Definition of “Cannabimimetic Agents” and Assignment of an Administration Controlled Substances Code Number for All “Cannabimimetic Agents”, 22388-22391 [2023-07578]
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22388
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
miles (previously 6.4 miles). The FAA
also proposes to amend Class E airspace
extending upward from 700 feet above
the surface of Daytona Beach
International Airport by updating the
geographical coordinates to coincide
with the FAA’s database. In addition,
this action would replace the outdated
terms Airport/Facility Directory with
the term Chart Supplement and Notice
to Airmen with the term Notice to Air
Missions in the Ormond Beach Class D
airspace and Class E airspace designated
as an extension to Class D descriptions.
Regulatory Notices and Analyses
The FAA has determined that this
proposed regulation only involves an
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current. It,
therefore: (1) is not a ‘‘significant
regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant
rule’’ under DOT Regulatory Policies
and Procedures (44 FR 11034; February
26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as
the anticipated impact is so minimal.
Since this is a routine matter that will
only affect air traffic procedures and air
navigation, it is certified that this
proposed rule, when promulgated, will
not have a significant economic impact
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Environmental Review
This proposal will be subject to an
environmental analysis per FAA Order
1050.1F, ‘‘Environmental Impacts:
Policies and Procedures,’’ before any
FAA final regulatory action.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
In consideration of the foregoing, the
Federal Aviation Administration
proposes to Amend 14 CFR part 71 as
follows:
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PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11G,
■
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Airspace Designations and Reporting
Points, dated August 19, 2022, and
effective September 15, 2022, is
amended as follows:
Paragraph 5000
Class D Airspace.
*
*
*
ASO FL D
*
Ormond Beach, FL
Paragraph 6004 Class E Airspace
Designated as an Extension to Class D
Surface Area.
*
*
ASO FL E4
*
*
Ormond Beach, FL
Ormond Beach Municipal Airport, FL
(Lat 29°18′04″ N, long. 81°06′50″ W)
Ormond Beach VORTAC
(Lat 29°18′12″ N, long 81°06′46″ W)
That airspace extending upward from the
surface within 2.4 miles on each side of the
Ormond Beach VORTAC 342° radial,
extending from the 3.2-mile radius to 6.9
miles northwest of the VORTAC. This Class
E4 airspace area is effective during the
specific days and times established in
advance by a Notice to Air Missions. The
effective days and times will thereafter be
continuously published in the Chart
Supplement.
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
ASO FL E5
*
*
Daytona Beach, FL
Daytona Beach International Airport, FL
(Lat 29°10′48″ N, long 81°03′29″ W)
Spruce Creek Airport
(Lat 29°04′49″ N, long 81°02′48″ W)
Ormond Beach Municipal Airport
(Lat 29°18′04″ N, long 81°06′50″ W)
That airspace extends upward from 700
feet or more above the earth’s surface within
a 10-mile radius of Daytona Beach
International Airport, within a 6.8-mile
radius of Spruce Creek Airport, and within
a 7.3-mile radius of Ormond Beach
Municipal Airport.
Issued in College Park, GA, on April 3,
2023.
Andreese C. Davis,
Manager, Airspace & Procedures Team South,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2023–07637 Filed 4–12–23; 8:45 am]
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Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–368]
*
Ormond Beach Municipal Airport, FL
(Lat 29°18′04″ N, long 81°06′50″ W)
That airspace extending upward from the
surface, to but not including 1,200 feet MSL
within a 3.2-mile radius of Ormond Beach
Municipal Airport, excluding that airspace
within the Daytona Beach, FL, Class C
airspace area. This Class D airspace area is
effective during the specific days and times
established in advance by a Notice to Air
Missions. The effective days and times will
be continuously published in the Chart
Supplement.
*
DEPARTMENT OF JUSTICE
Definition of ‘‘Cannabimimetic Agents’’
and Assignment of an Administration
Controlled Substances Code Number
for All ‘‘Cannabimimetic Agents’’
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
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
SUMMARY:
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Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
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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
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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.
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22389
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; JWH098; JWH-184; JWH-193; JWH-210;
MAM-2201; JWH-007; JWH-022; JWH147; 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
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
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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Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
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.
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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
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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
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.
2. In § 1308.11:
a. Add paragraphs (d)(102) and (103);
and
■ b. Revise paragraph (g).
The additions and revision read as
follows:
■
■
§ 1308.11
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Schedule I.
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(d) * * *
(102)
1-pentyl-3-(1-naphthoyl)indole
(JWH-018
and
AM678) .........................................
(103) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 7201 .......
*
7118
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-(1naphthylmethane)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 3benzoylindole 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 (CP47,497);
(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-47,497 C8homolog);
(iii) 1-butyl-3-(1-naphthoyl)indole
(JWH-073);
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(iv) 1-hexyl-3-(1-naphthoyl)indole
(JWH-019);
(v) 1-[2-(4-morpholinyl)ethyl]-3-(1naphthoyl)indole (JWH-200);
(vi) 1-pentyl-3-(2methoxyphenylacetyl)indole (JWH-250);
(vii) 1-pentyl-3-[1-(4methoxynaphthoyl)]indole (JWH-081);
(viii) 1-pentyl-3-(4-methyl-1naphthoyl)indole (JWH-122);
(ix) 1-pentyl-3-(4-chloro-1naphthoyl)indole (JWH-398);
(x) 1-(5-fluoropentyl)-3-(2iodobenzoyl)indole (AM694);
(xi) 1-pentyl-3-[(4-methoxy)benzoyl]indole (SR-19 and RCS-4);
(xii) 1-cyclohexylethyl-3-(2methoxyphenylacetyl)indole (SR-18 and
RCS-8);
(xiii) 1-pentyl-3-(2chlorophenylacetyl)indole (JWH-203);
(xiv) (1-((1-methylpiperidin-2yl)methyl)-1H-indol-3-yl)(naphthalen-1yl)methanone (AM-1220);
(xv) (2-iodophenyl)(1-((1methylpiperidin-2-yl)methyl)-1H-indol3-yl)methanone (AM-2233);
(xvi) (4-ethylnaphthalen-1-yl)(1-(5fluoropentyl)-1H-indol-3-yl)methanone
(EAM-2201);
(xvii) (4-methoxynaphthalen-1-yl)(2methyl-1-pentyl-1H-indol-3yl)methanone (JWH-098);
(xviii) 3-((4-methylnaphthalen-1yl)methyl)-1-pentyl-1H-indole (JWH184);
(xix) (4-methylnaphthalen-1-yl)(1-(2morpholinoethyl)-1H-indol-3yl)methanone (JWH-193);
(xx) (4-ethylnaphthalen-1-yl)(1pentyl-1H-indol-3-yl)methanone (JWH210);
(xxi) (1-(5-fluoropentyl)-1H-indol-3yl)(4-methylnaphthalen-1-yl)methanone
(MAM-2201);
(xxii) (2-methyl-1-pentyl-1H-indol-3yl)(naphthalen-1-yl)methanone (JWH007);
(xxiii) naphthalen-1-yl(1-(pent-4-en-1yl)-1H-indol-3-yl)methanone (JWH-022);
(xxiv) (1-hexyl-5-phenyl-1H-pyrrol-3yl)(naphthalen-1-yl)methanone (JWH147);
(xxv) 2-(3-methoxyphenyl)-1-(1pentyl-1H-indol-3-yl)ethan-1-one (JWH302);
(xxvi) (5-(2-fluorophenyl)-1-pentyl1H-pyrrol-3-yl)(naphthalen-1yl)methanone (JWH-307);
(xxvii) (4-fluoronaphthalen-1-yl)(1pentyl-1H-indol-3-yl)methanone (JWH412);
(xxviii) (5-methyl-3(morpholinomethyl)-2,3-dihydro[1,4]oxazino[2,3,4-hi]indol-6yl)(naphthalen-1-yl)methanone (WIN
55,212-2);
(xxix) 2-(5-hydroxy-2-(3hydroxypropyl)cyclohexyl)-5-(2methyloctan-2-yl)phenol (CP-55,940);
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(xxx) 2-(3-hydroxycyclohexyl)-5-(2methylheptan-2-yl)phenol (CP-47,497
C6 homolog); and
(xxxi) 2-(3-hydroxycyclohexyl)-5-(2methyldecan-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]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–1036]
Schedules of Controlled Substances:
Placement of Nine Specific FentanylRelated Substances in Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Drug Enforcement
Administration proposes placing nine
substances, as identified in this
proposed rule, in schedule I of the
Controlled Substances Act. These nine
substances fall within the definition of
fentanyl-related substances set forth in
the February 6, 2018, temporary
scheduling order. Through the
Temporary Reauthorization and Study
of Emergency Scheduling of Fentanyl
Analogues Act, which became law on
February 6, 2020, Congress extended the
temporary control of fentanyl-related
substances until May 6, 2021. This
temporary order was subsequently
extended multiple times, most recently
on December 29, 2022, through the
Consolidated Appropriations Act, 2023,
which extended the order until
SUMMARY:
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22391
December 31, 2024. If finalized, this
action would make permanent the
existing 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 these nine specific controlled
substances.
Comments must be submitted
electronically or postmarked on or
before May 15, 2023.
Interested persons may file a request
for a hearing or waiver of hearing
pursuant to 21 CFR 1308.44 and in
accordance with 21 CFR 1316.47 and/or
1316.49, as applicable. Requests for a
hearing, and waivers of an opportunity
for a hearing or to participate in a
hearing, must be received on or before
May 15, 2023.
ADDRESSES: Interested persons may file
written comments on this proposal in
accordance with 21 CFR 1308.43(g). 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. To ensure
proper handling of comments, please
reference ‘‘Docket No. DEA–1036’’ on
all electronic and written
correspondence, including any
attachments.
• Electronic comments: The Drug
Enforcement Administration (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
field on the web page or to attach a file
for lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon completion
of your submission you will receive a
Comment Tracking Number for your
comment. Submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
• Paper comments: Paper comments
that duplicate electronic submissions
are not necessary. 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
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
DATES:
E:\FR\FM\13APP1.SGM
13APP1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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''.
---------------------------------------------------------------------------
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