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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules benzimidazol-1-ylethan-1-amine metonitazene, 2-4-ethoxybenzyl-5-nitro-1-2pyrrolidin-1-ylethyl-1Hbenzimidazole N-pyrrolidino etonitazene; etonitazepyne, and N,N-diethyl-2-5-nitro-2-4propoxybenzyl-1H-benzimidazol-1ylethan-1-amine protonitazene.
The temporary scheduling order will be published in the Federal Register on or after January 6, 2022.

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Legal Authority The CSA provides the Attorney General as delegated to the Administrator of DEA Administrator pursuant to 28 CFR 0.100 with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811b, if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811h1. In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811a1 while the substance is temporarily controlled under section 811h, the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C.
811h2.
Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. 21 U.S.C. 811h1; 21
CFR part 1308.
Background The CSA requires the Administrator to notify the Secretary of the Department of Health and Human Services HHS of an intent to place a substance in schedule I of the CSA
temporarily i.e., to issue a temporary scheduling order. 21 U.S.C. 811h4.
The then-Acting Administrator transmitted the required notice to the Assistant Secretary for Health of HHS
Assistant Secretary,2 by letter dated June 16, 2021, regarding butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene. In a subsequent letter dated August 25, 2021, the Administrator transmitted the required notice to the Assistant Secretary for Npyrrolidino etonitazene. The Assistant Secretary responded to these notices by letters dated July 7 and September 10, 2 The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.

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2021, and advised that based on a review by the Food and Drug Administration FDA, there are currently no investigational new drug applications IND or approved new drug applications NDA for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene. The Assistant Secretary also stated that HHS
had no objection to the temporary placement of these substances in schedule I. Butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene currently are not listed in any schedule under the CSA, and no exemptions or approvals under 21
U.S.C. 355 are in effect for these seven benzimidazole-opioids.
To find that temporarily placing a substance in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811c: The substances history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21
U.S.C. 811h3. This consideration includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of these substances. 21 U.S.C. 811h3.
Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21
U.S.C. 811h1. Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, and no accepted safety for use under medical supervision. 21 U.S.C. 812b1.
Seven Benzimidazole-Opioids:
Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino Etonitazene, and Protonitazene The United States currently is experiencing an opioid overdose epidemic, and the presence of synthetic opioids in the illicit drug market threatens to exacerbate this. The trafficking, continued evolution, and abuse of new synthetic opioids are deadly trends posing imminent hazards to public safety. Adverse health effects associated with abuse of synthetic opioids and increased popularity of these substances have been serious concerns in recent years. Butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and
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protonitazene are synthetic opioids recently identified on the illicit drug market in the United States.
Data obtained from preclinical pharmacology studies show that butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene have pharmacological profiles similar to those of the potent benzimidazoleopioids etonitazene and isotonitazene, both schedule I controlled substances.
Because of their pharmacological similarities, use of these seven benzimidazole-opioid substances presents a high risk of abuse and may negatively affect users and communities. They have been identified in at least 44 toxicology and postmortem cases in the United States between November 2020 and July 2021.
Specifically, butonitazene has been identified in one case, etodesnitazene in five cases, flunitazene in four cases, metodesnitazene in one case, metonitazene in twenty cases, Npyrrolidino etonitazene in eight cases, and protonitazene in five cases, which together create serious public safety concerns.
Available data and information for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene, summarized below, indicate that these substances have high potential for abuse, no currently accepted medical use in treatment in the United States, and lack of accepted safety for use under medical supervision. DEAs threefactor analysis is available in its entirety under Supporting and Related Material of the public docket for this action at www.regulations.gov under Docket Number DEA900.
Factor 4. History and Current Pattern of Abuse In the late 1950s, pharmaceutical research laboratories of the Swiss chemical company CIBA
Aktiengesellschaft synthesized a group of benzimidazole derivatives with analgesic properties; however, the research did not lead to any medically approved analgesic products. These benzimidazole derivatives include schedule I substances such as synthetic opioids clonitazene, etonitazene, and isotonitazene. In 2019, isotonitazene emerged on the illicit drug market and was involved in numerous fatal overdose events. In August 2020, DEA
temporarily controlled it as a schedule I substance under the CSA 85 FR
51342.

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