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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Rules and Regulations
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, without change, affirms the amendment made by the interim final rule that is already in effect. Section 553 of the Administrative Procedure Act APA 5 U.S.C. 553
generally requires notice and comment for rulemakings. 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 interim final rule 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 interim final rule on April 7, 2020, and solicited public comments on that rule. Subsection j further states 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. 811 b through d and 812b. DEA is now responding to the comments submitted by the public and issuing the final rule in accordance with subsection j.
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.

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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.

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Executive Order 13132, Federalism This final rule does not have federalism implications warranting the application of E.O. 13132. The final 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 final 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. As noted in the above discussion regarding the applicability of the APA, DEA was not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act UMRA of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies 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 annually for inflation in any 1 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 final rule is not a major rule as defined by the Congressional Review Act CRA, 5 U.S.C. 804. This rule will not result in an annual effect on the
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economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the U.S.-based companies to compete with foreign-based companies in domestic and export markets.
However, pursuant to the CRA, DEA has submitted 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.
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
Accordingly, the interim final rule 85
FR 19387 amending 21 CFR part 1308, which published on April 7, 2020, is adopted as a final rule without change.

D. Christopher Evans, Acting Administrator.
FR Doc. 202104183 Filed 3221; 8:45 am BILLING CODE 441009P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 49
EPAR01OAR20200374; FRL10018
74Region 1

Approval and Promulgation of Air Quality Implementation Plan;
Mashantucket Pequot Tribal Nation Environmental Protection Agency EPA.
ACTION: Final rule.
AGENCY:

The Environmental Protection Agency EPA approves the Mashantucket Pequot Tribal Nations MPTN or the Tribe Tribal Implementation Plan TIP under the Clean Air Act CAA to regulate air pollution within the exterior boundaries of the Tribes reservation. The TIP is one of two CAA regulatory programs that comprise the Tribes Clean Air Program CAP. EPA approved the Tribe for treatment in the same manner as a State Treatment as State or TAS for purposes of administering New Source Review NSR and Title V operating permits under the CAA on July 10, 2008. In this action we act only on those portions of MPTNs CAP that constitute a TIP containing severable elements of
SUMMARY:

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