[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Rules and Regulations]
[Pages 5321-5323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01683]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-565]
Schedules of Controlled Substances: Extension of Temporary
Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl
fentanyl 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 cyclopentyl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), isobutyryl
fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-
chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-
4-yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-
N-(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide) including their isomers,
esters, ethers, salts, and salts of isomers, esters and ethers. The
schedule I status of cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl
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fentanyl currently is in effect until February 1, 2020. This temporary
order will extend the temporary scheduling of cyclopentyl fentanyl,
isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl 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
4580, February 1, 2018), is effective February 1, 2020, and expires on
February 1, 2021. If this order is made permanent, the DEA will publish
a document in the Federal Register on or before February 1, 2021.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
On February 1, 2018, the former Acting Administrator of the Drug
Enforcement Administration (DEA) published a temporary scheduling order
in the Federal Register (83 FR 4580) placing cyclopentyl fentanyl (N-
(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide),
isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-
chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide), para-
methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-
yl)butyramide), and valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylpentanamide), along with two other substances, 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 (Acting Administrator) that the temporary
scheduling of cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, valeryl
fentanyl, and the two other substances was necessary to avoid an
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).
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\1\ The order also temporarily placed ocfentanil (N-(2-
fluorophenyl)-2-methoxy-N-(phenethylpiperidin-4-yl)acetamide) and
para-fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)butyramide) in schedule I. DEA issued a
final order to permanently place ocfentanil and para-fluorobutyryl
fentanyl in schedule I on November 29, 2018 (83 FR 61320) and
October 25, 2019 (84 FR 57327), respectively, pursuant to 21 U.S.C.
811(d)(1).
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Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), provides that
the temporary control of these substances expires two years from the
effective date of the scheduling order, i.e., on February 1, 2020.
However, the CSA also provides that during the pendency of proceedings
under 21 U.S.C. 811(a)(1) for permanent scheduling of a substance, DEA
can extend the temporary scheduling \2\ of that substance for up to one
year. Proceedings for the permanent 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, or on the
petition of any interested party.
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\2\ 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, 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 cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl
fentanyl. The DEA has gathered and reviewed the available information
regarding the pharmacology, chemistry, trafficking, actual abuse,
pattern of abuse, and the relative potential for abuse for these
substances. On November 5, 2018, the DEA submitted a request to the
Department of Health and Human Services (HHS) to provide the DEA with a
scientific and medical evaluation of available information and a
scheduling recommendation for cyclopropyl fentanyl, para-fluorobutyryl
fentanyl, cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl
fentanyl in accordance with 21 U.S.C. 811(b) and (c). In a letter dated
September 6, 2019, DEA notified the HHS that it no longer needed
scientific and medical evaluations and scheduling recommendations for
cyclopropyl fentanyl and para-fluorobutyryl fentanyl. Subsequently, the
DEA permanently placed those two substances in schedule I of the CSA on
October 25, 2019, pursuant to a different scheduling authority in 21
U.S.C. 811(d)(1). See 84 FR 57323.
After evaluating the scientific and medical evidence, on November
12, 2019, the HHS submitted to the Acting Administrator its scientific
and medical evaluation and scheduling recommendation for cyclopentyl
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl.\3\ Upon receipt of the
scientific and medical evaluation and scheduling recommendation from
the HHS, in accordance with 21 U.S.C. 811(c) the DEA reviewed the
documents and all other relevant data, and conducted its own eight-
factor analysis of the abuse potential of cyclopentyl fentanyl,
isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl. DEA published a notice
of proposed rulemaking for the permanent placement of cyclopentyl
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl in schedule I elsewhere
in this issue of the Federal Register. If that proposed rule is
finalized, the DEA will publish a final rule in the Federal Register.
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\3\ Although HHS also provided information on cyclopropyl
fentanyl and para-fluorobutyryl fentanyl, those two substances will
not be discussed further in this temporary scheduling order, because
they have already been permanently controlled.
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Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders
that the temporary scheduling of cyclopentyl fentanyl, isobutyryl
fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl,
and valeryl fentanyl, including their isomers, esters, ethers, salts,
and salts of isomers, esters, and ethers, be extended for one year, or
until the permanent scheduling proceeding is completed, whichever
occurs first.
Regulatory Matters
The CSA provides for issuance of an expedited temporary scheduling
order to schedule a substance in schedule I on a temporary basis, where
such action is necessary to avoid an imminent hazard to the public
safety. (21 U.S.C. 811(h)). That section also 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 Attorney General may, during the pendency of
proceedings to permanently schedule the substance, extend the temporary
scheduling for up to one year.
Inasmuch as 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
[[Page 5323]]
that the notice and comment requirements of section 553 of the
Administrative Procedure Act (APA), 5 U.S.C. 553, which are applicable
to rulemaking, do not apply to this extension of the temporary
scheduling order. Under 21 U.S.C. 811(h), temporary scheduling orders
are not subject to notice and comment rulemaking procedures. 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. 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 a
regulatory flexibility analysis in 5 U.S.C. 603(a) and 604(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), and
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).
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, even 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 cyclopentyl
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl in schedule I because
they pose an imminent public health risk. The temporary scheduling
action was taken pursuant to 21 U.S.C. 811(h), which is specifically
designed to enable the DEA to act in an expeditious manner to avoid an
imminent hazard to the public safety. The 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. The DEA has submitted a copy of this temporary
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.
Dated: January 23, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-01683 Filed 1-29-20; 8:45 am]
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