Schedules of Controlled Substances: Placement of MAB-CHMINACA in Schedule I, 444-448 [2019-00254]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 84, Number 19 (Tuesday, January 29, 2019)]
[Rules and Regulations]
[Pages 444-448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00254]


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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.

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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

[[Page 445]]

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.
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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 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 https://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

[[Page 446]]

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 ([Delta]\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:
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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.
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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, 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

[[Page 447]]

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

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.


[[Page 448]]



0
2. In Sec.  1308.11, add paragraph (d)(72) and remove and reserve 
paragraph (h)(1).
    The addition to read as follows:


Sec.  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