Notice2021-22452
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
October 13, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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. Members will participate via teleconference. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 86 Issue 195 (Wednesday, October 13, 2021)</title>
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[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56959-56960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22452]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1088]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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. Members will participate via teleconference.
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 on October 26, 2021, from 8:30 a.m. to
5 p.m. Eastern Time. Submit either electronic or written comments on
this public meeting by October 25, 2021. Comments received on or before
October 21, 2021, will be provided to the committee. Comments received
after October 21, 2021, and by October 25, 2021, will be taken into
consideration by FDA.
ADDRESSES: Please note that due to the impact of this 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: <a href="https://youtu.be/laaL0_xKmmA">https://youtu.be/laaL0_xKmmA</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-1088. The docket will close on October
25, 2021. 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 25, 2021. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
In the event that the meeting is cancelled, FDA will continue to
evaluate any relevant applications, submissions, 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-2021-N-1088 for ``Vaccines and Related Biological Products; 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.
[[Page 56960]]
<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: Prabhakara Atreya or Kathleen Hayes,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver
Spring, MD 20993-0002, 301-796-7864; via email at
<a href="/cdn-cgi/l/email-protection#367574736460647466777576505257185e5e4518515940"><span class="__cf_email__" data-cfemail="94d7d6d1c6c2c6d6c4d5d7d4f2f0f5bafcfce7baf3fbe2">[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 Agency'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: Consistent with FDA's regulations, this
notice is being published with less than 15 days prior to the date of
the meeting based on a determination that convening a meeting of the
VRBPAC as soon as possible is warranted. This Federal Register notice
could not be published 15 days prior to the date of the meeting due to
a recent request to amend the Pfizer-BioNTech's Emergency Use
Authorization (EUA) for administration of their COVID-19 mRNA vaccine
to children 5 through 11 years of age and the need for prompt
discussion of this request given the COVID-19 pandemic.
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On October
26, 2021, the committee will meet in open session to discuss a request
to amend Pfizer-BioNTech's EUA for administration of their COVID-19
mRNA vaccine to children 5 through 11 years of age.
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, 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 meeting room will be available at <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar">https://www.fda.gov/advisory-committees/advisory-committee-calendar</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: 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 October 21, 2021, will be provided to the
committee. Comments received after October 21, 2021, and by October 25,
2021, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled between approximately 12:45 p.m. and 1:45
p.m. 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, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 19, 2021. 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 October 20,
2021.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#e08684818f8d81a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="e88e8c89878589a88e8c89c680809bc68f879e">[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 Prabhakara Atreya or Kathleen Hayes (<a href="/cdn-cgi/l/email-protection#7437363126222636243537341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="e3a0a1a6b1b5b1a1b3a2a0a3858782cd8b8b90cd848c95">[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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings</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: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22452 Filed 10-8-21; 4:15 pm]
BILLING CODE 4164-01-P
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