Emergency Use Declaration, 13907-13908 [2020-04823]
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
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Dated: March 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04866 Filed 3–9–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Emergency Use Declaration
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
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
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 personal respiratory
protective devices during the COVID–19
outbreak, 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 2, 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:
SUMMARY:
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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,1 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.2
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
1 42
U.S.C. 247d–6b.
amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.
2 As
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of
such an authorization under section 564
of the FD&C Act are met.
The Centers for Disease Control and
Prevention (CDC), HHS, requested that
the FDA, HHS, issue an EUA for
personal respiratory protective devices
to allow the Department to take
preparedness 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 personal respiratory
protective devices by the Secretary of
HHS, as described below, enable the
FDA Commissioner to issue an EUA for
respiratory protective 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.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Declaration of the Secretary of
Health and Human Services
On March 2, 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
personal respiratory protective devices
during the COVID–19 outbreak,
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.
Alex M. Azar II,
Secretary.
[FR Doc. 2020–04823 Filed 3–9–20; 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; Investigator Initiated
Extended Clinical Trial (R01 Clinical Trial
Required).
Date: March 24, 2020.
Time: 1:00 p.m. to 6:00 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 3G53A,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Julio C. Aliberti, Ph.D.,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, Room 3G53A, Rockville, MD 20892–
9823, 301–761–7322, julio.aliberti@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)
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; NIH Support for
Conferences and Scientific Meetings (Parent
R13 Clinical Trial Not Allowed).
Date: April 6–8, 2020.
Time: 8:00 a.m. to 1:00 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 (Virtual Meeting).
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,
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: March 4, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–04782 Filed 3–9–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 4, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2020–04780 Filed 3–9–20; 8:45 am]
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
BILLING CODE 4140–01–P
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
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Center for Scientific Review; Notice of
Closed Meetings
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[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13907-13908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Emergency Use Declaration
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
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
personal respiratory protective devices during the COVID-19 outbreak,
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 2, 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,\1\ 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.\2\
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6b.
\2\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act, Public Law 113-5, the Secretary may make
determination of a public health emergency, or a significant
potential for a public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency in accordance with
section 319 of the PHS Act, 42 U.S.C. 247d to support a
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------
Based on any of these four determinations, the Secretary of HHS may
then declare that circumstances
[[Page 13908]]
exist that justify the EUA, at which point the FDA Commissioner may
issue an EUA if the criteria for issuance of such an authorization
under section 564 of the FD&C Act are met.
The Centers for Disease Control and Prevention (CDC), HHS,
requested that the FDA, HHS, issue an EUA for personal respiratory
protective devices to allow the Department to take preparedness
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
personal respiratory protective devices by the Secretary of HHS, as
described below, enable the FDA Commissioner to issue an EUA for
respiratory protective 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 2, 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
personal respiratory protective devices during the COVID-19 outbreak,
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.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-04823 Filed 3-9-20; 8:45 am]
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