Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 47314-47316 [2021-18107]
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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
The total burden is estimated to be
235.5 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$12,312 annually.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs
Form name
Number of
responses
per POC
Hours per
response
Total burden
hours
Eligibility/Registration Form .............................................................................
Data Use Agreement .......................................................................................
Medical Office Information Form .....................................................................
Data Files Submission .....................................................................................
85
85
85
85
1
1
20
1
3/60
3/60
5/60
1
4.25
4.25
142
85
Total ..........................................................................................................
NA
NA
NA
235.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/
POCs
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Registration Form ............................................................................................
Data Use Agreement .......................................................................................
Medical Office Information Form .....................................................................
Data Files Submission .....................................................................................
85
85
85
85
4.25
4.25
142
85
$52.28
52.28
52.28
52.28
$222
222
7,424
4,444
Total ..........................................................................................................
NA
235.5
NA
12,312
* Mean hourly wage rate of $52.28 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2019 National
Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/oes/current/naics4_621100.htm.
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Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: August 18, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–18126 Filed 8–23–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0856]
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 or Agency)
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. Members will participate via
teleconference. At least one portion of
the meeting will be closed to the public.
FDA is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
September 30, 2021, from 8:30 a.m. to
3:40 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
SUMMARY:
PO 00000
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online teleconferencing platform. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://youtu.be/
VeknygU5MKM.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0856.
The docket will close on September 29,
2021. Submit either electronic or
written comments on this public
meeting by September 29, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before September 29, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 29, 2021. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before
September 23, 2021, will be provided to
the committee. Comments received after
September 23, 2021, and by September
29, 2021, 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.
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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–
2021–N–0856 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
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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:
Kathleen Hayes or Monique Hill, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6307C, Silver Spring, MD 20993–0002,
301–796–7864, Kathleen.Hayes@
fda.hhs.gov, or 301–796–4620,
Monique.Hill@fda.hhs.gov, respectively;
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/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
PO 00000
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47315
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
September 30, 2021, under Topic I, the
committee will meet in open session to
hear an overview of the research
programs in the Laboratory of Bacterial
Polysaccharides, Division of Bacterial,
Parasitic, and Allergenic Products,
Office of Vaccines Research and Review,
and the Center for Biologics Evaluation
and Research (CBER). Also, on
September 30, 2021, under Topic II,
CBER’s VRBPAC will meet in open
session to discuss and make
recommendations on the selection of
strains to be included in the influenza
virus vaccines for the 2021 to 2022
southern hemisphere influenza season.
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: On September 30, 2021,
under Topic I, from 8:30 a.m. to 10:45
a.m. the meeting is open to the public.
On September 30, 2021, under Topic II,
from 12:15 p.m. to 3:40 p.m. 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
September 23, 2021, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 10:15 a.m. and 10:45 a.m.
under Topic I and from 2:10 p.m. and
2:40 p.m. under Topic II. 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
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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
requested to make their presentation on
or before September 15, 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
September 16, 2021.
Closed Committee Deliberations: On
September 30, 2021, from 10:45 a.m. to
11:45 a.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The recommendations of the
advisory committee regarding the
progress of the individual investigator’s
research programs along with other
information, will be discussed during
this session. We believe that public
discussion of these recommendations on
individual scientists would constitute
an unwarranted invasion of personal
privacy.
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 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: August 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
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[FR Doc. 2021–18107 Filed 8–23–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0891]
Reauthorization of the Prescription
Drug User Fee Act; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is hosting a virtual public meeting
entitled ‘‘Reauthorization of the
Prescription Drug User Fee Act.’’ The
purpose of the public meeting is to
discuss proposed recommendations for
the reauthorization of the Prescription
Drug User Fee Act (PDUFA) for fiscal
years (FYs) 2023 through 2027. PDUFA
authorizes FDA to collect user fees to
support the process for the review of
human drug applications. The current
legislative authority for PDUFA expires
in September 2022. At that time, new
legislation will be required for FDA to
continue collecting prescription drug
user fees in future fiscal years.
Following discussions with the
regulated industry and periodic
consultations with public stakeholders,
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) directs FDA to publish
the recommendations for the
reauthorized program in the Federal
Register, hold a meeting at which the
public may present its views on such
recommendations, and provide for a
period of 30 days for the public to
provide written comments on such
recommendations. FDA will then
consider such public views and
comments and revise such
recommendations, as necessary.
DATES: The public meeting will be held
on September 28, 2021, from 9 a.m. to
2 p.m. Eastern Time, and will be held
by webcast only. Submit either
electronic or written comments on this
public meeting by October 28, 2021.
ADDRESSES: Registration to attend the
virtual meeting and other information
can be found at https://pdufaviireauthorization.eventbrite.com. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before October 28, 2021. The
https://www.regulations.gov electronic
filing system will accept comments
SUMMARY:
PO 00000
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until 11:59 p.m. Eastern Time at the end
of October 28, 2021. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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–0891 for ‘‘Reauthorization of
the Prescription Drug User Fee Act;
Public Meeting; 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
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]]>Agencies
[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Notices]
[Pages 47314-47316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0856]
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 or Agency) 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. Members will participate via teleconference.
At least one portion of the meeting will be closed to the public. FDA
is establishing a docket for public comment on this document.
DATES: The meeting will be held on September 30, 2021, from 8:30 a.m.
to 3:40 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 link on the
day of the meeting: https://youtu.be/VeknygU5MKM.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0856. The docket will close on
September 29, 2021. Submit either electronic or written comments on
this public meeting by September 29, 2021. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 29, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 29, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Comments received on or before September 23, 2021, will be provided
to the committee. Comments received after September 23, 2021, and by
September 29, 2021, 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.
[[Page 47315]]
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-0856 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: Kathleen Hayes or Monique Hill, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
0002, 301-796-7864, [email protected], or 301-796-4620,
[email protected], respectively; 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/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 September
30, 2021, under Topic I, the committee will meet in open session to
hear an overview of the research programs in the Laboratory of
Bacterial Polysaccharides, Division of Bacterial, Parasitic, and
Allergenic Products, Office of Vaccines Research and Review, and the
Center for Biologics Evaluation and Research (CBER). Also, on September
30, 2021, under Topic II, CBER's VRBPAC will meet in open session to
discuss and make recommendations on the selection of strains to be
included in the influenza virus vaccines for the 2021 to 2022 southern
hemisphere influenza season.
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 September 30, 2021, under Topic I, from 8:30 a.m. to
10:45 a.m. the meeting is open to the public. On September 30, 2021,
under Topic II, from 12:15 p.m. to 3:40 p.m. 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 September 23, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:15 a.m. and 10:45 a.m. under Topic I and from 2:10
p.m. and 2:40 p.m. under Topic II. 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
[[Page 47316]]
requested to make their presentation on or before September 15, 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 September 16, 2021.
Closed Committee Deliberations: On September 30, 2021, from 10:45
a.m. to 11:45 a.m., the meeting will be closed to permit discussion
where disclosure would constitute a clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the
advisory committee regarding the progress of the individual
investigator's research programs along with other information, will be
discussed during this session. We believe that public discussion of
these recommendations on individual scientists would constitute an
unwarranted invasion of personal privacy.
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 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: August 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18107 Filed 8-23-21; 8:45 am]
BILLING CODE 4164-01-P
