Federal Register - June 10, 2021
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Fuente: Federal Register
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-pyrrolo2,3bpyridine-3-carboxamide other name:
5F-CUMYL-P7AICA.
D. Christopher Evans, Acting Administrator.
FR Doc. 202111981 Filed 6921; 8:45 am BILLING CODE 441009P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA479
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-fluoropentyl1H-indole-3-carboxylate other names:
NM2201 or CBL2201, N-1-amino-3-methyl-1-oxobutan-2yl-1-5-fluoropentyl-1H-indazole-3carboxamide other name: 5FABPINACA,
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SUPPLEMENTARY INFORMATION:
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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. 811a.
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 1308.11h 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 Secretarys 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.
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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-yl1H-pyrrolo2,3-bpyridine-3carboxamide other name: 5F-CUMYLP7AICA in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. 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. 811h1.
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
1308.11d.
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-yllH-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 15-fluoropentyl-N-2-phenylpropan-2yl-1H-pyrrolo2,3-bpyridine-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. 811c, each substances abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21 U.S.C.
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