Federal Register - March 31, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 60 / Wednesday, March 31, 2021 / Rules and Regulations

effective date of that rule, if the effective date is earlier than April 16, 2022.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Drug Enforcement Administration; Telephone: 571 362
3249.

D. Christopher Evans, Acting Administrator.
FR Doc. 202106596 Filed 33021; 8:45 am BILLING CODE 441009P

DEPARTMENT OF JUSTICE

SUPPLEMENTARY INFORMATION:

Drug Enforcement Administration
Background and Legal Authority
21 CFR Part 1308
Docket No. DEA491

Schedules of Controlled Substances:
Extension of Temporary Placement of 5FEDMBPINACA, 5FMDMBPICA, FUBAKB48, 5FCUMYLPINACA and FUB144 in Schedule I of the Controlled Substances Act Drug Enforcement Administration, Department of Justice.
ACTION: Temporary rule; temporary scheduling order; extension.
AGENCY:

The Acting Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of ethyl 21-5-fluoropentyl-1H-indazole-3carboxamido-3,3-dimethylbutanoate trivial name: 5FEDMBPINACA;
methyl 2-1-5-fluoropentyl-1H-indole3-carboxamido-3,3-dimethylbutanoate trivial name: 5FMDMBPICA; Nadamantan-1-yl-1-4-fluorobenzyl-1Hindazole-3-carboxamide trivial names:
FUBAKB48; FUBAPINACA; AKB48
N-4-fluorobenzyl; 1-5-fluoropentylN-2-phenylpropan-2-yl-1H-indazole-3carboxamide trivial names: 5F
CUMYLPINACA; SGT25; and 1-4fluorobenzyl-1H-indol-3-yl2,2,3,3tetramethylcyclopropylmethanone trivial name: FUB144, and their optical, positional, and geometric isomers, salts, and salts of isomers. The schedule I status of 5FEDMBPINACA, 5FMDMBPICA, FUBAKB48, 5F
CUMYLPINACA and FUB144
currently is in effect until April 16, 2021. This temporary order will extend the temporary scheduling of 5FEDMB
PINACA, 5FMDMBPICA, FUB
AKB48, 5FCUMYLPINACA and FUB
144 for one year or until the permanent scheduling action for these substances is completed, whichever occurs first.
DATES: This order, which extends the temporary scheduling order that DEA
previously issued for these substances 84 FR 15505, April 16, 2019, is effective April 16, 2021, and expires on April 16, 2022. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the
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SUMMARY:

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On April 16, 2019, the former Acting Administrator of the Drug Enforcement Administration DEA published a temporary scheduling order in the Federal Register 84 FR 15505 placing ethyl 2-1-5-fluoropentyl-1H-indazole3-carboxamido-3,3-dimethylbutanoate trivial name: 5FEDMBPINACA;
methyl 2-1-5-fluoropentyl-1H-indole3-carboxamido-3,3-dimethylbutanoate trivial name: 5FMDMBPICA; Nadamantan-1-yl-1-4-fluorobenzyl-1Hindazole-3-carboxamide trivial names:
FUBAKB48; FUBAPINACA; AKB48
N-4-fluorobenzyl; 1-5-fluoropentylN-2-phenylpropan-2-yl-1H-indazole-3carboxamide trivial names: 5F
CUMYLPINACA; SGT25; and 1-4fluorobenzyl-1H-indol-3-yl2,2,3,3tetramethylcyclopropylmethanone trivial name: FUB144 in schedule I of the Controlled Substances Act CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. That order was effective on the date of publication, and was based on findings by the former Acting Administrator of DEA that the temporary scheduling of these substances was necessary to avoid an imminent hazard to the public safety pursuant to subsection h1.
Subsection h2 requires that the temporary control of these substances expire two years from the effective date of the scheduling order, i.e., on April 16, 2021. However, this same subsection also provides that during the pendency of proceedings under 21 U.S.C. 811a1
with respect to the substance, the temporary scheduling 1 of that substance may be extended for up to one year.
Proceedings for the scheduling of a substance under 21 U.S.C. 811a may be initiated by the Attorney General delegated to the Administrator of DEA
pursuant to 28 CFR 0.100 on his own motion, at the request of the Secretary of Health and Human Services HHS,2
1 Though DEA has used the term final order with respect to temporary scheduling orders in the past, this notice adheres to the statutory language of 21 U.S.C. 811h, which refers to a temporary scheduling order. No substantive change is intended.
2 The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations.

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or on the petition of any interested party.
The Acting Administrator of DEA, on his own motion, has initiated proceedings under 21 U.S.C. 811a1 to permanently schedule 5FEDMB
PINACA, 5FMDMBPICA, FUB
AKB48, 5FCUMYLPINACA and FUB
144. DEA is simultaneously publishing a notice of proposed rulemaking for the placement of 5FEDMBPINACA, 5F
MDMBPICA, FUBAKB48, 5F
CUMYLPINACA and FUB144 in schedule I elsewhere in this issue of the Federal Register. If that proposed rule is finalized, DEA will publish a final rule in the Federal Register to make permanent the schedule I status of these substances.
Pursuant to 21 U.S.C. 811h2, the Acting Administrator orders that the temporary scheduling of 5FEDMB
PINACA, 5FMDMBPICA, FUB
AKB48, 5FCUMYLPINACA and FUB
144, and their optical, positional, and geometric isomers, salts, and salts of isomers, be extended for one year, or until the permanent scheduling proceeding is completed, whichever occurs first.
Regulatory Matters The CSA provides for an expedited temporary scheduling action where the Attorney General, as delegated to the Administrator of DEA, may, by order, place a substance in schedule I if such action is necessary to avoid an imminent hazard to the public safety. 21
U.S.C. 811h. That same subsection also provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of such temporary scheduling order, except that the Attorney General may, during the pendency of proceedings under 21 U.S.C. 811a1 to permanently schedule the substance, extend the temporary scheduling for up to one year.
To the extent that subsection 811h directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act, 5 U.S.C.
553, do not apply to this extension of the temporary scheduling action. The specific language chosen by Congress indicates an intention for DEA to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, see 21 U.S.C. 811a, it is
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Federal Register - March 31, 2021

TitoloFederal Register

PaeseStati Uniti

Data31/03/2021

Conteggio pagine399

Numero di edizioni7794

Prima edizione14/03/1936

Ultima edizione12/06/2026

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