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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules
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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 to make it 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 to make it 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 generally make available in publicly redacted form comments containing personal identifying information and confidential business information identified as directed above. If a comment has so much confidential business information that it cannot be effectively redacted, DEA may not make available publicly all or part of that comment. 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 a hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44a or b, and they shall 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
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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 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.
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.
21 U.S.C. 811a. This proposed action is supported by a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services HHS 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 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144.
Background On April 16, 2019, pursuant to 21
U.S.C. 811h1, DEA published an order in the Federal Register 84 FR
15505 temporarily placing ethyl 2-1-5fluoropentyl-1H-indazole-3carboxamido-3,3-dimethylbutanoate trivial name: 5F-EDMB-PINACA;
methyl 2-1-5-fluoropentyl-1H-indole3-carboxamido-3,3-dimethylbutanoate trivial name: 5F-MDMB-PICA; Nadamantan-1-yl-1-4-fluorobenzyl-1Hindazole-3-carboxamide trivial names:
FUB-AKB48; FUB-APINACA; AKB48 N4-FLUOROBENZYL; 1-5fluoropentyl-N-2-phenylpropan-2-yl1H-indazole-3-carboxamide trivial names: 5F-CUMYL-PINACA; SGT-25;
and 1-4-fluorobenzyl-1H-indol-3yl2,2,3,3tetramethylcyclopropylmethanone trivial name: FUB-144 in schedule I of the CSA upon finding that these five synthetic cannabinoids SCs pose an imminent hazard to the public safety.
That temporary order was effective on the date of publication. Pursuant to 21
U.S.C. 811h2, the temporary control of these substances is set to expire on April 16, 2021. However, this same subsection also provides that during the pendency of proceedings under 21
U.S.C. 811a1 with respect to a
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substance, the temporary scheduling of that substance may be extended for up to one year. Proceedings for the scheduling of a substance under 21
U.S.C. 811a 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 HHS,1 or on the petition of any interested party. An extension of the existing temporary order is being ordered by the Acting Administrator of DEA Acting Administrator in a separate action, and is being simultaneously published elsewhere in this issue of the Federal Register.
The Acting Administrator, on his own motion, is initiating proceedings under 21 U.S.C. 811a1 to permanently schedule 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144. DEA gathered the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these five SCs. On December 4, 2019, the former Acting Administrator submitted this data to the Assistant Secretary for Health of HHS Assistant Secretary, and requested that HHS provide DEA with a scientific and medical evaluation and a scheduling recommendation for 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144, in accordance with 21 U.S.C.
811b and c. Upon evaluating the scientific and medical evidence, on February 26, 2021, the Acting Assistant Secretary submitted HHSs scientific and medical evaluation and scheduling recommendation for these five substances to the Acting Administrator.
Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA
reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144, in accordance with 21 U.S.C. 811c.
Proposed Determination To Schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144
As discussed in the background section, the Acting Administrator is initiating proceedings, pursuant to 21
1 Because the Secretary of HHS has delegated to the Assistant Secretary for Health of HHS Assistant Secretary the authority to make domestic drug scheduling recommendations, for purposes of this proposed scheduling action, all subsequent references to Secretary have been replaced with Assistant Secretary.

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