Notice2026-07248
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
April 15, 2026
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 titled "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 91 Issue 72 (Wednesday, April 15, 2026)</title>
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[Federal Register Volume 91, Number 72 (Wednesday, April 15, 2026)]
[Notices]
[Pages 20171-20173]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3273]
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 titled ``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 June 23, 2026, from 1:00 p.m.
to 2:30 p.m. ET. Either electronic or written comments on this public
meeting must be submitted by July 23, 2026. 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 via Microsoft Teams and an in-person option at the FDA
White Oak Campus, Great Room, Section A. Entrance for the public
meeting particiapnts (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For security and
parking information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information/public-meeting-information">https://www.fda.gov/about-fda/visitor-information/public-meeting-information</a> and <a href="https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map</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 July 23, 2026. 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 through the following:
[[Page 20172]]
<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-2026-N-3273 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 9:00
a.m. and 4:00 p.m. ET, 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, and Acquisitions, Food and Drug Administration, Three White
Flint North--11601 Landsdown St., North Bethesda, MD 20852, 301-796-
7251, <a href="/cdn-cgi/l/email-protection#66292024272413150f080315152b07080701030b030812350314100f05031526000207480e0e1548010910"><span class="__cf_email__" data-cfemail="642b2226252611170d0a01171729050a05030109010a10370116120d070117240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The meeting will include presentations from FDA on: (1) the five-
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 is 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 to publish a five-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 five-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.
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/7727cea2-45bc-45b4-844a-1f86f2772529@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/7727cea2-45bc-45b4-844a-1f86f2772529@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 June 12, 2026, 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#bef1f8fcfffccbcdd7d0dbcdcdf3dfd0dfd9dbd3dbd0caeddbccc8d7dddbcdfed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="014e474340437472686f6472724c606f6066646c646f755264737768626472416765602f6969722f666e77">[email protected]</span></a> no later than June 12, 2026.
Streaming Webcast of the Public Meeting: This public meeting will
be webcast. To register for the public
[[Page 20173]]
meeting and obtain the webcast information, please visit the following
website: <a href="https://events.gcc.teams.microsoft.com/event/7727cea2-45bc-45b4-844a-1f86f2772529@7d2fdb41-339c-4257-87f2-a665730b31fc">https://events.gcc.teams.microsoft.com/event/7727cea2-45bc-45b4-844a-1f86f2772529@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).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07248 Filed 4-14-26; 8:45 am]
BILLING CODE 4164-01-P
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