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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Proposed Rules
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 Particpation 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; 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, 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.

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Legal Authority The 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 on his own motion. 21
U.S.C. 811a. This proposed action is supported by a recommendation from the 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 for schedule I controlled substances on any person who handles manufactures, distributes, imports, exports, engages in research, conducts instructional activities or chemical analysis, or possesses or proposes to handle N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, or 4-chloro-a-PVP.

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Background On July 18, 2019, pursuant to 21
U.S.C. 811h1, DEA published an order in the Federal Register 84 FR
34291 temporarily placing Nethylhexedrone, alphapyrrolidinohexanophenone a-PHP, 4methyl-alphaethylaminopentiophenone 4-MEAP, 4methyl-alpha-pyrrolidinohexiophenone MPHP, alphapyrrolidinoheptaphenone PV8, and 4chloro-alpha-pyrrolidinovalerophenone 4-chloro-a-PVP in schedule I of the CSA upon finding that these synthetic cathinones 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 July 18, 2021. However, this same subsection also provides that, during the pendency of proceedings under 21 U.S.C. 811a1 with respect to a 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
Administrator 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 Administrator in a separate action, and is being simultaneously published elsewhere in this issue of the Federal Register.
The Administrator, on her own motion, is initiating proceedings under 21 U.S.C. 811a1 to permanently schedule N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-aPVP. DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these synthetic cathinones. On October 22, 2020, the Acting Administrator of DEA
submitted a request to the Assistant Secretary for Health of HHS Assistant Secretary to provide DEA with a scientific and medical evaluation of available information and a scheduling recommendation for N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP, in accordance with 21
U.S.C. 811b and c. Upon evaluating 1 Because the Secretary of HHS has delegated to the Assistant Secretary for Health Assistant Secretary the authority to make domestic drug scheduling recommendations, for purposes of this proposed rulemaking, all subsequent references to Secretary have been replaced with Assistant Secretary.

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the scientific and medical evidence, on July 8, 2021, the Assistant Secretary submitted to the Acting Administrator HHSs scientific and medical evaluation and scheduling recommendation for these substances. Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed the document and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-aPVP in accordance with 21 U.S.C.
811c.
Proposed Determination of Schedule N-Ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-Chloro-a-PVP
As discussed in the background section, the Administrator is initiating proceedings, pursuant to 21 U.S.C.
811a1, to add N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP permanently to schedule I. DEA has reviewed the scientific and medical evaluation and scheduling recommendation, received from HHS, and all other relevant data and conducted its own eight-factor analysis of the abuse potential of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
pursuant to 21 U.S.C. 811c. Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its proposed scheduling action. Please note that both the DEA and the HHS 8-Factor analyses and the Assistant Secretarys July 8, 2021 letter are available in their entirety under the tab Supporting Documents of the public docket of this rulemaking action at http www.regulations.gov, under Docket Number DEA495.
1. The Drugs Actual or Relative Potential for Abuse: Both the DEA and the HHS 8-factor analyses found that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP have abuse potential associated with its abilities to produce psychoactive effects that are similar to those produced by schedule I synthetic cathinones such as methcathinone, mephedrone, methylone, pentylone, and 3,4methylenedioxypyrovalerone MDPV
and schedule II stimulants such as methamphetamine and cocaine that have a high potential for abuse. In particular, the responses in humans to N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are stimulant-like and include paranoia, agitation, palpitations, tachycardia, hypertension, and hyperthermia.
N-Ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP have no approved medical uses in the United
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