[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20665-20666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]


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 (PDC) Grant 
Program. The goal of the PDC Grant Program is to facilitate the 
development, production, and distribution of pediatric medical devices. 
The PDC will provide grants to nonprofit consortia which provide expert 
advising and support services to innovators of pediatric devices. These 
services should include business and regulatory consulting as well as 
device testing capabilities. This program is intended to further the 
development of multiple pediatric devices; thus, grants are not awarded 
to support the development of a single device project.
    Although administered by the OOPD, this grant program is intended 
to encompass devices that could be used in all pediatric conditions and 
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 1, 2013.
    2. The anticipated start date is September, 2013.
    3. The opening date is May 1, 2013.
    4. The expiration date is June 2, 2013.

ADDRESSES: Submit the paper application to: Vieda Hubbard, Grants 
Management (HFA-500), 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT:

Linda C. Ulrich, Director, Pediatric Device Consortia Grants Program, 
Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002, 301-796-8660; or
Vieda Hubbard, Grants Management Specialist, Office of Acquisitions & 
Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 
2034, Rockville, MD 20857, 301-827-7177.

    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/ or http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-13-010
93.103

A. Background

    The development of pediatric medical devices currently lags behind 
the development of devices for adults. Pediatric patients often differ 
from adults in terms of their size, growth, development, body 
chemistry, and disease propensity, adding to the challenges of 
pediatric device development. There currently exists a great need for 
pediatric medical devices, including devices designed originally for 
pediatric patients as well as existing adult devices adapted for 
pediatric use. Recent passage of the Food and Drug Administration 
Safety and Improvement Act (FDASIA) (Pub. L. 112-144) reauthorized 
support of section 305 of the Pediatric Medical Device Safety and 
Improvement Act of 2007 (Pub. L. 110-85), which requires HHS to provide 
demonstration grants to nonprofit consortia to promote pediatric device 
development. While the consortia themselves are nonprofit entities, 
their contacts and membership can include for-profit partners.

B. Research Objectives

    The Pediatric Device Consortia Grant Program aims to fund networks 
of pediatric medical device advisors who are able to provide a platform 
of experienced regulatory, business planning, and device development 
services (such as intellectual property advising; prototyping; 
engineering; laboratory and animal testing; grant writing; and clinical 
trial design) to help foster and guide the advancement of medical 
devices for pediatric patients. A successful PDC brings together 
individuals and institutions that can support pediatric medical device 
progression through all stages of development--concept formation, 
prototyping, preclinical, clinical, manufacturing, marketing, and 
commercialization. The consortia are expected to support a mix of 
projects at all stages of development, particularly the later stages of 
clinical, manufacturing, and marketing.

[[Page 20666]]

    Specifically, 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, and post-marketing needs.

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 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 four to five 
consortia awarded as a result of this announcement is $3 million for 
fiscal year 2013. 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 PDC financial 
plans include support for this program, awards pursuant to 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 $750,000 in 
total (direct plus indirect) costs per year for up to 5 years, 
contingent upon favorable annual review and an additional mid-cycle 
review after 2\1/2\ years of funding.

III. Paper Application, Registration, and Submission Information

    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/ or http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. (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/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 System for Award Management.
    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: Vieda Hubbard, Grants 
Management Specialist, Office of Acquisitions & Grant Services, 5630 
Fishers Lane, Rm. 2034, Rockville, MD 20857, phone: 301-827-7177.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07948 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P