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Rules and Regulations
Federal Register Vol. 86, No. 112
Monday, June 14, 2021

This section of the FEDERAL REGISTER
contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA482

Schedules of Controlled Substances:
Placement of N-Ethylpentylone in Schedule I
Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
AGENCY:

The Drug Enforcement Administration places 1-1,3benzodioxol-5-yl-2ethylaminopentan-1-one known as Nethylpentylone or ephylone and its optical, positional, and geometric isomers, salts, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action makes permanent the current imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess, or propose to handle N-ethylpentylone.
DATES: Effective date: June 14, 2021.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
8207.
SUMMARY:

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SUPPLEMENTARY INFORMATION:

Legal Authority The Controlled Substances Act CSA
provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General 1 on his own motion;

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2 at the request of the Secretary of the Department of Health and Human Services HHS; 1 or 3 on the petition of any interested party. 21 U.S.C. 811a.
This action was initiated on the Attorney Generals own motion, as delegated to the Administrator of the Drug Enforcement Administration DEA, and it is supported by a recommendation from the Assistant Secretary for Health of HHS Assistant Secretary and an evaluation of all other relevant data by DEA. This action makes permanent the current, temporary imposition of regulatory controls and administrative, civil, and criminal sanctions for schedule I controlled substances on any person who handles or proposes to handle N-ethylpentylone.
Background On August 31, 2018, DEA published an order in the Federal Register amending 21 CFR 1308.11h to temporarily place 1-1,3-benzodioxol-5yl-2-ethylaminopentan-1-one known as N-ethylpentylone or ephylone in schedule I of the CSA pursuant to the temporary scheduling provisions of 21
U.S.C. 811h. 83 FR 44474. That temporary scheduling order was effective on the date of publication, and was based on findings by the Acting Administrator of DEA that the temporary scheduling of this synthetic cathinone was necessary to avoid an imminent hazard to the public safety pursuant to section 811h1. On August 27, 2020, DEA published an order to extend the temporary scheduling of N-ethylpentylone by one year, or until August 31, 2021, pursuant to section 811h2. 85 FR 52915. Also, on that same date and in the same issue of the Federal Register, DEA
simultaneously published a notice of proposed rulemaking NPRM to permanently control N-ethylpentylone in schedule I of the CSA. 85 FR 52935.
Specifically, DEA proposed to add Nethylpentylone to the hallucinogenic substances list under 21 CFR
1308.11d.
1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration FDA and the National Institute on Drug Abuse NIDA, FDA acts as the lead agency within HHS in carrying out the Secretarys scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
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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DEA and HHS Eight Factor Analyses On July 15, 2020, HHS provided DEA
with a scientific and medical evaluation document prepared by the Food and Drug Administration FDA entitled Basis for the Recommendation to Control N-ethylpentylone and Its Optical, Geometric, and Positional Isomers, Salts, and Salts of Isomers in Schedule I of the Controlled Substances Act. After considering the eight factors in 21 U.S.C. 811c pursuant to 21
U.S.C. 811b, and N-ethylpentylones abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21
U.S.C. 812b, the Assistant Secretary recommended that N-ethylpentylone be controlled in schedule I of the CSA.
In response, DEA conducted its own eightfactor analysis of N-ethylpentylone under 21 U.S.C. 811c, and concluded that this substance warrants control in schedule I of the CSA, as it meets the findings prescribed by 21 U.S.C.
812b1. Both DEA and HHS eightfactor analyses are available in their entirety in the public docket for this rule Docket Number DEA482 at http www.regulations.gov under Supporting Documents.
Determination to Schedule N-Ethylpentylone After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from HHS, DEA
published an NPRM entitled Schedules of Controlled Substances: Placement of N-ethylpentylone in Schedule I. This rule proposed to control Nethylpentylone, and its optical, positional, and geometric isomers, salts, and salts of isomers in schedule I of the CSA. 85 FR 52935, August 27, 2020. The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA
regulations on or before September 28, 2020. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit comments on the proposed rule on or before September 28, 2020.
Comment Received DEA received one anonymous comment on the proposed rule to control N-ethylpentylone in schedule I

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