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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Rules and Regulations Country

SINGAPORE

BILLING CODE 351033P

DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA631

Schedules of Controlled Substances:
Placement of Isotonitazene in Schedule I
Drug Enforcement Administration, Department of Justice.
ACTION: Final amendment; final order.
AGENCY:

With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing N,N-diethyl-2-24-isopropoxybenzyl-5-nitro-1Hbenzimidazol-1-ylethan-1-amine commonly known as isotonitazene, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs 1961.
This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess, or propose to handle isotonitazene.
DATES: Effective December 6, 2021.

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SUMMARY:

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NUMBER November 4, 2021.

Background On August 20, 2020, DEA issued a temporary scheduling order, placing isotonitazene N,N-diethyl-2-2-4isopropoxybenzyl-5-nitro-1Hbenzimidazol-1-ylethan-1-amine, in
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Legal Authority The United States is a party to the 1961 United Nations Single Convention on Narcotic Drugs Single Convention, March 30, 1961, 18 U.S.T. 1407, 570
U.N.T.S. 151, as amended by the 1972
Protocol. Article 3, paragraph 7 of the Single Convention requires that if the Commission on Narcotic Drugs Commission adds a substance to one of the schedules of such Convention, and the United States receives notification of such scheduling decision from the Secretary-General of the United Nations Secretary-General, the United States, as a signatory Member State, is obligated to control the substance under its national drug control legislation. Under 21 U.S.C. 811d1, if control of a substance is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by 21 U.S.C. 811a or 812b, and without regard to the procedures prescribed by 21 U.S.C.
811a and b. The Attorney General has delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the Drug Enforcement Administration Administrator of DEA or Administrator. 28 CFR 0.100.

PO 00000

Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION:

FR Doc. 202124123 Filed 11321; 8:45 am
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Presumption of denial

FOR FURTHER INFORMATION CONTACT:

Matthew S. Borman, Deputy Assistant Secretary for Export Administration.

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All items subject to the EAR. See 744.11 of the EAR.

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schedule I of the Controlled Substances Act CSA. 85 FR 51342. That order was based on findings by the Acting Administrator of DEA Acting Administrator that the temporary scheduling of this substance was necessary to avoid an imminent hazard to the public safety; the order was codified at 21 CFR 1308.11h48.
In November 2020, the DirectorGeneral of the World Health Organization recommended to the Secretary-General that isotonitazene be placed in Schedule I of the Single Convention, as this substance has an opioid mechanism of action and similarity to drugs that are controlled in Schedule I of the Single Convention i.e., isotonitazene is similar to drugs such as morphine and fentanyl, and has dependence and abuse potential. On June 10, 2021, the Secretary-General advised the Secretary of State of the United States, by letter, that during its 64th session in April 2021, the Commission voted to place isotonitazene in Schedule I of the Single Convention CND Apr/64/1.
Isotonitazene As discussed in the background section, isotonitazene is temporarily controlled in schedule I of the CSA
upon the Acting Administrators finding it poses imminent hazard to the public safety. Isotonitazene has a pharmacological profile similar to etonitazene schedule I, fentanyl schedule II, and other schedule I and II synthetic opioids that act as muopioid receptor agonists. Because of the pharmacological similarities of isotonitazene to etonitazene a potent mu-opioid agonist, the use of isotonitazene presents a high risk of abuse and has negatively affected users and communities. The abuse of isotonitazene has been associated with
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