Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 6746-6747 [2023-02096]
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6746
Federal Register / Vol. 88, No. 21 / Wednesday, February 1, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours 2
Phone Survey ..............................................................
Online Survey ..............................................................
17
56
1
1
17
56
0.5 (30 minutes) .....
1 .............................
9
56
Total ......................................................................
........................
........................
........................
................................
65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest hour.
2 Rounded
The targeted groups for this collection
of information include representatives
from the medical device industry,
academia, recipients of funding under
section 305 of the Pediatric Medical
Device Safety and Improvement Act of
2007 (Pub. L. 110–85; 42 U.S.C. 282
note), and trade organizations, medical
provider organizations, organizations
and individuals involved with financing
and reimbursement associated with
medical devices, pediatric healthcare
leaders, clinicians who regularly use
medical devices in caring for children,
and organizations and individuals
representing patients and consumers.
Phone survey: Respondents
participating in the phone survey will
be executives from companies either
producing products in pediatrics or
from companies that produce products
that could be used in pediatrics.
Executives will be invited to engage in
the 30-minute phone survey.
Online survey: The 1-hour online
survey will be administered to leaders
within pediatric companies and key
decision makers in the pediatric
medical device industry (e.g., venture
capitalists, banking investors, leaders in
children’s hospitals and research
networks, and pediatric patient
advocates).
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02057 Filed 1–31–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. FDA–2023–N–0246]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
VerDate Sep<11>2014
21:04 Jan 31, 2023
Jkt 259001
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. 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 February 28, 2023, from
8:30 a.m. to 5:10 p.m. Eastern Time and
on March 1, 2023, from 9 a.m. to 3:50
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 links: on
February 28, 2023, at: https://youtu.be/
ffmIyeXNOfk; on March 1, 2023, at:
https://youtu.be/sPbrzgkny3w.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–0246.
The docket will close on February 27,
2023. Either electronic or written
comments on this public meeting must
be submitted by February 27, 2023.
Please note that late, untimely filed
comments will not be considered. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of February 27, 2023. 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
February 20, 2023, will be provided to
the committee. Comments received after
February 20, 2023, and by February 27,
2023, 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.
SUMMARY:
PO 00000
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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–
2023–N–0246 for ‘‘Vaccines and Related
Biological Products Advisory
Committee (VRBPAC); Notice of
Meeting; Establishment of a Public
E:\FR\FM\01FEN1.SGM
01FEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 21 / Wednesday, February 1, 2023 / Notices
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
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-201509-18/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:
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,
CBERVRBPAC@fda.hhs.gov; or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
VerDate Sep<11>2014
21:04 Jan 31, 2023
Jkt 259001
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 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 February
28, 2023, under Topic 1, the committee
will meet in open session to discuss and
make recommendations on the safety
and effectiveness of ABRYSVO
(Respiratory Syncytial Virus Vaccine),
manufactured by Pfizer Inc., with a
requested indication, in Biologics
License Application (BLA) 125769 (STN
125769/0), for active immunization for
the prevention of acute respiratory
disease and lower respiratory tract
disease (LRTD) caused by respiratory
syncytial virus in adults 60 years of age
and older. On March 1, 2023, under
Topic 2, the committee will meet in
open session to discuss and make
recommendations on the safety and
effectiveness of AREXVY (Respiratory
Syncytial Virus Vaccine, Recombinant,
Adjuvanted), manufactured by GSK,
with a requested indication, in BLA
125775 (STN 125775/0), for active
immunization for the prevention of
LRTD caused by respiratory syncytial
virus RSV–A and RSV–B subtypes in
adults 60 years of age and older.
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
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. 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
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6747
written submissions submitted to the
Dockets (see ADDRESSES) on or before
February 20, 2023, will be provided to
the committee. Comments received after
February 20, 2023, and by February 27,
2023, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled approximately
between 1:10 p.m. and 2:10 p.m. Eastern
Time on February 28, 2023, and
approximately between 12:30 and 1:30
p.m. Eastern Time on March 1, 2023.
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
February 15, 2023. 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. Eastern Time
on February 22, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov 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
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm 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: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02096 Filed 1–31–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6746-6747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02096]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0246]
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. 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 February 28, 2023, from
8:30 a.m. to 5:10 p.m. Eastern Time and on March 1, 2023, from 9 a.m.
to 3:50 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 links: on
February 28, 2023, at: https://youtu.be/ffmIyeXNOfk; on March 1, 2023,
at: https://youtu.be/sPbrzgkny3w.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-0246. The docket will close on February
27, 2023. Either electronic or written comments on this public meeting
must be submitted by February 27, 2023. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of February 27, 2023. 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 February 20, 2023, will be provided
to the committee. Comments received after February 20, 2023, and by
February 27, 2023, 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:
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-2023-N-0246 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); Notice of Meeting; Establishment of a Public
[[Page 6747]]
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 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: 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, [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 FDA'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 February
28, 2023, under Topic 1, the committee will meet in open session to
discuss and make recommendations on the safety and effectiveness of
ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer
Inc., with a requested indication, in Biologics License Application
(BLA) 125769 (STN 125769/0), for active immunization for the prevention
of acute respiratory disease and lower respiratory tract disease (LRTD)
caused by respiratory syncytial virus in adults 60 years of age and
older. On March 1, 2023, under Topic 2, the committee will meet in open
session to discuss and make recommendations on the safety and
effectiveness of AREXVY (Respiratory Syncytial Virus Vaccine,
Recombinant, Adjuvanted), manufactured by GSK, with a requested
indication, in BLA 125775 (STN 125775/0), for active immunization for
the prevention of LRTD caused by respiratory syncytial virus RSV-A and
RSV-B subtypes in adults 60 years of age and older.
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
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 Dockets (see
ADDRESSES) on or before February 20, 2023, will be provided to the
committee. Comments received after February 20, 2023, and by February
27, 2023, will be taken into consideration by FDA. Oral presentations
from the public will be scheduled approximately between 1:10 p.m. and
2:10 p.m. Eastern Time on February 28, 2023, and approximately between
12:30 and 1:30 p.m. Eastern Time on March 1, 2023. 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 February 15, 2023.
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. Eastern Time on
February 22, 2023.
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 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02096 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P
