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SUMMARY: The Food and Drug DEPARTMENT OF JUSTICE substance may be initiated by the Administration (FDA) is withdrawing Attorney General (1) on his own motion; approval of a new animal drug Drug Enforcement Administration (2) at the request of the Secretary of the application (NADA) and two Department of Health and Human abbreviated new animal drug 21 CFR Part 1308 Services (HHS); 1 or (3) on the petition applications (ANADAs) at the sponsors’ [Docket No. DEA–446] of any interested party. 21 U.S.C. 811(a). request because the products are no This action was initiated on the longer manufactured or marketed. Schedules of Controlled Substances: Attorney General’s own motion, as Placement of 5F-ADB, 5F-AMB, 5F- delegated to the Administrator of the DATES: Withdrawal of approval is APINACA, ADB-FUBINACA, MDMB- DEA, and is supported by, inter alia, a applicable February 3, 2020. CHMICA and MDMB-FUBINACA in recommendation from the Assistant Secretary for Health of HHS and an FOR FURTHER INFORMATION CONTACT: Schedule I evaluation of all relevant data by the Sujaya Dessai, Center for Veterinary AGENCY: Drug Enforcement DEA. This action continues the Medicine (HFV–212), Food and Drug Administration, Department of Justice. imposition of the regulatory controls Administration, 7519 Standish Pl., ACTION: Final rule. and administrative, civil, and criminal Rockville, MD 20855, 240–402–5761, sanctions of schedule I controlled [email protected]. SUMMARY: The Drug Enforcement substances on any person who handles SUPPLEMENTARY INFORMATION: Fleming Administration places methyl 2-(1-(5- or proposes to handle 5F-ADB, 5F-AMB, Laboratories, Inc., P.O. Box 34384, fluoropentyl)-1H-indazole-3- 5F-APINACA, ADB-FUBINACA, carboxamido)-3,3-dimethylbutanoate Charlotte, NC 28234, has requested that MDMB-CHMICA and MDMB- [5F-ADB; 5F-MDMB-PINACA]; methyl FDA withdraw approval of NADA 010– FUBINACA. 2-(1-(5-fluoropentyl)-1H-indazole-3- 005 for use of WAZINE (dipiperazine carboxamido)-3-methylbutanoate [5F- Background sulfate and hydrochloride) AMB]; N-(adamantan-1-yl)-1-(5- On April 10, 2017, DEA published an Soluble Powders because the product is fluoropentyl)-1H-indazole-3- order in the Federal Register amending no longer manufactured or marketed. carboxamide [5F-APINACA, 5F-AKB48]; 21 CFR 1308.11(h) to temporarily place Also, Halocarbon Products Corp., N-(1-amino-3,3-dimethyl-1-oxobutan-2- the six synthetic (SCs) 6525 The Corners Pkwy., Suite 200, yl)-1-(4-fluorobenzyl)-1H-indazole-3- methyl 2-(1-(5-fluoropentyl)-1H- Peachtree Corners, GA 30092, has carboxamide [ADB-FUBINACA]; methyl indazole-3-carboxamido)-3,3- requested that FDA withdraw approval 2-(1-(cyclohexylmethyl)-1H-indole-3- dimethylbutanoate [5F-ADB; 5F-MDMB- of ANADA 200–200 for use of carboxamido)-3,3-dimethylbutanoate PINACA]; methyl 2-(1-(5-fluoropentyl)- Halothane USP (halothane) because the [MDMB-CHMICA, MMB-CHMINACA]; 1H-indazole-3-carboxamido)-3- product is no longer manufactured or and methyl 2-(1-(4-fluorobenzyl)-1H- methylbutanoate [5F-AMB]; N- (adamantan-1-yl)-1-(5-fluoropentyl)-1H- marketed. indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB- indazole-3-carboxamide [5F-APINACA, Lastly, Mylan Institutional LLC, 4901 FUBINACA], including their salts, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- Hiawatha Dr., Rockford, IL 61103, has isomers, and salts of isomers whenever oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- requested that FDA withdraw approval the existence of such salts, isomers, and indazole-3-carboxamide [ADB- of ANADA 200–472 for use of salts of isomers is possible, in schedule FUBINACA]; methyl 2-(1- Fomepizole Injection because the I of the Controlled Substances Act. This (cyclohexylmethyl)-1H-indole-3- product is no longer manufactured or action continues the imposition of the carboxamido)-3,3-dimethylbutanoate marketed. regulatory controls and administrative, [MDMB-CHMICA, MMB-CHMINACA]; Therefore, under authority delegated civil, and criminal sanctions applicable and methyl 2-(1-(4-fluorobenzyl)-1H- to the Commissioner of Food and Drugs to schedule I controlled substances on indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA] and in accordance with § 514.116 Notice persons who handle (manufacture, in schedule I of the CSA pursuant to the of withdrawal of approval of application distribute, import, export, engage in research, conduct instructional temporary scheduling provisions of 21 (21 CFR 514.116), notice is given that U.S.C. 811(h). 82 FR 17119. That approval of NADA 010–005 and activities or chemical analysis, or possess), or propose to handle 5F-ADB, temporary scheduling order was ANADAs 200–200 and 200–472, and all effective on the date of publication, and supplements and amendments thereto, 5F-AMB, 5F-APINACA, ADB- FUBINACA, MDMB-CHMICA, and was based on findings by the former is hereby withdrawn, effective February MDMB-FUBINACA. Acting Administrator of the DEA 3, 2020. (Acting Administrator) that the DATES: Effective: January 24, 2020. Elsewhere in this issue of the Federal temporary scheduling of these six SCs FOR FURTHER INFORMATION CONTACT: Register, FDA is amending the animal was necessary to avoid an imminent Scott A. Brinks, Regulatory Drafting and drug regulations to reflect the voluntary hazard to the public safety pursuant to Policy Support Section, Diversion 21 U.S.C. 811(h)(1). Section 201(h)(2) of withdrawal of approval of these Control Division, Drug Enforcement applications. Administration; Mailing Address: 8701 1 As set forth in a memorandum of understanding Dated: January 9, 2020. Morrissette Drive, Springfield, Virginia entered into by the Food and Drug Administration Lowell J. Schiller, 22152; Telephone: (202) 598–6812. (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the Principal Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: Department of Health and Human Services (HHS) [FR Doc. 2020–00422 Filed 1–23–20; 8:45 am] in carrying out the Secretary’s scheduling Legal Authority responsibilities under the CSA, with the BILLING CODE 4164–01–P The Controlled Substances Act (CSA) concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the provides that proceedings for the Assistant Secretary for Health of the HHS the issuance, amendment, or repeal of the authority to make domestic drug scheduling scheduling of any drug or other recommendations. 58 FR 35460, July 1, 1993.

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the CSA, 21 U.S.C. 811(h)(2), requires analyses are available in their entirety in with regulatory, administrative, and that the temporary control of these the public docket for this rule (Docket enforcement activities involving substances expire two years from the Number DEA–446) at http:// scheduled drugs and concern over issuance date of the scheduling order, www.regulations.gov under ‘‘Supporting potential tribal implications. on or before April 9, 2019. However, the Documents.’’ DEA response: DEA’s mission is to CSA also provides that during the Determination to Schedule 5F-ADB, 5F- enforce the controlled substance laws pendency of proceedings under 21 AMB, 5F-APINACA, ADB-FUBINACA, and regulations of the United States. U.S.C. 811(a)(1) with respect to the MDMB-CHMICA and MDMB- The CSA contains specific mandates substance, the temporary scheduling of FUBINACA pertaining to the scheduling of that substance could be extended for up controlled substances. DEA has to one year. Accordingly, on April 8, After a review of the available data, followed all of those mandates regarding 2019, DEA extended the temporary including the scientific and medical the scheduling of 5F-ADB, 5F-AMB, 5F- scheduling of 5F-ADB, 5F-AMB, 5F- evaluation and the scheduling APINACA, ADB-FUBINACA, MDMB- APINACA, ADB-FUBINACA, MDMB- recommendations from HHS, DEA CHMICA, and MDMB-FUBINACA, CHMICA, and MDMB-FUBINACA by published a NPRM entitled ‘‘Schedules including receiving from the Secretary one year, or until April 9, 2020. 84 FR of Controlled Substances: Placement of of HHS a scientific and medical 13796. Also, on April 8, 2019, DEA 5F-ADB, 5F-AMB, 5F-APINACA, ADB- evaluation, and recommendation, published a notice of proposed FUBINACA, MDMB-CHMICA, and regarding control (21 U.S.C. 811(b)); rulemaking (NPRM) to permanently MDMB-FUBINACA in Schedule I.’’ This considering the factors enumerated in control 5F-ADB, 5F-AMB, 5F- NPRM proposed to control 5F-ADB, 5F- 21 U.S.C. 811(c); determining, based on APINACA, ADB-FUBINACA, MDMB- AMB, 5F-APINACA, ADB-FUBINACA, the above, appropriate scheduling for CHMICA, and MDMB-FUBINACA in MDMB-CHMICA, and MDMB- these SCs (21 U.S.C. 812(b)); and schedule I of the CSA. 84 FR 13848. FUBINACA, and their salts, isomers, conducting a formal rulemaking to Specifically, DEA proposed to add these and salts of isomers in schedule I of the schedule these SCs (21 U.S.C. 811(a)). six SCs to the hallucinogenic substances CSA. 84 FR 13848, April 8, 2019. The These SCs satisfy the CSA’s criteria for list under 21 CFR 1308.11(d). proposed rule provided an opportunity placement in schedule I by virtue of for interested persons to file a request DEA and HHS Eight Factor Analyses their high potential for abuse, the fact for hearing in accordance with DEA that these substances have no currently On March 21, 2019, HHS provided regulations on or before May 8, 2019. No accepted medical use in treatment in the DEA with a scientific and medical requests for such a hearing were United States, and their lack of accepted evaluation document prepared by the received by DEA. The NPRM also safety for use of the substance under Food and Drug Administration (FDA) provided an opportunity for interested medical supervision. 21 U.S.C. entitled ‘‘Basis for the Recommendation persons to submit comments on the 812(b)(1). to Place Methyl 2-(1-(5-fluoropentyl)- proposed rule on or before May 8, 2019. 1H-indazole-3-carboxamido)-3,3- As per the commenter’s views dimethylbutanoate [5F-ADB; 5F-MDMB- Comments Received regarding the appropriateness and PINACA]; Methyl 2-(1-(5-fluoropentyl)- The DEA received three comments on effectiveness of current drug control 1H-indazole-3-carboxamido)-3- the proposed rule to control 5F-ADB, policy, use of alternative approaches methylbutanoate [5F-AMB]; N- 5F-AMB, 5F-APINACA, ADB- such as investing in treatment, (adamantan-1-yl)-1-(5-fluoropentyl)-1H- FUBINACA, MDMB-CHMICA, and education about harmful effects of SCs, indazole-3-carboxamide [5F-APINACA, MDMB-FUBINACA in schedule I of the and removal of from schedule 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- CSA. I, these are outside the scope of the oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- Support for rulemaking: Two current scheduling action. indazole-3-carboxamide [ADB- commenters recognized the dangers and Regarding the increased costs FUBINACA]; Methyl 2-(1- public health risks, and supported the associated with regulatory, (cyclohexylmethyl)-1H-indole-3- rulemaking to permanently place these administrative, and enforcement carboxamido)-3,3-dimethylbutanoate substances in schedule I. activities involving scheduled drugs, [MDMB-CHMICA, MMB-CHMINACA], DEA Response: The DEA appreciates these issues are not unique to the Methyl 2-(1-(4-fluorobenzyl)-1H- the comments in support of this substances that are currently being indazole-3-carboxamido)-3,3- rulemaking. controlled by this final rule. dimethylbutanoate [MDMB-FUBINACA] Dissent for rulemaking: One Regarding the commenter’s concern and their Salts in Schedule I of the commenter stated that while SCs, in that the scheduling of these SCs will Controlled Substances Act.’’ After general, could pose a public health risk, have tribal implications, DEA has considering the eight factors in 21 are more harmful than ‘‘traditional analyzed the expected impact of this U.S.C. 811(c), each substance’s abuse cannabis,’’ and have no known final rule, and has determined that it potential, lack of legitimate medical use legitimate medical use, this individual will not have substantial direct effects in the United States, and lack of disagreed with the permanent control of on one or more Indian tribes, on the accepted safety for use under medical these specific six substances. This relationship between the Federal supervision pursuant to 21 U.S.C. commenter also questioned the government and Indian tribes, or on the 812(b), the Assistant Secretary of HHS appropriateness and effectiveness of distribution of power and recommended that 5F-ADB, 5F-AMB, current drug control policy and responsibilities between the Federal 5F-APINACA, ADB-FUBINACA, mentioned use of alternative approaches government and Indian tribes. As MDMB-CHMICA and MDMB- such as investing in treatment of current evidence, the commenter cites the FUBINACA be controlled in schedule I SC users, education about harmful incarceration rates of Native Americans of the CSA. In response, DEA conducted effects of SCs, removal of cannabis from and native youths relative to the its own eight factor analysis of 5F-ADB, schedule I, and additional research into national average; however, does not 5F-AMB, 5F-APINACA, ADB- the substances at issue in this explain how this data is relevant to the FUBINACA, MDMB-CHMICA, and rulemaking. In addition, the commenter substances being permanently MDMB-FUBINACA. The DEA and HHS discussed the increased cost associated scheduled in this final rule.

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As per the comment related to (cyclohexylmethyl)-1H-indole-3- indazole-3-carboxamido)-3,3- additional research into the substances carboxamido)-3,3-dimethylbutanoate dimethylbutanoate [MDMB- at issue in this rulemaking, DEA has [MDMB-CHMICA, MMB-CHMINACA]; FUBINACA], including their salts, utilized funding of its own to conduct and methyl 2-(1-(4-fluorobenzyl)-1H- isomers and salts of isomers, whenever pharmacological research studies into indazole-3-carboxamido)-3,3- the existence of such salts, isomers, and all these six substances. The data dimethylbutanoate [MDMB-FUBINACA] salts of isomers is possible, warrant generated from these studies have been have a high potential for abuse that is control in schedule I of the CSA. 21 utilized in evaluating these substances comparable to other schedule I U.S.C. 812(b)(1). for control under the CSA. HHS, upon substances such as delta-9- Requirements for Handling 5F-ADB, 5F- conducting scientific and medical (D9-THC) and AMB, 5F-APINACA, ADB-FUBINACA, evaluation of these and all available JWH-018; MDMB-CHMICA, and MDMB- data, recommended schedule I controls (2) Methyl 2-(1-(5-fluoropentyl)-1H- FUBINACA for these substances. DEA conducted its indazole-3-carboxamido)-3,3- own review of HHS scientific and dimethylbutanoate [5F-ADB; 5F-MDMB- 5F-ADB, 5F-AMB, 5F-APINACA, medical evaluation and all other PINACA]; methyl 2-(1-(5-fluoropentyl)- ADB-FUBINACA, MDMB-CHMICA, and relevant data and determined that these 1H-indazole-3-carboxamido)-3- MDMB-FUBINACA will continue 2 to be substances warrant control as schedule methylbutanoate [5F-AMB]; N- subject to the CSA’s schedule I I substances under the CSA. Additional (adamantan-1-yl)-1-(5-fluoropentyl)-1H- regulatory controls and administrative, information about these substances can indazole-3-carboxamide [5F-APINACA, civil, and criminal sanctions applicable be viewed in the public docket for this 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- to the manufacture, distribution, rule (Docket Number DEA–446) at oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- dispensing, importing, exporting, http://www.regulations.gov under indazole-3-carboxamide [ADB- research, and conduct of instructional ‘‘Supporting Documents.’’ FUBINACA]; methyl 2-(1- activities, including the following: (cyclohexylmethyl)-1H-indole-3- 1. Registration. Any person who Scheduling Conclusion carboxamido)-3,3-dimethylbutanoate handles (manufactures, distributes, After consideration of the relevant [MDMB-CHMICA, MMB-CHMINACA]; imports, exports, engages in research, or matter presented as a result of public and methyl 2-(1-(4-fluorobenzyl)-1H- conducts instructional activities or comments, the scientific and medical indazole-3-carboxamido)-3,3- chemical analysis with, or possesses), or evaluations and accompanying dimethylbutanoate [MDMB-FUBINACA] who desires to handle, 5F-ADB, 5F- recommendation of HHS, and after its have no currently accepted medical use AMB, 5F-APINACA, ADB-FUBINACA, own eight-factor evaluation, DEA finds in treatment in the United States; and MDMB-CHMICA, or MDMB-FUBINACA that these facts and all other relevant (3) There is a lack of accepted safety must be registered with DEA to conduct data constitute substantial evidence of for use of methyl 2-(1-(5-fluoropentyl)- such activities pursuant to 21 U.S.C. potential for abuse of 5F-ADB, 5F-AMB, 1H-indazole-3-carboxamido)-3,3- 822, 823, 957, and 958 and in 5F-APINACA, ADB-FUBINACA, dimethylbutanoate [5F-ADB; 5F-MDMB- accordance with 21 CFR parts 1301 and MDMB-CHMICA, and MDMB- PINACA]; methyl 2-(1-(5-fluoropentyl)- 1312. FUBINACA. As such, DEA is 1H-indazole-3-carboxamido)-3- 2. Security. 5F-ADB, 5F-AMB, 5F- permanently scheduling 5F-ADB, 5F- methylbutanoate [5F-AMB]; N- APINACA, ADB-FUBINACA, MDMB- AMB, 5F-APINACA, ADB-FUBINACA, (adamantan-1-yl)-1-(5-fluoropentyl)-1H- CHMICA, and MDMB-FUBINACA are MDMB-CHMICA, and MDMB- indazole-3-carboxamide [5F-APINACA, subject to schedule I security FUBINACA as controlled substances 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- requirements and must be handled in under the CSA. oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- accordance with 21 CFR 1301.71– indazole-3-carboxamide [ADB- 1301.93. Determination of Appropriate Schedule FUBINACA]; methyl 2-(1- 3. Labeling and Packaging. All labels The CSA establishes five schedules of (cyclohexylmethyl)-1H-indole-3- and labeling for commercial containers controlled substances known as carboxamido)-3,3-dimethylbutanoate of 5F-ADB, 5F-AMB, 5F-APINACA, schedules I, II, III, IV, and V. The CSA [MDMB-CHMICA, MMB-CHMINACA]; ADB-FUBINACA, MDMB-CHMICA, and also outlines the findings required to and methyl 2-(1-(4-fluorobenzyl)-1H- MDMB-FUBINACA must be in place a drug or other substance in any indazole-3-carboxamido)-3,3- compliance with 21 U.S.C. 825 and particular schedule. 21 U.S.C. 812(b). dimethylbutanoate [MDMB-FUBINACA] 958(e), and be in accordance with 21 After consideration of the analysis and under medical supervision. CFR part 1302. recommendation of the Assistant Based on these findings, the Acting 4. Quota. Only registered Secretary for HHS and review of all Administrator of DEA concludes that manufacturers are permitted to other available data, the Acting methyl 2-(1-(5-fluoropentyl)-1H- manufacture 5F-ADB, 5F-AMB, 5F- Administrator of DEA, pursuant to 21 indazole-3-carboxamido)-3,3- APINACA, ADB-FUBINACA, MDMB- U.S.C. 811(a) and 21 U.S.C. 812(b)(1), dimethylbutanoate [5F-ADB; 5F-MDMB- CHMICA, or MDMB-FUBINACA in finds that: PINACA]; methyl 2-(1-(5-fluoropentyl)- accordance with a quota assigned (1) Methyl 2-(1-(5-fluoropentyl)-1H- 1H-indazole-3-carboxamido)-3- pursuant to 21 U.S.C. 826 and in indazole-3-carboxamido)-3,3- methylbutanoate [5F-AMB]; N- accordance with 21 CFR part 1303. dimethylbutanoate [5F-ADB; 5F-MDMB- (adamantan-1-yl)-1-(5-fluoropentyl)-1H- 5. Inventory. Every DEA registrant PINACA]; methyl 2-(1-(5-fluoropentyl)- indazole-3-carboxamide [5F-APINACA, who possesses any quantity of 5F-ADB, 1H-indazole-3-carboxamido)-3- 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- 5F-AMB, 5F-APINACA, ADB- methylbutanoate [5F-AMB]; N- oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- FUBINACA, MDMB-CHMICA, and (adamantan-1-yl)-1-(5-fluoropentyl)-1H- indazole-3-carboxamide [ADB- MDMB-FUBINACA was required to indazole-3-carboxamide [5F-APINACA, FUBINACA]; methyl 2-(1- 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- (cyclohexylmethyl)-1H-indole-3- 2 5F-ADB, 5F-AMB, 5F-APINACA, ADB- FUBINACA, MDMB-CHMICA, and MDMB- oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- carboxamido)-3,3-dimethylbutanoate FUBINACA are currently subject to schedule I indazole-3-carboxamide [ADB- [MDMB-CHMICA, MMB-CHMINACA]; controls on a temporary basis, pursuant to 21 U.S.C. FUBINACA]; methyl 2-(1- and methyl 2-(1-(4-fluorobenzyl)-1H- 811(h). 82 FR 17119, April 10, 2017.

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keep an inventory of all stocks of these Executive Order 12988 MDMB-FUBINACA also handle other substances on hand as of April 10, 2017, This regulation meets the applicable schedule I controlled substances, and pursuant to 21 U.S.C. 827 and 958 and standards set forth in sections 3(a) and have established and implemented (or in accordance with 21 CFR 1304.03, 3(b)(2) of Executive Order 12988 to maintain) the systems and processes 1304.04, and 1304.11. eliminate drafting errors and ambiguity, required to handle 5F-ADB, 5F-AMB, 6. Records and Reports. Every DEA minimize litigation, provide a clear legal 5F-APINACA, ADB-FUBINACA, registrant must maintain records and standard for affected conduct, and MDMB-CHMICA, or MDMB- submit reports with respect to 5F-ADB, promote simplification and burden FUBINACA. Therefore, DEA anticipates 5F-AMB, 5F-APINACA, ADB- reduction. that this rule will impose minimal or no FUBINACA, MDMB-CHMICA, and/or economic impact on any affected MDMB-FUBINACA, pursuant to 21 Executive Order 13132 entities; and, thus, will not have a U.S.C. 827 and 958(e), and in This rulemaking does not have significant economic impact on any of accordance with 21 CFR parts 1304 and federalism implications warranting the the 22 affected small entities. Therefore, 1312. application of Executive Order 13132. DEA has concluded that this rule will 7. Order Forms. Every DEA registrant The rule does not have substantial not have a significant effect on a who distributes 5F-ADB, 5F-AMB, 5F- direct effects on the States, on the substantial number of small entities. APINACA, ADB-FUBINACA, MDMB- relationship between the national CHMICA, or MDMB-FUBINACA must government and the States, or the Unfunded Mandates Reform Act of 1995 distribution of power and continue to comply with the order form In accordance with the Unfunded responsibilities among the various requirements, pursuant to 21 U.S.C. 828, Mandates Reform Act (UMRA) of 1995, levels of government. and 21 CFR part 1305. 2 U.S.C. 1501 et seq., DEA has 8. Importation and Exportation. All Executive Order 13175 determined and certifies that this action importation and exportation of 5F-ADB, This rule does not have tribal would not result in any Federal 5F-AMB, 5F-APINACA, ADB- mandate that may result ‘‘in the FUBINACA, MDMB-CHMICA, or implications warranting the application of Executive Order 13175. It does not expenditure by State, local, and tribal MDMB-FUBINACA must continue to be governments, in the aggregate, or by the in compliance with 21 U.S.C. 952, 953, have substantial direct effects on one or more Indian tribes, on the relationship private sector, of $100,000,000 or more 957, and 958, and in accordance with 21 (adjusted annually for inflation) in any CFR part 1312. between the Federal government and Indian tribes, or on the distribution of 1 year. . . .’’ Therefore, neither a Small 9. Liability. Any activity involving 5F- power and responsibilities between the Government Agency Plan nor any other ADB, 5F-AMB, 5F-APINACA, ADB- Federal government and Indian tribes. action is required under UMRA of 1995. FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA not authorized by, Regulatory Flexibility Act Paperwork Reduction Act of 1995 or in violation of, the CSA or its The Acting Administrator, in implementing regulations is unlawful, This action does not impose a new accordance with the Regulatory collection of information under the and may subject the person to Flexibility Act (RFA), 5 U.S.C. 601–602, administrative, civil, and/or criminal Paperwork Reduction Act of 1995. 44 has reviewed this final rule and by U.S.C. 3501–3521. This action would sanctions. approving it certifies that it will not not impose recordkeeping or reporting have a significant economic impact on Regulatory Analyses requirements on State or local a substantial number of small entities. governments, individuals, businesses, or Executive Orders 12866, 13563, and On April 10, 2017, DEA published an organizations. An agency may not 13771, Regulatory Planning and Review, order to temporarily place these six conduct or sponsor, and a person is not Improving Regulation and Regulatory substances in schedule I of the CSA required to respond to, a collection of Review, and Reducing Regulation and pursuant to the temporary scheduling information unless it displays a Controlling Regulatory Costs provisions of 21 U.S.C. 811(h). DEA currently valid OMB control number. In accordance with 21 U.S.C. 811(a), estimates that all entities handling or this final scheduling action is subject to planning to handle these substances Congressional Review Act formal rulemaking procedures have already established and performed ‘‘on the record after implemented the systems and processes This rule is not a major rule as opportunity for a hearing,’’ which are required to handle 5F-ADB, 5F-AMB, defined by the Congressional Review conducted pursuant to the provisions of 5F-APINACA, ADB-FUBINACA, Act (CRA), 5 U.S.C. 804. This rule will 5 U.S.C. 556 and 557. The CSA sets MDMB-CHMICA, or MDMB- not result in an annual effect on the forth the criteria for scheduling a drug FUBINACA. There are currently 33 economy of $100,000,000 or more; a or other substance. Such actions are registrations authorized to handle 5F- major increase in costs or prices for exempt from review by the Office of ADB, 5F-AMB, 5F-APINACA, ADB- consumers, individual industries, Management and Budget (OMB) FUBINACA, MDMB-CHMICA, and/or Federal, State, or local government pursuant to section 3(d)(1) of Executive MDMB-FUBINACA specifically, as well agencies, or geographic regions; or Order 12866 and the principles as a number of registered analytical labs significant adverse effects on reaffirmed in Executive Order 13563. that are authorized to handle schedule competition, employment, investment, This final rule does not meet the I controlled substances generally. These productivity, innovation, or on the definition of an Executive Order 13771 33 registrations represent 28 entities, of ability of United States-based regulatory action. OMB has previously which 22 are small entities. Therefore, enterprises to compete with foreign- determined that formal rulemaking DEA estimates 22 small entities are based enterprises in domestic and actions concerning the scheduling of affected by this rule. export markets. However, pursuant to controlled substances, such as this rule, A review of the 33 registrations the CRA, DEA has submitted a copy of are not significant regulatory actions indicates that all entities that currently this final rule to both Houses of under section 3(f) of Executive Order handle 5F-ADB, 5F-AMB, 5F-APINACA, Congress and to the Comptroller 12866. ADB-FUBINACA, MDMB-CHMICA, or General.

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List of Subjects in 21 CFR Part 1308 PART 1308—SCHEDULES OF ■ a. Add paragraphs (d)(73) through CONTROLLED SUBSTANCES (78); and Administrative practice and ■ b. Remove and reserve paragraphs procedure, Drug traffic control, ■ 1. The authority citation for 21 CFR (h)(6) through (11); Reporting and recordkeeping part 1308 continues to read as follows: The additions read as follows: requirements. Authority: 21 U.S.C. 811, 812, 871(b), § 1308.11 Schedule I. 956(b), unless otherwise noted. For the reasons set out above, 21 CFR * * * * * part 1308 is amended as follows: ■ 2. In § 1308.11, (d) * * *

(73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: 5F-ADB; 5F-MDMB-PINACA) 7034 (74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (Other names: 5F-AMB) ...... 7033 (75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (Other names: 5F-APINACA, 5F-AKB48) ...... 7049 (76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-FUBINACA) ...... 7010 (77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-CHMICA, MMB- CHMINACA) ...... 7042 (78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-FUBINACA) ...... 7020

* * * * * FOR FURTHER INFORMATION CONTACT: of any interested party. 21 U.S.C. 811(a). Dated: January 3, 2020. Scott A. Brinks, Regulatory Drafting and This action was initiated by two citizen b Uttam Dhillon, Policy Support Section, Diversion petitions to remove 6 -naltrexol from Control Division, Drug Enforcement the list of scheduled controlled Acting Administrator. Administration; Mailing Address: 8701 substances of the CSA, and is supported [FR Doc. 2020–00665 Filed 1–23–20; 8:45 am] Morrissette Drive, Springfield, Virginia by, inter alia, a recommendation from BILLING CODE 4410–09–P 22152; Telephone: (571) 362–8209. the Assistant Secretary of the HHS and SUPPLEMENTARY INFORMATION: an evaluation of all relevant data by the DEA. This action removes the regulatory DEPARTMENT OF JUSTICE Legal Authority controls and administrative, civil, and Drug Enforcement Administration Under the Controlled Substances Act criminal sanctions applicable to (CSA), each controlled substance is controlled substances, including those 21 CFR Part 1308 classified into one of five schedules specific to schedule II controlled based upon its potential for abuse, its substances, on persons who handle or [Docket No. DEA–492] currently accepted medical use in propose to handle 6b-naltrexol. treatment in the United States, and the Schedules of Controlled Substances: Background degree of dependence the drug or other Removal of 6β-Naltrexol From Control substance may cause. 21 U.S.C. 812. The 6b-Naltrexol is the major metabolite of naltrexone. Naltrexone and 6b-naltrexol AGENCY: Drug Enforcement initial schedules of controlled are reversible opioid receptor Administration, Department of Justice. substances established by Congress are found at 21 U.S.C. 812(c) and the antagonists. Opioid receptor antagonists ACTION: Final rule. are commonly used in the treatment of current list of scheduled substances is opioid addiction and overdose. On SUMMARY: With the issuance of this final published at 21 CFR part 1308. December 24, 1974, naloxone, an opioid rule, the Acting Administrator of the Pursuant to 21 U.S.C. 811(a)(2), the receptor antagonist that works similarly Drug Enforcement Administration Attorney General may, by rule, ‘‘remove to naltrexone, was removed from all removes (5a,6b)-17- any drug or other substance from the schedules for control under the CSA. (cyclopropylmethyl)-4,5- schedules if he finds that the drug or Effective on March 6, 1975, title 21 of epoxymorphinan-3,6,14-triol (6b- other substance does not meet the the Code of Federal Regulations was naltrexol) and its salts from the requirements for inclusion in any amended to remove naltrexone from all schedules of the Controlled Substances schedule.’’ The Attorney General has schedules for control under the CSA. Act (CSA). This scheduling action is delegated scheduling authority under 21 The Administrator of the DEA found pursuant to the CSA which requires that U.S.C. 811 to the Acting Administrator that both naltrexone and naloxone and such actions be made on the record after of the Drug Enforcement Administration their salts have an accepted medical use opportunity for a hearing through (DEA). 28 CFR 0.100. formal rulemaking. Prior to the effective The CSA provides that proceedings for treatment in the United States and date of this rule, 6b-naltrexol was a for the issuance, amendment, or repeal that they do not have a potential for schedule II controlled substance of the scheduling of any drug or other abuse to justify continued control in any because it can be derived from opium substance may be initiated by the schedule under the CSA. In June 2003 alkaloids. This action removes the Attorney General (1) on his own motion, and April 2008, the DEA received two regulatory controls and administrative, (2) at the request of the Secretary of the separate citizen petitions to initiate civil, and criminal sanctions applicable Department of Health and Human proceedings to amend 21 CFR 1308.12(b)(1) to decontrol 6b-naltrexol to controlled substances, including Services (HHS),1 or (3) on the petition those specific to schedule II controlled from schedule II of the CSA. These substances, on persons who handle 1 As discussed in a memorandum of petitions complied with the (manufacture, distribute, reverse understanding entered into by the Food and Drug requirements of 21 CFR 1308.44(b) and distribute, dispense, conduct research, Administration (FDA) and the National Institute on were accepted for filing. Both Drug Abuse (NIDA), the FDA acts as the lead agency petitioners argue that 6b-naltrexol has import, export, or conduct chemical within the HHS in carrying out the Secretary’s analysis) or propose to handle 6b- scheduling responsibilities under the CSA, with the been characterized as an opioid receptor naltrexol. concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the authority to make domestic drug scheduling DATES: Effective Date: January 24, 2020. Assistant Secretary for Health of the HHS the recommendations. 58 FR 35460, July 1, 1993.

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