[Federal Register Volume 90, Number 156 (Friday, August 15, 2025)]
[Notices]
[Pages 39397-39398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15571]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2786]
Biosimilar User Fee Act III Regulatory Science Program Interim
Public Meeting; Public Meeting; Interim Report; Availability; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; notice of availability; request for
comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Biosimilar User Fee
Act (BsUFA) III Regulatory Science Program Interim Public Meeting'' and
the availability of the report entitled ``BsUFA III Regulatory Science
Pilot Program Interim Report.'' The purpose of the public meeting is to
review the progress of the BsUFA III Regulatory Science Program aims,
or demonstration projects, and to solicit input on future research
priorities. Under the BsUFA reauthorization commitment letter for
fiscal years (FYs) 2023 through 2027 (BsUFA III), FDA committed to
piloting a regulatory science program to facilitate biosimilar and
interchangeable product development that focuses on: (1) advancing the
development of interchangeable products; and (2) improving the
efficiency of biosimilar product development. The purpose of the
interim progress report is to provide a summary of activities that
established the pilot program, an overview of research progress, and a
brief discussion of future directions.
DATES: The hybrid public meeting will be held on September 18, 2025,
from 9 a.m. to 3 p.m. Eastern Time, and will take place in person and
virtually. Either electronic or written comments on this public meeting
and report must be submitted by October 18, 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. In-person participants must be REAL ID
compliant to access federal facilities. For additional information
regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs.
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 October 18, 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 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-2786 for ``Biosimilar User Fee Act III Regulatory Science
Program
[[Page 39398]]
Interim Public Meeting; Public Meeting; Interim Report; Availability;
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: Sarah Ikenberry, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1128, Silver Spring, MD 20993-0002, 301-
796-6893, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under BsUFA III, FDA committed to piloting a regulatory science
program to facilitate biosimilar and interchangeable product
development that focuses on: (1) advancing the development of
interchangeable products; and (2) improving the efficiency of
biosimilar product development. FDA also committed to publish an
interim progress report and hold an interim public meeting by October
31, 2025, approximately midway through the pilot program.
FDA is hosting a hybrid public meeting on September 18, 2025, to
meet the BsUFA III commitment to review the progress of the pilot
program aims or demonstration projects, and to solicit input on future
research priorities. FDA has published the interim progress report
entitled ``BsUFA III Regulatory Science Pilot Program Interim Report''
at https://www.fda.gov/media/187445/download?attachment; this report
provides a summary of activities that established the pilot program, an
overview of research progress, and a brief discussion of future
directions.
II. Topics for Discussion at the Public Meeting
In general, the public meeting's format will include presentations
by FDA and other interested parties, including scientific and academic
experts participating in the BsUFA Regulatory Science pilot program and
biosimilar industry representatives. The agenda includes an overview of
the pilot program, awardee presentations on the progress of their
research, lessons learned, and the role of regulatory science in
biosimilar development. A draft agenda and other background information
for the public is available at: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-bsufa-iii-regulatory-science-program-interim-public-meeting-09182025.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-bsufa-iii-regulatory-science-program-interim-public-meeting-09182025. Please indicate either
in-person or virtual attendance and provide complete contact
information for each attendee, including name and email.
Registration is free for both in-person and virtual attendance. In-
person attendance is based on space availability, with priority given
to early registrants. Persons interested in attending this public
meeting must register by Thursday, September 18, 2025, at 9 a.m.
Eastern Time for in-person registration. Virtual attendees can register
and join at any time through the conclusion of the meeting. Early
registration for in-person attendance is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public meeting will be provided beginning at 8:30 a.m. We will let
registrants know if registration closes before the day of the public
meeting.
If you need special accommodations due to a disability, please
contact Sarah Ikenberry, 301-796-6893, [email protected],
no later than September 11, 2025.
Although FDA verified the website addresses in this document,
please note that websites are subject to change over time.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: August 12, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15571 Filed 8-14-25; 8:45 am]
BILLING CODE 4164-01-P