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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
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years, with a possible extension of one year, pending completion of the regular permanent scheduling process. 21
U.S.C. 811h1 and 2. The Administrator intends to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this document. Upon the temporary orders publication, butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene will then be subject to the CSAs schedule I regulatory controls and to administrative, civil, and criminal sanctions applicable to their manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession.
The CSA sets forth specific criteria for scheduling drugs or other substances.
Regular scheduling actions in accordance with 21 U.S.C. 811a are subject to formal rulemaking procedures on the record after opportunity for a hearing conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21
U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make determinations. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877.
Temporary scheduling orders are not subject to judicial review. 21 U.S.C.
811h6.
Regulatory Analyses The CSA provides for expedited temporary scheduling actions where 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, temporarily place substances in schedule I. Such orders may not be issued before the expiration of 30 days from: 1 The publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and 2
the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary for Health of HHS, as delegated by the Secretary of HHS. 21 U.S.C. 811h1.
Inasmuch as section 811h directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, including the requirement to publish in the Federal Register a Notice
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of Intent, the notice-and-comment requirements of section 553 of the Administrative Procedure Act APA, 5
U.S.C. 553, do not apply to this Notice of Intent. The APA expressly differentiates between orders and rules, as it defines an order to mean a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making. 5 U.S.C. 5516
emphasis added. The specific language chosen by Congress indicates its intent that DEA issue orders instead of proceeding by rulemaking when temporarily scheduling substances.
Given that Congress specifically requires the Administrator as delegated by the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, see 21 U.S.C.
811a, it is noteworthy that, in section 811h, Congress authorized the issuance of temporary scheduling actions by order rather than by rule.
Even assuming that this Notice of Intent is subject to section 553 of the APA, the Administrator finds that there is good cause to forgo its notice-andcomment requirements, as any further delays in the process for issuing temporary scheduling orders would be impracticable and contrary to the public interest given the manifest urgency to avoid an imminent hazard to the public safety.
Although DEA believes this Notice of Intent to issue a temporary scheduling order is not subject to the notice-andcomment requirements of section 553 of the APA, DEA notes that in accordance with 21 U.S.C. 811h4, the Administrator took into consideration comments submitted by the Assistant Secretary in response to the notices that DEA transmitted to the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this 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.
In accordance with the principles of Executive Orders E.O. 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential
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economic, environmental, public health, and safety effects; distributive impacts;
and equity. E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O.
12866. E.O. 12866 classifies a significant regulatory action, requiring review by the Office of Management and Budget, as any regulatory action that is likely to result in a rule that may: 1 Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition;
jobs; the environment; public health or safety; or State, local, or tribal governments or communities; 2 create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; 3
materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or 4 raise novel legal or policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the E.O.
Because this is not a rulemaking action, this is not a significant regulatory action as defined in Section 3f of E.O. 12866.
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
Federalism, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, DEA
proposes to amend 21 CFR part 1308 as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871b, 956b, unless otherwise noted.

2. In 1308.11, add paragraphs h50
through 56 to read as follows:

1308.11

Schedule I.

h

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