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

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Description

This funding opportunity supports research to develop, optimize, and evaluate in vivo neurophysiological and behavioral measures in animals as assays for early-phase screening of therapeutic candidates targeting mental illnesses. The goal is to improve the translational value of preclinical animal data by establishing robust, clinically relevant assays that can inform the therapeutic development pipeline. Projects should focus on measures that reflect neural processes of clinical interest, with the expectation that these assays will ultimately facilitate cross-species translation and future validation in humans.

Priority is given to projects that:

• Optimize novel, predominantly non-invasive neurophysiological or behavioral measures in animals that reflect clinically relevant brain processes.
• Evaluate the performance of these measures using FDA-approved drugs or interventions with known effects, including pharmacokinetic/pharmacodynamic (PK/PD) readouts.
• Conduct mechanistic testing to confirm the involvement of specific brain circuits or processes in the assay measures.

Assays developed should be innovative, have clear translational potential, and be designed for future comparison with analogous measures in humans.

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Due Dates

• New Applications:

  • February 5, 2025
  • June 5, 2025

• Renewal / Resubmission / Revision Applications:

  • March 5, 2025
  • July 5, 2025

• AIDS-related Applications (New/Renewal/Resubmission/Revision):

  • May 7, 2025
  • September 7, 2025

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Budget: No specific budget limit; budgets should reflect actual project needs.
• Typical Award: Most projects are expected to require $250,000 or less in direct costs per year (for projects optimizing a single measure).
• Project Duration: Up to 5 years.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education (U.S. and non-U.S.)
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities and components

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are encouraged to apply.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov. All PDs/PIs must have an eRA Commons account.
• Application Instructions: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Application Types Allowed: New, Renewal, Resubmission, Revision.
• Page Limits: As specified in the NIH Application Guide and FOA.
• Data Management and Sharing Plan: Required for all applications.

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Additional Information

• Clinical Trials: Not allowed under this opportunity.
• Human Subjects: Studies involving human subjects are not permitted.
• Assay Focus: Projects must not propose animal models "of" mental disorders, broad behavioral test batteries, or in vitro/cell culture assays.
• Milestones: Applications must include clear, quantifiable milestones for assay optimization, performance evaluation, mechanistic testing, and dissemination of results.
• Resource Sharing: A detailed plan for sharing data and experimental protocols is required.
• Foreign Organizations: Eligible and must follow NIH policies for foreign applicants.

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External Links

• NIH Funding Opportunity Announcement (PAR-25-035)
• NIH Grants & Funding Main Page
• Grants.gov Opportunity Listing
• NIMH FAQs for this NOFO
• NIH Application Guide (Forms-H)

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Contact Information

For additional contacts, see Section VII. Agency Contacts in the full announcement.