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The FDA’s Office of Orphan Products Development is offering the Pediatric Device Consortia Grant Program (P50) to nonprofit consortia aiming to enhance the creation, manufacturing, and dissemination of medical devices for pediatric use. This grant supports entities that provide guidance and assistance to developers of children’s medical devices, including business consultation, regulatory advice, and device testing services. The program focuses on advancing multiple pediatric devices and welcomes collaborations with for-profit partners. While managed by the Office of Orphan Products Development, the grant covers devices for all pediatric conditions, not solely rare diseases. Open to patients under 21 years old, this program aims to benefit neonates, infants, children, and adolescents.
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Opportunity ID: 227517
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-FD-13-010 |
| Funding Opportunity Title:: | Pediatric Device Consortia Grant Program (P50) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Agriculture |
| Category Explanation:: | |
| Expected Number of Awards:: | 5 |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 3 |
| Posted Date:: | Mar 19, 2013 |
| Last Updated Date:: | Mar 19, 2013 |
| Original Closing Date for Applications:: | Jun 02, 2013 |
| Current Closing Date for Applications:: | Jun 02, 2013 |
| Archive Date:: | Jul 02, 2013 |
| Estimated Total Program Funding:: | $ 3,000,000 |
| Award Ceiling:: | $750,000 |
| Award Floor:: | $250,000 |
Eligibility
| Eligible Applicants:: | Private institutions of higher education |
| Additional Information on Eligibility:: | The following types of Higher Education Institutions are encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
Hispanic-serving Institutions Eligible Agencies of the Federal Government, other than Health and Human Services |
Additional Information
| Agency Name:: | Food and Drug Administration |
| Description:: | This FOA, issued by FDA, Office of Orphan Products Development, Pediatric Devices Consortia, solicits grant applications from nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. While the pediatric device consortia are non-profit entities, their contacts and membership can include for-profit partners. FDA will provide grants to consortia which provide expert advising and support services to innovators of children’s devices. These services should include business and regulatory consulting, as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment. |
| Link to Additional Information:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 3 | Updated program total funding. | Mar 19, 2013 |
| Synopsis 2 | Correct opportunity title. | |
| Synopsis 1 |
Package Status
Package No: 1
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