Notice2026-07497
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
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
April 17, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled "Animal Generic Drug User Fee Act." The purpose of the public meeting is to invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 91 Issue 74 (Friday, April 17, 2026)</title>
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[Federal Register Volume 91, Number 74 (Friday, April 17, 2026)]
[Notices]
[Pages 20691-20693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07497]
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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; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual public meeting entitled ``Animal
Generic Drug User Fee Act.'' The purpose of the public meeting is to
invite public comment on the Animal Generic Drug User Fee Act (AGDUFA)
[[Page 20692]]
program and suggestions regarding the features FDA should consider for
the next reauthorization of the AGDUFA program. The meeting will be
open to the public.
DATES: The public meeting will be held virtually on May 27, 2026, from
11 a.m. to 1 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION
section for registration dates and information. To permit the widest
possible opportunity to obtain comments on all aspects of the public
meeting, the docket will remain open for comment throughout the
reauthorization process of AGDUFA, until December 1, 2027. In addition
to being publicly viewable at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, comments
received by July 1, 2026, suggesting changes to the program, will also
be published on <a href="https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 1, 2027. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 1, 2027. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
2011-N-0655 for ``Animal Generic Drug User Fee Act.'' Received
comments, those filed in a timely manner, will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500. A transcript of the public
meeting will be made available in the docket, as well as on the FDA
website at: <a href="https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>.
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#fabbbdbeafbcbba89f9b8f8e92ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="d392949786959281b6b2a6a7bb93b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Introduction
The authority for AGDUFA expires September 30, 2028. Without new
legislation, FDA will no longer have the authority to collect user fees
to help fund the new animal generic drug review process for future
fiscal years. Prior to beginning negotiations with the regulated
industry on AGDUFA reauthorization, section 742(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-22(d)(2))
requires FDA to: (1) Publish a notice in the Federal Register
requesting public input on the reauthorization; (2) hold a public
meeting at which the public may present its views on the
reauthorization, including specific suggestions for changes to the
goals referred in section 742(a) of FD&C Act; (3) provide a period of
30 days after the public meeting to obtain written comments from the
public suggesting changes; and (4) publish the comments on FDA's
website. This notice, the public meeting, the comment period after the
meeting, and the posting of the comments on the FDA website will
satisfy these requirements. FDA is holding a public meeting to gather
information on what FDA should consider including in the
reauthorization of AGDUFA. FDA is interested in responses from the
public on the following two general questions and welcomes other
pertinent information that stakeholders would like to share:
1. What is your assessment of the overall performance of the AGDUFA
program thus far?
2. What aspects of AGDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
[[Page 20693]]
II. Background
FDA considers the timely review of generic new animal drug
submissions to be central to the Agency's mission to protect and
promote human and animal health. The AGDUFA program began in FY 2009
and is currently in the fourth authorization (AGDUFA IV). FDA has
published a number of reports that provide useful background on AGDUFA
I, AGDUFA II, AGDUFA III, and AGDUFA IV. AGDUFA-related Federal
Register notices, guidances, legislation, performance reports, and
financial reports can be found at: <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa</a>.
III. Participating in the Public Meeting.
Registration: Persons interested in attending this public meeting
must register no later than midnight Eastern time on May 22, 2026, by
emailing complete contact information for each attendee, including
name, title, affiliation, address, email, telephone number, and if you
need reasonable accommodations due to a disability (e.g., Closed
Captioning) to <a href="/cdn-cgi/l/email-protection#e3a2a4a7b6a5a2b1868296978ba3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="19585e5d4c5f584b7c786c6d71597f7d783771716a377e766f">[email protected]</span></a>. Registration is free and early
registration is recommended. Registrants will receive confirmation when
their registration has been received and will be provided the webcast
link.
Requests for Oral Presentations: During online registration you may
indicate if you wish to make an oral presentation during the public
meeting. To facilitate agenda development, registrants requesting to
present will be asked to provide information regarding which topics
they intend to address and the title of their presentation. We will do
our best to accommodate requests to make an oral presentation.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate. All requests to make oral presentations must be
received by May 1, 2026.
We will determine the amount of time allotted to each presenter and
the approximate time each oral presentation is to begin, and we will
notify participants by May 8, 2026. Presenters planning to use an
electronic slide deck must email an electronic copy of their
presentation to Madeline Faunce at <a href="/cdn-cgi/l/email-protection#ecadaba8b9aaadbe898d999884ac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="6a2b2d2e3f2c2b380f0b1f1e022a0c0e0b44020219440d051c">[email protected]</span></a> (see FOR
FURTHER INFORMATION CONTACT) with the subject line ``AGDUFA Public
Meeting Presentation'' on or before May 15, 2026. If presenters choose
not to use a slide deck, they are requested to email a single slide
with their name, affiliation, title of their presentation, and contact
information. No commercial or promotional material will be permitted to
be presented at the public meeting.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07497 Filed 4-16-26; 8:45 am]
BILLING CODE 4164-01-P
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