2024-30359. Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I

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 Statis tics 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, ( print 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.

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.

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(d) * * *

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(105) 4-Chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2-(methylamino)propan-1-one)	1239
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