National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 50091 [2022-17453]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 156 / Monday, August 15, 2022 / Notices
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
exist that justify the EUA, at which
point the Commissioner of Food and
Drugs may issue an EUA if the criteria
for issuance of an authorization under
section 564 of the FD&C Act are met.
The ASPR requested that the
Secretary issue the determination and
declaration to allow the Department to
take measures based on information
currently available about monkeypox
virus. The determination of a public
health emergency or a significant
potential for a public health emergency,
and the declaration that circumstances
exist justifying emergency use of
vaccines by the Secretary of HHS, as
described below, enable the
Commissioner of Food and Drugs to
issue an EUA for vaccines for
emergency use under section 564 of the
FD&C Act.
42 U.S.C. 247d–6b.
As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make a 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.
1
khammond on DSKJM1Z7X2PROD with NOTICES
2
VerDate Sep<11>2014
17:24 Aug 12, 2022
Jkt 256001
II. Determination by the Secretary of
Health and Human Services
On August 9, 2022, pursuant to
section 564 of the FD&C Act, I
determined 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 that involves monkeypox virus.
III. Declaration of the Secretary of
Health and Human Services
Also on August 9, 2022, on the basis
of my determination 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 monkeypox virus, I
declared that circumstances exist
justifying the authorization of
emergency use of vaccines 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
Commissioner of Food and Drugs
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: August 10, 2022.
Xavier Becerra,
Secretary, U.S. Department of Health and
Human Services.
[FR Doc. 2022–17503 Filed 8–12–22; 8:45 am]
50091
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Emergency Care Clinical
Trials Panel 1.
Date: August 18, 2022.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Shanta Rajaram, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH, NSC, 6001 Executive Boulevard,
Suite 3208, MSC 9529, Bethesda, MD 20892,
301–435–6033, rajarams@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. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: August 9, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–17453 Filed 8–12–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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 Inherited
Disease Research Access Committee.
Date: September 9, 2022.
Time: 11:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 300, Bethesda, MD
20892 (Virtual Meeting).
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Page 50091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; 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 Neurological Disorders
and Stroke Special Emphasis Panel; Emergency Care Clinical Trials
Panel 1.
Date: August 18, 2022.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate cooperative agreement
applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).
Contact Person: Shanta Rajaram, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural
Activities, NINDS/NIH, NSC, 6001 Executive Boulevard, Suite 3208,
MSC 9529, Bethesda, MD 20892, 301-435-6033, [email protected].
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. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
Dated: August 9, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-17453 Filed 8-12-22; 8:45 am]
BILLING CODE 4140-01-P
