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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
812b, the Assistant Secretary recommended that NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYLP7AICA be placed in schedule I of the CSA. In response, DEA conducted its own eight-factor analysis of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA.
The NPRM stated that the DEA and HHS analyses, as well as the Assistant Secretarys May 29, 2020, letter to DEA, were available for viewing on the electronic docket. However, DEA
discovered that these documents were not posted to the electronic docket as stated, and were only available for viewing at DEA headquarters. Upon publication of this final rule, DEA will post these documents in their entirety in the public docket for this rule Docket Number DEA-479 at http
www.regulations.gov under Supporting Documents.
NPRM To Schedule NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYLP7AICA
On July 13, 2020, DEA published an NPRM entitled Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in Schedule I.
85 FR 42290. The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before August 12, 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 August 12, 2020.

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Comments Received DEA received two comments on the proposed rule to control NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA in schedule I of the CSA. However, neither comment was relevant to this specific rule. One commenter discussed an electronic database for use in pain clinics, while the second commenter focused on deaths resulting from COVID-19.
Therefore, DEA has no responses to these comments.
As indicated above, this final rule applies to five SCs that were the subject of a July 10, 2018 temporary scheduling order and the July 13, 2020 NPRM.
These five substances will now be listed in 21 CFR 1308.11d, as specified below.

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Scheduling Conclusion After considering the scientific and medical evaluations and accompanying recommendation of HHS, and conducting an independent eight-factor analysis, DEA finds substantial evidence of abuse potential for NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYLP7AICA. DEA is therefore permanently scheduling NM2201, 5F-AB-PINACA, 4CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA as controlled substances under the CSA.
Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary and review of all other available data, the Acting Administrator of DEA, pursuant to 21 U.S.C. 811a and 21 U.S.C. 812b1, finds that:
1 NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol D9-THC
and JWH-018;
2 NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA currently have no accepted medical use in treatment in the United States 2; and 3 There is a lack of accepted safety for use of NM2201, 5F-AB-PINACA, 4CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA
under medical supervision.
Based on these findings, the Acting Administrator concludes that naphthalen-1-yl 1-5-fluoropentyl-1Hindole-3-carboxylate other names:
NM2201; CBL2201, N-1-amino-3methyl-1-oxobutan-2-yl-1-52 Although there is no evidence suggesting that NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, or 5F-CUMYLP7AICA have currently accepted medical uses in treatment in the United States, it bears noting that a drug cannot be found to have such medical use unless DEA concludes that it satisfies a five-part test. Specifically, with respect to a drug that has not been approved by FDA, to have a currently accepted medical use in treatment in the United States, all of the following must be demonstrated:
i. the drugs chemistry must be known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available. 57 FR
10499 1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135
D.C. Cir. 1994.

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fluoropentyl-1H-indazole-3carboxamide other name: 5F-ABPINACA, 1-4-cyanobutyl-N-2phenylpropan-2-yl-1H-indazole-3carboxamide other names: 4-CNCUMYL-BUTINACA; 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA;
CUMYL-4CN-BINACA, SGT-78, methyl 2-1-cyclohexylmethyl-1H-indole-3carboxamido-3-methylbutanoate other names: MMB-CHMICA, AMB-CHMICA, and 1-5-fluoropentyl-N-2phenylpropan-2-yl-1H-pyrrolo2,3bpyridine-3-carboxamide other name:
5F-CUMYL-P7AICA, including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, warrant control in schedule I of the CSA. 21 U.S.C. 812b1.
Requirements for Handling NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA
NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA will continue 3
to be subject to the CSAs schedule I
regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:
1. Registration. Any person who handles, or desires to handle, NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, or 5FCUMYL-P7AICA must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR
parts 1301 and 1312.
2. Security. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA are subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71
1301.76. Non-practitioners handling these five substances must also comply with the employee screening requirements of 21 CFR 1301.90
1301.93.
3. Labeling and Packaging. All labels and labeling for commercial containers of NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA must be in compliance with 21 U.S.C. 825 and 3 NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5F-CUMYLP7AICA have been subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811h, by virtue of the July 10, 2018 temporary scheduling order 83 FR 31877 and the subsequent one year extension of that order July 13, 2020, 85 FR 42296.

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