Notice2025-08083
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2025-2026 Formula for COVID-19 Vaccines for Use in the United States
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 8, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will meet in an open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 90 Issue 88 (Thursday, May 8, 2025)</title>
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[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Notices]
[Pages 19494-19495]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08083]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1146]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments--2025-2026 Formula for COVID-19 Vaccines for Use in the United
States
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee. The general function of the
committee is to provide advice and recommendations to FDA on regulatory
issues. The committee will meet in an open session to discuss and make
recommendations on the selection of the 2025-2026 Formula for COVID-19
vaccines for use in the United States. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held virtually on May 22, 2025, from 8:30
a.m. to 4:30 p.m. Eastern Time.
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. The online web
conference meeting will be available on the day of the meeting by
visiting <a href="https://www.fda.gov/advisory-committees">https://www.fda.gov/advisory-committees</a>.
Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: <a href="https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-1146. The docket will close on May 23,
2025. 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 May
23, 2025. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
Comments received on or before noon by May 14, 2025, will be
provided to the committee. Comments received after May 14 and by May
23, 2025 will be taken into consideration by FDA. In the event that the
meeting is cancelled, FDA will continue to evaluate any relevant
applications or information, and consider any comments submitted to the
docket, as appropriate.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
<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-2025-N-1146 for ``Vaccines and Related Biological Products Advisory
Committee''; Notice of Meeting; Establishment of a Public Docket;
Request for Comments--2025-2026 formula for COVID-19 vaccines for use
in the United States.''
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 a.m.
and 4 p.m., 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
[[Page 19495]]
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA
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 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 the 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: CDR Valerie Marshall, MPH, PMP, USPHS,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002, 202-657-8533 <a href="/cdn-cgi/l/email-protection#91d2d3d4c3c7c3d3c1d0d2d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="1053525542464252405153507674713e7878633e777f66">[email protected]</span></a> or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572) in the
Washington, DC area. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the FDA's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the
appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing and/or video conferencing platform. On May 22, 2025,
the Committee will meet in open session to discuss and make
recommendations on the selection of the 2025-2026 Formula for COVID-19
vaccines for use in the United States. FDA regrets that it was unable
to publish this notice 15 days prior to the Vaccines and Related
Biological Products Advisory Committee meeting due to technical issues.
Because there is a need for an immediate meeting of the Committee,
including the time-sensitive need for input and public discussion on
the meeting subject, and because qualified members of the committee
were available at this time and scheduled to participate in the
meeting, the Agency concluded that there are exceptional circumstances
that support holding this meeting without the customary 15-day public
notice.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at: <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: On May 22, 2025, from 8:30 a.m. to 4:30 p.m. Eastern
Time the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. All electronic and written submissions submitted
to the Docket (see ADDRESSES) by noon of May 14, 2025, will be provided
to the committee. Comments received after May 14 and by May 21, 2025,
will be taken into consideration by FDA. Oral presentations from the
public will be scheduled between approximately 1:00 p.m. to 2:00 p.m.
Eastern Time on May 22, 2025. Those individuals interested in making
formal oral presentations should complete the online survey <a href="https://qualtricsxmjqffz4ktl.qualtrics.com/jfe/form/SV_dnXIVPWod1OPwdU">https://qualtricsxmjqffz4ktl.qualtrics.com/jfe/form/SV_dnXIVPWod1OPwdU</a> and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, along with their names, email
addresses, and direct contact phone numbers of proposed participants,
and an indication of the approximate time requested to make their
presentation on or before 12 p.m. Eastern Time on May 14, 2025. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by May 16, 2025.
For press inquiries, please contact the HHS Press Room at
<a href="http://www.hhs.gov/press-room/index.html">www.hhs.gov/press-room/index.html</a> or 202-690-6343.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact CDR Valerie Marshall, MPH, PMP, USPHS at <a href="/cdn-cgi/l/email-protection#3a79787f686c68786a7b797a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="793a3b3c2b2f2b3b29383a391f1d185711110a571e160f">[email protected]</span></a>
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and that the ends of justice will be served
by allowing for this modification to FDA's advisory committee meeting
procedures.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08083 Filed 5-7-25; 8:45 am]
BILLING CODE 4164-01-P
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