Notice2025-11769
Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate
Primary source
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Published
June 26, 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 interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly 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 representation by interested parties.
Full Text
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<title>Federal Register, Volume 90 Issue 121 (Thursday, June 26, 2025)</title>
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[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Notices]
[Pages 27323-27324]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1623]
Generic Drug User Fees; Consultation Meetings on Reauthorization
of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request
for Notification of 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 interested parties, including patient and
consumer advocacy groups, health care professionals, and scientific and
academic experts notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Generic Drug User
Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of
September 2027, new legislation will be required for FDA to continue
collecting
[[Page 27324]]
generic drug user fees for subsequent fiscal years for the generic drug
program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires
that FDA consult with a range of interested parties in developing
recommendations for the next GDUFA program. The FD&C Act also requires
that FDA hold continued discussions with patient and consumer advocacy
groups at least monthly 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 representation by interested parties.
DATES: Submit notification of intention to participate in these series
of meetings by September 4, 2025. Meetings will be held monthly
throughout the duration of negotiations with regulated industry, and it
is anticipated that they will commence in the Fall of 2025. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: Submit notification of intention to participate in monthly
consultation meetings by email to <a href="/cdn-cgi/l/email-protection#27606372616675424652534f48554e5d46534e484967414346094f4f5409404851"><span class="__cf_email__" data-cfemail="84c3c0d1c2c5d6e1e5f1f0ecebf6edfee5f0edebeac4e2e0e5aaececf7aae3ebf2">[email protected]</span></a>. The
meetings will be held in person at the FDA campus in White Oak, MD:
10903 New Hampshire Ave., Silver Spring, MD 20993 and virtually using
the Microsoft Teams platform.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002, 240-402-8926,
<a href="/cdn-cgi/l/email-protection#286f6c7d6e697a4d495d5c40475a4152495c414746684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="0d4a49584b4c5f686c787965627f64776c796462634d6b696c2365657e236a627b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that interested parties, including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts, notify the Agency of their intent to participate in
periodic consultation meetings on the reauthorization of GDUFA. GDUFA
authorizes FDA to collect user fees from the regulated industry for the
current program (GDUFA III). At the end of September 2027, new
legislation will be required for FDA to continue collecting user fees
for subsequent fiscal years for the generic drug program. Without new
legislation, FDA will no longer be able to collect user fees for future
fiscal years to fund human generic drug activities. Section 744C(f)(1)
(21 U.S.C. 379j-43(f)(1)) of the FD&C Act requires that FDA consult
with a range of interested parties in developing recommendations for
the next GDUFA program, including representatives from patient and
consumer groups, health care professionals, and scientific and academic
experts. FDA will initiate this process by holding a public meeting on
July 11, 2025, at which interested parties and other members of the
public will be given an opportunity to present their views on
reauthorization (90 FR 21313, May 19, 2025). Section 744C(f)(3) (21
U.S.C. 379j-43(f)(3)) of the FD&C Act further requires that FDA
continue meeting with these interested parties at least once every
month during negotiations with the regulated industry to continue
discussions of views from interested parties on the reauthorization. It
is anticipated that these monthly consultation meetings will commence
in the Fall of 2025.
FDA is issuing this Federal Register notice to request that
interested representatives from patient and consumer advocacy groups,
health care professional associations, as well as scientific and
academic experts notify FDA of their intent to participate in periodic
consultation meetings on GDUFA reauthorization. FDA believes that
consistent representation by interested parties at these meetings will
be important to ensure progress in these discussions. If you wish to
participate in the consultation meetings, please designate one or more
representatives from your organization who will commit to attending
these meetings and preparing for the discussions, as needed. Interested
parties who identify themselves through this notice will be included in
all discussions with interested parties during the period that FDA
negotiates with the regulated industry. Interested parties who decide
to participate in these monthly meetings at a later time may still
participate in remaining monthly meetings by notifying FDA (see
ADDRESSES). These discussions with interested parties will satisfy the
periodic consultation requirement in section 744C(f)(3) (21 U.S.C.
379j-43(f)(3)) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Consultation
Meetings
If you intend to participate in continued periodic consultation
meetings regarding GDUFA reauthorization, please provide notification
by email to <a href="/cdn-cgi/l/email-protection#57101302111605323622233f38253e2d36233e383917313336793f3f2479303821"><span class="__cf_email__" data-cfemail="6e292a3b282f3c0b0f1b1a06011c07140f1a0701002e080a0f4006061d40090118">[email protected]</span></a> by September 4, 2025. 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. Interested
parties will receive confirmation and additional information about the
first periodic consultation meeting after FDA receives this
notification. Information concerning GDUFA, including the GDUFA III
Commitment Letter, key Federal Register documents, GDUFA-related
guidances, performance reports, and financial reports may be found on
the FDA website at <a href="https://www.fda.gov/gdufa">https://www.fda.gov/gdufa</a>.
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11769 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P
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