[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Rules and Regulations]
[Pages 16669-16670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06555]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-491]


Schedules of Controlled Substances: Extension of Temporary 
Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA 
and FUB-144 in Schedule I of the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary rule; temporary scheduling order; extension.

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SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this order to extend the temporary schedule I 
status of ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-
fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial 
name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-
3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
fluorobenzyl)); 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-
3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-
fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 
(trivial name: FUB-144), and their optical, positional, and geometric 
isomers, salts, and salts of isomers. The schedule I status of 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 currently 
is in effect until April 16, 2021. This temporary order will extend the 
temporary scheduling of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA 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 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.

SUPPLEMENTARY INFORMATION:

Background and Legal Authority

    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-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial 
name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial 
names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-fluorobenzyl)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide 
(trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: 
FUB-144) in schedule I of the Controlled Substances Act (CSA) pursuant 
to the temporary scheduling provisions of 21 U.S.C. 811(h). 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 (h)(1). Subsection (h)(2) 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. 811(a)(1) 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. 811(a) 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\ 
or on the petition of any interested party.
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    \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. 811(h), 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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    The Acting Administrator of DEA, on his own motion, has initiated 
proceedings under 21 U.S.C. 811(a)(1) to permanently schedule 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. DEA is 
simultaneously publishing a notice of proposed rulemaking for the 
placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA 
and FUB-144 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. 811(h)(2), the Acting Administrator orders 
that the temporary scheduling of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA 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. 811(h). 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. 
811(a)(1) to permanently schedule the substance, extend the temporary 
scheduling for up to one year.
    To the extent that subsection 811(h) 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. 811(a), 
it is

[[Page 16670]]

noteworthy that, in subsection 811(h), Congress authorized the issuance 
of temporary scheduling actions by order rather than by rule. In the 
alternative, even if this action were subject to 5 U.S.C. 553, the 
Acting Administrator finds that there is good cause to forgo the notice 
and comment and the delayed effective date requirements of such 
section, as any further delays in the process for extending the 
temporary scheduling order would be impracticable and contrary to the 
public interest in view of the manifest urgency to avoid an imminent 
hazard to the public safety that these substances would present if 
scheduling expired, for the reasons expressed in the temporary 
scheduling order (84 FR 15505, April 16, 2019). Further, DEA believes 
that this order extending the temporary scheduling action is not a 
``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act. The 
requirements for the preparation of an initial regulatory flexibility 
analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is 
not required by 5 U.S.C. 553 or any other law to publish a general 
notice of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order (E.O.) 12866 (Regulatory Planning and 
Review) section 3(f), and the principles reaffirmed in E.O. 13563 
(Improving Regulation and Regulatory Review), and, accordingly, this 
action has not been reviewed by the Office of Management and Budget.
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with E.O. 13132 
(Federalism), it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. 5 U.S.C. 801, 804(3). It is in the public interest to 
maintain the temporary placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 in schedule I because they pose a 
public health risk, for the reasons expressed in the temporary 
scheduling order (84 FR 15505, April 16, 2019). The temporary 
scheduling action was taken pursuant to 21 U.S.C. 811(h), which is 
specifically designed to enable DEA to act in an expeditious manner to 
avoid an imminent hazard to the public safety. Under subsection 811(h), 
temporary scheduling orders are not subject to notice and comment 
rulemaking procedures. DEA understands that the CSA frames temporary 
scheduling actions as orders rather than rules to ensure that the 
process moves swiftly, and this extension of the temporary scheduling 
order continues to serve that purpose. For the same reasons that 
underlie subsection 811(h), that is, the need to place these substances 
in schedule I because they pose an imminent hazard to public safety, it 
would be contrary to the public interest to delay implementation of 
this extension of the temporary scheduling order.
    Therefore, in accordance with 5 U.S.C. 808(2), this order extending 
the temporary scheduling order shall take effect immediately upon its 
publication. DEA will submit a copy of this order to both Houses of 
Congress and to the Comptroller General, although such filing is not 
required under the CRA, 5 U.S.C. 801-808, because, as noted above, this 
action is an order, not a rule.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-06555 Filed 3-30-21; 8:45 am]
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