Quiero saber acerca de...

jbell on DSKJLSW7X2PROD with PROPOSALS

Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 4. Quota. Only registered manufacturers are permitted to manufacture 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must have an initial inventory of all stocks of controlled substances including these substances 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 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of all stocks of controlled substances including 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl 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.
6. Records and Reports. Every DEA
registrant is required to maintain records and submit reports with respect to 2-fluoro ortho-fluorofentanyl, 4methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, pursuant to 21
U.S.C. 827 and 958e, and in accordance with 21 CFR parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl is required to comply with the order form requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.

VerDate Sep<11>2014

16:34 Mar 02, 2021

Jkt 253001

8. Importation and Exportation. All importation and exportation of 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must 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 2fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, bphenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and could 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 done 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.

PO 00000

Frm 00011

Fmt 4702

Sfmt 4702

12303

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 Acting 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.
On February 6, 2018, DEA published an order to temporarily place fentanylrelated substances, as defined in the order, in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. DEA estimates that all entities handling or planning to handle 2-fluoro ortho-fluorofentanyl, 4methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl have already established and implemented the systems and processes required to handle these substances which meet the definition of fentanyl-related substances.
There are currently 57 registrations authorized to handle the fentanylrelated substances as a class, which include 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, as well as a number of registered analytical labs that are authorized to handle schedule I
controlled substances generally. These 57 registrations represent 51 entities, of which eight are small entities.
Therefore, DEA estimates eight small entities are affected by this proposed rule.
A review of the 57 registrations indicates that all entities that currently handle fentanyl-related substances, including 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
E:FRFM03MRP1.SGM

03MRP1