Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)

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Description

This opportunity supports exploratory and developmental research (R21 mechanism) to advance the development, improvement, characterization, and preservation of animal models and related biological materials, technologies, and new approach methodologies (NAMs) for biomedical research relevant to human health and disease. Projects may also address the diagnosis and control of diseases that could confound or interfere with animal use in research.

The program is administered by the NIH Office of Research Infrastructure Programs (ORIP) and is intended to have broad applicability across multiple NIH Institutes or Centers (ICs). Proposals must include animal models and address multiple body systems or categories of diseases. Applications focused on a single disease, a single research area, or only relevant to one NIH IC are not eligible and will be withdrawn.

Examples of suitable projects include:

• Development or characterization of new or improved genetically modified animal models relevant to multiple organ systems.
• Animal models for microbiome, epigenetic, or stem cell research with broad relevance.
• Novel technologies for animal model production, validation, or preservation.
• Informatics and AI tools for deep phenotyping in animal models.
• Development of NAMs (in vitro, in chemico, in silico) that complement animal research, provided animal-origin components are predominant.

Projects must not propose clinical trials.

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Due Dates

• New Applications: June 16, 2025 | October 16, 2025 | February 16, 2026 | June 16, 2026 | October 16, 2026 | February 16, 2027 | June 16, 2027 | October 16, 2027 | February 16, 2028
• Renewal/Resubmission/Revision: July 16, 2025 | November 16, 2025 | March 16, 2026 | July 16, 2026 | November 16, 2026 | March 16, 2027 | July 16, 2027 | November 16, 2027 | March 16, 2028
• AIDS-related Applications: September 7, 2025 | January 7, 2026 | May 7, 2026 | September 7, 2026 | January 7, 2027 | May 7, 2027 | September 7, 2027 | January 7, 2028 | May 7, 2028

All applications are due by 5:00 PM local time of the applicant organization. See NIH Standard Due Dates for more details.

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Funding Amount

• Direct Costs: Up to $200,000 per year; total direct costs for the two-year project period may not exceed $275,000.
• Project Period: Maximum of 2 years.
• Award Type: Grant (R21 Exploratory/Developmental mechanism).
• No cost sharing required.
• The number of awards depends on NIH appropriations and the number of meritorious applications.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education (both public/state-controlled and private)
• Nonprofits with or without 501(c)(3) status (excluding higher education institutions)
• 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
• Eligible agencies of the federal government

Not eligible: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations.

Note: Foreign components, as defined by NIH, may be included in projects but cannot be the applicant organization.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov using the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must have active registrations with SAM.gov, eRA Commons, and Grants.gov. Registration can take 6+ weeks.
• Application Guide: Follow the NIH SF424 (R&R) Application Guide and the funding opportunity announcement.
• Page Limits: Standard NIH page limits apply.
• Data Management and Sharing Plan: Required for all applications.
• Resource Sharing Plan: Required if model organisms are developed.
• No clinical trials: Applications proposing clinical trials will not be accepted.

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Additional Information

• Scope: Projects must be broadly relevant to multiple NIH ICs and address multiple body systems or disease categories.
• Nonresponsive Applications: Proposals focused on a single disease, single research area, or only relevant to one NIH IC will be withdrawn.
• Contact with Program Staff: Strongly encouraged before submission to ensure project fit.
• Review Criteria: Scientific merit, innovation, rigor, feasibility, investigator expertise, and resource sharing/dissemination plans.
• Reporting: Annual Research Performance Progress Reports (RPPR) and final reports are required.

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External Links

• Full Funding Opportunity Announcement (PAR-25-273)
• NIH Office of Research Infrastructure Programs (ORIP)
• NIH Standard Due Dates
• NIH SF424 (R&R) Application Guide
• Apply via Grants.gov

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Contact Information

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