Schedules of Controlled Substances: Extension of Temporary Placement of Seven Specific Fentanyl-Related Substances in Schedule I of the Controlled Substances Act, 106311-106315 [2024-31130]
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(i) Violation as specified (1988),
maximum from $63,991 to $65,653.
(ii) Violation as specified (1988),
maximum from $30,715 to $31,513.
(iii) Otherwise violation (1978),
maximum from $2,103 to $2,158.
(15) 16 U.S.C. 1858(a), MagnusonStevens Fishery Conservation and
Management Act (1990), violation,
maximum from $230,464 to $236,451.
(16) 16 U.S.C. 2437(a), Antarctic
Marine Living Resources Convention
Act of 1984,5 violation, maximum from
$230,464 to $236,451.
(17) 16 U.S.C. 2465(a), Antarctic
Protection Act of 1990,6 violation,
maximum from $230,464 to $236,451.
(18) 16 U.S.C. 3373(a), Lacey Act
Amendments of 1981 (1981):
(i) 16 U.S.C. 3373(a)(1), violation,
maximum from $32,942 to $33,798.
(ii) 16 U.S.C. 3373(a)(2), violation,
maximum from $823 to $844.
(19) 16 U.S.C. 3606(b)(1), Atlantic
Salmon Convention Act of 1982,7
violation, maximum from $230,464 to
$236,451.
(20) 16 U.S.C. 3637(b), Pacific Salmon
Treaty Act of 1985,8 violation,
maximum from $230,464 to $236,451.
(21) 16 U.S.C. 4016(b)(1)(B), Fish and
Seafood Promotion Act of 1986 (1986);
violation, minimum from $1,394 to
$1,430; maximum from $13,946 to
$14,308.
(22) 16 U.S.C. 5010, North Pacific
Anadromous Stocks Act of 1992,9
violation, maximum from $230,464 to
$236,451.
(23) 16 U.S.C. 5103(b)(2), Atlantic
Coastal Fisheries Cooperative
Management Act,10 violation, maximum
from $230,464 to $236,451.
(24) 16 U.S.C. 5154(c)(1), Atlantic
Striped Bass Conservation Act,11
violation, maximum from $230,464 to
$236,451.
(25) 16 U.S.C. 5507(a), High Seas
Fishing Compliance Act of 1995 (1995),
violation, maximum from $200,174 to
$205,375,
(26) 16 U.S.C. 5606(b), Northwest
Atlantic Fisheries Convention Act of
1995,12 violation, maximum from
$230,464 to $236,451.
(27) 16 U.S.C. 6905(c), Western and
Central Pacific Fisheries Convention
Implementation Act,13 violation,
maximum from $230,464 to $236,451.
5 See
footnote 1.
footnote 1.
7 See footnote 1.
8 See footnote 1.
9 See footnote 1.
10 See footnote 1.
11 See footnote 1.
12 See footnote 1.
13 See footnote 1.
(28) 16 U.S.C. 7009(c) and (d), Pacific
Whiting Act of 2006,14 violation,
maximum from $230,464 to $236,451.
(29) 22 U.S.C. 1978(e), Fishermen’s
Protective Act of 1967 (1971):
(i) Violation, maximum from $35,574
to $36,498.
(ii) Subsequent violation, maximum
from $105,105 to $107,836.
(30) 30 U.S.C. 1462(a), Deep Seabed
Hard Mineral Resources Act (1980),
violation, maximum, from $90,702 to
$93,058.
(31) 42 U.S.C. 9152(c), Ocean Thermal
Energy Conversion Act of 1980 (1980),
violation, maximum from $90,702 to
$93,058.
(32) 16 U.S.C. 1827a, Billfish
Conservation Act of 2012,15 violation,
maximum from $230,464 to $236,451.
(33) 16 U.S.C. 7407(b), Port State
Measures Agreement Act of 2015,16
violation, maximum from $230,464 to
$236,451.
(34) 16 U.S.C. 1826g(f), High Seas
Driftnet Fishing Moratorium Protection
Act,17 violation, maximum from
$230,464 to $236,451.
(35) 16 U.S.C. 7705, Ensuring Access
to Pacific Fisheries Act,18 violation,
maximum from $230,464 to $236,451.
(36) 16 U.S.C. 7805, Ensuring Access
to Pacific Fisheries Act,19 violation,
maximum from $230,464 to $236,451.
(37) 16 U.S.C. 1857 note, James M.
Inhofe National Defense Authorization
Act for Fiscal Year 2023,20 violation,
maximum from $230,464 to $236,451.
(g) National Technical Information
Service. 42 U.S.C. 1306c(c), Bipartisan
Budget Act of 2013 (2013), violation,
minimum from $1,196 to $1,227;
maximum total penalty on any person
for any calendar year, excluding willful
or intentional violations, from $298,887
to $306,652.
(h) Office of the Under Secretary for
Economic Affairs. 15 U.S.C. 113,
Concrete Masonry Products Research,
Education, and Promotion Act of 2018
(2018), violation, maximum from $5,162
to $5,296.
§ 6.4 Effective date of adjustments for
inflation to civil monetary penalties.
The Department of Commerce’s 2025
adjustments for inflation made by § 6.3,
of the civil monetary penalties there
specified, are effective on January 15,
2025, and said civil monetary penalties,
as thus adjusted by the adjustments for
inflation made by § 6.3, apply only to
6 See
VerDate Sep<11>2014
21:04 Dec 27, 2024
14 See
footnote 1.
footnote 1.
16 See footnote 1.
17 See footnote 1.
18 See footnote 1.
19 See footnote 1.
20 See footnote 1.
15 See
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106311
those civil monetary penalties,
including those whose associated
violation predated such adjustment,
which are assessed by the Department of
Commerce after the effective date of the
new civil monetary penalty level, and
before the effective date of any future
adjustments for inflation to civil
monetary penalties thereto made
subsequent to January 15, 2025 as
provided in § 6.5.
§ 6.5 Subsequent annual adjustments for
inflation to civil monetary penalties.
The Secretary of Commerce or his or
her designee by regulation shall make
subsequent adjustments for inflation to
the Department of Commerce’s civil
monetary penalties annually, which
shall take effect not later than January
15, notwithstanding section 553 of title
5, United States Code.
[FR Doc. 2024–31310 Filed 12–27–24; 8:45 am]
BILLING CODE 3510–DP–P
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Temporary rule; temporary
scheduling order; extension.
AGENCY:
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
SUMMARY:
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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-(4chlorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide),
• ortho-chlorofentanyl (N-(2chlorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide),
• meta-fluorofuranyl fentanyl (N-(3fluorophenyl)-N-(1-phenethylpiperidin4-yl)furan-2-carboxamide),
• ortho-methylcyclopropyl fentanyl
(N-(2-methylphenyl)-N-(1phenethylpiperidin-4yl)cyclopropanecarboxamide),
• beta-methylacetyl fentanyl (Nphenyl-N-(1-(2-phenylpropyl)piperidin4-yl)acetamide),
• tetrahydrothiofuranyl fentanyl (N(1-phenethylpiperidin-4-yl)-Nphenyltetrahydrothiophene-2carboxamide),
• para-fluoro valeryl fentanyl (N-(4fluorophenyl)-N-(1-phenethylpiperidin4-yl)pentanamide).
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.
As defined in the February 6, 2018
temporary scheduling order, fentanylrelated 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;
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
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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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(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
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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
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, orthochlorofentanyl, 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 (parachlorofentanyl, ortho-chlorofentanyl,
meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl 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
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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Federal Register, DEA is publishing a
notice of proposed rulemaking for the
placement of these seven fentanylrelated 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, orthochlorofentanyl, 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 parachlorofentanyl, ortho-chlorofentanyl,
meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl 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.
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
8 21
U.S.C. 811(h).
9 Id.
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106313
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.
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
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
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).
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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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
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, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl 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
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.
2. In § 1308.11, add paragraphs (h)(70)
through (76) to read as follows:
■
§ 1308.11
*
Schedule I.
*
*
(h) * * *
*
*
(70) N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)acetamide, its 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-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-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-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-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-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-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other names: tetrahydrothiofuranyl fentanyl; tetrahydrothiophene fentanyl ...................................................
15 5
U.S.C. 808(2).
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Rules and Regulations
requested or held. Five public
comments responding to the proposed
regulations were received and are
available at https://www.regulations.gov
or upon request. After careful
consideration of all the written
comments, the proposed regulations are
adopted as amended by this Treasury
decision in response to such comments
as described in the Summary of
Comments and Explanation of
Revisions.
[FR Doc. 2024–31130 Filed 12–27–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 10020]
RIN 1545–BI22
Reissuance of State or Local Bonds
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
This document contains final
regulations that address when taxexempt bonds are treated as retired for
certain Federal income tax purposes.
The final regulations are necessary to
unify and to clarify existing guidance on
this subject. The final regulations affect
State and local governments that issue
tax-exempt bonds.
DATES:
Effective date: These regulations are
effective on December 30, 2024.
Applicability date: For dates of
applicability, see § 1.150–3(f).
FOR FURTHER INFORMATION CONTACT:
Zoran Stojanovic, (202) 317–6980 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
ddrumheller on DSK120RN23PROD with RULES1
Authority
This document contains final
regulations that amend the Income Tax
Regulations (26 CFR part 1) by adding
final regulations under section 150 and
amending the regulations under section
1001 of the Internal Revenue Code
(Code) to provide rules for determining
when tax-exempt bonds are treated as
retired for purposes of sections 103 and
141 through 150 of the Code (final
regulations).
These final regulations are
promulgated under the express
delegation of authority in section
7805(a) of the Code, which authorizes
the Secretary of the Treasury or her
delegate to ‘‘prescribe all needful rules
and regulations for the enforcement of
[the Code], including all rules and
regulations as may be necessary by
reason of any alteration of law in
relation to internal revenue.’’
Background
On December 31, 2018, a notice of
proposed rulemaking (REG–141739–08)
regarding retirement of tax-exempt
bonds was published in the Federal
Register (83 FR 67701) (proposed
regulations). No public hearing was
VerDate Sep<11>2014
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1. Overview
In general, under section 103, interest
received by the holders of certain bonds
issued by State and local governments is
exempt from Federal income tax. To
qualify for the tax exemption, a bond
issued by a State or local government
must satisfy various eligibility
requirements under sections 141
through 150 at the time of issuance of
the bond. If the issuer and holder agree
after issuance to modify the terms of a
tax-exempt bond significantly, the
original bond may be treated as having
been retired and exchanged for a newly
issued, modified bond. Similarly, if the
issuer or its agent acquires and resells
the bond, the bond may be treated as
having been extinguished upon
acquisition and replaced upon resale
with a newly issued bond.
The term ‘‘reissuance’’ commonly
refers to the effect of a transaction in
which a new bond is deemed to be
issued in place of an old bond as a
result of retirement of the old bond
pursuant to such an exchange or
extinguishment. In the case of a
reissuance, the reissued bond must be
retested for qualification under sections
103 and 141 through 150. The
reissuance of an issue of tax-exempt
bonds may result in various negative
consequences to the issuer, such as
changes in yield for purposes of the
arbitrage investment yield restrictions
under section 148(a), acceleration of
arbitrage rebate payment obligations
under section 148(f), and change-in-law
risk.
2. Tender Option Bonds
Tender option bonds and variable rate
demand bonds (collectively, tender
option bonds) have special features that
present reissuance questions.
Specifically, tender option bonds have
original terms that provide for a tender
option interest rate mode, as described
in this paragraph. Issuers of tax-exempt
bonds often preauthorize several
different interest rate modes in the bond
documents and retain an option to
switch interest rate modes under
parameters set forth in the bond
documents. During a tender option
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106315
mode, tender option bonds have shortterm interest rates that are reset
periodically at various short-term
intervals (typically, every seven days)
based on the current market rate
necessary to remarket the bonds at par.
In connection with each resetting of the
interest rate, the holder of a tender
option bond has a right or requirement
to tender the bond back to the issuer or
its agent for purchase at par. Tender
option bonds generally are structured
with these short-term features supported
by put options to enable the bonds to be
eligible for purchase by tax-exempt
money market funds pursuant to 17 CFR
270.2a–7 (Rule 2a–7 under the
Investment Company Act of 1940).
Tender option bonds also may have
interest rate mode conversion options
that permit the issuer or conduit
borrower to change the interest rate
mode on the bonds from a tender option
mode to another short-term interest rate
mode or to a fixed interest rate to
maturity. At the time of a conversion to
another interest rate mode, the holder of
a tender option bond typically has the
right or requirement to tender the bond
for purchase at par.
Tender option bonds generally have
third-party liquidity facilities from
banks or other liquidity providers to
ensure that there is sufficient cash to
repurchase the bonds upon a holder’s
tender, and they also commonly have
credit enhancement from bond insurers
or other third-party guarantors. Upon a
holder’s exercise of its tender rights in
connection with either a resetting of the
interest rate during a tender option
mode or a conversion to another interest
rate mode, a remarketing agent or a
liquidity provider typically will acquire
the bonds subject to the tender and
resell the bonds either to the same
bondholders or to others willing to
purchase such bonds.
3. Existing Guidance
To address reissuance questions
related to tax-exempt bonds, on
December 27, 1988, the Department of
the Treasury (Treasury Department) and
the IRS published Notice 88–130, 1988–
2 CB 543, which provides rules for
determining when a tax-exempt bond is
retired for purposes of sections 103 and
141 through 150. Notice 88–130
provides in part that a tax-exempt bond
is retired when there is a change to the
terms of the bond that results in a
disposition of the bond for purposes of
section 1001. In addition, Notice 88–130
provides special rules for retirement of
certain tender option bonds that meet a
definition of the term ‘‘qualified tender
bond.’’
E:\FR\FM\30DER1.SGM
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Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\8\ 21 U.S.C. 811(h).
\9\ Id.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\15\ 5 U.S.C. 808(2).
---------------------------------------------------------------------------
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.........................
[[Page 106315]]
[FR Doc. 2024-31130 Filed 12-27-24; 8:45 am]
BILLING CODE 4410-09-P