82 FR 47971 - Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 198 (October 16, 2017)

Page Range		47971-47974
FR Document		2017-22325
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.
Federal Register, Volume 82 Issue 198 (Monday, October 16, 2017)
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47971-47974]
From the Federal Register Online  [www.thefederalregister.org]
[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

[[Page 47974]]

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
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47971

final order. The necessary special casing containing an inert polymer with Dated: October 10, 2017.
controls appear in the regulation a covalently bound enzyme through Anna K. Abram,
codified by this order. This device is which nutritional formula is directed. Deputy Commissioner for Policy, Planning,
subject to premarket notification The device fits in line with enteral Legislation, and Analysis.
requirements under section 510(k). feeding systems. [FR Doc. 2017–22286 Filed 10–13–17; 8:45 am]
At the time of classification, enzyme (b) Classification. Class II (special BILLING CODE 4164–01–P
packed cartridges are for prescription controls). The special controls for this
use only. Prescription devices are device are:
exempt from the requirement for (1) The patient contacting DEPARTMENT OF JUSTICE
adequate directions for use for the components of the device must be
layperson under section 502(f)(1) of the demonstrated to be biocompatible. Drug Enforcement Administration
FD&C Act (21 U.S.C. 352(f)(1)) and 21 (2) In vivo testing must be performed
CFR 801.5, as long as the conditions of and must demonstrate that the device 21 CFR Part 1308
21 CFR 801.109 are met. causes neither an adverse tissue
[Docket No. DEA–402]
III. Analysis of Environmental Impact response nor adverse performance.
(3) Non-clinical testing must Schedules of Controlled Substances:
The Agency has determined under 21 demonstrate that the device performs as
CFR 25.34(b) that this action is of a type Placement of AB-CHMINACA, AB-
intended under anticipated conditions PINACA and THJ-2201 Into Schedule I
that does not individually or of use. The following performance
cumulatively have a significant effect on characteristics must be demonstrated: AGENCY: Drug Enforcement
the human environment. Therefore, (i) Mechanical testing to demonstrate Administration, Department of Justice.
neither an environmental assessment that the device can withstand clinical ACTION: Final rule.
nor an environmental impact statement forces;
is required. SUMMARY: With the issuance of this final
(ii) Flow rate and leakage testing to
IV. Paperwork Reduction Act of 1995 demonstrate that the device does not rule, the Drug Enforcement
impede the flow of enteral formula; Administration places N-(1-amino-3-
This final administrative order methyl-1-oxobutan-2-yl)-1-
establishes special controls that refer to (iii) Demonstration of enzymatic effect
on intended macronutrient; (cyclohexylmethyl)-1H-indazole-3-
previously approved collections of carboxamide (AB-CHMINACA), N-(1-
information found in other FDA (iv) The amount of enzyme that exits
the cartridge must be characterized; amino-3-methyl-1-oxobutan-2-yl)-1-
regulations. These collections of pentyl-1H-indazole-3-carboxamide (AB-
information are subject to review by the (v) Validation that the device does not
adversely impact the nutritional PINACA), and [1-(5-fluoropentyl)-1H-
Office of Management and Budget indazol-3-yl](naphthalen-1-
(OMB) under the Paperwork Reduction composition of enteral formula; and
(vi) Validation that the device does yl)methanone (THJ-2201), including
Act of 1995 (44 U.S.C. 3501–3520). The their salts, isomers, and salts of isomers
collections of information in part 807, not impede flow alarms on enteral
feeding pumps. whenever the existence of such salts,
subpart E, regarding premarket isomers, and salts of isomers is possible,
notification submissions have been (4) Human factors testing must be
performed to characterize use error into schedule I of the Controlled
approved under OMB control number Substances Act. This scheduling action
0910–0120, and the collections of risks.
(5) Performance data must support is pursuant to the Controlled Substances
information in 21 CFR part 801, Act which requires that such actions be
regarding labeling, have been approved shelf life by demonstrating package
integrity and device functionality over made on the record after opportunity for
under OMB control number 0910–0485. a hearing through formal rulemaking.
the identified shelf life.
List of Subjects in 21 CFR Part 876 (6) Labeling must include the This rule continues the imposition of
Medical devices. following: the regulatory controls and
(i) A detailed summary of in vivo administrative, civil, and criminal
Therefore, under the Federal Food,
testing pertinent to use of the device, sanctions applicable to schedule I
Drug, and Cosmetic Act and under
including device-related adverse events; controlled substances on persons who
authority delegated to the Commissioner
(ii) A detailed summary of compatible handle (manufacture, distribute, import,
of Food and Drugs, 21 CFR part 876 is
formulas that is supported by non- export, engage in research, conduct
amended as follows:
clinical testing, including the expected instructional activities or chemical
PART 876—GASTROENTEROLOGY- enzymatic conversion as a percentage; analysis, or possess), or propose to
UROLOGY DEVICES (iii) Detailed instructions on how to handle AB-CHMINACA, AB-PINACA
place the device into an enteral feeding and THJ-2201.
■ 1. The authority citation for part 876 circuit; DATES: Effective October 16, 2017.
continues to read as follows: (iv) A warning regarding the FOR FURTHER INFORMATION CONTACT:
Authority: 21 U.S.C. 351, 360, 360c, 360e, possibility for misconnections; and Michael J. Lewis, Diversion Control
360j, 360l, 371. (v) Expiration date or shelf life. Division, Drug Enforcement
■ 2. Add § 876.5985 to subpart F to read (7) Patient labeling must be provided Administration; Mailing Address: 8701
as follows: and must include: Morrissette Drive, Springfield, Virginia
(i) Relevant warnings, precautions, 22152; Telephone: (202) 598–6812.
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§ 876.5985 Enzyme packed cartridge. adverse effects, and complications; SUPPLEMENTARY INFORMATION:
(a) Identification. An enzyme packed (ii) A description of the device and
cartridge is an ex vivo prescription how it operates; Legal Authority
device that is used in enzymatic (iii) Instructions on how to correctly Under the Controlled Substances Act
hydrolysis of macronutrients into their use the device; and (CSA), each controlled substance is
essential nutrient forms at the time of (iv) The benefits and risks associated classified into one of five schedules
delivery. The device consists of an outer with the use of the device. based upon its potential for abuse, its

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47972 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations

currently accepted medical use, and the Fluoropentyl)-1H-indazol-3- docket for this rule (Docket Number
degree of dependence the substance yl](naphthalen-1-yl) methanone (THJ- DEA–402/DEA–2017–0001) at http://
may cause. 21 U.S.C. 812. The initial 2201) into schedule I of the CSA www.regulations.gov under ‘‘Supporting
schedules of controlled substances pursuant to the temporary scheduling Documents.’’
established by Congress are found at 21 provisions of 21 U.S.C. 811(h). 80 FR
5042. That final order was effective on Determination to Schedule AB-
U.S.C. 812(c), and the current list of
scheduled substances is published at 21 the date of publication, and was based CHMINACA, AB-PINACA and THJ-
CFR part 1308. on findings by the Administrator of the 2201
Pursuant to 21 U.S.C. 811(a)(1), the DEA that the temporary scheduling of After a review of the available data,
Attorney General may, by rule, ‘‘add to these three synthetic cannabinoids was including the scientific and medical
such a schedule or transfer between necessary to avoid an imminent hazard evaluation and the scheduling
such schedules any drug or other to the public safety pursuant to 21 recommendations from the HHS, the
substance if he (A) finds that such drug U.S.C. 811(h)(1). Section 201(h)(2) of the DEA published an NPRM entitled
or other substance has a potential for CSA, 21 U.S.C. 811(h)(2), requires that ‘‘Schedules of Controlled Substances:
abuse, and (B) makes with respect to the temporary control of these Placement of AB-CHMINACA, AB-
such drug or other substance the substances expire two years from the PINACA and THJ-2201 into Schedule I,’’
findings prescribed by subsection (b) of issuance date of the scheduling order, proposing to control AB-CHMINACA,
section 812 of this title for the schedule on or before January 29, 2017. However, AB-PINACA and THJ-2201, and their
in which such drug is to be the CSA also provides that during the salts, isomers, and salts of isomers in
placed. . . .’’ The Attorney General has pendency of proceedings under 21 schedule I of the CSA. 82 FR 8593,
delegated scheduling authority under 21 U.S.C. 811(a)(1) with respect to the January 27, 2017. The proposed rule
U.S.C. 811 to the Administrator of the substance, the temporary scheduling of provided an opportunity for interested
DEA. 28 CFR 0.100. that substance could be extended for up persons to file a request for hearing in
The CSA provides that proceedings to one year. Accordingly, on January 27, accordance with the DEA regulations on
for the issuance, amendment, or repeal 2017, the DEA extended the temporary or before February 27, 2017. No requests
of the scheduling of any drug or other scheduling of AB-CHMINACA, AB- for such a hearing were received by the
substance may be initiated by the PINACA and THJ-2201 by one year, or DEA. The NPRM also provided an
Attorney General (1) on his own motion; until January 29, 2018. 82 FR 8590. opportunity for interested persons to
(2) at the request of the Secretary of the Also, on January 27, 2017, the DEA submit written comments on the
Department of Health and Human published a notice of proposed proposal on or before February 27, 2017.
Services (HHS); 1 or (3) on the petition rulemaking (NPRM) to permanently
of any interested party. 21 U.S.C. 811(a). control AB-CHMINACA, AB-PINACA Comments Received
This action was initiated on the and THJ-2201 in schedule I of the CSA. The DEA received five comments on
Attorney General’s own motion, as 82 FR 8593. Specifically, DEA proposed the proposed rule to control AB-
delegated to the Administrator of the to add these three synthetic CHMINACA, AB-PINACA and THJ-2201
DEA, and is supported by, inter alia, a cannabinoids to 21 CFR 1308.11(d), in schedule I of the CSA.
recommendation from the Assistant hallucinogenic substances. Support for rulemaking: Five
Secretary for Health of the HHS and an commenters gave support for the
DEA and HHS Eight Factor Analyses
evaluation of all relevant data by the rulemaking stating in unison that these
DEA. This action continues the On November 14, 2016, the HHS substances have no medical use and are
imposition of the regulatory controls provided the DEA with a scientific and a danger to the community.
and administrative, civil, and criminal medical evaluation document prepared DEA Response: The DEA appreciates
sanctions of schedule I controlled by the FDA entitled ‘‘Basis for the the comments in support of this
substances on any person who handles Recommendation to Place [1-(5- rulemaking.
or proposes to handle AB-CHMINACA, Fluoropentyl)-1H-Indazol-3-yl]
(Naphthalen-1-yl) Methanone (THJ- Scheduling Conclusion
AB-PINACA and THJ-2201.
2201), N-[(2S)-1-Amino-3-Methyl-1- After consideration of the relevant
Background Oxo-2-Butanyl]-1-Pentyl-1H-Indazole-3- matter presented as a result of public
On January 30, 2015, the DEA Carboxamide (AB-PINACA), and N- comments, the scientific and medical
published a final order in the Federal [(2S)-1-Amino-3-Methyl-1-Oxo-2- evaluations and accompanying
Register amending 21 CFR 1308.11(h) to Butanyl]-1-(Cyclohexylmethyl)-1H- recommendation of the HHS, and after
temporarily place the three synthetic Indazole-3-Carboxamide (AB- its own eight-factor evaluation, the DEA
cannabinoids N-(1-amino-3-methyl-1- CHMINACA) and their Salts in finds that these facts and all other
oxobutan-2-yl)-1-(cyclohexylmethyl)- Schedule I of the Controlled Substances relevant data constitute substantial
1H-indazole-3-carboxamide (AB- Act.’’ After considering the eight factors evidence of potential for abuse of AB-
CHMINACA), N-(1-amino-3-methyl-1- in 21 U.S.C. 811(c), and also considering CHMINACA, AB-PINACA and THJ-
oxobutan-2-yl)-1-pentyl-1H-indazole-3- each substance’s abuse potential, lack of 2201. As such, the DEA is permanently
carboxamide (AB-PINACA), and[1-(5- legitimate medical use in the United scheduling AB-CHMINACA, AB-
States, and lack of accepted safety for PINACA and THJ-2201 as controlled
1 As set forth in a memorandum of understanding use under medical supervision pursuant substances under the CSA.
entered into by the Food and Drug Administration to 21 U.S.C. 812(b), the Assistant
(FDA) and the National Institute on Drug Abuse Secretary of the HHS recommended that Determination of Appropriate Schedule
jstallworth on DSKBBY8HB2PROD with RULES

(NIDA), the FDA acts as the lead agency within the
Department of Health and Human Services (HHS)
AB-CHMINACA, AB-PINACA and THJ- The CSA establishes five schedules of
in carrying out the Secretary’s scheduling 2201 be controlled in schedule I of the controlled substances known as
responsibilities under the CSA, with the CSA. In response, the DEA conducted schedules I, II, III, IV, and V. The CSA
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. its own eightfactor analysis of AB- also outlines the findings required to
The Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the
CHMINACA, AB-PINACA and THJ- place a drug or other substance in any
authority to make domestic drug scheduling 2201. The DEA and HHS analyses are particular schedule. 21 U.S.C. 812(b).
recommendations. 58 FR 35460, July 1, 1993. available in their entirety in the public After consideration of the analyses and

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Document Created: 2017-10-14 01:42:44
Document Modified: 2017-10-14 01:42:44
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		Effective October 16, 2017.
Contact		Michael J. Lewis, Diversion Control
FR Citation		82 FR 47971
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements
82 FR 47971 - Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 82, Issue 198 (October 16, 2017)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
