2011-997. Pediatric Device Consortia Grant Program (P50)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program. The goal of the Pediatric Device Consortia Grant Program is to promote pediatric device development by providing grants to nonprofit 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. The program does not support the development of single device projects. 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 or 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.

DATES:

Important dates are as follows:

1. The application due date is May 2, 2011.

2. The anticipated start date is September, 2011.

3. The opening date is January 15, 2011.

4. The expiration date is May 3, 2011.

For Further Information and Additional Requirements Contact:

Linda C. Ulrich or Debra Y. Lewis, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 5271, Silver Spring, MD 20993-0002, 301-796-8660 or Camille Peake, Office of Acquisitions & Grant Services, Food and Drug Administration, 5630 Fishers Lane, rm. 2139, Rockville, MD 20852, 301-827-7175.

For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA when posted and located at: http://grants.nih.gov/​grants/​guide/​index.html.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-011-002.

Catalog of Federal Domestic Assistance Number: 93.103.

A. Background

The development of pediatric medical devices currently lags 5 to 10 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 Food and Drug Administration Amendments Act of 2007 (FDAAA), Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007. Section 305 of FDAAA requires the Secretary of Health and Human Services to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development.

B. Research Objectives

The goal of FDA's Pediatric Device Consortia Grant Program is to promote pediatric device development by providing grants to nonprofit consortia. 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, post-marketing needs, and other activities.

C. Eligibility Information

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 (HHS) may apply. Agencies that are part of HHS may not 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.

II. Award Information/Funds Available

A. Award Amount

Approximately $2.5 million will fund two to four new awards. Grants will be awarded up to $1,500,000 in total cost (direct costs plus indirect costs) per year.

B. Length of Support

Grants will be awarded on a competitive basis for up to 2 years.

III. Paper Application, Registration, and Submission Information

To submit a paper application in response to this FOA, applicants should first review the full announcement when posted and located at http://grants.nih.gov/​grants/​guide/​index.html. (The FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register). Persons interested in applying for a grant may obtain an application at http://grants.nih.gov/​grants/​funding/​phs398/​phs398.html. For all paper application submissions, the following steps are required:

• Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
• Step 2: Register With Central Contractor Registration.

Steps 1 and 2, in detail, can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. After you have followed these steps, submit paper applications to: Division of Acquisition Support and Grants, Office of Acquisition & Grant Services, 5630 Fishers Lane, rm. 2128, Rockville, MD 20857, 301-827-7175.

Dated: January 13, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.