The funding opportunity "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)" is an initiative by the National Institutes of Health (NIH) to advance therapeutic development for mental illnesses. This grant supports research focusing on developing and optimizing in vivo neurophysiological and behavioral assays in animals. These assays are intended to serve as surrogate markers for neural processes of clinical relevance, facilitating the early screening of treatment candidates. The goal is to improve the scientific utility of preclinical animal data by linking neurobiological mechanisms to potential therapeutic interventions.

The primary objective is to support the development and refinement of screening assays based on systems neurobiology and clinical neuroscience. Researchers are encouraged to use available neurobiological insights to design tools that measure neurophysiological or behavioral processes relevant to mental health. The resulting assays will contribute to the therapeutic development pipeline by evaluating the impact of therapeutic targets and treatment candidates on brain function and behavior. This initiative aligns with broader NIH goals to integrate preclinical findings into clinical contexts, enhancing the understanding of mental illnesses and treatment responses.

The funding scope allows up to $250,000 per award, with no cost-sharing or matching requirement. The program focuses on health-related research, emphasizing the use of animal models to develop reliable measures for therapeutic screening. While the award ceiling is defined, the total program funding and the number of awards have not been specified.

Eligible applicants include a diverse range of entities, such as public and private higher education institutions, nonprofits with or without 501(c)(3) status, state and local governments, tribal organizations, small businesses, for-profit organizations, and U.S. territories. Additionally, faith-based and community-based organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, and foreign organizations are eligible to apply, ensuring a wide pool of potential contributors.

Applications must adhere to NIH submission standards, including detailed research proposals outlining the proposed assay development and validation methods. Projects should demonstrate clear relevance to mental health neurobiology and therapeutic screening. Proposals will be evaluated on significance, innovation, methodology, and potential impact, as well as investigator qualifications and resource availability.

The current application deadline is January 7, 2025, with the original closing date set for September 7, 2025. Applicants are encouraged to submit their proposals well before the deadline to ensure compliance with all requirements. The grant's archive date is February 6, 2025.

Further details about this funding opportunity, including application materials and resources, can be found on the NIH grant page linked in the announcement. For assistance or questions, applicants can contact NIH Grants Information via email or refer to Section VII of the full opportunity announcement.