Notice2025-15936
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
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Published
August 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled "Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments." The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Notices]
[Pages 40833-40835]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15936]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1875]
Financial Transparency and Efficiency of the Prescription Drug
User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee
Amendments; 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 or the Agency) is
announcing the following public meeting entitled ``Financial
Transparency and Efficiency of the Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic Drug User Fee Amendments.'' The
topic to be discussed is the financial transparency and efficiency of
the Prescription Drug User Fee Act, Biosimilar User Fee Act, and
Generic Drug User Fee Amendments.
DATES: The public meeting will be held on September 30, 2025, from 9:30
a.m. to 10:40 a.m. via Microsoft Teams. Either electronic or written
comments
[[Page 40834]]
on this public meeting must be submitted by October 30, 2025. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held as a hybrid event with a
virtual option and in-person option at the FDA White Oak Campus, Great
Room, Section A.
You may submit comments 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 October 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-2019-N-1875 for ``Financial Transparency and Efficiency of the
Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic
Drug User Fee Amendments; Public Meeting; Request for Comments.''
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 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: Kichelle Joseph, Office of Finance,
Budget, Acquisitions, and Planning, Food and Drug Administration, 4041
Powder Mill Rd., Rm. 72064, Beltsville, MD 20705, 301-796-7251,
<a href="/cdn-cgi/l/email-protection#efa0a9adaead9a9c86818a9c9ca28e818e888a828a819bbc8a9d99868c8a9caf898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="d09f96929192a5a3b9beb5a3a39db1beb1b7b5bdb5bea483b5a2a6b9b3b5a390b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The meeting will include presentations from FDA on: (1) the 5-year
plan for the Prescription Drug User Fee Act (PDUFA) VII, Biosimilar
User Fee Act (BsUFA) III, and Generic Drug User Fee Amendments (GDUFA)
III; and (2) the Agency's progress in implementing resource capacity
planning as part of fee setting and modernized time reporting. This
meeting is intended to satisfy FDA's commitment to host an annual
public meeting in the third quarter of each fiscal year and can be
found in the Commitment Letters listed below (sections II.B.2 of PDUFA
VII (p. 58), III.B.2 of BsUFA III (p. 33), and VIII.D.3 of GDUFA III
(p. 40-41)).
PDUFA VII, BsUFA III, and GDUFA III represent the reauthorization
of these user fee programs for FYs 2023-2027 as part of the FDA User
Fee Reauthorization Act of 2022, which was signed by the President on
September 30, 2022. The complete set of performance goals for each
program are available at:
<bullet> PDUFA VII: <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
<bullet> BsUFA III: <a href="https://www.fda.gov/media/152279/download">https://www.fda.gov/media/152279/download</a>.
<bullet> GDUFA III: <a href="https://www.fda.gov/media/153631/download">https://www.fda.gov/media/153631/download</a>.
Each of these user fee programs' Commitment Letters included a set
of commitments related to financial management. These included
commitments to publish a 5-year financial plan and update that plan
annually, continue activities to mature FDA's resource capacity
planning capability, and modernize time reporting practices. In
addition, each user fee program includes a commitment to host a public
meeting in the third quarter of each fiscal year to discuss specific
topics.
II. Topics for Discussion at the Public Meeting
This meeting will provide FDA with the opportunity to update
interested public stakeholders on topics related to the financial
management of PDUFA VII, BsUFA III, and GDUFA III. These topics include
the 5-year financial plans for each of these programs and FDA's
progress toward implementing resource capacity planning as part of fee
setting and modernized time reporting.
[[Page 40835]]
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: <a href="https://events.gcc.teams.microsoft.com/event/516d6231-aede-4035-88cd-c307c6dda9a5@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/516d6231-aede-4035-88cd-c307c6dda9a5@7d2fdb41-339c-4257-87f2-a665730b31fc</a>. Please provide complete contact information for each
attendee, including name, title, affiliation, and email.
Persons interested in attending this public meeting must register
by September 20, 2025 at 11:59 p.m. Eastern Time. If registration
closes before the day of the public meeting, the Webinar Registration
website will be updated.
If you need special accommodations due to a disability, please
indicate this during registration or contact Kichelle Joseph at
<a href="/cdn-cgi/l/email-protection#8ac5ccc8cbc8fff9e3e4eff9f9c7ebe4ebedefe7efe4fed9eff8fce3e9eff9caeceeeba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="cd828b8f8c8fb8bea4a3a8bebe80aca3acaaa8a0a8a3b99ea8bfbba4aea8be8daba9ace3a5a5bee3aaa2bb">[email protected]</span></a> no later than September 20,
2025.
Streaming Webcast of the Public Meeting: This public meeting will
be webcast. To register for the public meeting and obtain the webcast
information, please visit the following website: <a href="https://events.gcc.teams.microsoft.com/event/516d6231-aede-4035-88cd-c307c6dda9a5@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/516d6231-aede-4035-88cd-c307c6dda9a5@7d2fdb41-339c-4257-87f2-a665730b31fc</a>.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may also be viewed at the Dockets Management
Staff (see ADDRESSES).
Dated: August 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15936 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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