[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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