Requiring Online Submission of Applications for and Renewals of DEA Registration: Technical Correction

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1301</CFR> <DEPDOC>[Docket No. DEA-1111]</DEPDOC> <SUBJECT>Requiring Online Submission of Applications for and Renewals of DEA Registration: Technical Correction</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule; technical correction. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final rule updates an existing Drug Enforcement Administration (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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective October 2, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">A. Legal Authority</HD> 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. <SU>1</SU> <FTREF/> 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. <FTNT> <SU>1</SU>  21 U.S.C. 801-971. </FTNT> 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. <SU>2</SU> <FTREF/> 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. <SU>3</SU> <FTREF/> <FTNT> <SU>2</SU>  21 U.S.C. 823. </FTNT> <FTNT> <SU>3</SU>  21 U.S.C. 871(b) and 958(f). </FTNT> <HD SOURCE="HD1">B. Background and Summary of Changes</HD> 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. <SU>4</SU> <FTREF/> 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. <SU>5</SU> <FTREF/> 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 submission of the application or renewal for DEA registration. <SU>6</SU> <FTREF/> <FTNT> <SU>4</SU>  Amending Regulations To Require Online Submission of Applications for and Renewals of DEA Registration, 86 FR 1030. </FTNT> <FTNT> <SU>5</SU>   <E T="03">Id.</E> </FTNT> <FTNT> <SU>6</SU>  Requiring Online Submission of Applications for and Renewals of DEA Registration, 87 FR 21019. </FTNT> 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. <SU>7</SU> <FTREF/> 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. <SU>8</SU> <FTREF/> <FTNT> <SU>7</SU>  21 CFR 1309.12(a). </FTNT> <FTNT> <SU>8</SU>  21 CFR 1309.12(b). </FTNT> <HD SOURCE="HD1">C. Technical Correction</HD> 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. <HD SOURCE="HD1">Regulatory Analyses</HD> <HD SOURCE="HD2">Administrative Procedure Act</HD> 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. <SU>9</SU> <FTREF/> 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. <SU>10</SU> <FTREF/> <FTNT> <SU>9</SU>  5 U.S.C. 553(b)(B). </FTNT> <FTNT> <SU>10</SU>   <E T="03">Id.</E> </FTNT> 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.”  <SU>11</SU> <FTREF/> 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 <E T="04">Federal Register</E> . <FTNT> <SU>11</SU>  5 U.S.C. 553(d)(3). </FTNT> <HD SOURCE="HD2">Executive Orders 12866, 13563, and 14192 (Regulatory Review)</HD> 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. <HD SOURCE="HD2">Executive Order 12988, Civil Justice Reform</HD> 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. <HD SOURCE="HD2">Executive Order 13132, Federalism</HD> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 15k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━