[Federal Register Volume 86, Number 117 (Tuesday, June 22, 2021)]
[Rules and Regulations]
[Pages 32633-32635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13040]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 86, No. 117 / Tuesday, June 22, 2021 / Rules 
and Regulations

[[Page 32633]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-819]


Specific Listing for 4F-MDMB-BINACA, a Currently Controlled 
Schedule I Substance

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is establishing a specific 
listing and Administration Controlled Substances Code Number (drug 
code) for 4F-MDMB-BINACA (also known as 4F-MDMB-BUTINACA or methyl 2-
(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) in 
schedule I of the Controlled Substances Act (CSA). Although 4F-MDMB-
BINACA is not specifically listed in schedule I of the CSA with its own 
unique drug code, it has been controlled in the United States since 
April 2017 as a positional isomer of 5F-AMB, a schedule I hallucinogen. 
Therefore, DEA is simply amending the schedule I hallucinogenic 
substances list in its regulations to separately include 4F-MDMB-
BINACA.

DATES: Effective June 22, 2021.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

4F-MDMB-BINACA Control

    4F-MDMB-BINACA (also known as 4F-MDMB-BUTINACA or methyl 2-(1-(4-
fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a 
chemical substance which is structurally related to 5F-AMB (also known 
as methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate). 5F-AMB is listed as a hallucinogenic substance in 
schedule I at 21 CFR 1308.11(d)(74). The introductory text to 
subparagraph (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,'' and (2) the term 
``isomer'' includes the optical, position[al], and geometric isomers.
    When compared to the chemical structure of 5F-AMB, 4F-MDMB-BINACA 
meets the statutory 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 5F-AMB and 4F-MDMB-BINACA possess the same 
molecular formula and core structure, and have the same functional 
groups. They only differ from one another by a rearrangement of an 
alkyl moiety between functional groups. Accordingly, under 21 CFR 
1308.11(d), 4F-MDMB-BINACA, as a positional isomer of 5F-AMB, has been 
and continues to be a schedule I controlled substance.\1\
---------------------------------------------------------------------------

    \1\ 5F-AMB (and its isomers) has been subject to schedule I 
controls since April 2017, first pursuant to a temporary scheduling 
order (April 10, 2017, 82 FR 17119) and the subsequent one-year 
extension of that order (April 8, 2019, 84 FR 13796), and then 
permanently pursuant to a final rule which continued the imposition 
of those controls (Jan. 24, 2020, 85 FR 4211).
---------------------------------------------------------------------------

The Drug Enforcement Administration's Authority To Control 4F-MDMB-
BINACA

    This rule is prompted by a letter dated May 7, 2020, in which the 
United States government was informed by the Secretary-General of the 
United Nations that 4F-MDMB-BINACA has been added to Schedule II of the 
Convention on Psychotropic Substances of 1971 (1971 Convention). This 
letter was prompted by a decision at the 63rd Session of the Commission 
on Narcotic Drugs (CND) in March 2020 to schedule 4F-MDMB-BINACA under 
Schedule II of the 1971 Convention (CND Dec/63/8). Preceding this 
decision, 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, Sept. 10, 2019, 84 FR 47521 and Dec. 31, 2019, 84 FR 
72370. In both instances, FDA noted that 4F-MDMB-BINACA was already 
controlled in schedule I of the Controlled Substances Act (CSA) as a 
positional isomer of 5F-AMB, and the December 2019 notice stated that 
no additional permanent controls for 4F-MDMB-BINACA 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, 4F-MDMB-BINACA--by virtue of 
being a positional isomer of 5F-AMB--has been controlled in schedule I 
of the CSA temporarily since April 10, 2017 (82 FR 17119), and 
permanently since January 24, 2020 (85 FR 4211). Therefore, all 
regulations and criminal sanctions applicable to schedule I substances 
have been and remain applicable to 4F-MDMB-BINACA. 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 4F-MDMB-BINACA as a schedule I controlled substance in any way. This 
action, as an administrative matter, merely establishes a separate, 
specific listing for 4F-MDMB-BINACA in schedule I of the CSA and 
assigns a DEA controlled substances code number (drug code) for the 
substance. This action will allow DEA to establish an aggregate 
production quota and grant individual manufacturing and procurement 
quotas to DEA-registered manufacturers of 4F-MDMB-BINACA, who had 
previously been granted individual quotas for such purposes under the 
drug code for 5F-AMB.

Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), 
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. 4F-MDMB-BINACA is currently controlled 
in schedule I as a positional isomer of 5F-AMB, and 4F-MDMB-BINACA has 
no currently accepted medical use in treatment to

[[Page 32634]]

qualify for placement in a schedule other than schedule I (see 21 
U.S.C. 812(b)(2)-(5)).
    Pursuant to 5 U.S.C. 553(b)(3)(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 4F-
MDMB-BINACA and its DEA controlled substances code number in the list 
of schedule I substances in 21 CFR 1308.11(d) makes no substantive 
difference in the status of this drug as a schedule I controlled 
substance, 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'') (int. 
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 4F-MDMB-BINACA is already subject to domestic 
control under schedule I as a positional isomer of 5F-AMB 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 4F-MDMB-BINACA. 4F-MDMB-
BINACA is currently controlled as a schedule I controlled substance, 
and this level of control does not change with this rulemaking.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This regulation has been drafted and reviewed in accordance with 
the principles of Executive Orders (E.O.) 12866 and 13563. This rule is 
not a significant regulatory action under E.O. 12866. 4F-MDMB-BINACA 
already is a controlled substance in the United States under schedule 
I, as it is a positional isomer of a schedule I hallucinogen, 5F-AMB. 
In this final rule, DEA is merely making an administrative change by 
amending its regulations to separately list 4F-MDMB-BINACA in schedule 
I and to assign the DEA controlled substances code number 7043 to the 
substance. A separate listing for 4F-MDMB-BINACA and its DEA controlled 
substances code number will not alter the status of 4F-MDMB-BINACA as a 
schedule I controlled substance. 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.

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.

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 paragraph (d)(87) to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(87) methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-        7043
 3,3-dimethylbutanoate (4F-MDMB-BINACA, 4F-MDMB-BUTINACA).....
 


[[Page 32635]]

* * * * *


D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-13040 Filed 6-21-21; 8:45 am]
BILLING CODE 4410-09-P