National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 41916 [E9-19877]
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41916
Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19879 Filed 8–18–09; 8:45 am]
[Docket No. FDA–2009–N–0664]
Food and Drug Administration
Methodologies for Post-Approval
Studies of Medical Devices; Public
Workshop
AGENCY:
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Food and Drug Administration,
HHS.
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
jlentini on DSKJ8SOYB1PROD with NOTICES
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
Allergy and Infectious Diseases Special
Emphasis Panel, Clinical Trials and Planning
Grants.
Date: September 9, 2009.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge 6700, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference
Call).
Contact Person: Brenda Lange-Gustafson,
PhD, Scientific Review Officer, NIAID/NIH/
DHHS, Scientific Review Program, Room
3122, 6700–B Rockledge Drive, MSC–7616,
Bethesda, MD 20892–7616, 301–451–3684,
bgustafson@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19877 Filed 8–18–09; 8:45 am]
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Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled
‘‘Methodologies for Post-Approval
Studies of Medical Devices.’’ The
purpose of the workshop is to facilitate
discussion among FDA, industry,
academia, professional societies,
clinical investigators and other
interested parties on issues related to
methodologies for post-approval studies
of medical devices. The target audiences
for this workshop are Epidemiologists,
Statisticians, Clinicians and Regulatory
Affairs Specialists.
Dates and Times: The workshop will
be held on September 9, 2009, from 9
a.m. to 5 p.m. and September 10, 2009,
from 9 a.m. to 5 p.m. Participants are
encouraged to arrive early to ensure
time for parking and security screening
before the meeting. Security screening
will begin at 8 a.m., and registration will
begin at 8:30 a.m. Please pre-register for
the workshop by following the
instructions in this document.
Location: The workshop will be held
at the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD
20993.
˜
Contact Persons: Daniel Canos, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., WO66/Room
4120, Silver Spring, MD 20993, 240–
796–6057, daniel.canos@fda.hhs.gov ; or
Ellen Pinnow, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., WO66/Room 4106, Silver Spring,
MD 20993, 301–796–6066,
ellen.pinnow@fda.hhs.gov
Registration: To register for the
conference please visit the following
Web site: https://medsun2.S-3.net/
FDAPASWkshpSep09. There is no fee to
attend the workshop, but attendees must
register in advance. The registration
process will be handled by Social and
Scientific Systems, which has extensive
experience in planning, executing, and
organizing educational meetings.
Although the facility is spacious,
registration will be on a first-come, firstserved basis. In-person attendance is
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limited to 120 participants. You may
also register to attend the meeting via
webcast. Non-U.S. citizens are subject to
additional security screening, and they
should register as soon as possible. If
you need special accommodations
because of a disability, please contact
˜
Daniel Canos (see Contact Persons) at
least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public
Workshop?
The purpose of the public workshop
is to facilitate discussion among FDA
and other interested parties on
methodological issues related to PostApproval Studies for medical devices.
II. What Are the Topics We Intend To
Address at the Public Workshop?
We hope to discuss a large number of
issues at the workshop, including, but
not limited to:
• Regulatory requirements for
conducting Post-Approval Studies for
medical devices;
• Using existing infrastructure (e.g.,
registries) to facilitate Post-Approval
Studies;
• Using innovative study design
strategies and advanced epidemiologic
methods to enhance and facilitate PostApproval Studies;
• Review important measurement
considerations inherent to PostApproval Studies;
• Clinical research organizations,
industry, academia, and other clinical
trial consultant’s perspectives on all of
the previous issues related to PostApproval Study methodologies for
medical devices.
III. Where Can I Find Out More About
This Public Workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.fda.gov/cdrh/
meetings.html.
Dated: August 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. 09–19904 Filed 8–18–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 159 (Wednesday, August 19, 2009)]
[Notices]
[Page 41916]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19877]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 Allergy and Infectious
Diseases Special Emphasis Panel, Clinical Trials and Planning
Grants.
Date: September 9, 2009.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge 6700, 6700B
Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Brenda Lange-Gustafson, PhD, Scientific Review
Officer, NIAID/NIH/DHHS, Scientific Review Program, Room 3122, 6700-
B Rockledge Drive, MSC-7616, Bethesda, MD 20892-7616, 301-451-3684,
bgustafson@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: August 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-19877 Filed 8-18-09; 8:45 am]
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