Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)-Funding Opportunity Announcement (FOA), PAR 16-098, Cooperative Research Agreements to the World Trade Center Health Program (U01); Amended Notice of Meeting, 3785 [2019-02164]
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Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Centers for Disease Control and
Prevention
Food and Drug Administration
Notice of Closed Meeting
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Ebola virus; Availability
[FR Doc. 2019–02165 Filed 2–12–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—Funding
Opportunity Announcement (FOA),
PAR 16–098, Cooperative Research
Agreements to the World Trade Center
Health Program (U01); Amended
Notice of Meeting
khammond on DSKBBV9HB2PROD with NOTICES
3785
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—
Funding Opportunity Announcement
(FOA), PAR 16–098, Cooperative
Research Agreements to the World
Trade Center Health Program (U01);
Dates and Times: March 27, 2019, 8:00
a.m.–5:00 p.m., EDT and March 28,
2019, 8:00 a.m.–12:00 p.m., EDT.
Hampton Inn & Suites Atlanta
Buckhead, 3312 Piedmont Road,
Atlanta, Georgia 30305, which was
published in the Federal Register on
January 31, 2019, Volume 84, Number
21, pages 730.
The meeting is being amended to
Atlanta Marriott Buckhead Hotel &
Conference Center, 3405 Lenox Road
NE, Atlanta, GA 30326, Telephone:
(404) 261–9250. The meeting is closed
to the public.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
CDC/NIOSH, 1095 Willowdale Road,
Mailstop L1055, Morgantown, West
Virginia 26505, Telephone: (304) 285–
5975, nxt2@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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, and Determination of the
Chief Operating Officer, Centers for
Disease Control and Prevention,
pursuant to Public Law 92–463. 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: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—SIP19–004, Cancer
Prevention and Control Research Network
Coordinating Center and SIP19–005, Cancer
Prevention and Control Research Network
Collaborating Center.
Dates: April 30, 2019–May 1, 2019.
Times: 10:00 a.m.–6:30 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer, CDC,
4770 Buford Highway, Mailstop F80, Atlanta,
Georgia 30341, Telephone: (770) 488–6511,
kva5@cdc.gov.
The Chief Operating Officer, Centers for
Disease Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–02172 Filed 2–12–19; 8:45 am]
BILLING CODE 4163–18–P
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Jkt 247001
Food and Drug Administration,
HHS.
ACTION:
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 Ebola virus (species Zaire
ebolavirus and hereafter referred to as
Ebola virus) in response to the Ebola
virus outbreak in the Democratic
Republic of the Congo. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Chembio Diagnostic
Systems, Inc. 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 diagnostic
devices 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 November 9, 2018.
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.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
SUMMARY:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
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17:22 Feb 12, 2019
AGENCY:
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2019–02164 Filed 2–12–19; 8:45 am]
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Agencies
[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Page 3785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP)--Funding Opportunity Announcement (FOA), PAR 16-
098, Cooperative Research Agreements to the World Trade Center Health
Program (U01); Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the Disease,
Disability, and Injury Prevention and Control Special Emphasis Panel
(SEP)-- Funding Opportunity Announcement (FOA), PAR 16-098, Cooperative
Research Agreements to the World Trade Center Health Program (U01);
Dates and Times: March 27, 2019, 8:00 a.m.-5:00 p.m., EDT and March 28,
2019, 8:00 a.m.-12:00 p.m., EDT. Hampton Inn & Suites Atlanta Buckhead,
3312 Piedmont Road, Atlanta, Georgia 30305, which was published in the
Federal Register on January 31, 2019, Volume 84, Number 21, pages 730.
The meeting is being amended to Atlanta Marriott Buckhead Hotel &
Conference Center, 3405 Lenox Road NE, Atlanta, GA 30326, Telephone:
(404) 261-9250. The meeting is closed to the public.
For Further Information Contact: Nina Turner, Ph.D., Scientific
Review Officer, CDC/NIOSH, 1095 Willowdale Road, Mailstop L1055,
Morgantown, West Virginia 26505, Telephone: (304) 285-5975,
nxt2@cdc.gov.
The Chief Operating Officer, Centers for Disease Control and
Prevention, has been delegated the authority to sign Federal Register
notices pertaining to announcements of meetings and other committee
management activities, for both the Centers for Disease Control and
Prevention and the Agency for Toxic Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2019-02164 Filed 2-12-19; 8:45 am]
BILLING CODE 4163-18-P