Document ID: FDA-2011-N-0012-0003
Agency: fda
Document Type: Notice
Title: Supplemental Funding Under the Pediatric Device Consortia Grant Program
Posted Date: 2011-04-11T04:00Z

[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19998-19999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8513]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: Linda.Ulrich@fda.hhs.gov; 
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: 
Vieda.Hubbard@fda.hhs.gov.
    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]
BILLING CODE 4160-01-P