[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Proposed Rules]
[Pages 22388-22391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07578]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-368]


Definition of ``Cannabimimetic Agents'' and Assignment of an 
Administration Controlled Substances Code Number for All 
``Cannabimimetic Agents''

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: On July 9, 2012, the President signed into law the Synthetic 
Drug Abuse Prevention Act of 2012. The Synthetic Drug Abuse Prevention 
Act of 2012 included a definition of ``cannabimimetic agents'' that are 
controlled under schedule I. The Drug Enforcement Administration is 
proposing this rule to address the broader definition of 
``cannabimimetic agents,'' identify 18 additional substances that meet 
the definition, and consolidate most existing administration controlled 
substances code numbers (drug codes) into a single drug code number for 
substances that meet this definition. The listing for two schedule I 
``cannabimimetic agents'' that are under international control, JWH-018 
and AM2201, will be moved to the ``hallucinogens'' paragraph of 
schedule I in order to retain the existing drug codes for these two 
substances to facilitate quota and international reporting 
requirements. While the 18 additional substances are already controlled 
under schedule I because they meet the definition of ``cannabimimetic 
agents,'' this proposed rule establishes a single new drug code number 
for these and most other substances meeting this definition. This 
single drug code will simplify the registration and recordkeeping 
requirements for any ``cannabimimetic agents'' that the Drug 
Enforcement Administration may register persons to handle.

DATES: Comments must be submitted electronically or postmarked on or 
before May 15, 2023.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-368'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: DEA encourages commenters to submit 
all comments electronically through the Federal eRulemaking Portal, 
which provides the ability to type short comments directly into the 
comment

[[Page 22389]]

field on the web page or attach a file for lengthier comments. Please 
go to https://www.regulations.gov and follow the on-line instructions 
at that site for submitting comments. Upon completion of your 
submission, you will receive a Comment Tracking Number. Submitted 
comments are not instantaneously available for public view on 
regulations.gov. If you have received a Comment Tracking Number, you 
have submitted your comment successfully and there is no need to 
resubmit the same comment. Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
     Paper comments: Paper comments that duplicate electronic 
submissions are not necessary and are discouraged. Should you wish to 
mail a paper comment in lieu of an electronic comment, it should be 
sent via regular or express mail to: Drug Enforcement Administration, 
Attn: DEA FR Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    All comments received in response to this docket are considered 
part of the public record. The Drug Enforcement Administration (DEA) 
will make comments available, unless reasonable cause is given, for 
public inspection online at https://www.regulations.gov. Such 
information includes personal identifying information (such as your 
name, address, etc.) voluntarily submitted by the commenter. The 
Freedom of Information Act applies to all comments received. If you 
want to submit personal identifying information (such as your name, 
address, etc.) as part of your comment, but do not want DEA to make it 
publicly available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all of the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want DEA to make it publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    DEA will generally make available in publicly redacted form 
comments containing personal identifying information and confidential 
business information identified, as directed above. If a comment has so 
much confidential business information that DEA cannot effectively 
redact it, DEA may not make available publicly all or part of that 
comment. Comments posted to https://www.regulations.gov may include any 
personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as confidential as directed above.
    An electronic copy of this document is available at https://www.regulations.gov for easy reference.

Legal Authority

    On July 9, 2012, the Synthetic Drug Abuse Prevention Act of 2012 
(SDAPA), Public Law 112-144, Title XI, Subtitle D, became effective. 
SDAPA amended the CSA by legislatively placing ``cannabimimetic 
agents'' in schedule I. Public Law 112-144, Title XI, Subtitle D, 
Section 1152; 21 U.S.C. 812(d). On January 4, 2013, DEA published a 
final rule that added paragraph (g) to 21 CFR 1308.11 with the title 
``cannabimimetic agents,'' and assigned unique administration 
controlled substances code numbers (drug codes) for 15 substances 
included in SDAPA that met this definition. 78 FR 664.
    DEA is proposing this rule to make technical, organizational, and 
conforming amendments to paragraph (g). This rule would make no change 
in the current and continuing schedule I status for all of the 
substances discussed in this rule. This action proposes to:
     incorporate the structural and pharmacological definition 
of ``cannabimimetic agents'' found in 21 U.S.C. 812(d) into paragraph 
(g),
     list 18 additional substances that meet the structural and 
pharmacological definition of ``cannabimimetic agents'' in paragraph 
(g),
     consolidate 13 of the 15 existing drug codes previously 
assigned to ``cannabimimetic agents'' and establish a single drug code 
for most substances that meet this definition, and
     move two substances (JWH-018 and AM2201) from paragraph 
(g) to paragraph (d) and retain the existing drug codes (7118 and 7201, 
respectively) to facilitate quota and international reporting 
requirements.
    DEA has collected data for 18 additional substances that meet the 
structural and pharmacological definition in accordance with SDAPA: AM-
1220; AM-2233; EAM-2201; JWH-098; JWH-184; JWH-193; JWH-210; MAM-2201; 
JWH-007; JWH-022; JWH-147; JWH-302; JWH-307; JWH-412; WIN 55,212-2; CP-
55,940; CP-47,497 C6 homolog; and CP-47,497 C9 homolog.
    Two of the substances (JWH-018 and AM2201) that are currently 
listed in 21 CFR 1308.11(g) are also listed in Schedule II of the 
Convention on Psychotropic Substances of 1971 (1971 Convention).\1\ In 
order to continue to establish aggregate production quota and grant 
individual manufacturing and procurement quota to DEA-registered 
manufacturers of JWH-018 and AM2201, and report these data as required 
under Article 16 the 1971 Convention, DEA proposes to move the listing 
for these two substances from 21 CFR 1308.11(g) to 21 CFR 1308.11(d). 
With the proposal to assign all substances in 21 CFR 1308.11(g) a 
single drug code, moving the listing of these two drugs will maintain 
their current drug codes (7118 and 7201, respectively) and allows DEA 
to continue collecting data reported to the International Narcotics 
Control Board (INCB) on Form P.\2\
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    \1\ On March 13, 2015, the Commission on Narcotic Drugs decided 
to include JWH-018 and AM2201 in Schedule II of the Convention on 
Psychotropic Substances of 1971.
    \2\ The current form can be downloaded from the INCB website: 
www.incb.org, under ``Psychotropic Substances'', Toolkit: ``Form 
P''.
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Regulatory Analyses

Executive Orders 12866 and 13563 (Regulatory Planning and Review; 
Improving Regulation and Regulatory Review)

    This regulation has been drafted and reviewed in accordance with 
the principles of Executive Orders (E.O.) 12866 and 13563. This 
proposed rule is not a significant regulatory action under E.O. 12866. 
All of the substances listed in this proposed rule are already listed 
or defined as controlled substances in the United States under schedule 
I. In this proposed rule, DEA is proposing technical, organizational, 
and conforming amendments to its regulations to incorporate definitions 
found in 21 U.S.C. 812(d), list additional ``cannabimimetic agents'' 
that meet these definitions, and simplify drug codes assigned to 
``cannabimimetic agents.'' These proposed changes only apply to 
substances that are already listed or defined as schedule I controlled 
substances. Creating listings for these substances and modifying drug

[[Page 22390]]

codes will not alter the status of any of these substances as schedule 
I controlled substances. Accordingly, this rule has not been reviewed 
by the Office of Management and Budget (OMB).

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988, to eliminate drafting 
errors and ambiguity, minimize litigation, provide a clear legal 
standard for affected conduct, and promote simplification and burden 
reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of E.O. 13132. The proposed rule does not 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of E.O. 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.

Paperwork Reduction Act of 1995

    This proposed action does not impose a new collection of 
information requirement under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521).

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612), has reviewed this proposed rule, and by 
approving it, certifies that it will not have a significant economic 
impact on a substantial number of small entities.
    DEA proposes technical, organizational, and conforming amendments 
to its regulations to incorporate definitions found in 21 U.S.C. 
812(d), list additional ``cannabimimetic agents'' that meet these 
definitions, and simplify drug codes assigned to ``cannabimimetic 
agents.'' These proposed changes only apply to substances that are 
already listed or defined as schedule I controlled substances. If 
finalized, this action would not impose any new regulatory controls or 
new administrative, civil, and/or criminal sanctions applicable to 
schedule I controlled substances on persons who handle (manufacture, 
distribute, reverse distribute, import, export, engage in research, 
conduct instructional activities or chemical analysis with, or 
possess), or propose to handle ``cannabimimetic agents.''
    Anyone currently handling ``cannabimimetic agents'' must already be 
registered with DEA and have all security and other handling processes 
in place, resulting in minimal impact to their operations. Therefore, 
DEA estimates the cost of this rule, in form of lost sales, if any, on 
small entities is minimal. DEA welcomes any public comment regarding 
this estimate.
    Because of these facts, this proposed rule will not, if 
promulgated, result in a significant economic impact on a substantial 
number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, DEA has determined pursuant to the 
Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.) 
that this proposed action would not result in any Federal mandate that 
may result ``in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any 1 year * 
* *.'' Therefore, neither a Small Government Agency Plan nor any other 
action is required under UMRA of 1995.

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, DEA proposes to amend 21 CFR part 
1308 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), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11:
0
a. Add paragraphs (d)(102) and (103); and
0
b. Revise paragraph (g).
    The additions and revision read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

(102) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678).......     7118
(103) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 7201...     7201
 

* * * * *
    (g) Cannabimimetic agents. Unless specifically exempted or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of cannabimimetic agents, or 
which contains their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible 
within the specific chemical designation:
    (1) Cannabimimetic agents--7000.
    (2) In this paragraph (g), the term cannabimimetic agents means any 
substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist 
as demonstrated by binding studies and functional assays within any of 
the following structural classes:
    (i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-
position of the phenolic ring by alkyl or alkenyl, whether or not 
substituted on the cyclohexyl ring to any extent.
    (ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by 
substitution at the nitrogen atom of the indole ring, whether or not 
further substituted on the indole ring to any extent, whether or not 
substituted on the naphthoyl or naphthyl ring to any extent.
    (iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom 
of the pyrrole ring, whether or not further substituted in the pyrrole 
ring to any extent, whether or not substituted on the naphthoyl ring to 
any extent.
    (iv) 1-(1-naphthylmethylene)indene by substitution of the 3-
position of the indene ring, whether or not further substituted in the 
indene ring to any extent, whether or not substituted on the naphthyl 
ring to any extent.
    (v) 3-phenylacetylindole or 3-benzoylindole by substitution at the 
nitrogen atom of the indole ring, whether or not further substituted in 
the indole ring to any extent, whether or not substituted on the phenyl 
ring to any extent.
    (3) The definition in this paragraph (g) includes, but is not 
limited to, the following substances:
    (i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 
(CP-47,497);
    (ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 
(cannabicyclohexanol or CP-47,497 C8-homolog);
    (iii) 1-butyl-3-(1-naphthoyl)indole (JWH-073);

[[Page 22391]]

    (iv) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);
    (v) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
    (vi) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
    (vii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081);
    (viii) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
    (ix) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
    (x) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
    (xi) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4);
    (xii) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and 
RCS-8);
    (xiii) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203);
    (xiv) (1-((1-methylpiperidin-2-yl)methyl)-1H-indol-3-
yl)(naphthalen-1-yl)methanone (AM-1220);
    (xv) (2-iodophenyl)(1-((1-methylpiperidin-2-yl)methyl)-1H-indol-3-
yl)methanone (AM-2233);
    (xvi) (4-ethylnaphthalen-1-yl)(1-(5-fluoropentyl)-1H-indol-3-
yl)methanone (EAM-2201);
    (xvii) (4-methoxynaphthalen-1-yl)(2-methyl-1-pentyl-1H-indol-3-
yl)methanone (JWH-098);
    (xviii) 3-((4-methylnaphthalen-1-yl)methyl)-1-pentyl-1H-indole 
(JWH-184);
    (xix) (4-methylnaphthalen-1-yl)(1-(2-morpholinoethyl)-1H-indol-3-
yl)methanone (JWH-193);
    (xx) (4-ethylnaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone 
(JWH-210);
    (xxi) (1-(5-fluoropentyl)-1H-indol-3-yl)(4-methylnaphthalen-1-
yl)methanone (MAM-2201);
    (xxii) (2-methyl-1-pentyl-1H-indol-3-yl)(naphthalen-1-yl)methanone 
(JWH-007);
    (xxiii) naphthalen-1-yl(1-(pent-4-en-1-yl)-1H-indol-3-yl)methanone 
(JWH-022);
    (xxiv) (1-hexyl-5-phenyl-1H-pyrrol-3-yl)(naphthalen-1-yl)methanone 
(JWH-147);
    (xxv) 2-(3-methoxyphenyl)-1-(1-pentyl-1H-indol-3-yl)ethan-1-one 
(JWH-302);
    (xxvi) (5-(2-fluorophenyl)-1-pentyl-1H-pyrrol-3-yl)(naphthalen-1-
yl)methanone (JWH-307);
    (xxvii) (4-fluoronaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone 
(JWH-412);
    (xxviii) (5-methyl-3-(morpholinomethyl)-2,3-dihydro-
[1,4]oxazino[2,3,4-hi]indol-6-yl)(naphthalen-1-yl)methanone (WIN 
55,212-2);
    (xxix) 2-(5-hydroxy-2-(3-hydroxypropyl)cyclohexyl)-5-(2-
methyloctan-2-yl)phenol (CP-55,940);
    (xxx) 2-(3-hydroxycyclohexyl)-5-(2-methylheptan-2-yl)phenol (CP-
47,497 C6 homolog); and
    (xxxi) 2-(3-hydroxycyclohexyl)-5-(2-methyldecan-2-yl)phenol (CP-
47,497 C9 homolog).
* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
March 29, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-07578 Filed 4-12-23; 8:45 am]
BILLING CODE 4410-09-P