The synopsis for this grant opportunity is detailed below, following
this paragraph. This synopsis contains all of the updates to this
document that have been posted as of
05/07/2009
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updates have been made to the opportunity synopsis, update information
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Document Type:
Grants Notice
Funding Opportunity Number:
RFA-FD-09-007
Opportunity Category:
Discretionary
Posted Date:
May 07, 2009
Creation Date:
May 07, 2009
Original Closing Date for Applications:
Jun 15, 2009
Current Closing Date for Applications:
Jun 15, 2009
Archive Date:
Jul 15, 2009
Funding Instrument Type:
Grant
Category of Funding Activity:
Education
Food and Nutrition
Health
Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards:
4
Estimated Total Program Funding:
$2,000,000
Award Ceiling:
$2,000,000
Award Floor:
$2,000,000
CFDA Number(s):
93.103
--
Food and Drug Administration_Research
Cost Sharing or Matching Requirement:
No
Eligible Applicants
State governments
County governments
City or township governments
Special district governments
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility:
Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Indian/Native American Tribal Governments (Federally Recognized),
Indian/Native American Tribally Designated Organizations, City or Township Governments
Special District Governments, U.S. Territory or Possession, Indian/Native American Tribal Governments (Other than Federally Recognized), Regional Organizations
Other(s):
Eligible Agencies of the Federal Government, other than Health and Human Services
Agency Name
Food & Drug Administration
Description
Purpose
The development of pediatric medical devices currently lags five to ten years behind the development of devices for adults. Children differ from adults in terms of their size, growth, development, and body chemistry, adding to the challenges of pediatric device development. There currently exists a great need for medical devices designed specifically with children in mind. Such needs include the original development of pediatric medical devices, as well as the specific adaptation of existing adult devices for children. Thus, as part of the 2007 FDAAA legislation, Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007. Section 305 of this Act requires the Secretary to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development.
The FDA definition of “pediatric” devices, for purposes of device development, refers to devices intended to be used for patients who are 21 years of age or younger at time of diagnosis or treatment. The FDA’s Center for Devices and Radiologic Health defines “pediatric use” as any use of a medical device in a pediatric population in which there is a primary pediatric indication OR a more general indication where significant pediatric application is anticipated.
Research Objectives
The goal of FDA's Pediatric Device Consortia Grant Program is to support nonprofit consortia in stimulating projects which will promote pediatric device development. The consortia will facilitate the development, production, and distribution of pediatric medical devices by
1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
3) connecting innovators and physicians to existing Federal and non-Federal resources;
4) assessing the scientific and medical merit of proposed pediatric device projects; and
5) providing assistance and advice as needed on business development, personnel training, prototype development, and post-marketing needs.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
