Rule2021-15113
Schedules of Controlled Substances: Extension of Temporary Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-ethylaminopentiophenone, 4′-Methyl-alpha-pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4′-Chloro-alpha-pyrrolidinovalerophenone in Schedule I of the Controlled Substances Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 16, 2021
Effective
July 18, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of six synthetic cathinones, as identified in this order. The schedule I status of these six substances currently is in effect until July 18, 2021. This temporary order extends the temporary scheduling of these six substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Full Text
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<title>Federal Register, Volume 86 Issue 134 (Friday, July 16, 2021)</title>
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[Federal Register Volume 86, Number 134 (Friday, July 16, 2021)]
[Rules and Regulations]
[Pages 37672-37674]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15113]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-495]
Schedules of Controlled Substances: Extension of Temporary
Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-
Methyl-alpha-ethylaminopentiophenone, 4'-Methyl-alpha-
pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-
alpha-pyrrolidinovalerophenone 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 Administrator of the Drug Enforcement Administration is
issuing this order to extend the temporary schedule I status of six
synthetic cathinones, as identified in this order. The schedule I
status of these six substances currently is in effect until July 18,
2021. This temporary order extends the temporary scheduling of these
six substances 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 34291, July 18,
2019), is effective July 18, 2021 and expires on July 18, 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 July 18, 2022.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this order, the Drug Enforcement
Administration (DEA) extends the temporary scheduling of the following
six controlled substances in schedule I of the Controlled Substances
Act (CSA), including their optical, positional, and geometric isomers,
salts, and salts of isomers:
<bullet> N-ethylhexedrone (other name: 2-(ethylamino)-1-
phenylhexan-1-one),
<bullet> alpha-pyrrolidinohexanophenone (other names: [alpha]-PHP,
alpha-pyrrolidinohexiophenone, 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-
one),
[[Page 37673]]
<bullet> 4-methyl-alpha-ethylaminopentiophenone (other names: 4-
MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one),
<bullet> 4'-methyl-alpha-pyrrolidinohexiophenone (other names:
MPHP, 4'-methyl-alpha-pyrrolidinohexanophenone; 1-(4-methylphenyl)-2-
(pyrrolidin-1-yl)hexan-1-one),
<bullet> alpha-pyrrolidinoheptaphenone (other names: PV8, 1-phenyl-
2-(pyrrolidin-1-yl)heptan-1-one), and
<bullet> 4'-chloro-alpha-pyrrolidinovalerophenone (other names: 4-
chloro-[alpha]-PVP, 4'-chloro-alpha-pyrrolidinopentiophenone, 1-(4-
chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one).
Background and Legal Authority
On July 18, 2019, the Acting Administrator of DEA (Acting
Administrator) published a temporary scheduling order in the Federal
Register (84 FR 34291) placing N-ethylhexedrone (other name: 2-
(ethylamino)-1-phenylhexan-1-one); alpha-pyrrolidinohexanophenone
(other names: [alpha]-PHP, alpha-pyrrolidinohexiophenone, 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one); 4-methyl-alpha-ethylaminopentiophenone
(other names: 4-MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one);
4'-methyl-alpha-pyrrolidinohexiophenone (other names: MPHP, 4'-methyl-
alpha-pyrrolidinohexanophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-
yl)hexan-1-one); alpha-pyrrolidinoheptaphenone (other names: PV8, 1-
phenyl-2-(pyrrolidin-1-yl)heptan-1-one); and 4'-chloro-alpha-
pyrrolidinovalerophenone (other names: 4-chloro-[alpha]-PVP, 4'-chloro-
alpha-pyrrolidinopentiophenone, 1-(4-chlorophenyl)-2-(pyrrolidin-1-
yl)pentan-1-one), synthetic cathinones, in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h).\1\
That order was effective on the date of publication, and was based on
findings by the Acting Administrator that the temporary scheduling of
these substances was necessary to avoid an imminent hazard to the
public safety pursuant to 21 U.S.C. 811(h)(1). Subsection (h)(2)
provides that the temporary control of these substances expires two
years from the effective date of the temporary scheduling order, i.e.,
on July 18, 2021. 21 U.S.C. 811(h)(2). 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 of
that substance can 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
(Administrator) 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 Administrator, on her own motion, has initiated proceedings
under 21 U.S.C. 811(a)(1) to permanently schedule N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. DEA is
simultaneously publishing a notice of proposed rulemaking for the
permanent placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP 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 Administrator orders that the
temporary scheduling of N-ethylhexedrone, alpha-
pyrrolidinohexanophenone, 4-methyl-alpha-ethylaminopentiophenone, 4'-
methyl-alpha-pyrrolidinohexiophenone, alpha-pyrrolidinoheptaphenone,
and 4'-chloro-alpha-pyrrolidinovalerophenone, 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
such action is necessary to avoid an imminent hazard to the public
safety. Under 21 U.S.C. 811(h), the Administrator, as delegated by the
Attorney General, may, by order, place a substance in schedule I on a
temporary basis. This same subsection provides that the temporary
scheduling of a substance shall expire at the end of two years from the
date of the issuance of the order scheduling such substance, except
that the Administrator 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 section 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
(APA), 5 U.S.C. 553, do not apply to this extension of the temporary
scheduling order. 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 noteworthy that, in
subsection 811(h), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule. In the alternative,
even assuming that this action might be subject to section 553 of the
APA, the Administrator finds that there is good cause to forgo the
notice and comment requirements of section 553, 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 34291, July 18,
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 section 553 of the APA 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). 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
[[Page 37674]]
(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) \3\ 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 N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I because they
pose a public health risk, for the reasons expressed in the temporary
scheduling order (84 FR 34291, July 18, 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 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 section 808(2) of the CRA, this order extending the temporary
scheduling order shall take effect immediately upon its publication.
DEA will submit a copy of this extension of the temporary scheduling
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.
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\3\ This is the colloquial name for Subtitle E of the Small
Business Regulatory Enforcement Fairness Act of 1996.
Anne Milgram,
Administrator.
[FR Doc. 2021-15113 Filed 7-15-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 16, 2021.
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