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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 WHOs consideration.
The full text of the notification from the Secretary-General is provided in section II. Section 201d2B 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.

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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; 1961CArt.3, 1971CArt.2
CU 2021/7A/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
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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 WHOs Expert Committee on Drug Dependence ECDD:
Substance recommended to be added to Schedule I of the 1961 Convention:
Isotonitazene chemical name: N,N-diethyl-2-2-4isopropoxybenzyl-5-nitro-1Hbenzodimidazol-1-ylethan-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-pyrido4,3-bindol-1one MDMB-4en-PINACA
chemical name: methyl 3,3-dimethyl-2-1pent-4-en-1-yl-1H-indazole-3carboxamidobutanoate 3-Methoxyphencyclidine chemical name: 1-1-3methoxyphenylcyclohexylpiperidine Diphenidine chemical name: 1-1,2diphenylethylpiperidine Substances recommended to be added to Schedule IV of the 1971 Convention:
Clonazolam chemical name: 6-2-chlorophenyl-1-methyl8-nitro-4H-benzof1,2,4triazolo4,3a1,4diazepine Diclazepam chemical name: 7-chloro-5-2-chlorophenyl1- methyl-1,3-dihydro-2Hbenzoe1,4diazepin2-one Flubromazolam chemical name: 8-bromo-6-2-fluorophenyl1-methyl-4H-benzof1,2,4triazolo4,3a1,4diazepine 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 1216 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
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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 WHOs 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-2-2-4isopropoxybenzyl-5-nitro-1Hbenzodimidazol-1-ylethan-1-amine
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