Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3) | Apply Online

FAQs: Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3) - PAR 16-065

What is the title and funding opportunity number for this program?

The opportunity is titled "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)" and the Funding Opportunity Number is PAR 16-065.

Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH), listed as HHS-NIH11.

What is the main purpose of this FOA?

The central purpose is to improve how mental health treatments are developed and translated from preclinical work into meaningful clinical outcomes by identifying, refining, and testing neurophysiological measures that can serve as reliable assays during treatment development.

What problem is NIH trying to solve with this initiative?

This initiative targets a key bottleneck in neuropsychiatric treatment development: promising preclinical findings often fail to replicate or predict success in human clinical settings. The program aims to strengthen the connection between early-stage screening and later clinical evaluation by improving the measurement tools used to assess whether an intervention is affecting the intended brain mechanism.

What kinds of measures or tools is the program focused on?

The program focuses on neurophysiological measures tied to brain-based processes that are disrupted in mental disorders. These measures are intended to function as assays during treatment development, helping researchers evaluate treatment targets and treatment effects more efficiently.

Is the program focused on a single mental health diagnosis?

No. Rather than focusing on one diagnosis at a time, the opportunity is oriented toward neurophysiological processes that may cut across multiple mental disorders.

What does "translational gaps" mean in the context of this FOA?

In this context, "translational gaps" refers to the disconnect between preclinical research (often in animals) and clinical outcomes in humans. The program is intended to reduce that gap by developing measures that are conceptually aligned and empirically comparable across stages and species.

What is the cross-species requirement described in the summary?

Applicants are expected to work with healthy human participants and at least one additional species that is commonly used or otherwise relevant in the therapeutic development pipeline. The goal is to optimize and evaluate a neurophysiological measure in both humans and an animal model in a way that supports later use as a preclinical assay.

Does the program require work in clinical patient populations?

Based on the provided summary, the expectation explicitly includes healthy human participants and at least one additional species. The summary does not state a requirement to include patient populations.

Why does the FOA emphasize cross-species relevance?

The emphasis is meant to create measurement tools that can be used in both preclinical and clinical contexts, improving confidence that a candidate drug or device is engaging the intended neural mechanism in ways that can be compared across species and are relevant to humans.

What kinds of interventions is this program meant to support?

The program supports proof-of-concept work to develop measures useful for testing new interventions, including drug therapies and device-based approaches.

What is meant by using a measure as an "assay" for treatment development?

Here, an "assay" is a neurophysiological measure intended to help determine whether a candidate intervention is affecting the targeted brain mechanism, ideally allowing earlier and clearer decisions about whether a development program is on track.

Does the FOA assume that animal-to-human translation will always work?

No. A stated aim is to generate data showing where measures align across species and where they diverge. Documenting mismatches is treated as valuable because it can reduce overinterpretation and speculative extrapolation from animal results to human outcomes.

What are the expected deliverables or outcomes from funded projects?

Based on the summary, a core outcome is data that clarifies whether candidate neurophysiological measures behave similarly across species or show important differences. The broader practical outcome NIH is pursuing is a more efficient therapeutic development process through improved preclinical screening and clearer links to human clinical measures.

What grant mechanism is used for this opportunity?

This is an NIH cooperative agreement initiative using the UG3/UH3 model.

What does it mean that this is a "cooperative agreement"?

In general terms as stated in the summary, a cooperative agreement implies substantial involvement from NIH staff compared with a standard research grant.

How does the UG3/UH3 phased approach typically work?

The summary describes the model as milestone-driven and phased: an initial exploratory or optimization phase is typically followed by a second phase that expands or confirms performance if predefined goals are met. The summary does not list specific milestones for this FOA.

What is the funding category and area for this opportunity?

It is categorized as discretionary funding in the health area.

When was this opportunity posted and created?

The opportunity was posted and created on December 21, 2015.

What was the closing date for this FOA?

The original and current closing date listed is October 24, 2018.

Is the award ceiling or number of expected awards provided in the summary?

No. The source data does not specify an award ceiling or the number of expected awards in the fields provided. Those details would need to be confirmed in the full announcement or related NIH materials.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.242.

Who is eligible to apply?

Eligibility is described as broad and includes many types of domestic organizations, including state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; and for-profit organizations (including small businesses and other for-profits). The summary also notes that additional eligible applicants may be described in the full FOA text.

Are for-profit entities eligible?

Yes. For-profit organizations are included in the eligibility list, including small businesses and other for-profits.

Are tribal governments and tribal organizations eligible?

Yes. Tribal governments and tribal organizations are explicitly included in the eligibility list.

Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are explicitly included in the eligibility list.

What is the overall long-term goal NIH is pursuing through this program?

The overall goal is to make therapeutic development for mental disorders more efficient and less wasteful by improving the quality and interpretability of preclinical screening and by creating clearer, more reliable links to measures used in humans.

What is the key distinguishing feature of this FOA compared to more typical approaches?

A defining feature described in the summary is the explicit emphasis on cross-species relevance (healthy humans plus at least one other relevant species) and the explicit value placed on identifying both alignment and misalignment across species rather than assuming translation will always hold.