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[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]

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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.

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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:
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    \1\ 21 CFR 1308.41 through 1308.45; 21 CFR part 1316, subpart D.
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    (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\
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    \2\ 21 CFR 1316.49.
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    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.
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    \3\ 21 CFR 1308.44(b), 1316.53.
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    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.
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    \4\ 21 U.S.C. 811(a).
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    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.
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    \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).
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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.
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    \7\ See 21 U.S.C. 812(b).

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[[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\
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    \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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    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.
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    \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).
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    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.
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    \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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    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.
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    \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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    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\
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    \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.
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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 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.
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    \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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    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.
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    \14\ NFLIS-Drug was queried on September 4, 2024.
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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
```