[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32420-32421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0904]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting; Establishment of a Public Docket; Request for 
Comments

AGENCY: Food and Drug Administration, 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. The general function of 
the committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. Members will participate via teleconference. 
This 2-day virtual meeting will be held to discuss recent requests to 
amend the Emergency Use Authorization (EUA) of the Moderna COVID-19 
mRNA vaccine to include the administration of a primary series to 
infants, children, and adolescents 6 months through 17 years of age and 
to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to 
include the administration of a primary series to infants and children 
6 months through 4 years of age. The meeting will be open to the public 
on both days. FDA is establishing a docket for public comment on this 
document.

DATES: The meeting will be held June 14 and June 15, 2022, from 8:30 
a.m. to 5 p.m. Eastern Time (ET). Comments received on or before June 
7, 2022, will be provided to the committee. Comments received after 
June 7, 2022, and by June 13, 2022, 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 separate 
links on the respective days of the meeting:

Day 1: https://youtu.be/GbNpaZeDPiA
Day 2: https://youtu.be/Ixm4UmldTGQ

    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2022-N-0904. The docket will close on June 13, 
2022. Submit either electronic or written comments on this public 
meeting by June 13, 2022. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before June 13, 2022. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. ET at the end of 
June 13, 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 June 7, 2022, will be provided to 
the committee. Comments received after June 7, 2022, and by June 13, 
2022, will be taken into consideration by FDA. If the meeting is 
canceled, 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:
     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.
     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:
     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.
     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-0904 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.
     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

[[Page 32421]]

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: Prabhakara Atreya or Sussan Paydar, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver 
Spring, MD 20993-0002, 240-506-4946, via email at 
[email protected]; 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/advisory-committees and scroll down to the appropriate advisory 
committee meeting link or call the advisory committee information line 
to learn about possible modifications before joining 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 
Vaccines and Related Biological Products Advisory Committee 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 recent 
requests to amend the EUA of the Moderna COVID-19 mRNA vaccine to 
include the administration of a primary series to infants, children, 
and adolescents 6 months through 17 years of age and to amend the EUA 
of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the 
administration of a primary series to infants and children 6 months 
through 4 years of age, and the need for prompt discussion of such 
requests given the COVID-19 pandemic.
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On June 14, 
2022, under Topic 1, the committee will meet in open session to discuss 
amending the EUA of the Moderna COVID-19 mRNA vaccine to include the 
administration of the primary series to children and adolescents 6 
years through 17 years of age. On June 15, 2022, under Topic II, the 
committee will meet in open session to discuss amending the EUA of the 
Moderna COVID-19 mRNA vaccine to include the administration of the 
primary series to infants and children 6 months through 5 years of age 
and to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA 
vaccine to include the administration of the primary series to infants 
and children 6 months through 4 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 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 June 14 and June 15, 2022, from 8:30 a.m. to 5 p.m. 
ET, 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 June 7, 2022, will be 
provided to the committee. Comments received after June 7, 2022, and by 
June 13, 2022, will be taken into consideration by FDA. Oral 
presentations from the public will be scheduled approximately between 1 
p.m. and 2 p.m. ET on June 14, 2022, and approximately between 1 p.m. 
and 2 p.m. ET on June 15, 2022. 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 date and time requested to make their 
presentation on or before 6 p.m. ET on June 8, 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 June 10, 2022.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] 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 Sussan Paydar ([email protected]) 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: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11669 Filed 5-26-22; 11:15 am]
BILLING CODE 4164-01-P


