Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 21688-21690 [2023-07550]
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21688
Federal Register / Vol. 88, No. 69 / Tuesday, April 11, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
contact information to 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 this 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:
Monica Ellerbe, Office of Finance,
Budget, Acquisitions, and Planning,
Food and Drug Administration, Rm.
72044, Beltsville, MD 20705, 301–796–
5276, OFBAPBusinessManagement
Services@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The meeting will include
presentations from FDA on: (1) the 5year plan for the Prescription Drug User
Fee Act (PDUFA) VII, Biosimilar User
Fee Act (BsUFA) III, and Generic Drug
User Fee Amendments (GDUFA) III; and
(2) the Agency’s progress in
implementing resource capacity
planning and modernized time
reporting. This meeting is intended to
satisfy FDA’s commitment to host an
annual public meeting in the third
quarter of each fiscal year and can be
found in the Commitment Letters listed
below (sections II.B.2 of PDUFA VII (p.
58), III.B.2 of BsUFA III (p. 33), and
VIII.D.3 of GDUFA III (p.40–41)).
PDUFA VII, BsUFA III, and GDUFA
III were reauthorized as part of the FDA
User Fee Reauthorization Act of 2022,
which was signed by the President on
September 30, 2022. The complete set of
performance goals for each program are
available at:
• PDUFA VII: https://www.fda.gov/
media/151712/download
• BsUFA III: https://www.fda.gov/
media/152279/download
• GDUFA III: https://www.fda.gov/
media/153631/download
Each of these user fee programs’
Commitment Letters included a set of
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17:45 Apr 10, 2023
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commitments related to financial
management. These included
commitments to publish a 5-year
financial plan and update that plan
annually, continue activities to mature
FDA’s resource capacity planning
capability, and modernize time
reporting practices. In addition, each
user fee program includes a
commitment to host a public meeting in
the third quarter of each fiscal year to
discuss specific topics.
II. Topics for Discussion at the Public
Meeting
This meeting will provide FDA with
the opportunity to update interested
public stakeholders on topics related to
the financial management of PDUFA
VII, BsUFA III, and GDUFA III. These
topics include the 5-year financial plans
for each of these programs and FDA’s
progress toward implementing resource
capacity planning and modernizing its
time reporting approach.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://fda.zoomgov.com/
webinar/register/WN_K0tpd9eXTvCyfQ_
1iJrgXg. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Persons interested in attending this
public meeting must register by June 5,
2023, at 11:59 p.m. Eastern Time. If
registration closes before the day of the
public meeting, the Webinar
Registration website will be updated.
If you need special accommodations
due to a disability, please indicate this
during registration or contact Monica
Ellerbe at OFBAPBusinessManagement
Services@fda.hhs.gov no later than June
5, 2023.
Streaming Webcast of the Public
Meeting: This public meeting will be
webcast. To register for the public
meeting and obtain the webcast
information, please visit the following
website: https://fda.zoomgov.com/
webinar/register/WN_K0tpd9eXTvCyfQ_
1iJrgXg.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
also be viewed at the Dockets
Management Staff (see ADDRESSES).
Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07506 Filed 4–10–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0378]
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:
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 committee will
discuss the biologics license application
(BLA) 125768 from Pfizer, Inc. for
ABRYSVO (Respiratory Syncytial Virus
Vaccine) with the requested indication
for the prevention of lower respiratory
tract disease and severe lower
respiratory tract disease caused by
respiratory syncytial virus (RSV) in
infants from birth through 6 months of
age by active immunization of pregnant
individuals. The meeting will be open
to the public. FDA is establishing a
docket for public comment on this
document.
SUMMARY:
The meeting will be held
virtually on May 18, 2023, from 8:30
a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of COVID–19, all meeting
participants will be joining this advisory
committee meeting via an online
teleconferencing platform. Answers to
commonly asked questions about FDA
advisory committee meetings, including
information regarding special
accommodations due to a disability,
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The online web
conference meeting will be available at
the following link at: https://
youtube.com/live/NXVMILYvocM?
feature=share.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–0378.
Please note that late, untimely filed
comments will not be considered. The
docket will close on May 17, 2023. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
DATES:
E:\FR\FM\11APN1.SGM
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Federal Register / Vol. 88, No. 69 / Tuesday, April 11, 2023 / Notices
of May 17, 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 May
11, 2023, will be provided to the
committee. Comments received after
May 11, 2023, and by May 17, 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:
lotter on DSK11XQN23PROD with NOTICES1
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–0378 for ‘‘Vaccines and Related
Biological Products Advisory
Committee (VRBPAC); Notice of
VerDate Sep<11>2014
17:45 Apr 10, 2023
Jkt 259001
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
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, September18, 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:
Valerie Vashio and 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
PO 00000
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21689
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 May 18,
2023, 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 BLA 125768 (STN
125768/0), for the prevention of lower
respiratory tract disease and severe
lower respiratory tract disease caused by
RSV in infants from birth through 6
months of age by active immunization
of pregnant individuals.
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 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/
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
Docket (see ADDRESSES) on or before
May 11, 2023, will be provided to the
committee. Comments received after
May 11, 2023, and by May 17, 2023, will
be taken into consideration by FDA.
Oral presentations from the public will
be scheduled between approximately
1:15 p.m. and 2:15 p.m. Eastern Time.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
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21690
Federal Register / Vol. 88, No. 69 / Tuesday, April 11, 2023 / Notices
statement of the general nature of the
evidence or arguments they wish to
present; the names, phone numbers, and
email addresses of proposed
participants; and an indication of the
approximate time requested to make
their presentation on or before 6 p.m.
Eastern Time on May 3, 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 May 5, 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 Valerie Vashio
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: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07550 Filed 4–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2023–N–1114]
lotter on DSK11XQN23PROD with NOTICES1
Peripheral and Central Nervous
System Drugs 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:
The Food and Drug
Administration (FDA) announces a
SUMMARY:
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17:45 Apr 10, 2023
Jkt 259001
forthcoming public advisory committee
meeting of the Peripheral and Central
Nervous System Drugs Advisory
Committee. 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 June 9, 2023, from 10 a.m.
to 5 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of COVID–19, all meeting
participants will be joining this advisory
committee meeting via an online
teleconferencing platform. Answers to
commonly asked questions about FDA
advisory committee meetings, including
information regarding special
accommodations due to a disability,
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm408555.
htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–1114.
Please note that late, untimely filed
comments will not be considered. The
docket will close on June 8, 2023. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of June 8, 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 May
25, 2023, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, 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:
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
PO 00000
Frm 00089
Fmt 4703
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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–1114 for ‘‘Peripheral and
Central Nervous System Drugs Advisory
Committee; 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
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
E:\FR\FM\11APN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21688-21690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07550]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0378]
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 committee will discuss the biologics license
application (BLA) 125768 from Pfizer, Inc. for ABRYSVO (Respiratory
Syncytial Virus Vaccine) with the requested indication for the
prevention of lower respiratory tract disease and severe lower
respiratory tract disease caused by respiratory syncytial virus (RSV)
in infants from birth through 6 months of age by active immunization of
pregnant individuals. 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 May 18, 2023, from 8:30
a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of COVID-19, all meeting
participants will be joining this advisory committee meeting via an
online teleconferencing platform. Answers to commonly asked questions
about FDA advisory committee meetings, including information regarding
special accommodations due to a disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
The online web conference meeting will be available at the following
link at: https://youtube.com/live/NXVMILYvocM?feature=share.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-0378. Please note that late, untimely
filed comments will not be considered. The docket will close on May 17,
2023. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end
[[Page 21689]]
of May 17, 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 May 11, 2023, will be provided to
the committee. Comments received after May 11, 2023, and by May 17,
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-0378 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); 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 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, September18, 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: Valerie Vashio and 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 May 18,
2023, 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 BLA 125768 (STN 125768/0), for the prevention of lower
respiratory tract disease and severe lower respiratory tract disease
caused by RSV in infants from birth through 6 months of age by active
immunization of pregnant individuals.
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 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/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 Docket (see
ADDRESSES) on or before May 11, 2023, will be provided to the
committee. Comments received after May 11, 2023, and by May 17, 2023,
will be taken into consideration by FDA. Oral presentations from the
public will be scheduled between approximately 1:15 p.m. and 2:15 p.m.
Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
[[Page 21690]]
statement of the general nature of the evidence or arguments they wish
to present; the names, phone numbers, and email addresses of proposed
participants; and an indication of the approximate time requested to
make their presentation on or before 6 p.m. Eastern Time on May 3,
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 May
5, 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 Valerie Vashio 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: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07550 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P
