Meetings: Pediatric Medical Device Stakeholders Workshop

Federal Register: June 12, 2008 (Volume 73, Number 114)

Notices

Page 33432

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr12jn08-68

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 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