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

DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1246]</DEPDOC> <SUBJECT>Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Notice of proposed rulemaking. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> 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 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. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> 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. • <E T="03">Electronic comments:</E> 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 <E T="03">https://www.regulations.gov</E> 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. • <E T="03">Paper comments:</E> Paper comments that duplicate the electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment, <E T="03">in lieu of</E> 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. • <E T="03">Hearing requests:</E> 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 <E T="04">Federal Register</E> Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. • <E T="03">Paperwork Reduction Act Comments:</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; telephone: (571) 362-3249. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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). <HD SOURCE="HD1">Posting of Public Comments</HD> 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 <E T="03">https://www.regulations.gov.</E> 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 <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> <HD SOURCE="HD1">Request for Hearing or Appearance; Waiver</HD> 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. <SU>1</SU> <FTREF/> 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: <FTNT> <SU>1</SU>  21 CFR 1308.41 through 1308.45; 21 CFR part 1316, subpart D. </FTNT> (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. <SU>2</SU> <FTREF/> <FTNT> <SU>2</SU>  21 CFR 1316.49. </FTNT> 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 <E T="04">Federal Register</E> . <SU>3</SU> <FTREF/> 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. <FTNT> <SU>3</SU>  21 CFR 1308.44(b), 1316.53. </FTNT> 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. <HD SOURCE="HD1">Legal Authority</HD> 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. <SU>4</SU> <FTREF/> This proposed action is initiated on the Administrator's own motion and supported by, <E T="03">inter alia,</E> a recommendation from the Assistant Secretary for Health of HHS. <FTNT> <SU>4</SU>  21 U.S.C. 811(a). </FTNT> In addition, the United States is a party to the 1971 United Nations Conventio ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 56k characters. 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