Specific Listing for 4F-MDMB-BINACA, a Currently Controlled Schedule I Substance
| Published date | 22 June 2021 |
| Citation | 86 FR 32633 |
| Record Number | 2021-13040 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 86 Issue 117 (Tuesday, June 22, 2021)
[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]
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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.
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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.
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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\
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\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).
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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]
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