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Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Rules and Regulations
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screening requirements of 21 CFR 1301.90
1301.93.
3. Labeling and Packaging. All labels and labeling for commercial containers of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl must be in compliance with 21 U.S.C. 825 and 958e, and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to manufacture fentanyl carbamate, ortho-fluoroacryl fentanyl, orthofluoro isobutyryl fentanyl, and para-fluoro furanyl 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 fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl 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 fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl 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 fentanyl carbamate, ortho-fluoroacryl fentanyl, orthofluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl, pursuant to 21 U.S.C. 827
and 958e, and in accordance with 21 CFR
1301.74b and c and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl must 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 fentanyl carbamate, ortho-fluoroacryl fentanyl, orthofluoro isobutyryl fentanyl, and para-fluoro furanyl 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 fentanyl carbamate, ortho-fluoroacryl fentanyl, orthofluoro isobutyryl fentanyl, and para-fluoro furanyl 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 final scheduling action is subject to
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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 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 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 fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl have already established and implemented the systems and processes required to handle these substances which meet the
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definition of fentanyl-related substances.
There are currently 57 registrations authorized to handle the fentanylrelated substances as a class, which include fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl 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 final rule.
A review of the 57 registrations indicates that all entities that currently handle fentanyl-related substances, including fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl, also handle other schedule I controlled substances, and have established and implemented or maintain the systems and processes required to handle fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl. Therefore, DEA
anticipates that this final rule will impose minimal or no economic impact on any affected entities, and thus will not have a significant economic impact on any of the eight affected small entities. Therefore, DEA has concluded that this 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 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 in the Congressional Review Act CRA, 5 U.S.C. 804. However, DEA
is submitting the required reports to the Government Accountability Office, the House, and the Senate under the CRA.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44
U.S.C. 35013521. This action would not impose recordkeeping or reporting
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