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Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations
and 958 and in accordance with 21 CFR
parts 1304, 1312, and 1317, and section 1307.11. Current DEA registrants authorized to handle brorphine shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.
7. Reports. All DEA registrants who manufacture or distribute brorphine must submit reports pursuant to 21
U.S.C. 827 and in accordance with 21
CFR parts 1304 and 1312 as of March 1, 2021.
8. Order Forms. All DEA registrants who distribute brorphine must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of March 1, 2021.
9. Importation and Exportation. All importation and exportation of brorphine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312 as of March 1, 2021.
10. Quota. Only DEA registered manufacturers may manufacture brorphine in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of March 1, 2021.
11. Liability. Any activity involving brorphine not authorized by, or in violation of the CSA, occurring as of March 1, 2021, is unlawful and may subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Matters The CSA provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811h1.
As provided in this subsection, the Administrator as delegated by the Attorney General by order may schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30
days from: 1 The publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and 2 the date that comment requirements of section 553 of the Administrative Procedure Act APA, 5
U.S.C. 553, do not apply to this temporary scheduling order. The APA
expressly differentiates between an order and a rule, as it defines an order to mean a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a
matter other than rule making. 5 U.S.C.
5516 emphasis added. The specific language chosen by Congress indicates an intention for DEA to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Administrator to follow rulemaking procedures for other kinds of scheduling actions, see 21 U.S.C. 811a, note that in 21 U.S.C. 811h1, Congress authorized the issuance of temporary scheduling actions by order rather than by rule.
Alternatively, even if this action was subject to section 553 of the APA, the Acting Administrator finds that there is good cause to forgo the notice-andcomment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
Although DEA believes this temporary scheduling order is not subject to the notice-and-comment requirements of section 553 of the APA, DEA notes that in accordance with 21
U.S.C. 811h4, the Acting Administrator took into consideration comments submitted by the Assistant Secretary in response to the notice that DEA transmitted to the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this temporary scheduling action is not a rule as defined by 5 U.S.C. 6012, and accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603a are not applicable here, as DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.
In accordance with the principles of Executive Orders E.O. 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health, and safety effects; distributive impacts;
and equity. E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O.
12866. E.O. 12866 classifies a significant regulatory action, requiring review by the Office of Management and Budget, as any regulatory action that is likely to result in a rule that may: 1 Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition;
jobs; the environment; public health or safety; or State, local, or tribal governments or communities; 2 create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; 3
materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or 4 raise novel legal or policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the E.O.
Because this is not a rulemaking action, this is not a significant regulatory action as defined in Section 3f of E.O. 12866.
This action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132
Federalism, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, DEA
amends 21 CFR part 1308 as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871b, 956b, unless otherwise noted.

2. In 1308.11, add paragraph h49
to read as follows:

1308.11

Schedule I

h

49 1-1-1-4-bromophenylethylpiperidin-4-yl-1,3-dihydro-2H-benzodimidazol-2-one, its isomers, esters, ethers, salts and salts of isomers, esters and ethers Other names: brorphine; 1-1-1-4-bromophenylethyl-4-piperidinyl-1,3-dihydro-2H-benzimidazol-2one

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