[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 [www.gpo.gov]
[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:
     butonitazene (2-(2-(4-butoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)-N,N-diethylethan-1-amine),
     flunitazene (N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine),
     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

[[Page 25518]]

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]
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