[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Notices]
[Pages 47314-47316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0856]


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.

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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. 
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 on September 30, 2021, from 8:30 a.m. 
to 3:40 p.m. Eastern Time.

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: https://youtu.be/VeknygU5MKM.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2021-N-0856. The docket will close on 
September 29, 2021. Submit either electronic or written comments on 
this public meeting by September 29, 2021. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 29, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 29, 2021. 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 September 23, 2021, will be provided 
to the committee. Comments received after September 23, 2021, and by 
September 29, 2021, 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.

[[Page 47315]]

    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-0856 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 https://www.regulations.gov 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 https://www.regulations.gov. 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: 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: Kathleen Hayes or Monique Hill, 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, <a href="/cdn-cgi/l/email-protection#d893b9acb0b4bdbdb6f690b9a1bdab98bebcb9f6b0b0abf6bfb7ae"><span class="__cf_email__" data-cfemail="afe4cedbc7c3cacac181e7ced6cadcefc9cbce81c7c7dc81c8c0d9">[email protected]</span></a>, or 301-796-4620, 
<a href="/cdn-cgi/l/email-protection#2e634140475f5b4b00664742426e484a4f0046465d00494158"><span class="__cf_email__" data-cfemail="aae7c5c4c3dbdfcf84e2c3c6c6eacccecb84c2c2d984cdc5dc">[email protected]</span></a>, respectively; 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 https://www.fda.gov/AdvisoryCommittees/default.htm 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 platform. On September 
30, 2021, under Topic I, the committee will meet in open session to 
hear an overview of the research programs in the Laboratory of 
Bacterial Polysaccharides, Division of Bacterial, Parasitic, and 
Allergenic Products, Office of Vaccines Research and Review, and the 
Center for Biologics Evaluation and Research (CBER). Also, on September 
30, 2021, under Topic II, CBER's VRBPAC will meet in open session to 
discuss and make recommendations on the selection of strains to be 
included in the influenza virus vaccines for the 2021 to 2022 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, 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 https://www.fda.gov/advisory-committees/advisory-committee-calendar. 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 September 30, 2021, under Topic I, from 8:30 a.m. to 
10:45 a.m. the meeting is open to the public. On September 30, 2021, 
under Topic II, from 12:15 p.m. to 3:40 p.m. 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 23, 2021, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 10:15 a.m. and 10:45 a.m. under Topic I and from 2:10 
p.m. and 2:40 p.m. under Topic II. 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

[[Page 47316]]

requested to make their presentation on or before September 15, 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 September 16, 2021.
    Closed Committee Deliberations: On September 30, 2021, from 10:45 
a.m. to 11:45 a.m., the meeting will be closed 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 
investigator's research programs along with other information, will be 
discussed during this session. We believe that public discussion of 
these 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#93f5f7f2fcfef2d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="eb8d8f8a84868aab8d8f8ac5838398c58c849d">[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 (<a href="/cdn-cgi/l/email-protection#d09392958286829280919390b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="1a59585f484c48584a5b595a7c7e7b34727269347d756c">[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: https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18107 Filed 8-23-21; 8:45 am]
BILLING CODE 4164-01-P


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