[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47971-47974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22325]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-402]


Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-
PINACA and THJ-2201 Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-
3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-
PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone (THJ-2201), including their salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible, into schedule I of the Controlled Substances Act. 
This scheduling action is pursuant to the Controlled Substances Act 
which requires that such actions be made on the record after 
opportunity for a hearing through formal rulemaking. This rule 
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 AB-CHMINACA, AB-
PINACA and THJ-2201.

DATES: Effective October 16, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

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

[[Page 47972]]

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. 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 of the DEA, and is supported by, 
inter alia, a recommendation from the Assistant Secretary for Health of 
the 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 AB-CHMINACA, AB-PINACA and 
THJ-2201.
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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 January 30, 2015, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place the three 
synthetic cannabinoids N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-
3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-
PINACA), and[1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl) 
methanone (THJ-2201) into schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). 80 FR 5042. That 
final order was effective on the date of publication, and was based on 
findings by the Administrator of the DEA that the temporary scheduling 
of these three synthetic cannabinoids 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 these substances expire two years from the 
issuance date of the scheduling order, on or before January 29, 2017. 
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 27, 2017, the DEA extended the temporary 
scheduling of AB-CHMINACA, AB-PINACA and THJ-2201 by one year, or until 
January 29, 2018. 82 FR 8590. Also, on January 27, 2017, the DEA 
published a notice of proposed rulemaking (NPRM) to permanently control 
AB-CHMINACA, AB-PINACA and THJ-2201 in schedule I of the CSA. 82 FR 
8593. Specifically, DEA proposed to add these three synthetic 
cannabinoids to 21 CFR 1308.11(d), hallucinogenic substances.

DEA and HHS Eight Factor Analyses

    On November 14, 2016, the HHS provided the DEA with a scientific 
and medical evaluation document prepared by the FDA entitled ``Basis 
for the Recommendation to Place [1-(5-Fluoropentyl)-1H-Indazol-3-yl] 
(Naphthalen-1-yl) Methanone (THJ-2201), N-[(2S)-1-Amino-3-Methyl-1-Oxo-
2-Butanyl]-1-Pentyl-1H-Indazole-3-Carboxamide (AB-PINACA), and N-[(2S)-
1-Amino-3-Methyl-1-Oxo-2-Butanyl]-1-(Cyclohexylmethyl)-1H-Indazole-3-
Carboxamide (AB-CHMINACA) and their Salts in Schedule I of the 
Controlled Substances Act.'' After considering the eight factors in 21 
U.S.C. 811(c), and also considering 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 the HHS recommended that AB-
CHMINACA, AB-PINACA and THJ-2201 be controlled in schedule I of the 
CSA. In response, the DEA conducted its own eightfactor analysis of AB-
CHMINACA, AB-PINACA and THJ-2201. The DEA and HHS analyses are 
available in their entirety in the public docket for this rule (Docket 
Number DEA-402/DEA-2017-0001) at http://www.regulations.gov under 
``Supporting Documents.''

Determination to Schedule AB-CHMINACA, AB-PINACA and THJ-2201

    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 AB-CHMINACA, AB-PINACA and THJ-2201 into Schedule I,'' 
proposing to control AB-CHMINACA, AB-PINACA and THJ-2201, and their 
salts, isomers, and salts of isomers in schedule I of the CSA. 82 FR 
8593, January 27, 2017. The proposed rule provided an opportunity for 
interested persons to file a request for hearing in accordance with the 
DEA regulations on or before February 27, 2017. 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 proposal on or 
before February 27, 2017.

Comments Received

    The DEA received five comments on the proposed rule to control AB-
CHMINACA, AB-PINACA and THJ-2201 in schedule I of the CSA.
    Support for rulemaking: Five commenters gave support for the 
rulemaking stating in unison that these substances have no medical use 
and are a danger to the community.
    DEA Response: The DEA appreciates the comments in support of this 
rulemaking.

Scheduling Conclusion

    After consideration of the relevant matter presented as a result of 
public comments, the scientific and medical evaluations and 
accompanying recommendation of the 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 AB-CHMINACA, 
AB-PINACA and THJ-2201. As such, the DEA is permanently scheduling AB-
CHMINACA, AB-PINACA and THJ-2201 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 analyses and

[[Page 47973]]

recommendations of the Assistant Secretary for HHS and review of all 
other available data, the Administrator of the DEA, pursuant to 21 
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    (1) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-
yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-
fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) 
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) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-
yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-
fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) 
have 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-
methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 
(AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-
3-yl](naphthalen-1-yl)methanone (THJ-2201) under medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-
yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-
fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) 
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 AB-CHMINACA, AB-PINACA and THJ-2201

    AB-CHMINACA, AB-PINACA and THJ-2201 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\ AB-CHMINACA, AB-PINACA or THJ-2201 are currently subject to 
schedule I controls on a temporary basis, pursuant to 21 U.S.C. 
811(h). 80 FR 5042, Jan. 30, 2015.
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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 AB-CHMINACA, AB-PINACA or THJ-2201, 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. AB-CHMINACA, AB-PINACA or THJ-2201are 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 through 1301.93.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of AB-CHMINACA, AB-PINACA or THJ-2201 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 AB-CHMINACA, AB-PINACA or THJ-2201 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 
AB-CHMINACA, AB-PINACA and THJ-2201 on the effective date of this final 
rule, must take an inventory of all stocks of these substances on hand 
as of October 16, 2017, 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 AB-CHMINACA, AB-
PINACA and THJ-2201) on hand on a 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 AB-CHMINACA, AB-PINACA and/or THJ-
2201 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 AB-CHMINACA, 
AB-PINACA or THJ-2201 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 
AB-CHMINACA, AB-PINACA or THJ-2201 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 AB-CHMINACA, AB-PINACA or THJ-
2201 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 and 13563

    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.

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 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

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substantial number of small entities. On January 30, 2015, the DEA 
published a final order to temporarily place these three substances 
into 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 AB-CHMINACA, AB-PINACA or THJ-2201. There are currently 25 
registrations authorized to handle AB-CHMINACA, AB-PINACA and/or THJ-
2201 specifically, as well as a number of registered analytical labs 
that are authorized to handle schedule I controlled substances 
generally. These 25 registrations represent 18 entities, of which 8 are 
small entities. Therefore, the DEA estimates eight small entities are 
affected by this rule.
    A review of the 25 registrations indicates that all entities that 
currently handle AB-CHMINACA, AB-PINACA or THJ-2201 also handle other 
schedule I controlled substances, and have established and implemented 
(or maintain) the systems and processes required to handle AB-CHMINACA, 
AB-PINACA or THJ-2201. 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 section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). 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 U.S.-based companies to 
compete with foreign based companies 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 part 1308 continues to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. In Sec.  1308.11,
0
a. Add paragraphs (d)(69) through (71);
0
b. Remove paragraphs (h)(1) through (3); and
0
c. Redesignate paragraphs (h)(4) through (17) as (h)(1) through (14).
    The additions to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(69) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-                      (7031)
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)..............................................
(70) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-            (7023)
 indazole-3-carboxamide (AB-PINACA).....................
(71) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-           (7024)
 yl)methanone (THJ-2201)................................
 

* * * * *

    Dated: October 6, 2017.
Robert Patterson,
Acting Administrator.
[FR Doc. 2017-22325 Filed 10-13-17; 8:45 am]
BILLING CODE 4410-09-P