Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 9071-9073 [2021-02845]
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9071
Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices
circumstances or conditions related to
the subject accounts; or failure to satisfy
conditions applicable to each. The
following exception was granted by the
FDIC as of February 4, 2021.
I. Mortgage Servicing Accounts for
Which the Covered Institution’s System
of Record Cannot Calculate Principal
and Interest at an Account Level at a
Given Point in Time
The FDIC granted time-limited
exception relief to covered institutions
up to March 31, 2022, from the
information technology system
requirements of 12 CFR 370.3 and the
recordkeeping requirements of 12 CFR
370.4 for principal and interest
payments held in mortgage servicing
accounts for which the covered
institutions act as servicers or subservicers. The recommended relief will
provide the covered institutions
additional time to remediate their
servicing platforms and internal
processing capabilities pending further
direction from the FDIC.
Pursuant to 12 CFR 330.7(d), mortgage
principal and interest payments are
insured for the cumulative balance paid
into the account by the mortgagors, up
to the limit of the standard maximum
deposit insurance amount per
mortgagor. If a covered institution does
not maintain deposit records that enable
it to calculate deposit insurance, the
covered institution must maintain, at a
minimum, the following in its deposit
account records: (i) The unique
identifier of the account holder; and (ii)
the corresponding ‘‘pending reason’’
code listed in pending file format set
forth in Appendix B to Part 370.
The covered institutions service the
mortgage loans using platforms hosted
by third party vendors. Principal and
interest payments from mortgagors are
placed into the mortgage servicing
accounts with the funds held in custody
for the investors that own the
underlying mortgages. Because the loans
are tracked and managed as a group by
pool, the servicing platforms do not
have a mechanism to allocate the
mortgage servicing accounts balances to
specific mortgagors. As a result, the
covered institutions do not have a
process to input mortgagor principal
and interest data into their information
technology systems to calculate deposit
insurance coverage for the mortgage
servicing accounts.
Remediation efforts are underway and
include the development of a business
requirements document, system
updates, implementation, and testing.
However, a number of the covered
institutions have asked the FDIC for
additional clarification of the part 370
recordkeeping rule with respect to the
mortgage servicing accounts to
determine how to produce borrower
account level principal and interest data
on a date of failure. Given the
complexities of payments to investors
under the agreements with the covered
institutions, additional information
from the FDIC is needed to finalize
programming logic and various business
requirements documents between the
Banks and their service providers.
The FDIC’s grant of relief is subject to
the condition that each covered
institution must submit within 60 days,
upon receipt of additional information
from the FDIC with respect to the part
370 processing for the mortgage
servicing account ownership right and
capacity code, a status report setting
forth the project plan and timeline for
integrating the mortgage servicing
account ownership right and capacity
code processing capabilities into the
covered institution’s information
technology system.
The FDIC reserves the right to rescind
or modify the grant of relief upon any
material change of circumstances or
conditions related to the accounts
subject to this request.
Federal Deposit Insurance Corporation.
Dated at Washington, DC, on February 5,
2021.
James P. Sheesley,
Assistant Executive Secretary.
[FR Doc. 2021–02781 Filed 2–10–21; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL DEPOSIT INSURANCE
CORPORATION
Notice of Termination of Receiverships
The Federal Deposit Insurance
Corporation (FDIC or Receiver), as
Receiver for each of the following
insured depository institutions, was
charged with the duty of winding up the
affairs of the former institutions and
liquidating all related assets. The
Receiver has fulfilled its obligations and
made all dividend distributions
required by law.
NOTICE OF TERMINATION OF RECEIVERSHIPS
Fund
khammond on DSKJM1Z7X2PROD with NOTICES
10152
10245
10277
10280
10502
.............
.............
.............
.............
.............
Receivership name
City
State
The Buckhead Community Bank .......................
Sun West Bank ..................................................
Palos Bank And Trust Company .......................
Imperial Savings & Loan Association ................
Valley Bank ........................................................
Atlanta ................................................................
Las Vegas ..........................................................
Palos Heights .....................................................
Martinsville .........................................................
Moline .................................................................
GA ..........
NV ..........
IL ............
VA ..........
IL ............
The Receiver has further irrevocably
authorized and appointed FDICCorporate as its attorney-in-fact to
execute and file any and all documents
that may be required to be executed by
the Receiver which FDIC-Corporate, in
its sole discretion, deems necessary,
including but not limited to releases,
discharges, satisfactions, endorsements,
assignments, and deeds. Effective on the
termination dates listed above, the
Receiverships have been terminated, the
Receiver has been discharged, and the
VerDate Sep<11>2014
16:39 Feb 10, 2021
Jkt 253001
Receiverships have ceased to exist as
legal entities.
(Authority: 12 U.S.C. 1819)
Federal Deposit Insurance Corporation.
Dated at Washington, DC, on February 5,
2021.
James P. Sheesley,
Assistant Executive Secretary.
[FR Doc. 2021–02783 Filed 2–10–21; 8:45 am]
BILLING CODE 6714–01–P
PO 00000
Food and Drug Administration
[Docket No. FDA–2021–N–0173]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
Food and Drug Administration,
HHS.
Fmt 4703
Sfmt 4703
02/01/2021
02/01/2021
02/01/2021
02/01/2021
02/01/2021
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Frm 00028
Termination
date
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Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices
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 (the
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.
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
a recent submission by Janssen Biotech
Inc. of a request for emergency use
authorization (EUA) for an
investigational vaccine to prevent
Coronavirus Disease 2019 (COVID–19)
and the need for prompt discussion of
such submission, given the COVID–19
pandemic.
SUMMARY:
The meeting will be held on
February 26, 2021, from 9 a.m. Eastern
Time to 5:30 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.
Answers to commonly asked questions
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 on the day of the
meeting: https://youtu.be/Qd7mlCDrEA.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0173.
The docket will close on February 25,
2021. Submit either electronic or
written comments on this public
meeting by February 25, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before February 25, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 25, 2021. Comments received
by mail/hand delivery/courier (for
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:39 Feb 10, 2021
Jkt 253001
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
February 18, 2021, will be provided to
the committee. Comments received after
February 18, 2021, and by February 25,
2021, will be taken into consideration
by FDA. In the event that the meeting
is cancelled, 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–0173 for ‘‘Vaccines and Related
PO 00000
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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-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, CBERVRBPAC@
fda.hhs.gov; or FDA Advisory
Committee Information Line, 1–800–
E:\FR\FM\11FEN1.SGM
11FEN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/advisory-committees and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before joining the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. The
committee will meet in open session to
discuss EUA of the Janssen Biotech Inc.
COVID–19 Vaccine for active
immunization to prevent COVID–19
caused by SARS–CoV–2 in individuals
18 years and older. EUA authority
allows FDA to help strengthen the
nation’s public health protections
against chemical, biological,
radiological, nuclear (CBRN) threats by
facilitating the availability and use of
Medical Countermeasures (MCMs)
needed during public health
emergencies. Under section 564 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb–3), FDA may allow
unapproved medical products or
unapproved uses of approved medical
products to be used in an emergency to
diagnose, treat, or prevent serious or
life-threatening diseases or conditions
caused by CBRN threat agents when
certain statutory criteria have been met,
including that there are no adequate,
approved, and available alternatives.
Additional information about EUAs can
be found at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
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
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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
February 18, 2021, will be provided to
the committee. Comments received after
February 18, 2021, and by February 25,
2021, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled between
approximately 1:25 p.m. Eastern Time
and 2:25 p.m. Eastern Time. 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 February 17, 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
February 18, 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: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–02845 Filed 2–10–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Public Comment Request;
Information Collection Request Title:
Health Professions Student Loan
Program, Loans for Disadvantaged
Students, Primary Care Loan Program,
and Nursing Student Loan Program
Administrative Requirements. OMB No.
0915–0047—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than March 15, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Professions Student Loan (HPSL)
Program, Loans for Disadvantaged
Students, Primary Care Loan Program
(PCL), and Nursing Student Loan
Program Administrative Requirements.
SUMMARY:
OMB No. 0915–0047—Revision
Abstract: This clearance request is for
approval of the Health Professions
Student Loan (HPSL) Program, Loans for
Disadvantaged Students (LDS), Primary
Care Loan Program (PCL), and Nursing
Student Loan (NSL) Program
E:\FR\FM\11FEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 27 (Thursday, February 11, 2021)]
[Notices]
[Pages 9071-9073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02845]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0173]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
[[Page 9072]]
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 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. 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 a recent submission by Janssen
Biotech Inc. of a request for emergency use authorization (EUA) for an
investigational vaccine to prevent Coronavirus Disease 2019 (COVID-19)
and the need for prompt discussion of such submission, given the COVID-
19 pandemic.
DATES: The meeting will be held on February 26, 2021, from 9 a.m.
Eastern Time to 5:30 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. Answers to
commonly asked questions 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 on the day of the meeting: https://youtu.be/Qd7mlCD-rEA.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0173. The docket will close on February
25, 2021. Submit either electronic or written comments on this public
meeting by February 25, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before February 25, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of February 25, 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 February 18, 2021, will be provided
to the committee. Comments received after February 18, 2021, and by
February 25, 2021, will be taken into consideration by FDA. In the
event that the meeting is cancelled, 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-0173 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, [email protected]; or FDA Advisory
Committee Information Line, 1-800-
[[Page 9073]]
741-8138 (301-443-0572 in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's website at https://www.fda.gov/advisory-committees and scroll down to the appropriate advisory
committee meeting link, or call the advisory committee information line
to learn about possible modifications before joining the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will meet in open session to discuss EUA of the Janssen Biotech Inc.
COVID-19 Vaccine for active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 18 years and older. EUA authority allows FDA
to help strengthen the nation's public health protections against
chemical, biological, radiological, nuclear (CBRN) threats by
facilitating the availability and use of Medical Countermeasures (MCMs)
needed during public health emergencies. Under section 564 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), FDA may
allow unapproved medical products or unapproved uses of approved
medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
CBRN threat agents when certain statutory criteria have been met,
including that there are no adequate, approved, and available
alternatives. Additional information about EUAs can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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 February 18, 2021, will be provided to the
committee. Comments received after February 18, 2021, and by February
25, 2021, will be taken into consideration by FDA. Oral presentations
from the public will be scheduled between approximately 1:25 p.m.
Eastern Time and 2:25 p.m. Eastern Time. 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 February 17, 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 February 18, 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: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-02845 Filed 2-10-21; 8:45 am]
BILLING CODE 4164-01-P
