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appropriate principal inspector, or lacking a DEPARTMENT OF JUSTICE • N-phenyl-N-(1-(2- principal inspector, the manager of the phenylpropyl)piperidin-4- responsible Flight Standards Office. Drug Enforcement Administration yl)propionamide (b-methyl fentanyl); (2) Contacting the Manufacturer: For any • N-(2-fluorophenyl)-N-(1- requirement in this AD to obtain instructions 21 CFR Part 1308 phenethylpiperidin-4-yl)butyramide from a manufacturer, the instructions must [Docket No. DEA–476] (ortho-fluorobutyryl fentanyl; 2- be accomplished using a method approved fluorobutyryl fentanyl); by the Manager, New York ACO Branch, Schedules of Controlled Substances: • N-(2-methylphenyl)-N-(1- FAA; or TCCA; or Airbus Canada Limited Placement of 10 Specific Fentanyl- phenethylpiperidin-4-yl)acetamide Partnership’s TCCA Design Approval Related Substances in Schedule I (ortho-methyl acetylfentanyl; 2-methyl Organization (DAO). If approved by the DAO, acetylfentanyl); the approval must include the DAO- AGENCY: Drug Enforcement • 2-methoxy-N-(2-methylphenyl)-N- authorized signature. Administration, Department of Justice. (1-phenethylpiperidin-4-yl)acetamide ACTION: Final rule. (k) Related Information (ortho-methyl methoxyacetylfentanyl; 2- methyl methoxyacetyl fentanyl); For more information about this AD, SUMMARY: In this rule, the Drug • N-(4-methylphenyl)-N-(1- contact Deep Gaurav, Aerospace Engineer, Enforcement Administration places 10 phenethylpiperidin-4-yl)propionamide Airframe and Propulsion Section, FAA, New specified fentanyl-related substances (para-methylfentanyl; 4- York ACO Branch, 1600 Stewart Avenue, permanently in schedule I of the methylfentanyl); Suite 410, Westbury, NY 11590; telephone Controlled Substances Act. These 10 • N-(1-phenethylpiperidin-4-yl)-N- 516–228–7300; fax 516–794–5531; email 9- specific substances all fall within the phenylbenzamide (phenyl fentanyl; [email protected]. definition of fentanyl-related substances benzoyl fentanyl); and set forth in a February 6, 2018, • (l) Material Incorporated by Reference N-(1-phenethylpiperidin-4-yl)-N- temporary scheduling order. Through phenylthiophene-2-carboxamide (1) The Director of the Federal Register the Temporary Reauthorization and (thiofuranyl fentanyl; 2-thiofuranyl approved the incorporation by reference Study of the Emergency Scheduling of fentanyl; thiophene fentanyl). (IBR) of the service information listed in this Fentanyl Analogues Act, which became The schedule I listing of these 10 paragraph under 5 U.S.C. 552(a) and 1 CFR law on February 6, 2020, Congress fentanyl-related substances includes part 51. extended the temporary control of their isomers, esters, ethers, salts, and (2) You must use this service information fentanyl-related substances until May 6, salts of isomers, esters, and ethers as applicable to do the actions required by 2021. The regulatory controls and this AD, unless this AD specifies otherwise. whenever the existence of such isomers, administrative, civil, and criminal esters, ethers, and salts is possible. (3) The following service information was sanctions applicable to schedule I approved for IBR on May 4, 2021 (86 FR controlled substances on persons who Legal Authority 20266, April 19, 2021). handle (manufacture, distribute, reverse The CSA provides that proceedings (i) Transport Canada Civil Aviation (TCCA) distribute, import, export, engage in for the issuance, amendment, or repeal AD CF–2021–10, dated March 18, 2021. research, conduct instructional of the scheduling of any drug or other (ii) [Reserved] activities or chemical analysis, or substance may be initiated by the (4) For TCCA AD CF–2021–10, contact possess), or propose to handle any of TCCA, Transport Canada National Aircraft Attorney General (delegated to the these 10 specified fentanyl-related Administrator of the Drug Enforcement Certification, 159 Cleopatra Drive, Nepean, substances will continue to be Ontario K1A 0N5, Canada; telephone 888– Administration (DEA) pursuant to 28 applicable permanently as a result of CFR 0.100) on his own motion. 21 663–3639; email [email protected]; internet this action. https://tc.canada.ca/en/aviation. U.S.C. 811(a). This action is supported DATES: Effective date: April 27, 2021. (5) You may view this service information by, inter alia, a recommendation from at the FAA, Airworthiness Products Section, FOR FURTHER INFORMATION CONTACT: the Assistant Secretary for Health of Operational Safety Branch, 2200 South 216th Terrence L. Boos, Drug and Chemical HHS (Assistant Secretary) and an St., Des Moines, WA. For information on the Evaluation Section, Diversion Control evaluation of all relevant data by DEA. availability of this material at the FAA, call Division, Drug Enforcement This action continues the imposition of 206–231–3195. This material may be found Administration; Mailing Address: 8701 the regulatory controls and in the AD docket on the internet at https:// Morrissette Drive, Springfield, Virginia administrative, civil, and criminal www.regulations.gov by searching for and 22152; Telephone: (571) 362–3249. sanctions of schedule I controlled locating Docket No. FAA–2021–0313. SUPPLEMENTARY INFORMATION: This final substances on any person who handles (6) You may view this service information rule imposes permanent controls on 10 (manufactures, distributes, imports, that is incorporated by reference at the specified fentanyl-related substances, exports, engages in research, or National Archives and Records which will continue to be listed in conducts instructional activities or Administration (NARA). For information on schedule I of the Controlled Substances chemical analysis with, or possesses) or the availability of this material at NARA, Act (CSA). These 10 fentanyl-related proposes to handle 2′-fluoro ortho- email [email protected], or go to: https:// substances are: fluorofentanyl, 4′-methyl acetyl www.archives.gov/federal-register/cfr/ibr- • N-(1-(2-fluorophenethyl)piperidin- fentanyl, b′-phenyl fentanyl, b-methyl locations.html. 4-yl)-N-(2-fluorophenyl)propionamide fentanyl, ortho-fluorobutyryl fentanyl, ′ ′ Issued on April 22, 2021. (2 -fluoro ortho-fluorofentanyl; 2 -fluoro ortho-methyl acetylfentanyl, ortho- 2-fluorofentanyl); methyl methoxyacetyl fentanyl, para- Lance T. Gant, • N-(1-(4-methylphenethyl)piperidin- methylfentanyl, phenyl fentanyl, and Director, Compliance & Airworthiness 4-yl)-N-phenylacetamide (4′-methyl thiofuranyl fentanyl. Division, Aircraft Certification Service. acetyl fentanyl); [FR Doc. 2021–08760 Filed 4–23–21; 11:15 am] • N-(1-phenethylpiperidin-4-yl)-N,3- Background BILLING CODE 4910–13–P diphenylpropanamide (b′-phenyl On February 6, 2018, pursuant to 21 fentanyl; beta′-Phenyl fentanyl; 3- U.S.C. 811(h)(1), DEA published a phenylpropanoyl fentanyl); temporary scheduling order in the

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Federal Register (83 FR 5188), DEA and HHS Eight Factor Analyses Comments Received temporarily placing fentanyl-related On July 2, 2020, HHS provided DEA DEA received ten comments on the substances, as defined in that order, in proposed rule to control 2′-fluoro ortho- schedule I of the CSA based upon a with a scientific and medical evaluation ′ and scheduling recommendation, fluorofentanyl, 4 -methyl acetyl finding that these substances pose an fentanyl, b′-phenyl fentanyl, b-methyl imminent hazard to the public safety. prepared by the Food and Drug ′ fentanyl, ortho-fluorobutyryl fentanyl, That temporary order was effective Administration (FDA), for 2 -fluoro ′ ortho-methyl acetylfentanyl, ortho- upon the date of publication. Pursuant ortho-fluorofentanyl, 4 -methyl acetyl ′ methyl methoxyacetyl fentanyl, para- to 21 U.S.C. 811(h)(2), the temporary fentanyl, b -phenyl fentanyl, b-methyl methylfentanyl, phenyl fentanyl, and control of fentanyl-related substances, a fentanyl, ortho-fluorobutyryl fentanyl, thiofuranyl fentanyl in schedule 1 of the class of substances as defined in the ortho-methyl acetylfentanyl, ortho- CSA. One submission was from a public order, as well as the 10 specific methyl methoxyacetyl fentanyl, para- health group called The Partnership for substances already covered by that methylfentanyl, phenyl fentanyl, and Safe Medicines, which is made up of order, was set to expire on February 6, thiofuranyl fentanyl and their salts.1 more than 45 non-profit organizations 2020. However, as explained in DEA’s After considering the eight factors in 21 committed to the safety of prescription April 10, 2020, correcting amendment U.S.C. 811(c), each substance’s abuse drugs and protection of consumers (85 FR 20155), Congress overrode and potential, lack of legitimate medical use against counterfeit or unsafe medicines. extended that expiration date until May in the United States, and lack of Other submissions were from individual 6, 2021, by enacting the Temporary accepted safety for use under medical or anonymous commenters. Nine of the Reauthorization and Study of the supervision pursuant to 21 U.S.C. commenters provided support for the Emergency Scheduling of Fentanyl 812(b), the Assistant Secretary rule, and one commenter did not state Analogues Act (Pub. L. 116–114, sec. 2, recommended that these substances be a position on the rule. 134 Stat. 103) (Feb. 6, 2020). placed in schedule I of the CSA. In Rather, the latter commenter inquired about DEA’s concern with synthetic On March 3, 2021 (86 FR 12296), DEA response, DEA conducted its own eight- factor analysis of 2′-fluoro ortho- opioids versus natural substances, and published a notice of proposed ′ the possibility of reducing opioid rulemaking (NPRM) to permanently fluorofentanyl, 4 -methyl acetyl fentanyl, b′-phenyl fentanyl, b-methyl addiction risks by managing pain control 10 specific fentanyl-related differently without the use of prescribed ′ fentanyl, ortho-fluorobutyryl fentanyl, substances: 2 -fluoro ortho- opioid medications. This comment is fluorofentanyl, 4′-methyl acetyl ortho-methyl acetylfentanyl, ortho- methyl methoxyacetyl fentanyl, para- outside the scope of this rulemaking. As fentanyl, b′-phenyl fentanyl, b-methyl such, this rule will not provide a methylfentanyl, phenyl fentanyl, and fentanyl, ortho-fluorobutyryl fentanyl, response to this comment. ortho-methyl acetylfentanyl, ortho- thiofuranyl fentanyl. Please note that methyl methoxyacetyl fentanyl, para- both the DEA and HHS 8-Factor Support of the Proposed Rule methylfentanyl, phenyl fentanyl, and analyses and the Assistant Secretary’s Nine commenters supported thiofuranyl fentanyl in schedule I of the July 2, 2020, letter are available in their controlling 2′-fluoro ortho- CSA. Specifically, DEA proposed to add entirety under the tab ‘‘Supporting fluorofentanyl, 4′-methyl acetyl these substances to the opiates list Documents’’ of the public docket for fentanyl, b′-phenyl fentanyl, b-methyl under 21 CFR 1308.11(b), and assign this action at http:// fentanyl, ortho-fluorobutyryl fentanyl, paragraph numbers 17, 18, 41, 50, 61, www.regulations.gov under Docket ortho-methyl acetylfentanyl, ortho- 62, 64, 69, 75, and 83 under paragraph Number ‘‘DEA–476.’’ methyl methoxyacetyl fentanyl, para- ′ (b) to beta-Methyl fentanyl, beta -Phenyl Determination To Schedule Ten methylfentanyl, phenyl fentanyl, and ′ thiofuranyl fentanyl as schedule I fentanyl, 2 -Fluoro ortho-fluorofentanyl, Specific Fentanyl-Related Substances 4′-Methyl acetyl fentanyl, ortho- controlled substances. These Fluorobutyryl fentanyl, ortho-Methyl After review of the available data commenters indicated support for acetylfentanyl, ortho-Methyl including the scientific and medical permanent scheduling of these methoxyacetyl fentanyl, para- evaluation and the scheduling substances for the reasons such as Methylfentanyl, Phenyl fentanyl, and recommendations from HHS, DEA similarity in their abuse potential to Thiofuranyl fentanyl, respectively. published an NPRM entitled ‘‘Schedules fentanyl, safety concerns with fentanyl, of Controlled Substances: Placement of such as deaths, overdoses, addiction, Since the publication of this NPRM, and trafficking, and the involvement of DEA issued a correcting amendment 10 Specific Fentanyl-Related Substances in Schedule I.’’ 86 FR 12296, March 3, fentanyl and fentanyl-related substances which updated the numbering of all in the current public health crisis listed opiates in paragraph (b). See 86 2021. The NPRM provided an opportunity for interested persons to file associated with the opioid abuse FR 16667, March 31, 2021. As a result, epidemic. Most commenters indicated a request for hearing in accordance with this final rule assigns different that DEA needs to impose the DEA regulations on or before April 2, paragraph numbers under paragraph (b) permanent control to help curb 2021. No requests for such a hearing than originally proposed, to nine of the addiction and opioid overdose. ten substances (though the numbering were received by DEA. The NPRM also In addition to supporting control of for ortho-Methyl acetylfentanyl remains provided an opportunity for interested these 10 substances, a commenter the same). In addition, after publication persons to submit comments on the highlighted the need for more specific of the NPRM, DEA discovered that the proposed rule on or before April 2, guidelines for regulatory controls and NPRM inadvertently assigned a 2021. administrative, civil, and criminal duplicate drug code to 2′-fluoro ortho- sanctions specific to these substances. fluorofentanyl (9829). As such, with this 1 Although HHS also provided information on In particular, this commenter desired final rule, DEA hereby corrects this error crotonyl fentanyl, this substance will not be that DEA ensure that vulnerable discussed in this final rule since it was permanently by assigning a new drug code (9855) for placed in schedule I on October 2, 2020. 85 FR populations (e.g., those addicted to or 2′-fluoro ortho-fluorofentanyl. 62215. dependent on opioids) would not be

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unduly punished by broad convictions accepted medical use in treatment in the be subject to the CSA’s regulatory or sentencing guidelines, and advocated United States; 2 and controls and administrative, civil, and for no mandatory minimums for (3) There is a lack of accepted safety criminal sanctions applicable to the subsequent convictions (after the first for use of 2′-fluoro ortho-fluorofentanyl, manufacture, distribution, reverse conviction) related to simple possession 4′-methyl acetyl fentanyl, b′-phenyl distribution, dispensing, importation, or ‘‘low level handling’’ of the 10 fentanyl, b-methyl fentanyl, ortho- exportation, research, and conduct of fentanyl-related substances. fluorobutyryl fentanyl, ortho-methyl instructional activities involving the DEA Response. DEA appreciates the acetylfentanyl, ortho-methyl handling of controlled substances, support for this rulemaking. Regarding methoxyacetyl fentanyl, para- including the following: the comment for more specific methylfentanyl, phenyl fentanyl, and 1. Registration. Any person who guidelines related to regulatory control thiofuranyl fentanyl under medical handles (manufactures, distributes, for these 10 substances, this comment is supervision. Based on these findings, reverse distributes, dispenses, imports, outside the scope of this rulemaking the Acting Administrator concludes that exports, engages in research, or since sentencing guidelines are set by 2′-fluoro ortho-fluorofentanyl, 4′-methyl conducts instructional activities or the CSA. acetyl fentanyl, b′-phenyl fentanyl, b- chemical analysis with, or possesses), or ′ methyl fentanyl, ortho-fluorobutyryl who desires to handle, 2 -fluoro ortho- Scheduling Conclusion ′ fentanyl, ortho-methyl acetylfentanyl, fluorofentanyl, 4 -methyl acetyl After consideration of the relevant ′ ortho-methyl methoxyacetyl fentanyl, fentanyl, b -phenyl fentanyl, b-methyl matter presented through public para-methylfentanyl, phenyl fentanyl, fentanyl, ortho-fluorobutyryl fentanyl, comments, the scientific and medical and thiofuranyl fentanyl, including their ortho-methyl acetylfentanyl, ortho- evaluation and accompanying isomers, esters, ethers, salts, and salts of methyl methoxyacetyl fentanyl, para- recommendation of HHS, and after its isomers, esters, and ethers whenever the methylfentanyl, phenyl fentanyl, and own eight-factor evaluation, DEA finds existence of such isomers, esters, ethers, thiofuranyl fentanyl must be registered that these facts and all other relevant and salts is possible, warrant continued with DEA to conduct such activities data constitute substantial evidence of control in schedule I of the CSA. 21 pursuant to 21 U.S.C. 822, 823, 957, and the potential for abuse of 2′-fluoro ortho- U.S.C. 812(b)(1). 958, and in accordance with 21 CFR fluorofentanyl, 4′-methyl acetyl parts 1301 and 1312. fentanyl, b′-phenyl fentanyl, b-methyl Requirements for Handling 2′-Fluoro 2. Security. 2′-Fluoro ortho- fentanyl, ortho-fluorobutyryl fentanyl, Ortho-Fluorofentanyl, 4′-Methyl Acetyl fluorofentanyl, 4′-methyl acetyl ortho-methyl acetylfentanyl, ortho- Fentanyl, b′-Phenyl Fentanyl, b-Methyl fentanyl, b′-phenyl fentanyl, b-methyl methyl methoxyacetyl fentanyl, para- Fentanyl, Ortho-Fluorobutyryl fentanyl, ortho-fluorobutyryl fentanyl, methylfentanyl, phenyl fentanyl, and Fentanyl, Ortho-Methyl Acetylfentanyl, ortho-methyl acetylfentanyl, ortho- thiofuranyl fentanyl. DEA is therefore Ortho-Methyl Methoxyacetyl Fentanyl, methyl methoxyacetyl fentanyl, para- permanently scheduling these 10 Para-Methylfentanyl, Phenyl Fentanyl, methylfentanyl, phenyl fentanyl, and specific fentanyl-related substances as and Thiofuranyl Fentanyl thiofuranyl fentanyl are subject to controlled substances under the CSA. 2′-Fluoro ortho-fluorofentanyl, 4′- schedule I security requirements and Determination of Appropriate Schedule methyl acetyl fentanyl, b′-phenyl must be handled and stored pursuant to 21 U.S.C. 821, 823, and in accordance The CSA establishes five schedules of fentanyl, b-methyl fentanyl, ortho- fluorobutyryl fentanyl, ortho-methyl with 21 CFR 1301.71–1301.76. Non- controlled substances known as practitioners handling 2′-fluoro ortho- schedules I, II, III, IV, and V. The CSA acetylfentanyl, ortho-methyl ′ methoxyacetyl fentanyl, para- fluorofentanyl, 4 -methyl acetyl also outlines the findings required to fentanyl, b′-phenyl fentanyl, b-methyl place a drug or other substance in any methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl will continue 3 to fentanyl, ortho-fluorobutyryl fentanyl, particular schedule. 21 U.S.C. 812(b). ortho-methyl acetylfentanyl, ortho- After consideration of the analysis and 2 Although there is no evidence suggesting that 2′- methyl methoxyacetyl fentanyl, para- recommendation of the Assistant fluoro ortho-fluorofentanyl, 4′-methyl acetyl methylfentanyl, phenyl fentanyl, and Secretary and review of all other fentanyl, b′-phenyl fentanyl, b-methyl fentanyl, thiofuranyl fentanyl also must comply available data, the Acting ortho-fluorobutyryl fentanyl, ortho-methyl with the employee screening acetylfentanyl, ortho-methyl methoxyacetyl Administrator, pursuant to 21 U.S.C. requirements of 21 CFR 1301.90– 811(a) and 812(b)(1), finds that: fentanyl, para-methylfentanyl, phenyl fentanyl, and ′ ′ thiofuranyl fentanyl have a currently accepted 1301.93. (1) 2 -Fluoro ortho-fluorofentanyl, 4 - medical use in treatment in the United States, it 3. Labeling and Packaging. All labels ′ methyl acetyl fentanyl, b -phenyl bears noting that a drug cannot be found to have and labeling for commercial containers fentanyl, b-methyl fentanyl, ortho- such medical use unless DEA concludes that it of 2′-fluoro ortho-fluorofentanyl, 4′- fluorobutyryl fentanyl, ortho-methyl satisfies a five-part test. Specifically, with respect to a drug that has not been approved by FDA, to methyl acetyl fentanyl, b′-phenyl acetylfentanyl, ortho-methyl have a currently accepted medical use in treatment fentanyl, b-methyl fentanyl, ortho- methoxyacetyl fentanyl, para- in the United States, all of the following must be fluorobutyryl fentanyl, ortho-methyl methylfentanyl, phenyl fentanyl, and demonstrated: i. The drug’s chemistry must be acetylfentanyl, ortho-methyl thiofuranyl fentanyl have a high known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and well- methoxyacetyl fentanyl, para- potential for abuse that is comparable to controlled studies proving efficacy; iv. the drug methylfentanyl, phenyl fentanyl, and other schedule I substances such as must be accepted by qualified experts; and v. the thiofuranyl fentanyl must be in acetyl fentanyl and furanyl fentanyl. scientific evidence must be widely available. 57 FR compliance with 21 U.S.C. 825 and (2) 2′-Fluoro ortho-fluorofentanyl, 4′- 10499 (1992), pet. for rev. denied, Alliance for ′ Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 958(e), and be in accordance with 21 methyl acetyl fentanyl, b -phenyl (D.C. Cir. 1994). CFR part 1302. fentanyl, b-methyl fentanyl, ortho- 3 2′-Fluoro ortho-fluorofentanyl, 4′-methyl acetyl 4. Quota. Only registered fluorobutyryl fentanyl, ortho-methyl fentanyl, b′-phenyl fentanyl, b-methyl fentanyl, manufacturers are permitted to acetylfentanyl, ortho-methyl ortho-fluorobutyryl fentanyl, ortho-methyl ′ acetylfentanyl, ortho-methyl methoxyacetyl manufacture 2 -fluoro ortho- methoxyacetyl fentanyl, para- fentanyl, para-methylfentanyl, phenyl fentanyl, and methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl are covered by the February 6, subject to schedule I controls on a temporary basis, thiofuranyl fentanyl have no currently 2018, temporary scheduling order, and are currently pursuant to 21 U.S.C. 811(h). 83 FR 5188.

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fluorofentanyl, 4′-methyl acetyl fentanyl, b′-phenyl fentanyl, b-methyl substantial direct effects on one or more fentanyl, b′-phenyl fentanyl, b-methyl fentanyl, ortho-fluorobutyryl fentanyl, Indian tribes, on the relationship fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho- between the Federal Government and ortho-methyl acetylfentanyl, ortho- methyl methoxyacetyl fentanyl, para- Indian tribes, or on the distribution of methyl methoxyacetyl fentanyl, para- methylfentanyl, phenyl fentanyl, and power and responsibilities between the methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must be in Federal Government and Indian tribes. thiofuranyl fentanyl in accordance with compliance with 21 U.S.C. 952, 953, Regulatory Flexibility Act a quota assigned pursuant to 21 U.S.C. 957, and 958, and in accordance with 21 826 and in accordance with 21 CFR part CFR part 1312. The Acting Administrator, in 1303. 9. Liability. Any activity involving 2′- accordance with the Regulatory 5. Inventory. Any person registered fluoro ortho-fluorofentanyl, 4′-methyl Flexibility Act, 5 U.S.C. 601–602, has with DEA to handle 2′-fluoro ortho- acetyl fentanyl, b′-phenyl fentanyl, b- reviewed this rule and by approving it, fluorofentanyl, 4′-methyl acetyl methyl fentanyl, ortho-fluorobutyryl certifies that it will not have a fentanyl, b′-phenyl fentanyl, b-methyl fentanyl, ortho-methyl acetylfentanyl, significant economic impact on a fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl methoxyacetyl fentanyl, substantial number of small entities. On ortho-methyl acetylfentanyl, ortho- para-methylfentanyl, phenyl fentanyl, February 6, 2018, DEA published an methyl methoxyacetyl fentanyl, para- and thiofuranyl fentanyl not authorized order to temporarily place fentanyl- methylfentanyl, phenyl fentanyl, and by, or in violation of, the CSA or its related substances, as defined in the thiofuranyl fentanyl must have an initial implementing regulations is unlawful, order, in schedule I of the CSA pursuant inventory of all stocks of controlled and could subject the person to to the temporary scheduling provisions substances (including these substances) administrative, civil, and/or criminal of 21 U.S.C. 811(h). DEA estimates that on hand on the date the registrant first sanctions. all entities handling or planning to engages in the handling of controlled handle 2′-fluoro ortho-fluorofentanyl, 4′- Regulatory Analyses substances pursuant to 21 U.S.C. 827 methyl acetyl fentanyl, b′-phenyl and 958, and in accordance with 21 CFR Executive Orders 12866 (Regulatory fentanyl, b-methyl fentanyl, ortho- 1304.03, 1304.04, and 1304.11. Planning and Review) and 13563 fluorobutyryl fentanyl, ortho-methyl After the initial inventory, every DEA (Improving Regulation and Regulatory acetylfentanyl, ortho-methyl registrant must take a new inventory of Review) methoxyacetyl fentanyl, para- all stocks of controlled substances methylfentanyl, phenyl fentanyl, and ′ In accordance with 21 U.S.C. 811(a), (including 2 -fluoro ortho- this final scheduling action is subject to thiofuranyl fentanyl have already fluorofentanyl, 4′-methyl acetyl established and implemented the ′ formal rulemaking procedures done ‘‘on fentanyl, b -phenyl fentanyl, b-methyl the record after opportunity for a systems and processes required to fentanyl, ortho-fluorobutyryl fentanyl, hearing,’’ which are conducted pursuant handle these substances which meet the ortho-methyl acetylfentanyl, ortho- to the provisions of 5 U.S.C. 556 and definition of fentanyl-related methyl methoxyacetyl fentanyl, para- 557. The CSA sets forth the criteria for substances. There are currently 57 registrations methylfentanyl, phenyl fentanyl, and scheduling a drug or other substance. authorized to handle the fentanyl- thiofuranyl fentanyl) on hand every two Such actions are exempt from review by related substances as a class, which years pursuant to 21 U.S.C. 827 and 958, the Office of Management and Budget include 2′-fluoro ortho-fluorofentanyl, and in accordance with 21 CFR 1304.03, (OMB) pursuant to section 3(d)(1) of 4′-methyl acetyl fentanyl, b′-phenyl 1304.04, and 1304.11. Executive Order (E.O.) 12866 and the 6. Records and Reports. Every DEA fentanyl, b-methyl fentanyl, ortho- principles reaffirmed in E.O. 13563. registrant is required to maintain fluorobutyryl fentanyl, ortho-methyl records and submit reports with respect Executive Order 12988, Civil Justice acetylfentanyl, ortho-methyl to 2′-fluoro ortho-fluorofentanyl, 4′- Reform methoxyacetyl fentanyl, para- ′ methyl acetyl fentanyl, b -phenyl This regulation meets the applicable methylfentanyl, phenyl fentanyl, and fentanyl, b-methyl fentanyl, ortho- standards set forth in sections 3(a) and thiofuranyl fentanyl, as well as a fluorobutyryl fentanyl, ortho-methyl 3(b)(2) of E.O. 12988 to eliminate number of registered analytical labs that acetylfentanyl, ortho-methyl drafting errors and ambiguity, minimize are authorized to handle schedule I methoxyacetyl fentanyl, para- litigation, provide a clear legal standard controlled substances generally. These methylfentanyl, phenyl fentanyl, and for affected conduct, and promote 57 registrations represent 51 entities, of thiofuranyl fentanyl, pursuant to 21 simplification and burden reduction. which eight are small entities. U.S.C. 827 and 958(e), and in Therefore, DEA estimates eight small accordance with 21 CFR 1301.74(b) and Executive Order 13132, Federalism entities are affected by this final rule. (c) and parts 1304, 1312, and 1317. This rulemaking does not have A review of the 57 registrations 7. Order Forms. Every DEA registrant federalism implications warranting the indicates that all entities that currently who distributes 2′-fluoro ortho- application of E.O. 13132. The rule does handle fentanyl-related substances, fluorofentanyl, 4′-methyl acetyl not have substantial direct effects on the including 2′-fluoro ortho-fluorofentanyl, fentanyl, b′-phenyl fentanyl, b-methyl States, on the relationship between the 4′-methyl acetyl fentanyl, b′-phenyl fentanyl, ortho-fluorobutyryl fentanyl, National Government and the States, or fentanyl, b-methyl fentanyl, ortho- ortho-methyl acetylfentanyl, ortho- the distribution of power and fluorobutyryl fentanyl, ortho-methyl methyl methoxyacetyl fentanyl, para- responsibilities among the various acetylfentanyl, ortho-methyl methylfentanyl, phenyl fentanyl, and levels of government. methoxyacetyl fentanyl, para- thiofuranyl fentanyl must comply with methylfentanyl, phenyl fentanyl, and the order form requirements, pursuant Executive Order 13175, Consultation thiofuranyl fentanyl, also handle other to 21 U.S.C. 828 and in accordance 21 and Coordination With Indian Tribal schedule I controlled substances, and CFR part 1305. Governments have established and implemented (or 8. Importation and Exportation. All This rule does not have tribal maintain) the systems and processes importation and exportation of 2′-fluoro implications warranting the application required to handle 2′-fluoro ortho- ortho-fluorofentanyl, 4′-methyl acetyl of E.O. 13175. It does not have fluorofentanyl, 4′-methyl acetyl

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fentanyl, b′-phenyl fentanyl, b-methyl organizations. An agency may not Reporting and recordkeeping fentanyl, ortho-fluorobutyryl fentanyl, conduct or sponsor, and a person is not requirements. ortho-methyl acetylfentanyl, ortho- required to respond to, a collection of For the reasons set out above, DEA methyl methoxyacetyl fentanyl, para- information unless it displays a amends 21 CFR part 1308 as follows: methylfentanyl, phenyl fentanyl, and currently valid OMB control number. thiofuranyl fentanyl. Therefore, DEA Determination To Make Rule Effective PART 1308—SCHEDULES OF anticipates that this final rule will Immediately CONTROLLED SUBSTANCES impose minimal or no economic impact on any affected entities, and thus will As indicated above, this rule finalizes ■ 1. The authority citation for 21 CFR not have a significant economic impact the schedule I control status of 10 part 1308 continues to read as follows: on any of the eight affected small substances that has already been in effect for over three years. These 10 Authority: 21 U.S.C. 811, 812, 871(b), entities. Therefore, DEA has concluded 956(b), unless otherwise noted. that this rule will not have a significant substances all fall within the definition effect on a substantial number of small of fentanyl-related substances set forth ■ 2. In § 1308.11: entities. in the February 6, 2018, temporary ■ a. Redesignate paragraphs (b)(73) scheduling order (83 FR 5188). Through Unfunded Mandates Reform Act of 1995 through (b)(76) as paragraphs (b)(83) the Temporary Reauthorization and through (b)(86); In accordance with the Unfunded Study of the Emergency Scheduling of ■ b. Redesignate paragraphs (b)(66) Mandates Reform Act (UMRA) of 1995, Fentanyl Analogues Act, which became through (b)(72) as paragraphs (b)(75) 2 U.S.C. 1501 et seq., DEA has law on February 6, 2020, Congress through (b)(81); determined and certifies that this action extended the temporary control of ■ would not result in any Federal fentanyl-related substances until May 6, c. Redesignate paragraphs (b)(61) mandate that may result ‘‘in the 2021. The February 2018 order was through (b)(65) as paragraphs (b)(69) expenditure by State, local, and tribal effective on the date of publication, and through (b)(73); governments, in the aggregate, or by the was based on findings by the then- ■ d. Redesignate paragraphs (b)(57) private sector, of $100,000,000 or more Acting Administrator that the temporary through (b)(60) as paragraphs (b)(64) (adjusted annually for inflation) in any scheduling of the fentanyl-related through (b)(67); 1 year. . . .’’ Therefore, neither a Small substances was necessary to avoid an ■ e. Redesignate paragraph (b)(56) as Government Agency Plan nor any other imminent hazard to the public safety paragraph (b)(61); action is required under UMRA of 1995. pursuant to 21 U.S.C. 811(h)(1). Because ■ f. Redesignate paragraphs (b)(46) this rule finalizes the control status of through (b)(55) as paragraphs (b)(50) Congressional Review Act 10 substances that has already been in through (b)(59); This rule is not a ‘‘major rule’’ as effect for over three years, it does not ■ g. Redesignate paragraphs (b)(38) defined in the Congressional Review alter the legal obligations of any person through (b)(45) as paragraphs (b)(41) Act (CRA), 5 U.S.C. 804. However, DEA who handles these substances. Rather, it through (b)(48); is submitting the required reports to the merely makes permanent the current ■ h. Redesignate paragraphs (b)(19) Government Accountability Office, the scheduling status and corresponding through (b)(37) as paragraphs (b)(21) House, and the Senate under the CRA. legal obligations. Therefore, DEA is through (b)(39); and making the rule effective on the date of Paperwork Reduction Act of 1995 ■ i. Add new paragraphs (19), (20), (40), publication in the Federal Register, as (49), (60), (62), (63), (68), (74), and (82). This action does not impose a new any delay in the effective date is collection of information under the unnecessary and would be contrary to The additions read as follows: Paperwork Reduction Act of 1995. 44 the public interest. § 1308.11 Schedule I. U.S.C. 3501–3521. This action would not impose recordkeeping or reporting List of Subjects in 21 CFR Part 1308 * * * * * requirements on State or local Administrative practice and (b) * * * governments, individuals, businesses, or procedure, Drug traffic control, * * * * *

(19) beta-Methyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide; also known as b-methyl fentanyl) ...... 9856 (20) beta′-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N,3-diphenylpropanamide; also known as b′-phenyl fentanyl; 3- phenylpropanoyl fentanyl) ...... 9842

******* (40) 2′-Fluoro ortho-fluorofentanyl (N-(1-(2-fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamide; also known as 2′- fluoro 2-fluorofentanyl) ...... 9855

******* (49) 4′-Methyl acetyl fentanyl (N-(1-(4-methylphenethyl)piperidin-4-yl)-N-phenylacetamide) ...... 9819

******* (60) ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide; also known as 2-fluorobutyryl fentanyl) ...... 9846

******* (62) ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also known as 2-methyl acetylfentanyl) ...... 9848 (63) ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also known as 2-methyl methoxyacetyl fentanyl) ...... 9820

******* (68) para-Methylfentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)propionamide; also known as 4-methylfentanyl) ...... 9817

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******* (74) Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide; also known as benzoyl fentanyl) ...... 9841

******* (82) Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylthiophene-2-carboxamide; also known as 2-thiofuranyl fentanyl; thiophene fentanyl) ...... 9839

* * * * * the calendar year. The Secretary of million or more by State, local, or tribal State, however, may determine that governments, or by the private sector. D. Christopher Evans, publication of particular categories of This rule will not result in any such Acting Administrator. agreements is not required if certain expenditure nor would it significantly [FR Doc. 2021–08720 Filed 4–26–21; 8:45 am] criteria are met (See 1 U.S.C. 112a(b)). or uniquely affect small governments. BILLING CODE 4410–09–P As explained in the NPRM, the Department is amending 22 CFR Executive Orders 12372 and 13132: 181.8(a)(9) to read ‘‘Agreements that Federalism and Executive Order 13175, DEPARTMENT OF STATE have been given a national security Impact on Tribes classification pursuant to Executive 22 CFR Part 181 Order No. 13526, its predecessors or This rule will not have substantial direct effects on the States, on the [Public Notice: 11408] successors, or are otherwise exempt from public disclosure pursuant to U.S. relationship between the national RIN 1400–AE98 law.’’ government and the States, or on the The scope of this new exemption distribution of power and Publication, Coordination, and includes agreements that have not been responsibilities among the various Reporting of International Agreements given a national security classification levels of government. Nor will the AGENCY: Department of State. pursuant to Executive Order No. 13526, regulations have federalism ACTION: Final rule. its predecessors or successors, but implications warranting the application nonetheless are exempt from public of Executive Orders 12372 and 13132. SUMMARY: The Treaties and Other disclosure pursuant to U.S. law. The This rule will not have tribal International Acts Series (TIAS) is the principal category of agreements for implications, will not impose costs on official treaty series of the United States which this clarification is relevant are Indian tribal governments, and will not and serves as evidence of the treaties, agreements that are exempt from public pre-empt tribal law. Accordingly, the and international agreements other than disclosure pursuant to 10 U.S.C. 130c, requirements of Executive Order 13175 treaties, in all courts of law and equity which authorizes specified national do not apply to this rulemaking. of the United States, and in public security officials to withhold from offices of the federal government and of public disclosure otherwise required by Executive Orders 12866 and 13563: the states, without any need of further law sensitive information of foreign Regulatory Review authentication. Certain international governments and international This rule has been drafted in agreements may be exempted from organizations. accordance with the principles of publication in TIAS, if the Department Regulatory Analysis of State (the Department) provides Executive Orders 12866 and 13563. This notice in its regulations. This rule Administrative Procedure Act rule has been determined to be a significant rulemaking under section 3 updates those regulations to clarify the The Department issued the rule for scope of an existing exemption. comment in accordance with the of Executive Order 12866, but not economically significant. With respect DATES: This rule is effective May 27, Administrative Procedure Act (5 U.S.C. 2021. 553). to the costs and benefits of this rule, the Department notes that agreements FOR FURTHER INFORMATION CONTACT: Regulatory Flexibility Act/Executive addressed by the proposed clarification Michael Mattler, Treaty Affairs, Office Order 13272: Small Business are, by definition, already exempt from of the Legal Adviser, Department of This rulemaking is hereby certified as public disclosure pursuant to U.S. law. State, Washington, DC 20520, (202) not expected to have a significant The proposed rule is intended to 647–1345, or at [email protected]. impact on a substantial number of small provide greater clarity to the application SUPPLEMENTARY INFORMATION: This rule entities under the criteria of the of the existing rule rather than to effect finalizes a proposed rule published by Regulatory Flexibility Act, 5 U.S.C. 601 a change in existing practices regarding the Department of State on December 7, et seq. the publication of agreements. For this 2020. 85 FR 78813. The Department Congressional Review Act reason, the Department does not provided 60 days for comment; no anticipate any costs to the public from relevant public comments were This rulemaking does not constitute a this rulemaking. Therefore, the received. major rule, as defined by 5 U.S.C. 804, Department believes that the benefits of for purposes of congressional review of Background this rulemaking outweigh any costs. agency rulemaking. Pursuant to 1 U.S.C. 112a, the Executive Order 12988: Civil Justice The Unfunded Mandates Reform Act of Secretary of State is required to cause to Reform be published annually a compilation of 1995 all treaties and international agreements The Unfunded Mandates Reform Act This rule has been reviewed in light to which the United States is a party of 1995, 2 U.S.C. 1532, generally of sections 3(a) and 3(b)(2) of Executive that were signed, proclaimed, or ‘‘with requires agencies to prepare a statement Order 12988 to eliminate ambiguity, reference to which any other final before proposing any rule that may minimize litigation, establish clear legal formality ha[d] been executed’’ during result in an annual expenditure of $100 standards, and reduce burden.

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