Determination of Public Health Emergency, 7316-7317 [2020-02496]
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7316
Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Nurse Faculty Loan Program—Program Specific Data
Form .................................................................................
Nurse Faculty Loan Program—Annual Performance Report Financial Data Form .................................................
90
1
90
8
720
260
1
260
6
1,560
Total Burden .................................................................
350
........................
350
........................
2,280
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section.
DATES: The determination and
declaration took effect February 4, 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).
[FR Doc. 2020–02408 Filed 2–6–20; 8:45 am]
SUPPLEMENTARY INFORMATION:
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I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Determination of Public Health
Emergency
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).
On the basis of this determination, he
also declared that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of this novel
coronavirus (2019-nCoV) pursuant to
SUMMARY:
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Number of
responses per
respondent
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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 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
1 42
PO 00000
U.S.C. 247d–6b.
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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
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 determination of a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of in vitro diagnostics for
detection and/or diagnosis of the novel
coronavirus (2019-nCoV) by the
Secretary of HHS, as described below,
enable the FDA Commissioner to issue
EUAs for certain in vitro diagnostics for
emergency use under section 564 of the
FD&C Act. The Centers for Disease
Control and Prevention (CDC) requested
that the FDA issue an EUA for its in
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.
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Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
April 16, 2020, 6:00 p.m. The meeting
is closed to the public.
vitro diagnostic for detection of 2019nCoV to allow the Department to take
preparedness measures based on
information currently available about
2019-nCoV.
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).
III. Declaration of the Secretary of
Health and Human Services
Also on February 4, 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 (2019nCoV), I declared that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of the novel
coronavirus (2019-nCoV) pursuant to
section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section.
Notice of any 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. 2020–02496 Filed 2–6–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, April
16, 4:00 p.m. to April 17, 2020, 5:00
p.m., Bethesda North Marriott Hotel &
Conference Hotel, 5701 Marinelli Road,
Rockville, MD, 20850 which was
published in the Federal Register on
January 30, 2020, 85 FR 5456.
This meeting notice is amended to
change the meeting dates and start and
end times. The meeting will now be
held on April 15, 2020, 3:00 p.m. to
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Dated: February 3, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
7317
Dated: February 3, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–02406 Filed 2–6–20; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2020–02402 Filed 2–6–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
National Institute of General Medical
Sciences; 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
General Medical Sciences Special Emphasis
Panel; Review the U01 Diversity Program
Consortium—Dissemination and Translation
Award applications.
Date: March 25, 2020.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites—Chevy Chase
Pavilion, Conference Room Chevy Chase
Ballroom, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, 45 Center
Drive, Bethesda, MD 20892, (301) 594–2771,
johnsonrh@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
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Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel,
February 27, 2020, 11:00 a.m. to 3:00
p.m., National Cancer Institute, Shady
Grove, 9609 Medical Center Drive,
Room 7W108, Rockville, MD 20850
which was published in the Federal
Register on December 30, 2019, 84 FR
71964.
This meeting notice is amended to
change the meeting start time from
11:00 a.m. to 10:00 a.m. on February 27,
2020. The meeting is closed to the
public.
Dated: February 3, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–02401 Filed 2–6–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Cellular, Molecular
and Integrative Reproduction Study
Section, February 19, 2020, 8:00 a.m. to
February 20, 2020, 5:00 p.m. at the
Embassy Suites Alexandria Old Town,
1900 Diagonal Road, Alexandria, VA
22314, which was published in the
Federal Register on January 27, 2020, 85
FR 4672.
The Contact Person for this meeting
has been changed to Elaine SierraRivera, Ph.D., Scientific Review Officer,
Phone (301) 435–1053, email: riverase@
csr.nih.gov. The meeting date and time
remain the same. The meeting is closed
to the public.
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]]>Agencies
[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7316-7317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Determination of Public Health Emergency
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). On
the basis of this determination, he also declared that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of this novel coronavirus
(2019-nCoV) pursuant to section 564 of the FD&C Act, subject to the
terms of any authorization issued under that section.
DATES: The determination and declaration took effect February 4, 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, 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 \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 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 determination of a public health emergency, and the declaration
that circumstances exist justifying emergency use of in vitro
diagnostics for detection and/or diagnosis of the novel coronavirus
(2019-nCoV) by the Secretary of HHS, as described below, enable the FDA
Commissioner to issue EUAs for certain in vitro diagnostics for
emergency use under section 564 of the FD&C Act. The Centers for
Disease Control and Prevention (CDC) requested that the FDA issue an
EUA for its in
[[Page 7317]]
vitro diagnostic for detection of 2019-nCoV to allow the Department to
take preparedness measures based on information currently available
about 2019-nCoV.
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).
III. Declaration of the Secretary of Health and Human Services
Also on February 4, 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 (2019-
nCoV), I declared that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection and/or diagnosis
of the novel coronavirus (2019-nCoV) pursuant to section 564 of the
FD&C Act, subject to the terms of any authorization issued under that
section.
Notice of any 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. 2020-02496 Filed 2-6-20; 8:45 am]
BILLING CODE 4150-28-P
