Schedules of Controlled Substances: Placement of MAB-CHMINACA in Schedule I
| Citation | 84 FR 444 |
| Record Number | 2019-00254 |
| Published date | 29 January 2019 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration,Justice Department |
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Federal Register / Vol. 84, No. 19 / Tuesday, January 29, 2019 / Rules and Regulations
AD is required to be furnished with the
aircraft, per 14 CFR 25.1581. Further, operators of the aircraft affected by this AD
must operate in accordance with the limitations specified in the AFM, per 14 CFR
91.9.
(h) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards
District Office, as appropriate. If sending
information directly to the manager of the
certification office, send it to the attention of
the person identified in paragraph (i) of this
AD. Information may be emailed to: 9-ANM-
Seattle-ACO-AMOC-Requests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by the Boeing
Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Seattle ACO
Branch, to make those findings. To be
approved, the repair method, modification
deviation, or alteration deviation must meet
the certification basis of the airplane, and the
approval must specifically refer to this AD.
(i) Related Information
For more information about this AD,
contact Rebel Nichols, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines,
WA 98198; phone and fax: 206–231–3556;
email: Rebel.Nichols@faa.gov.
(j) Material Incorporated by Reference
None.
Issued in Des Moines, Washington, on
January 23, 2019.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft
Certification Service.
[FR Doc. 2019–00297 Filed 1–28–19; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–421]
Schedules of Controlled Substances:
Placement of MAB-CHMINACA in
Schedule I
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Final rule.
SUMMARY
: The Drug Enforcement
Administration places N-(1-amino-3,3-
dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide (MAB-CHMINACA; ADB-
CHMINACA), 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
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ER29JA19.000</GPH>
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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.
persons who handle (manufacture,
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis, or
possess), or propose to handle MAB-
CHMINACA.
DATES
: Effective January 29, 2019.
FOR FURTHER INFORMATION CONTACT
:
Regulatory Drafting and Policy Section,
Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(202) 598–8953.
SUPPLEMENTARY INFORMATION
:
Legal Authority
Under the Controlled Substances Act
(CSA), each controlled substance is
classified into one of five schedules
based upon its potential for abuse, its
currently accepted medical use, and the
degree of dependence the substance
may cause. 21 U.S.C. 812. The initial
schedules of controlled substances
established by Congress are found at 21
U.S.C. 812(c), and the current list of
scheduled substances is published at 21
CFR part 1308.
Pursuant to 21 U.S.C. 811(a)(1), the
Attorney General may, by rule, ‘‘add to
such a schedule or transfer between
such schedules any drug or other
substance if he (A) finds that such drug
or other substance has a potential for
abuse, and (B) makes with respect to
such drug or other substance the
findings prescribed by subsection (b) of
section 812 of this title for the schedule
in which such drug is to be placed.
. . . ’’ The Attorney General has
delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the
DEA (Administrator). 28 CFR 0.100.
The 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, and is
supported by, inter alia, a
recommendation from the Acting
Assistant Secretary for Health of the
HHS (Acting Assistant Secretary) 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 MAB-
CHMINACA.
Background
On February 5, 2016, the DEA
published a final order in the Federal
Register amending 21 CFR 1308.11(h) to
temporarily place the synthetic
cannabinoid N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (other
names: MAB-CHMINACA; ADB-
CHMINACA) in schedule I of the CSA
pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). 81 FR
6171. That final order was effective on
the date of publication, and was based
on findings by the Acting Administrator
of the DEA (Acting Administrator) that
the temporary scheduling of this
synthetic cannabinoid 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 expire two
years from the issuance date of the
scheduling order, on or before February
4, 2018. 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 January 30, 2018, the
DEA extended the temporary scheduling
of MAB-CHMINACA by one year, or
until February 5, 2019. 83 FR 4411.
Also, on January 30, 2018, the DEA
published a notice of proposed
rulemaking (NPRM) to permanently
control MAB-CHMINACA in schedule I
of the CSA. 83 FR 4406. Specifically, the
DEA proposed to add this synthetic
cannabinoid to the hallucinogenic
substances list under 21 CFR
1308.11(d).
DEA and HHS Eight Factor Analyses
On January 19, 2018, the HHS
provided the DEA with a scientific and
medical evaluation document prepared
by the Food and Drug Administration
(FDA) entitled ‘‘Basis for the
Recommendation to Place N-(1-amino-
3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide (MAB-CHMINACA; ADB-
CHMINACA), and its 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 Acting Assistant Secretary
recommended that MAB-CHMINACA be
controlled in schedule I of the CSA. In
response, the DEA conducted its own
eightfactor analysis of MAB-
CHMINACA. The DEA and HHS
analyses are available in their entirety in
the public docket for this rule (Docket
Number DEA–421/DEA–2018–0001) at
http://www.regulations.gov under
‘‘Supporting Documents.’’
Determination to Schedule MAB-
CHMINACA
After a review of the available data,
including the scientific and medical
evaluation, and the scheduling
recommendations from the HHS, the
DEA published an NPRM entitled
‘‘Schedules of Controlled Substances:
Placement of MAB-CHMINACA into
Schedule I.’’ This NPRM proposed to
control MAB-CHMINACA, and its salts,
isomers, and salts of isomers in
schedule I of the CSA. 83 FR 4406,
January 30, 2018. The proposed rule
provided an opportunity for interested
persons to file a request for hearing in
accordance with the DEA regulations on
or before March 1, 2018. No requests for
such a hearing were received by the
DEA. The NPRM also provided an
opportunity for interested persons to
submit written comments on the
proposed rule on or before March 1,
2018.
Comments Received
The DEA received six comments on
the proposed rule to control MAB-
CHMINACA in schedule I of the CSA.
Not related to rulemaking: Four
commenters submitted responses that
did not pertain to the rulemaking and
were not considered.
DEA’s Future Diversion Efforts: One
commenter quoted various statements
from the proposed rule pertaining to the
risk of MAB-CHMINACA to the public
health (i.e., information about clusters
of overdoses, deaths, and adverse health
effects associated with these incidents)
and questioned the DEA’s future
response to stay ahead of synthetic
cannabinoid manufacturers who alter
the chemical formulation of substances
to circumvent current controls.
DEA Response: The DEA continues to
monitor various synthetic cannabinoids
and has taken additional control actions
against new substances as they are
encountered. The DEA is continuing to
use all available resources to address the
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2
MAB-CHMINACA is currently subject to
schedule I controls on a temporary basis, pursuant
to 21 U.S.C. 811(h). 81 FR 6171, Feb. 5, 2016.
issue of trafficking and abuse of novel
psychoactive substances to safeguard
the public from hazards associated with
these substances.
Dissent for rulemaking: One
commenter acknowledged that MAB-
CHMINACA has no currently accepted
medical use in treatment and there is a
lack of accepted safety for its use under
medical supervision. However, the
commenter believes this does not
represent the danger or high abuse
potential of the substance, attributed to
it by DEA. Rather, the commenter
believes MAB-CHMINACA is so similar
to tetrahydrocannabinol (THC) that its
use is ‘‘a symptom of’’ the schedule I
controls placed on THC, and questions
the reliability of the data that DEA
provided—as reported by state public
health entities over a two-month period
in 2015—to support Factor 4 (Its History
and Current Pattern of Abuse). The
commenter predicted that use of this
drug has likely dropped since 2015 due
to ‘‘medicinal THC use’’ becoming more
acceptable by the general public
nationwide, and therefore does not
reflect the current abuse potential.
Additionally, this commenter expressed
concern that placing MAB-CHMINACA
in schedule I would prevent medical
research.
DEA Response: The DEA does not
agree. Both the DEA and HHS analyses
documented serious adverse effects
including the deaths of individuals
following the ingestion of MAB-
CHMINACA. Pharmacology studies,
overdose reports, law enforcement
seizures, and other data collectively
demonstrated the hazard to public
safety and the dangers associated with
this substance. With regard to the
commenter’s prediction that abuse of
MAB-CHMINACA will become
secondary due to the notion that THC is
becoming more widely accepted, it is
important to note that the extent of
trafficking and abuse of a given
substance at a given time is not typically
determined by a sole factor. Complex
factors related to the substance’s abuse
potential, market dynamics such as
availability of similar other novel
substances, and drug use trends in the
drug abuser community are also
considered when scheduling a
substance. In fact, following temporary
control of MAB-CHMINACA, several
pharmacologically similar new
substances appeared on the illicit
market and the DEA has taken control
actions on these substances. While
MAB-CHMINACA continues to be
abused in the United States, law
enforcement encounters have decreased,
as normally occur following the control
of synthetic cannabinoids, including
MAB-CHMINACA. As with other
dangerous substances, the placement of
a drug in schedule I does require
additional regulatory controls. The
Diversion Control Division’s mission is
to prevent, detect and investigate the
diversion of controlled substances while
ensuring an adequate and uninterrupted
supply of these substances to meet
legitimate medical, commercial and
scientific needs. The DEA ensures that
adequate security measures and
background investigations are
conducted for researchers who have
legitimate need to conduct research and
development with schedule I controlled
synthetic drug substances.
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, the DEA
finds that these facts and all other
relevant data constitute substantial
evidence of potential for abuse of MAB-
CHMINACA. As such, the DEA is
permanently scheduling MAB-
CHMINACA as a controlled substance
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 analyses and
recommendations of the Assistant
Secretary and review of all other
available data, the Acting
Administrator, pursuant to 21 U.S.C.
811(a) and 812(b)(1), finds that:
(1) N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (MAB-
CHMINACA; ADB-CHMINACA) has a
high potential for abuse that is
comparable to other schedule I
substances such as delta-9-
tetrahydrocannabinol (D
9
-THC) and
JWH–018;
(2) N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (MAB-
CHMINACA; ADB-CHMINACA) has no
currently accepted medical use in
treatment in the United States; and
(3) There is a lack of accepted safety
for use of N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (MAB-
CHMINACA; ADB-CHMINACA) under
medical supervision.
Based on these findings, the Acting
Administrator concludes that N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide (MAB-CHMINACA; ADB-
CHMINACA), 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 MAB-
CHMINACA
MAB-CHMINACA 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:
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, MAB-
CHMINACA must be registered with the
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. MAB-CHMINACA is
subject to schedule I security
requirements and must be handled and
stored pursuant to 21 U.S.C. 821, 823,
871(b) and in accordance with 21 CFR
1301.71–1301.93.
3. Labeling and Packaging. All labels
and labeling for commercial containers
of MAB-CHMINACA 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 MAB-CHMINACA 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 MAB-
CHMINACA on the effective date of this
final rule, must take an inventory of all
stocks of these substances on hand as of
January 29, 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). Current DEA registrants shall
have 30 calendar days from the effective
date of this order to be in compliance
with all inventory requirements.
After the initial inventory, every DEA
registrant must take a new inventory of
all controlled substances (including
MAB-CHMINACA) on hand on a
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biennial basis, 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 MAB-
CHMINACA 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 MAB-CHMINACA 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 MAB-
CHMINACA 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
MAB-CHMINACA 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 scheduling action is subject to
formal rulemaking procedures done ‘‘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, 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 February 6, 2016, the DEA published
a final order to temporarily place this
substance in schedule I of the CSA
pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). The DEA
estimates that all entities handling or
planning to handle these substances
have already established and
implemented the systems and processes
required to handle MAB-CHMINACA.
As of January 2018, there were 16
registrations authorized to handle MAB-
CHMINACA specifically, as well as a
number of registered analytical labs that
are authorized to handle schedule I
controlled substances generally. These
16 registrations represent 14 entities, of
which 8 are small entities. Therefore,
the DEA estimates eight small entities
are affected by this rule.
A review of the 16 registrations
indicates that all entities that currently
handle MAB-CHMINACA also handle
other schedule I controlled substances,
and have established and implemented
(or maintain) the systems and processes
required to handle MAB-CHMINACA.
Therefore, the 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 eight affected small entities.
Therefore, the 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., the 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 for inflation) in any one 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, the 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
■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.
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■2. In § 1308.11, add paragraph (d)(72)
and remove and reserve paragraph
(h)(1).
The addition to read as follows:
§ 1308.11 Schedule I.
* * * * *
(d) * * *
(72) N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(cyclohexylmethyl)-
1H-indazole-3-carboxamide (MAB-
CHMINACA; ADB-
CHMINACA)....................(7032)
* * * * *
Dated: January 18, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–00254 Filed 1–28–19; 8:45 am]
BILLING CODE 4410–09–P
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