Notice2025-22619
Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Primary source
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Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The statutory authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next BsUFA program. The FD&C Act also requires that FDA hold discussions at least once every month with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Full Text
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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Pages 57763-57764]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22619]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-5997]
Biosimilar User Fee Act; Stakeholder Consultation Meetings on
Biosimilar User Fee Act Reauthorization; Request for Notification of
Stakeholder Intention 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 or Agency) is issuing
this notice to request that public stakeholders--including patient and
consumer advocacy groups--notify FDA of their intent to participate in
periodic consultation meetings on the reauthorization of the Biosimilar
User Fee Act (BsUFA). The statutory authority for BsUFA expires in
September 2027. At that time, new legislation will be required for FDA
to continue collecting biosimilar biological product user fees in
future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a range of stakeholders in
developing recommendations for the next BsUFA program. The FD&C Act
also requires that FDA hold discussions at least once every month with
patient and consumer advocacy groups during FDA's negotiations with the
regulated industry. The purpose of this request for notification is to
ensure continuity and progress in these monthly discussions by
establishing consistent stakeholder representation.
DATES: Submit notification of intention to participate in these series
of meetings by January 30, 2026. Stakeholder meetings will be held
monthly. It is anticipated that they will commence in April 2026. See
the SUPPLEMENTARY INFORMATION section for registration information.
ADDRESSES: Submit notification of intention to participate in monthly
stakeholder meetings by email to <a href="/cdn-cgi/l/email-protection#e7a5b4b2a1a6b5828692938f88958e9d86938e8889a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="b1f3e2e4f7f0e3d4d0c4c5d9dec3d8cbd0c5d8dedff1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>. The
meetings will be held in person at the FDA White Oak Campus, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, and virtually using the
Microsoft Teams platform. In-person participants must be REAL ID
compliant to access federal facilities. For additional information
regarding REAL ID, refer to <a href="https://www.dhs.gov/real-id/real-id-faqs">https://www.dhs.gov/real-id/real-id-faqs</a>.
Entrance for the stakeholder meeting participants (non-FDA employees)
is through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to
<a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
FOR FURTHER INFORMATION CONTACT: Thamar Bailey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 32, Rm. 4103, Silver Spring, MD 20993-0002, 301-
796-6645, <a href="/cdn-cgi/l/email-protection#9ad8c9cfdcdbc8fffbefeef2f5e8f3e0fbeef3f5f4dafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="b3f1e0e6f5f2e1d6d2c6c7dbdcc1dac9d2c7dadcddf3d5d7d29ddbdbc09dd4dcc5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public stakeholders--including patient and
consumer advocacy groups--notify the Agency of their intent to
participate in periodic stakeholder consultation meetings on the
reauthorization of BsUFA. BsUFA authorizes FDA to collect user fees
from the regulated industry to support the process for the review of
biosimilar biological products. The authorization for the current
program (BsUFA III) expires in September 2027. Without new legislation,
FDA will no longer be able to collect user fees for future fiscal
years.
Section 744I(f)(1) of the FD&C Act (21 U.S.C. 379j-53(f)(1))
requires that FDA consult with a range of stakeholders, including
representatives from patient and consumer advocacy groups, in
developing recommendations for the next BsUFA program. FDA will
initiate the reauthorization process by holding a public meeting on
December 3, 2025, where stakeholders and other members of the public
will be given an opportunity to present their views on the
reauthorization (90 FR 52967, November 24, 2025). Section 744I(f)(3) of
the FD&C Act (21 U.S.C. 379j-53(f)(3)) further requires that FDA
continue meeting with representatives from patient and consumer
advocacy groups at least once every month during negotiations with the
regulated industry to continue discussions of these stakeholders' views
on the reauthorization. It is anticipated that these monthly
stakeholder consultation meetings will commence in April 2026.
FDA is issuing this Federal Register notice to request that
representatives from patient and consumer advocacy groups notify FDA of
their intent to participate in the periodic stakeholder consultation
meetings on BsUFA reauthorization. FDA believes that consistent
stakeholder representation at these meetings will be important to
ensure progress in these discussions. If you wish to participate in
these stakeholder consultation meetings, 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 patient
and consumer advocacy group stakeholder consultation discussions while
FDA negotiates with the regulated industry. If a representative from a
patient or consumer advocacy group decides to participate in these
monthly meetings at a later time, that stakeholder may join the
remaining monthly patient and consumer advocacy group stakeholder
consultation meetings after notifying FDA of this intention (see
ADDRESSES). These stakeholder discussions will satisfy the consultation
requirement in section 744I(f)(3) of the FD&C Act.
[[Page 57764]]
II. Notification of Intent To Participate in Periodic Patient and
Consumer Advocacy Group Stakeholder Consultation Meetings
If you intend to participate in these continued periodic
stakeholder consultation meetings regarding BsUFA reauthorization,
please provide notification by email to
<a href="/cdn-cgi/l/email-protection#56140503101704333723223e39243f2c37223f393816303237783e3e2578313920"><span class="__cf_email__" data-cfemail="c88a9b9d8e899aada9bdbca0a7baa1b2a9bca1a7a688aeaca9e6a0a0bbe6afa7be">[email protected]</span></a> by January 30, 2026. Your email should
contain complete contact information, including name, title,
affiliation, address, email address, phone number, and notice of any
special accommodations required because of disability. Stakeholders
will receive confirmation and additional information about the first
meeting after FDA receives this notification. Information concerning
BsUFA, including the text of the law, the BsUFA III Commitment Letter,
key Federal Register documents, BsUFA-related guidances, performance
reports, and financial reports may be found on the FDA website at
<a href="https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments</a>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22619 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
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