Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 55846-55847 [2021-22037]
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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
any relevant applications, submissions,
or information, and consider any
comments submitted to the docket, as
appropriate.
You may submit comments as
follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0965]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; establishment of a
public docket; request for comments.
AGENCY:
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. 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 on
October 14 through 15, 2021, from 8:30
a.m. to 5 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by October 13,
2021. Comments received on or before
October 12, 2021, will be provided to
the committee. Comments received after
October 12, 2021, and by October 13,
2021, will 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 days of the meeting:
Day 1: https://youtu.be/BhlshZ7Lkr0.
Day 2: https://youtu.be/c-H40GrvWz4.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0965.
The docket will close on October 13,
2021. 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 October 13, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
In the event that the meeting is
canceled, FDA will continue to evaluate
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SUMMARY:
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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–
2021–N–0965 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.
PO 00000
Frm 00048
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• 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:
Prabhakara Atreya or Kathleen Hayes,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6306, Silver Spring,
MD 20993–0002, 240–818–7798, via
email at 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 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
E:\FR\FM\07OCN1.SGM
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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
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 Emergency Use
Authorization (EUA) of the Moderna
COVID–19 mRNA vaccine for the
administration of a booster dose,
following completion of the primary
series, to individuals 18 years of age and
older, and also the EUA of the Janssen
Biotech Inc. COVID–19 vaccine for the
administration of a booster dose, to
individuals 18 years of age and older,
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 October
14, 2021, under Topic 1, the committee
will meet in open session to discuss the
EUA of the Moderna COVID–19 mRNA
vaccine for the administration of a
booster dose, following completion of
the primary series, to individuals 18
years of age and older. On October 15,
2021, under Topic II, the committee will
meet in open session to discuss the EUA
of the Janssen Biotech Inc. COVID–19
vaccine for the administration of a
booster dose, to individuals 18 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, 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/advisorycommittee-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: 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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17:46 Oct 06, 2021
Jkt 256001
written submissions submitted to the
Docket (see ADDRESSES) on or before
October 12, 2021, will be provided to
the committee. Comments received after
October 12, 2021, and by October 13,
2021, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled approximately
between 12:45 p.m. and 1:45 p.m.
Eastern Time on October 14, 2021, and
approximately between 11 a.m. and 12
noon Eastern Time on October 15, 2021.
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
requested to make their presentation on
or before 6 p.m. October 8, 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
October 12, 2021.
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 Prabhakara
Atreya or Kathleen Hayes
(CBERVRBPAC@fda.hhs.gov) 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/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-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: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–22037 Filed 10–5–21; 4:15 pm]
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55847
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0271]
Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Hospital and
Health System Compounding Under
Section 503A of the Federal Food, Drug,
and Cosmetic Act’’ (‘‘revised draft
guidance’’). This revised draft guidance,
when finalized, will describe how FDA
intends to apply certain provisions of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to human drug products
compounded by State-licensed
pharmacies that are not outsourcing
facilities and distributed for use within
a hospital or health system. First, it
addresses the requirement that
compounding be based on the receipt of
a valid prescription order for an
identified individual patient. Second, it
addresses the provision concerning
compounded drug products that are
essentially copies of a commercially
available drug product. This draft
guidance revises the draft guidance
issued in 2016 entitled, ‘‘Hospital and
Health System Compounding Under the
Federal Food, Drug, and Cosmetic Act’’
(‘‘draft guidance’’). FDA is revising the
draft guidance to address stakeholder
feedback and provide further
clarification on policies regarding
hospital and health system
compounding. This revised draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the revised draft
guidance by December 6, 2021 to ensure
that the Agency considers your
comment on this revised draft guidance
before it begins work on the final
version of the guidance. Submit
electronic or written comments on the
proposed collection of information in
the revised draft guidance by December
6, 2021.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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]]>Agencies
[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55846-55847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22037]
[[Page 55846]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0965]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments
AGENCY: Food and Drug Administration, Department of 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.
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 on October 14 through 15, 2021, from
8:30 a.m. to 5 p.m. Eastern Time. Submit either electronic or written
comments on this public meeting by October 13, 2021. Comments received
on or before October 12, 2021, will be provided to the committee.
Comments received after October 12, 2021, and by October 13, 2021, will
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 days of the meeting:
Day 1: https://youtu.be/BhlshZ7Lkr0.
Day 2: https://youtu.be/c-H40GrvWz4.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0965. The docket will close on October
13, 2021. 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
October 13, 2021. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
In the event that 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-2021-N-0965 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 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 Kathleen Hayes,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002, 240-818-7798, 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
[[Page 55847]]
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 Emergency Use Authorization (EUA) of the Moderna
COVID-19 mRNA vaccine for the administration of a booster dose,
following completion of the primary series, to individuals 18 years of
age and older, and also the EUA of the Janssen Biotech Inc. COVID-19
vaccine for the administration of a booster dose, to individuals 18
years of age and older, 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 October
14, 2021, under Topic 1, the committee will meet in open session to
discuss the EUA of the Moderna COVID-19 mRNA vaccine for the
administration of a booster dose, following completion of the primary
series, to individuals 18 years of age and older. On October 15, 2021,
under Topic II, the committee will meet in open session to discuss the
EUA of the Janssen Biotech Inc. COVID-19 vaccine for the administration
of a booster dose, to individuals 18 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, 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: 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 October 12, 2021, will be provided to the
committee. Comments received after October 12, 2021, and by October 13,
2021, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled approximately between 12:45 p.m. and 1:45
p.m. Eastern Time on October 14, 2021, and approximately between 11
a.m. and 12 noon Eastern Time on October 15, 2021. 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
requested to make their presentation on or before 6 p.m. October 8,
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 October 12, 2021.
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 Kathleen Hayes ([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: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22037 Filed 10-5-21; 4:15 pm]
BILLING CODE 4164-01-P
