[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4211-4215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00665]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-446]
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration places methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB;
5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and
methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [MDMB-FUBINACA], including their salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, in schedule I of the Controlled
Substances Act. This action continues the imposition of 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 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA.
DATES: Effective: January 24, 2020.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Controlled Substances Act (CSA) provides that proceedings for
the issuance, amendment, or repeal 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). This action was initiated on the Attorney
General's own motion, as delegated to the Administrator of the DEA, and
is supported by, inter alia, a recommendation from the Assistant
Secretary for Health of HHS and an evaluation of all relevant data by
the DEA. This action continues the imposition of the regulatory
controls and administrative, civil, and criminal sanctions of schedule
I controlled substances on any person who handles or proposes to handle
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA.
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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), the FDA acts as the lead agency within the
Department of Health and Human Services (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 the
HHS has delegated to the Assistant Secretary for Health of the HHS
the authority to make domestic drug scheduling recommendations. 58
FR 35460, July 1, 1993.
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Background
On April 10, 2017, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place the six synthetic
cannabinoids (SCs) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-
(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-
AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
[5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] in
schedule I of the CSA pursuant to the temporary scheduling provisions
of 21 U.S.C. 811(h). 82 FR 17119. That temporary scheduling order was
effective on the date of publication, and was based on findings by the
former Acting Administrator of the DEA (Acting Administrator) that the
temporary scheduling of these six SCs was necessary to avoid an
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).
Section 201(h)(2) of
[[Page 4212]]
the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of
these substances expire two years from the issuance date of the
scheduling order, on or before April 9, 2019. However, the CSA also
provides that during the pendency of proceedings under 21 U.S.C.
811(a)(1) with respect to the substance, the temporary scheduling of
that substance could be extended for up to one year. Accordingly, on
April 8, 2019, DEA extended the temporary scheduling of 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA by one year,
or until April 9, 2020. 84 FR 13796. Also, on April 8, 2019, DEA
published a notice of proposed rulemaking (NPRM) to permanently control
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA in schedule I of the CSA. 84 FR 13848. Specifically, DEA
proposed to add these six SCs to the hallucinogenic substances list
under 21 CFR 1308.11(d).
DEA and HHS Eight Factor Analyses
On March 21, 2019, HHS provided DEA with a scientific and medical
evaluation document prepared by the Food and Drug Administration (FDA)
entitled ``Basis for the Recommendation to Place Methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB;
5F-MDMB-PINACA]; Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA], Methyl
2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-FUBINACA] and their Salts in Schedule I of the Controlled
Substances Act.'' 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 Assistant
Secretary of HHS recommended that 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA be controlled in schedule I of
the CSA. In response, DEA conducted its own eight factor analysis of
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA. The DEA and HHS analyses are available in their entirety in
the public docket for this rule (Docket Number DEA-446) at http://www.regulations.gov under ``Supporting Documents.''
Determination to Schedule 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and MDMB-FUBINACA
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendations from HHS, DEA
published a NPRM entitled ``Schedules of Controlled Substances:
Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and
MDMB-FUBINACA in Schedule I.'' This NPRM proposed to control 5F-ADB,
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA, and
their salts, isomers, and salts of isomers in schedule I of the CSA. 84
FR 13848, April 8, 2019. The proposed rule provided an opportunity for
interested persons to file a request for hearing in accordance with DEA
regulations on or before May 8, 2019. No requests for such a hearing
were received by DEA. The NPRM also provided an opportunity for
interested persons to submit comments on the proposed rule on or before
May 8, 2019.
Comments Received
The DEA received three comments on the proposed rule to control 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA
in schedule I of the CSA.
Support for rulemaking: Two commenters recognized the dangers and
public health risks, and supported the rulemaking to permanently place
these substances in schedule I.
DEA Response: The DEA appreciates the comments in support of this
rulemaking.
Dissent for rulemaking: One commenter stated that while SCs, in
general, could pose a public health risk, are more harmful than
``traditional cannabis,'' and have no known legitimate medical use,
this individual disagreed with the permanent control of these specific
six substances. This commenter also questioned the appropriateness and
effectiveness of current drug control policy and mentioned use of
alternative approaches such as investing in treatment of current SC
users, education about harmful effects of SCs, removal of cannabis from
schedule I, and additional research into the substances at issue in
this rulemaking. In addition, the commenter discussed the increased
cost associated with regulatory, administrative, and enforcement
activities involving scheduled drugs and concern over potential tribal
implications.
DEA response: DEA's mission is to enforce the controlled substance
laws and regulations of the United States. The CSA contains specific
mandates pertaining to the scheduling of controlled substances. DEA has
followed all of those mandates regarding the scheduling of 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA,
including receiving from the Secretary of HHS a scientific and medical
evaluation, and recommendation, regarding control (21 U.S.C. 811(b));
considering the factors enumerated in 21 U.S.C. 811(c); determining,
based on the above, appropriate scheduling for these SCs (21 U.S.C.
812(b)); and conducting a formal rulemaking to schedule these SCs (21
U.S.C. 811(a)). These SCs satisfy the CSA's criteria for placement in
schedule I by virtue of their high potential for abuse, the fact that
these substances have no currently accepted medical use in treatment in
the United States, and their lack of accepted safety for use of the
substance under medical supervision. 21 U.S.C. 812(b)(1).
As per the commenter's views regarding the appropriateness and
effectiveness of current drug control policy, use of alternative
approaches such as investing in treatment, education about harmful
effects of SCs, and removal of cannabis from schedule I, these are
outside the scope of the current scheduling action.
Regarding the increased costs associated with regulatory,
administrative, and enforcement activities involving scheduled drugs,
these issues are not unique to the substances that are currently being
controlled by this final rule.
Regarding the commenter's concern that the scheduling of these SCs
will have tribal implications, DEA has analyzed the expected impact of
this final rule, and has determined that it will 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. As evidence, the commenter cites the
incarceration rates of Native Americans and native youths relative to
the national average; however, does not explain how this data is
relevant to the substances being permanently scheduled in this final
rule.
[[Page 4213]]
As per the comment related to additional research into the
substances at issue in this rulemaking, DEA has utilized funding of its
own to conduct pharmacological research studies into all these six
substances. The data generated from these studies have been utilized in
evaluating these substances for control under the CSA. HHS, upon
conducting scientific and medical evaluation of these and all available
data, recommended schedule I controls for these substances. DEA
conducted its own review of HHS scientific and medical evaluation and
all other relevant data and determined that these substances warrant
control as schedule I substances under the CSA. Additional information
about these substances can be viewed in the public docket for this rule
(Docket Number DEA-446) at http://www.regulations.gov under
``Supporting Documents.''
Scheduling Conclusion
After consideration of the relevant matter presented as a result of
public comments, the scientific and medical evaluations and
accompanying recommendation of HHS, and after its own eight-factor
evaluation, DEA finds that these facts and all other relevant data
constitute substantial evidence of potential for abuse of 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA. As such,
DEA is permanently scheduling 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA, and MDMB-FUBINACA 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 Assistant Secretary for HHS and review of all
other available data, the Acting Administrator of DEA, pursuant to 21
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
(1) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] 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) Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] have no
currently accepted medical use in treatment in the United States; and
(3) There is a lack of accepted safety for use of methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB;
5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and
methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [MDMB-FUBINACA] under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA],
including their salts, isomers and salts of isomers, whenever the
existence of such salts, isomers, and salts of isomers is possible,
warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA, and MDMB-FUBINACA
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA will continue \2\ to be subject to the CSA's schedule I
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, dispensing, importing,
exporting, research, and conduct of instructional activities, including
the following:
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\2\ 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and
MDMB-FUBINACA are currently subject to schedule I controls on a
temporary basis, pursuant to 21 U.S.C. 811(h). 82 FR 17119, April
10, 2017.
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1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research, or conducts instructional
activities or chemical analysis with, or possesses), or who desires to
handle, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-
FUBINACA 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA,
and MDMB-FUBINACA are subject to schedule I security requirements and
must be handled in accordance with 21 CFR 1301.71-1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA,
and MDMB-FUBINACA 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or
MDMB-FUBINACA 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA was required to
[[Page 4214]]
keep an inventory of all stocks of these substances on hand as of April
10, 2017, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA, and/or MDMB-FUBINACA, pursuant to 21 U.S.C. 827
and 958(e), and in accordance with 21 CFR parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA must
continue to comply with the order form requirements, pursuant to 21
U.S.C. 828, and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA
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-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA 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, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
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 12866 and the principles reaffirmed in
Executive Order 13563.
This final rule does not meet the definition of an Executive Order
13771 regulatory action. OMB has previously determined that formal
rulemaking actions concerning the scheduling of controlled substances,
such as this rule, are not significant regulatory actions under section
3(f) of Executive Order 12866.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 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
This rulemaking does not have federalism implications warranting
the application of Executive Order 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
This rule does not have tribal implications warranting the
application of Executive Order 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 Acting Administrator, in accordance with the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601-602, 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 10,
2017, DEA published an order to temporarily place these six 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-
FUBINACA. There are currently 33 registrations authorized to handle 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and/or MDMB-
FUBINACA specifically, as well as a number of registered analytical
labs that are authorized to handle schedule I controlled substances
generally. These 33 registrations represent 28 entities, of which 22
are small entities. Therefore, DEA estimates 22 small entities are
affected by this rule.
A review of the 33 registrations indicates that all entities that
currently handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA,
or MDMB-FUBINACA also handle other schedule I controlled substances,
and have established and implemented (or maintain) the systems and
processes required to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA, or MDMB-FUBINACA. Therefore, DEA anticipates that this
rule will impose minimal or no economic impact on any affected
entities; and, thus, will not have a significant economic impact on any
of the 22 affected small entities. Therefore, DEA has concluded that
this rule will not have a significant effect 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 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.
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.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices for consumers, individual industries, Federal, State,
or local government agencies, or geographic regions; or significant
adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
However, pursuant to the CRA, DEA has submitted a copy of this final
rule to both Houses of Congress and to the Comptroller General.
[[Page 4215]]
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)(73) through (78); and
0
b. Remove and reserve paragraphs (h)(6) through (11);
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)- 7034
3,3-dimethylbutanoate (Other names: 5F-ADB; 5F-MDMB-PINACA)...
(74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3- 7033
methylbutanoate (Other names: 5F-AMB).........................
(75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3- 7049
carboxamide (Other names: 5F-APINACA, 5F-AKB48)...............
(76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- 7010
fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-
FUBINACA).....................................................
(77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)- 7042
3,3-dimethylbutanoate (Other names: MDMB-CHMICA, MMB-CHMINACA)
(78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)- 7020
3,3-dimethylbutanoate (Other names: MDMB-FUBINACA)............
* * * * *
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-00665 Filed 1-23-20; 8:45 am]
BILLING CODE 4410-09-P