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U.S. Department of Health and Human Services

For Industry

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Frequently Asked Questions Concerning the Pediatric Device Consortia (PDC) Grant Program

 

What is the Pediatric Device Consortia Grant Program? 
 
FDA will provide grants to consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children.  Although administered by the Office of Orphan Products Development (OOPD), this grant program is intended to encompass devices used in all pediatric diseases, not just rare diseases.
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Who may apply for a Pediatric Device Consortia (PDC) Grant?
 
The grants are available to any domestic, public or private, nonprofit entity, including State and local units of government. Federal agencies that are not part of the Department of Health and Human Services may also apply. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. Both non-academic and academic centers are encouraged to apply for this program. Eligibility is not limited to any particular sector.
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How can I learn more about the PDC Grant Program?
 
The Request for Applications (RFA) for the 2013 Grant Cycle awards due date is June 1, 2013. To view the RFA click here
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What defines Pediatric and Pediatric Use?
 
The FDA definition of “pediatric” for purposes of device development encompasses devices used for patients who are 21 years of age or younger at the 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 considerable pediatric application is anticipated.
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What are the Objectives of the PDC Grant Program?
 
The goal of the FDA’s PDC Grant Program is to support the development of a nonprofit consortia designed to stimulate 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.
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How much money is available for PDC Grant Program Grants?
 
The anticipated annual budget for funding new grants is $3.0 million for FY 2013.  The actual amount of funding will depend on annual appropriations.
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When are applications Due?
 
The 2013 receipt date for applications must be postmarked by June 1, 2013. 
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How are applications reviewed? 
 
Applications are first reviewed by the OOPD program staff for relevance and responsiveness to the Request for Applications (RFA). Responsive applications are reviewed and evaluated for merit by an ad hoc panel of independent experts. Responsive applications will be subject to a second review by the National Cancer Institute, National Cancer Advisory Board (NCAB) for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee. Rank ordered priority scores determine final awards.
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What are the criteria for review?
 
Criteria for review will be delineated in the published, 2013 PDC Grant Cycle RFA.
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Who can I contact for questions concerning the budget of my potential grant application?
 
Questions regarding financial aspects of a proposed application should be addressed to Vieda Hubbard, Office of Acquisitions & Grant Services, 5630 Fishers Lane (HFA-500), Room 2034, Rockville, MD 20857, 301-827-7177, e-mail: Vieda.Hubbard@fda.hhs.gov. 
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Who can I contact for questions regarding the research/clinical protocol sections of my potential grant application?
 
Scientific and Research questions should be addressed to Linda Ulrich, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Avenue (WO 32-5271), Silver Spring, MD 20993-0002, e-mail: Linda.Ulrich@fda.hhs.gov
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How and where do I submit my application?
 
All applications must be submitted in paper. Applications may be obtained at nih.gov/grants forms2.
 
For paper submissions the following steps are required: 
 
• Step 1: Obtain a DUNS Number (D&B Data Universal Numbering system Number, a universal identifier used when applying for federal grants.)
• Step 2: Register with the System for Award Management. Applicants must maintain an active registration, to be renewed at least annually: https://www.sam.gov/portal/public/SAM