86266 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 

1AB–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). 

2a-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). 

3Positional 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). 

Cologne, Germany; phone: +49 221 8999 000; 

email: ADs@easa.europa.eu; website: 

easa.europa.eu. You may find this EASA AD 

on the EASA website at ad.easa.europa.eu. 

(4) You may view this service information 

at the FAA, Airworthiness Products Section, 

Operational Safety Branch, 1200 District 

Avenue, Burlington, MA 01803. For 

information on the availability of this 

material at the FAA, call (817) 222–5110. 

(5) You may view this material at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

visit www.archives.gov/federal-register/cfr/ 

ibr-locations or email fr.inspection@nara.gov. 

Issued on November 30, 2023. 

Ross Landes, 

Deputy Director for Regulatory Operations, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[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 

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-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-(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, 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. 

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

a-PiHP Control 

a-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 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), 

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-(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 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 


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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 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, 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 

under the drug codes for AB–PINACA, 

a-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, 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 

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, 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. 


khammond on DSKJM1Z7X2PROD with RULES
86268 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. 

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 

■ 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) ............................ 7027 

(103) 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (other names: a-PiHP; alpha-PiHP) .................................................................... 7551 

(104) 2-(methylamino)-1-(3-methylphenyl)propan-1-one (other names: 3–MMC; 3-methylmethcathinone) ............................................... 1259 

* * * * * * * 

* * * * * 

[FR Doc. 2023–27292 Filed 12–12–23; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0657; FRL–11567–01– 

OCSPP] 

Dodine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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). 

DATES: 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). 

ADDRESSES: 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. 

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). 


khammond on DSKJM1Z7X2PROD with RULES