Meeting of the Advisory Committee on Blood and Tissue Safety and Availability, 48545-48546 [2020-17508]
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Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. Members will
participate via teleconference.
DATES: The meeting will be held on
October 2, 2020, from 11 a.m. Eastern
Time to 3:30 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,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
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
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. In open
session, the committee will discuss and
make recommendations on the selection
of strains to be included in an influenza
virus vaccine for the 2021 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, 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/
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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. Written
submissions may be made to the contact
person on or before September 25, 2020.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. Eastern Time and 2:30 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
September 17, 2020. 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 18, 2020.
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 (Kathleen.Hayes@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/Advisory
Committees/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: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17495 Filed 8–10–20; 8:45 am]
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48545
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood and Tissue Safety and
Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As required by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood and
Tissue Safety and Availability
(ACBTSA) will hold a meeting. The
meeting will be open to the public. The
committee will discuss
recommendations to improve the blood
community’s response to future public
health emergencies. In order to facilitate
this discussion, key stakeholders from
across the nation will present on their
lessons learned during the latest
pandemic. The committee will analyze
strengths and weaknesses from the
COVID–19 response on the blood
community and blood supply.
DATES: The meeting will take place
virtually on Wednesday, August 26,
2020 from approximately 12:30 p.m.–
5:15 p.m. and Thursday, August 27,
2020 from approximately 8:00 a.m.–5:00
p.m. Meeting times are tentative and
subject to change. The confirmed times
and agenda items for the meeting will be
posted on the ACBTSA web page at
https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/meetings/2020-08-26/
index.html when this information
becomes available.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the ACBTSA; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Suite L600, Washington,
DC 20024. Email: ACBTSA@hhs.gov;
Phone: 202–795–7608.
SUPPLEMENTARY INFORMATION: The
registration link for the meeting will be
posted at https://www.hhs.gov/oidp/
advisory-committee/blood-tissue-safetyavailability/meetings/2020-08-26/
index.html when it becomes available.
After registering, you will receive an
email confirmation with a personalized
link to access the webcast on August
26–27.
The public will have an opportunity
to present their views to the ACBTSA
orally during the meeting’s public
SUMMARY:
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48546
Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
comment session or by submitting a
written public comment. Comments
should be pertinent to the meeting
discussion. Persons who wish to
provide verbal or written public
comment should review instructions at
https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/meetings/2020-08-26/
index.html and respond by midnight
August 19, 2020, ET. Verbal comments
will be limited to three minutes each to
accommodate as many speakers as
possible.
The ACBTSA provides advice to the
Secretary through the Assistant
Secretary for Health. The Committee
advises on a range of policy issues to
include: (1) Identification of public
health issues through surveillance of
blood and tissue safety issues with
national survey and data tools; (2)
identification of public health issues
that affect availability of blood, blood
products, and tissues; (3) broad public
health, ethical, and legal issues related
to the safety of blood, blood products,
and tissues; (4) the impact of various
economic factors (e.g., product cost and
supply) on safety and availability of
blood, blood products, and tissues; (5)
risk communications related to blood
transfusion and tissue transplantation;
and (6) identification of infectious
disease transmission issues for blood,
organs, blood stem cells and tissues.
The Committee has met regularly since
its establishment in 1997.
Dated: July 22, 2020.
James J. Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2020–17508 Filed 8–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Opportunities for
Collaborative Research at the NIH Clinical
Center (U01 Clinical Trials Optional).
Date: August 14, 2020.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mirela Milescu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH, NSC, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Bethesda, MD 20892,
mirela.milescu@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: August 5, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–17439 Filed 8–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Co-Clinical
Imaging—Quantitative Methods.
Date: September 17, 2020.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W108, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Clifford W. Schweinfest,
Ph.D., Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W108,
Rockville, MD 20850, 240–276–6343,
schweinfestcw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Provocative
Question 7.
Date: September 24, 2020.
Time: 11:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W640, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Saejeong J. Kim, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W640, Rockville, MD
20850, 240–276–7684, saejeong.kim@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Mechanisms of Cancer Drug Resistance.
Date: September 28, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W246, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Jun Fang, Ph.D., Scientific
Review Officer, Research Technology and
Contract Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W246, Rockville, MD 20850, 240–
276–5460, jfang@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–4: NCI
Clinical and Translational R21 and Omnibus
R03 Review.
Date: October 1–2, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W254, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Eduardo Emilio Chufan,
Ph.D., Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W254, Rockville, MD 20850,
240–276–7975, chufanee@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–1:
Research Answers to NCI Provocative
Questions.
Date: October 8, 2020.
Time: 8:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
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]]>Agencies
[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48545-48546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17508]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood and Tissue Safety and
Availability
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As required by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services is hereby giving notice that
the Advisory Committee on Blood and Tissue Safety and Availability
(ACBTSA) will hold a meeting. The meeting will be open to the public.
The committee will discuss recommendations to improve the blood
community's response to future public health emergencies. In order to
facilitate this discussion, key stakeholders from across the nation
will present on their lessons learned during the latest pandemic. The
committee will analyze strengths and weaknesses from the COVID-19
response on the blood community and blood supply.
DATES: The meeting will take place virtually on Wednesday, August 26,
2020 from approximately 12:30 p.m.-5:15 p.m. and Thursday, August 27,
2020 from approximately 8:00 a.m.-5:00 p.m. Meeting times are tentative
and subject to change. The confirmed times and agenda items for the
meeting will be posted on the ACBTSA web page at https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2020-08-26/ when this information becomes available.
FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal
Officer for the ACBTSA; Office of Infectious Disease and HIV/AIDS
Policy, Office of the Assistant Secretary for Health, Department of
Health and Human Services, Mary E. Switzer Building, 330 C Street SW,
Suite L600, Washington, DC 20024. Email: [email protected]; Phone: 202-
795-7608.
SUPPLEMENTARY INFORMATION: The registration link for the meeting will
be posted at https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2020-08-26/ when it becomes
available. After registering, you will receive an email confirmation
with a personalized link to access the webcast on August 26-27.
The public will have an opportunity to present their views to the
ACBTSA orally during the meeting's public
[[Page 48546]]
comment session or by submitting a written public comment. Comments
should be pertinent to the meeting discussion. Persons who wish to
provide verbal or written public comment should review instructions at
https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2020-08-26/ and respond by midnight
August 19, 2020, ET. Verbal comments will be limited to three minutes
each to accommodate as many speakers as possible.
The ACBTSA provides advice to the Secretary through the Assistant
Secretary for Health. The Committee advises on a range of policy issues
to include: (1) Identification of public health issues through
surveillance of blood and tissue safety issues with national survey and
data tools; (2) identification of public health issues that affect
availability of blood, blood products, and tissues; (3) broad public
health, ethical, and legal issues related to the safety of blood, blood
products, and tissues; (4) the impact of various economic factors
(e.g., product cost and supply) on safety and availability of blood,
blood products, and tissues; (5) risk communications related to blood
transfusion and tissue transplantation; and (6) identification of
infectious disease transmission issues for blood, organs, blood stem
cells and tissues. The Committee has met regularly since its
establishment in 1997.
Dated: July 22, 2020.
James J. Berger,
Designated Federal Officer, Tick-Borne Disease Working Group, Office of
Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2020-17508 Filed 8-10-20; 8:45 am]
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