Limited Competition for NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules (UG3/UH3) | RFA TR 17 003

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.

• 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.

Apply for RFA TR 17 003

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