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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules
handled and stored pursuant to 21
U.S.C. 821, 823, 871b and in accordance with 21 CFR 1301.71
1301.93 as of the effective date of a final scheduling action. Non-practitioners handling methiopropamine would also need to comply with the employee screening requirements of 21 CFR
1301.901301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of methiopropamine would need to be in compliance with 21 U.S.C.
825 and 958e and be in accordance with 21 CFR part 1302 as of the effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to manufacture methiopropamine in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of the effective date of a final scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of methiopropamine on the effective date of a final scheduling action would be required to take an inventory of methiopropamine on hand at that time, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and d.
Any person who becomes registered with DEA to handle methiopropamine on or after the effective date of a final scheduling action would be required to have an initial inventory of all stocks of controlled substances including methiopropamine on hand on the date the registrant first engages in the handling of controlled substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and b.
After the initial inventory, every DEA
registrant must take an inventory of all controlled substances including methiopropamine on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant would be required to maintain records and submit reports with respect to methiopropamine pursuant to 21
U.S.C. 827 and 958e and in accordance with 21 CFR parts 1304 and 1312, as of the effective date of a final scheduling action. Manufacturers and distributors would be required to submit reports regarding methiopropamine to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21
CFR parts 1304 and 1312, as of the effective date of a final scheduling action.

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8. Order Forms. Every DEA registrant who distributes methiopropamine would be required to comply with the order form requirements, pursuant to 21
U.S.C. 828 and in accordance with 21
CFR part 1305, as of the effective date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of methiopropamine would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR part 1312, as of the effective date of a final scheduling action.
10. Liability. Any activity involving methiopropamine not authorized by, or in violation of, the CSA or its implementing regulations would be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses Executive Orders 12866 Regulatory Planning and Review and 13563
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 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 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 the distribution of power and responsibilities among the various levels of government.

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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.
Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act, 5
U.S.C. 601602, 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 methiopropamine chemical name: Nmethyl-1-thiophen-2-ylpropan-2amine, including its salts, isomers, and salts of isomers, in schedule I of the CSA. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and 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, methiopropamine.
According to HHS, methiopropamine has a 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 legitimate commercial market for methiopropamine in the United States. Therefore, DEA estimates that no United States entity currently handles methiopropamine and does not expect any United States entity to handle methiopropamine in the foreseeable future. DEA concludes that no legitimate United States entity would be affected by this rule if finalized. As such, the proposed rule will not have a significant effect on a substantial number of small entities.
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
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