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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules
fact and law asserted in the hearing, must be received on or before October 4, 2021.
ADDRESSES: To ensure proper handling of comments, please reference Docket No. DEA737 on all electronic and written 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, 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. 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: 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 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: Dr.
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments Please note that all comments received in response to this docket are
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considered part of the public record.
The Drug Enforcement Administration DEA will make them available, unless reasonable cause is given, 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.
DEA will make available publicly in redacted form comments containing personal identifying information or confidential business information identified as directed above. If a comment has so much confidential business information that it cannot be redacted effectively, all or part of that comment may not be made available publicly. 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 as directed above.
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 Appearance;
Waiver 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
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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. 21 CFR
1316.47a. 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, together with a written statement of position on the matters of fact and law asserted in the hearing, must be sent to DEA using the address information provided above.
Legal Authority The United States is a party to the 1971 United Nations Convention on Psychotropic Substances 1971
Convention, February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811d24.
When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971
Convention adding a drug or other substance to a specific schedule, the Secretary of the Department of Health and Human Services HHS,1 after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the Controlled Substances Act CSA and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. 21 U.S.C. 811d3. In the event that the Secretary of HHS
Secretary did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811d4, the procedures for permanent scheduling set forth in 21 U.S.C. 811a and b control. Pursuant to 21 U.S.C.
811a1, the Attorney General, by rule, may add to such a schedule any drug or other substance, if he finds that such drug or other substance has a potential 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 Controlled Substances Act, 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 domestic drug scheduling recommendations. 58 FR 35460 July 1, 1993.

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