Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) | PAR 19 214

Opportunity Information: Apply for PAR 19 214

Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional), funding opportunity number PAR-19-214, is an NIH cooperative agreement program focused on a common bottleneck in mental health therapeutics: the disconnect between what looks promising in preclinical testing and what actually translates into measurable, reliable effects in people. The central aim is to identify, optimize, and evaluate neurophysiological measures that can function as assays for treatment development research. In practical terms, the opportunity is trying to strengthen the measurement "bridge" between early-stage preclinical work and later clinical evaluation by supporting tools that capture neurophysiological processes relevant to mental disorders.

A defining feature of the program is its emphasis on parallel assessment in both humans and at least one additional species that is relevant to the therapeutic development pipeline. Applicants are expected to work with neurophysiological measures that can be meaningfully examined in healthy humans as well as in another species used in preclinical research, with an eye toward developing assays that are suitable for screening or evaluating the effects of new drug or device interventions and their biological targets. The initiative is not just looking for interesting biomarkers; it is specifically oriented toward measures that can be refined into reliable, interpretable assays that inform treatment development decisions.

The project scope includes early proof-of-concept studies that test whether a candidate neurophysiological measure has the performance characteristics needed for assay development. That includes optimization and evaluation work that clarifies how well a measure captures a disrupted process that is relevant within or across mental disorders. A key deliverable is evidence about cross-species coherence: whether the same measure, collected in comparable ways, behaves similarly across species. Just as importantly, the FOA explicitly values results showing when measures do not align between animal models and humans. Those negative or mismatched findings are treated as useful, because they can reduce overconfident extrapolation from animal data to human outcomes and help the field avoid investing heavily in assay strategies that are unlikely to translate.

The longer-term objective is to improve the efficiency and success rate of the therapeutic development pipeline for mental disorders. By identifying where preclinical screening measures and clinical evaluation measures agree, and where they diverge, the program aims to make treatment development more data-driven and less speculative. In effect, it supports the creation of a more dependable set of translational tools that can speed progress toward effective interventions, whether pharmacological or device-based, by giving researchers better ways to read out target engagement, mechanism-related effects, or other neurophysiological signals that matter for treatment response.

Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, meaning the NIH is likely to have substantial involvement in the project compared to a standard research grant. The activity category is Health, and the CFDA number listed is 93.242. The opportunity was created on 2019-03-08, with an original closing date of 2022-02-21. The title indicates a UG3/UH3 structure, which commonly reflects a phased approach in which an initial stage supports early milestones (often feasibility or optimization work) followed by a later stage supporting expansion once predefined criteria are met; the announcement also indicates that clinical trials are optional, allowing projects that include clinical trial elements as well as those that do not.

Eligibility is broad and includes many types of U.S. entities and several additional categories. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also highlights additional eligible applicant types 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; eligible federal agencies; regional organizations; non-domestic (non-U.S.) entities (foreign organizations); Indian/Native American Tribal Governments other than federally recognized; and U.S. territories or possessions.

• 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 2019-03-08.
• Applicants must submit their applications by 2022-02-21. (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.

Apply for PAR 19 214

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