Specific Listing for Three Currently Controlled Schedule I Substances, 86266-86268 [2023-27292]
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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations
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[FR Doc. 2023–27257 Filed 12–12–23; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–1222]
Specific Listing for Three Currently
Controlled Schedule I Substances
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
The Drug Enforcement
Administration (DEA) is establishing a
specific listing and DEA Controlled
Substances Code Number (drug code)
for three substances: N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-butyl-1Hindazole-3-carboxamide (also known as
ADB–BUTINACA); 4-methyl-1-phenyl2-(pyrrolidin-1-yl)pentan-1-one (also
known as a-PiHP or alpha-PiHP); and 2(methylamino)-1-(3methylphenyl)propan-1-one (also
known as 3–MMC or 3methylmethcathinone) in schedule I of
the Controlled Substances Act (CSA).
Although ADB–BUTINACA, a-PiHP,
and 3–MMC are not specifically listed
in schedule I of the CSA with their own
unique drug codes, they are schedule I
controlled substances in the United
States because they are positional
isomers of AB–PINACA (controlled
January 30, 2015), a-PHP (controlled
July 18, 2019), and mephedrone
(controlled as a hallucinogen July 9,
2012), respectively, each of which are
schedule I hallucinogens. Therefore,
DEA is simply amending the schedule I
hallucinogenic substances list in its
regulations to separately include ADB–
BUTINACA, a-PiHP, and 3–MMC.
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SUMMARY:
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Effective December 13, 2023.
Dr.
Terrence L. Boos, Drug and Chemical
Evaluation, Diversion Control Division,
Drug Enforcement Administration;
Telephone: (571) 362–3249.
SUPPLEMENTARY INFORMATION:
DATES:
FOR FURTHER INFORMATION CONTACT:
ADB–BUTINACA Control
ADB–BUTINACA (also known as N(1-amino-3,3-dimethyl-1-oxobutan-2-yl)1-butyl-1H-indazole-3-carboxamide) is a
chemical substance that is structurally
related to AB–PINACA (also known as
N-(1-amino-3-methyl-1-oxobutan-2-yl)1-pentyl-1H-indazole-3-carboxamide).
AB–PINACA is listed as a
hallucinogenic substance in schedule I
at 21 CFR 1308.11(d)(70). The
introductory text to paragraph (d)
provides: (1) A listed substance includes
‘‘any of its salts, isomers, and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible within the specific chemical
designation,’’ and (2) the term ‘‘isomer’’
includes the ‘‘optical, position[al], and
geometric isomers.’’
When compared to the chemical
structure of AB–PINACA, ADB–
BUTINACA meets the definition of a
positional isomer in 21 CFR 1300.01(b),
which cross-references the term
‘‘positional isomer’’ in 21 CFR
1308.11(d). Both AB–PINACA and
ADB–BUTINACA possess the same
molecular formula and core structure,
and they have the same functional
groups. They only differ from one
another by a rearrangement of an alkyl
moiety between functional groups that
does not create new chemical
functionalities or destroy existing
chemical functionalities. Accordingly,
under 21 CFR 1308.11(d), ADB–
BUTINACA, as a positional isomer of
AB–PINACA, has been and continues to
be a schedule I controlled substance.1
a-PiHP Control
a-PiHP (also known as 4-methyl-1phenyl-2-(pyrrolidin-1-yl)pentan-1-one
or alpha-PiHP) is a chemical substance
that is structurally related to a-PHP
(also known as 1-phenyl-2-(pyrrolidin1-yl)hexan-1-one). a-PHP is listed as a
hallucinogenic substance in schedule I
at 21 CFR 1308.11(d)(95). When
compared to the chemical structure of aPHP, a-PiHP meets the definition of a
positional isomer in 21 CFR 1300.01(b),
1 AB–PINACA (and its isomers) has been subject
to temporary schedule I controls since January 30,
2015, first pursuant to a final order (January 30,
2015, 80 FR 5042) and the subsequent one-year
extension of that order (January 27, 2017, 82 FR
8590), and then permanently pursuant to a final
rule, which continued the imposition of those
controls (October 16, 2017, 82 FR 47971).
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which cross-references the term
‘‘positional isomer’’ in 21 CFR
1308.11(d). Both a-PHP and a-PiHP
possess the same molecular formula and
core structure, and they have the same
functional groups. They only differ from
one another by a rearrangement of an
alkyl moiety that does not create new
chemical functionalities or destroy
existing chemical functionalities.
Accordingly, under 21 CFR 1308.11(d),
a-PiHP, as a positional isomer of a-PHP,
has been and continues to be a schedule
I controlled substance.2
3–MMC Control
3–MMC (also known 2(methylamino)-1-(3methylphenyl)propan-1-one or 3methylmethcathinone) is a chemical
substance that is structurally related to
mephedrone (also known as 4methylmethcathinone). Mephedrone is
listed as a hallucinogenic substance in
schedule I at 21 CFR 1308.11(d)(36).
When compared to the chemical
structure of mephedrone, 3–MMC meets
the definition of a positional isomer in
21 CFR 1300.01(b), which crossreferences the term ‘‘positional isomer’’
in 21 CFR 1308.11(d). Both mephedrone
and 3–MMC possess the same molecular
formula and core structure, and they
have the same functional groups. They
only differ from one another by a
repositioning of an alkyl moiety.
Accordingly, under 21 CFR 1308.11(d),
3–MMC, as a positional isomer of
mephedrone, has been and continues to
be a schedule I controlled substance.3
The Drug Enforcement Administration’s
(DEA) Authority To Control ADB–
BUTINACA, a-PiHP, and 3–MMC
This rule is prompted by a letter dated
May 17, 2023, in which the United
States government was informed by the
Secretariat of the United Nations that
ADB–BUTINACA, a-PiHP, and 3–MMC
have been added to Schedule II of the
Convention on Psychotropic Substances
of 1971 (1971 Convention). This letter
was prompted by decisions at the 66th
Session of the Commission on Narcotic
Drugs (CND) in March 2023 to schedule
ADB–BUTINACA, a-PiHP, and 3–MMC
under Schedule II of the 1971
2 a-PHP (and its isomers) has been subject to
temporary schedule I controls since July 18, 2019,
first pursuant to a temporary scheduling order (July
18, 2019, 84 FR 34291) and the subsequent one-year
extension of that order (July 16, 2021, 86 FR 37672),
and then permanently pursuant to a final rule
which continued the imposition of those controls
(June 1, 2022, 87 FR 32996).
3 Positional isomers of mephedrone have been
subject to permanent schedule I controls since July
9, 2012 (Synthetic Drug Abuse Prevention Act of
2012 or SDAPA, Public Law 112–144, Title XI,
Subtitle D).
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Convention (CND Decisions 66/5, 66/6,
and 66/7). Preceding these decisions,
the Food and Drug Administration
(FDA), on behalf of the Secretary of
Health and Human Services and
pursuant to 21 U.S.C. 811(d)(2),
published two notices in the Federal
Register with an opportunity to submit
domestic information and opportunity
to comment on this action (August 3,
2022, 87 FR 47428 and February 17,
2023, 88 FR 10344). In each instance,
FDA noted that ADB–BUTINACA, aPiHP, and 3–MMC were already
controlled in schedule I of the
Controlled Substances Act (CSA) as
positional isomers of AB–PINACA, aPHP, and mephedrone, respectively,
and the February 2023 notice stated that
no additional permanent controls for
ADB–BUTINACA, a-PiHP, and 3–MMC
under the CSA would be necessary to
fulfill United States’ obligations as a
party to the 1971 Convention.
As discussed above in this final rule,
ADB–BUTINACA—by virtue of being a
positional isomer of AB–PINACA—has
been controlled in schedule I of the CSA
temporarily since January 30, 2015 (80
FR 5042), and permanently since
October 16, 2017 (82 FR 47971). a-PiHP,
a positional isomer of a-PHP, has been
controlled in schedule I of the CSA
temporarily since July 18, 2019 (84 FR
34291), and permanently since June 1,
2022 (87 FR 32996). 3–MMC, a
positional isomer of mephedrone, has
been controlled in schedule I of the CSA
permanently since July 9, 2012 (Pub. L.
112–144, Title XI, Subtitle D).
Therefore, all regulations and criminal
sanctions applicable to schedule I
substances have been and remain
applicable to ADB–BUTINACA, a-PiHP,
and 3–MMC. Drugs controlled in
schedule I of the CSA satisfy and exceed
the required domestic controls of
Schedule II under Article 2 of the 1971
Convention.
Effect of Action
As discussed above, this rule does not
affect the continuing status of ADB–
BUTINACA, a-PiHP, and 3–MMC as
schedule I controlled substances in any
way. This action, as an administrative
matter, merely establishes a separate,
specific listing for ADB–BUTINACA, aPiHP, and 3–MMC in schedule I of the
CSA and assigns a DEA controlled
substances code number (drug code) for
these substances. This action will allow
DEA to establish an aggregate
production quota and grant individual
manufacturing and procurement quotas
to DEA-registered manufacturers of
ADB–BUTINACA, a-PiHP, or 3–MMC,
who had previously been granted
individual quotas for such purposes
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86267
under the drug codes for AB–PINACA,
a-PHP, or mephedrone.
substances, and this level of control
does not change with this rulemaking.
Regulatory Analyses
Executive Orders 12866 (Regulatory
Planning and Review), 13563
(Improving Regulation and Regulatory
Review), and 14094 (Modernizing
Regulatory Review)
Administrative Procedure Act
An agency may find good cause to
exempt a rule from certain provisions of
the Administrative Procedure Act (APA)
including notice of proposed
rulemaking and the opportunity for
public comment, if it is determined to
be unnecessary, impracticable, or
contrary to the public interest (5 U.S.C.
553). ADB–BUTINACA, a-PiHP, and 3–
MMC are currently controlled in
schedule I as positional isomers of AB–
PINACA, a-PHP, and mephedrone,
respectively.
Pursuant to 5 U.S.C. 553(b) (B), DEA
finds that notice and comment
rulemaking is unnecessary and that
good cause exists to dispense with these
procedures. The addition of a separate
listing for ADB–BUTINACA, a-PiHP,
and 3–MMC and their DEA controlled
substances code numbers in the list of
schedule I substances in 21 CFR
1308.11(d) makes no substantive
difference in the status of these drugs as
schedule I controlled substances, but
instead is ‘‘a minor or merely technical
amendment in which the public is not
particularly interested.’’ National
Nutritional Foods Ass’n v. Kennedy, 572
F.2d 377, 385 (2d Cir. 1978) (quoting S.
Rep. No. 79–752, at 200 (1945)). See also
Utility Solid Waste Activities Group v.
E.P.A., 236 F.3d 749, 755 (D.C. Cir.
2001) (the ‘‘unnecessary’’ prong ‘‘is
confined to those situations in which
the administrative rule is a routine
determination, insignificant in nature
and impact, and inconsequential to the
industry and public’’) (internal
quotations and citation omitted). This
rule is a ‘‘technical amendment’’ to 21
CFR 1308.11(d) as it is ‘‘insignificant in
nature and impact, and inconsequential
to the industry and public.’’ Therefore,
publishing a notice of proposed
rulemaking and soliciting public
comment are unnecessary.
In addition, because ADB–
BUTINACA, a-PiHP, and 3–MMC are
already subject to domestic control
under schedule I as positional isomers
and no additional requirements are
being imposed through this action, DEA
finds good cause exists to make this rule
effective immediately upon publication
in accordance with 5 U.S.C. 553(d)(3).
DEA is concerned that delaying the
effective date of this rule potentially
could cause confusion regarding the
regulatory status of ADB–BUTINACA,
a-PiHP, and 3–MMC. ADB–BUTINACA,
a-PiHP, and 3–MMC are currently
controlled as schedule I controlled
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This regulation has been drafted and
reviewed in accordance with the
principles of Executive Orders (E.O.)
12866, 13563, and 14094. This rule is
not a significant regulatory action under
section 3(f) of E.O. 12866. ADB–
BUTINACA, a-PiHP, and 3–MMC are
already controlled substances in the
United States under schedule I, as they
are positional isomers of schedule I
hallucinogens AB–PINACA, a-PHP, and
mephedrone, respectively. In this final
rule, DEA is merely making an
administrative change by amending its
regulations to separately list ADB–
BUTINACA, a-PiHP, and 3–MMC in
schedule I and to assign DEA controlled
substances code numbers to these
substances. A separate listing for ADB–
BUTINACA, a-PiHP, and 3–MMC and
their DEA controlled substances code
numbers will not alter the status of
these substances as a schedule I
controlled substances. Accordingly, this
rule has not been reviewed by the Office
of Management and Budget (OMB).
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, provide a
clear legal standard for affected conduct,
and promote simplification and burden
reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The rule does
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.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA or other
laws. As noted in the above section
regarding the applicability of the APA,
DEA determined that there was good
cause to exempt this final rule from
notice and comment. Consequently, the
RFA does not apply.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501–3521. This action
would not impose recordkeeping or
reporting requirements on State or local
governments, individuals, businesses, or
organizations. An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1532, DEA has determined that
this action would not result in any
Federal mandate that may result ‘‘in the
expenditure by State, local, and Tribal
Governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
1 year.’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under UMRA of 1995.
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.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of this rule to both Houses of
Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
Signing Authority
This document of the Drug
Enforcement Administration was signed
on December 7, 2023, 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
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
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:
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. Amend § 1308.11 by adding new
paragraphs (d)(102) to (104) to read as
follows:
■
§ 1308.11
*
Schedule I.
*
*
(d) * * *
*
*
*
*
*
*
*
*
*
(102) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H-indazole-3-carboxamide (other name: ADB–BUTINACA) ............................
(103) 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (other names: a-PiHP; alpha-PiHP) ....................................................................
(104) 2-(methylamino)-1-(3-methylphenyl)propan-1-one (other names: 3–MMC; 3-methylmethcathinone) ...............................................
*
*
*
*
*
*
*
*
This regulation is effective
December 13, 2023. Objections and
requests for hearings must be received
on or before February 12, 2024, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
BILLING CODE 4410–09–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Dodine; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of dodine in or
on Fruit, pome, group 11–10; Fruit,
stone, group 12–12; Nut, tree, group 14–
12; and Olive, with pit. Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0657, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
[EPA–HQ–OPP–2021–0657; FRL–11567–01–
OCSPP]
15:50 Dec 12, 2023
*
DATES:
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FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
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]]>Agencies
[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Rules and Regulations]
[Pages 86266-86268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27292]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1222]
Specific Listing for Three Currently Controlled Schedule I
Substances
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is establishing a
specific listing and DEA Controlled Substances Code Number (drug code)
for three substances: N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-
1H-indazole-3-carboxamide (also known as ADB-BUTINACA); 4-methyl-1-
phenyl-2-(pyrrolidin-1-yl)pentan-1-one (also known as [alpha]-PiHP or
alpha-PiHP); and 2-(methylamino)-1-(3-methylphenyl)propan-1-one (also
known as 3-MMC or 3-methylmethcathinone) in schedule I of the
Controlled Substances Act (CSA). Although ADB-BUTINACA, [alpha]-PiHP,
and 3-MMC are not specifically listed in schedule I of the CSA with
their own unique drug codes, they are schedule I controlled substances
in the United States because they are positional isomers of AB-PINACA
(controlled January 30, 2015), [alpha]-PHP (controlled July 18, 2019),
and mephedrone (controlled as a hallucinogen July 9, 2012),
respectively, each of which are schedule I hallucinogens. Therefore,
DEA is simply amending the schedule I hallucinogenic substances list in
its regulations to separately include ADB-BUTINACA, [alpha]-PiHP, and
3-MMC.
DATES: Effective December 13, 2023.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
ADB-BUTINACA Control
ADB-BUTINACA (also known as N-(1-amino-3,3-dimethyl-1-oxobutan-2-
yl)-1-butyl-1H-indazole-3-carboxamide) is a chemical substance that is
structurally related to AB-PINACA (also known as N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide). AB-PINACA is listed
as a hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(70).
The introductory text to paragraph (d) provides: (1) A listed substance
includes ``any of its salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation,'' and (2) the term ``isomer''
includes the ``optical, position[al], and geometric isomers.''
When compared to the chemical structure of AB-PINACA, ADB-BUTINACA
meets the definition of a positional isomer in 21 CFR 1300.01(b), which
cross-references the term ``positional isomer'' in 21 CFR 1308.11(d).
Both AB-PINACA and ADB-BUTINACA possess the same molecular formula and
core structure, and they have the same functional groups. They only
differ from one another by a rearrangement of an alkyl moiety between
functional groups that does not create new chemical functionalities or
destroy existing chemical functionalities. Accordingly, under 21 CFR
1308.11(d), ADB-BUTINACA, as a positional isomer of AB-PINACA, has been
and continues to be a schedule I controlled substance.\1\
---------------------------------------------------------------------------
\1\ AB-PINACA (and its isomers) has been subject to temporary
schedule I controls since January 30, 2015, first pursuant to a
final order (January 30, 2015, 80 FR 5042) and the subsequent one-
year extension of that order (January 27, 2017, 82 FR 8590), and
then permanently pursuant to a final rule, which continued the
imposition of those controls (October 16, 2017, 82 FR 47971).
---------------------------------------------------------------------------
[alpha]-PiHP Control
[alpha]-PiHP (also known as 4-methyl-1-phenyl-2-(pyrrolidin-1-
yl)pentan-1-one or alpha-PiHP) is a chemical substance that is
structurally related to [alpha]-PHP (also known as 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one). [alpha]-PHP is listed as a
hallucinogenic substance in schedule I at 21 CFR 1308.11(d)(95). When
compared to the chemical structure of [alpha]-PHP, [alpha]-PiHP meets
the definition of a positional isomer in 21 CFR 1300.01(b), which
cross-references the term ``positional isomer'' in 21 CFR 1308.11(d).
Both [alpha]-PHP and [alpha]-PiHP possess the same molecular formula
and core structure, and they have the same functional groups. They only
differ from one another by a rearrangement of an alkyl moiety that does
not create new chemical functionalities or destroy existing chemical
functionalities. Accordingly, under 21 CFR 1308.11(d), [alpha]-PiHP, as
a positional isomer of [alpha]-PHP, has been and continues to be a
schedule I controlled substance.\2\
---------------------------------------------------------------------------
\2\ [alpha]-PHP (and its isomers) has been subject to temporary
schedule I controls since July 18, 2019, first pursuant to a
temporary scheduling order (July 18, 2019, 84 FR 34291) and the
subsequent one-year extension of that order (July 16, 2021, 86 FR
37672), and then permanently pursuant to a final rule which
continued the imposition of those controls (June 1, 2022, 87 FR
32996).
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3-MMC Control
3-MMC (also known 2-(methylamino)-1-(3-methylphenyl)propan-1-one or
3-methylmethcathinone) is a chemical substance that is structurally
related to mephedrone (also known as 4-methylmethcathinone). Mephedrone
is listed as a hallucinogenic substance in schedule I at 21 CFR
1308.11(d)(36). When compared to the chemical structure of mephedrone,
3-MMC meets the definition of a positional isomer in 21 CFR 1300.01(b),
which cross-references the term ``positional isomer'' in 21 CFR
1308.11(d). Both mephedrone and 3-MMC possess the same molecular
formula and core structure, and they have the same functional groups.
They only differ from one another by a repositioning of an alkyl
moiety. Accordingly, under 21 CFR 1308.11(d), 3-MMC, as a positional
isomer of mephedrone, has been and continues to be a schedule I
controlled substance.\3\
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\3\ Positional isomers of mephedrone have been subject to
permanent schedule I controls since July 9, 2012 (Synthetic Drug
Abuse Prevention Act of 2012 or SDAPA, Public Law 112-144, Title XI,
Subtitle D).
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The Drug Enforcement Administration's (DEA) Authority To Control ADB-
BUTINACA, [alpha]-PiHP, and 3-MMC
This rule is prompted by a letter dated May 17, 2023, in which the
United States government was informed by the Secretariat of the United
Nations that ADB-BUTINACA, [alpha]-PiHP, and 3-MMC have been added to
Schedule II of the Convention on Psychotropic Substances of 1971 (1971
Convention). This letter was prompted by decisions at the 66th Session
of the Commission on Narcotic Drugs (CND) in March 2023 to schedule
ADB-BUTINACA, [alpha]-PiHP, and 3-MMC under Schedule II of the 1971
[[Page 86267]]
Convention (CND Decisions 66/5, 66/6, and 66/7). Preceding these
decisions, the Food and Drug Administration (FDA), on behalf of the
Secretary of Health and Human Services and pursuant to 21 U.S.C.
811(d)(2), published two notices in the Federal Register with an
opportunity to submit domestic information and opportunity to comment
on this action (August 3, 2022, 87 FR 47428 and February 17, 2023, 88
FR 10344). In each instance, FDA noted that ADB-BUTINACA, [alpha]-PiHP,
and 3-MMC were already controlled in schedule I of the Controlled
Substances Act (CSA) as positional isomers of AB-PINACA, [alpha]-PHP,
and mephedrone, respectively, and the February 2023 notice stated that
no additional permanent controls for ADB-BUTINACA, [alpha]-PiHP, and 3-
MMC under the CSA would be necessary to fulfill United States'
obligations as a party to the 1971 Convention.
As discussed above in this final rule, ADB-BUTINACA--by virtue of
being a positional isomer of AB-PINACA--has been controlled in schedule
I of the CSA temporarily since January 30, 2015 (80 FR 5042), and
permanently since October 16, 2017 (82 FR 47971). [alpha]-PiHP, a
positional isomer of [alpha]-PHP, has been controlled in schedule I of
the CSA temporarily since July 18, 2019 (84 FR 34291), and permanently
since June 1, 2022 (87 FR 32996). 3-MMC, a positional isomer of
mephedrone, has been controlled in schedule I of the CSA permanently
since July 9, 2012 (Pub. L. 112-144, Title XI, Subtitle D). Therefore,
all regulations and criminal sanctions applicable to schedule I
substances have been and remain applicable to ADB-BUTINACA, [alpha]-
PiHP, and 3-MMC. Drugs controlled in schedule I of the CSA satisfy and
exceed the required domestic controls of Schedule II under Article 2 of
the 1971 Convention.
Effect of Action
As discussed above, this rule does not affect the continuing status
of ADB-BUTINACA, [alpha]-PiHP, and 3-MMC as schedule I controlled
substances in any way. This action, as an administrative matter, merely
establishes a separate, specific listing for ADB-BUTINACA, [alpha]-
PiHP, and 3-MMC in schedule I of the CSA and assigns a DEA controlled
substances code number (drug code) for these substances. This action
will allow DEA to establish an aggregate production quota and grant
individual manufacturing and procurement quotas to DEA-registered
manufacturers of ADB-BUTINACA, [alpha]-PiHP, or 3-MMC, who had
previously been granted individual quotas for such purposes under the
drug codes for AB-PINACA, [alpha]-PHP, or mephedrone.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (APA) including notice
of proposed rulemaking and the opportunity for public comment, if it is
determined to be unnecessary, impracticable, or contrary to the public
interest (5 U.S.C. 553). ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
currently controlled in schedule I as positional isomers of AB-PINACA,
[alpha]-PHP, and mephedrone, respectively.
Pursuant to 5 U.S.C. 553(b) (B), DEA finds that notice and comment
rulemaking is unnecessary and that good cause exists to dispense with
these procedures. The addition of a separate listing for ADB-BUTINACA,
[alpha]-PiHP, and 3-MMC and their DEA controlled substances code
numbers in the list of schedule I substances in 21 CFR 1308.11(d) makes
no substantive difference in the status of these drugs as schedule I
controlled substances, but instead is ``a minor or merely technical
amendment in which the public is not particularly interested.''
National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 385 (2d Cir.
1978) (quoting S. Rep. No. 79-752, at 200 (1945)). See also Utility
Solid Waste Activities Group v. E.P.A., 236 F.3d 749, 755 (D.C. Cir.
2001) (the ``unnecessary'' prong ``is confined to those situations in
which the administrative rule is a routine determination, insignificant
in nature and impact, and inconsequential to the industry and public'')
(internal quotations and citation omitted). This rule is a ``technical
amendment'' to 21 CFR 1308.11(d) as it is ``insignificant in nature and
impact, and inconsequential to the industry and public.'' Therefore,
publishing a notice of proposed rulemaking and soliciting public
comment are unnecessary.
In addition, because ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
already subject to domestic control under schedule I as positional
isomers and no additional requirements are being imposed through this
action, DEA finds good cause exists to make this rule effective
immediately upon publication in accordance with 5 U.S.C. 553(d)(3). DEA
is concerned that delaying the effective date of this rule potentially
could cause confusion regarding the regulatory status of ADB-BUTINACA,
[alpha]-PiHP, and 3-MMC. ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are
currently controlled as schedule I controlled substances, and this
level of control does not change with this rulemaking.
Executive Orders 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), and 14094 (Modernizing
Regulatory Review)
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders (E.O.) 12866, 13563, and 14094. This
rule is not a significant regulatory action under section 3(f) of E.O.
12866. ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are already controlled
substances in the United States under schedule I, as they are
positional isomers of schedule I hallucinogens AB-PINACA, [alpha]-PHP,
and mephedrone, respectively. In this final rule, DEA is merely making
an administrative change by amending its regulations to separately list
ADB-BUTINACA, [alpha]-PiHP, and 3-MMC in schedule I and to assign DEA
controlled substances code numbers to these substances. A separate
listing for ADB-BUTINACA, [alpha]-PiHP, and 3-MMC and their DEA
controlled substances code numbers will not alter the status of these
substances as a schedule I controlled substances. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, provide a clear legal standard for affected conduct, and
promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does 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.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
[[Page 86268]]
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or other laws. As noted in the above section regarding the
applicability of the APA, DEA determined that there was good cause to
exempt this final rule from notice and comment. Consequently, the RFA
does not apply.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1532, DEA has determined that this action would not result in
any Federal mandate that may result ``in the expenditure by State,
local, and Tribal Governments, in the aggregate, or by the private
sector, of $100,000,000 or more (adjusted annually for inflation) in
any 1 year.'' Therefore, neither a Small Government Agency Plan nor any
other action is required under UMRA of 1995.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this rule to both Houses of Congress and to the
Comptroller General.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 7, 2023, 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.
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 part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. Amend Sec. 1308.11 by adding new paragraphs (d)(102) to (104) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
* * * * * * *
(102) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H- 7027
indazole-3-carboxamide (other name: ADB-BUTINACA)...............
(103) 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (other 7551
names: [alpha]-PiHP; alpha-PiHP)................................
(104) 2-(methylamino)-1-(3-methylphenyl)propan-1-one (other 1259
names: 3-MMC; 3-methylmethcathinone)............................
* * * * * * *
* * * * *
[FR Doc. 2023-27292 Filed 12-12-23; 8:45 am]
BILLING CODE 4410-09-P
