Rule2024-07689
Schedules of Controlled Substances: Extension of Temporary Placement of Butonitazene, Flunitazene, and Metodesnitazene in Schedule I of the Controlled Substances Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 11, 2024
Effective
April 12, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of butonitazene, flunitazene, and metodesnitazene, as identified in this order. The schedule I status of these three substances currently is in effect through April 12, 2024. This temporary order will extend the temporary scheduling of these three substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Full Text
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<title>Federal Register, Volume 89 Issue 71 (Thursday, April 11, 2024)</title>
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[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Rules and Regulations]
[Pages 25517-25519]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07689]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-900E]
Schedules of Controlled Substances: Extension of Temporary
Placement of Butonitazene, Flunitazene, and Metodesnitazene 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 butonitazene, flunitazene, and metodesnitazene, as
identified in this order. The schedule I status of these three
substances currently is in effect through April 12, 2024. This
temporary order will extend the temporary scheduling of these three
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 three substances covered by an order (87 FR 21556, April 12,
2022), is effective April 12, 2024, and expires on April 12, 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 April 12, 2025.
FOR FURTHER INFORMATION CONTACT: Dr. 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
three 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:
<bullet> butonitazene (2-(2-(4-butoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)-N,N-diethylethan-1-amine),
<bullet> flunitazene (N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine),
<bullet> metodesnitazene (N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-
benzimidazol-1-yl)ethan-1-amine).
Background and Legal Authority
On April 12, 2022, pursuant to 21 U.S.C. 811(h)(1), DEA published
an order in the Federal Register (87 FR 21556) temporarily placing
butonitazene, flunitazene, metodesnitazene, and four \1\ additional
benzimidazole-opioids in schedule I of the Controlled Substances Act
(CSA) based upon a finding that these substances pose an imminent
hazard to the public safety. That temporary order was effective upon
the date of publication.
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\1\ The four additional benzimidazole-opioids were
etodesnitazene, metonitazene, N-pyrrolidino etonitazene, and
protonitazene. DEA pursued separate scheduling actions for
metonitazene, see 88 FR 56466 (Aug. 18, 2023), and for
etodesnitazene, N-pyrrolidino etonitazene, and protonitazene, to
remain as a schedule I substances under the CSA in order to meet the
United States' obligations under the United Nations Single
Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407, 520
U.N.T.S. 151 (Single Convention), as amended by the 1972 Protocol.
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Under 21 U.S.C. 811(h)(2), the temporary scheduling of a substance
expires at the end of two years from the
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date of issuance of the scheduling order, except that DEA may extend
temporary scheduling of that substance for up to one year during the
pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the
substance. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of
butonitazene, flunitazene, and metodesnitazene expires on April 12,
2024, unless extended.
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Administrator of DEA on her own motion under authority
delegated by the Attorney General pursuant to 28 CFR 0.100, at the
request of the Secretary of Health and Human Services (HHS),\2\ or on
the petition of any interested party.\3\ The Administrator, on her own
motion, has initiated proceedings under 21 U.S.C. 811(a)(1) to
permanently schedule butonitazene, flunitazene, and metodesnitazene.
DEA is publishing a notice of proposed rulemaking elsewhere in this
issue of the Federal Register for the permanent placement of
butonitazene, flunitazene, and metodesnitazene in schedule I elsewhere
in this issue of the Federal Register. If that proposed rule is
finalized, DEA will publish a final rule in the Federal Register to
make permanent the schedule I status of these substances.
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\2\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations.
\3\ 21 U.S.C. 811(a).
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Pursuant to 21 U.S.C. 811(h)(2), the Administrator orders that the
temporary scheduling of butonitazene, flunitazene, and metodesnitazene
and their isomers, esters, ethers, salts, and salts of isomers, esters,
and ethers whenever the existence of such isomers, esters, ethers, and
salts is possible, be extended for one year, or until the permanent
scheduling proceeding is completed, whichever occurs first.
Regulatory Matters
The CSA provides for expedited temporary scheduling actions where
necessary to avoid an imminent hazard to the public safety. Under 21
U.S.C. 811(h)(1), the Administrator, as delegated by the Attorney
General, may, by order, temporarily place substances in schedule I.
That same subsection also provides that the temporary scheduling of a
substance shall expire at the end of two years from the date of the
issuance of such temporary scheduling order, except that the Attorney
General may, during the pendency of proceedings under 21 U.S.C.
811(a)(1) 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, DEA believes that 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. 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.'' \4\ 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.\5\ 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,\6\ 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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\4\ 5 U.S.C. 551(6) (emphasis added).
\5\ 21 U.S.C. 811(a) and 877.
\6\ 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.\7\
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\7\ See 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, the DEA is not required by section 553 of
the APA or any other law to publish a general notice of proposed
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 E.O. 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.\8\ It is in the public interest to maintain the temporary
placement of butonitazene, flunitazene, and metodesnitazene in schedule
I because they pose a public health risk, for the reasons expressed in
the temporary scheduling order.\9\ 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. DEA
understands that the CSA frames temporary scheduling actions as orders
rather than rules to
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ensure that the process moves swiftly, and this extension of the
temporary scheduling order for these three 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 three 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 butonitazene, flunitazene, and metodesnitazene,
shall take effect immediately upon its publication.
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\8\ 5 U.S.C. 801, 804(3).
\9\ See 87 FR 21556 (Apr. 12, 2022).
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DEA will submit 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
April 5, 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-07689 Filed 4-10-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on April 11, 2024.
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