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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
legitimate purposes consistent with the drugs labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act, as applicable, and the CSA.
11. Importation and Exportation. All importation and exportation of oliceridine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
12. Liability. Any activity involving oliceridine not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses Administrative Procedure Act This final rule, with a correction in the chemical name of oliceridine as discussed above, affirms the amendment made by the IFR that is already in effect.
Section 553 of the Administrative Procedure Act APA 5 U.S.C. 553
generally requires notice and comment for rulemaking. However, 21 U.S.C.
811j provides that in cases where a certain new drug is: 1 Approved by HHS and 2 HHS recommends control in CSA schedule IIV, DEA shall issue an IFR scheduling the drug within 90
days. Additionally, subsection j specifies that the rulemaking shall become immediately effective as an interim final rule without requiring DEA
to demonstrate good cause. DEA issued an IFR on October 30, 2020, and solicited public comments on that rule.
Subsection j further provides that after giving interested persons the opportunity to comment and to request a hearing, the Attorney General, as delegated to the Administrator of DEA, shall issue a final rule in accordance with the scheduling criteria of 21 U.S.C.
811b through d and 812b. DEA is now responding to the comments submitted by the public and issuing the final rule, in conformity with the APA
and the procedure required by 21 U.S.C.
811.

khammond on DSKJM1Z7X2PROD with RULES

Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a and j, this scheduling action is subject
to formal rulemaking procedures performed on the record after opportunity for a hearing, which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance.
Such actions are exempt from review by the Office of Management and Budget OMB pursuant to section 3d1 of Executive Order E.O.12866 and the principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does 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.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act The Regulatory Flexibility Act RFA
5 U.S.C. 601612 applies to rules that are subject to notice and comment under section 553b of the APA. Under 21 U.S.C. 811j, DEA is not required to publish a general notice of proposed rulemaking. Consequently, the RFA
does not apply.

2 U.S.C. 1501 et seq., DEA has determined that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more adjusted for inflation in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 35013521. This action does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Congressional Review Act This rule is not a major rule as defined by the Congressional Review Act CRA, 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
Accordingly, the interim final rule amending 21 CFR part 1308, which published on October 30, 2020 85 FR
68749, is adopted as a final rule with the following amendment:
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. Amend 1308.12 by revising paragraph c18 to read as follows:

Unfunded Mandates Reform Act of 1995

1308.12

In accordance with the Unfunded Mandates Reform Act UMRA of 1995,

Schedule II.

c

18 Oliceridine N-3-methoxythiophen-2-ylmethyl2-9R-9-pyridin-2-yl-6-oxaspiro4.5decan-9-ylethylamine

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