Opportunity Information: Apply for RFA FD 09 007
Apply for RFA FD 09 007
- The Food Drug Administration in the education food and nutrition health science and technology and other research and development sector is offering a public funding opportunity titled "Pediatric Device Consortia Grant Program (P50)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on May 7, 2009 and posted on May 7, 2009.
- Applicants must submit their applications by Jun 15, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) State governments Special district governments Private institutions of higher education City or township governments Others (see text field entitled Additional Information on Eligibility for clarification).
- Hispanic serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribally Designated Organizations, City or Township Governments Special District Governments, U.S. Territory or Possession, Indian/Native American Tribal Governments (Other than Federally Recognized), Regional Organizations Other(s) Eligible Agencies of the Federal Government, other than Health and Human Services
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Opportunity Summary:
The Pediatric Device Consortia Grant Program (P50) is an FDA funding opportunity created to speed up the development of medical devices designed for children, an area that historically trails adult device development by roughly five to ten years. That gap exists largely because children are not simply smaller adults: their bodies change as they grow, their anatomy and physiology differ by age, and their metabolism and body chemistry can affect how devices perform and how safe they are. As a result, many pediatric needs remain unmet, both for entirely new child-focused devices and for thoughtful, evidence-based adaptations of devices originally built for adults. This program stems from the Pediatric Medical Device Safety and Improvement Act of 2007 (passed under the FDA Amendments Act of 2007), which directed the federal government to provide demonstration grants or contracts to nonprofit consortia specifically to promote pediatric device development. For this program, the FDA considers a pediatric device to be one intended for patients 21 years old or younger at the time of diagnosis or treatment, and the FDA Center for Devices and Radiologic Health uses a broad idea of "pediatric use" that includes devices with a primary pediatric indication as well as devices with general indications where substantial pediatric use is expected.
At its core, the program funds nonprofit consortia that act as practical, hands-on hubs for pediatric device innovation. Rather than focusing on a single research project, these consortia are expected to create a pipeline that helps good ideas move toward real products that can be manufactured, distributed, and ultimately used in clinical care. The FDA describes several key functions these consortia should provide: they should encourage innovation by finding and supporting promising pediatric device concepts and connecting qualified inventors with potential manufacturers; mentor and manage device projects across the development lifecycle (from identifying the product need through prototype design, device development, and marketing planning); link innovators and clinicians to existing federal and non-federal resources that can help advance a device; evaluate proposed projects for scientific and medical merit so effort is focused on ideas with real clinical value; and offer targeted support on business development issues such as training personnel, refining prototypes, and planning for post-marketing needs once a device is in use. In practice, the program is designed to reduce common barriers in pediatric device work, such as limited commercial incentives, small and fragmented patient populations, engineering challenges tied to growth and sizing, and the complexity of translating early prototypes into products that meet regulatory, clinical, and market realities.
Administratively, this opportunity is a discretionary grant with the funding instrument type listed as a grant and a P50-style consortium structure. It is associated with CFDA number 93.103 (Food and Drug Administration). The opportunity number is RFA-FD-09-007, posted May 7, 2009, with an original and current closing date of June 15, 2009, and an archive date of July 15, 2009. The announcement anticipated four awards and listed an estimated total funding amount of $2,000,000. The award ceiling and floor are both shown as $2,000,000, indicating the published funding table for this posting emphasizes a fixed figure, although the presence of multiple expected awards suggests the detailed announcement would clarify how funding is distributed across awardees. There is no cost-sharing or matching requirement specified.
Eligibility is broad and includes many public and nonprofit entities that could anchor or participate in a consortium. Eligible applicants listed include state and local governments (including city or township governments, counties, special districts), federally recognized and other tribal governments and tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, public housing authorities/Indian housing authorities, and nonprofits both with and without 501(c)(3) status (with the noted category exclusions tied to institutions of higher education). The eligibility notes also explicitly call out minority-serving and specialized institutions such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, and U.S. territories or possessions, along with regional organizations and certain eligible federal agencies outside HHS as described in the full text.
Overall, the Pediatric Device Consortia Grant Program is structured to build durable capacity, not just fund isolated studies. It supports organized networks that can scout needs, evaluate ideas, mentor innovators, connect to manufacturers and resources, and guide pediatric device concepts through the messy middle steps between invention and real-world adoption. For applicants, the core expectation is a consortium that can demonstrate it will actively stimulate and manage a portfolio of pediatric device efforts and measurably improve the chances that pediatric-focused technologies move from concept to commercially viable, clinically relevant devices. For access issues or questions about the full announcement, the listed contact for this opportunity is Marc Pitts at the FDA (301-827-7162, marc.pitts@fda.hhs.gov).
Frequently Asked Questions (FAQs): Pediatric Device Consortia Grant Program (P50)
What is the Pediatric Device Consortia Grant Program (P50)?
The Pediatric Device Consortia Grant Program (P50) is an FDA funding opportunity designed to speed up the development of medical devices intended for children. The program supports nonprofit consortia that serve as hands-on hubs for pediatric device innovation, helping move strong device ideas toward real products that can ultimately be manufactured, distributed, and used in clinical care.
Why does the FDA fund pediatric device development through this program?
Pediatric device development has historically lagged adult device development by roughly five to ten years. A major reason is that children are not simply smaller adults: their bodies change as they grow, anatomy and physiology vary by age, and differences in metabolism and body chemistry can affect device performance and safety. This program is intended to reduce that gap and help address unmet pediatric needs, including new child-focused devices and evidence-based adaptations of devices initially built for adults.
What law or authority created this grant program?
This program stems from the Pediatric Medical Device Safety and Improvement Act of 2007, which was passed under the FDA Amendments Act of 2007. That law directed the federal government to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development.
How does the FDA define a "pediatric device" for this opportunity?
For this program, the FDA considers a pediatric device to be one intended for patients 21 years old or younger at the time of diagnosis or treatment.
What does the FDA mean by "pediatric use" in this context?
The FDA Center for Devices and Radiologic Health uses a broad concept of "pediatric use." It includes devices with a primary pediatric indication as well as devices with more general indications where substantial pediatric use is expected.
Does this grant fund a single research project or something broader?
This opportunity is structured to fund consortia rather than a single research project. The expectation is that the funded consortium builds and runs a pipeline that identifies needs, supports innovation, and actively manages multiple pediatric device efforts toward real-world products.
What is a "consortium" expected to do under this program?
The FDA describes consortia as practical, hands-on hubs for pediatric device innovation. They are expected to create a pipeline to help good ideas move toward commercially viable, clinically relevant devices that can be manufactured and distributed.
What specific functions should a funded pediatric device consortium provide?
Based on the opportunity description, key functions include:
- Encouraging innovation by finding and supporting promising pediatric device concepts and connecting qualified inventors with potential manufacturers.
- Mentoring and managing device projects across the development lifecycle, from identifying the product need through prototype design, device development, and marketing planning.
- Linking innovators and clinicians to existing federal and non-federal resources that can help advance a device.
- Evaluating proposed projects for scientific and medical merit to focus effort on ideas with real clinical value.
- Providing targeted business development support, such as training personnel, refining prototypes, and planning for post-marketing needs once a device is in use.
What barriers in pediatric device development is the program trying to reduce?
The program is designed to address common barriers including limited commercial incentives, small and fragmented patient populations, engineering challenges tied to growth and sizing, and the difficulty of translating early prototypes into products that meet regulatory, clinical, and market realities.
What type of funding opportunity is this (grant vs. contract, discretionary vs. mandatory)?
This opportunity is described as a discretionary grant. The funding instrument type is a grant, and it uses a P50-style consortium structure.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.103 (Food and Drug Administration).
What is the opportunity number?
The opportunity number is RFA-FD-09-007.
When was the opportunity posted?
The posting date listed is May 7, 2009.
What is the closing date for applications?
The original and current closing date listed is June 15, 2009.
Is there an archive date for the announcement?
Yes. The archive date listed is July 15, 2009.
How many awards were anticipated?
The announcement anticipated four awards.
What was the estimated total funding amount?
The estimated total funding amount listed is $2,000,000.
What are the award floor and award ceiling?
The award ceiling and award floor are both shown as $2,000,000 in the published funding table for this posting.
How can the award be $2,000,000 if there are multiple anticipated awards?
The posting shows both the ceiling and floor as $2,000,000 while also anticipating four awards, which suggests the detailed announcement would clarify how funding is distributed among awardees. The information provided indicates a fixed figure in the table but also indicates multiple expected awards.
Is cost sharing or matching required?
No cost-sharing or matching requirement is specified in the information provided.
Who is eligible to apply?
Eligibility is broad and includes many public and nonprofit entities that could anchor or participate in a consortium. Eligible applicants listed include state and local governments (including city or township governments, counties, and special districts), federally recognized tribal governments and other tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, public housing authorities/Indian housing authorities, and nonprofits with or without 501(c)(3) status (with noted category exclusions tied to institutions of higher education).
Are minority-serving and specialized institutions included in the eligibility list?
Yes. Eligibility notes explicitly call out Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, and U.S. territories or possessions.
Does the eligibility description include regional organizations or federal agencies?
Yes. The eligibility notes mention regional organizations and certain eligible federal agencies outside HHS as described in the full text.
What is the main goal for applicants applying to this opportunity?
The core expectation is a consortium that can demonstrate it will actively stimulate and manage a portfolio of pediatric device efforts and measurably improve the chances that pediatric-focused technologies move from concept to commercially viable, clinically relevant devices.
What kinds of device activities does the consortium support across the lifecycle?
The consortium is expected to support activities from identifying product needs, through prototype design and device development, to marketing planning, along with business development support such as refining prototypes, training personnel, and planning for post-marketing needs once devices are in use.
Who can be contacted for access issues or questions about the full announcement?
The listed contact is Marc Pitts at the FDA. Phone: 301-827-7162. Email: marc.pitts@fda.hhs.gov.
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