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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Rules and Regulations
administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:
1. Registration. Any person who handles manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses, or who desires to handle 4,4-DMAR, must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. Any person who currently handles 4,4DMAR and is not registered with DEA
must submit an application for registration and may not continue to handle 4,4-DMAR, unless DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person unwilling or unable to obtain a schedule I registration must surrender all quantities of currently held 4,4-DMAR, or may transfer all quantities of currently held 4,4-DMAR to a person registered with DEA. 4,4-DMAR is required to be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
3. Security. 4,4-DMAR is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823 and in accordance with 21 CFR 1301.71
1301.76. Non-practitioners handling 4,4-DMAR must also 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 4,4-DMAR must comply with 21 U.S.C. 825 and 958e, and be in accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to manufacture 4,4-DMAR in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of 4,4DMAR, must take an inventory of 4,4DMAR on hand 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 registers with DEA
must take an initial inventory of all stocks of controlled substances including 4,4-DMAR on hand on the date the registrant first engages in the handling of controlled substances,
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pursuant to 21 U.S.C. 827, 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 4,4DMAR 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 must maintain records and submit reports with respect to 4,4DMAR, pursuant to 21 U.S.C. 827 and 958e, and in accordance with 21 CFR
parts 1304, 1312, and 1317.
Manufacturers and distributors must submit reports regarding 4,4-DMAR 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.
8. Order Forms. Every DEA registrant who distributes 4,4-DMAR must comply with the order form requirements, pursuant to 21 U.S.C. 828
and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of 4,4DMAR must comply with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving 4,4-DMAR 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 Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a, this final 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 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
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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 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 Administrator, in accordance with the Regulatory Flexibility Act, 5
U.S.C. 601602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities.
DEA is placing the substance 4,4DMAR, 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.
This action imposes 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 4,4-DMAR.
Based on the review of HHS scientific and medical evaluation and all other relevant data, DEA determined that 4,4DMAR 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 4,4-DMAR in the United States. Therefore, DEA estimates that no United States entity currently handles 4,4-DMAR and does not expect any United States entity to handle 4,4DMAR in the foreseeable future. DEA
concludes that no legitimate United States entity would be affected by this rule. As such, this rule will not have a
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