[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[[Page 3146]]
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]
BILLING CODE 4160-01-P