National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 70154 [2011-29142]
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70154
Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
5. FDA Review
Under the pilot program, early
feasibility study IDE applications will
be reviewed according to the
approaches outlined in the early
feasibility study draft guidance. The
essential elements announced in the
early feasibility study draft guidance
are:
• FDA may approve an IDE
application for an early feasibility study,
including certain first in human studies,
based on less nonclinical data than
would be expected for a traditional
feasibility or a pivotal study. This is
because early feasibility studies are only
appropriate where additional
nonclinical testing is not available or
adequate to provide the information
needed to advance the developmental
process. Identification of the data
necessary to support an early feasibility
study should be based on a thorough
device evaluation strategy that describes
the device and procedure-related
attributes and addresses the potential
failure modes. Appropriate human
subject protection measures and risk
mitigation strategies must also be
identified. This policy is intended to
facilitate initiation of clinical studies in
the United States earlier in the device
development process than has
historically occurred, when appropriate.
• New approaches that facilitate
timely device and clinical protocol
modifications during an early feasibility
study while still requiring compliance
with the IDE regulations in 21 CFR part
812.
FDA has provided additional
information regarding its expectations
for early feasibility study IDE
applications in the early feasibility
study draft guidance.
D. Duration of the Pilot
FDA intends to accept requests for
participation in the pilot program for
180 days from the date of publication of
this notice. FDA may decide to
terminate the pilot program before the
close of the 180-day period or extend
the pilot program beyond the 180-day
period. The decision to terminate or
extend the pilot will be announced in
the Federal Register. FDA may also
decide to modify the pilot program
while it is in effect. Any modifications
will also be announced in the Federal
Register. FDA intends to terminate the
pilot program when the early feasibility
study draft guidance is finalized.
E. Evaluation
FDA intends to use the experience
gained from the pilot program to inform
the final version of the early feasibility
study draft guidance.
VerDate Mar<15>2010
16:38 Nov 09, 2011
Jkt 226001
Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29116 Filed 11–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
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 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
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Life after Linkage: The Future of Family
Studies.
Date: December 1–2, 2011.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn, 7301 Waverly
Street, Bethesda, MD 20814.
Contact Person: YingYing Li-Smerin, MD,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924. (301) 435–0277.
lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
COPD Case Finding Methodology.
Date: December 1, 2011.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Wardman Park Washington
DC Hotel, 2660 Woodley Road NW.,
Washington, DC 20008.
Contact Person: Stephanie J Webb, Ph.D.,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196,
Bethesda, MD 20892. (301) 435–0291.
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
PPG Review: Endothelium and
cardiovascular function.
Date: December 2, 2011.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Place: Hyatt Regency Crystal City, 2799
Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Tony L Creazzo, Ph.D.,
Scientific Review Officer.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–29142 Filed 11–9–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 Cancer
Institute Special Emphasis Panel, Small
Grants Program for Cancer Epidemiology.
Date: November 17–18, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Boulevard, Room 8059,
Bethesda, MD 20892–8329, (301) 496–7904,
decluej@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
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[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Page 70154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29142]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meetings
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
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 applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel, Life after Linkage: The Future of Family
Studies.
Date: December 1-2, 2011.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD
20814.
Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD
20892-7924. (301) 435-0277. lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel, COPD Case Finding Methodology.
Date: December 1, 2011.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: Marriott Wardman Park Washington DC Hotel, 2660 Woodley
Road NW., Washington, DC 20008.
Contact Person: Stephanie J Webb, Ph.D., Scientific Review
Officer, Review Branch/DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892.
(301) 435-0291. stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel, PPG Review: Endothelium and cardiovascular
function.
Date: December 2, 2011.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Crystal City, 2799 Jefferson Davis Highway,
Arlington, VA 22202.
Contact Person: Tony L Creazzo, Ph.D., Scientific Review
Officer.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: November 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-29142 Filed 11-9-11; 8:45 am]
BILLING CODE 4140-01-P
