[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Rules and Regulations]
[Pages 52915-52916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19011]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-482]


Schedules of Controlled Substances: Extension of Temporary 
Placement of N-Ethylpentylone 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 a synthetic cathinone, 1-(1,3-benzodioxol-5-yl)-2-
(ethylamino)pentan-1-one (N-ethylpentylone, ephylone), including its 
optical, positional and geometric isomers, salts, and salts of isomers. 
The schedule I status of N-ethylpentylone currently is in effect until 
August 31, 2020. This order extends the temporary scheduling of N-
ethylpentylone for one year, or until the permanent scheduling action 
for this substance is completed, whichever occurs first.

DATES: This order, which extends the temporary scheduling order that 
DEA previously issued for this substance (83 FR 44474, August 31, 
2018), is effective August 31, 2020, and expires on August 31, 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 August 31, 2021.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, 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 August 31, 2018, the former Acting Administrator of the Drug 
Enforcement Administration (DEA) published a temporary scheduling order 
in the Federal Register (83 FR 44474) placing 1-(1,3-benzodioxol-5-yl)-
2-(ethylamino)-pentan-1-one (N-ethylpentylone, ephylone), a synthetic 
cathinone, in schedule I of the Controlled Substances Act (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 former Acting Administrator of DEA that the temporary 
scheduling of this substance was necessary to avoid an imminent hazard 
to the public safety pursuant to 21 U.S.C. 811(h)(1). The CSA provides 
that the temporary control of this substance expire two years from the 
effective date of the temporary scheduling order, or on August 31, 
2020. 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) to 
permanently add the substance to a schedule, 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

[[Page 52916]]

General (delegated to the Administrator of DEA pursuant to 28 CFR 
0.100) on his own motion.
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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.
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    The Acting Administrator of DEA, on his own motion pursuant to 21 
U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule N-ethylpentylone. DEA is simultaneously 
publishing, elsewhere in this issue of the Federal Register, a notice 
of proposed rulemaking for the permanent placement of N-ethylpentylone 
in schedule I. If that proposed rule is finalized, scheduling of this 
substance 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 of DEA 
orders that the temporary scheduling of N-ethylpentylone, including its 
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 of DEA, 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 to 
permanently schedule the substance, extend the temporary scheduling for 
up to one year.
    Given 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 Acting 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 this substance would present if scheduling expired, for the 
reasons expressed in the temporary scheduling order (83 FR 44474, 
August 31, 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 (RFA). 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 12866 (Regulatory Planning and Review), 
section 3(f), and the principles reaffirmed in Executive Order 13563 
(Improving Regulation and Regulatory Review). 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. However, if this were a rule, pursuant to the CRA, ``any rule 
for which an agency for good cause finds that notice and public 
procedure thereon are impracticable, unnecessary, or contrary to the 
public interest, shall take effect at such time as the federal agency 
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the 
public interest to maintain the temporary placement of N-ethylpentylone 
in schedule I because it poses a public health risk, for the reasons 
expressed in the temporary scheduling order (83 FR 44474, August 31, 
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 
this substance in schedule I because it poses 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 has submitted 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.

    Dated: August 25, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-19011 Filed 8-26-20; 8:45 am]
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