SUPPLEMENTARY INFORMATION:

A. Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA), and the Controlled Substances Import and Export Act, as amended.^[1] DEA publishes the implementing regulations for these statutes in 21 CFR part 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for the manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA authorizes the Administrator of DEA (by delegation of authority from the Attorney General) to register an applicant to manufacture, distribute or dispense controlled substances if the Administrator determines such registration is consistent with the public interest.^[2] The CSA further authorizes the Administrator 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.^[3]

B. Background and Summary of Changes

DEA published a Notice of Proposed Rulemaking (NPRM) on January 7, 2021 that proposed requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online.^[4] The NPRM also proposed removing the paper payment option by requiring that all payments be made online using credit card at the time of submission of the application or renewal for DEA registration.^[5] On April 11, 2022, DEA published a final rule adopting the regulatory changes as stated in the NPRM but expanded online payment options to include Automated Clearing House (ACH) funds transfer, credit card, and any other means available at the time of ( printed page 47562) submission of the application or renewal for DEA registration.^[6]

As such, Section 1309.12 of Title 21 of the Code of Federal Regulations (CFR) requires all applicants shall pay the fee at the time of submission of the application for registration or reregistration using the secure application portal.^[7] The online payment may be made via ACH funds transfer, credit card, or any other means available at the time of submission using the secure application portal.^[8]

C. Technical Correction

DEA is amending 21 CFR 1301.13(e) by removing the sentence that states that fee payments may be made by personal, certified, or cashier's check or money order. As payments may only be submitted online by the means mentioned above, the reference to paper payment options found in 21 CFR 1301.13(e) is obsolete. This was an unintentional oversight and DEA is now correcting this technical error. The deletion of this sentence will eliminate any remaining confusion as to the acceptable means of payment when submitting an application for registration or reregistration.

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 pre-promulgation opportunity for public comment, if such actions are determined to be unnecessary, impracticable, or contrary to the public interest.^[9] This rule contains only a technical correction; it imposes no new substantive requirement on the public or DEA registrants. Public notice and comment for this action is unnecessary because the underlying NPRM was already subject to a 60-day comment period, and this action is consistent with the purpose and rationale of the final rule, merely making technical changes and updating the regulatory text accordingly. Because this action does not change DEA's analyses or overall actions, no purpose would be served by an additional public notice and comment period. Consequently, DEA has determined that notice and the opportunity for public comment on this rule are unnecessary.^[10]

Additionally, DEA finds that there is good cause under APA section 553(d)(3) for this final rule to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date of less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” ^[11] As stated, this final rule does not create any new regulatory requirements. It is merely a technical correction that removes a sentence and aligns the affected regulation with the previously published final rule. Because this is not a substantive rule, and as DEA finds good cause under 5 U.S.C. 553(d)(3) for the above reason, this final rule takes effect upon the date of publication in the Federal Register .

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 proposed rule has not been submitted to the Office of Management and Budget (OMB) for review. This proposed rule has been drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation; E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation; and E.O. 14192, “Unleashing Prosperity Through Deregulation.” This rule is not subject to E.O. 14192 because it is not a significant regulatory action under section 3(f) of E.O. 12866. Because it is removing a reference to paper payments for applications to DEA registrations, it is a deregulatory action. This final rule updates an existing DEA regulation by removing the reference to paper payments by check or money order for all applications for DEA registrations and renewal of those registrations. This action makes no substantive changes to this regulation.

The paper payment option became obsolete when the final rule was promulgated requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. The removal of the obsolete sentence will add clarity to DEA's regulations.

Additionally, DEA continues to accept ACH fund transfer and card payment, and registrants are still able to pay with their checking accounts or debit cards associated with their checking accounts. All current and prospective registrants are expected to have a checking account with an online means of payment; therefore, this rulemaking would not impose any economic burdens on the registrants and is not a significant regulatory action under section 3(f)(1) of E.O. 12866.

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, Civil Justice Reform, to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

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 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 final rule does not have substantial direct effects on the tribes, on the relationship between the national government and the tribes, or the distribution of power and responsibilities between the Federal government and Indian tribes.

Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers

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

Executive Order 14294, Overcriminalization of Federal Regulations

E.O. 14294 specifies that all notices of proposed rulemaking (NPRMs) and final rules published in the Federal Register , the violation of which may constitute criminal regulatory offenses, 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.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that ( printed page 47563) 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 (UMRA) of 1995, 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 annually for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

This final rule does not impose a new collection or modify an existing collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Also, this final rule does not impose a recordkeeping or reporting requirement on State or local governments, individuals, businesses, or other organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.

Congressional Review Act

This final rule is not a major rule as defined by Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act or CRA).^[12] Because this is a rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties, the reporting requirement under 5 U.S.C. 801 does not apply.

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