Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed) | PAR 22 170

Opportunity Information: Apply for PAR 22 170

Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (PAR 22-170) is an NIH R01 funding opportunity focused on improving the early, preclinical phase of treatment development for mental illnesses. The central idea is to create and refine animal-based assays that can show whether a potential therapy is actually engaging the brain circuits and mechanisms that matter for psychiatric symptoms. Rather than relying only on broad animal behaviors or indirect readouts, this program emphasizes in vivo neurophysiological and behavioral measures that are closely tied to known neural circuitry and the underlying biology of mental disorders. The goal is to make preclinical findings more informative and more likely to translate into meaningful clinical progress.

A key feature of the announcement is its emphasis on developing screening-ready assays. Applicants are expected to optimize and evaluate measures of neurophysiological and behavioral processes that could function as surrogate markers for neural processes of clinical interest. In practical terms, that means proposing measures that can reliably detect changes in circuit function when a therapeutic target is manipulated or when a treatment candidate is administered, and demonstrating that these measures are robust enough to be useful in the earlier decision-making stages of a therapeutic pipeline. The work should build on existing knowledge from systems neurobiology and clinical neuroscience, using what is already known about brain circuits implicated in mental illnesses to guide assay selection, design, and validation.

The scientific premise is that better preclinical assays of circuit engagement can improve how therapeutic ideas are filtered before they move toward costly later-stage development. This FOA supports projects that strengthen the mechanistic bridge between animal models and clinical relevance by focusing on neurobiological mechanisms rather than only symptom-like behaviors. The assays developed are intended to help determine whether a target or compound affects the neural systems believed to contribute to psychiatric disease processes, thereby increasing the scientific value and interpretability of animal data used in therapeutic development.

This is an R01 (research project grant) opportunity in the health category (CFDA 93.242) administered by the National Institutes of Health. Clinical trials are not allowed under this FOA, which signals that the proposed work should remain in the preclinical/animal research domain and should not include clinical trial activities. The listing shows an award ceiling of $250,000 (as provided in the source data), and the original closing date was January 9, 2023. The opportunity was created on July 7, 2022.

Eligibility is broad and includes many types of U.S. applicants such as state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also notes additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. (foreign) organizations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)" 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 2023-01-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• 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 22 170

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: