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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
Regulatory Analyses Executive Orders 12866 and 13563, Regulatory Planning and Review, Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a, this proposed 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 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 proposed 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 proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed 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 proposed 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.

commercial market for methoxetamine in the United States. As such, the proposed rule will not have a significant effect on a substantial number of small entities.

Paperwork Reduction Act of 1995
This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995 44 U.S.C. 3501
3521.

Unfunded Mandates Reform Act of 1995

Regulatory Flexibility Act The Acting Administrator of DEA, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601612, has reviewed this proposed rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
DEA proposes placing the substance methoxetamine chemical name: 2ethylamino-2-3methoxyphenylcyclohexan-1-one, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the CSA.
This action is being taken to enable the United States to meet its obligations under the 1971 Convention. If finalized, this action would impose the regulatory controls and administrative, civil, and/
or criminal sanctions applicable to schedule I controlled substances on persons who handle manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess or propose to handle methoxetamine.
According to HHS, and also per DEAs findings in this proposed rule, methoxetamine has high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. DEAs research confirms that there is no
On the basis of information contained in the Regulatory Flexibility Act section above, DEA has determined pursuant to the Unfunded Mandates Reform Act UMRA of 1995 2 U.S.C.
1501 et seq. that this proposed 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 $100,000,000 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.
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, 21 CFR
part 1308 is proposed to be amended as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:

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

2. In 1308.11, as proposed to be amended at 86 FR 16553 March 30, 2021 and 86 FR 37719 July 16, 2021, add paragraph d100 to read as follows:

1308.11

Schedule I.

d

100 2-ethylamino-2-3-methoxyphenylcyclohexan-1-one methoxetamine, MXE

Anne Milgram, Administrator.
FR Doc. 202126293 Filed 12621; 8:45 am
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