SUPPLEMENTARY INFORMATION:

Legal Authority

The Controlled Substances Act (CSA) grants the Attorney General authority to promulgate and enforce rules and regulations pertaining to the registration and control of the manufacture, distribution, and dispensing of controlled substances and the maintenance and submission of records and reports related thereto.^[1] The CSA further authorizes the Attorney General to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA.^[2] The Attorney General has delegated this authority to the Administrator of the Drug Enforcement Administration (DEA).^[3]

Technical Amendment

DEA regulations state that an application shall be deemed to be withdrawn if an applicant requests an application to be returned, or if an applicant fails to respond to official correspondence regarding the application when sent by registered or certified mail, return receipt requested.^[4] The use of the term “applicant” may inadvertently suggest that this provision applies only to new registration applications and is not applicable to registration renewal applications. In this final rule, DEA is adding “or registrant” after “applicant” in 21 CFR 1301.16(b) to clarify that this provision regarding amendments to and withdrawal of registration applications applies to both registration and registration renewal applications.

Regulatory Analyses

Administrative Procedure Act

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including those requiring the publication of a prior notice of proposed rulemaking and the opportunity for public comment, if such actions are determined to be unnecessary, impracticable, or contrary to the public interest.^[5] The “unnecessary” prong of the APA good cause provision covers amendments that are “ `minor or merely technical' and of little public interest,” ^[6] or that involve “routine determination[s], insignificant in nature and impact, and inconsequential to the industry . . . and to the public.” ^[7] This rule contains only a technical amendment: it merely resolves a potential ambiguity by clarifying that the DEA regulation ^[8] regarding amendments to and withdrawal of applications applies to both registration and registration renewal applications. DEA has always understood and applied the regulation at 21 CFR 1301.16(b) to include renewals. DEA has accordingly determined that notice and comment are not required.

Similarly, the APA provides that a delayed effective date is unnecessary when the agency finds good cause for dispensing with the delay. The APA's delayed-effective-date provision is intended “to give affected parties time to adjust their behavior before the final rule takes effect.” ^[9] Here, regulated parties will not need any time to adjust their behavior to the changes made in this final rule because the rule does no more than ensure that the regulatory text of 21 CFR 1301.16(b) more clearly indicates the way that DEA has always understood and applied that provision.

In addition, the APA excepts from the requirements of notice and comment and a delayed effective date those rules that are non-substantive.^[10] Substantive rules make “substantive changes in prior regulations” or “create new law, rights, or duties.” ^[11] Here, as already explained, this final rule makes no substantive changes in DEA's regulations because this rule simply clarifies the way that 21 CFR 1301.16(b) has always been understood and applied.

Executive Orders 12866, 13563, and 14192 (Regulatory Review)

DEA has determined that this rulemaking is not a “significant regulatory action” under section 3(f) of Executive Order (E.O.) 12866 (Regulatory Planning and Review). Accordingly, this final rule has not been submitted to the Office of Management and Budget for review. This final rule was developed in accordance with section 1(b) of E.O. 12866, section 1(b) of E.O. 13563 (Improving Regulation and Regulatory Review), and E.O. 14192 (Unleashing Prosperity Through Deregulation).

As stated above, this final rule is a technical amendment to clarify that the provision regarding amendments to and withdrawal of registration applications also applies to applications for registration renewal. DEA has always applied this provision to both new and renewal applications, and therefore, this final rule does not impose any new or substantive requirements on the public or DEA registrants. DEA anticipates that ( printed page 69501) this final rule will have no economic impact.

This rule is not subject to E.O. 14192 because it is neither a significant regulatory action under section 3(f) of E.O. 12866 nor a significant guidance document that has been reviewed by the Office of Information and Regulatory Affairs.^[12]

Executive Order 12988, Civil Justice Reform

This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burdens.

Executive Order 13132, Federalism

This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the Federal 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 final 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 the Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, DEA was not required to publish a general notice of proposed rulemaking prior to this final rule. Consequently, the RFA does not apply to this final rule.

Unfunded Mandates Reform Act of 1995

In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., DEA has determined that this action will 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 million or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA.

Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers

This final rule does not reduce competition, entrepreneurship, and innovation.

Executive Order 14294, Fighting Overcriminalization of Federal Regulations

E.O. 14294 specifies that all notices of proposed rulemaking and final rules published in the FR, the violation of which may constitute a criminal regulatory offense, should include a statement identifying that the rule or proposed rule is a criminal regulatory offense, the authorizing statute, and the mens rea requirement for each element of the offense. This final rule does not involve a criminal regulatory offense and thus E.O. 14294 does not apply.

Paperwork Reduction Act

This final rule does not impose a new collection of information requirement or modify an existing collection of information requirement under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. This final rule does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations.

Congressional Review Act

This is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This final rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons stated above, DEA amends 21 CFR part 1301 as follows:

91 FR 69500