Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (UG3/UH3) | RFA TR 17 002

Opportunity Information: Apply for RFA TR 17 002

The Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (UG3/UH3) funding opportunity (RFA-TR-17-002) is an NIH cooperative agreement designed to speed up drug development by repurposing existing experimental drugs or biologics, referred to as "Assets." Instead of starting from scratch with a brand-new compound, applicants propose a new therapeutic use for an Asset that is already held by a participating pharmaceutical or industry partner. The program is intentionally broad in scope and can support projects across a wide range of human diseases and conditions, as long as the scientific rationale is strong. Competitive proposals are expected to show convincing evidence that acting on the Asset's biological target (for example, inhibiting or activating a specific protein or pathway) is likely to improve the proposed disease or condition, rather than relying on speculative or weakly supported hypotheses.

A key feature of this opportunity is that it is limited competition and uses a two-step entry process. The first step is submitting an X02 pre-application, which functions as a screening stage for this program (and is specifically described as the first step for both RFA-TR-17-002 and the related RFA-TR-17-003). These X02 pre-applications are reviewed by outside experts. Only investigators whose pre-applications are judged highly meritorious and aligned with NIH program priorities are invited to move forward and submit the full UG3/UH3 application under this FOA. Practically, this means applicants cannot assume they can submit a full proposal immediately; the program is structured to narrow the pool early and focus NIH and industry resources on the most promising repurposing ideas.

The award structure follows the UG3/UH3 phased model. The UG3 phase supports preparatory work that is necessary before launching a clinical trial. This includes developing rigorous preclinical efficacy studies (for example, well-designed animal or mechanistic studies that test whether the Asset meaningfully affects disease-relevant outcomes) and completing clinical trial planning activities (such as protocol development, feasibility assessments, operational planning, and other trial-readiness steps). Progression is milestone-driven: if the UG3 phase meets predefined preclinical milestones, the project can transition to the UH3 phase. The UH3 phase then provides support to actually conduct clinical trials, which is the ultimate goal of demonstrating whether the repurposed Asset has real therapeutic value in humans. Because the mechanism is a cooperative agreement, applicants should also expect substantial NIH program involvement during the project, including active oversight tied to milestones and trial planning decisions.

Eligibility is broad across many U.S.-based organization types and includes public and private institutions of higher education, nonprofits (both with and without 501(c)(3) status), for-profit organizations (other than small businesses as well as small businesses), and multiple levels of government such as state, county, city/township, special district governments, independent school districts, and eligible federal agencies. The FOA explicitly highlights additional eligible applicant categories including 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, U.S. territories or possessions, and tribal entities (including tribal organizations and tribal governments other than federally recognized, alongside federally recognized tribal governments listed in the general eligibility section). On the foreign eligibility side, the FOA draws a clear boundary: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed when they meet the NIH Grants Policy Statement definition, meaning a U.S. applicant may include certain foreign elements in the work if appropriately justified and compliant, even though the applicant organization itself must be domestic.

From the source details provided, the opportunity is administered by the National Institutes of Health under CFDA numbers 93.121 and 93.350, categorized under health, and uses the cooperative agreement funding instrument. The posting indicates an award ceiling of $500,000 and lists an original closing date of 2017-09-15, with a creation date of 2017-02-15. Overall, the opportunity is best understood as an NIH-industry-enabled translational pipeline: it is built to identify high-confidence repurposing hypotheses, fund the preclinical and planning work needed to responsibly move into human testing, and then, only when milestones demonstrate readiness and promise, support the clinical trial phase to determine whether an existing experimental molecule can become a viable therapy in a new disease area.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH-Industry Program: Discovering 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 $500,000.00 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 17 002

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