[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3145-3146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0611]


Pediatric Device Consortia Grant Program (P50)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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,

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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.
[FR Doc. 2011-997 Filed 1-18-11; 8:45 am]
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