Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) | PAR 25 034

Opportunity Information: Apply for PAR 25 034

The NIH funding opportunity "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)" (PAR-25-034) is a discretionary cooperative agreement aimed at improving how mental health treatments are developed and evaluated as they move from preclinical studies into human testing. The core idea is to find and refine neurophysiological measures that can serve as practical, reliable assays for treatment development research. In plain terms, NIH is looking for research teams to identify measurable brain or nervous system signals that reflect processes disrupted in mental disorders, and to do so in a way that makes those measures useful for screening and understanding potential drug or device therapies.

A central requirement is that the proposed neurophysiological measures be studied in both humans (including healthy participants) and at least one other species that is relevant to the therapeutic development pipeline. This cross-species design is meant to directly address a common bottleneck in psychiatric treatment development: findings that look promising in animals often fail to translate in people. By optimizing and evaluating the same (or closely analogous) measures across species, the program seeks to determine where there is genuine coherence between preclinical and clinical readouts, and where there are meaningful mismatches. Importantly, the NOFO is also explicitly interested in revealing measures that do not perform similarly between animals and humans, because that evidence helps establish clear limits on how far animal findings can be extrapolated to human outcomes.

The NOFO emphasizes early, proof-of-concept work. Projects should focus on optimizing neurophysiological measures and evaluating their performance as potential assays that could be used later to test treatment candidates and their biological targets. While the opportunity is framed around treatment development, it is not limited to any single mental disorder; instead it targets neurophysiological processes that are disrupted within or across mental disorders, reflecting a broader, mechanism-oriented approach. The practical end goal is to make treatment development more efficient by strengthening the connection between what is measured during preclinical screening and what is measured during clinical evaluation. If successful, this should help reduce costly late-stage failures and speed the development of more effective therapies for mental disorders.

The funding mechanism is UG3/UH3, which typically reflects a phased cooperative agreement structure, where an initial phase supports milestone-driven planning and early feasibility or optimization work (UG3), followed by an implementation or expansion phase (UH3) if predefined milestones are met. The NOFO states "Clinical Trial Optional," meaning applicants may propose studies that meet the definition of a clinical trial, but they are not required to do so. Because this is a cooperative agreement, awardees should also expect substantial NIH program involvement during the life of the project, often including active scientific partnership, milestone monitoring, and coordination.

Eligibility is broad and includes many types of organizations. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education where specified); for-profit organizations other than small businesses; small businesses; and other entities. The opportunity also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities.

Key administrative details provided include the agency (National Institutes of Health), CFDA number 93.242, and an original closing date of 2025-06-20. The posting notes "SRF Reissue," indicating the opportunity is a reissued version associated with the NIH scientific review framework or a prior solicitation cycle. An award ceiling and expected number of awards are not specified in the provided listing, so applicants would need to consult the full NOFO text for budget guidance, project period limits, milestone expectations, and review criteria.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2025-06-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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