Technical Amendment to the Regulation Regarding Amendments to Applications

Issuing agencies

Abstract

This final rule updates a Drug Enforcement Administration regulation to clarify that the provision regarding amendments to and withdrawal of registration applications also applies to applications for registration renewal. This action makes no substantive changes to this regulation.

Full Text

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<title>Federal Register, Volume 91 Issue 212 (Wednesday, November 4, 2026)</title>
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[Federal Register Volume 91, Number 212 (Wednesday, November 4, 2026)]
[Rules and Regulations]
[Pages 69500-69501]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22484]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-1303]
RIN 1117-ZA09


Technical Amendment to the Regulation Regarding Amendments to 
Applications

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule; technical amendment.

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SUMMARY: This final rule updates a Drug Enforcement Administration 
regulation to clarify that the provision regarding amendments to and 
withdrawal of registration applications also applies to applications 
for registration renewal. This action makes no substantive changes to 
this regulation.

DATES: This rule is effective November 4, 2026.

FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory 
Drafting and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 776-3882.

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\
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    \1\ 21 U.S.C. 821, 827.
    \2\ 21 U.S.C. 871(b), 958(f).
    \3\ 28 CFR 0.100(b).
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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.
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    \4\ 21 CFR 1301.16(b).
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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.
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    \5\ 5 U.S.C. 553(b)(B).
    \6\ N.C. Growers' Ass'n, Inc. v. United Farm Workers, 702 F.3d 
755, 766 (4th Cir. 2012) (citation omitted).
    \7\ Nat. Res. Def. Council v. Nat'l Highway Traffic Safety 
Admin., 894 F.3d. 95, 114 (2d Cir. 2018) (citation omitted).
    \8\ 21 CFR 1301.16(b).
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    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.
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    \9\ Riverbend Farms, Inc. v. Madigan, 958 F.2d 1479, 1485 (9th 
Cir. 1992).
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    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.
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    \10\ 5 U.S.C. 553(b)(A), (d).
    \11\ Minard Run Oil Co. v. U.S. Forest Serv., 670 F.3d 236, 255 
(3d Cir. 2011), as amended (Mar. 7, 2012) (citation omitted).
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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

[[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\
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    \12\ See Office of Management and Budget Memorandum M-25-20, 
Guidance Implementing Section 3 of Executive Order 14192, titled 
``Unleashing Prosperity Through Deregulation'' (Mar. 26, 2025), 
<a href="https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-20-Guidance-Implementing-Section-3-of-Executive-Order-14192-Titled-Unleashing-Prosperity-Through-Deregulation.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-20-Guidance-Implementing-Section-3-of-Executive-Order-14192-Titled-Unleashing-Prosperity-Through-Deregulation.pdf</a>.
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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.

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

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

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1301 continues to read as follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.


0
2. In Sec.  1301.16, revise paragraph (b) to read as follows:


Sec.  1301.16  Amendments to and withdrawal of applications.

* * * * *
    (b) After an application has been accepted for filing, the request 
by the applicant or registrant that it be returned or the failure of 
the applicant or registrant to respond to official correspondence 
regarding the application, when sent by registered or certified mail, 
return receipt requested, shall be deemed to be a withdrawal of the 
application.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 28, 2026, by DEA Administrator Terrance C. Cole. That document 
with the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-22484 Filed 11-3-26; 8:45 am]
BILLING CODE 4410-09-P


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