National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings, 17336-17337 [2020-06444]
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17336
Federal Register / Vol. 85, No. 60 / Friday, March 27, 2020 / Notices
Services, 200 Independence Avenue
SW, Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
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I. Background
Under section 564 of the FD&C Act,
21 U.S.C. 360bbb–3, the Commissioner
of the Food and Drug Administration
(FDA), acting under delegated authority
from the Secretary of HHS, may issue an
Emergency Use Authorization (EUA)
authorizing (1) the emergency use of an
unapproved drug, an unapproved or
uncleared device, or an unlicensed
biological product; or (2) an unapproved
use of an approved drug, approved or
cleared device, or licensed biological
product. Before an EUA may be issued,
the Secretary of HHS must declare that
circumstances exist justifying the
authorization based on one of four
determinations: (1) A determination by
the Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces, including personnel operating
under the authority of title 10 or title 50,
of attack with (i) a biological, chemical,
radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause,
or are otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad, and
that involves a CBRN agent or agents, or
a disease or condition that may be
attributable to such agent or agents.
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
authorization under section 564 of the
FD&C Act are met. The Office of the
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Assistant Secretary for Preparedness
and Response, HHS, requested that the
FDA, HHS, issue an EUA for certain
medical devices to allow the
Department to take response measures
based on information currently available
about the virus that causes COVID–19.
The determination of a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of certain medical
devices by the Secretary of HHS, as
described below, enable the FDA
Commissioner to issue an EUA for these
devices for emergency use under section
564 of the FD&C Act.
II. Determination by the Secretary of
Health and Human Services
On February 4, 2020, pursuant to
section 564 of the FD&C Act, I
determined that there is a public health
emergency that has a significant
potential to affect national security or
the health and security of United States
citizens living abroad and that involves
a novel (new) coronavirus (nCoV) first
detected in Wuhan City, Hubei
Province, China in 2019 (2019–nCoV).
The virus is now named SARS–CoV–2,
which causes the illness COVID–19.
III. Declaration of the Secretary of
Health and Human Services
On March 24, 2020, on the basis of my
determination of a public health
emergency that has a significant
potential to affect national security or
the health and security of United States
citizens living abroad and that involves
the novel (new) coronavirus, SARS–
CoV–2, I declared that circumstances
exist justifying the authorization of
emergency use of medical devices,
including alternative products used as
medical devices, pursuant to section
564 of the FD&C Act, subject to the
terms of any authorization issued under
that section.
Notice of the EUAs issued by the FDA
Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Dated: March 24, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020–06541 Filed 3–25–20; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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 Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel NIAAA Review
Subcommittee Member Conflict Review
Panel.
Date: April 7, 2020.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive, Suite
2118, Bethesda, MD 20817 (Telephone
Conference Call).
Contact Person: Philippe Marmillot, Ph.D.,
National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health,
6700B Rockledge Drive, Bethesda, MD 20817
301–443–2861 marmillotp@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group Epidemiology, Prevention and
Behavior Research Review Subcommittee.
Date: June 8, 2020.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Conference Room B, Bethesda, MD 20817.
Contact Person: Anna Ghambaryan, M.D.,
Ph.D., Scientific Review Officer, Extramural
Project Review Branch Office of Extramural
Activities National Institute on Alcohol
Abuse and Alcoholism, 6700b Rockledge
Drive, Room 2120, MSC 6902 Bethesda, MD
20892, 301–443–4032, anna.ghambaryan@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
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Federal Register / Vol. 85, No. 60 / Friday, March 27, 2020 / Notices
17337
Dated: March 24, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: March 23, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06438 Filed 3–26–20; 8:45 am]
[FR Doc. 2020–06437 Filed 3–26–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Federal Emergency Management
Agency
and Research Support Awards., National
Institutes of Health, HHS)
Dated: March 23, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06444 Filed 3–26–20; 8:45 am]
BILLING CODE 4140–01–P
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Genetic Toxicology Support
for the National Toxicology Program (NTP).
Date: April 23, 2020.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Environmental
Health Sciences, National Institutes of
Health, Keystone Building, 530 Davis Drive,
Research Triangle Park, NC 27709 (Virtual
Meeting).
Contact Person: Laura A., Thomas,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, Research Triangle Park, NC
27709 (919) 541–2824, laura.thomas@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
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16:28 Mar 26, 2020
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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: Center for Scientific
Review Special Emphasis Panel; RFA–HD–
20–002: Pediatric HIV/AIDS Cohort Study.
Date: April 22, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Translational Research.
Date: April 22, 2020.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Laura Asnaghi, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Room 6200, Bethesda, MD
20892, 301–443–1196, laura.asnaghi@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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[Docket ID FEMA–2020–0002; Internal
Agency Docket No. FEMA–B–2018]
Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment
regarding the preliminary FIRM, and
where applicable, the FIS report that the
Federal Emergency Management Agency
(FEMA) has provided to the affected
communities. The FIRM and FIS report
are the basis of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
in order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP). In addition,
the FIRM and FIS report, once effective,
will be used by insurance agents and
others to calculate appropriate flood
insurance premium rates for new
buildings and the contents of those
buildings.
SUMMARY:
Comments are to be submitted
on or before June 25, 2020.
ADDRESSES: The Preliminary FIRM, and
where applicable, the FIS report for
each community are available for
inspection at both the online location
https://www.fema.gov/
preliminaryfloodhazarddata and the
respective Community Map Repository
address listed in the tables below.
Additionally, the current effective FIRM
and FIS report for each community are
accessible online through the FEMA
DATES:
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Agencies
[Federal Register Volume 85, Number 60 (Friday, March 27, 2020)]
[Notices]
[Pages 17336-17337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06444]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; 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 Institute on Alcohol Abuse and
Alcoholism Special Emphasis Panel NIAAA Review Subcommittee Member
Conflict Review Panel.
Date: April 7, 2020.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Suite 2118,
Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Philippe Marmillot, Ph.D., National Institute on
Alcohol Abuse and Alcoholism, National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817 301-443-2861
[email protected].
Name of Committee: National Institute on Alcohol Abuse and
Alcoholism Initial Review Group Epidemiology, Prevention and
Behavior Research Review Subcommittee.
Date: June 8, 2020.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Conference Room
B, Bethesda, MD 20817.
Contact Person: Anna Ghambaryan, M.D., Ph.D., Scientific Review
Officer, Extramural Project Review Branch Office of Extramural
Activities National Institute on Alcohol Abuse and Alcoholism, 6700b
Rockledge Drive, Room 2120, MSC 6902 Bethesda, MD 20892, 301-443-
4032, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research
[[Page 17337]]
and Research Support Awards., National Institutes of Health, HHS)
Dated: March 23, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-06444 Filed 3-26-20; 8:45 am]
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