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jbell on DSKJLSW7X2PROD with PROPOSALS

Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess, or propose to handle 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-phenyl fentanyl, b-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.
DATES: Comments must be submitted electronically or postmarked on or before April 2, 2021.
Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before April 2, 2021.
ADDRESSES: To ensure proper handling of comments, please reference Docket No. DEA476 on all electronic and written correspondence, including any attachments.
Electronic comments: Interested persons may file written comments on this proposal in accordance with 21 CFR
1308.43g. 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 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.
Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Easter Time on the last day of the comment period.
Paper comments: Paper comments that duplicate the electronic submission 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: Interested persons may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44
and in accordance with 21 CFR 1316.45
and/or 1316.47, as applicable. All
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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 and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: 571 3623249
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 confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will 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
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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.
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, 5 U.S.C.
551559. 21 CFR 1308.411308.45; 21
CFR part 1316, subpart D. Interested persons may file requests for hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44a or b, and include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested persons position on the matters of fact and law involved in any hearing as set forth in 21 CFR
1308.44c.
All requests for a hearing and waivers of participation must be sent to DEA
using the address information provided 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 delegated to the Administrator of DEA pursuant to 28
CFR 0.100 on his own motion. 21
U.S.C. 811a. This proposed action is supported by a recommendation from the Assistant Secretary for Health of U.S. Department of Health and Human Services HHS Assistant Secretary and an evaluation of all other relevant data by DEA. If finalized, this action would make permanent the existing temporary regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle 2fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-phenyl fentanyl, bmethyl fentanyl, ortho-fluorobutyryl
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