Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed) | PAR 19 289

Frequently Asked Questions (FAQs)

What is the PAR-19-289 funding opportunity?

Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (PAR-19-289) is an NIH R01 funding opportunity focused on improving early-stage (preclinical) therapeutic development for mental illnesses by developing and validating in vivo assays in animal models that measure neural circuit engagement.

Which agency is offering this grant?

The opportunity is administered by the National Institutes of Health (NIH).

What type of grant mechanism is used?

This opportunity uses the NIH R01 Research Project Grant mechanism.

What is the main goal of this FOA?

The central aim is to strengthen preclinical treatment development for mental illnesses by creating and validating in vivo animal assays that can reliably demonstrate whether an intervention engages the neural circuits and processes that are clinically relevant to psychiatric symptoms.

Is this opportunity for clinical research or preclinical research?

This FOA is explicitly limited to preclinical work. It is intended for in vivo studies in animal models and does not support clinical studies.

Are clinical trials allowed under this FOA?

No. Clinical trials are not allowed under this announcement.

What kinds of assays is NIH seeking under this opportunity?

NIH is seeking in vivo assays in animal models that measure neural circuit engagement using neurophysiological readouts (such as electrophysiology or other real-time measures of brain activity) alongside behavioral measures.

What does "circuit engagement" mean in the context of this FOA?

Within this FOA, circuit engagement refers to demonstrating that an intervention affects specific neural circuits or neural processes implicated in mental illnesses, using measures that provide meaningful information about brain mechanisms rather than relying only on broad behavioral outcomes.

Why is NIH emphasizing neurophysiological readouts?

The FOA is based on the concern that many therapeutic targets fail because preclinical studies do not adequately show whether candidate treatments are affecting the relevant brain mechanisms. Neurophysiological readouts are emphasized because they can provide direct, real-time indicators of brain activity and circuit function.

Are behavioral measures still important for proposed projects?

Yes. The FOA describes using neurophysiological readouts alongside behavioral measures, with the intent of connecting observed behavior to underlying circuit-level mechanisms that are relevant to mental health conditions.

What stage of therapeutic development is this FOA intended to support?

The emphasis is on the early, screening phase of therapeutic development, where practical and informative assays can support early go/no-go decisions before a candidate moves further down the development pipeline.

What kinds of outcomes should the developed assays support?

The assays are expected to help quantify engagement of specific neural circuits or processes implicated in psychiatric disorders and to serve as surrogate markers of clinically relevant neural processes, improving how animal research informs therapeutic decisions.

Does the FOA focus on mechanisms or only on behavioral outcomes?

The FOA is specifically aimed at linking interventions to neurobiological mechanisms of interest (circuit function and engagement), not merely to broad behavioral outcomes.

What does the FOA say about standardization and validation?

Projects are expected to optimize, standardize, and evaluate neurophysiological and behavioral measures so they can function as reliable, validated assays for assessing circuit engagement in preclinical research.

What mental health area is this opportunity associated with?

The FOA is focused on mental illnesses and the development of preclinical tools that can improve translation to clinically useful treatments for psychiatric conditions.

What is the CFDA number or program category listed for this opportunity?

The opportunity is categorized under Health with CFDA 93.242.

Is the funding opportunity described as discretionary?

Yes. The opportunity is described as discretionary.

What was the original closing date listed for this opportunity?

The original closing date listed in the provided information is September 7, 2022.

Does the provided information include an award ceiling?

No. The provided source data does not specify an award ceiling.

Does the provided information state how many awards NIH expects to make?

No. The provided source data does not specify the expected number of awards.

Who is eligible to apply?

Eligibility is broad and includes many applicant types, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA highlights eligibility for several institution types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, and Tribally Controlled Colleges and Universities.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among eligible applicants.

Can federal agencies apply?

Yes. Eligible federal agencies are included among the additional eligible applicants listed.

Are U.S. territories and possessions eligible to apply?

Yes. U.S. territories or possessions are included among the eligible applicants.

Are regional organizations eligible?

Yes. Regional organizations are included among eligible applicants.

Are non-U.S. (foreign) organizations eligible?

Yes. Non-U.S. entities (foreign organizations) are explicitly included in the eligibility description.

Are Indian/Native American Tribal Governments that are not federally recognized eligible?

Yes. Indian/Native American Tribal Governments that are not federally recognized are included among the eligible applicants listed.

What problem in therapeutic development is this FOA trying to address?

The FOA is designed around the idea that promising therapeutic targets often fail because preclinical studies do not adequately demonstrate whether candidate treatments impact the brain mechanisms most relevant to psychiatric symptoms. The goal is to improve that early evidence by measuring circuit engagement directly and reliably.

What is the intended benefit of better preclinical assays of circuit engagement?

The intended benefit is to increase the scientific value and translational relevance of preclinical animal data, making early therapeutic development decisions more informative and improving the likelihood that preclinical findings will translate into clinically useful treatments for mental illnesses.

What kinds of measures does the FOA want assays to be grounded in?

The measures should reflect current knowledge of systems neurobiology and clinical neuroscience and be grounded in what is known about the neurobiology of mental illnesses.

What is the practical use case NIH emphasizes for these assays?

The FOA emphasizes assays that can function as screening tools during early development, supporting practical evaluation of whether a target, pathway, or treatment candidate changes circuit function in a meaningful way for mental health conditions.