or through injection. 

Unconfirmed anecdotal reports indicate 

that it can also produce hypnotic, 

muscle relaxant, and euphoric effects as 

well as physical dependence 

demonstrated through a withdrawal 

syndrome. Since 2021, bromazolam has 

been detected in 637 law enforcement 

seizures and has been implicated in 53 

fatalities. There are no commercial or 

approved medical uses for bromazolam 

in the United States, and it is not a 

controlled substance under the CSA. As 

such, additional permanent controls 

will be necessary to fulfill U.S. 

obligations if bromazolam is controlled 

under Schedule IV of the Convention on 

Psychotropic Substances, 1971. 

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 March 2024. 

Comments regarding the WHO 

recommendations for control of 

butonitazene 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 5, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02573 Filed 2–7–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 1009 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. 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: National Cancer 

Institute Special Emphasis Panel; Cancer 

Technologies for Global Health. 

Date: February 13, 2024. 

Time: 9:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W238, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Jeffrey E. DeClue, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W238, Rockville, Maryland 

20850, 240–276–6371, decluej@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 


lotter on DSK11XQN23PROD with NOTICES1