[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]
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