[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Page 33432]
From the Federal Register Online via the Government Publishing 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.

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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: [email protected].

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 [email protected] 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 http://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