Notice2022-17784
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Primary source
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
August 18, 2022
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 (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 159 (Thursday, August 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 159 (Thursday, August 18, 2022)]
[Notices]
[Pages 50863-50864]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17784]
[[Page 50863]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1745]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
regulatory issues. This meeting will be held to discuss the Strain
Selection for the Influenza Virus Vaccines for the 2023 Southern
Hemisphere Influenza Season. The meeting will be open to the public.
FDA is establishing a docket for public comment on this document.
DATES: The meeting will be held virtually on October 6, 2022, from 8:30
a.m. to 12:40 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. The online web
conference meeting will be available at the following link on the day
of the meeting at: <a href="https://youtu.be/qazitJMHZK4">https://youtu.be/qazitJMHZK4</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-1745. The docket will close on October
5, 2022. Either electronic or written comments on this public meeting
must be submitted by September 29, 2022. 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 5, 2022. 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 September 28, 2022, will be provided
to the committee. Comments received after September 28, 2022, and by
October 5, 2022, will be taken into consideration by FDA. In the event
that the meeting is canceled, 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-2022-N-1745 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); 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., Eastern Time 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, September18, 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: Sussan Paydar or Prabhakara Atreya,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002, 240-506-4946, <a href="/cdn-cgi/l/email-protection#b4f7f6f1e6e2e6f6e4f5f7f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="286b6a6d7a7e7a6a78696b684e4c490640405b064f475e">[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
[[Page 50864]]
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 platform. On October 6,
2022, the committee will meet in open session to discuss the Strain
Selection for the Influenza Virus Vaccines for the 2023 Southern
Hemisphere Influenza Season.
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 at the time of the
advisory committee meeting, and the background material will be posted
on FDA's website after the meeting. Background material is 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 components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
Procedure: On October 6, 2022, from 8:30 a.m. to 12:40 p.m.
EasternTime, 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) on or before September 28,
2022, will be provided to the committee. Comments received after
September 28, 2022, and by October 5, 2022, will be taken into
consideration by FDA. Oral presentations from the public will be
scheduled between approximately 10:40 a.m. and 11:40 a.m. EasternTime.
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, on or before 12 p.m. Eastern Time on September
21, 2022. 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 6 p.m. September
22, 2022.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#513735303e3c30113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="157371747a7874557371743b7d7d663b727a63">[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 Sussan Paydar or Prabhakara Atreya (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. app. 2).
Dated: August 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17784 Filed 8-17-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.