[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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