Opportunity Information: Apply for RFA FD 11 002
Apply for RFA FD 11 002
- The National Institutes of Health in the health 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 Jan 18, 2011 and posted on Jan 18, 2011.
- Applicants must submit their applications by May 2, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
- Eligible applicants include: County governments Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public housing authorities/Indian housing authorities State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments For profit organizations other than small businesses Small businesses Private 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 Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Pediatric Device Consortia Grant Program (P50) is a discretionary grant opportunity intended to strengthen and speed up the development pipeline for medical devices specifically designed for children. Issued by the FDA's Office of Orphan Products Development (OOPD), the program funds nonprofit consortia that can demonstrate a practical, sustainable model for helping pediatric devices move from concept and early development through the steps needed for eventual market approval. The emphasis is on building and operating a consortium that supports multiple pediatric device efforts rather than backing a single invention or one-off product.
A key point in this funding opportunity is that it is not limited to rare diseases even though it is administered by OOPD. Instead, it is meant to cover devices relevant to the full spectrum of pediatric conditions and diseases. The eligible patient population is broadly defined as neonates, infants, children, and adolescents, and it includes patients up to age 21 at the time of diagnosis or treatment. In other words, the program is focused on pediatric use cases generally, with the underlying goal of addressing the well-known gap where many devices are designed for adults and then adapted for children without being optimized for pediatric anatomy, physiology, safety needs, or clinical contexts.
The program is structured to fund consortia that can provide coordinated, real-world support to pediatric device innovators and developers. While the announcement does not list specific required services in the excerpt provided, the description makes clear that FDA is looking for a consortium approach that can "facilitate the development, production, and distribution" of devices and that will either directly result in, or meaningfully contribute to, eventual market approval. In practice, that framing signals interest in consortia that can offer capabilities such as needs identification, device concept vetting, engineering and prototyping support, clinical and regulatory strategy guidance, connections to pediatric clinical sites, and support for manufacturing scale-up and commercialization planning. The central evaluation question is whether the consortium's business model and operating approach are credible pathways to advancing multiple pediatric devices toward clearance or approval, rather than simply funding research activity without a clear route to patient access.
Funding for this opportunity was estimated at $2.5 million total. The funding instrument is a grant, and there is no cost sharing or matching requirement. The opportunity was posted on January 18, 2011, with an original and current closing date of May 2, 2011, and an archive date of June 2, 2011. It is associated with CFDA number 93.103 (Food and Drug Administration Research). The Funding Opportunity Number is RFA FD 11 002, and the title is Pediatric Device Consortia Grant Program (P50).
Eligibility is broad across many organization types, but the core description emphasizes applications from nonprofit consortia. The eligible applicant list includes state, county, city, township, special district governments, independent school districts, tribal governments and tribal organizations, U.S. territories or possessions, public housing authorities, regional organizations, private and public institutions of higher education, nonprofits with and without 501(c)(3) status (with certain distinctions), and also for-profit organizations including small businesses (with the caveat that the FOA text highlights nonprofit consortia as the intended applicant type). The eligibility section also explicitly calls out a range of institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations, indicating a wide-open posture toward who may participate in or lead a consortium as long as the consortium structure and mission align with the program purpose.
Administratively, the announcement is linked through the NIH grants system even though the program is FDA-led through OOPD, which is why the Agency Name field references the National Institutes of Health. The full announcement was available via the NIH grants guide link provided in the source, and the contact for technical issues accessing the announcement is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.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 a discretionary government grant opportunity intended to strengthen and speed up the development pipeline for medical devices specifically designed for children. It is focused on building and operating a consortium that can support multiple pediatric device efforts, rather than funding a single invention or one-off product.
Which federal office issues this funding opportunity?
The opportunity is issued by the FDA's Office of Orphan Products Development (OOPD). Even though it is FDA-led through OOPD, the announcement is linked through the NIH grants system, which is why the Agency Name field references the National Institutes of Health.
Is this grant only for devices related to rare diseases?
No. A key point is that the program is not limited to rare diseases even though it is administered by OOPD. It is intended to cover devices relevant to the full spectrum of pediatric conditions and diseases.
Who is considered part of the pediatric patient population for this program?
The eligible patient population is broadly defined as neonates, infants, children, and adolescents. It includes patients up to age 21 at the time of diagnosis or treatment.
What problem is this program trying to address?
The program targets the well-known gap where many medical devices are designed for adults and then adapted for children without being optimized for pediatric anatomy, physiology, safety needs, or pediatric clinical contexts.
What type of projects does the program prioritize?
The emphasis is on funding a practical, sustainable consortium model that helps pediatric devices move from concept and early development through the steps needed for eventual market approval. The consortium approach should support multiple pediatric device efforts rather than a single product.
Does the program fund research activity alone?
The description indicates FDA is looking for a credible pathway to advancing multiple pediatric devices toward clearance or approval, rather than supporting research activity without a clear route to patient access.
What kinds of support is a funded consortium expected to provide?
The excerpt does not list required services, but it does state that FDA is looking for a consortium approach that can "facilitate the development, production, and distribution" of devices and that will either directly result in, or meaningfully contribute to, eventual market approval. In practice, this framing signals interest in coordinated, real-world support for pediatric device innovators and developers.
Is the grant meant to support one pediatric device or multiple devices?
Multiple devices. The central purpose is to build and operate a consortium that supports multiple pediatric device efforts, not to back a single invention or one-off product.
What is the estimated total funding amount for this opportunity?
The total estimated funding for this opportunity was $2.5 million.
What is the funding instrument?
The funding instrument is a grant.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement stated for this opportunity.
What is the Funding Opportunity Number and title?
The Funding Opportunity Number is RFA FD 11 002. The title is Pediatric Device Consortia Grant Program (P50).
What is the CFDA number associated with this grant?
The opportunity is associated with CFDA number 93.103 (Food and Drug Administration Research).
When was the opportunity posted, and what were the key dates?
The opportunity was posted on January 18, 2011. The original and current closing date was May 2, 2011. The archive date was June 2, 2011.
Who is eligible to apply?
Eligibility is broad across many organization types, with an emphasis on nonprofit consortia. The eligible applicant list includes state, county, city, township, and special district governments; independent school districts; tribal governments and tribal organizations; U.S. territories or possessions; public housing authorities; regional organizations; private and public institutions of higher education; nonprofits with and without 501(c)(3) status (with certain distinctions); and for-profit organizations including small businesses. While many entity types are listed as eligible, the core description highlights nonprofit consortia as the intended applicant type.
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility section explicitly calls out institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations, indicating a wide-open posture toward who may participate in or lead a consortium as long as the consortium structure and mission align with the program purpose.
Does this opportunity require the applicant to be a consortium?
The program is described as funding nonprofit consortia and places emphasis on building and operating a consortium model that supports multiple pediatric device efforts. The intent described in the opportunity centers on a consortium approach.
Why does the announcement show an NIH connection if the program is FDA-led?
The announcement is linked through the NIH grants system even though the program is FDA-led through OOPD. This is why the Agency Name field references the National Institutes of Health.
Where was the full announcement available?
The full announcement was available via the NIH grants guide link referenced in the source information.
Who should be contacted for technical issues accessing the announcement?
For technical issues accessing the announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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