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. 

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. 

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 

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. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore: (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under DOT Regulatory Policies 

and Procedures (44 FR 11034; February 

26, 1979); and (3) does not warrant 

preparation of a regulatory evaluation as 

the anticipated impact is so minimal. 

Since this is a routine matter that will 

only affect air traffic procedures and air 

navigation, it is certified that this 

proposed rule, when promulgated, will 

not have a significant economic impact 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis 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: 

Paragraph 6010(b) Alaskan VOR Federal 

Airways. 

* * * * * 

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. 

* * * * * 

V–504 [Amended] 

From Nenana, AK; to Bettles, AK. 

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 

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 


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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106377 

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. 

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) 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 4- 

chloromethcathinone meets the 

statutory criteria for placement in 

schedule I, as proposed in this rule. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
106378 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 

4 21 U.S.C. 811(a). 

5As 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). 7See 21 U.S.C. 812(b). 

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 

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 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106379 

8Comprehensive 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. 

9Schedules 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). 

10While 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). 

11NFLIS-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. 

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

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. 

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. 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 


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12To 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, 

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. 

13AAPCC 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. 14NFLIS-Drug was queried on September 4, 2024. 

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

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. 

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 


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15 21 U.S.C. 812(b). 

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: 

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)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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16Executive 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) 

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)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


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17Statistics 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). 

18U.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). 

19See footnote 17. 

20 20/(931 + 6,664 + 5,781) = 0.15%. 

21 44 U.S.C. 3501–3521. 

TABLE 1—BUSINESS ACTIVITY AND CORRESPONDING NAICS INDUSTRIES

Business activity NAICS 

code NAICS industry description 

Manufacturer ............................................. 325412 Pharmaceutical Preparation Manufacturing. 

Distributor, Importer, Exporter .................. 424210 

424690 

Drugs and Druggists’ Sundries Merchant Wholesalers. 

Other Chemical and Allied Products Merchant Wholesalers. 

Researcher ............................................... 541715 

611310 

Research and 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. 

TABLE 2—PERCENT AFFECTED SMALL ENTITIES BY INDUSTRY

NAICS industry Firms 17 SBA size 

standard 18 Small firms 19

Percent small 

entities 

(%) 

325412-Pharmaceutical Preparation Manufacturing ....................................... 1,007 1,300 931 92.4 

424210—Drugs and Druggists’ Sundries Merchant Wholesalers ................... 6,958 250 6,663 95.8 

424690—Other Chemical and Allied Products Merchant Wholesalers ........... 6,069 175 5,781 95.3 

541715—Research and Development in the Physical, Engineering, and Life 

Sciences (except Nanotechnology and Biotechnology) ............................... 8,019 1,000 7,571 94.4 

611310—Colleges, Universities and Professional Schools ............................. 2,433 $34.5 1,515 62.3 

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 

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, 


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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 Schedule I. 

* * * * * 

(d) * * * 

* * * * * 

(105) 4-Chloromethcathinone 

(4–CMC, 1-(4-chlorophenyl)- 

2-(methylamino)propan-1- 

one) ....................................... 1239 

* * * * * 

* * * * * 

[FR Doc. 2024–30359 Filed 12–27–24; 8:45 am] 

BILLING CODE 4410–09–P 

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 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: 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) 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1