Implementation of Post-Approval Studies for Medical Devices; Public Workshop, 20960 [E9-10426]
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20960
Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
interested in collaborative research
directed toward molecular strategies for
vaccine and antiviral development, and
animal models of viral hepatitis C. For
more information, please contact Dr. T.
Jake Liang at 301–496–1721,
jliang@nih.gov, or Ms. Patricia Lake at
301–594–6762, lakep@mail.nih.gov.
Dated: April 29, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–10410 Filed 5–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 issues
related to the conduct of Post-Approval
Studies for medical devices.
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Implementation of Post-Approval
Studies for Medical Devices; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Implementation of PostApproval Studies for Medical Devices.’’
The purpose of the workshop is to
facilitate discussion among FDA and
other interested parties on issues related
to the implementation of Post-Approval
Studies for medical devices.
Date and Time: The workshop will be
held on June 4, 2009, from 9 a.m. to 5
p.m. and June 5, 2009, from 9 a.m. to 12
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 by May 28,
2009, using 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: Ellen Pinnow,
Center for Devices and Radiological
Health (HFZ–541), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 240–276–2373, email: ellen.pinnow@fda.hhs.gov; or
Daniel Canos, Center for Devices and
Radiological Health (HFZ–450), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
2369, daniel.canos@fda.hhs.gov.
Registration: E-mail your name, title,
organization affiliation, address, and email contact information to Stephanie
VerDate Nov<24>2008
18:36 May 05, 2009
Jkt 217001
Zafonte at SZafonte@s-3.com. 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 firstcome, first-served basis. 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
Ellen Pinnow (see Contact Persons) at
least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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.
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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Unsolicited Multi-Project
Application.
Date: May 22, 2009.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
(Telephone Conference Call).
Contact Person: Peter R Jackson, Ph.D.,
Scientific Review Administrator, Scientific
Review Program, Division of Extramural
Activities, NIH/NIAID/DHHS, 6700–B
Rockledge Drive, MSC 7616 Room 2220,
Bethesda, MD 20892–7616. 301–496–2550.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Ancillary Studies in
Immunomodulation Clinical Trials.
Date: May 29, 2009.
Time: 2 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Paul A. Amstad, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616. 301–
402–7098. pamstad@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: April 29, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E9–10426 Filed 5–5–09; 8:45 am]
Dated: April 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–10422 Filed 5–5–09; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4140–01–P
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
implementing a Post-Approval Study for
medical devices;
• Challenges and successful strategies
for the recruitment of participants for
Post-Approval Studies;
• Challenges and successful strategies
for the retention and compliance with
follow-up requirements of participants
for Post-Approval Studies;
• Using existing infrastructure (e.g.,
national registries) to facilitate PostApproval Studies; Using innovative
strategies to facilitate Post-Approval
Studies;
• Clinical research organizations,
industry, academia, and other clinical
trial consultant’s perspectives on all of
the previous issues related to
implementing Post-Approval Studies for
medical devices.
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]]>Agencies
[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Page 20960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Implementation of Post-Approval Studies for Medical Devices;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Implementation of Post-Approval Studies for Medical
Devices.'' The purpose of the workshop is to facilitate discussion
among FDA and other interested parties on issues related to the
implementation of Post-Approval Studies for medical devices.
Date and Time: The workshop will be held on June 4, 2009, from 9
a.m. to 5 p.m. and June 5, 2009, from 9 a.m. to 12 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 by May 28,
2009, using 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: Ellen Pinnow, Center for Devices and Radiological
Health (HFZ-541), Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 240-276-2373, e-mail: ellen.pinnow@fda.hhs.gov; or
Daniel Canos, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850,
240-276-2369, daniel.canos@fda.hhs.gov.
Registration: E-mail your name, title, organization affiliation,
address, and e-mail contact information to Stephanie Zafonte at
3.com">SZafonte@s-3.com. 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, first-
served basis. 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 Ellen Pinnow (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 issues related to the conduct
of Post-Approval 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 implementing a Post-Approval
Study for medical devices;
Challenges and successful strategies for the recruitment
of participants for Post-Approval Studies;
Challenges and successful strategies for the retention and
compliance with follow-up requirements of participants for Post-
Approval Studies;
Using existing infrastructure (e.g., national registries)
to facilitate Post-Approval Studies; Using innovative strategies to
facilitate Post-Approval Studies;
Clinical research organizations, industry, academia, and
other clinical trial consultant's perspectives on all of the previous
issues related to implementing Post-Approval Studies 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: April 29, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-10426 Filed 5-5-09; 8:45 am]
BILLING CODE 4160-01-S
