National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 34641-34642 [2020-12259]
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Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices
• Terumo BCT Inc. and Marker
Therapeutics AG’s, Spectra Optia
Apheresis System with the Depuro
D2000 Adsorption Cartridge (an
Extracorporeal Blood Purification (EBP)
Device), issued on April 9, 2020;9 and,
• CytoSorbents, Inc.’s, CytoSorb EBP
Device, issued on April 10, 2020.10
Dated: May 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12117 Filed 6–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
lotter on DSK9F5VC42PROD with NOTICES
Name: National Committee on Vital
and Health Statistics (NCVHS), Full
Committee Meeting.
Dates and Times:
Wednesday, June 17, 2020: 10:00 a.m.–
5:00 p.m. EDT
Thursday, June 18, 2020 10:00 a.m.–4:00
p.m. EDT
9 As set forth in the EUA, FDA has concluded
that: (1) SARS–CoV–2, the virus that causes
COVID–19, can cause a serious or life-threatening
disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based
on the totality of scientific evidence available to
FDA, it is reasonable to believe that the Spectra
Optia Apheresis System with the Depuro D2000
Adsorption Cartridge may be effective in treating
patients 18 years of age or older with confirmed
COVID–19 admitted to the intensive care unit (ICU)
with confirmed or imminent respiratory failure, and
that the known and potential benefits of the Spectra
Optia Apheresis System with the Depuro D2000
Adsorption Cartridge, when used to treat COVID–
19 patients 18 years of age or older, outweigh the
known and potential risks of the Spectra Optia
Apheresis System with the Depuro D2000
Adsorption Cartridge; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the Spectra Optia Apheresis
System with the Depuro D2000 Adsorption
Cartridge for the treatment of these COVID–19
patients.
10 As set forth in the EUA, FDA has concluded
that: (1) SARS–CoV–2, the virus that causes
COVID–19, can cause a serious or life-threatening
disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based
on the totality of scientific evidence available to
FDA, it is reasonable to believe that the CytoSorb
device may be effective in treating patients 18 years
of age or older with confirmed COVID–19 admitted
to the ICU with confirmed or imminent respiratory
failure, and that the known and potential benefits
of the CytoSorb device, when used to treat such
patients, outweigh the known and potential risks of
the CytoSorb device; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the CytoSorb device for the
treatment of these COVID–19 patients.
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Place: Virtual.
Status: Open.
Purpose: At the June 17–18, 2020
meeting, the Committee will receive
briefings from HHS officials, hold
discussions on several health data
policy topics and refine its workplan for
the upcoming 12-month period.
The Subcommittee on Privacy,
Confidentiality and Security will lead a
discussion with the full Committee to
reach consensus on plans for a project
focused on data privacy and security
protections related to current public
health surveillance activities.
The Subcommittee on Standards will
provide updates on plans for the
upcoming August hearing intended to
solicit information about the costs and
benefits of a new operating rule for
connectivity and operating rules for the
prior authorization transaction proposed
by the Council for Affordable Quality
Healthcare (CAQH), Committee on
Operating Rules for Information
Exchange (CORE) Board. The
Subcommittee also will provide an
update on progress of the Office of the
National Coordinator (ONC) Health
Information Technology Advisory
Committee (HITAC) Task Force on
Intersection of Clinical and
Administrative Data (ICAD), on which
four NCVHS members participate. The
Committee will initiate a discussion of
the NCVHS 14th Report to Congress,
including a proposed approach, major
themes, and timeline including
reflection on previous reports to
Congress for context.
The Committee has invited
presentations from the HHS Office of
the Assistant Secretary for Planning and
Evaluation, Science and Data Policy
Division, the National Center for Health
Statistics (NCHS), and CDC’s Deputy
Director for Public Health Science and
Surveillance (DDPHSS), to inform
Committee discussion of the data
landscape transformed by the COVID–
19 epidemic. The Committee also has
invited CMS’s Division of National
Standards to provide an update on its
activities and plans. On the afternoon of
the second day, members will consider
and discuss priorities for Committee
focus and revise the Committee
workplan based on information
presented during the meeting.
A public comment period will be
offered on the second day. Meeting
times and topics are subject to change.
Please refer to the posted agenda for any
updates.
For Further Information Contact:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
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34641
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Summaries of meetings and a roster of
Committee members are available on the
home page of the NCVHS website:
ncvhs.hhs.gov, where further
information including an agenda and
instructions to access the broadcast of
the meeting will also be posted.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Sharon Arnold,
Associate Deputy Assistant Secretary for
Planning and Evaluation, Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
[FR Doc. 2020–12236 Filed 6–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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
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
Allergy and Infectious Diseases Special
Emphasis Panel Vaccine and Treatment
Evaluation Units (VTEUs): Enhancing
Capability and Capacity (UM1 Clinical Trial
Required).
Date: July 7, 2020.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
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Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices
Bethesda, MD 20892–9834, (240) 669–5026,
haririmf@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 1, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–12259 Filed 6–4–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of
Meetings Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Literature Selection
Technical Review Committee, June 11–
12, 2020, 8:30 a.m. to 5:00 p.m., video
assisted meeting, which was published
in the Federal Register on April 20,
2020, 85 FR 76, Page 21868.
This notice is being amended to
change the meeting dates to June 10–11,
2020 and the times for both days from
10:00 a.m. to 3:00 p.m. This meeting
will be a video assisted meeting and
will be closed to the public.
Dated: June 2, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–12254 Filed 6–4–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK9F5VC42PROD with NOTICES
National Institute of Mental Health;
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.
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Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BICCN: Human and NHP Brain Cell Atlases
(U01) & Scalable Tech and Tools for Brain
Cell Census (R01).
Date: July 1, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–9734,
millerda@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Interventions and Services RFA.
Date: July 1, 2020.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–1225,
aschulte@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Dysregulation and Proximal Risk for Suicide
Review Meeting (R01 & R21).
Date: July 9, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Rebecca Steiner Garcia,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6149, MSC 9608,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: June 2, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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
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
Allergy and Infectious Diseases Special
Emphasis Panel Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19).
Date: June 25, 2020.
Time: 11:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Ruth S. Grossman, DDS,
Scientific Review Officer, Office Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12J, Bethesda, MD
20892, grossmanrs@mail.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. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 1, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–12252 Filed 6–4–20; 8:45 am]
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[FR Doc. 2020–12253 Filed 6–4–20; 8:45 am]
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[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34641-34642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 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 Allergy and Infectious
Diseases Special Emphasis Panel Vaccine and Treatment Evaluation
Units (VTEUs): Enhancing Capability and Capacity (UM1 Clinical Trial
Required).
Date: July 7, 2020.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: Maryam Feili-Hariri, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F21B,
[[Page 34642]]
Bethesda, MD 20892-9834, (240) 669-5026, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: June 1, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-12259 Filed 6-4-20; 8:45 am]
BILLING CODE 4140-01-P
