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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations 958e, and be in accordance with 21
CFR part 1302.
4. Quota. Only registered manufacturers are permitted to manufacture NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMBCHMICA, or 5F-CUMYL-P7AICA in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
5. Inventory. Every DEA registrant who possesses any quantity of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and 5FCUMYL-P7AICA was required to keep an inventory of all stocks of these substances on hand as of July 10, 2018, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and d.
6. Records and Reports. Every DEA
registrant must maintain records and submit reports with respect to NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and/or 5FCUMYL-P7AICA, 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 NM2201, 5FAB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, and/or 5FCUMYL-P7AICA 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.
7. Order Forms. Every DEA registrant who distributes NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA
must continue to comply with the order form requirements, pursuant to 21
U.S.C. 828 and in accordance with 21
CFR part 1305.
8. Importation and Exportation. All importation and exportation of NM2201, 5F-AB-PINACA, 4-CN-CUMYLBUTINACA, MMB-CHMICA, or 5FCUMYL-P7AICA must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR part 1312.
9. Liability. Any activity involving NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA 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.

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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 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 Acting 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.
On July 10, 2018, DEA published an order to temporarily place these five substances in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811h.

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DEA estimates that all entities handling or planning to handle these substances have already established and implemented the systems and processes required to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA
as schedule I controlled substances.
There are currently 28 registrations authorized to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and/or 5F-CUMYLP7AICA specifically, as well as a number of registered analytical labs that are authorized to handle schedule I
controlled substances generally. DEA
estimates these 28 registrations encompass 22 entities. Some of these entities are likely to be large entities.
However, DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities. Therefore, DEA conservatively estimates as many as 22 small entities are affected by this rule.
A review of the 28 registrations indicates that all entities that currently handle NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA also handle other schedule I controlled substances, and have established and implemented or maintain the systems and processes required to handle NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA.
Therefore, DEA anticipates that this rule will impose minimal or no economic impact 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 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.
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 the Government Accountability Office, the House, and the Senate under the CRA.

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