Pediatric Medical Device Stakeholders Workshop, 33432 [E8-13278]
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33432
Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
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TIME AND DATE:
Dated: June 10, 2008.
Thomas K. Emswiler,
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Investment Board.
[FR Doc. 08–1353 Filed 6–10–08; 1:59 pm]
BILLING CODE 6760–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pediatric Medical Device Stakeholders
Workshop
Agency for Healthcare
Research and Quality (AHRQ); U.S.
Food and Drug Administration (FDA);
and National Institutes of Health (NIH).
ACTION: Notice.
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AGENCIES:
SUMMARY: The Interagency (AHRQ–
FDA–NIH) Pediatric Devices Working
Group is holding a workshop to gather
information about the development of
pediatric devices.
DATES: The workshop will be held on
July 23, 2008 from 8 a.m. until 5 p.m.
EDT.
ADDRESSES: The workshop will be held
in Natcher Auditorium, located in
Building 45, NIH Main Campus,
Bethesda, Maryland 20814.
FOR FURTHER INFORMATION CONTACT:
Steven Hirschfeld, MD, PhD, Associate
Director for Clinical Research, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
31 Center Drive, Room 2A03, Bethesda,
Maryland 20814; Tel: 301–496–3454;
Fax: 301–402–1104; E-mail:
hirschfs@mail.nih.gov.
In
September 2007, the Congress passed
Title III of the FDA Amendments Act,
called the Pediatric Medical Device
Safety and Improvement Act. The
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
legislation requires that the DHHS
Secretary submit a plan to Congress for
expanding pediatric medical device
research and development. In
developing the plan, the DHHS
Secretary shall consult with individuals
and organizations with appropriate
expertise in pediatric medical devices.
The plan shall include the current status
of federally funded pediatric medical
device research; any gaps in such
research, which may include a survey of
pediatric medical providers regarding
unmet pediatric medical device needs,
as needed; and a research agenda for
improving pediatric medical device
development and Food and Drug
Administration clearance or approval of
pediatric medical devices, and
evaluating the short- and long-term
safety and effectiveness of pediatric
medical devices.
This meeting of the Interagency
Pediatric Devices Working Group,
which includes AHRQ, FDA, and NIH,
seeks to elicit feedback about expanding
pediatric device research and
development from interested
communities and the public to help
inform the plan that the DHHS Secretary
will submit in accordance with the
legislation.
The purpose of this workshop is to:
• Inform the community of the
current status of pediatric device
development;
• Describe available mechanisms for
device product registration;
• Describe available mechanisms for
pediatric device project funding;
• Understand what stakeholders see
to be important areas of study;
• Determine gaps in knowledge and
where the needs for research are; and
• Discuss ways to gather the
information needed to move ahead,
such as overcoming barriers, handling
logistics, determining classes of devices
to study, and identifying available
databases, registries, surveillance
systems.
You are not required to preregister for
this meeting to attend. However,
preregistering allows you to receive
current information about the meeting,
its agenda, and other details (such as
how to prepare statements, participating
in working lunch sessions, etc.). To
register, please send an e-mail to
hirschfs@mail.nih.gov with ‘‘Device
Workshop Registration’’ in the subject
line. Please also include the following
information. (Note: Incomplete
information may limit the organizers’
ability to keep you informed about the
workshop; please provide accurate and
complete information):
• First and Last Name
• Degree (optional)
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
• Professional Title (optional)
• Organization and Department
• Type of Organization (e.g.,
government agency, non-profit hospital,
for-profit company, etc.)
• Address
• City, State, and ZIP Code
• Country
• Phone (Main contact number):
• Fax:
• E-mail:
The agenda; logistics; legislation;
background material and information;
and a link to the Request for Information
(RFI) issued for this topic can be found
at https://www.nichd.nih.gov/about/
meetings/2008/devices.cfm.
Duane Alexander,
Director, Eunice Kennedy Shriver Institute of
Child Health and Human Development,
National Institutes of Health.
[FR Doc. E8–13278 Filed 6–11–08; 8:45 am]
BILLING CODE 4140–01–P
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E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Page 33432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Pediatric Medical Device Stakeholders Workshop
AGENCIES: Agency for Healthcare Research and Quality (AHRQ); U.S. Food
and Drug Administration (FDA); and National Institutes of Health (NIH).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Interagency (AHRQ-FDA-NIH) Pediatric Devices Working Group
is holding a workshop to gather information about the development of
pediatric devices.
DATES: The workshop will be held on July 23, 2008 from 8 a.m. until 5
p.m. EDT.
ADDRESSES: The workshop will be held in Natcher Auditorium, located in
Building 45, NIH Main Campus, Bethesda, Maryland 20814.
FOR FURTHER INFORMATION CONTACT: Steven Hirschfeld, MD, PhD, Associate
Director for Clinical Research, Eunice Kennedy Shriver National
Institute of Child Health and Human Development, 31 Center Drive, Room
2A03, Bethesda, Maryland 20814; Tel: 301-496-3454; Fax: 301-402-1104;
E-mail: hirschfs@mail.nih.gov.
SUPPLEMENTARY INFORMATION: In September 2007, the Congress passed Title
III of the FDA Amendments Act, called the Pediatric Medical Device
Safety and Improvement Act. The legislation requires that the DHHS
Secretary submit a plan to Congress for expanding pediatric medical
device research and development. In developing the plan, the DHHS
Secretary shall consult with individuals and organizations with
appropriate expertise in pediatric medical devices. The plan shall
include the current status of federally funded pediatric medical device
research; any gaps in such research, which may include a survey of
pediatric medical providers regarding unmet pediatric medical device
needs, as needed; and a research agenda for improving pediatric medical
device development and Food and Drug Administration clearance or
approval of pediatric medical devices, and evaluating the short- and
long-term safety and effectiveness of pediatric medical devices.
This meeting of the Interagency Pediatric Devices Working Group,
which includes AHRQ, FDA, and NIH, seeks to elicit feedback about
expanding pediatric device research and development from interested
communities and the public to help inform the plan that the DHHS
Secretary will submit in accordance with the legislation.
The purpose of this workshop is to:
Inform the community of the current status of pediatric
device development;
Describe available mechanisms for device product
registration;
Describe available mechanisms for pediatric device project
funding;
Understand what stakeholders see to be important areas of
study;
Determine gaps in knowledge and where the needs for
research are; and
Discuss ways to gather the information needed to move
ahead, such as overcoming barriers, handling logistics, determining
classes of devices to study, and identifying available databases,
registries, surveillance systems.
You are not required to preregister for this meeting to attend.
However, preregistering allows you to receive current information about
the meeting, its agenda, and other details (such as how to prepare
statements, participating in working lunch sessions, etc.). To
register, please send an e-mail to hirschfs@mail.nih.gov with ``Device
Workshop Registration'' in the subject line. Please also include the
following information. (Note: Incomplete information may limit the
organizers' ability to keep you informed about the workshop; please
provide accurate and complete information):
First and Last Name
Degree (optional)
Professional Title (optional)
Organization and Department
Type of Organization (e.g., government agency, non-profit
hospital, for-profit company, etc.)
Address
City, State, and ZIP Code
Country
Phone (Main contact number):
Fax:
E-mail:
The agenda; logistics; legislation; background material and
information; and a link to the Request for Information (RFI) issued for
this topic can be found at https://www.nichd.nih.gov/about/meetings/
2008/devices.cfm.
Duane Alexander,
Director, Eunice Kennedy Shriver Institute of Child Health and Human
Development, National Institutes of Health.
[FR Doc. E8-13278 Filed 6-11-08; 8:45 am]
BILLING CODE 4140-01-P
