Emergency Use Authorization Declaration, 18250-18251 [2020-06905]
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices
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Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06747 Filed 3–31–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Emergency Use Authorization
Declaration
Department of Health and
Human Services.
ACTION: Notice of Emergency Use
Authorization Declaration.
AGENCY:
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564 of the
Federal Food, Drug, and Cosmetic
(FD&C) Act. On February 4, 2020, the
Secretary determined pursuant to his
authority under section 564 of the FD&C
Act that there is a public health
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SUMMARY:
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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. On
the basis of this determination, he also
declared that circumstances exist
justifying the authorization of
emergency use of drugs and biological
products during the COVID–19
pandemic, pursuant to section 564 of
the FD&C Act, subject to the terms of
any authorization issued under that
section.
DATES: The determination was effective
February 4, 2020, and this declaration is
effective March 27, 2020.
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, M.D., MTM&H, MS,
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act,
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
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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
Assistant Secretary for Preparedness
and Response, HHS, requested that the
FDA, HHS, issue an EUA for drugs and
biological products 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 drugs and biological
products by the Secretary of HHS, as
described below, enable the FDA
Commissioner to issue an EUA for drugs
and biological products 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 27, 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, I declared
that circumstances exist justifying the
authorization of emergency use of drugs
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices
and biological products during the
COVID–19 pandemic, 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 27, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020–06905 Filed 3–30–20; 2:00 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Board of Regents,
May 12–13, 2020, 9:00 a.m. to 4:00 p.m.
at the National Institutes of Health,
Building 38, Lindberg Room, 8600
Rockville Pike, Bethesda, MD 20892
which was published in the Federal
Register on February 4, 2020, 85 FR 23,
Page 6210.
This notice is being amended to
change the meeting location from the
National Institutes of Health, Building
38, Lindberg Room, 8600 Rockville Pike,
Bethesda, MD 20892 to a virtual
meeting. The URL link to this meeting
is: https://videocast.nih.gov. Any
member of the public may submit
written comments no later than 15 days
after the meeting.
Dated: March 27, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06768 Filed 3–31–20; 8:45 am]
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; Member
Conflict: Health Informatics and Health Care
Delivery.
Date: April 10, 2020.
Time: 2:00 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 (Telephone Conference Call).
Contact Person: Ping Wu, Ph.D., Scientific
Review Officer, HDM IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
Bethesda, MD 20892, 301–451–8428, wup4@
csr.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. 93.306, 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)
Dated: March 26, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06766 Filed 3–31–20; 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
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Center for Scientific Review; 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.,
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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.
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Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator-Initiated
Clinical Trial Planning Grant (R34).
Date: April 23, 2020.
Time: 1:00 p.m. to 4:00 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 3G41,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, National Institutes
of Health, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane, Room
3G41, Rockville, MD 20852, 240–669–5067,
kelly.hudspeth@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: March 26, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06765 Filed 3–31–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; PAR 19–
059: Global Noncommunicable Diseases and
Injury Across the Lifespan (R21).
Date: April 10, 2020.
Time: 10:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Weijia Ni, Ph.D., Chief/
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3100,
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]]>Agencies
[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18250-18251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Emergency Use Authorization Declaration
AGENCY: Department of Health and Human Services.
ACTION: Notice of Emergency Use Authorization Declaration.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564 of the Federal Food, Drug, and
Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined
pursuant to his authority under section 564 of the FD&C Act 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. On
the basis of this determination, he also declared that circumstances
exist justifying the authorization of emergency use of drugs and
biological products during the COVID-19 pandemic, pursuant to section
564 of the FD&C Act, subject to the terms of any authorization issued
under that section.
DATES: The determination was effective February 4, 2020, and this
declaration is effective March 27, 2020.
FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, M.D., MTM&H, MS,
Assistant Secretary for Preparedness and Response, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW, Washington, DC 20201, Telephone (202) 205-2882 (this is not
a toll free number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act, 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 Assistant Secretary for Preparedness and Response,
HHS, requested that the FDA, HHS, issue an EUA for drugs and biological
products 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 drugs and
biological products by the Secretary of HHS, as described below, enable
the FDA Commissioner to issue an EUA for drugs and biological products
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 27, 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, I declared that
circumstances exist justifying the authorization of emergency use of
drugs
[[Page 18251]]
and biological products during the COVID-19 pandemic, 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 27, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-06905 Filed 3-30-20; 2:00 pm]
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