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Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Rules and Regulations
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handle manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess, or propose to handle any of these four specified fentanyl-related substances will continue to be applicable permanently as a result of this action.
DATES: Effective date: May 4, 2021.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION: This final rule imposes permanent controls on four specified fentanyl-related substances, which will continue to be listed in schedule I of the Controlled Substances Act CSA. These four fentanyl-related substances are:
Ethyl 1-phenethylpiperidin-4ylphenylcarbamate fentanyl carbamate;
N-2-fluorophenyl-N-1phenethylpiperidin-4-ylacrylamide ortho-fluoroacryl fentanyl;
N-2-fluorophenyl-N-1phenethylpiperidin-4-ylisobutyramide ortho-fluoroisobutyryl fentanyl; and N-4-fluorophenyl-N-1phenethylpiperidin-4-ylfuran-2carboxamide para-fluoro furanyl fentanyl.
The schedule I listing of these four fentanyl-related substances includes their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible.
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 delegated to the Administrator of the Drug Enforcement Administration DEA pursuant to 28
CFR 0.100 on his own motion. 21
U.S.C. 811a. This action is supported by, inter alia, a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services Assistant Secretary for HHS or Assistant Secretary and an evaluation of all relevant data by DEA. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses or
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proposes to handle fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl.
Background On February 6, 2018, pursuant to 21
U.S.C. 811h1, DEA published a temporary scheduling order in the Federal Register 83 FR 5188
temporarily placing fentanyl-related substances, as defined in that order, in schedule I of the CSA based upon a finding that these substances pose an imminent hazard to the public safety.
That temporary order was effective upon the date of publication. Pursuant to 21 U.S.C. 811h2, the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the four specific substances already covered by that order, was set to expire on February 6, 2020. However, as explained in DEAs April 10, 2020, correcting amendment 85 FR 20155, Congress overrode and extended that expiration date until May 6, 2021, by enacting the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act Pub. L. 116114, sec. 2, 134 Stat. 103 Feb. 6, 2020.
On March 18, 2021 86 FR 14707, DEA published a notice of proposed rulemaking NPRM to permanently control four specific fentanyl-related substances: fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl in schedule I of the CSA. Specifically, DEA proposed to add these substances to the opiates list under 21 CFR 1308.11b, and assign paragraph numbers 39, 62, 66, and 73
under paragraph b to Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-Fluoro isobutyryl fentanyl, and para-Fluoro furanyl fentanyl, respectively. Since the publication of this NPRM, DEA issued a correcting amendment which updated the numbering of all listed opiates in paragraph b. See 86 FR 16667, March 31, 2021. As a result, this final rule assigns different paragraph numbers under paragraph b, than originally proposed, to three of the four fentanylrelated substances though the numbering for Fentanyl carbamate remains the same.
DEA and HHS Eight Factor Analyses On March 2, 2021, HHS provided DEA with a scientific and medical evaluation and scheduling recommendation, prepared by the Food and Drug Administration FDA, for fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl
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fentanyl, and para-fluoro furanyl fentanyl and their salts. After considering the eight factors in 21
U.S.C. 811c, each substances 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 these substances be placed in schedule I of the CSA. In response, DEA conducted its own eightfactor analysis of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl. Please note that both the DEA and HHS 8-Factor analyses and the Assistant Secretarys March 2, 2021, letter are available in their entirety under the tab Supporting Documents of the public docket for this action at http www.regulations.gov under Docket Number DEA806.
Determination To Schedule Four Specific Fentanyl-Related Substances After review of the available data including the scientific and medical evaluation and the scheduling recommendations from HHS, DEA
published an NPRM entitled Schedules of Controlled Substances: Placement of Four Specific Fentanyl-Related Substances in Schedule I. 86 FR 14707, March 18, 2021. The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before April 19, 2021. 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 April 19, 2021.
Comments Received DEA received 35 comments on the proposed rule to control fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl in schedule 1 of the CSA. Submissions were from individual or anonymous commenters.
Twenty-one commenters provided support for the rule. Three other commenters supported the proposal, but it is not clear whether they were referring to these specific four fentanylrelated substances or the class of fentanyl-related substances that was the subject of DEAs February 6, 2018, temporary scheduling order and that was extended until May 6, 2021 by legislation Pub. L. 116114, Sec. 2.
Eleven other commenters did not state a position on the rule. Rather, these 11
commenters expressed adverse health concerns, including mortality associated with fentanyl and fentanyl-related
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