[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]


=======================================================================
-----------------------------------------------------------------------

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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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