Opportunity ID: 47243
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-007 |
| Funding Opportunity Title: | Pediatric Device Consortia Grant Program (P50) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| 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 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 07, 2009 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 15, 2009 |
| Current Closing Date for Applications: | Jun 15, 2009 |
| Archive Date: | Jul 15, 2009 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $2,000,000 |
| Award Floor: | $2,000,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education City or township governments Native American tribal governments (Federally recognized) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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): |
Additional Information
| Agency Name: | Food and 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 FDAs 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. |
| Link to Additional Information: | NIH Guide for Grants & Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
FDA – Electronic Integration Liaison Phone: 301-827-7162 Email:marc.pitts@fda.hhs.gov |
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