[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Rules and Regulations]
[Pages 42296-42297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14902]



  Federal Register / Vol. 85, No. 134 / Monday July 13, 2020 / Rules 
and Regulations  

[[Page 42296]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-479]


Schedules of Controlled Substances: Extension of Temporary 
Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 
5F-CUMYL-P7AICA 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 temporary scheduling order to extend the 
temporary schedule I status of naphthalen-1-yl 1-(5-fluoropentyl)-1H-
indole-3-carboxylate (trivial names: NM2201; CBL2201), N-(1-amino-3-
methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide 
(trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-
1H-indazole-3-carboxamide (trivial 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 
(trivial names: MMB-CHMICA, AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial 
name: 5F-CUMYL-P7AICA), including their optical, positional, and 
geometric isomers, salts, and salts of isomers. The schedule I status 
of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA currently is in effect until July 10, 2020. This temporary order 
will extend the temporary scheduling of NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA for one year or until 
the permanent scheduling action for these substances is completed, 
whichever occurs first.

DATES: This temporary scheduling order, which extends the order (83 FR 
31877, July 10, 2018), is effective July 10, 2020, and expires on July 
10, 2021. 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 July 10, 2021.

FOR FURTHER INFORMATION CONTACT: Scott Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-
8209.

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority

    On July 10, 2018, the former Acting Administrator of the Drug 
Enforcement Administration (DEA) published a temporary scheduling order 
in the Federal Register (83 FR 31877) placing naphthalen-1-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (trivial names: NM2201; CBL2201), 
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide (trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial 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 (trivial names: MMB-CHMICA, AMB-CHMICA), 
and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA) 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 (Acting Administrator) 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 
July 10, 2020. 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, on his own motion, has initiated 
proceedings under 21 U.S.C. 811(a)(1) to permanently schedule NM2201, 
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. DEA 
is simultaneously publishing a notice of proposed rulemaking for the 
placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 
5F-CUMYL-P7AICA in schedule I elsewhere in this issue of the Federal 
Register. If that proposed rule is finalized, scheduling of these 
substances will be made permanent by publication of a final rule in the 
Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders 
that the temporary scheduling of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, including 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 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 21 U.S.C. 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

[[Page 42297]]

General to follow rulemaking procedures for other kinds of scheduling 
actions, see 21 U.S.C. 811(a), it is 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 period 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 (83 FR 31877, July 
10, 2018). 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 12866 (Regulatory Planning and Review) 
section 3(f), the principles reaffirmed in Executive Order 13563 
(Improving Regulation and Regulatory Review), and, accordingly, this 
action has not been reviewed by the Office of Management and Budget 
(OMB). This order is not an Executive Order 13771 regulatory action.
    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 Executive Order 
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 NM2201, 5F-AB-PINACA, 
4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in schedule I 
because they pose a public health risk, for the reasons expressed in 
the temporary scheduling order (83 FR 31877, July 10, 2018). 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 21 
U.S.C. 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 21 U.S.C. 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 has submitted a copy of this order to both Houses of 
Congress and to the Comptroller General, although such filing is not 
required under the Congressional Review Act, 5 U.S.C. 801-808 because, 
as noted above, this action is an order, not a rule.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-14902 Filed 7-9-20; 10:00 am]
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