2011-8513. Supplemental Funding Under the Food and Drug Administration 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 supplemental grant funds for the Pediatric Device Consortia Grant Program. The goal of this announcement is to allow an existing active grantee to compete for further funds listed under RFA-FD-11-002.

DATES:

Important dates are as follows:

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

2. The anticipated start date is in September 2011.

3. The opening date is April 11, 2011.

4. The expiration date is May 3, 2011.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Linda C. Ulrich, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993-0002, 301-796-8686. e-mail: [e-mail]; or Vieda Hubbard, Office of Acquisitions & Grants Service (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm.1079, Rockville, MD 20857, 301-827-7177, FAX: [phone], e-mail: [e-mail].

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/​rfa-files/​RFA-FD-11-002.html.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-11-025; 93.103

The purpose of this Federal Register notice is to allow an existing grantee to compete to receive a competitive supplement under a previous funding opportunity announcement.

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) legislation, Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSI Act). Section 305 of the PMDSI Act 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, postmarketing needs, and other activities.

C. Eligibility Information

This supplement is only available to a current, existing, ongoing grant recipient.

II. Award Information/Funds Available

A. Award Amount

The maximum amount of this supplement would be $1,000,000 in total cost (direct costs plus indirect costs) per year.

B. Length of Support

The supplement may 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, the applicant should first review the full announcement located at http://grants.nih.gov/​grants/​guide/​rfa-files/​RFA-FD-11-002.html. (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/​guide/​rfa-files/​RFA-FD-11-002.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. 1079, Rockville, MD 20857, 301-827-7177.

Dated: April 6, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.