National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 13854 [2015-05968]
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Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
for people with intellectual disabilities:
(A) Expansion of educational
opportunities; (B) promotion of
homeownership; (C) assurance of
workplace integration; (D) improvement
of transportation options; (E) expansion
of full access to community living; and
(F) increasing access to assistive and
universally designed technologies.
Dated: March 11, 2015.
Aaron Bishop,
Commissioner, Administration on Intellectual
and Developmental Disabilities.
Dated: March 11, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05968 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1206]
BILLING CODE 4154–01–P
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Ebola Zaire Virus;
Availability
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
[FR Doc. 2015–06085 Filed 3–16–15; 8:45 am]
ACTION:
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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; NINDS Center Core (P30)
and Research Resource (R24) Review.
Date: April 17, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle NW., Washington, DC 20005.
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS/Neuroscience
Center, 6001 Executive Boulevard, Suite
3208, MSC 9529, Bethesda, MD 20892–9529,
301–402–0288, natalia.strunnikova@nih.gov.
(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)
VerDate Sep<11>2014
18:09 Mar 16, 2015
Jkt 235001
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the Ebola Zaire virus in
response to the 2014 Ebola virus
outbreak in West Africa. FDA is issuing
this Authorization under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as requested by Roche
Molecular Systems, Inc. (Roche). The
Authorization contains, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
device. The Authorization follows the
September 22, 2006, determination by
then-Secretary of the Department of
Homeland Security (DHS), Michael
Chertoff, that the Ebola virus presents a
material threat against the U.S.
population sufficient to affect national
security. On the basis of such
determination, the Secretary of Health
and Human Services (HHS) declared on
August 5, 2014, that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection of Ebola virus subject to the
terms of any authorization issued under
the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is reprinted in this
document.
DATES: The Authorization is effective as
of December 23, 2014.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
SUMMARY:
PO 00000
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See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of
Counterterrorism and Emerging Threats,
and Acting Deputy Chief Scientist, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4340,
Silver Spring, MD 20993–0002, 301–
796–8510 (this is not a toll free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (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 biological, chemical, radiological,
or nuclear agent or agents; (2) 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 U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS 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 U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
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[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Page 13854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05968]
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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 (5 U.S.C. App.), 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; NINDS Center Core (P30) and
Research Resource (R24) Review.
Date: April 17, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Plaza Hotel, 10 Thomas Circle NW., Washington,
DC 20005.
Contact Person: Natalia Strunnikova, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite
3208, MSC 9529, Bethesda, MD 20892-9529, 301-402-0288,
natalia.strunnikova@nih.gov.
(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: March 11, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-05968 Filed 3-16-15; 8:45 am]
BILLING CODE 4140-01-P
