Notice2026-09284
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate
Primary source
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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 Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA 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 AGDUFA 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 25577-25578]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09284]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Stakeholder Consultation
Meetings on the Animal Generic 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 Generic Drug User Fee Act (AGDUFA). The
statutory authority for AGDUFA 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 AGDUFA 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 AGDUFA
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#3776707362717665525642435f77515356195f5f4419505841"><span class="__cf_email__" data-cfemail="2465636071626576414551504c644240450a4c4c570a434b52">[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#d495939081929586b1b5a1a0bc94b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="0647414253404754636773726e46606267286e6e7528616970">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Introduction
In 2023, Congress passed the Animal Generic Drug User Fee
Amendments of 2023 (Pub. L. 118-15; AGDUFA IV). The authority for
AGDUFA IV 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 generic new animal drug review
process. Section 742(d)(1) of the FD&C Act (21 U.S.C. 379j-22(d)(1))
requires that FDA consult with a range of stakeholders in developing
recommendations for consideration for the next AGDUFA 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 20691) 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 742(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 AGDUFA 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
AGDUFA 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 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 742(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 AGDUFA reauthorization, please submit
notification by email to: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="b2f3f5f6e7f4f3c0d7d3c7c6daf2d4d6d39cdadac19cd5ddc4">[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).
[[Page 25578]]
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. 2026-09284 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P
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