[Federal Register Volume 90, Number 95 (Monday, May 19, 2025)]
[Notices]
[Pages 21313-21315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08872]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0873]
Reauthorization of the 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, the Agency, or we) is
hosting a public meeting on the reauthorization of the Generic Drug
User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the
end of September 2027, new legislation will be required for FDA to
continue to collect generic drug user fees for future FYs. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins
negotiations with the regulated industry on GDUFA reauthorization, we
publish a notice in the Federal Register requesting public input on the
reauthorization; hold a public meeting at which the public may present
its views on the reauthorization, including specific suggestions for
changes to the goals referred to in the GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027
(i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a
period of 30 days after the public meeting to obtain written comments
from the public; and publish the comments on FDA's website. FDA invites
public comment on the GDUFA program and suggestions regarding the
features FDA should propose for the next GDUFA program cycle. These
comments will be published and available on FDA's website.
DATES: The hybrid public meeting will be held in person and virtually
on July 11, 2025, from 9 a.m. to 2 p.m. Either electronic or written
comments on this public meeting must be submitted by August 11, 2025.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held in person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room, Silver Spring, MD 20993-0002 and virtually using the
Microsoft Teams platform. Entrance for the public 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 https://www.fda.gov/about-fda/visitor-information.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on August 11, 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:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to
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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 https://www.regulations.gov.
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:
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. 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-0873 for ``Reauthorization of the 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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration,
[email protected], 240-402-8926.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act, which included GDUFA (Pub. L. 112-144, Title III), was
signed into law by the President. The GDUFA program was reauthorized
two times since then, most recently in the Generic Drug User Fee
Amendments of 2022 (GDUFA III), which authorizes FDA to collect fees
for certain generic human drug applications, drug master files, and
facilities. Designed to facilitate timely access to safe and effective
generic drugs for the public, GDUFA III requires that generic drug
manufacturers and other relevant entities pay user fees to finance
critical and measurable generic drug program enhancements. As described
in the GDUFA III Commitment Letter, FDA committed to achieve certain
performance goals, and to provide enhancements designed to maximize the
efficiency and utility of each assessment cycle, with the intent to
reduce the number of assessment cycles for abbreviated new drug
applications, and to foster the development, assessment, and approval
of complex generic products.
Additional information concerning GDUFA, including the text of the
law, 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 https://www.fda.gov/gdufa.
II. Topics for Discussion at the Public Meeting
FDA is interested in responses to the following general questions:
What is your assessment of the overall performance of the
GDUFA program to date?
What aspects of GDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
What new features, if any, should FDA consider adding to
the program to enhance efficiency and effectiveness of the generic drug
review process?
What changes, if any, could be made to the current fee
structures and amounts to better advance the goals of the agreement,
including facilitating product development and timely access for
consumers?
FDA welcomes any other relevant information the public would like
to share as it relates to the GDUFA program. In general, the public
meeting's format will include presentations by FDA and other interested
parties, which may include scientific and academic experts, health care
professionals, representatives of patient and consumer advocacy groups,
the generic drug industry, and the general public. The amount of time
available for public testimony will be determined by the number of
persons who register to present during the hybrid public meeting. A
draft agenda and other background information for the public meeting
will be posted at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-06272025 by July 7, 2025.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://GDUFAIVReauthorizationKickoff.eventbrite.com. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone number.
Registration is free for both in person and virtual attendance. In
person attendance is based on space availability, with priority given
to early registrants. Early registration is recommended because seating
is
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limited; therefore, FDA may limit the number of in person participants
from each organization.
If you need special accommodations due to a disability, please
contact Dat Doan [see FOR FURTHER INFORMATION CONTACT] no later than
June 27, 2025.
Opportunity for Public Comment: Those who register online by June
16, 2025, at 11:59 p.m. Eastern Time will receive a notification about
an opportunity to participate in the public comment session of the
meeting. If you wish to speak during the public comment session, follow
the instructions in the notification and identify which topic(s) you
wish to address. All requests to make a public comment during the
meeting must be received by June 27, 2025, 11:59 p.m. Eastern Time. We
will do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time jointly. We
will determine the amount of time allotted to each commenter, the
approximate time each comment is to begin, and will select and notify
participants by July 9, 2025. No commercial or promotional material
will be permitted to be presented at the public meeting.
Streaming of the Public Meeting: This public meeting will also be
webcast. Please visit the following website to register: https://GDUFAIVReauthorizationKickoff.eventbrite.com.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/gdufa.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: May 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08872 Filed 5-16-25; 8:45 am]
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