[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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