Notice2026-09283
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate
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
May 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2028. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts--in developing recommendations for the next ADUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Full Text
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<title>Federal Register, Volume 91 Issue 90 (Monday, May 11, 2026)</title>
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[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Pages 25576-25577]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09283]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0656]
Animal Drug User Fee Act; Stakeholder Consultation Meetings on
the Animal Drug User Fee Act Reauthorization; Request for Notification
of Stakeholder Intent To Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this notice to request that public stakeholders notify FDA of
their intent to participate in periodic consultation meetings on
reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory
authority for ADUFA expires September 30, 2028. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) requires that FDA consult with a range of
stakeholders--including patient and consumer advocacy groups,
veterinary professionals, and scientific and academic experts--in
developing recommendations for the next ADUFA program and hold
discussions with these stakeholders at least once every 4 months during
FDA's negotiations with the regulated industry. The purpose of this
request for notification is to ensure consistent stakeholder
representation at the consultation meetings.
DATES: Submit notification of intent to participate in continued
periodic stakeholder consultation meetings regarding ADUFA
reauthorization by June 1, 2026. These stakeholder meetings are
expected to commence in June 2026 and will continue at least once every
4 months during reauthorization negotiations with the regulated
industry. See the SUPPLEMENTARY INFORMATION section for further
information regarding notification of intent to participate.
ADDRESSES: Submit notification of intent to participate in this series
of meetings by June 1, 2026 to <a href="/cdn-cgi/l/email-protection#56171203101704333723223e16303237783e3e2578313920"><span class="__cf_email__" data-cfemail="2a6b6e7f6c6b784f4b5f5e426a4c4e4b04424259044d455c">[email protected]</span></a>. These meetings
will be held in person at the FDA Harvey W. Wiley Federal Building in
College Park, MD, 5001 Campus Drive, College Park, MD 20740 and
virtually using the Microsoft Teams platform.
FOR FURTHER INFORMATION CONTACT: Madeline Faunce, on detail to Office
of Operations, Office of Finance, Budget, and Acquisitions, Food and
Drug Administration, 301-796-3464, <a href="/cdn-cgi/l/email-protection#7f3e3b2a393e2d1a1e0a0b173f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="75343120333427101400011d351311145b1d1d065b121a03">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Introduction
In 2023, Congress passed the Animal Drug User Fee Amendments of
2023 (Pub. L. 118-15; ADUFA V). The authority for ADUFA V expires
September 30, 2028. Without new legislation to reauthorize the program,
FDA will no longer be able to collect user fees for future fiscal years
to fund the new animal drug review process. Section 740A(d)(1) of the
FD&C Act (21 U.S.C. 379j-13(d)(1)) requires that FDA consult with a
range of stakeholders in developing recommendations for consideration
for the next ADUFA program, including representatives from patient and
consumer advocacy groups, veterinary professionals, and scientific and
academic experts. To initiate this process of consultation, we
announced in the Federal Register of April 17, 2026 (91 FR 20695) that
a public meeting is to be held on May 27, 2026, where stakeholders and
other members of the public will be given an opportunity to present
their views on the reauthorization. The meeting and written comments
submitted to the docket will provide critical input as the Agency
prepares for reauthorization discussions. Section 740A(d)(3) of the
FD&C Act further requires that FDA continue meeting with these
stakeholders at least once every 4 months during negotiations with the
regulated industry to continue discussions of their views on the
reauthorization, including suggested changes to the ADUFA program.
FDA is issuing this Federal Register notice to request that
stakeholders--including veterinary professionals, patient and consumer
advocacy groups, as well as scientific and academic experts--notify FDA
of their intent to participate in the periodic consultation meetings on
ADUFA reauthorization. FDA believes that consistent stakeholder
representation at these meetings is essential in the reauthorization
process. If you wish to participate in this part of the
[[Page 25577]]
reauthorization process, please designate one or more representatives
from your organization who will commit to attending these meetings and
preparing for the discussions. Stakeholders who identify themselves
through this notice will be included in all future stakeholder
discussions while FDA negotiates with the regulated industry. If a
stakeholder decides to participate in these meetings at a later time,
they may still participate in remaining meetings by notifying FDA (see
FOR FURTHER INFORMATION CONTACT). These stakeholder discussions will
satisfy the requirement in section 740A(d)(3) of the FD&C Act.
II. Notification of Intent to Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding ADUFA reauthorization, please submit
notification by email to: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="e9a8adbcafa89b8c889c9d81a98f8d88c781819ac78e869f">[email protected]</a> by June 1, 2026. Your
email should contain complete contact information for each attendee,
including name, title, affiliation, address, email address, telephone
number, and notice of any special accommodations required due to a
disability (e.g., Closed Captioning). Stakeholders will receive
confirmation and additional information about the first meeting, and
subsequent meetings when scheduled, after FDA receives this
notification of intent to participate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09283 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P
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