Rule2022-07320
Schedules of Controlled Substances: Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 7, 2022
Effective
April 7, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
By this rule, the Drug Enforcement Administration permanently places five synthetic cannabinoids, as identified in this final rule, in schedule I of the Controlled Substances Act. These five substances are currently listed in schedule I pursuant to a temporary scheduling order. As a result of this rule, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these five specified controlled substances will continue to apply.
Full Text
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<title>Federal Register, Volume 87 Issue 67 (Thursday, April 7, 2022)</title>
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Rules and Regulations]
[Pages 20318-20321]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07320]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-491]
Schedules of Controlled Substances: Placement of 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: By this rule, the Drug Enforcement Administration permanently
places five synthetic cannabinoids, as identified in this final rule,
in schedule I of the Controlled Substances Act. These five substances
are currently listed in schedule I pursuant to a temporary scheduling
order. As a result of this rule, the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
import, export, engage in research, conduct instructional activities or
chemical analysis, or possess), or propose to handle these five
specified controlled substances will continue to apply.
DATES: Effective April 7, 2022.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
In this final rule, the Drug Enforcement Administration (DEA) is
permanently scheduling the following five controlled substances in
schedule I of the Controlled Substances Act (CSA), including their
salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation:
<bullet> Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate (other name: 5F-EDMB-PINACA),
<bullet> Methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201),
<bullet> N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
fluorobenzyl)),
<bullet> 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide (other names: 5F-CUMYL-PINACA; SGT-25), and
<bullet> (1-(4-Fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (other name: FUB-144).
Legal Authority
The CSA provides that issuing, amending, or repealing of the
scheduling of any drug or other substance may be initiated by the
Attorney General (1) on his own motion; (2) at the request of the
Secretary of the Department of Health and Human Services (HHS); \1\ or
(3) on the petition of any interested party. 21 U.S.C. 811(a). The
then-Acting Administrator of DEA (as delegated by the Attorney General
to the Administrator of DEA) initiated this action on his own motion,
and is supported by, inter alia, a recommendation from the then-Acting
Assistant Secretary for Health of HHS and an evaluation of all relevant
data by DEA. The regulatory controls and administrative, civil, and
criminal sanctions of schedule I controlled substances on any person
who handles (manufactures, distributes, imports, exports, engages in
research, or conducts instructional activities or chemical analysis
with, or possesses) or proposes to handle 5F-EDMB-PINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 will continue to apply as a
result of this action.
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\1\ As set forth in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
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Background
On April 16, 2019, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place ethyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial
name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial
names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide
(trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name:
FUB-144) in schedule I of the CSA pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). 84 FR 15505. That temporary scheduling
order took effect on the date of publication, and was based on findings
by the then-Acting Administrator of DEA that the temporary scheduling
of these five synthetic cannabinoids (SCs) was necessary to avoid an
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).
On March 30, 2021, DEA published a notice of proposed rulemaking
(NPRM) in the Federal Register to permanently control the five SCs in
schedule I of the CSA. 86 FR 16553. On March 31, 2021, DEA published an
order to extend the temporary scheduling of the five SCs by one year,
until April 16, 2022. 86 FR 16669.
DEA and HHS Eight Factor Analyses
On February 26, 2021, HHS provided DEA with a scientific and
medical evaluation and scheduling recommendation, prepared by the Food
and Drug Administration (FDA), entitled ``Basis for the Recommendation
to Place Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [5F-EDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-
indole-3-carboxamido)-3,3-dimethylbutanoate [5F-MDMB-PICA]; N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [FUB-
AKB48;FUB-APINACA; AKB48 N-(4-fluorobenzyl)]; 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide [5F-CUMYL-PINACA; SGT-25];
and (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone [FUB-144; FUB-UR-144] and Their Salts,
Isomers, and Salts of Isomers in Schedule I of the Controlled
Substances Act.''
[[Page 20319]]
After considering the eight factors in 21 U.S.C. 811(c), each
substance's abuse potential, lack of legitimate medical use in the
United States, and lack of accepted safety for use under medical
supervision pursuant to 21 U.S.C. 812(b), the then-Acting Assistant
Secretary for Health of HHS recommended that 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 be placed in schedule I
of the CSA. In response, DEA conducted its own eightfactor analysis of
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144.
Both DEA and HHS eight-factor analyses are available in their
entirety in the public docket for this rule (Docket Number DEA-491) at
<a href="http://www.regulations.gov">http://www.regulations.gov</a> under ``Supporting Documents.''
NPRM To Schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA and FUB-144
On March 30, 2021, DEA published an NPRM entitled ``Schedules of
Controlled Substances: Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I.'' 86 FR 16553.
Specifically, the NPRM proposed to add the five SCs to the
hallucinogenic substances list under 21 CFR 1308.11(d), and assign them
paragraph numbers 87 through 91 under paragraph (d). In addition, the
NPRM listed these five SCs by their chemical and trivial names as
follows:
<bullet> (87) Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA);
<bullet> (88) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA);
<bullet> (89) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
fluorobenzyl));
<bullet> (90) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-
indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and
<bullet> (91) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (trivial name: FUB-144).
The NPRM provided an opportunity for interested persons to file a
request for hearing in accordance with DEA regulations, as well as to
submit comments on the proposed rule, on or before April 29, 2021. DEA
did not receive any requests for such a hearing or any public comments
on the proposed rule.
Scheduling Conclusion
After considering the scientific and medical evaluations and
accompanying recommendation of HHS, and conducting an independent
eight-factor analysis, DEA finds substantial evidence of abuse
potential for 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA,
and FUB-144. DEA is therefore permanently scheduling 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 as controlled
substances under the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the then-Acting Assistant Secretary for Health of HHS
and review of all other available data, the Administrator of DEA,
pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:
(1) 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and
FUB-144 have a high potential for abuse that is comparable to other
schedule I substances such as delta-9-tetrahydrocannabinol ([Delta]\9\-
THC) and JWH-018;
(2) 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and
FUB-144 currently have no accepted medical use in treatment in the
United States; \2\ and
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\2\ Although there is no evidence suggesting that 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 have
currently accepted medical uses in treatment in the United States,
it bears noting that a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by
FDA, to have a currently accepted medical use in treatment in the
United States, all of the following must be demonstrated: i. The
drug's chemistry must be known and reproducible; ii. there must be
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted
by qualified experts; and v. the scientific evidence must be widely
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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(3) There is a lack of accepted safety for use of 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 under medical
supervision.
Based on these findings, the Administrator concludes that ethyl 2-
(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate
(other name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-
2201); N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide
(other names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-fluorobenzyl)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (other
names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-indol-3-
yl)(2,2,3,3-tetramethylcyclopropyl)methanone (other name: FUB-144),
including their salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation, warrant control in schedule I
of the CSA. 21 U.S.C. 812(b)(1).
Summary of Minor Changes in the Final Rule
As discussed in the above NPRM section, DEA proposed to place 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in
21 CFR 1308.11(d) as paragraphs 87 through 91, respectively. The NPRM
listed chemical, as well as trivial, names for the five substances.
Regarding the substance methyl 2-(1-(5-fluoropentyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate, the NPRM listed only one trivial
name (5F-MDMB-PICA). Since the publication of the NPRM, DEA has found
another trivial name (5F-MDMB-2201) for this substance. In addition,
DEA has issued several final rules which updated the numbering of
listed hallucinogenic substances in paragraph (d). As a result, this
final rule assigns paragraphs 89 through 93 to 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144, respectively. This final
rule now refers to ``trivial'' names as ``other'' names, and lists both
5F-MDMB-PICA and 5F-MDMB-2201 as other names for methyl 2-(1-(5-
fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate.
Requirements for Handling 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA, and FUB-144
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-
144 will continue \3\ to be subject to the CSA's schedule I regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture,
[[Page 20320]]
distribution, dispensing, importing, exporting, research, and conduct
of instructional activities, including the following:
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\3\ 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA,
and FUB-144 have been subject to schedule I controls on a temporary
basis, pursuant to 21 U.S.C. 811(h), by virtue of the April 16, 2019
temporary scheduling order (84 FR 15505) and the subsequent one year
extension of that order (March 31, 2021, 86 FR 16669).
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1. Registration. Any person who handles, or desires to handle, 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 must
be registered with DEA to conduct such activities pursuant to 21 U.S.C.
822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and
1312.
2. Security. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA, and FUB-144 are subject to schedule I security requirements and
must be handled in accordance with 21 CFR 1301.71-1301.76. Non-
practitioners handling these five substances must also comply with the
employee screening requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA, and FUB-144 must be in compliance with 21 U.S.C. 825 and
958(e), and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA,
or FUB-144 in accordance with a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part 1303.
5. Inventory. Every DEA registrant who possesses any quantity of
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144
was required to keep an inventory of all stocks of these substances on
hand as of April 16, 2019, pursuant to 21 U.S.C. 827 and 958 and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA, and/or FUB-144, pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1301.74(b) and (c) and parts
1304, 1312, and 1317. Manufacturers and distributors must submit
reports regarding 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA, and/or FUB-144 to the Automation of Reports and Consolidated
Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR
parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 must
continue to comply with the order form requirements, pursuant to 21
U.S.C. 828 and in accordance with 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144
must continue to be in compliance with 21 U.S.C. 952, 953, 957, and
958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving 5F-EDMB-PINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 not authorized by, or in
violation of, the CSA or its implementing regulations is unlawful, and
may subject the person to administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures performed ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563.
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, minimize litigation, 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 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 Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-612, has reviewed this final rule and by approving it
certifies that it will not have a significant economic impact on a
substantial number of small entities. On April 16, 2019, DEA published
an order to temporarily place these five substances in schedule I of
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h).
DEA estimates that all entities handling or planning to handle
these substances have already established and implemented the systems
and processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA, and FUB-144 as schedule I controlled
substances. There are currently 28 registrations authorized to handle
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and/or FUB-
144 specifically, as well as a number of registered analytical labs
that are authorized to handle schedule I controlled substances
generally. DEA estimates these 28 registrations encompass 22 entities.
Some of these entities are likely to be large entities. However, DEA
does not have information of registrant size and the majority of DEA
registrants are small entities or are employed by small entities.
Therefore, DEA conservatively estimates as many as 22 small entities
are affected by this rule.
A review of the 28 registrations indicates that all entities that
currently handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA, or FUB-144 also handle other schedule I controlled substances,
and have established and implemented (or maintain) the systems and
processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48,
5F-CUMYL-PINACA, or FUB-144. Therefore, DEA anticipates that this rule
will impose minimal or no economic impact on a substantial number of
small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies 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
[[Page 20321]]
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 final rule to the Government Accountability
Office, the House, and the Senate under the CRA.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information 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.
Determination To Make Rule Effective Immediately
As indicated above, this rule finalizes the schedule I control
status of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and
FUB-144 that has already been in effect for over two years by virtue of
the April 16, 2019, temporary scheduling order (84 FR 15505) and the
subsequent one-year extension of that order (March 31, 2021, 86 FR
16669). The April 2019 order was effective on the date of publication,
and was based on findings by the then-Acting Administrator that the
temporary scheduling of these substances was necessary to avoid an
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).
Because this rule finalizes the control status of 5F-EDMB-PINACA,
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 that has already
been in effect for over two years, it does not alter the legal
obligations of any person who handles these substances. Rather, it
merely makes permanent the current scheduling status and corresponding
legal obligations. Therefore, DEA is making the rule effective on the
date of publication in the Federal Register, as any delay in the
effective date is unnecessary and would be contrary to the public
interest. See 5 U.S.C. 553(d).
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, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Add paragraphs (d)(89) through (d)(93); and
0
b. Remove and reserve paragraphs (h)(37) through (41);
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(89) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- 7036
dimethylbutanoate (other name: 5F-EDMB-PINACA).................
(90) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3- 7041
dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201)....
(91) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3- 7047
carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
FLUOROBENZYL)).................................................
(92) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3- 7083
carboxamide (other names: 5F-CUMYL-PINACA; SGT-25).............
(93) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 7014
tetramethylcyclopropyl)methanone (other name: FUB-144).........
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2022-07320 Filed 4-6-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on April 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.