Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I, 106376-106384 [2024-30359]
Download as PDF
ddrumheller on DSK120RN23PROD with PROPOSALS1
106376
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules
effective September 15, 2024. These
updates would be published in the next
update to FAA Order JO 7400.11. That
order is publicly available as listed in
the ADDRESSES section of this document.
FAA Order JO 7400.11J lists Class A,
B, C, D, and E airspace areas, air traffic
service routes, and reporting points.
Gulkana, AK, VOR/DME 062° (M), 079°
(T) radials.
V–504: V–504 currently extends
between the Nenana, AK, VORTAC and
the Deadhorse, AK, VOR/DME. As
amended, V–504 would extend between
the Neana VORTAC and the Bettles, AK,
VOR/DME.
Paragraph 6010(b)
Airways.
Background
In 2003, Congress enacted the Vision
100-Century of Aviation
Reauthorization Act (Pub L., 108–176),
which established a joint planning and
development office in the FAA to
manage the work related to the Next
Generation Air Transportation System
(NextGen). Today, NextGen is an
ongoing FAA-led modernization of the
nation’s air transportation system to
make flying safer, more efficient, and
more predictable.
In support of NextGen, this proposal
is part of an ongoing, large, and
comprehensive airway modernization
project in the state of Alaska. Part of this
project is to transition the Alaskan en
route navigation structure away from
dependency on NDBs and move to
develop and improve the Area
Navigation (RNAV) route structure. The
FAA is planning to decommission the
Evansville, AK, NDB. As a result, the
segment of Alaskan Federal Airway V–
444 between the Evansville NDB and
the Browerville, AK, VOR will become
unusable. The mitigation to the loss of
this segment of V–444 is RNAV route T–
232. T–232 directly overlays the
segment of V–444 proposed for removal.
Additionally, the segment of Alaskan
Federal Airway V–504 between the
Evansville NDB and the Deadhorse, AK,
VOR/Distance Measuring Equipment
(DME) will become unusable. The
mitigation to the loss of this segment of
V–504 is RNAV route T–240. T–240
directly overlays the segment of V–504
proposed for removal.
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.
V–504 [Amended]
From Nenana, AK; to Bettles, AK.
The Proposal
The FAA is proposing an amendment
to 14 CFR part 71 to amend Alaskan
VOR Federal Airways V–444 and V–504
in Alaska. The FAA is proposing these
actions due to the pending
decommissioning of the Evansville, AK,
NDB.
V–444: V–444 in Alaska currently
extends between the Barrow, AK, VOR/
DME and the intersection of the
Northway, AK, VOR/Tactical Air
Navigation (VORTAC) 120° (M), 138°
(T), and the Gulkana, AK, VOR/DME
062° (M), 079° (T) radials. As amended,
V–444 would extend between the
Bettles, AK, VOR/DME and the
intersection of the Northway, AK,
VORTAC 120° (M), 138° (T), and the
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Environmental Review
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to 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:
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); 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 7400.11J,
Airspace Designations and Reporting
Points, dated July 31, 2024, and
effective September 15, 2024, is
amended as follows:
■
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*
*
*
Alaskan VOR Federal
*
*
V–444 [Amended]
From Bettles, AK; Fairbanks, AK; Big Delta,
AK; Northway, AK; intersection of the
Northway 120° (M), 138° (T), and Gulkana
062° (M), 079°(T) radials.
*
*
*
*
Issued in Washington, DC, on December
20, 2024.
Richard Lee Parks,
Manager (A), Airspace Rules and Regulations.
[FR Doc. 2024–31104 Filed 12–27–24; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–1246]
Schedules of Controlled Substances:
Placement of 4-Chloromethcathinone
in Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Drug Enforcement
Administration proposes placing the
substance 4-chloromethcathinone (4–
CMC, 1-(4-chlorophenyl)-2(methylamino)propan-1-one), including
its salts, isomers, and salts of isomers,
in schedule I of the Controlled
Substances Act. This action is being
taken, in part, to enable the United
States to meet its obligations under the
1971 Convention on Psychotropic
Substances. If finalized, this action
would impose the regulatory controls
and administrative, civil, and 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 4chloromethcathinone.
DATES: Comments must be submitted
electronically, and written comments
must be postmarked or shipped on or
before January 29, 2025.
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
SUMMARY:
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules
hearing, together with a written
statement of position on the matters of
fact and law asserted in the hearing,
must be received on or before January
29, 2025.
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–1246’’ on
all electronic and written
correspondence, including any
attachments.
• Electronic comments: The Drug
Enforcement Administration (DEA)
encourages commenters to submit
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 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 comment submission, you will
receive a Comment Tracking Number. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted 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 the 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 Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
• Hearing requests: All requests for a
hearing and waivers of participation,
together with a written statement of
position on the matters of fact and law
asserted in the hearing, must be filed
with the DEA Administrator, who will
make the determination of whether a
hearing will be needed to address such
matters of fact and law in the
rulemaking. Such requests must be sent
to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. For
informational purposes, a courtesy copy
of requests for hearing and waivers of
participation should also be sent to: (1)
Drug Enforcement Administration, Attn:
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21:44 Dec 27, 2024
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Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
• Paperwork Reduction Act
Comments: All comments concerning
collections of information under the
Paperwork Reduction Act must be
submitted to the Office of Information
and Regulatory Affairs, OMB, Attention:
Desk Officer for DOJ, Washington, DC
20503. Please state that your comment
refers to Docket No. DEA–1246.
FOR FURTHER INFORMATION CONTACT: Dr.
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION: In this
proposed rule, the Drug Enforcement
Administration (DEA) proposes to place
4-chloromethcathinone (also known as
4–CMC or 1-(4-chlorophenyl)-2(methylamino)propan-1-one) including
its salts, isomers, and salts of isomers in
schedule I of the Controlled Substances
Act (CSA).
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
DEA will make comments available for
public inspection online at https://
www.regulations.gov. Such information
includes personal or business identifiers
(such as name, address, state or Federal
identifiers, etc.) voluntarily submitted
by the commenter. In general,
information voluntarily submitted by
the commenter, unless clearly marked
as Confidential Information in the
method described below, will be
publicly posted. Comments may be
submitted anonymously.
Commenters submitting comments
which include personal identifying
information (PII), confidential, or
proprietary business information that
the commenter does not want made
publicly available should submit two
copies of the comment. One copy must
be marked ‘‘CONTAINS
CONFIDENTIAL INFORMATION’’ and
should clearly identify all PII or
business information the commenter
does not want to be made publicly
available, including any supplemental
materials. DEA will review this copy,
including the claimed PII and
confidential business information, in its
consideration of comments. The second
copy should be marked ‘‘TO BE
PUBLICLY POSTED’’ and must have all
claimed confidential PII and business
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information already redacted. DEA will
post only the redacted comment on
https://www.regulations.gov for public
inspection. The Freedom of Information
Act applies to all comments received.
For easy reference, an electronic copy
of this document and supplemental
information to this proposed scheduling
action are available at https://
www.regulations.gov.
Request for Hearing or Appearance;
Waiver
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act (APA), 5
U.S.C. 551–559.1 Interested persons, as
defined in 21 CFR 1300.01(b), may file
requests for a hearing in conformity
with the requirements of 21 CFR
1308.44(a) and 1316.47(a), and such
requests must:
(1) state with particularity the interest
of the person in the proceeding;
(2) state with particularity the
objections or issues concerning which
the person desires to be heard; and
(3) state briefly the position of the
person with regarding to the objections
or issues.
Any interested person may file a
waiver of an opportunity for a hearing
or to participate in a hearing in
conformity with the requirements of 21
CFR 1308.44(c), together with a written
statement of position on the matters of
fact and law involved in any hearing.2
All requests for a hearing and waivers
of participation, together with a written
statement of position on the matters of
fact and law involved in such hearing,
must be sent to DEA using the address
information provided above. The
decision whether a hearing will be
needed to address such matters of fact
and law in the rulemaking will be made
by the Administrator. If a hearing is
needed, DEA will publish a notice of
hearing on the proposed rulemaking in
the Federal Register.3 Once the
Administrator designates an
Administrative Law Judge (ALJ) to
preside over the hearing, the ALJ’s
functions shall commence, as provided
in 21 CFR 1316.52.
In accordance with 21 U.S.C. 811 and
812, the purpose of a hearing would be
to determine whether 4chloromethcathinone meets the
statutory criteria for placement in
schedule I, as proposed in this rule.
1 21 CFR 1308.41 through 1308.45; 21 CFR part
1316, subpart D.
2 21 CFR 1316.49.
3 21 CFR 1308.44(b), 1316.53.
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ddrumheller on DSK120RN23PROD with PROPOSALS1
Legal Authority
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 (delegated to the
Administrator of DEA pursuant to 28
CFR 0.100) on his own motion, at the
request of the Secretary of Health and
Human Services (HHS), or on the
petition of an interested party.4 This
proposed action is initiated on the
Administrator’s own motion and
supported by, inter alia, a
recommendation from the Assistant
Secretary for Health of HHS.
In addition, the United States is a
party to the 1971 United Nations
Convention on Psychotropic Substances
(1971 Convention), Feb. 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as
amended. Procedures respecting
changes in drug schedules under the
1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2)–(4).
When the United States receives
notification of a scheduling decision
pursuant to Article 2 of the 1971
Convention indicating that a drug or
other substance has been added to a
schedule specified in the notification,
the Secretary of HHS (Secretary),5 after
consultation with the Attorney General,
shall first determine whether existing
legal controls under subchapter I of the
CSA and the Federal Food, Drug, and
Cosmetic Act meet the requirements of
the schedule specified in the
notification with respect to the specific
drug or substance.6 In the event that the
Secretary did not consult with the
Attorney General, and the Attorney
General did not issue a temporary order,
as provided under 21 U.S.C. 811(d)(4),
the procedures for permanent
scheduling set forth in 21 U.S.C. 811(a)
and (b) control. Pursuant to 21 U.S.C.
811(a)(1) and (2), the Attorney General
(as delegated to the Administrator of
DEA) may, by rule, and upon the
recommendation of the Secretary, add to
such a schedule or transfer between
such schedules any drug or other
substance, if he finds that such drug or
other substance has a potential for
abuse, and makes with respect to such
drug or other substance the findings
4 21
U.S.C. 811(a).
discussed in a memorandum of
understanding entered into by the FDA and the
National Institute on Drug Abuse (NIDA), FDA acts
as the lead agency within 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 has delegated to the
Assistant Secretary for Health of HHS the authority
to make domestic drug scheduling
recommendations. 58 FR 35460 (July 1, 1993).
6 21 U.S.C. 811(d)(3).
5 As
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prescribed by 21 U.S.C. 812(b) for the
schedule in which such drug or other
substance is to be placed.
Background
4-Chloromethcathinone (4–CMC) is a
central nervous system stimulant that
shares structural and pharmacological
similarities with schedule I synthetic
cathinones such as 4methylethcathinone (4–MEC), 4fluoromethcathinone (4–FMC), and 3fluoromethcathinone (3–FMC), and
schedule II stimulants such as
amphetamine and methamphetamine.
On May 7, 2020, the Secretary-General
of the United Nations advised the
Secretary of State of the United States
that the Commission on Narcotic Drugs
(CND) voted to place 4–CMC in
Schedule II of the 1971 Convention
during its 63rd session held in March
2020 (CND Dec/63/9).
As a signatory to the 1971
Convention, the United States is
required, by scheduling under the CSA,
to place appropriate controls on 4–CMC
to meet the minimum requirements of
the treaty. Because the procedures in 21
U.S.C. 811(d)(3) and (4) for consultation
and issuance of a temporary order for 4–
CMC, discussed in the above legal
authority section, were not followed,
DEA is utilizing the procedures for
permanent scheduling set forth in 21
U.S.C. 811(a) and (b) to control 4–CMC.
Such scheduling would satisfy the
United States’ international obligations.
Article 2, paragraph 7(b), of the 1971
Convention sets forth the minimum
requirements that the United States
must meet when a substance has been
added to Schedule II of the 1971
Convention. Pursuant to the 1971
Convention, the United States must
require licenses for the manufacture,
export and import, and distribution of
4–CMC. This license requirement is
accomplished by the CSA’s registration
requirement as set forth in 21 U.S.C.
822, 823, 957, and 958, and in
accordance with 21 CFR parts 1301 and
1312.
In addition, the United States must
adhere to specific export and import
provisions set forth in the 1971
Convention. This requirement is
accomplished by the CSA with the
export and import provisions
established in 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR
part 1312. Likewise, under Article 13,
paragraphs 1 and 2 of the 1971
Convention, a party to the 1971
Convention may notify through the UN
Secretary-General another party that it
prohibits the importation of a substance
in Schedule II, III, or IV of the 1971
Convention. If such notice is presented
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to the United States, the United States
shall take measures to ensure that the
named substance is not exported to the
notifying country. This requirement is
also accomplished by the CSA’s export
provisions mentioned above.
Under Article 16, paragraph 4, of the
1971 Convention, the United States is
required to provide annual statistical
reports to the International Narcotics
Control Board (INCB). Using INCB Form
P, the United States shall provide the
following information: (1) In regard to
each substance in Schedule I and II of
the 1971 Convention, quantities
manufactured, exported to, and
imported from each country or region as
well as stocks held by manufacturers;
(2) in regard to each substance in
Schedule III and IV of the 1971
Convention, quantities manufactured, as
well as quantities exported and
imported; (3) in regard to each
substance in Schedule II and III of the
1971 Convention, quantities used in the
manufacture of exempt preparations;
and (4) in regard to each substance in
Schedule II–IV of the 1971 Convention,
quantities used for the manufacture of
non-psychotropic substances or
products.
Lastly, under Article 2 of the 1971
Convention, the United States must
adopt measures in accordance with
Article 22 to address violations of any
statutes or regulations that are adopted
pursuant to its obligations under the
1971 Convention. Persons acting outside
the legal framework established by the
CSA are subject to administrative, civil,
and/or criminal action; therefore, the
United States complies with this
provision.
DEA notes that there are differences
between the schedules of substances in
the 1971 Convention and the CSA. The
CSA has five schedules (schedules I–V)
with specific criteria set forth for each
schedule. Schedule I is the only
possible schedule in which a drug or
other substance may be placed if it has
high potential for abuse and no
currently accepted medical use in
treatment in the United States.7 In
contrast, the 1971 Convention has four
schedules (Schedules I–IV) but does not
have specific criteria for each schedule.
The 1971 Convention simply defines its
four schedules, in Article 1, to mean the
correspondingly numbered lists of
psychotropic substances annexed to the
Convention, and altered in accordance
with Article 2.
7 See
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21 U.S.C. 812(b).
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Proposed Determination to Schedule 4–
CMC
Pursuant to 21 U.S.C. 811(b), DEA
gathered the necessary data on 4–CMC
and on May 12, 2021, submitted it to the
Assistant Secretary for Health of HHS
with a request for a scientific and
medical evaluation of available
information and a scheduling
recommendation for 4–CMC.
On December 22, 2022, HHS provided
DEA a scientific and medical evaluation
entitled ‘‘Basis for the Recommendation
to Control 4-Chloro-N-methylcathinone
(4–CMC) and its Optical Isomers, Salts,
and Salts of Optical Isomers, in
Schedule I of the Controlled Substances
Act’’ and a scheduling recommendation.
Pursuant to 21 U.S.C. 811(b), following
consideration of the eight-factors and
findings related to the substance’s abuse
potential, legitimate medical use, safety,
and dependence liability, HHS
recommended that 4–CMC be controlled
in schedule I of the CSA under 21
U.S.C. 812(b). Upon receipt of the
scientific and medical evaluation and
scheduling recommendation from HHS,
DEA reviewed the documents and all
other relevant data and conducted its
own eight-factor analysis in accordance
with 21 U.S.C. 811(c). Included below is
a brief summary of each factor as
analyzed by HHS and DEA, and as
considered by DEA in its proposed
scheduling action. Readers should refer
to the full eight-factor analyses prepared
by HHS and by DEA in support of this
proposal, which are available in their
entirety under the tab ‘‘Supporting
Documents’’ of the public docket of this
rulemaking action at https://
www.regulations.gov, under docket
number ‘‘DEA–1246.’’
ddrumheller on DSK120RN23PROD with PROPOSALS1
1. The Drug’s Actual or Relative
Potential for Abuse
In addition to considering the
information HHS provided in its
scientific and medical evaluation
document for 4–CMC, DEA also
considered all other relevant data
regarding actual or relative potential for
abuse of 4–CMC. The term ‘‘abuse’’ is
not defined in the CSA; however, the
legislative history of the CSA suggests
the following four prongs in
determining whether a particular drug
or substance has a potential for abuse: 8
a. There is evidence that individuals
are taking the drug or drugs containing
such a substance in amounts sufficient
to create a hazard to their health or to
8 Comprehensive Drug Abuse Prevention and
Control Act of 1970, H.R. Rep. No. 91–1444, 91st
Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4601.
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the safety of other individuals or of the
community; or
b. There is a significant diversion of
the drug or substance from legitimate
drug channels; or
c. Individuals are taking the drug or
drugs containing such a substance on
their own initiative rather than on the
basis of medical advice from a
practitioner licensed by law to
administer such drugs in the course of
his professional practice; or
d. The drug or drugs containing such
a substance are new drugs so related in
their action to a drug or drugs already
listed as having a potential for abuse to
make it likely that the drug will have
the same potentiality for abuse as such
drugs, thus making it reasonable to
assume that there may be significant
diversions from legitimate channels,
significant use contrary to or without
medical advice, or that it has a
substantial capability of creating
hazards to the health of the user or to
the safety of the community.
Both DEA and HHS eight-factor
analyses found that 4–CMC produces
pharmacological effects that are similar
to those of the ten schedule I cathinone
stimulants,9 MDMA, and the schedule II
drugs cocaine and methamphetamine.
4–CMC exhibits a typical stimulant-like
pharmacological profile in preclinical
studies and in human case reports. 4–
CMC produces full generalization to the
schedule II stimulants,
methamphetamine, and cocaine, and to
MDMA, and, in humans, 4–CMC caused
stimulant-like adverse effects, like that
of these schedule I and II stimulants.
4–CMC does not have an approved
medical use in the United States, but
evidence indicates that 4–CMC is being
abused and trafficked in the United
States. Because this substance is not an
approved drug product, a practitioner
may not legally prescribe it, and it
cannot be dispensed to an individual.
However, case reports, coroner/medical
examiner reports, and law enforcement
data 10 demonstrate that 4–CMC is being
abused because it is being used without
medical advice. 4–CMC has been
identified during the toxicological
9 Schedules of Controlled Substances: Placement
of 10 Synthetic Cathinones Into Schedule I, 82 FR
12171–12177 (Mar. 1, 2017). The ten synthetic
cathinones were 4-methethcathinone (4–MEC), 4′–
Methyl–a–pyrrolidinopropiophenone (4–MePPP),
a–pyrrolidinovalerophenone (a–PVP), butylone,
pentedrone, pentylone, 4–fluoromethcathinone (4–
FMC), 3–fluoromethcathinone (3–FMC), naphyrone,
and a–Pyrrolidinobutiophenone (a–PBP).
10 While law enforcement data is not direct
evidence of abuse, it can lead to an inference that
a drug has been diverted and abused. See Schedules
of Controlled Substances: Placement of
Carisoprodol Into Schedule IV, 76 FR 77330, 77332
(Dec. 12, 2011).
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106379
screening of human urine or serum
samples indicating that it is being
abused by individuals. In humans,
stimulant effects, like those of
amphetamine, were observed following
the oral administration of 4–CMC. Nonfatal intoxications and overdoses have
also been associated with the abuse of
4–CMC.
Law enforcement data show that 4–
CMC has been encountered in the
United States’ illicit drug market. From
January 2014 to August 2024, the
National Forensic Laboratory
Information System (NFLIS)-Drug
registered 399 reports 11 pertaining to
the trafficking, distribution, and abuse
of 4–CMC. These encounters of 4–CMC
by law enforcement indicate that this
substance is being trafficked and abused
by individuals in the United States as a
recreational drug of abuse.
Overall, these data demonstrate that
4–CMC has a high potential for abuse.
Thus, based on these data, it is
reasonable to conclude that 4–CMC,
having no medical use, and thus no
therapeutic value, presents a hazard to
the health and safety of individuals and
the community.
2. Scientific Evidence of the Drug’s
Pharmacological Effects, if Known
As discussed in the eight-factor
analyses prepared by DEA and by HHS,
the available pharmacology data
indicate that 4–CMC produces
pharmacological effects that are similar
to those produced by schedule I and II
substances, such as mephedrone, 4–
FMC, methamphetamine, cocaine,
methcathinone, and MDMA. Similar to
these schedule I and II stimulants, 4–
CMC affects monoamine
neurotransmission via action at
monoamine transporters. 4–CMC binds
to monoamine transporters for
dopamine, serotonin, or norepinephrine
and promotes the release of these
monoamines or blocks their uptake.
Actions at these transporters, especially
actions that alter dopaminergic
neurotransmission, are believed to be
involved in the production of the
stimulant effects of this class of drugs.
Data also demonstrate that 4–CMC
produces locomotor behavior and
discriminative stimulus effects that are
similar to those of the schedule I and II
substances methamphetamine and
cocaine. Furthermore, in humans,
adverse effects of 4–CMC are similar to
those reported following the use of
11 NFLIS-Drug is a national forensic laboratory
reporting system that systematically collects results
from drug chemistry analyses conducted by State
and local forensic laboratories in the United States.
NFLIS-Drug data was queried on September 4,
2024.
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schedule I synthetic cathinones and
schedule II stimulants. These
pharmacological characteristics of 4–
CMC are predictive of substances that
have a high potential for abuse. Overall,
these data indicate that 4–CMC
produces pharmacology effects and
stimulant-like behaviors that are similar
to those of methamphetamine and
MDMA.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance
4–CMC is a synthetic cathinone that
is structurally similar to schedule I
substances such as 4–FMC,
methcathinone, and mephedrone.
Anecdotal information in the record
indicates that the effects of 4–CMC can
be felt more quickly after insufflation
(2–3 minutes) than after oral ingestion
(30–60 minutes), but its duration of
effect is longer with oral ingestion. In
addition, toxicology data show that 4–
CMC is rapidly metabolized in the
human body. DEA is not aware of any
legitimate medical use for 4–CMC.
Additionally, there are no therapeutic
applications or recorded medical uses of
4–CMC. According to HHS, the Food
and Drug Administration (FDA)
concluded that 4–CMC has no currently
accepted medical use in the United
States. Similarly, DEA concludes 4–
CMC has no currently accepted medical
use according to established DEA
procedure and case law.12
ddrumheller on DSK120RN23PROD with PROPOSALS1
12 To
place a drug or other substance in schedule
I under the CSA, DEA must consider whether the
substance has a currently accepted medical use in
treatment in the United States. 21 U.S.C.
812(b)(1)(B). There is no evidence suggesting that
4–CMC has a currently accepted medical use in
treatment in the United States. To determine
whether a drug or other substance has a currently
accepted medical use, DEA has traditionally
applied a five-part test to a drug that has not been
approved by FDA: i. The drug’s chemistry must be
known and reproducible; ii. there must be adequate
safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug
must be accepted by qualified experts; and v. the
scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition;
Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev.
denied, Alliance for Cannabis Therapeutics v. Drug
Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir.
1994). DEA and HHS applied the traditional fivepart test for currently accepted medical use in this
matter. In a recent published letter in a different
context, HHS applied an additional two-part test to
determine currently accepted medical use for
substances that do not satisfy the five-part test: (1)
whether there exists widespread, current
experience with medical use of the substance by
licensed health care practitioners operating in
accordance with implemented jurisdictionauthorized programs, where medical use is
recognized by entities that regulate the practice of
medicine, and, if so, (2) whether there exists some
credible scientific support for at least one of the
medical conditions for which part 1 is satisfied. On
April 11, 2024, the Department of Justice’s Office
of Legal Counsel (OLC) issued an opinion, which,
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4. History and Current Pattern of Abuse
4–CMC is a synthetic cathinone that
has been identified in the United States’
illicit drug market. Thus, it is highly
likely that this substance is abused in
the same manner as schedule I synthetic
cathinones. That is, 4–CMC, similar to
other stimulant substances, is most
likely ingested by swallowing capsules
or tablets or snorted by nasal
insufflation of the powder tablets.
Demographic data collected from
toxicology analyses suggest that the
main users of 4–CMC are young adults.
In addition, there is evidence that 4–
CMC is being ingested with other
substances, including other synthetic
cathinones, common cutting agents, or
other substances of abuse.
5. Scope, Duration, and Significance of
Abuse
Evidence in the record shows that 4–
CMC is a recreational drug of abuse.
According to HHS, based on the
pharmacological properties of 4–CMC,
the scope, duration, and significance of
abuse of 4–CMC would be similar to
stimulants that are scheduled under the
CSA, including the schedule I substance
MDMA as well as the schedule II
stimulants cocaine and
methamphetamine, if uncontrolled. Law
enforcement data is also evidence of the
abuse of 4–CMC.
According to HHS, evidence of 4–
CMC abuse is confirmed by data from
poison control centers (PCC). PCC data
is derived from the National Poison Data
System (NPDS), a database managed by
the American Association of Poison
Control Centers (AAPCC).13 Between
2010 and 2019, there were 13,238 PCC
cases involving synthetic cathinones, of
which 10,482 were abuse cases.
Approximately 7,775 (74 percent) of the
synthetic cathinone cases involved a
synthetic cathinone as a single drug
substance. HHS reported that it is likely
that some portion of these cases
involved 4–CMC exposure because 4–
CMC is a synthetic cathinone. PCC data
also showed that the most common
category of medical outcome were cases
among other things, concluded that HHS’s two-part
test would be sufficient to establish that a drug has
a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland
Attorney General Re: Questions Related to the
Potential Rescheduling of Marijuana at 3 (April 11,
2024). For purposes of this proposed rule, there is
no evidence that health care providers have
widespread experience with medical use of 4–CMC,
or that the use of 4–CMC is recognized by entities
that regulate the practice of medicine under either
the traditional five-part test or the two-part test.
13 AAPCC is a nationwide network of PCCs that
receive reports from individuals, healthcare
professionals, and other interested persons in the
general U.S. population regarding exposures to
prescription drugs and other substances.
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with moderate effects (i.e., symptoms
that are prolonged and involved some
treatments) (3,746 of 5,654, or 66.3
percent). Of the cases admitted to a
health care facility, most (3,039 of 4,720,
or 64.4 percent) were admitted to a
critical care unit. From these data, HHS
concluded that individuals likely seek
aid through PCCs or emergency
departments (ED) following ingestion of
synthetic cathinones because of the
known adverse effects of synthetic
cathinones.
Evidence of 4–CMC abuse is also
confirmed by law enforcement seizure
data. According to analyses by forensic
laboratories, drug exhibits received from
State, local, or Federal law enforcement
agencies were found to contain 4–CMC.
Between January 2014 and August 2024,
NFLIS-Drug registered 399 reports from
Federal, State, and local forensic
laboratories identifying this substance
in drug-related exhibits from 33 states.14
There is additional evidence that 4–
CMC is abused internationally. 4–CMC
has been identified in items seized by
law enforcement agencies in countries
such as China, Czechia, Hungary,
Indonesia, and Poland. These
encounters of 4–CMC by law
enforcement indicate that this substance
is being trafficked in the United States
and internationally. The abuse of 4–
CMC in the United States and
internationally indicates that the abuse
of 4–CMC is widespread.
6. What, if Any, Risk There Is to the
Public Health
Available evidence in the record on
the overall public health risks
associated with the use of 4–CMC
suggests that it can cause acute health
problems leading to ED admissions and
death. Indeed, 4–CMC has been
associated with overdoses and deaths of
individuals. Acute effects of 4–CMC are
those typical of sympathomimetic
agents (e.g., cocaine, methamphetamine,
amphetamine) and among other effects
include euphoria, increased energy,
sociability and sexuality, visual and
auditory hallucinations, strong
empathogenic feelings, bruxism, lightheadedness, dizziness, slurred speech,
slowed behavior, mydriasis, increased
drive, disorientation as to time, place,
and surroundings, tachycardia,
agitation, logorrhea, poor light reflex,
and difficulty walking and holding
items. In addition, products containing
4–CMC often do not bear labeling
information regarding their ingredients
and, if they do, such labels may not
contain the expected active ingredient
or identify the health risks and potential
14 NFLIS-Drug
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hazards associated with these products.
These factors demonstrate that 4–CMC
is a serious public health threat.
7. Its Psychic or Physiological
Dependence Liability
According to the HHS eight-factor
analysis, the psychic or physiological
dependence liability of 4–CMC is
demonstrated by animal abuse-related
studies. HHS found that the
pharmacological data (e.g., locomotor
studies) strongly suggest that 4–CMC
produces behavioral effects that are
similar to those of schedule I and II
stimulants. Because 4–CMC shares
pharmacological properties with those
of the schedule I and II substances that
have dependence potential, such as
methamphetamine, cocaine, and
MDMA, it is probable that 4–CMC has
a dependence profile similar to these
substances which are known to cause
substance dependence. It is also
probable that 4–CMC will have
rewarding properties similar to those of
schedule I and II stimulants and,
consequently, psychic dependence of 4–
CMC can develop and may contribute to
its continued use among individuals
who abuse it despite its adverse
consequences. Thus, as HHS notes, it is
likely that 4–CMC will produce similar
psychic dependence to schedule I and II
stimulant drugs.
8. Whether the Substance Is an
Immediate Precursor of a Substance
Already Controlled Under the CSA
4–CMC is not an immediate precursor
of any substance controlled under the
CSA, as defined in 21 U.S.C. 802(23).
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Conclusion
After considering the scientific and
medical evaluation conducted by HHS,
HHS’s scheduling recommendation, and
DEA’s own eight-factor analysis, DEA
finds that the facts and all relevant data
constitute substantial evidence of the
potential for abuse of 4–CMC. As such,
DEA hereby proposes to permanently
schedule 4–CMC as a schedule I
controlled substance under the CSA.
This action would enable the United
States to meet its obligations under the
1971 Convention on Psychotropic
Substances.
Proposed 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.15 After
15 21
U.S.C. 812(b).
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consideration of the analysis and
recommendation of the Assistant
Secretary for Health of HHS and review
of all other available data, the
Administrator of DEA, pursuant to 21
U.S.C. 811(a) and 812(b)(1), finds that:
1. 4–CMC Has a High Potential for
Abuse
According to HHS, 4–CMC is
structurally and pharmacologically
similar to schedule I and II stimulant
substances, such as schedule I synthetic
cathinones, methamphetamine, and
MDMA. 4–CMC demonstrated activity
as a monoamine reuptake inhibitor at
dopamine, serotonin, and
norepinephrine transporters. This
mechanism of action is similar to the
schedule I substances 4–FMC,
mephedrone, MDMA, and
methcathinone, as well as the schedule
II stimulants, cocaine and
methamphetamine. In locomotor
studies, 4–CMC produced behavioral
stimulation similar to that of the
schedule II stimulants cocaine and
methamphetamine and the schedule I
stimulant MDMA. In drug
discrimination studies, 4–CMC fully
generalized to the discriminative
stimulus effects of the schedule II
stimulants cocaine and
methamphetamine and the schedule I
stimulant MDMA. Thus, 4–CMC elicits
pharmacological effects similar to
cocaine, methamphetamine, MDMA,
and methcathinone, illustrating a high
potential for abuse that is similar to
substances in schedules I and II of the
CSA. Overall, these data provide
supportive evidence that 4–CMC has a
high potential for abuse that is similar
to substances in schedule I or II of the
CSA.
2. 4–CMC has No Currently Accepted
Medical Use in Treatment in the United
States
HHS stated that FDA has not
approved a marketing application for a
drug product containing 4–CMC for any
indication. Moreover, FDA is not aware
of any adequate and well-controlled
clinical studies that show 4–CMC is safe
and effective for any intended use. DEA
further notes that, according to
established DEA procedure and case
law, 4–CMC has no currently accepted
medical use. Thus, evidence
demonstrates that 4–CMC has no
currently accepted medical use in
treatment in the United States.
3. There is a Lack of Accepted Safety for
Use of 4–CMC Under Medical
Supervision
Currently, 4–CMC does not have an
accepted medical use. And because it
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106381
has not been approved for use by FDA,
its safety under medical supervision has
not been determined. Thus, there is a
lack of accepted safety for use of 4–CMC
under medical supervision.
Based on these findings, the
Administrator concludes that 4chloromethcathinone (4–CMC, 1-(4chlorophenyl)-2-(methylamino)propan1-one), including its salts, isomers, and
salts of isomers, warrants control in
schedule I of the CSA.
Requirements for Handling 4–CMC
If this rule is finalized as proposed, 4–
CMC would be subject to the CSA’s
schedule I regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
importation, exportation, engagement in
research, and conduct of instructional
activities or chemical analysis with, and
possession of schedule I controlled
substances including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, imports, exports,
engages in research, or conducts
instructional activities or chemical
analysis with, or possesses) 4–CMC, or
who desires to handle 4–CMC, would be
required to be registered with 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, as of the effective date of a final
scheduling action. Any person who
currently handles 4–CMC, and is not
registered with DEA, would need to
submit an application for registration
and may not continue to handle 4–CMC
as of the effective date of a final
scheduling action, unless DEA has
approved that application for
registration pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who
does not desire or is not able to obtain
a schedule I registration would be
required to surrender all quantities of
currently held 4–CMC or to transfer all
quantities of currently held 4–CMC to a
person registered with DEA before the
effective date of a final scheduling
action, in accordance with all applicable
Federal, State, local, and Tribal laws. As
of the effective date of a final scheduling
action, 4–CMC would be required to be
disposed of in accordance with 21 CFR
part 1317, in addition to all other
applicable Federal, State, local, and
Tribal laws.
3. Security. 4–CMC would be subject
to schedule I security requirements and
would need to be handled and stored
pursuant to 21 U.S.C. 821, 823, and
871(b) and in accordance with 21 CFR
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1301.71 through 1301.76 as of the
effective date of a final scheduling
action. Non-practitioners handling 4–
CMC would also need to comply with
the employee screening requirements of
21 CFR 1301.90 through 1301.93.
4. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of 4–CMC would need to
comply with 21 U.S.C. 825 and 958(e)
and be in accordance with 21 CFR part
1302, as of the effective date of a final
scheduling action.
5. Quota. Only registered
manufacturers would be permitted to
manufacture 4–CMC in accordance with
a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part
1303 as of the effective date of a final
scheduling action.
6. Inventory. Every DEA registrant
who possesses any quantity of 4–CMC
on the effective date of a final
scheduling action would be required to
take an inventory of 4–CMC on hand at
that time, pursuant to 21 U.S.C. 827 and
958 and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
Any person who becomes registered
with DEA to handle 4–CMC on or after
the effective date of a final scheduling
action would be required to have an
initial inventory of all stocks of
controlled substances (including 4–
CMC) on hand on the date the registrant
first engages in the handling of
controlled substances pursuant to 21
U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and
1304.11(a) and (b).
After the initial inventory, every DEA
registrant must take an inventory of all
controlled substances (including 4–
CMC) on hand every two years,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant would be required to maintain
records and submit reports with respect
to 4–CMC pursuant to 21 U.S.C. 827 and
958(e) and in accordance with 21 CFR
parts 1304 and 1312, as of the effective
date of a final scheduling action.
Manufacturers and distributors would
be required to submit reports regarding
4–CMC to the Automation of Reports
and Consolidated Order System
(ARCOS) pursuant to 21 U.S.C. 827 and
in accordance with 21 CFR parts 1304
and 1312, as of the effective date of a
final scheduling action.
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8. Order Forms. Every DEA registrant
who distributes 4–CMC would be
required to comply with the order form
requirements, pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part
1305, as of the effective date of a final
scheduling action.
9. Importation and Exportation. All
importation and exportation of 4–CMC
would need to comply with 21 U.S.C.
952, 953, 957, and 958, and in
accordance with 21 CFR part 1312, as of
the effective date of a final scheduling
action.
10. Liability. Any activity involving
4–CMC not authorized by, or in
violation of, the CSA or its
implementing regulations would be
unlawful, and may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, and
14094 (Regulatory Review)
In accordance with 21 U.S.C. 811(a),
this proposed 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 (E.O.) 12866 and the principles
reaffirmed in E.O. 13563. E.O. 14094
modernizes the regulatory review
process to advance policies that
promote the public interest and address
national priorities.
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
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Fmt 4702
Sfmt 4702
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.
Regulatory Flexibility Act
The Administrator, in accordance
with the Regulatory Flexibility Act, 5
U.S.C. 601–602, 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 placing the substance
4-chloromethcathinone (4–CMC, 1-(4chlorophenyl)-2-(methylamino)propan1-one), including its salts, isomers, and
salts of isomers, in schedule I of the
CSA. This action is being taken to
enable the United States to meet its
obligations under the 1971 Convention
on Psychotropic Substances. If finalized,
this action would impose the regulatory
controls and administrative, civil, and
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, 4–CMC.
The entities affected by this proposed
rule include the manufacturers,
distributors, importers, exporters, and
researchers of 4–CMC. DEA determines
the North American Industry
Classification System (NAICS)
industries that best represent these
business activities. Table 1 lists the
business activities and corresponding
NAICS industries.16
16 Executive Office of the President Office of
Management and Budget, North American Industry
Classification System, United States, 2022, https://
www.census.gov/naics/reference_files_tools/2022_
NAICS_Manual.pdf. (Accessed 4/2/2024)
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106383
TABLE 1—BUSINESS ACTIVITY AND CORRESPONDING NAICS INDUSTRIES
NAICS
code
Business activity
Manufacturer .............................................
Distributor, Importer, Exporter ..................
325412
424210
424690
541715
611310
Researcher ...............................................
From Statistics of U.S. Businesses
(SUSB) data, DEA determined the
number of firms and small firms for
each of the affected industries, and by
NAICS industry description
Pharmaceutical Preparation Manufacturing.
Drugs and Druggists’ Sundries Merchant Wholesalers.
Other Chemical and Allied Products Merchant Wholesalers.
Research and Development in the Physical, Engineering, and Life Sciences (except
Nanotechnology and Biotechnology).
Colleges, Universities and Professional Schools.
comparing the number of affected small
entities to the number of small entities
for each industry, DEA determine
whether a substantial number of small
entities are affected in any of the
industries. Table 2 lists the number of
firms, small firms, and percent small
firms in each affected industry.
TABLE 2—PERCENT AFFECTED SMALL ENTITIES BY INDUSTRY
Firms 17
NAICS industry
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325412-Pharmaceutical Preparation Manufacturing .......................................
424210—Drugs and Druggists’ Sundries Merchant Wholesalers ...................
424690—Other Chemical and Allied Products Merchant Wholesalers ...........
541715—Research and Development in the Physical, Engineering, and Life
Sciences (except Nanotechnology and Biotechnology) ...............................
611310—Colleges, Universities and Professional Schools .............................
931
6,663
5,781
92.4
95.8
95.3
8,019
2,433
1,000
$34.5
7,571
1,515
94.4
62.3
17 Statistics of U.S. Businesses, 2021 SUSB
Annual Data Tables by Establishment Industry,
https://www.census.gov/data/tables/2021/econ/
susb/2021-susb-annual.html. (Accessed 4/2/2024).
18 U.S. Small Business Administration, Table of
size standards, Version March 2023, Effective:
March 17, 2023, https://www.sba.gov/sites/sbagov/
files/2023-06/Table%20of%20Size%20Standards_
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Percent small
entities
(%)
1,300
250
175
researchers). As mentioned above, DEA
has identified 13 domestic suppliers of
4–CMC from the SciFinder database and
none of these suppliers has registered
with DEA to handle Schedule I
controlled substances. However, it is
common for suppliers to have items in
their catalog while not actually having
any material level of sales because FDA
has not approved a marketing
application for a drug product
containing 4–CMC. Therefore, some
suppliers may simply remove 4–CMC
from their catalog without any impact.
Additionally, as discussed above, the
researchers working with 4–CMC are
likely to work with other controlled
substances and hence, must already
register with DEA.
In summary, the small entities
impacted by this proposed rule are
those in 325412-Pharmaceutical
Preparation Manufacturing, 424210—
Drugs and Druggists’ Sundries Merchant
Wholesalers, and 424690-Other
Chemical and Allied Products Merchant
Wholesalers. The affected small entities
account for less than 0.15 percent of the
small businesses and are not likely to
manufacture or carry inventory of 4–
CMC. As such, the proposed rule, if
finalized, is not expected to result in a
21:44 Dec 27, 2024
Small firms 19
1,007
6,958
6,069
Based on the American Chemical
Society’s SciFinder database, DEA
identified 10 entities supplying 4–CMC
across these industries. Suppliers
include 325412, 424210, and 424690
industries. Even if all affected suppliers
were small entities, they would account
for only 0.15 percent of the small
entities in those industries, not a
substantial number.20 Additionally,
DEA expects the number of researchers
working with 4–CMC is small because
4–CMC lacks current marketing
approval under a new drug application
or an abbreviated new drug application,
and is not subject to an investigational
new drug application as noted in the
HHS review. Also, DEA believes the
researchers working with 4–CMC may
also work with other controlled
substances; hence, they have probably
already registered with DEA and are
qualified to handle controlled
substances. For these reasons, DEA
believes the number of affected
researchers that are small entities is not
a substantial number of small entities in
541715 and 622310 industries.
The primary costs associated with this
proposed rule would be the annual
registration fee for Schedule I controlled
substances ($3,699 for manufacturers,
$1,850 for distributors, and $296 for
VerDate Sep<11>2014
SBA size
standard 18
significant economic impact on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1501 et seq., 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 annually for inflation) in any
1 year . . . .’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under the UMRA.
Paperwork Reduction Act of 1995
This proposed rule would not impose
a new collection or modify an existing
collection of information under the
Paperwork Reduction Act of 1995.21
Also, this proposed rule would not
impose new or modify existing
recordkeeping or reporting requirements
on state or local governments,
individuals, businesses, or
organizations. However, this proposed
rule would require compliance with the
following existing OMB collections:
1117–0003, 1117–0004, 1117–0006,
1117–0008, 1117–0009, 1117–0010,
Effective%20March%2017%2C%202023_.xlsx.
(Accessed 4/2/2024).
19 See footnote 17.
20 20/(931 + 6,664 + 5,781) = 0.15%.
21 44 U.S.C. 3501–3521.
E:\FR\FM\30DEP1.SGM
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules
1117–0012, 1117–0014, 1117–0021,
1117–0023, 1117–0029, and 1117–0056.
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.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on December 13, 2024, 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.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
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 21 CFR
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, add paragraph (d)(105)
to read as follows:
■
§ 1308.11
ddrumheller on DSK120RN23PROD with PROPOSALS1
*
Schedule I.
*
*
(d) * * *
*
*
*
*
*
*
(105) 4-Chloromethcathinone
(4–CMC, 1-(4-chlorophenyl)2-(methylamino)propan-1one) .......................................
*
*
*
*
*
*
*
*
1239
*
*
[FR Doc. 2024–30359 Filed 12–27–24; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
21:44 Dec 27, 2024
Jkt 265001
*
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–1457]
Schedules of Controlled Substances:
Placement of Seven Specific FentanylRelated Substances in Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Drug Enforcement
Administration proposes placing seven
fentanyl-related substances, as
identified in this proposed rule, in
schedule I of the Controlled Substances
Act. These seven 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 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
seven specific controlled substances.
DATES: Comments must be submitted
electronically or postmarked on or
before January 29, 2025.
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
January 29, 2025.
ADDRESSES: Interested persons may file
written comments on this proposal in
accordance with 21 CFR 1308.43(g). To
ensure proper handling of comments,
please reference ‘‘Docket No. DEA–
1457’’ on all electronic and written
correspondence, including any
attachments.
• Electronic comments: The Drug
Enforcement Administration (DEA)
SUMMARY:
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
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.
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. 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.
• Hearing requests: All requests for a
hearing and waivers of participation,
together with a written statement of
position on the matters of fact and law
asserted in the hearing, must be filed
with the DEA Administrator, who will
make the determination of whether a
hearing will be needed to address such
matters of fact and law in the
rulemaking. Such requests must be sent
to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. For
informational purposes, a courtesy copy
of requests for hearing and waivers of
participation should also be sent to: (1)
Drug Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
• Paperwork Reduction Act
Comments: All comments concerning
collections of information under the
Paperwork Reduction Act must be
submitted to the Office of Information
and Regulatory Affairs, OMB, Attention:
Desk Officer for DOJ, Washington, DC
20503. Please state that your comment
refers to Docket No. DEA–1457.
FOR FURTHER INFORMATION CONTACT: Dr.
Terrence L. Boos, Drug and Chemical
E:\FR\FM\30DEP1.SGM
30DEP1
Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Proposed Rules]
[Pages 106376-106384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30359]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1246]
Schedules of Controlled Substances: Placement of 4-
Chloromethcathinone in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration proposes placing the
substance 4-chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2-
(methylamino)propan-1-one), including its salts, isomers, and salts of
isomers, in schedule I of the Controlled Substances Act. This action is
being taken, in part, to enable the United States to meet its
obligations under the 1971 Convention on Psychotropic Substances. If
finalized, this action would impose the regulatory controls and
administrative, civil, and 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 4-chloromethcathinone.
DATES: Comments must be submitted electronically, and written comments
must be postmarked or shipped on or before January 29, 2025.
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
[[Page 106377]]
hearing, together with a written statement of position on the matters
of fact and law asserted in the hearing, must be received on or before
January 29, 2025.
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-1246'' on all
electronic and written correspondence, including any attachments.
Electronic comments: The Drug Enforcement Administration
(DEA) encourages commenters to submit 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
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 comment submission, you
will receive a Comment Tracking Number. If you have received a Comment
Tracking Number, your comment has been successfully submitted 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 the
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 Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152.
Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be filed with the
DEA Administrator, who will make the determination of whether a hearing
will be needed to address such matters of fact and law in the
rulemaking. Such requests must be sent to: Drug Enforcement
Administration, Attn: Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. For informational purposes, a courtesy
copy of requests for hearing and waivers of participation should also
be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/
OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
Paperwork Reduction Act Comments: All comments concerning
collections of information under the Paperwork Reduction Act must be
submitted to the Office of Information and Regulatory Affairs, OMB,
Attention: Desk Officer for DOJ, Washington, DC 20503. Please state
that your comment refers to Docket No. DEA-1246.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this proposed rule, the Drug Enforcement
Administration (DEA) proposes to place 4-chloromethcathinone (also
known as 4-CMC or 1-(4-chlorophenyl)-2-(methylamino)propan-1-one)
including its salts, isomers, and salts of isomers in schedule I of the
Controlled Substances Act (CSA).
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. DEA will make comments
available for public inspection online at https://www.regulations.gov.
Such information includes personal or business identifiers (such as
name, address, state or Federal identifiers, etc.) voluntarily
submitted by the commenter. In general, information voluntarily
submitted by the commenter, unless clearly marked as Confidential
Information in the method described below, will be publicly posted.
Comments may be submitted anonymously.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on https://www.regulations.gov for public inspection. The
Freedom of Information Act applies to all comments received.
For easy reference, an electronic copy of this document and
supplemental information to this proposed scheduling action are
available at https://www.regulations.gov.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA), 5 U.S.C. 551-559.\1\ Interested persons, as defined in 21
CFR 1300.01(b), may file requests for a hearing in conformity with the
requirements of 21 CFR 1308.44(a) and 1316.47(a), and such requests
must:
---------------------------------------------------------------------------
\1\ 21 CFR 1308.41 through 1308.45; 21 CFR part 1316, subpart D.
---------------------------------------------------------------------------
(1) state with particularity the interest of the person in the
proceeding;
(2) state with particularity the objections or issues concerning
which the person desires to be heard; and
(3) state briefly the position of the person with regarding to the
objections or issues.
Any interested person may file a waiver of an opportunity for a
hearing or to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(c), together with a written statement of
position on the matters of fact and law involved in any hearing.\2\
---------------------------------------------------------------------------
\2\ 21 CFR 1316.49.
---------------------------------------------------------------------------
All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
involved in such hearing, must be sent to DEA using the address
information provided above. The decision whether a hearing will be
needed to address such matters of fact and law in the rulemaking will
be made by the Administrator. If a hearing is needed, DEA will publish
a notice of hearing on the proposed rulemaking in the Federal
Register.\3\ Once the Administrator designates an Administrative Law
Judge (ALJ) to preside over the hearing, the ALJ's functions shall
commence, as provided in 21 CFR 1316.52.
---------------------------------------------------------------------------
\3\ 21 CFR 1308.44(b), 1316.53.
---------------------------------------------------------------------------
In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing
would be to determine whether 4-chloromethcathinone meets the statutory
criteria for placement in schedule I, as proposed in this rule.
[[Page 106378]]
Legal Authority
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 (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on his own motion, at the request of the
Secretary of Health and Human Services (HHS), or on the petition of an
interested party.\4\ This proposed action is initiated on the
Administrator's own motion and supported by, inter alia, a
recommendation from the Assistant Secretary for Health of HHS.
---------------------------------------------------------------------------
\4\ 21 U.S.C. 811(a).
---------------------------------------------------------------------------
In addition, the United States is a party to the 1971 United
Nations Convention on Psychotropic Substances (1971 Convention), Feb.
21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures
respecting changes in drug schedules under the 1971 Convention are
governed domestically by 21 U.S.C. 811(d)(2)-(4). When the United
States receives notification of a scheduling decision pursuant to
Article 2 of the 1971 Convention indicating that a drug or other
substance has been added to a schedule specified in the notification,
the Secretary of HHS (Secretary),\5\ after consultation with the
Attorney General, shall first determine whether existing legal controls
under subchapter I of the CSA and the Federal Food, Drug, and Cosmetic
Act meet the requirements of the schedule specified in the notification
with respect to the specific drug or substance.\6\ In the event that
the Secretary did not consult with the Attorney General, and the
Attorney General did not issue a temporary order, as provided under 21
U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in
21 U.S.C. 811(a) and (b) control. Pursuant to 21 U.S.C. 811(a)(1) and
(2), the Attorney General (as delegated to the Administrator of DEA)
may, by rule, and upon the recommendation of the Secretary, add to such
a schedule or transfer between such schedules any drug or other
substance, if he finds that such drug or other substance has a
potential for abuse, and makes with respect to such drug or other
substance the findings prescribed by 21 U.S.C. 812(b) for the schedule
in which such drug or other substance is to be placed.
---------------------------------------------------------------------------
\5\ As discussed in a memorandum of understanding entered into
by the FDA and the National Institute on Drug Abuse (NIDA), FDA acts
as the lead agency within 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 has delegated to the
Assistant Secretary for Health of HHS the authority to make domestic
drug scheduling recommendations. 58 FR 35460 (July 1, 1993).
\6\ 21 U.S.C. 811(d)(3).
---------------------------------------------------------------------------
Background
4-Chloromethcathinone (4-CMC) is a central nervous system stimulant
that shares structural and pharmacological similarities with schedule I
synthetic cathinones such as 4-methylethcathinone (4-MEC), 4-
fluoromethcathinone (4-FMC), and 3-fluoromethcathinone (3-FMC), and
schedule II stimulants such as amphetamine and methamphetamine. On May
7, 2020, the Secretary-General of the United Nations advised the
Secretary of State of the United States that the Commission on Narcotic
Drugs (CND) voted to place 4-CMC in Schedule II of the 1971 Convention
during its 63rd session held in March 2020 (CND Dec/63/9).
As a signatory to the 1971 Convention, the United States is
required, by scheduling under the CSA, to place appropriate controls on
4-CMC to meet the minimum requirements of the treaty. Because the
procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance
of a temporary order for 4-CMC, discussed in the above legal authority
section, were not followed, DEA is utilizing the procedures for
permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to control
4-CMC. Such scheduling would satisfy the United States' international
obligations.
Article 2, paragraph 7(b), of the 1971 Convention sets forth the
minimum requirements that the United States must meet when a substance
has been added to Schedule II of the 1971 Convention. Pursuant to the
1971 Convention, the United States must require licenses for the
manufacture, export and import, and distribution of 4-CMC. This license
requirement is accomplished by the CSA's registration requirement as
set forth in 21 U.S.C. 822, 823, 957, and 958, and in accordance with
21 CFR parts 1301 and 1312.
In addition, the United States must adhere to specific export and
import provisions set forth in the 1971 Convention. This requirement is
accomplished by the CSA with the export and import provisions
established in 21 U.S.C. 952, 953, 957, and 958, and in accordance with
21 CFR part 1312. Likewise, under Article 13, paragraphs 1 and 2 of the
1971 Convention, a party to the 1971 Convention may notify through the
UN Secretary-General another party that it prohibits the importation of
a substance in Schedule II, III, or IV of the 1971 Convention. If such
notice is presented to the United States, the United States shall take
measures to ensure that the named substance is not exported to the
notifying country. This requirement is also accomplished by the CSA's
export provisions mentioned above.
Under Article 16, paragraph 4, of the 1971 Convention, the United
States is required to provide annual statistical reports to the
International Narcotics Control Board (INCB). Using INCB Form P, the
United States shall provide the following information: (1) In regard to
each substance in Schedule I and II of the 1971 Convention, quantities
manufactured, exported to, and imported from each country or region as
well as stocks held by manufacturers; (2) in regard to each substance
in Schedule III and IV of the 1971 Convention, quantities manufactured,
as well as quantities exported and imported; (3) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in the manufacture of exempt preparations; and (4) in regard to
each substance in Schedule II-IV of the 1971 Convention, quantities
used for the manufacture of non-psychotropic substances or products.
Lastly, under Article 2 of the 1971 Convention, the United States
must adopt measures in accordance with Article 22 to address violations
of any statutes or regulations that are adopted pursuant to its
obligations under the 1971 Convention. Persons acting outside the legal
framework established by the CSA are subject to administrative, civil,
and/or criminal action; therefore, the United States complies with this
provision.
DEA notes that there are differences between the schedules of
substances in the 1971 Convention and the CSA. The CSA has five
schedules (schedules I-V) with specific criteria set forth for each
schedule. Schedule I is the only possible schedule in which a drug or
other substance may be placed if it has high potential for abuse and no
currently accepted medical use in treatment in the United States.\7\ In
contrast, the 1971 Convention has four schedules (Schedules I-IV) but
does not have specific criteria for each schedule. The 1971 Convention
simply defines its four schedules, in Article 1, to mean the
correspondingly numbered lists of psychotropic substances annexed to
the Convention, and altered in accordance with Article 2.
---------------------------------------------------------------------------
\7\ See 21 U.S.C. 812(b).
---------------------------------------------------------------------------
[[Page 106379]]
Proposed Determination to Schedule 4-CMC
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on 4-
CMC and on May 12, 2021, submitted it to the Assistant Secretary for
Health of HHS with a request for a scientific and medical evaluation of
available information and a scheduling recommendation for 4-CMC.
On December 22, 2022, HHS provided DEA a scientific and medical
evaluation entitled ``Basis for the Recommendation to Control 4-Chloro-
N-methylcathinone (4-CMC) and its Optical Isomers, Salts, and Salts of
Optical Isomers, in Schedule I of the Controlled Substances Act'' and a
scheduling recommendation. Pursuant to 21 U.S.C. 811(b), following
consideration of the eight-factors and findings related to the
substance's abuse potential, legitimate medical use, safety, and
dependence liability, HHS recommended that 4-CMC be controlled in
schedule I of the CSA under 21 U.S.C. 812(b). Upon receipt of the
scientific and medical evaluation and scheduling recommendation from
HHS, DEA reviewed the documents and all other relevant data and
conducted its own eight-factor analysis in accordance with 21 U.S.C.
811(c). Included below is a brief summary of each factor as analyzed by
HHS and DEA, and as considered by DEA in its proposed scheduling
action. Readers should refer to the full eight-factor analyses prepared
by HHS and by DEA in support of this proposal, which are available in
their entirety under the tab ``Supporting Documents'' of the public
docket of this rulemaking action at https://www.regulations.gov, under
docket number ``DEA-1246.''
1. The Drug's Actual or Relative Potential for Abuse
In addition to considering the information HHS provided in its
scientific and medical evaluation document for 4-CMC, DEA also
considered all other relevant data regarding actual or relative
potential for abuse of 4-CMC. The term ``abuse'' is not defined in the
CSA; however, the legislative history of the CSA suggests the following
four prongs in determining whether a particular drug or substance has a
potential for abuse: \8\
---------------------------------------------------------------------------
\8\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4601.
---------------------------------------------------------------------------
a. There is evidence that individuals are taking the drug or drugs
containing such a substance in amounts sufficient to create a hazard to
their health or to the safety of other individuals or of the community;
or
b. There is a significant diversion of the drug or substance from
legitimate drug channels; or
c. Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of medical
advice from a practitioner licensed by law to administer such drugs in
the course of his professional practice; or
d. The drug or drugs containing such a substance are new drugs so
related in their action to a drug or drugs already listed as having a
potential for abuse to make it likely that the drug will have the same
potentiality for abuse as such drugs, thus making it reasonable to
assume that there may be significant diversions from legitimate
channels, significant use contrary to or without medical advice, or
that it has a substantial capability of creating hazards to the health
of the user or to the safety of the community.
Both DEA and HHS eight-factor analyses found that 4-CMC produces
pharmacological effects that are similar to those of the ten schedule I
cathinone stimulants,\9\ MDMA, and the schedule II drugs cocaine and
methamphetamine. 4-CMC exhibits a typical stimulant-like
pharmacological profile in preclinical studies and in human case
reports. 4-CMC produces full generalization to the schedule II
stimulants, methamphetamine, and cocaine, and to MDMA, and, in humans,
4-CMC caused stimulant-like adverse effects, like that of these
schedule I and II stimulants.
---------------------------------------------------------------------------
\9\ Schedules of Controlled Substances: Placement of 10
Synthetic Cathinones Into Schedule I, 82 FR 12171-12177 (Mar. 1,
2017). The ten synthetic cathinones were 4-methethcathinone (4-MEC),
4'-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP), [alpha]-
pyrrolidinovalerophenone ([alpha]-PVP), butylone, pentedrone,
pentylone, 4-fluoromethcathinone (4-FMC), 3-fluoromethcathinone (3-
FMC), naphyrone, and [alpha]-Pyrrolidinobutiophenone ([alpha]-PBP).
---------------------------------------------------------------------------
4-CMC does not have an approved medical use in the United States,
but evidence indicates that 4-CMC is being abused and trafficked in the
United States. Because this substance is not an approved drug product,
a practitioner may not legally prescribe it, and it cannot be dispensed
to an individual. However, case reports, coroner/medical examiner
reports, and law enforcement data \10\ demonstrate that 4-CMC is being
abused because it is being used without medical advice. 4-CMC has been
identified during the toxicological screening of human urine or serum
samples indicating that it is being abused by individuals. In humans,
stimulant effects, like those of amphetamine, were observed following
the oral administration of 4-CMC. Non-fatal intoxications and overdoses
have also been associated with the abuse of 4-CMC.
---------------------------------------------------------------------------
\10\ While law enforcement data is not direct evidence of abuse,
it can lead to an inference that a drug has been diverted and
abused. See Schedules of Controlled Substances: Placement of
Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).
---------------------------------------------------------------------------
Law enforcement data show that 4-CMC has been encountered in the
United States' illicit drug market. From January 2014 to August 2024,
the National Forensic Laboratory Information System (NFLIS)-Drug
registered 399 reports \11\ pertaining to the trafficking,
distribution, and abuse of 4-CMC. These encounters of 4-CMC by law
enforcement indicate that this substance is being trafficked and abused
by individuals in the United States as a recreational drug of abuse.
---------------------------------------------------------------------------
\11\ NFLIS-Drug is a national forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by State and local forensic laboratories in the
United States. NFLIS-Drug data was queried on September 4, 2024.
---------------------------------------------------------------------------
Overall, these data demonstrate that 4-CMC has a high potential for
abuse. Thus, based on these data, it is reasonable to conclude that 4-
CMC, having no medical use, and thus no therapeutic value, presents a
hazard to the health and safety of individuals and the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, if Known
As discussed in the eight-factor analyses prepared by DEA and by
HHS, the available pharmacology data indicate that 4-CMC produces
pharmacological effects that are similar to those produced by schedule
I and II substances, such as mephedrone, 4-FMC, methamphetamine,
cocaine, methcathinone, and MDMA. Similar to these schedule I and II
stimulants, 4-CMC affects monoamine neurotransmission via action at
monoamine transporters. 4-CMC binds to monoamine transporters for
dopamine, serotonin, or norepinephrine and promotes the release of
these monoamines or blocks their uptake. Actions at these transporters,
especially actions that alter dopaminergic neurotransmission, are
believed to be involved in the production of the stimulant effects of
this class of drugs. Data also demonstrate that 4-CMC produces
locomotor behavior and discriminative stimulus effects that are similar
to those of the schedule I and II substances methamphetamine and
cocaine. Furthermore, in humans, adverse effects of 4-CMC are similar
to those reported following the use of
[[Page 106380]]
schedule I synthetic cathinones and schedule II stimulants. These
pharmacological characteristics of 4-CMC are predictive of substances
that have a high potential for abuse. Overall, these data indicate that
4-CMC produces pharmacology effects and stimulant-like behaviors that
are similar to those of methamphetamine and MDMA.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance
4-CMC is a synthetic cathinone that is structurally similar to
schedule I substances such as 4-FMC, methcathinone, and mephedrone.
Anecdotal information in the record indicates that the effects of 4-CMC
can be felt more quickly after insufflation (2-3 minutes) than after
oral ingestion (30-60 minutes), but its duration of effect is longer
with oral ingestion. In addition, toxicology data show that 4-CMC is
rapidly metabolized in the human body. DEA is not aware of any
legitimate medical use for 4-CMC. Additionally, there are no
therapeutic applications or recorded medical uses of 4-CMC. According
to HHS, the Food and Drug Administration (FDA) concluded that 4-CMC has
no currently accepted medical use in the United States. Similarly, DEA
concludes 4-CMC has no currently accepted medical use according to
established DEA procedure and case law.\12\
---------------------------------------------------------------------------
\12\ To place a drug or other substance in schedule I under the
CSA, DEA must consider whether the substance has a currently
accepted medical use in treatment in the United States. 21 U.S.C.
812(b)(1)(B). There is no evidence suggesting that 4-CMC has a
currently accepted medical use in treatment in the United States. To
determine whether a drug or other substance has a currently accepted
medical use, DEA has traditionally applied a five-part test to a
drug that has not been approved by FDA: i. The drug's chemistry must
be known and reproducible; ii. there must be adequate safety
studies; iii. there must be adequate and well-controlled studies
proving efficacy; iv. the drug must be accepted by qualified
experts; and v. the scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter. In a recent published
letter in a different context, HHS applied an additional two-part
test to determine currently accepted medical use for substances that
do not satisfy the five-part test: (1) whether there exists
widespread, current experience with medical use of the substance by
licensed health care practitioners operating in accordance with
implemented jurisdiction-authorized programs, where medical use is
recognized by entities that regulate the practice of medicine, and,
if so, (2) whether there exists some credible scientific support for
at least one of the medical conditions for which part 1 is
satisfied. On April 11, 2024, the Department of Justice's Office of
Legal Counsel (OLC) issued an opinion, which, among other things,
concluded that HHS's two-part test would be sufficient to establish
that a drug has a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland Attorney General Re:
Questions Related to the Potential Rescheduling of Marijuana at 3
(April 11, 2024). For purposes of this proposed rule, there is no
evidence that health care providers have widespread experience with
medical use of 4-CMC, or that the use of 4-CMC is recognized by
entities that regulate the practice of medicine under either the
traditional five-part test or the two-part test.
---------------------------------------------------------------------------
4. History and Current Pattern of Abuse
4-CMC is a synthetic cathinone that has been identified in the
United States' illicit drug market. Thus, it is highly likely that this
substance is abused in the same manner as schedule I synthetic
cathinones. That is, 4-CMC, similar to other stimulant substances, is
most likely ingested by swallowing capsules or tablets or snorted by
nasal insufflation of the powder tablets. Demographic data collected
from toxicology analyses suggest that the main users of 4-CMC are young
adults. In addition, there is evidence that 4-CMC is being ingested
with other substances, including other synthetic cathinones, common
cutting agents, or other substances of abuse.
5. Scope, Duration, and Significance of Abuse
Evidence in the record shows that 4-CMC is a recreational drug of
abuse. According to HHS, based on the pharmacological properties of 4-
CMC, the scope, duration, and significance of abuse of 4-CMC would be
similar to stimulants that are scheduled under the CSA, including the
schedule I substance MDMA as well as the schedule II stimulants cocaine
and methamphetamine, if uncontrolled. Law enforcement data is also
evidence of the abuse of 4-CMC.
According to HHS, evidence of 4-CMC abuse is confirmed by data from
poison control centers (PCC). PCC data is derived from the National
Poison Data System (NPDS), a database managed by the American
Association of Poison Control Centers (AAPCC).\13\ Between 2010 and
2019, there were 13,238 PCC cases involving synthetic cathinones, of
which 10,482 were abuse cases. Approximately 7,775 (74 percent) of the
synthetic cathinone cases involved a synthetic cathinone as a single
drug substance. HHS reported that it is likely that some portion of
these cases involved 4-CMC exposure because 4-CMC is a synthetic
cathinone. PCC data also showed that the most common category of
medical outcome were cases with moderate effects (i.e., symptoms that
are prolonged and involved some treatments) (3,746 of 5,654, or 66.3
percent). Of the cases admitted to a health care facility, most (3,039
of 4,720, or 64.4 percent) were admitted to a critical care unit. From
these data, HHS concluded that individuals likely seek aid through PCCs
or emergency departments (ED) following ingestion of synthetic
cathinones because of the known adverse effects of synthetic
cathinones.
---------------------------------------------------------------------------
\13\ AAPCC is a nationwide network of PCCs that receive reports
from individuals, healthcare professionals, and other interested
persons in the general U.S. population regarding exposures to
prescription drugs and other substances.
---------------------------------------------------------------------------
Evidence of 4-CMC abuse is also confirmed by law enforcement
seizure data. According to analyses by forensic laboratories, drug
exhibits received from State, local, or Federal law enforcement
agencies were found to contain 4-CMC. Between January 2014 and August
2024, NFLIS-Drug registered 399 reports from Federal, State, and local
forensic laboratories identifying this substance in drug-related
exhibits from 33 states.\14\ There is additional evidence that 4-CMC is
abused internationally. 4-CMC has been identified in items seized by
law enforcement agencies in countries such as China, Czechia, Hungary,
Indonesia, and Poland. These encounters of 4-CMC by law enforcement
indicate that this substance is being trafficked in the United States
and internationally. The abuse of 4-CMC in the United States and
internationally indicates that the abuse of 4-CMC is widespread.
---------------------------------------------------------------------------
\14\ NFLIS-Drug was queried on September 4, 2024.
---------------------------------------------------------------------------
6. What, if Any, Risk There Is to the Public Health
Available evidence in the record on the overall public health risks
associated with the use of 4-CMC suggests that it can cause acute
health problems leading to ED admissions and death. Indeed, 4-CMC has
been associated with overdoses and deaths of individuals. Acute effects
of 4-CMC are those typical of sympathomimetic agents (e.g., cocaine,
methamphetamine, amphetamine) and among other effects include euphoria,
increased energy, sociability and sexuality, visual and auditory
hallucinations, strong empathogenic feelings, bruxism, light-
headedness, dizziness, slurred speech, slowed behavior, mydriasis,
increased drive, disorientation as to time, place, and surroundings,
tachycardia, agitation, logorrhea, poor light reflex, and difficulty
walking and holding items. In addition, products containing 4-CMC often
do not bear labeling information regarding their ingredients and, if
they do, such labels may not contain the expected active ingredient or
identify the health risks and potential
[[Page 106381]]
hazards associated with these products. These factors demonstrate that
4-CMC is a serious public health threat.
7. Its Psychic or Physiological Dependence Liability
According to the HHS eight-factor analysis, the psychic or
physiological dependence liability of 4-CMC is demonstrated by animal
abuse-related studies. HHS found that the pharmacological data (e.g.,
locomotor studies) strongly suggest that 4-CMC produces behavioral
effects that are similar to those of schedule I and II stimulants.
Because 4-CMC shares pharmacological properties with those of the
schedule I and II substances that have dependence potential, such as
methamphetamine, cocaine, and MDMA, it is probable that 4-CMC has a
dependence profile similar to these substances which are known to cause
substance dependence. It is also probable that 4-CMC will have
rewarding properties similar to those of schedule I and II stimulants
and, consequently, psychic dependence of 4-CMC can develop and may
contribute to its continued use among individuals who abuse it despite
its adverse consequences. Thus, as HHS notes, it is likely that 4-CMC
will produce similar psychic dependence to schedule I and II stimulant
drugs.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA
4-CMC is not an immediate precursor of any substance controlled
under the CSA, as defined in 21 U.S.C. 802(23).
Conclusion
After considering the scientific and medical evaluation conducted
by HHS, HHS's scheduling recommendation, and DEA's own eight-factor
analysis, DEA finds that the facts and all relevant data constitute
substantial evidence of the potential for abuse of 4-CMC. As such, DEA
hereby proposes to permanently schedule 4-CMC as a schedule I
controlled substance under the CSA. This action would enable the United
States to meet its obligations under the 1971 Convention on
Psychotropic Substances.
Proposed 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.\15\ After consideration of the analysis and recommendation of
the Assistant Secretary for Health of HHS and review of all other
available data, the Administrator of DEA, pursuant to 21 U.S.C. 811(a)
and 812(b)(1), finds that:
---------------------------------------------------------------------------
\15\ 21 U.S.C. 812(b).
---------------------------------------------------------------------------
1. 4-CMC Has a High Potential for Abuse
According to HHS, 4-CMC is structurally and pharmacologically
similar to schedule I and II stimulant substances, such as schedule I
synthetic cathinones, methamphetamine, and MDMA. 4-CMC demonstrated
activity as a monoamine reuptake inhibitor at dopamine, serotonin, and
norepinephrine transporters. This mechanism of action is similar to the
schedule I substances 4-FMC, mephedrone, MDMA, and methcathinone, as
well as the schedule II stimulants, cocaine and methamphetamine. In
locomotor studies, 4-CMC produced behavioral stimulation similar to
that of the schedule II stimulants cocaine and methamphetamine and the
schedule I stimulant MDMA. In drug discrimination studies, 4-CMC fully
generalized to the discriminative stimulus effects of the schedule II
stimulants cocaine and methamphetamine and the schedule I stimulant
MDMA. Thus, 4-CMC elicits pharmacological effects similar to cocaine,
methamphetamine, MDMA, and methcathinone, illustrating a high potential
for abuse that is similar to substances in schedules I and II of the
CSA. Overall, these data provide supportive evidence that 4-CMC has a
high potential for abuse that is similar to substances in schedule I or
II of the CSA.
2. 4-CMC has No Currently Accepted Medical Use in Treatment in the
United States
HHS stated that FDA has not approved a marketing application for a
drug product containing 4-CMC for any indication. Moreover, FDA is not
aware of any adequate and well-controlled clinical studies that show 4-
CMC is safe and effective for any intended use. DEA further notes that,
according to established DEA procedure and case law, 4-CMC has no
currently accepted medical use. Thus, evidence demonstrates that 4-CMC
has no currently accepted medical use in treatment in the United
States.
3. There is a Lack of Accepted Safety for Use of 4-CMC Under Medical
Supervision
Currently, 4-CMC does not have an accepted medical use. And because
it has not been approved for use by FDA, its safety under medical
supervision has not been determined. Thus, there is a lack of accepted
safety for use of 4-CMC under medical supervision.
Based on these findings, the Administrator concludes that 4-
chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2-(methylamino)propan-1-
one), including its salts, isomers, and salts of isomers, warrants
control in schedule I of the CSA.
Requirements for Handling 4-CMC
If this rule is finalized as proposed, 4-CMC would be subject to
the CSA's schedule I regulatory controls and administrative, civil, and
criminal sanctions applicable to the manufacture, distribution, reverse
distribution, importation, exportation, engagement in research, and
conduct of instructional activities or chemical analysis with, and
possession of schedule I controlled substances including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) 4-
CMC, or who desires to handle 4-CMC, would be required to be registered
with 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, as of
the effective date of a final scheduling action. Any person who
currently handles 4-CMC, and is not registered with DEA, would need to
submit an application for registration and may not continue to handle
4-CMC as of the effective date of a final scheduling action, unless DEA
has approved that application for registration pursuant to 21 U.S.C.
822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and
1312.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration would be required to surrender
all quantities of currently held 4-CMC or to transfer all quantities of
currently held 4-CMC to a person registered with DEA before the
effective date of a final scheduling action, in accordance with all
applicable Federal, State, local, and Tribal laws. As of the effective
date of a final scheduling action, 4-CMC would be required to be
disposed of in accordance with 21 CFR part 1317, in addition to all
other applicable Federal, State, local, and Tribal laws.
3. Security. 4-CMC would be subject to schedule I security
requirements and would need to be handled and stored pursuant to 21
U.S.C. 821, 823, and 871(b) and in accordance with 21 CFR
[[Page 106382]]
1301.71 through 1301.76 as of the effective date of a final scheduling
action. Non-practitioners handling 4-CMC would also need to comply with
the employee screening requirements of 21 CFR 1301.90 through 1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of 4-CMC would need to comply with 21 U.S.C. 825
and 958(e) and be in accordance with 21 CFR part 1302, as of the
effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to
manufacture 4-CMC in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303 as of the effective
date of a final scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of 4-
CMC on the effective date of a final scheduling action would be
required to take an inventory of 4-CMC on hand at that time, pursuant
to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
Any person who becomes registered with DEA to handle 4-CMC on or
after the effective date of a final scheduling action would be required
to have an initial inventory of all stocks of controlled substances
(including 4-CMC) on hand on the date the registrant first engages in
the handling of controlled substances pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and
(b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including 4-CMC) on hand every
two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant would be required to
maintain records and submit reports with respect to 4-CMC pursuant to
21 U.S.C. 827 and 958(e) and in accordance with 21 CFR parts 1304 and
1312, as of the effective date of a final scheduling action.
Manufacturers and distributors would be required to submit reports
regarding 4-CMC to the Automation of Reports and Consolidated Order
System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21 CFR
parts 1304 and 1312, as of the effective date of a final scheduling
action.
8. Order Forms. Every DEA registrant who distributes 4-CMC would be
required to comply with the order form requirements, pursuant to 21
U.S.C. 828 and in accordance with 21 CFR part 1305, as of the effective
date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of
4-CMC would need to comply with 21 U.S.C. 952, 953, 957, and 958, and
in accordance with 21 CFR part 1312, as of the effective date of a
final scheduling action.
10. Liability. Any activity involving 4-CMC not authorized by, or
in violation of, the CSA or its implementing regulations would be
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, and 14094 (Regulatory Review)
In accordance with 21 U.S.C. 811(a), this proposed 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 (E.O.) 12866 and the
principles reaffirmed in E.O. 13563. E.O. 14094 modernizes the
regulatory review process to advance policies that promote the public
interest and address national priorities.
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.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-602, 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 placing the substance 4-chloromethcathinone (4-CMC, 1-
(4-chlorophenyl)-2-(methylamino)propan-1-one), including its salts,
isomers, and salts of isomers, in schedule I of the CSA. This action is
being taken to enable the United States to meet its obligations under
the 1971 Convention on Psychotropic Substances. If finalized, this
action would impose the regulatory controls and administrative, civil,
and 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, 4-CMC.
The entities affected by this proposed rule include the
manufacturers, distributors, importers, exporters, and researchers of
4-CMC. DEA determines the North American Industry Classification System
(NAICS) industries that best represent these business activities. Table
1 lists the business activities and corresponding NAICS industries.\16\
---------------------------------------------------------------------------
\16\ Executive Office of the President Office of Management and
Budget, North American Industry Classification System, United
States, 2022, https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf. (Accessed 4/2/2024)
[[Page 106383]]
Table 1--Business Activity and Corresponding NAICS Industries
------------------------------------------------------------------------
NAICS industry
Business activity NAICS code description
------------------------------------------------------------------------
Manufacturer................... 325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter 424210 Drugs and Druggists'
424690 Sundries Merchant
Wholesalers.
Other Chemical and
Allied Products
Merchant Wholesalers.
Researcher..................... 541715 Research and
611310 Development in the
Physical, Engineering,
and Life Sciences
(except Nanotechnology
and Biotechnology).
Colleges, Universities
and Professional
Schools.
------------------------------------------------------------------------
From Statistics of U.S. Businesses (SUSB) data, DEA determined the
number of firms and small firms for each of the affected industries,
and by comparing the number of affected small entities to the number of
small entities for each industry, DEA determine whether a substantial
number of small entities are affected in any of the industries. Table 2
lists the number of firms, small firms, and percent small firms in each
affected industry.
---------------------------------------------------------------------------
\17\ Statistics of U.S. Businesses, 2021 SUSB Annual Data Tables
by Establishment Industry, https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html. (Accessed 4/2/2024).
\18\ U.S. Small Business Administration, Table of size
standards, Version March 2023, Effective: March 17, 2023, https://www.sba.gov/sites/sbagov/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023_.xlsx.
(Accessed 4/2/2024).
\19\ See footnote 17.
Table 2--Percent Affected Small Entities by Industry
----------------------------------------------------------------------------------------------------------------
SBA size Small firms Percent small
NAICS industry Firms \17\ standard \18\ \19\ entities (%)
----------------------------------------------------------------------------------------------------------------
325412-Pharmaceutical Preparation Manufacturing. 1,007 1,300 931 92.4
424210--Drugs and Druggists' Sundries Merchant 6,958 250 6,663 95.8
Wholesalers....................................
424690--Other Chemical and Allied Products 6,069 175 5,781 95.3
Merchant Wholesalers...........................
541715--Research and Development in the 8,019 1,000 7,571 94.4
Physical, Engineering, and Life Sciences
(except Nanotechnology and Biotechnology)......
611310--Colleges, Universities and Professional 2,433 $34.5 1,515 62.3
Schools........................................
----------------------------------------------------------------------------------------------------------------
Based on the American Chemical Society's SciFinder database, DEA
identified 10 entities supplying 4-CMC across these industries.
Suppliers include 325412, 424210, and 424690 industries. Even if all
affected suppliers were small entities, they would account for only
0.15 percent of the small entities in those industries, not a
substantial number.\20\ Additionally, DEA expects the number of
researchers working with 4-CMC is small because 4-CMC lacks current
marketing approval under a new drug application or an abbreviated new
drug application, and is not subject to an investigational new drug
application as noted in the HHS review. Also, DEA believes the
researchers working with 4-CMC may also work with other controlled
substances; hence, they have probably already registered with DEA and
are qualified to handle controlled substances. For these reasons, DEA
believes the number of affected researchers that are small entities is
not a substantial number of small entities in 541715 and 622310
industries.
---------------------------------------------------------------------------
\20\ 20/(931 + 6,664 + 5,781) = 0.15%.
---------------------------------------------------------------------------
The primary costs associated with this proposed rule would be the
annual registration fee for Schedule I controlled substances ($3,699
for manufacturers, $1,850 for distributors, and $296 for researchers).
As mentioned above, DEA has identified 13 domestic suppliers of 4-CMC
from the SciFinder database and none of these suppliers has registered
with DEA to handle Schedule I controlled substances. However, it is
common for suppliers to have items in their catalog while not actually
having any material level of sales because FDA has not approved a
marketing application for a drug product containing 4-CMC. Therefore,
some suppliers may simply remove 4-CMC from their catalog without any
impact. Additionally, as discussed above, the researchers working with
4-CMC are likely to work with other controlled substances and hence,
must already register with DEA.
In summary, the small entities impacted by this proposed rule are
those in 325412-Pharmaceutical Preparation Manufacturing, 424210--Drugs
and Druggists' Sundries Merchant Wholesalers, and 424690-Other Chemical
and Allied Products Merchant Wholesalers. The affected small entities
account for less than 0.15 percent of the small businesses and are not
likely to manufacture or carry inventory of 4-CMC. As such, the
proposed rule, if finalized, is not expected to result in a significant
economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1501 et seq., 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 annually
for inflation) in any 1 year . . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under the UMRA.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995.\21\ Also, this proposed rule would not impose new or modify
existing recordkeeping or reporting requirements on state or local
governments, individuals, businesses, or organizations. However, this
proposed rule would require compliance with the following existing OMB
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009,
1117-0010,
[[Page 106384]]
1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and 1117-0056.
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.
---------------------------------------------------------------------------
\21\ 44 U.S.C. 3501-3521.
---------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 13, 2024, 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
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 21 CFR 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, add paragraph (d)(105) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * *
(105) 4-Chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2- 1239
(methylamino)propan-1-one)...............................
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-30359 Filed 12-27-24; 8:45 am]
BILLING CODE 4410-09-P