Opportunity Information: Apply for RFA TR 17 003
The Limited Competition for NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules (UG3/UH3) (RFA-TR-17-003) is a National Institutes of Health funding opportunity designed to speed up the discovery of new treatments for diseases and conditions that primarily affect children. Instead of starting from scratch with brand-new drug discovery, the program focuses on finding new pediatric uses for existing experimental drugs or biologics, referred to in the announcement as "Assets." These Assets come from pharmaceutical company partners, and applicants are expected to build a strong scientific case for why a given Asset could plausibly work in a specific pediatric disease, including evidence that changing or modulating the Asset's biological target is likely to improve the disease or condition.
A defining feature of this program is that it is limited competition and uses a staged application process. The first step is an X02 pre-application (linked as the entry point for both RFA-TR-17-002 and RFA-TR-17-003). These X02 submissions are reviewed by external experts, and only those judged to be both highly meritorious and aligned with NIH program priorities are invited to submit a full UG3/UH3 application under this FOA. In practice, this means applicants need to treat the pre-application as a serious down-selection step, where the clarity of the therapeutic hypothesis, the strength of the supporting biology, and the feasibility of the plan are critical to advancing.
The award mechanism is a cooperative agreement, which generally signals substantial NIH scientific or programmatic involvement during the life of the project compared with a standard grant. The funding is split into two phases. The first phase is the UG3, which supports key preparatory work needed before a pediatric clinical trial can responsibly begin. That includes developing and running rigorous preclinical efficacy studies and completing the planning activities required for a clinical trial. The second phase is the UH3, which may be awarded only if the UG3 phase meets clearly defined preclinical milestones. If those milestones are achieved, the project can transition into the UH3 phase to support the execution of clinical trials. This milestone-driven structure is meant to reduce risk, ensure readiness, and push only the best-supported concepts into pediatric testing.
The opportunity is broad in terms of disease scope as long as the focus is on pediatric populations, and it is also broad in the types of Assets considered, encompassing experimental drugs and biologics. Strong applications are expected to connect mechanistic rationale to disease impact: the proposal should not merely suggest a possible benefit, but should present credible evidence that the Asset's target is meaningfully involved in the pediatric disease biology and that intervening at that target could lead to a therapeutic effect.
Eligibility is wide and includes many common applicant types such as state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it places clear limits on foreign involvement: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants, though foreign components, as defined in the NIH Grants Policy Statement, are allowed.
From the source details provided, the opportunity sits under the NIH, falls within the health activity category, and uses the cooperative agreement funding instrument. It lists CFDA numbers 93.121 and 93.350, shows an award ceiling of $1,750,000, and had an original closing date of September 15, 2017, with a creation date of February 15, 2017. Overall, the program is built to bridge the gap between promising industry-held therapeutic molecules and unmet pediatric clinical needs by funding the work needed to justify and launch pediatric clinical trials, while using a competitive, milestone-based pathway to focus resources on the most evidence-supported ideas.Apply for RFA TR 17 003
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules (UG3/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.350.
- This funding opportunity was created on 2017-02-15.
- Applicants must submit their applications by 2017-09-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,750,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
1) What is the NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules (UG3/UH3) (RFA-TR-17-003)?
It is a National Institutes of Health (NIH) funding opportunity designed to accelerate the discovery of treatments for diseases and conditions that primarily affect children. The program focuses on identifying new pediatric therapeutic uses for existing experimental drugs or biologics, referred to as "Assets" in the announcement.
2) What does the program mean by "Assets"?
"Assets" are existing experimental drugs or biologics that come from pharmaceutical company partners. Applicants are expected to propose a pediatric disease or condition where an Asset could plausibly be effective.
3) Does this program fund brand-new drug discovery?
No. A central feature is that it does not start from scratch with brand-new drug discovery. Instead, it supports finding new pediatric uses for existing experimental molecules (Assets).
4) What is the main scientific expectation for applications?
Applicants are expected to build a strong scientific case that connects the Asset to the pediatric disease biology. This includes credible evidence that modulating the Asset's biological target is likely to improve the pediatric disease or condition.
5) How broad is the disease scope?
The opportunity is broad in terms of disease scope as long as the focus is on pediatric populations and the proposal provides a convincing mechanistic rationale linking the Asset's target to disease impact.
6) What types of products can be proposed under this opportunity?
The program is broad in the types of Assets considered and includes experimental drugs and biologics.
7) What makes this a "limited competition" opportunity?
It uses a staged application process with an initial X02 pre-application. Only pre-applications that are judged highly meritorious and aligned with NIH program priorities are invited to submit a full UG3/UH3 application under this funding opportunity announcement (FOA).
8) What is the first step in applying?
The first step is submitting an X02 pre-application, which is described as the entry point for both RFA-TR-17-002 and RFA-TR-17-003.
9) How are X02 pre-applications evaluated?
X02 submissions are reviewed by external experts. Only those considered both highly meritorious and aligned with NIH program priorities are invited to apply for the full UG3/UH3.
10) Why is the pre-application important?
The pre-application functions as a serious down-selection step. Advancing to the full application depends on the clarity of the therapeutic hypothesis, the strength of supporting biology, and the feasibility of the plan.
11) What award mechanism does this FOA use?
The award mechanism is a cooperative agreement.
12) What does a cooperative agreement imply for how the project will be run?
A cooperative agreement generally signals substantial NIH scientific or programmatic involvement during the life of the project compared with a standard grant.
13) How is the funding structured across phases?
The opportunity is split into two phases: an initial UG3 phase followed by a potential UH3 phase.
14) What is supported during the UG3 phase?
The UG3 phase supports key preparatory work needed before a pediatric clinical trial can responsibly begin. This includes developing and running rigorous preclinical efficacy studies and completing clinical trial planning activities.
15) What is supported during the UH3 phase?
The UH3 phase supports the execution of clinical trials, but it may be awarded only if the UG3 phase meets clearly defined preclinical milestones.
16) How does a project transition from UG3 to UH3?
Transition is milestone-driven. The project can move to the UH3 phase only if clearly defined preclinical milestones in the UG3 phase are achieved.
17) Why does the program use milestones and a staged design?
The milestone-driven structure is intended to reduce risk, ensure readiness for pediatric testing, and focus resources on the most evidence-supported concepts before proceeding into clinical trials.
18) Who is eligible to apply?
Eligibility is wide and includes: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.
19) Are any additional organization types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, tribal governments that are not federally recognized, and U.S. territories or possessions.
20) Are non-U.S. (foreign) organizations eligible to apply as applicants?
No. Non-domestic (non-U.S.) entities are not eligible to apply as applicants under this opportunity.
21) Can a U.S. organization submit an application that includes a non-domestic component?
No. Non-domestic components of U.S. organizations are not eligible to apply under this opportunity.
22) Are foreign components allowed in any way?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed, even though non-domestic entities and non-domestic components of U.S. organizations are not eligible to apply as applicants.
23) What is the activity/category area for this opportunity?
Based on the source details provided, the opportunity falls within the health activity category.
24) What agency is offering this opportunity?
The funding opportunity is offered by the National Institutes of Health (NIH).
25) What are the CFDA numbers listed for this opportunity?
The opportunity lists CFDA numbers 93.121 and 93.350.
26) What is the award ceiling listed in the source details?
The award ceiling listed is $1,750,000.
27) What was the original closing date for the opportunity?
The original closing date provided is September 15, 2017.
28) When was the opportunity created (per the source details)?
The creation date provided is February 15, 2017.
29) What kinds of evidence are expected to support the therapeutic hypothesis?
Applications are expected to provide evidence that the Asset's biological target is meaningfully involved in the pediatric disease biology and that intervening at that target could plausibly lead to a therapeutic effect. The proposal is expected to go beyond suggesting possible benefit and instead present a credible mechanistic case tied to disease impact.
30) What is the overall goal of the program?
The program aims to bridge the gap between promising industry-held therapeutic molecules and unmet pediatric clinical needs by funding the work needed to justify and launch pediatric clinical trials through a competitive, milestone-based pathway.
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