[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19998-19999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0012]
Supplemental Funding Under the Food and Drug Administration
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 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: [email protected];
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: 301-827-7039, e-mail:
[email protected].
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
[[Page 19999]]
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.
[FR Doc. 2011-8513 Filed 4-8-11; 8:45 am]
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