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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations
dexmethylphenidate hydrochloride, for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age or older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place serdexmethylphenidate and its salts in schedule IV of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act, thereby facilitating the commercial distribution of AZSTARYS
as a lawful controlled substance.
DATES: The effective date of this rulemaking is May 7, 2021. Interested persons may file written comments on this rulemaking in accordance with 21
U.S.C. 811j3 and 21 CFR 1308.43g.
Electronic comments must be submitted, and written comments must be postmarked, on or before June 7, 2021. 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.
Interested persons may file a request for hearing or waiver of hearing in accordance with 21 U.S.C. 811j3 and 21 CFR 1308.44. Requests for 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 June 7, 2021.
ADDRESSES: To ensure proper handling of comments, please reference Docket No. DEA808 on all correspondence, including any attachments.
Electronic comments: The Drug Enforcement Administration DEA
encourages that all comments be submitted 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 http
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. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number,
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your comment has been successfully submitted and there is no need to resubmit the same comment.
Paper comments: Paper comments that duplicate the electronic submission 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, VA
22152.
Hearing requests: All requests for hearing and waivers of participation must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 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.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug & Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION: This interim final rule refers to the single entity, serdexmethylphenidate. The chloride salt of serdexmethylphenidate is chemically known as 3-1S-1carboxy-2-hydroxyethylaminocarbonyl-1-2R-2-1R-2methoxy-2-oxo-1-phenylethyl-1piperidinyl carbonyloxymethylpyridinium chloride. This rule places serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act CSA, thereby facilitating the commercial distribution of AZSTARYS as a controlled substance.
Posting of Public Comments Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration DEA for public inspection online at http
www.regulations.gov. Such information includes personal identifying information such as your name, address, etc. voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments
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received. If you want to submit personal identifying information such as your name, address, etc. as part of your comment, but do not want it to be made publicly available, you must include the phrase PERSONAL IDENTIFYING
INFORMATION in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase CONFIDENTIAL BUSINESS
INFORMATION in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http
www.regulations.gov may include any personal identifying information such as name, address, and phone number included in the text of your electronic submission that is not identified as directed above as confidential.
An electronic copy of this document and supplemental information, including the complete Department of Health and Human Services HHS and DEA eight-factor analyses, to this interim final rule are available at http
www.regulations.gov for easy reference.
Request for Hearing or Waiver of Participation in a Hearing Pursuant to 21 U.S.C. 811a, 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. 551559. 21 CFR 1308.41
1308.45; 21 CFR part 1316, subpart D.
Such requests or notices must conform to the requirements of 21 CFR
1308.44a or b, and 1316.47 or 1316.48, as applicable, and include a statement of the persons interests in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR
1308.44c and may include a written statement regarding the interested
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