Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) | PAR 22 169

Opportunity Information: Apply for PAR 22 169

The National Institutes of Health (NIH) funding opportunity "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)" (PAR-22-169) is a cooperative agreement designed to tackle a common problem in mental health therapeutics: promising findings in preclinical research often fail to translate into reliable effects in humans. The core aim is to identify and refine neurophysiological measures that could function as practical, dependable assays for treatment development. In this context, "neurophysiological measures" refers to quantifiable readouts of nervous system function (for example, signals that reflect brain or circuit activity) that can be used to evaluate whether a drug or device is engaging a target or changing a relevant biological process.

A central feature of the initiative is its deliberate cross-species emphasis. Projects are expected to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders, and to do so in healthy humans as well as in at least one other species that is relevant to the therapeutic development pipeline. The reason for requiring work in both humans and another species is practical: the field needs assays that behave similarly across preclinical models and people, so that early screening results can meaningfully inform clinical development decisions. Just as importantly, the FOA explicitly supports generating data that show when an assay does not match across species. Those negative or discordant results are treated as valuable because they provide a solid basis for limiting overconfident extrapolations from animal studies to human outcomes.

The work supported under this opportunity is described as proof-of-concept and assay-focused rather than late-stage efficacy testing. Applicants are expected to conduct initial studies that move a measure toward being usable as a preclinical assay for evaluating new drug and device therapies and their targets. In other words, the grant is aimed at strengthening the tools used to test treatments, not necessarily at proving a specific treatment works. The long-term payoff NIH is targeting is improved efficiency of the overall therapeutic development process: better assays should help researchers detect meaningful biological effects earlier, avoid pursuing misleading signals, and align preclinical screening with what can be measured and interpreted in clinical evaluation. By clarifying both coherence (where measures line up across species) and inconsistency (where they do not), the program is meant to speed the development of more effective treatments for mental disorders and reduce wasted effort on measures that do not generalize to humans.

Mechanistically, this FOA uses the UG3/UH3 phased structure under a cooperative agreement funding instrument. That generally means an initial, milestone-driven phase (UG3) intended for planning, optimization, and early feasibility work, followed by a second phase (UH3) that typically supports more advanced validation or expansion once predefined milestones are met. Because it is a cooperative agreement, NIH staff are expected to have substantial involvement compared to a standard research grant, often through collaboration on milestones, study coordination, and alignment with program goals. The announcement is labeled "Clinical Trial Optional," which signals that applicants may propose studies that meet the NIH definition of a clinical trial, but they are not required to do so; the deciding factor is whether the proposed human work involves prospective assignment to an intervention and evaluation of outcomes.

In terms of eligibility and who can apply, the FOA is broadly open. Eligible applicants include a wide range of government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and Native American tribal organizations that are not federally recognized. It also allows nonprofits both with and without 501(c)(3) status, public housing authorities/Indian housing authorities, for-profit organizations other than small businesses, and small businesses. The announcement also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, U.S. territories or possessions, and non-domestic (non-U.S.) entities/foreign organizations. This breadth is consistent with the translational nature of the program, where progress may come from academic labs, clinical research centers, industry-linked developers, or cross-sector partnerships.

Administratively, the opportunity is categorized as discretionary funding in the health area, associated with CFDA number 93.242, and is run by the NIH. The source listing notes an original closing date of 2023-01-13 and a creation date of 2022-07-07. The award ceiling and expected number of awards are not specified in the provided data, which often means applicants need to consult the full FOA text for budget limits, project period expectations, milestone requirements, and any institute-specific constraints.

• 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 2022-07-07.
• Applicants must submit their applications by 2023-01-13. (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 22 169

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