Notice2025-18483
ADUFA V Third-Party Assessment Report: Notice of Availability; Virtual 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
September 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a report entitled "ADUFA V Third-Party Assessment Report" and a related virtual public meeting. The purpose of the virtual public meeting is to provide an overview of a third- party assessment that examines the implementation of the Animal Drug User Fee Act (ADUFA). FDA is soliciting comments on the assessment.
Full Text
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<title>Federal Register, Volume 90 Issue 183 (Wednesday, September 24, 2025)</title>
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[Federal Register Volume 90, Number 183 (Wednesday, September 24, 2025)]
[Notices]
[Pages 45947-45948]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18483]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3708]
ADUFA V Third-Party Assessment Report: Notice of Availability;
Virtual Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; announcement of virtual public meeting;
and request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a report entitled ``ADUFA V Third-Party
Assessment Report'' and a related virtual public meeting. The purpose
of the virtual public meeting is to provide an overview of a third-
party assessment that examines the implementation of the Animal Drug
User Fee Act (ADUFA). FDA is soliciting comments on the assessment.
DATES: The virtual public meeting will be held on Thursday, October 30,
2025, at 10:00 a.m. (EST). Either electronic or written/paper comments
on this public workshop must be submitted by December 30, 2025. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: This public meeting is virtual only. Persons interested in
attending this virtual public meeting must register at: <a href="https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc</a>. Additional details
about the virtual public meeting are available on the ADUFA V Third-
Party Assessment meeting web page listed on the Center for Veterinary
Medicine's ``Workshops, Conferences and Meetings'' page: <a href="https://www.fda.gov/animal-veterinary/news-events/workshops-conferences-meetings">https://www.fda.gov/animal-veterinary/news-events/workshops-conferences-meetings</a>.
You may submit comments identified by Docket No. FDA-2025-N-3708 as
follows. Please note that late, untimely filed comments will not be
considered. 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 30, 2025. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received 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.
FDA-2025-N-3708 for ``ADUFA V Third-Party Assessment Report.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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
[[Page 45948]]
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.
FOR FURTHER INFORMATION CONTACT: Petra Garosi, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-0632, <a href="/cdn-cgi/l/email-protection#8dfde8f9ffeca3eaecffe2fee4cdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="6d1d08191f0c430a0c1f021e042d0b090c4305051e430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act)
was originally signed into law in 2003 and was subsequently
reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA
authorizes FDA to collect fees for certain new animal drug
applications, products, establishments, and sponsors. Resources
generated under ADUFA supplement the Agency's funding to enhance the
performance of the drug review process, ensuring that new animal drug
products are safe and effective for animals, and that food derived from
treated animals will be safe for consumption. FDA considers the timely
review of the safety and effectiveness of new animal drug applications
to be central to the Agency's mission to protect and promote human and
animal health.
In 2023, during negotiations for the reauthorization of ADUFA,
FDA's Center for Veterinary Medicine (CVM) and stakeholders from the
animal drug industry agreed that the Agency would engage an independent
third-party to conduct a comprehensive assessment of the process for
the review of animal drug applications. The assessment, completed in
December 2024, evaluated the effectiveness of the ADUFA program,
including the review process, the tools used to improve efficiency, and
the allocation of available resources. The assessment consisted of
stakeholder interviews with CVM and industry personnel, a comprehensive
review of CVM system records and performance data, and an examination
of the activities in the review process. This assessment examined user
fee enhancements to the ADUFA program and animal drug review process,
and it assessed the effectiveness of these enhancements against their
intended objectives and goals. The assessment was conducted from
January 2024-December 2024. The purpose of this virtual public meeting
is to provide an overview of the results of the assessment.
II. Topics To Be Presented at the Virtual Public Meeting
At the virtual public meeting, FDA will provide a general overview
of the Third-Party Assessment. FDA is seeking input, via written
comments to the docket referenced above, on all aspects of the third-
party assessment. FDA encourages respondents to provide the specific
rationale and basis for their comments, including any available
supporting data and information. Respondents need not address all
topics of the assessment.
III. Participating in the Virtual Public Meeting
Registration: Persons interested in attending this virtual public
meeting must register online at <a href="https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc</a>. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone number.
Registration is free but limited to 1000 participants. Persons
interested in attending this virtual public meeting must register by
11:59 p.m. Eastern Time on October 29, 2025. Registrants will receive
confirmation when they have been accepted. We will inform registrants
if the limit of 1000 is reached, at which point we will no longer be
able to accommodate additional participants.
Information on requesting special accommodations due to a
disability will be provided during registration.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18483 Filed 9-23-25; 8:45 am]
BILLING CODE 4164-01-P
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