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

Background
The National Institutes of Health (NIH), specifically the National Institute of Mental Health (NIMH), is issuing this Notice of Funding Opportunity (NOFO) to support the development of in vivo neurophysiological and behavioral measures for early screening in treatment development for mental illnesses.

The goal is to enhance the scientific value of preclinical animal data by identifying surrogate markers that reflect neural processes relevant to clinical outcomes. This initiative aims to bridge gaps in understanding disease mechanisms and improve the therapeutic development pipeline.

Grant Details
The NOFO supports the initial stages of developing, optimizing, and evaluating novel in vivo measures as potential assays for early screening of therapeutic candidates.

Key tasks include:
1) Identification and optimization of measures reflecting clinically relevant brain processes conserved between preclinical species and humans;
2) Evaluation of the sensitivity and selectivity of these measures through performance testing with FDA-approved drugs or interventions;
3) Mechanistic testing of brain pathways hypothesized to underlie physiological or behavioral assay measures.

The focus is on innovative, non-invasive neurophysiological or behavioral measures that can be studied in live animals and are adaptable for future human studies.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and foreign organizations.

Special encouragement is given to institutions serving underrepresented groups such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and others. Individuals with diverse backgrounds are also encouraged to apply.

Period of Performance
The maximum project period is 5 years, with specific milestones required for each phase of assay development: optimization, performance evaluation, and mechanistic testing.

Grant Value
While application budgets are not limited, it is expected that most projects will require budgets around $250,000 in direct costs per year. The total number of awards will depend on NIH appropriations and the submission of meritorious applications.

Place of Performance
The grant activities will primarily take place in research facilities associated with eligible applicant organizations.