[Federal Register Volume 74, Number 84 (Monday, May 4, 2009)]
[Notices]
[Pages 20488-20489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0199]


Pediatric Device Consortia Grant Program

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 
(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,

[[Page 20489]]

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.
[FR Doc. E9-10329 Filed 5-1-09; 8:45 am]
BILLING CODE 4160-01-S