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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Rules and Regulations
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4-methyl-alphaethylaminopentiophenone other names:
4-MEAP, 2-ethylamino-1-4methylphenylpentan-1-one, 4-methyl-alphapyrrolidinohexiophenone other names:
MPHP, 4-methyl-alphapyrrolidinohexanophenone; 1-4methylphenyl-2-pyrrolidin-1-ylhexan1-one, alpha-pyrrolidinoheptaphenone other names: PV8, 1-phenyl-2pyrrolidin-1-ylheptan-1-one, and 4-chloro-alphapyrrolidinovalerophenone other names:
4-chloro-a-PVP, 4-chloro-alphapyrrolidinopentiophenone, 1-4chlorophenyl-2-pyrrolidin-1ylpentan-1-one.
Background and Legal Authority On July 18, 2019, the Acting Administrator of DEA Acting Administrator published a temporary scheduling order in the Federal Register 84 FR 34291 placing N-ethylhexedrone other name: 2-ethylamino-1phenylhexan-1-one; alphapyrrolidinohexanophenone other names: a-PHP, alphapyrrolidinohexiophenone, 1-phenyl-2pyrrolidin-1-ylhexan-1-one; 4-methylalpha-ethylaminopentiophenone other names: 4-MEAP, 2-ethylamino-1-4methylphenylpentan-1-one; 4-methylalpha-pyrrolidinohexiophenone other names: MPHP, 4-methyl-alphapyrrolidinohexanophenone; 1-4methylphenyl-2-pyrrolidin-1-ylhexan1-one; alpha-pyrrolidinoheptaphenone other names: PV8, 1-phenyl-2pyrrolidin-1-ylheptan-1-one; and 4chloro-alpha-pyrrolidinovalerophenone other names: 4-chloro-a-PVP, 4-chloroalpha-pyrrolidinopentiophenone, 1-4chlorophenyl-2-pyrrolidin-1ylpentan-1-one, synthetic cathinones, in schedule I of the CSA pursuant to the temporary scheduling provisions of 21
U.S.C. 811h.1 That order was effective on the date of publication, and was based on findings by the Acting Administrator that the temporary scheduling of these substances was necessary to avoid an imminent hazard to the public safety pursuant to 21
U.S.C. 811h1. Subsection h2
provides that the temporary control of these substances expires two years from the effective date of the temporary scheduling order, i.e., on July 18, 2021.
21 U.S.C. 811h2. However, this same subsection also provides that, during the 1 Though DEA has used the term final order with respect to temporary scheduling orders in the past, this notice adheres to the statutory language of 21 U.S.C. 811h, which refers to a temporary scheduling order. No substantive change is intended.

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pendency of proceedings under 21
U.S.C. 811a1 with respect to the substance, the temporary scheduling of that substance can 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 Health and Human Services HHS,2 or on the petition of any interested party.
The Administrator, on her own motion, has initiated proceedings under 21 U.S.C. 811a1 to permanently schedule N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-aPVP. DEA is simultaneously publishing a notice of proposed rulemaking for the permanent placement of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP in schedule I elsewhere in this issue of the Federal Register. If that proposed rule is finalized, DEA will publish a final rule in the Federal Register to make permanent the schedule I status of these substances.
Pursuant to 21 U.S.C. 811h2, the Administrator orders that the temporary scheduling of N-ethylhexedrone, alphapyrrolidinohexanophenone, 4-methylalpha-ethylaminopentiophenone, 4methyl-alpha-pyrrolidinohexiophenone, alpha-pyrrolidinoheptaphenone, and 4chloro-alpha-pyrrolidinovalerophenone, and their optical, positional, and geometric isomers, salts, and salts of isomers, be extended for one year, or until the permanent scheduling proceeding is completed, whichever occurs first.
Regulatory Matters The CSA provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety.
Under 21 U.S.C. 811h, the Administrator, as delegated by the Attorney General, may, by order, place a substance in schedule I on a temporary basis. This same subsection provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of the order scheduling such substance, except that the Administrator may, during the pendency of proceedings under 21 U.S.C. 811a1 to permanently schedule the substance, extend the temporary scheduling for up to one year.
2 The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations.

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To the extent that section 811h directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act APA, 5
U.S.C. 553, do not apply to this extension of the temporary scheduling order. The specific language chosen by Congress indicates an intention for DEA
to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, see 21 U.S.C. 811a, it is noteworthy that, in subsection 811h, Congress authorized the issuance of temporary scheduling actions by order rather than by rule. In the alternative, even assuming that this action might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety that these substances would present if scheduling expired, for the reasons expressed in the temporary scheduling order 84 FR 34291, July 18, 2019.
Further, DEA believes that this order extending the temporary scheduling action is not a rule as defined by 5
U.S.C. 6012, and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5
U.S.C. 603a are not applicable where, as here, DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as defined by Executive Order E.O. 12866
Regulatory Planning and Review, section 3f, and the principles reaffirmed in E.O. 13563 Improving Regulation and Regulatory Review.
Accordingly, this action has not been reviewed by the Office of Management and Budget.
This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132

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