Schedules of Controlled Substances: Extension of Temporary Placement of Butonitazene, Flunitazene, and Metodesnitazene in Schedule I of the Controlled Substances Act, 25517-25519 [2024-07689]
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Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Rules and Regulations
Congressional Review Act
This order is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However, DEA
is submitting reports under the CRA to
both Houses of Congress and to the
Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
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
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 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:
a. Redesignate paragraphs (b)(95)
through (103) as paragraphs (b)(98)
through (106);
■ b. Redesignate paragraphs (b)(69)
through (94) as paragraphs (b)(71)
through (96);
■ c. Redesignate paragraphs (b)(40)
through (68) as paragraphs (b)(41)
through (69);
■ d. Add new paragraph (b)(40), (70),
and (97); and
■ e. Remove and reserve paragraphs
(h)(51), (55), and (56).
The addition reads as follows:
■
■
§ 1308.11
*
Schedule I.
*
*
(b) * * *
*
*
*
*
*
*
*
*
*
(40) 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine (Other names: etodesnitazene; etazene) ...........................
9765
*
*
*
*
*
*
*
(70) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole (Other names: N-pyrrolidino etonitazene;
etonitazepyne) ...............................................................................................................................................................................................
9758
*
*
*
*
*
*
*
(97) N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine (Other name: protonitazene) ..............................
9759
*
*
*
*
*
[FR Doc. 2024–07684 Filed 4–10–24; 8:45 am]
BILLING CODE 4410–09–P
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
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 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
SUMMARY:
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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.
25517
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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-(4butoxybenzyl)-5-nitro-1H-benzimidazol1-yl)-N,N-diethylethan-1-amine),
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Fmt 4700
Sfmt 4700
• flunitazene (N,N-diethyl-2-(2-(4fluorobenzyl)-5-nitro-1H-benzimidazol1-yl)ethan-1-amine),
• metodesnitazene (N,N-diethyl-2-(2(4-methoxybenzyl)-1H-benzimidazol-1yl)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.
Under 21 U.S.C. 811(h)(2), the
temporary scheduling of a substance
expires at the end of two years from the
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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11APR1
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Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Rules and Regulations
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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.
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
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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15:36 Apr 10, 2024
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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.
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
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
45
U.S.C. 551(6) (emphasis added).
U.S.C. 811(a) and 877.
6 See 21 U.S.C. 811(a).
7 See 87 FR 21556 (Apr. 12, 2022).
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
5 21
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Sfmt 4700
85
U.S.C. 801, 804(3).
87 FR 21556 (Apr. 12, 2022).
9 See
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Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Rules and Regulations
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.
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.
BILLING CODE 4410–09–P
PEACE CORPS
22 CFR Part 303
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RIN 0420–AA31
Procedures for Disclosure of
Information Under the Freedom of
Information Act
The Peace Corps.
Final rule.
AGENCY:
This final rule amends the
regulations that the Peace Corps follows
in processing requests under the
SUMMARY:
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15:36 Apr 10, 2024
Jkt 262001
FOR FURTHER INFORMATION CONTACT:
David van Hoogstraten, 202–692–2150,
policy@peacecorps.gov.
SUPPLEMENTARY INFORMATION: On June
30, 2016, President Obama signed into
law the FOIA Improvement Act of 2016,
Public Law 114–185, 130 Stat. 538 (the
Act). The Act specifically requires all
agencies to review and update their
FOIA regulations in accordance with its
provisions, and the Peace Corps is
making changes to its regulations
accordingly. Among other requirements,
the Act addresses a range of procedural
issues that affect Peace Corps FOIA
regulations, including requirements that
agencies establish a minimum of 90
days for requesters to file an
administrative appeal and that agencies
provide notice to requesters of dispute
resolution services at various times
throughout the FOIA process. The final
rule revises and updates policies and
procedures concerning the Peace Corps
FOIA process, which was last published
as a final rule in the Federal Register
(FR) on April 10, 2014 (79 FR 19816),
entered into effect on May 12, 2014, and
currently appears at 22 CFR part 303.
The final rule makes adjustments for
clarification, rearranges and
redesignates sections in a more logical
order, streamlines the language of some
procedural provisions, and makes the
following key amendments:
22 CFR Part 303
[FR Doc. 2024–07689 Filed 4–10–24; 8:45 am]
ACTION:
Freedom of Information Act (FOIA) to
comply with the FOIA Improvement Act
of 2016. These amendments clarify and
update procedures for requesting
information from the Peace Corps and
procedures that the Peace Corps follows
in responding to requests from the
public for information.
DATES: This rule is effective May 13,
2024.
Section 303.2 is expanded to revise
current definitions and add definitions
for the following terms: ‘‘Compelling
need,’’ ‘‘Confidential commercial
information,’’ ‘‘Direct costs,’’ ‘‘Unusual
circumstances,’’ and ‘‘Initial denial
authority (IDA).’’
Section 303.5 is revised to delete
reference to a physical public reading
room and to provide for a public
electronic FOIA Library on the Peace
Corps website on which certain
specified records will be made
available. Also, related to this change,
the former § 303.6 (Procedures for use of
public reading room.) is deleted.
The former § 303.8, has been
redesignated as § 303.7 and is updated
to provide revised procedures for the
following paragraphs:
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25519
• (b) through (d) Submitting a FOIA
request;
• (f) Requesting a waiver or reduction
of fees;
• (h) Initial response/delays to FOIA
requests;
• (j) Giving notice of delays; and
• (l) Requesting expedited processing
and appeals from denials of requests for
expedited processing.
A new § 303.8 sets forth guidelines
and procedures for:
• Order of response to FOIA requests;
• Multitrack processing;
• Delays in responses due to unusual
circumstances and notice of such delays
and of the availability of both the FOIA
Public Liaison and the dispute
resolution services provided for by the
Office of Government Information
Services (OGIS);
• Aggregating requests; and
• Expedited processing.
A revised § 303.9 provides that the
deliberative process privilege shall not
apply to records created 25 years or
more before the date on which the
records were requested.
A new § 303.11 sets forth guidelines
and procedures for:
• Electronic communication with
requesters;
• Acknowledgement of requests that
will take longer than 10 working days to
process;
• Estimated dates of completion and
interim responses;
• The granting of requests;
• Adverse determination of requests;
• Markings on released documents;
and
• Use of records exclusions.
A renumbered § 303.13, formerly
§ 303.12, is updated to set forth revised
guidelines and procedures for:
• Submitting appeals;
• Adjudication of appeals;
• Decisions on appeals;
• Engaging in dispute resolution
services offered by OGIS; and
• When an appeal is required.
A new § 303.14 sets forth guidelines
and procedures for:
• Designation of confidential
commercial information;
• When notice to submitters is
required;
• Exceptions to submitter notice
requirements;
• Opportunity to object to disclosure;
• Analysis of objections;
• Notice of intent to disclose;
• Notice of FOIA lawsuit; and
• Requester notification.
A new § 303.15 sets forth guidelines
and procedures for preserving records
pertaining to the requests it receives
under this subpart.
A revised § 303.16, formerly § 303.13,
incorporates the new statutory
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
[[Page 25519]]
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
