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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Rules and Regulations]
[Pages 106311-106315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31130]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-1457]

Schedules of Controlled Substances: Extension of Temporary 
Placement of Seven Specific Fentanyl-Related Substances 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 temporary scheduling order to extend the temporary 
schedule I status of seven specific fentanyl-related substances, as 
identified in this order, including their isomers, esters, ethers, 
salts, and salts of isomers, esters and ethers. These seven substances 
fall within the definition of fentanyl-related substances set forth in 
the February 6, 2018, temporary scheduling order. Through the Temporary 
Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues 
Act, which became law on February 6, 2020, Congress extended the 
temporary control of fentanyl-related substances until May 6, 2021. 
This temporary order was subsequently extended multiple times, most 
recently on December 29, 2022, through the Consolidated Appropriations 
Act, 2023, which extended the order until December 31, 2024. This 
temporary order will extend

[[Page 106312]]

the temporary scheduling of seven specific fentanyl-related substances 
for one year, or until the permanent scheduling action for these 
substances is completed, whichever occurs first.

DATES: This temporary scheduling order, which extends schedule I 
control of seven specific substances covered by an order (83 FR 5188, 
February 6, 2018), is effective December 31, 2024, and expires on 
December 31, 2025. 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 December 31, 2025.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: In this order, the Drug Enforcement 
Administration (DEA) extends the temporary scheduling of the following 
seven controlled substances in schedule I of the Controlled Substances 
Act (CSA), including their isomers, esters, ethers, salts, and salts of 
isomers, esters, and ethers whenever the existence of such isomers, 
esters, ethers, and salts is possible within the specific chemical 
designation:
     para-chlorofentanyl (N-(4-chlorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
     ortho-chlorofentanyl (N-(2-chlorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
     meta-fluorofuranyl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
     ortho-methylcyclopropyl fentanyl (N-(2-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)cyclopropanecarboxamide),
     beta-methylacetyl fentanyl (N-phenyl-N-(1-(2-
phenylpropyl)piperidin-4-yl)acetamide),
     tetrahydrothiofuranyl fentanyl (N-(1-phenethylpiperidin-4-
yl)-N-phenyltetrahydrothiophene-2-carboxamide),
     para-fluoro valeryl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)pentanamide).

Background and Legal Authority

    On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published 
an order in the Federal Register temporarily placing fentanyl-related 
substances, as defined in that order, in schedule I of the CSA based 
upon a finding that these substances pose an imminent hazard to the 
public safety.\1\ As discussed below, the seven substances named in 
this rule meet the existing definition of fentanyl-related substances 
as they are not otherwise controlled in any other schedule (i.e., not 
included under another DEA Controlled Substance Code Number) and are 
structurally related to fentanyl by one or more of the five 
modifications listed under the definition. Additionally, as required by 
21 U.S.C. 811(h)(2), these specific seven substances have no exemption 
or approval in effect under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355). That temporary order was effective upon 
the date of publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary 
control of fentanyl-related substances, a class of substances as 
defined in the order, as well as the seven specific substances already 
covered by that order, was set to expire on February 6, 2020. However, 
on February 6, 2020, as explained in DEA's April 10, 2020 correcting 
amendment,\2\ Congress extended that expiration date until May 6, 2021, 
by enacting the Temporary Reauthorization and Study of the Emergency 
Scheduling of Fentanyl Analogues Act.\3\ This temporary order was 
subsequently extended multiple times, most recently on December 29, 
2022, through the Consolidated Appropriations Act, 2023,\4\ which 
extended the order until December 31, 2024. Consequently, the temporary 
control of these seven substances will remain in effect until December 
31, 2024, unless DEA permanently places them in schedule I prior to 
that date.
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    \1\ Schedules of Controlled Substances: Temporary Placement of 
Fentanyl-Related Substances in Schedule I, 83 FR 5188 (Feb. 6, 
2018).
    \2\ Schedules of Controlled Substances: Temporary Placement of 
Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155 
(Apr. 10, 2020).
    \3\ Public Law 116-114, sec. 2, 134 Stat. 103.
    \4\ Public Law 117-328, division O, title VI, sec. 601.
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    As defined in the February 6, 2018 temporary scheduling order, 
fentanyl-related substances include any substance not otherwise 
controlled in any schedule (i.e., not included under any other 
Administration Controlled Substance Code Number) that is structurally 
related to fentanyl by one or more of the following modifications:
    (A) Replacement of the phenyl portion of the phenethyl group by any 
monocycle, whether or not further substituted in or on the monocycle;
    (B) substitution in or on the phenethyl group with alkyl, alkenyl, 
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
    (C) substitution in or on the piperidine ring with alkyl, alkenyl, 
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro 
groups;
    (D) replacement of the aniline ring with any aromatic monocycle 
whether or not further substituted in or on the aromatic monocycle; 
and/or
    (E) replacement of the N-propionyl group by another acyl group.
    Further, according to the temporary scheduling order, the existence 
of a substance with any one, or any combination, of the above-mentioned 
modifications would meet the structural requirements of the definition 
of fentanyl-related substance. The present seven substances were not 
otherwise controlled under any schedule at the time of the temporary 
order and are covered by the order due to having the following 
modifications:
    1. para-chlorofentanyl: substitution on the aniline ring (meets 
definition for modification D);
    2. ortho-chlorofentanyl: substitution on the aniline ring (meets 
definition for modification D);
    3. meta-fluorofuranyl fentanyl: substitution on the aniline ring 
and replacement of the N-propionyl group with another acyl group (meets 
definition for modifications D and E);
    4. ortho-methylcyclopropyl fentanyl: substitution on the aniline 
ring and replacement of the N-propionyl group with another acyl group 
(meets definition for modifications D and E);
    5. beta-methylacetyl fentanyl: substitution on the phenethyl group 
with an alkyl group and replacement of the N-propionyl group with 
another acyl group (meets definition for modifications B and E);
    6. tetrahydrothiofuranyl fentanyl: replacement of the N-propionyl 
group with another acyl group (meets definition for modification E);
    7. para-fluoro valeryl fentanyl: substitution on the aniline ring 
and replacement of the N-propionyl group with another acyl group (meets 
definition for modifications D and E).
    As noted above, these specific seven substances have no exemption 
or approval in effect under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355). As explained above, the temporary control 
of these seven substances will remain in effect until December 31, 
2024, unless DEA permanently places them in schedule I prior to that 
date. However, the CSA also provides that during the pendency of 
proceedings to permanently schedule a substance under 21 U.S.C. 
811(a)(1), such temporary scheduling may be

[[Page 106313]]

extended for up to one year.\5\ Proceedings 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,\6\ or on the petition of any 
interested party.\7\
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    \5\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this document adheres to 
the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
    \6\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this 
temporary order, all subsequent references to ``Secretary'' have 
been replaced with ``Assistant Secretary.''
    \7\ 21 U.S.C. 811(a).
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    The Administrator of DEA, on her own motion pursuant to 21 U.S.C. 
811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule these seven fentanyl-related substances: para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl, 
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl, 
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl. 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 April 3, 
2023, DEA submitted a request to HHS to provide DEA with a scientific 
and medical evaluation of available information and a scheduling 
recommendation for these seven fentanyl-related substances (para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl, 
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl, 
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl) in 
accordance with 21 U.S.C. 811(b) and (c).
    Upon evaluating the scientific and medical evidence, on October 25, 
2024, HHS provided DEA with a scientific and medical evaluation and 
scheduling recommendation to place these seven fentanyl-related 
substances in schedule I of the CSA.
    Upon receipt of the scientific and medical evaluation and 
scheduling recommendation from HHS, DEA reviewed the documents, and all 
other relevant data, and conducted its own eight-factor analysis of the 
abuse potential of these seven fentanyl-related substances in 
accordance with 21 U.S.C. 811(c). Based on this review, as discussed 
elsewhere in this issue of the Federal Register, DEA is publishing a 
notice of proposed rulemaking for the placement of these seven 
fentanyl-related substances in schedule I of the CSA. If the proposed 
rule is finalized, DEA will publish a final rule in the Federal 
Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Administrator orders that the 
temporary scheduling of seven substances, covered by the February 6, 
2018 temporary scheduling order, be extended for one year, or until the 
permanent scheduling proceeding is completed, whichever occurs first. 
These seven substances are: para-chlorofentanyl, ortho-chlorofentanyl, 
meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro 
valeryl fentanyl, including their isomers, esters, ethers, salts and 
salts of isomers, esters, and ethers.
    In accordance with this temporary scheduling order, the schedule I 
requirements for handling para-chlorofentanyl, ortho-chlorofentanyl, 
meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro 
valeryl fentanyl, including their isomers, esters, ethers, salts and 
salts of isomers, esters, ethers, will remain in effect 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.\8\ This provision of the CSA allows the Attorney General, by 
order, to schedule a substance in schedule I on a temporary basis.\9\ 
It 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.
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    \8\ 21 U.S.C. 811(h).
    \9\ Id.
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    To the extent that 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, 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 action.\10\ The APA expressly differentiates between orders 
and rules, as it defines an ``order'' to mean a ``final disposition, 
whether affirmative, negative, injunctive, or declaratory in form, of 
an agency in a matter other than rule making .'' \11\ This contrasts 
with permanent scheduling actions, which are subject to formal 
rulemaking procedures done ``on the record after opportunity for a 
hearing,'' and final decisions that conclude the scheduling process and 
are subject to judicial review.\12\ 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,\13\ it is noteworthy 
that, in subsection 811(h), Congress authorized the issuance of 
temporary scheduling actions by order rather than by rule.
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    \10\ Even if this action were 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.
    \11\ 5 U.S.C. 551(6) (emphasis added).
    \12\ 21 U.S.C. 811(a) and 877.
    \13\ See 21 U.S.C. 811(a).
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    In the alternative, even if this action were subject to 5 U.S.C. 
553, the Administrator finds that there is good cause to forgo the 
notice-and-comment requirements and the delayed effective date 
requirements of such section, 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.\14\
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    \14\ See Schedules of Controlled Substances: Temporary Placement 
of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, 
Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in 
Schedule I, 87 FR 21556 (Apr. 12, 2022).
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    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

[[Page 106314]]

rulemaking. Therefore, in this instance, since DEA believes this 
temporary scheduling action is not a ``rule,'' it is not subject to the 
requirements of the RFA when issuing this temporary action.
    Additionally, in accordance with the principles of Executive Orders 
(E.O.) 12866, 13563, and 14094, this action is not a significant 
regulatory action. E.O. 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health, and safety 
effects; distributive impacts; and equity). E.O. 13563 is supplemental 
to and reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f), 
as amended by E.O. 14094, sec. 1(b), provides the definition of a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget. Because this is not a rulemaking action, this is 
not a significant regulatory action as defined in section 3(f) of E.O. 
12866.
    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.'' \15\
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    \15\ 5 U.S.C. 808(2).
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    It is in the public interest to maintain the temporary placement of 
these seven substances in schedule I because they pose a public health 
risk. These substances are: para-chlorofentanyl, ortho-chlorofentanyl, 
meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro 
valeryl fentanyl. 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. 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 for these seven substances continues to serve that 
purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is, 
the need to keep these seven 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 for seven 
specific substances, currently covered under the definition of 
fentanyl-related substances in the temporary order, shall take effect 
immediately upon its publication.
    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 Small Business Regulatory Enforcement Fairness Act 
of 1996 (Congressional Review Act), 5 U.S.C. 801-808, because, as noted 
above, this action is an order, not a rule.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
December 19, 2024, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add paragraphs (h)(70) through (76) to read as 
follows:

Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(70) N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)acetamide, its    9868
 isomers, esters, ethers, salts and salts of isomers, esters and
 ethers; other name: beta-methylacetyl fentanyl.................
(71) N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-       9871
 carboxamide, its isomers, esters, ethers, salts and salts of
 isomers, esters and ethers; other name: meta-Fluorofuranyl
 fentanyl)......................................................
(72) N-(2-chlorophenyl)-N-(1-phenethylpiperidin-4-                  9828
 yl)propionamide, its isomers, esters, ethers, salts and salts
 of isomers, esters and ethers; other name: ortho-
 Chlorofentanyl)................................................
(73) N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-                  9849
 yl)cyclopropanecarboxamide, its isomers, esters, ethers, salts
 and salts of isomers, esters and ethers; other name: ortho-
 methylcyclopropylfentanyl).....................................
(74) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-                  9818
 yl)propionamide, its isomers, esters, ethers, salts and salts
 of isomers, esters and ethers; other name: para-Chlorofentanyl)
(75) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-                  9870
 yl)pentanamide, its isomers, esters, ethers, salts and salts of
 isomers, esters and ethers; other name: para-fluoro valeryl
 fentanyl.......................................................
(76) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrothiophene-2-   9869
 carboxamide, its isomers, esters, ethers, salts and salts of
 isomers, esters and ethers; other names: tetrahydrothiofuranyl
 fentanyl; tetrahydrothiophene fentanyl.........................
 

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[FR Doc. 2024-31130 Filed 12-27-24; 8:45 am]
BILLING CODE 4410-09-P
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