Notice2024-21431
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strain Selection for Influenza Vaccines
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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
September 19, 2024
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 Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will meet in open session to discuss three separate topics. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 89 Issue 182 (Thursday, September 19, 2024)</title>
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[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76849-76851]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21431]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4189]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments: Strain Selection for Influenza Vaccines
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
[[Page 76850]]
Biological Products Advisory Committee (the Committee). The general
function of the Committee is to provide advice and recommendations to
FDA on regulatory issues. The Committee will meet in open session to
discuss three separate topics. At least one portion of the meeting will
be closed to the public. FDA is establishing a docket for public
comment on this document.
DATES: The meeting will be held virtually on October 10, 2024, from 8
a.m. to 5:30 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 at the
following link on the day of the meeting: <a href="https://youtube.com/live/RXdJ2BfutAE">https://youtube.com/live/RXdJ2BfutAE</a>.
Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-4189. The docket will close on October
9, 2024. 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
October 9, 2024. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before October 2, 2024, will be provided to
the Committee. Comments received after that date 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-2024-N-4189 for ``Vaccines and Related Biological Products Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; 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 <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 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: Kathleen Hayes or Sussan Paydar,
Center for Biologics Evaluation and Research (CBER), 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#4102030413171303110002012725206f2929326f262e37"><span class="__cf_email__" data-cfemail="581b1a1d0a0e0a1a08191b183e3c397630302b763f372e">[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 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
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 October 10, 2024, the Committee will meet in
open session to discuss the following three separate topics. Under
Topic I, the Committee will discuss and make recommendations on the
strain selection for the influenza virus vaccines for the 2025 southern
hemisphere influenza season. Under Topic II, the Committee will discuss
pandemic preparedness for highly pathogenic avian influenza virus
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including considerations for vaccine composition for (H5) vaccines.
Under Topic III, the Committee will hear an overview of the research
programs in the Laboratory of Pediatric & Respiratory Viral Diseases
and the Laboratory of DNA Viruses in the Division of Viral Products,
Office of Vaccines Research and Review, CBER. After the open session,
the meeting will be closed to the public for committee deliberations.
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 October 10, 2024, from 8 a.m. to 11:15 a.m. Eastern
Time for Topic I, from 11:45 a.m. to 2:30 p.m. Eastern Time for Topic
II, and from 2:40 p.m. to 4:20 p.m. Eastern Time for Topic III, 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 to the Docket
(see ADDRESSES) on or before October 2, 2024, will be provided to the
Committee. Comments received on or after October 2, 2024, and by
October 9, 2024, will be taken into consideration by FDA. Oral
presentations from the public will be scheduled between approximately
9:55 a.m. to 10:15 a.m. Eastern Time for Topic I, 1:10 p.m. to 1:30
p.m. Eastern Time for Topic II, and 4 p.m. to 4:20 p.m. Eastern Time
for Topic III. Those individuals interested in making formal oral
presentations should notify the contact person 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 September 24, 2024. 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 September 27, 2024.
Closed Committee Deliberations: On October 10, 2024, the meeting
will be closed from 4:30 p.m. to 5:30 p.m. to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory
committee regarding the progress of the individual investigators'
research programs, along with other information, will be discussed
during this session. We believe that public discussion of these
discussions and committee recommendations on individual scientists
would constitute an unwarranted invasion of personal privacy.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#e88e8c89878589a88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="47212326282a2607212326692f2f3469202831">[email protected]</span></a> or 301-796-4540.
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 Kathleen Hayes or Sussan Paydar (see FOR FURTHER INFORMATION
CONTACT) 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. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21431 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 19, 2024.
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