[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