Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in Schedule I, 30775-30778 [2021-11974]

Download as PDF Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations * * * * • 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, or SGT-78), • methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3methylbutanoate (other names: MMBCHMICA or AMB-CHMICA), and • 1-(5-fluoropentyl)-N-(2phenylpropan-2-yl)-1H-pyrrolo[2,3b]pyridine-3-carboxamide (other name: 5F-CUMYL-P7AICA). * D. Christopher Evans, Acting Administrator. [FR Doc. 2021–11981 Filed 6–9–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–479] Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA in Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: By this rule, the Drug Enforcement Administration permanently places five synthetic cannabinoids, as identified in this final rule, in schedule I of the Controlled Substances Act. These five substances are currently listed in Schedule I pursuant to a temporary scheduling order. As a result of this rule, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these five specified controlled substances will continue to apply. DATES: Effective June 10, 2021. FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362– 3249. SUMMARY: In this final rule, the Drug Enforcement Administration (DEA) is permanently scheduling the following five controlled substances in schedule I of the Controlled Substances Act (CSA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible: • naphthalen-1-yl 1-(5-fluoropentyl)1H-indole-3-carboxylate (other names: NM2201 or CBL2201), • N-(1-amino-3-methyl-1-oxobutan-2yl)-1-(5-fluoropentyl)-1H-indazole-3carboxamide (other name: 5F–ABPINACA), khammond on DSKJM1Z7X2PROD with RULES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 15:59 Jun 09, 2021 Jkt 253001 Legal Authority The CSA provides that issuing, amending, or repealing of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (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. 811(a). The Attorney General initiated this action on his own motion, as delegated to the Administrator of DEA, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of HHS (Assistant Secretary) and an evaluation of all relevant data by DEA. 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 proposes to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYLP7AICA will continue to apply as a result of this action. Background On July 10, 2018, DEA published an order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place naphthalen-1-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (other names: NM2201 or CBL2201); N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide (other name: 5F-ABPINACA); 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H-indazole-3carboxamide (other names: 4-CN1 As set forth 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 Secretary’s 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. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 30775 CUMYL-BUTINACA, 4-cyano-CUMYLBUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-BINACA or SGT-78); methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3methylbutanoate (other names: MMBCHMICA or AMB-CHMICA) and 1-(5fluoropentyl)-N-(2-phenylpropan-2-yl)1H-pyrrolo[2,3-b]pyridine-3carboxamide (other name: 5F-CUMYLP7AICA) in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 83 FR 31877. That temporary scheduling order took effect on the date of publication, and was based on findings by the former Acting Administrator of DEA that the temporary scheduling of these five synthetic cannabinoids (SCs) was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). On July 13, 2020, DEA published an order to extend the temporary scheduling of the five SCs by one year, until July 10, 2021. 85 FR 42296. Also, on that same date and in the same issue of the Federal Register, DEA published a notice of proposed rulemaking (NPRM) to permanently control the five SCs in schedule I of the CSA. 85 FR 42290. Specifically, DEA proposed to add these five SCs to the hallucinogenic substances list under 21 CFR 1308.11(d). DEA and HHS Eight Factor Analyses On May 29, 2020, HHS provided DEA with a scientific and medical evaluation and scheduling recommendation, prepared by the Food and Drug Administration (FDA), entitled ‘‘Basis for the Recommendation to Place Naphthalen-1-yl 1-(5-fluoropentyl)-lHindole-3-carboxylate [NM2201; CBL2201], N-(1-amino-3-methyl-1oxobutan-2-yl)-1-(5-fluoropentyl)-lHindazole-3-carboxamide [5F-ABPINACA], 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)lH-indazole-3carboxamide (4-CN-CUMYLBUTINACA; 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78], methyl 2-(1-(cyclohexylmethyl)-lH-indole-3carboxamido)-3-methylbutanoate [MMB-CHMICA; AMB-CHMICA], and 1(5-fluoropentyl)-N-(2-phenylpropan-2yl)-1H-pyrrolo[2,3-b]pyridine-3carboxamide [5F-CUMYL-P7AICA; CUMYL-5F-P7AICA; SGT-263] and Their Salts in Schedule I of the Controlled Substances Act.’’ After considering the eight factors in 21 U.S.C. 811(c), each substance’s 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. E:\FR\FM\10JNR1.SGM 10JNR1 30776 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations 812(b), 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 Secretary’s 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 https:// 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. khammond on DSKJM1Z7X2PROD with RULES 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 1308.11(d), as specified below. VerDate Sep<11>2014 15:59 Jun 09, 2021 Jkt 253001 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. 812(b). 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. 811(a) and 21 U.S.C. 812(b)(1), 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 drug’s 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). PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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-pyrrolo[2,3b]pyridine-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. 812(b)(1). 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 CSA’s 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. 811(h), 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). E:\FR\FM\10JNR1.SGM 10JNR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations 958(e), and be in accordance with 21 CFR part 1302. 4. Quota. Only registered manufacturers are permitted to manufacture NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMBCHMICA, or 5F-CUMYL-P7AICA in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303. 5. Inventory. Every DEA registrant who possesses any quantity of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA was required to keep an inventory of all stocks of these substances on hand as of July 10, 2018, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). 6. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and/or 5FCUMYL-P7AICA, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317. Manufacturers and distributors must submit reports regarding NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and/or 5FCUMYL-P7AICA to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312. 7. Order Forms. Every DEA registrant who distributes NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305. 8. Importation and Exportation. All importation and exportation of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, or 5FCUMYL-P7AICA must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. 9. Liability. Any activity involving NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. VerDate Sep<11>2014 15:59 Jun 09, 2021 Jkt 253001 Regulatory Analyses Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) In accordance with 21 U.S.C. 811(a), this final scheduling action is subject to formal rulemaking procedures performed ‘‘on the record after opportunity for a hearing,’’ which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563. Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Regulatory Flexibility Act The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601–602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On July 10, 2018, DEA published an order to temporarily place these five substances in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 30777 DEA estimates that all entities handling or planning to handle these substances have already established and implemented the systems and processes required to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA as schedule I controlled substances. There are currently 28 registrations authorized to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and/or 5F-CUMYLP7AICA specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. DEA estimates these 28 registrations encompass 22 entities. Some of these entities are likely to be large entities. However, DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities. Therefore, DEA conservatively estimates as many as 22 small entities are affected by this rule. A review of the 28 registrations indicates that all entities that currently handle NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA. Therefore, DEA anticipates that this rule will impose minimal or no economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in any Federal mandate that may result ‘‘in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.’’ Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. Congressional Review Act This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to the Government Accountability Office, the House, and the Senate under the CRA. E:\FR\FM\10JNR1.SGM 10JNR1 30778 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations Paperwork Reduction Act of 1995 This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501–3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Determination To Make Rule Effective Immediately As indicated above, this rule finalizes the schedule I control status of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA that has already been in effect for over two and a half years 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). The July 2018 order was effective on the date of publication, and was based on findings by the then-Acting Administrator that the temporary scheduling of these substances was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Because this rule finalizes the control status of NM2201, 5F-AB-PINACA, 4CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA that has already been in effect for over two and a half years, it does not alter the legal obligations of any person who handles these substances. Rather, it merely makes permanent the current scheduling status and corresponding legal obligations. Therefore, DEA is making the rule effective on the date of publication in the Federal Register, as any delay in the effective date is unnecessary and would be contrary to the public interest. See 5 U.S.C. 553(d). List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is amended as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1308 continues to read as follows: ■ Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. 2. In § 1308.11, a. Add paragraphs (d)(81) through (d)(85); and ■ b. Remove and reserve paragraphs (h)(31) through (35); The additions read as follows: ■ ■ § 1308.11 * Schedule I. * * (d) * * * * * (81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (Other names: NM2201; CBL2201) .................................................... (82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (Other name: 5F-AB-PINACA) ................. (83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (Other names: 4-CN-CUMYL-BUTINACA; 4-cyanoCUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78) ................................................................................... (84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate (Other names: MMB-CHMICA; AMB-CHMICA) (85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (Other name: 5F-CUMYL-P7AICA) .......... * * * * * D. Christopher Evans, Acting Administrator. [FR Doc. 2021–11974 Filed 6–9–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF STATE 22 CFR Part 120 [Public Notice: 11443] International Traffic in Arms Regulations: Notification of Temporary Suspensions, Modifications, and Exceptions to Regulations Department of State. Extension of temporary suspensions, modifications, and exceptions. AGENCY: ACTION: The Department of State is issuing this document to inform the public of a third extension to temporary suspensions, modifications, and exceptions to certain provisions of the International Traffic in Arms Regulations (ITAR) to provide for continued telework operations during the current SARS–COV2 public health emergency. This action is taken in order to ensure continuity of operations khammond on DSKJM1Z7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 15:59 Jun 09, 2021 Jkt 253001 among members of the regulated community. DATES: This document is issued June 10, 2021. FOR FURTHER INFORMATION CONTACT: Ms. Engda Wubneh, Office of Defense Trade Controls Policy, U.S. Department of State, telephone (202) 663–1809, or email ddtccustomerservice@state.gov. ATTN: Extension of Suspension, Modification, and Exception— Telework. SUPPLEMENTARY INFORMATION: In March 2020 a national emergency was declared as a result of the COVID–19 pandemic. On May 1, 2020, the Department of State (the Department) published in the Federal Register a notification of certain temporary suspensions, modifications, and exceptions to the ITAR, that were necessary to ensure continuity of operations within the Directorate of Defense Trade Controls (DDTC) and among entities registered with DDTC pursuant to part 122 of the ITAR (85 FR 25287). These actions were taken pursuant to ITAR § 126.2, which allows for the temporary suspension or modification of provisions of the ITAR, and ITAR § 126.3, which allows for exceptions to provisions of the ITAR. These actions were taken in the interest of the security and foreign policy of the United States and were warranted due PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 7221 7025 7089 7044 7085 to the exceptional and undue hardships and risks to safety caused by the public health emergency related to the SARS– COV2 pandemic. Subsequently, on June 10, 2020 (85 FR 35376), the Department published in the Federal Register a request for comment from the regulated community regarding the efficacy and termination dates of the temporary suspensions, modifications, and exceptions provided in 85 FR 25287, and requesting comment as to whether additional measures should be considered in response to the public health crisis. Of the four temporary suspensions, modifications, and exceptions to the ITAR announced in the May 1 notification referenced above, DDTC reviewed the public comments and decided to extend two measures until December 31, 2020: (1) ITAR § 120.39(a)(2) allowance for remote work; and (2) authorization to allow remote work under technical assistance agreement, manufacturing agreement, or exemption. Based upon continued public health recommendations and as informed by responses to the request for public comment in June 2020, it is apparent to DDTC that regulated entities will continue to engage in telework for the foreseeable future. Many commenters, E:\FR\FM\10JNR1.SGM 10JNR1

Agencies

[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Rules and Regulations]
[Pages 30775-30778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11974]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-479]


Schedules of Controlled Substances: Placement of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: By this rule, the Drug Enforcement Administration permanently 
places five synthetic cannabinoids, as identified in this final rule, 
in schedule I of the Controlled Substances Act. These five substances 
are currently listed in Schedule I pursuant to a temporary scheduling 
order. As a result of this rule, the regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule I 
controlled substances on persons who handle (manufacture, distribute, 
import, export, engage in research, conduct instructional activities or 
chemical analysis, or possess), or propose to handle these five 
specified controlled substances will continue to apply.

DATES: Effective June 10, 2021.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: In this final rule, the Drug Enforcement 
Administration (DEA) is permanently scheduling the following five 
controlled substances in schedule I of the Controlled Substances Act 
(CSA), including their salts, isomers, and salts of isomers whenever 
the existence of such salts, isomers, and salts of isomers is possible:
     naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 
(other names: NM2201 or CBL2201),
     N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-
1H-indazole-3-carboxamide (other name: 5F-AB-PINACA),
     1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide (other names: 4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL-BUTINACA; 
4-CN-CUMYL BINACA, CUMYL-4CN-BINACA, or SGT-78),
     methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
methylbutanoate (other names: MMB-CHMICA or AMB-CHMICA), and
     1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide (other name: 5F-CUMYL-P7AICA).

Legal Authority

    The CSA provides that issuing, amending, or repealing of the 
scheduling of any drug or other substance may be initiated by the 
Attorney General (1) on his own motion; (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. 811(a). The 
Attorney General initiated this action on his own motion, as delegated 
to the Administrator of DEA, and is supported by, inter alia, a 
recommendation from the Assistant Secretary for Health of HHS 
(Assistant Secretary) and an evaluation of all relevant data by DEA. 
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 proposes to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA will continue to apply as a 
result of this action.
---------------------------------------------------------------------------

    \1\ As set forth 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 Secretary's 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.
---------------------------------------------------------------------------

Background

    On July 10, 2018, DEA published an order in the Federal Register 
amending 21 CFR 1308.11(h) to temporarily place naphthalen-1-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (other names: NM2201 or CBL2201); 
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide (other name: 5F-AB-PINACA); 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide (other names: 4-CN-CUMYL-
BUTINACA, 4-cyano-CUMYL-BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-BINACA 
or SGT-78); methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
methylbutanoate (other names: MMB-CHMICA or AMB-CHMICA) and 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-
carboxamide (other name: 5F-CUMYL-P7AICA) in schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 83 
FR 31877. That temporary scheduling order took effect on the date of 
publication, and was based on findings by the former Acting 
Administrator of DEA that the temporary scheduling of these five 
synthetic cannabinoids (SCs) was necessary to avoid an imminent hazard 
to the public safety pursuant to 21 U.S.C. 811(h)(1).
    On July 13, 2020, DEA published an order to extend the temporary 
scheduling of the five SCs by one year, until July 10, 2021. 85 FR 
42296. Also, on that same date and in the same issue of the Federal 
Register, DEA published a notice of proposed rulemaking (NPRM) to 
permanently control the five SCs in schedule I of the CSA. 85 FR 42290. 
Specifically, DEA proposed to add these five SCs to the hallucinogenic 
substances list under 21 CFR 1308.11(d).

DEA and HHS Eight Factor Analyses

    On May 29, 2020, HHS provided DEA with a scientific and medical 
evaluation and scheduling recommendation, prepared by the Food and Drug 
Administration (FDA), entitled ``Basis for the Recommendation to Place 
Naphthalen-1-yl 1-(5-fluoropentyl)-lH-indole-3-carboxylate [NM2201; 
CBL2201], N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-lH-
indazole-3-carboxamide [5F-AB-PINACA], 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)lH-indazole-3-carboxamide (4-CN-CUMYL-BUTINACA; 4-
cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78], 
methyl 2-(1-(cyclohexylmethyl)-lH-indole-3-carboxamido)-3-
methylbutanoate [MMB-CHMICA; AMB-CHMICA], and 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide [5F-CUMYL-
P7AICA; CUMYL-5F-P7AICA; SGT-263] and Their Salts in Schedule I of the 
Controlled Substances Act.''
    After considering the eight factors in 21 U.S.C. 811(c), each 
substance's 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.

[[Page 30776]]

812(b), the Assistant Secretary recommended that NM2201, 5F-AB-PINACA, 
4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA be placed in 
schedule I of the CSA. In response, DEA conducted its own eight-factor 
analysis of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA.
    The NPRM stated that the DEA and HHS analyses, as well as the 
Assistant Secretary's 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 https://www.regulations.gov under ``Supporting Documents.''

NPRM To Schedule NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA

    On July 13, 2020, DEA published an NPRM entitled ``Schedules of 
Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
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.

Comments Received

    DEA received two comments on the proposed rule to control NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-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 
1308.11(d), as specified below.

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-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA. DEA is therefore permanently scheduling NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 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. 812(b). 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. 
811(a) and 21 U.S.C. 812(b)(1), finds that:
    (1) NM2201, 5F-AB-PINACA, 4-CN-CUMYL-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 
([Delta]\9\-THC) and JWH-018;
    (2) NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA currently have no accepted medical use in treatment in the 
United States \2\; and
---------------------------------------------------------------------------

    \2\ Although there is no evidence suggesting that NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA 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 
drug's chemistry must be known and reproducible; ii. there must be 
adequate safety studies; iii. there must be adequate and well-
controlled 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).
---------------------------------------------------------------------------

    (3) There is a lack of accepted safety for use of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA under 
medical supervision.
    Based on these findings, the Acting Administrator concludes that 
naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (other 
names: NM2201; CBL2201), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide (other name: 5F-AB-PINACA), 1-
(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (other 
names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; 
CUMYL-4CN-BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate (other names: MMB-CHMICA, AMB-CHMICA), 
and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-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. 812(b)(1).

Requirements for Handling NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, 
MMB-CHMICA, and 5F-CUMYL-P7AICA

    NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA will continue \3\ to be subject to the CSA's 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:
---------------------------------------------------------------------------

    \3\ NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA have been subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h), 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).
---------------------------------------------------------------------------

    1. Registration. Any person who handles, or desires to handle, 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-
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, MMB-CHMICA, 
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-CN-CUMYL-BUTINACA, MMB-CHMICA, 
and 5F-CUMYL-P7AICA must be in compliance with 21 U.S.C. 825 and

[[Page 30777]]

958(e), and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 
5F-CUMYL-P7AICA in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Every DEA registrant who possesses any quantity of 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA was required to keep an inventory of all stocks of these 
substances on hand as of July 10, 2018, pursuant to 21 U.S.C. 827 and 
958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and 
(d).
    6. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and/or 5F-CUMYL-P7AICA, pursuant to 21 U.S.C. 827 
and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317. 
Manufacturers and distributors must submit reports regarding NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and/or 5F-CUMYL-P7AICA 
to the Automation of Reports and Consolidated Order System pursuant to 
21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.
    7. Order Forms. Every DEA registrant who distributes NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA must 
continue to comply with the order form requirements, pursuant to 21 
U.S.C. 828 and in accordance with 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-
P7AICA must continue to be in compliance with 21 U.S.C. 952, 953, 957, 
and 958, and in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA not authorized by, or in 
violation of, the CSA or its implementing regulations is unlawful, and 
may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    In accordance with 21 U.S.C. 811(a), this final scheduling action 
is subject to formal rulemaking procedures performed ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget (OMB) pursuant to section 
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed 
in E.O. 13563.

Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act, 5 U.S.C. 601-602, has reviewed this final rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. On July 10, 2018, DEA 
published an order to temporarily place these five substances in 
schedule I of the CSA pursuant to the temporary scheduling provisions 
of 21 U.S.C. 811(h).
    DEA estimates that all entities handling or planning to handle 
these substances have already established and implemented the systems 
and processes required to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA as schedule I controlled 
substances. There are currently 28 registrations authorized to handle 
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and/or 5F-CUMYL-
P7AICA specifically, as well as a number of registered analytical labs 
that are authorized to handle schedule I controlled substances 
generally. DEA estimates these 28 registrations encompass 22 entities. 
Some of these entities are likely to be large entities. However, DEA 
does not have information of registrant size and the majority of DEA 
registrants are small entities or are employed by small entities. 
Therefore, DEA conservatively estimates as many as 22 small entities 
are affected by this rule.
    A review of the 28 registrations indicates that all entities that 
currently handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, 
or 5F-CUMYL-P7AICA also handle other schedule I controlled substances, 
and have established and implemented (or maintain) the systems and 
processes required to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, 
MMB-CHMICA, or 5F-CUMYL-P7AICA. Therefore, DEA anticipates that this 
rule will impose minimal or no economic impact on a substantial number 
of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year * * *.'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this final rule to the Government Accountability 
Office, the House, and the Senate under the CRA.

[[Page 30778]]

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
would not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

Determination To Make Rule Effective Immediately

    As indicated above, this rule finalizes the schedule I control 
status of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA that has already been in effect for over two and a half 
years 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). The July 2018 order was effective on the date of 
publication, and was based on findings by the then-Acting Administrator 
that the temporary scheduling of these substances was necessary to 
avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 
811(h)(1).
    Because this rule finalizes the control status of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA that has 
already been in effect for over two and a half years, it does not alter 
the legal obligations of any person who handles these substances. 
Rather, it merely makes permanent the current scheduling status and 
corresponding legal obligations. Therefore, DEA is making the rule 
effective on the date of publication in the Federal Register, as any 
delay in the effective date is unnecessary and would be contrary to the 
public interest. See 5 U.S.C. 553(d).

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. In Sec.  1308.11,
0
a. Add paragraphs (d)(81) through (d)(85); and
0
b. Remove and reserve paragraphs (h)(31) through (35);
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate     7221
 (Other names: NM2201; CBL2201)................................
(82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-    7025
 indazole-3-carboxamide (Other name: 5F-AB-PINACA).............
(83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-        7089
 carboxamide (Other names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-
 BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78)........
(84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-     7044
 methylbutanoate (Other names: MMB-CHMICA; AMB-CHMICA).........
(85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-     7085
 b]pyridine-3-carboxamide (Other name: 5F-CUMYL-P7AICA)........
 

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-11974 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P

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