[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 [www.gpo.gov]
[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:
     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),

[[Page 37673]]

     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).

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