Frequently Asked Questions Concerning the Pediatric Device Grant Program

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. 

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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 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 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 current annual budget for funding grants is $2 million to be awarded on a competitive basis between one to four awards. Grants will be awarded up to $2,000,000 in total (direct plus indirect) costs per year for up to 2 years. Future year amounts will depend on annual appropriations. It is anticipated that funding for the number of non-competing continuation awards in FY 2010 will be similar to FY 2009. When are applications due? Applications must be post-marked on or before the application receipt date of June 15, 2009.

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When will funds become available to successful applicants? 

Mid-to-late September, 2009. Applicants will be made aware of their scores and outcome by September 30, 2009.

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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. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether the proposed study will provide acceptable data that could contribute to product approval. 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? 

Applications will be judged equally on both: 1) The Consortium’s Organization/Capability to Develop Pediatric Devices and; 2) Likelihood of Success of the Consortium’s Proposed Device Development Projects. 

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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 Camille Peake, Office of Acquisitions & Grant Services, 5630 Fishers Lane (HFA-500), rm. 2139, Rockville, MD 20857, 301-827-7175, e-mail: camille.peake@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 or Debra Lewis, Office of Orphan Products Development, Food and Drug Administration (HF-35), rm. 6A-55, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3666, e-mail: Linda.Ulrich@fda.hhs.gov or Debra.Lewis@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 http://grants.nih.gov/grants/forms.htm. 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 CCR (Central Contractor Registration) These steps can be found at http://www.grants.gov/applicants/get_registered.jsp