Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
| Published date | 30 March 2020 |
| Citation | 85 FR 17494 |
| Record Number | 2020-06176 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 61 (Monday, March 30, 2020)
[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Rules and Regulations]
[Pages 17494-17497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06176]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-472]
Schedules of Controlled Substances: Placement of FUB-AMB in
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) places methyl 2-(1-
(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its 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 FUB-AMB.
DATES: Effective March 30, 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) 598-8953.
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 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 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 FUB-AAMB.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Background
On November 3, 2017, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 82
FR 51154. 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 FUB-AMB 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 the
CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of this
substance expires two years from the issuance date of the scheduling
order, on or before November 3, 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 October 30, 2019,
DEA extended the temporary scheduling of FUB-AMB by one year, or until
November 2, 2020. 84 FR 58045. Also, on October 30, 2019, DEA published
a notice of proposed rulemaking (NPRM) to permanently control FUB-AMB
in schedule I of the CSA. 84 FR 58090. Specifically, DEA proposed to
add FUB-AMB to the hallucinogenic substances list under 21 CFR
1308.11(d).
DEA and HHS Eight Factor Analyses
On September 19, 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-(4-fluorobenzyl)-1H -indazole-3- carboxamido)-3-
methylbutanoate (FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), and its salts,
in schedule I of the CSA.'' After considering the eight factors in 21
U.S.C. 811(c), FUB-AMB'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), HHS Assistant
Secretary recommended that FUB-AMB be controlled in schedule I of the
CSA. In response, DEA conducted its own eightfactor analysis of FUB-AMB
and concluded that this substance warrants control in schedule I of the
CSA. Both DEA's and HHS's eight-factor analyses are available in their
entirety in the public docket for this rule (Docket Number DEA-472) at
http://
[[Page 17495]]
www.regulations.gov under ``Supporting Documents.''
Determination to Schedule FUB-AMB
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendation from HHS, DEA
published an NPRM entitled ``Schedules of Controlled Substances:
Placement of FUB-AMB in Schedule I.'' This NPRM proposed to control
FUB-AMB, and its salts, isomers, and salts of isomers in schedule I of
the CSA. 84 FR 58090, October 30, 2019. The proposed rule provided an
opportunity for interested persons to file a request for hearing in
accordance with DEA regulations on or before November 29, 2019. No
requests for such a hearing were received by DEA. The Notice of
Proposed Rulemaking also provided an opportunity for interested persons
to submit comments on the proposed rule on or before November 29, 2019.
Comments Received
DEA received four comments on the proposed rule to control FUB-AMB
in schedule I of the CSA.
Support for rulemaking: One commenter recognized the dangers and
public health risks, and supported the rulemaking to permanently place
FUB-AMB in schedule I.
DEA Response: DEA appreciates the comment in support of this
rulemaking.
Unrelated to rulemaking: One comment did not pertain to the
rulemaking.
Mixed support for rulemaking: One commenter referred to FUB-AMB as
a stimulant, and stated that they knew why the situation is being
addressed following its abuse. The commenter stated that there are
people that need this substance, and stimulants in general, for their
health, but did not go further into details specifically for FUB-AMB.
DEA Response: Contrary to the commenter's statement, FUB-AMB is not
a stimulant, and is a synthetic cannabinoid substance. As stated by HHS
in its letter dated June 9, 2017 to DEA, there are currently no
approved drug applications or active investigational new drug
applications for FUB-AMB, and FUB-AMB has not been shown to be safe and
effective for any clinical condition. Therefore, FUB-AMB has no
accepted medical use for treatment in the United States. Further, since
its initial identification in the United States in June 2014, serious
adverse effects including deaths have been reported following its use
(see eight-factor analysis at Docket Number DEA-472).
Research on Schedule I Controlled Substances: One commenter stated
that no drug should be barred from use in academic and clinical
research settings. The commenter stated that it is important to study
the therapeutic effects and potential benefits of a substance. The
commenter further mentioned that placing drugs in schedule I reduces
their access and prohibits research. The commenter also suggested
decriminalization of all drugs.
DEA response: DEA disagrees with the commenter's statement that
schedule I drugs are prohibited from being researched by the scientific
community. Placing a substance in schedule I of the CSA does not
prohibit research on that substance, including FUB-AMB. The CSA
provided the specific administrative process to approve the bonafide
research with schedule I drug substances. A schedule I registrant can
conduct research with schedule I substances upon receiving appropriate
approval from DEA.
With regard to the commenter's statement related to drug policy
involving decriminalization of all drugs, this comment is outside the
scope of the current scheduling action. DEA's mission is to enforce the
controlled substance laws and regulations. The CSA contains specific
mandates pertaining to the scheduling of controlled substances. DEA has
followed all of those mandates regarding the scheduling of FUB-AMB,
including receiving from HHS Assistant Secretary a scientific and
medical evaluation, and scheduling 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 FUB-AMB (21
U.S.C. 812(b)); and conducting a formal rulemaking to schedule FUB-AMB
(21 U.S.C. 811(a)). FUB-AMB satisfies the CSA's criteria for placement
in schedule I by virtue of its high potential for abuse, the fact that
FUB-AMB has no currently accepted medical use in treatment in the
United States, and its lack of accepted safety for use of this
substance under medical supervision. 21 U.S.C. 812(b)(1).
Additional information about FUB-AMB can be viewed in the public
docket for this rule (Docket Number DEA-472) 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 evaluation and the
accompanying scheduling 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 FUB-AMB.
As such, DEA is permanently scheduling FUB-AMB as a controlled
substance under the CSA.
Determination of Appropriate SSchedule
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 the DEA, pursuant to
21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
(1) Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) has
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-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) has
no currently accepted medical use in treatment in the United States
\2\; and
---------------------------------------------------------------------------
\2\ Although there is no evidence suggesting that methyl 2-(1-
(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) has a currently accepted
medical use 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 the 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).
---------------------------------------------------------------------------
(3) There is a lack of accepted safety for use of methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-
[[Page 17496]]
FUBINACA), including its salts, isomers and salts of isomers, whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling FUB-AMB
FUB-AMB will continue \3\ 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:
---------------------------------------------------------------------------
\3\ FUB-AMB is currently subject to schedule I controls on a
temporary basis, pursuant to 21 U.S.C. 811(h). 82 FR 51154, November
3, 2017.
---------------------------------------------------------------------------
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, FUB-AMB, 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. FUB-AMB is subject to schedule I security requirements
and must be handled and stored pursuant to 21 U.S.C. 821 and 823 and in
accordance with 21 CFR parts 1301.71-1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of FUB-AMB 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 FUB-AMB 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 whose registration currently
authorizes handling FUB-AMB and who possesses any quantity of FUB-AMB
on the effective date of this final rule must maintain an inventory of
all stocks of FUB-AMB on hand, pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Any person who
becomes registered with DEA on or after the effective date of this
final rule must take an initial inventory of all stocks of FUB-AMB on
hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11. After the initial inventory, every DEA
registrant must take a new inventory of all stocks of controlled
substances (including FUB-AMB) on hand every two years 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 FUB-AMB, 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 FUB-AMB 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
FUB-AMB 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 FUB-AMB 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, Civil Justice Reform
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, Federalism
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, Consultation and Coordination With Indian Tribal
Governments
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 (RFA)
The Acting Administrator, in accordance with the 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 November 3, 2017, DEA published an order to
temporarily place FUB-AMB in schedule I of the CSA pursuant to the
temporary scheduling provisions of 21 U.S.C. 811(h). On October 30,
2019, DEA published a temporary scheduling order extending the
temporary scheduling of FUB-AMB for up to one year pursuant to 21
U.S.C. 8119h)(2). Accordingly, all entities that currently handle or
plan to handle FUB-AMB have already established and implemented the
systems and processes required to handle FUB-AMB. There are currently
22 registrations authorized to handle FUB-AMB specifically, as well as
a number of registered analytical labs that are authorized to handle
schedule I controlled substances generally. These 22 registrations
represent 20 entities, of which 12 are small entities. Therefore, DEA
estimates 12 small entities are affected by this rule.
A review of the 22 registrations indicates that all entities that
currently handle FUB-AMB also handle other schedule I controlled
substances, and have established and implemented (or maintain) the
systems and processes required to handle FUB-AMB. 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 12 affected small entities. Therefore, DEA
[[Page 17497]]
has concluded that this rule will not have a significant effect on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995 (UMRA)
In accordance with the 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 (CRA)
This rule is not a major rule as defined by the 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.
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 paragraph (d)(79); and
0
b. Remove and reserve paragraph (h)(18).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(79) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate, (FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) . . . (7021)
* * * * *
Dated: March 13, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-06176 Filed 3-27-20; 8:45 am]
BILLING CODE 4410-09-P
