Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers and research institutions seeking to develop novel animal models and related biological materials that advance biomedical research. Eligible applicants include universities, medical colleges, hospitals, research institutions, nonprofit organizations, and other academic or research entities with 501(c)(3) status or equivalent, as well as state and local government agencies. This is an NIH R21 grant mechanism (exploratory/developmental research), which emphasizes novel and high-risk/high-reward approaches. Clinical trials are explicitly not allowed. The geographic scope is primarily U.S.-based institutions, though some international collaborations may be permitted. Applicants must have appropriate institutional infrastructure and IRB/IACUC oversight. The grant supports development and characterization of animal models, breeding colonies, transgenic lines, and associated biological materials intended to enable future research across multiple scientific domains.
Program description
This notice of funding opportunity (NOFO) encourages innovative research to develop, improve, characterize, and preserve animal models as well as animal model related biological materials, technologies, and new approach methodologies (NAMs) for studies relevant to human health and disease. This NOFO also seeks projects aimed at improving the diagnosis and control of diseases that could confound or interfere with animal use in biomedical research. The proposed project must have broad applicability to multiple NIH Institutes or Centers (ICs) to align with the NIH-wide mission of the Office of Research Infrastructure Programs (ORIP). The proposed studies must include animal models and explore multiple body systems or multiple categories of diseases. Applications that develop models focused on a specific disease or area of research, or only propose studies primarily relevant to a single NIH IC, will be considered not acceptable to this NOFO and will be withdrawn.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&D) or equivalent federal grant application form
- Project narrative/research plan (typically 15 pages)
- Detailed budget and budget justification
- Institutional IACUC approval or commitment letter for animal oversight
- Biosketches of key personnel (NIH format, 5 pages each)
- Letters of support from collaborating institutions or core facilities
- Current and pending support documentation
- Institutional certification of compliance with animal welfare regulations
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.351 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$191,271,017
-
$189,307,929
-
$188,853,963
-
$156,271,917
-
$140,230,629
-
$133,830,113
-
$122,234,337
-
$37,946,246
-
$37,475,785
-
$33,218,050
Top States by Funding
- OR 7 awards $273.8M
- CA 8 awards $266.7M
- TX 10 awards $224.3M
- WA 2 awards $219.0M
- LA 5 awards $184.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.351). How funding has trended year over year.
| 2024 | $279,889,905 | |
| 2025 | $284,089,258 | |
| 2026 est. | $283,084,958 |
FAQ
Who is eligible to apply for this R21 grant?
Universities, medical schools, hospitals, research institutions, nonprofit organizations, and government agencies with 501(c)(3) status or equivalent are eligible. Applicants must have institutional capacity and appropriate oversight for animal research.
Is this grant available to international organizations?
Typically, R21 grants from NIH are available primarily to U.S. institutions. Some foreign institutions may be eligible if they meet specific criteria, but this should be confirmed with the program officer.
Can clinical trials be included in the project?
No. This specific R21 mechanism explicitly excludes clinical trials. The focus is on preclinical development of animal models and biological materials.
What types of animal models are supported?
The grant supports development of novel mouse models, transgenic organisms, zebrafish lines, nonhuman primate models, and other species with research relevance, along with related biological materials and breeding colonies.
What is the typical funding range and project period?
R21 grants typically provide $275,000 total costs over two years. However, you should verify exact funding limits in the current FOA, as these can vary.
💡 Tips for applicants
- Emphasize the novelty and potential high impact of your animal model. R21 grants reward innovative approaches that open new research directions, even if preliminary data is limited.
- Clearly articulate the unmet research need that your model addresses and how it advances the field beyond existing models.
- Include a detailed feasibility and development timeline. Show that your team can generate a functional model within two years, even if full characterization extends beyond the grant period.
- Budget carefully for breeding, husbandry, and characterization costs. These are major expenses often underestimated by first-time applicants.
- Secure letters of institutional commitment regarding animal care resources, IACUC oversight, and breeding colony management before submission.
⚠️ Common mistakes
Many applicants underestimate the cost and complexity of maintaining breeding colonies and fail to budget adequately for veterinary care and facility resources. A second common mistake is proposing a clinical trial component or outcomes that blur the line between preclinical development and clinical translation—keep the scope strictly to model development. Finally, weak preliminary data or unclear feasibility timelines make reviewers skeptical that the applicant can deliver a functional model within two years.
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