E9-10329. Pediatric Device Consortia Grant Program

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 (PDCGP). The goal of the PDCGP 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. Although administered by the OOPD, 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 June 15, 2009.

2. The anticipated start date is September 2009.

3. The opening date is May 1, 2009.

4. The expiration date is June 16, 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Linda C. Ulrich or Debra Y. Lewis, Pediatric Device Consortia Grants Program, Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6A-55, Rockville, MD 20857, 301-827-3666.

Camille Peake, Division of Acquisition Support and Grants, Office of Acquisitions & Grant Services (HFA-500), 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 located at http://grants.nih.gov/​grants/​guide/​index.html.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-009-007

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 2007 Food and Drug Administration Amendments Act (FDAAA) legislation, 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 PDCGP 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

The estimated amount of funds available for support of 1 to 4 consortia awarded as a result of this announcement is $2 million for fiscal year 2009. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of FDA provide support for this program, awards under this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

B. Length of Support

Grants will be awarded on a competitive basis up to $2,000,000 in total costs (direct costs plus indirect costs) per year for up to 2 years.

III. How to Submit a Paper Application

To submit a paper application in response to this FOA, applicants should first review the full announcement located at http://grants.nih.gov/​grants/​guide/​index.html. Persons interested in applying for a grant may obtain an application at http://grants.nih.gov/​grants/​forms.htm. 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

These steps can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. Submit paper applications by express mail to Camille Peake. (See the FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT section.)

Dated: April 29, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.