Rule2026-11998
Amendment and Revocation of Organizational Information Regulations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 15, 2026
Effective
June 15, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available on the Agency's website. FDA is also revoking certain regulations that are no longer necessary in light of this amendment. These changes are appropriate to provide the public with a uniform source of Agency organizational and contact information that can be readily updated as needed in the future.
Full Text
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<title>Federal Register, Volume 91 Issue 114 (Monday, June 15, 2026)</title>
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[Federal Register Volume 91, Number 114 (Monday, June 15, 2026)]
[Rules and Regulations]
[Pages 35884-35886]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11998]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
[Docket No. FDA-2026-N-6404]
RIN 0910-AJ24
Amendment and Revocation of Organizational Information
Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its regulations to direct the public to organizational and
contact information available on the Agency's website. FDA is also
revoking certain regulations that are no longer necessary in light of
this amendment. These changes are appropriate to provide the public
with a uniform source of Agency organizational and contact information
that can be readily updated as needed in the future.
DATES: This action is effective June 15, 2026.
FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-4614, <a href="/cdn-cgi/l/email-protection#c280b0aba3acec92a7aca6aea7b6adac82a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="4507372c242b6b15202b212920312a2b052321246b2d2d366b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
President Trump has directed the heads of executive departments and
agencies to eliminate unnecessary and burdensome regulations (Executive
Order 14192, ``Unleashing Prosperity Through Deregulation'' (90 FR
9065, February 6, 2025)). Independently, the Secretary of Health and
Human Services (HHS) has expressed support for deregulatory initiatives
across all HHS components (see ``Request for Information (RFI):
Ensuring Lawful Regulation and Unleashing Innovation to Make America
Healthy Again'' (90 FR 20478, May 14, 2025)). This action is consistent
with each of these directives.
Section 552(a)(1)(A) of the Administrative Procedure Act (APA) (5
U.S.C. 552(a)(1)(A)) requires each agency to separately state and
currently publish in the Federal Register, for the guidance of the
public, descriptions of its central and field organization and the
established places at which, the employees (and in the case of a
uniformed service, the members) from whom, and the methods whereby, the
public may obtain information, make submittals or requests, or obtain
decisions. FDA has for many years published in the Code of Federal
Regulations information on its organizational structure, public
information offices, and relevant mailing addresses; \1\ these
regulations are currently set forth in part 5, subpart M, of Title 21
of the Code of Federal Regulations (21 CFR part 5, subpart M).\2\ This
action streamlines these regulations while providing the public with a
uniform source of Agency organizational and contact information that
can be readily updated as needed in the future.
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\1\ These regulations were originally published in the Federal
Register in 1964 (see 29 FR 471, January 18, 1964)). They have since
been amended and recodified on various occasions (see, e.g.,
``Delegations of Authority and Organization; Reorganization and
Republication,'' 66 FR 30992, June 8, 2001).
\2\ Subpart M is the only active subpart of part 5, as subparts
A through L have been reserved.
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II. Description of the Action
As previously noted, subpart M of part 5 contains information on
FDA's organizational structure, public information offices, and
relevant mailing addresses. Section 5.1100 provides FDA's central and
field organization with relevant mailing addresses in footnotes.
Section 5.1105 specifies the mailing address of the Office of the Chief
Counsel for FDA, and Sec. 5.1110 states the names and contact
information for FDA public information offices.
To centralize FDA organizational information and facilitate public
access to information, this action amends part 5 by revoking Sec. Sec.
5.1105 and 5.1110 and amending Sec. 5.1100. As amended, Sec. 5.1100
will now direct the public to information on FDA's website at <a href="http://www.fda.gov">http://www.fda.gov</a>. The regulation will specifically refer to information on
FDA's organization, including the Agency's central and field offices,
in FDA's Staff Manual Guides (available at <a href="https://www.fda.gov/about-fda/staff-manual-guides/organizations-and-functions-volume-i-1000-1300">https://www.fda.gov/about-fda/staff-manual-guides/organizations-and-functions-volume-i-1000-1300</a>).
The regulation will also state that relevant contact information
for FDA offices, including email addresses, is available on our
website. Regulated entities and the general public typically contact
FDA electronically at an Agency web address rather than by mail. Among
other web pages, FDA's ``Contact FDA'' web page provides website and
email addresses for the Agency's offices. Revising Sec. 5.1100 to
reference FDA contact information, including email addresses, on the
Agency's website will
[[Page 35885]]
enable us to more effectively provide the public with information.
In light of these amendments to Sec. 5.1100, we have determined
that Sec. Sec. 5.1105 and 5.1110 are no longer necessary. The
direction to visit FDA's website will facilitate public access to a
uniform source of Agency organizational and contact information that
can be readily updated as needed in the future.
III. Notice and Public Comment
Under section 551(4) of the APA (5 U.S.C. 551(4)), a rule means
``the whole or a part of an agency statement of general or particular
applicability and future effect designed to implement, interpret, or
prescribe law or policy or describing the organization, procedure, or
practice requirements of an agency.'' Section 553(b)(A) of the APA (5
U.S.C. 553(b)(A)) exempts rules of agency organization, procedure, or
practice from notice and comment rulemaking procedures. Under section
553(b)(B), rules are also exempt when an agency for good cause finds
that notice and comment rulemaking procedures would be impracticable,
unnecessary, or contrary to the public interest.
To the extent that this action is a rule, FDA has determined that
it meets the notice and comment exemptions in section 553(b)(A) and (B)
of the APA. We are amending regulations describing the Agency's
organizational structure, not any substantive requirements. In
addition, we have determined that because these revisions are minor and
insignificant in nature and impact, public comment is unnecessary. For
these two independent reasons, notice and comment is not required.
Section 553(d)(3) of the APA allows an effective date less than 30
days after publication as provided by the agency for good cause found
and published with a rule. A delayed effective date is unnecessary in
this case because, to the extent this action is a rule, the amendments
do not impose any new regulatory requirements. As a result, affected
parties do not need time to ``adjust to the new regulation'' before it
takes effect. Am. Federation of Government Emp., AFL-CIO v. Block, 655
F.2d 1153, 1156 (D.C. Cir. 1981). Therefore, we find good cause for the
amendments to become effective on the date of their publication.
IV. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of this action under Executive Order
12866, Executive Order 13563, and Executive Order 14192.
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are economically significant under Executive Order 12866 if they
have an annual effect on the economy of $100 million or more; or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The Office of Information and Regulatory Affairs has
determined that this action is not a significant regulatory action
under Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This action is not an
Executive Order 14192 regulatory action because it is not significant
under Executive Order 12866.
B. Overview of Benefits, Costs, and Transfers
This action generates net cost savings which we discuss
qualitatively. The cost savings accrue to FDA because we no longer have
to devote resources to developing and publishing regulations to update
the organizational structure after a reorganization. There are no costs
associated with this rulemaking.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Action
[Millions of 2025 dollars]
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Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
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Benefits:
Annualized Monetized ($millions/year).... $0 $0 $0 2025 7 .......... .................................
3
Annualized Quantified.................... .......... .......... .......... .......... 7 .......... .................................
3
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Qualitative..............................
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Costs:
Annualized Monetized ($millions/year).... $0 $0 $0 2025 7 .......... .................................
3
Annualized Quantified.................... .......... .......... .......... .......... 7 .......... .................................
3
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Qualitative..............................
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Transfers:
Federal Annualized Monetized ($millions/ .......... .......... .......... .......... 7 .......... .................................
year). 3
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From:
To:
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Other Annualized Monetized ($millions/ .......... .......... .......... .......... 7 .......... .................................
year). 3
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From:
To:
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[[Page 35886]]
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: None................................................................................................................................
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
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Note: Benefits encompass positive and negative benefits. Costs encompass costs and cost savings.
In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon of this action.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over an infinite time horizon at a 7 percent discount rate]
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Primary
estimate Low estimate High estimate
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Present Value of Costs.......................................... $0 .............. ..............
Present Value of Cost Savings................................... 0 .............. ..............
Present Value of Net Costs...................................... 0 .............. ..............
Annualized Costs................................................ 0 .............. ..............
Annualized Cost Savings......................................... 0 .............. ..............
Annualized Net Costs............................................ 0 .............. ..............
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Note: Values in parentheses denote net negative costs (i.e., net cost savings).
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.32(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
FDA concludes that this action contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this action in accordance with the principles set
forth in Executive Order 13132. We have determined that it does not
contain policies that 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. Accordingly, we conclude that the action does not
contain policies that have federalism implications as defined in the
Executive Order and, consequently, a federalism summary impact
statement is not required.
VIII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this action in accordance with the principles set
forth in Executive Order 13175. We have determined that the action does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
List of Subjects in 21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 5 is amended as follows:
PART 5--ORGANIZATION
0
1. The authority citation for part 5 continues to read as follows:
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
0
2. Revise Sec. 5.1100 to read as follows:
Sec. 5.1100 Agency Organization Information.
Information about the organization of the Food and Drug
Administration (including its central and field offices) is available
on the Agency's website at <a href="http://www.fda.gov">http://www.fda.gov</a>, including in FDA's Staff
Manual Guides. Relevant contact information for Agency offices,
including email addresses, is also available on the Agency's website.
Sec. 5.1105 [Removed]
0
3. Remove Sec. 5.1105.
Sec. 5.1110 [Removed]
0
4. Remove Sec. 5.1110.
Robert F. Kennedy, Jr.
Secretary, Department of Health and Human Services.
[FR Doc. 2026-11998 Filed 6-12-26; 8:45 am]
BILLING CODE 4164-01-P
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