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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Proposed Rules
conduct chemical analysis or propose to handle 18FFP-CIT.
DATES: Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43g.
Electronic comments must be submitted, and written comments must be postmarked, on or before December 6, 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 participation pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as applicable. Requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before December 6, 2021.
ADDRESSES: To ensure proper handling of comments, please reference Docket No. DEA837 on all correspondence, including any attachments.
Electronic comments: DEA
encourages that all comments be submitted 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 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, your comment has been successfully submitted and there is no need to resubmit the same comment.
Paper comments: Paper comments that duplicate electronic submissions are not necessary and are discouraged.
Should you wish to mail a paper comment in lieu of an electronic format, 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 must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug & Chemical Evaluation Section, Diversion Control
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Division, Drug Enforcement Administration; Telephone: 571 362
3261.
SUPPLEMENTARY INFORMATION:

Posting of Public Comments Please note that all comments received in response to this docket 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 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 to this proposed rule are available at http
www.regulations.gov for easy reference.
DEA specifically solicits written comments regarding DEAs economic analysis of the impact of these proposed changes. DEA requests that commenters provide detailed descriptions in their
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comments of any expected economic impacts, especially to small entities.
Commenters should provide empirical data to illustrate the nature and scope of such impact.
Request for Hearing, Notice of Appearance at or Waiver of Participation in 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 5 U.S.C.
551559. 21 CFR 1308.411308.45, and 21 CFR part 1316 subpart D. In accordance with 21 CFR 1308.44 ac, requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted by interested persons. 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 interest of the person 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 1316.49, including a written statement regarding the interested persons position on the matters of fact and law involved in any hearing.
Please note that, pursuant to 21 U.S.C.
811a2, the purpose of a hearing would be to determine whether 18FFPCIT should be removed from the list of controlled substances based on a finding that the drug does not meet the requirements for inclusion in any schedule. All requests for hearing and waivers of participation must be sent to DEA using the address information above, on or before the date specified above.
Legal Authority The Controlled Substances Act 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 1 on his own motion, 2 at the request of the Secretary of the Department of Health and Human Services HHS,1 or 3 on the petition 1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration FDA and the National Institute on Drug Abuse NIDA, FDA acts as the lead agency within HHS in carrying out the Secretarys scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, March 8, 1985.
The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make
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