Development of Models, New Approach Methodologies, and Biological Materials for Studying Human Health and Diseases (R21 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 9, 2026
Can you apply?
This grant is for researchers seeking funding to develop research models, new methodologies, and biological materials for studying human health and disease. Eligible applicants include academic institutions, research hospitals, nonprofits, and government agencies. Projects must demonstrate broad applicability across multiple NIH Institutes or Centers and explore multiple body systems or disease categories. Narrow disease-specific or single-system research is not eligible.
Applicants must be affiliated with an eligible domestic or international organization. The research must involve developing or improving models, methodologies, or technologies. Applications focused on a single NIH Institute's mission or a single body system will be rejected.
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Key dates
- Sep 16, 2026 Applications open
- Feb 16, 2028 Application deadline in 494 days
- Oct 10, 2028 Award announced
- Dec 10, 2028 Project start
Program description
This notice of funding opportunity (NOFO) encourages innovative research to develop, characterize, improve or preserve research models and model related biological materials, and to develop or improve technologies, including new approach methodologies (NAMs), for studies relevant to human health and diseases. This NOFO also seeks projects aimed at improving the identification and control of factors that could confound or interfere with the use of research models 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 research model(s) or NAM(s) and must explore multiple body systems or multiple categories of diseases affecting multiple body systems. Applications that develop models focused on a specific disease, a narrow area of research, or a single body system, or propose studies primarily relevant to a single NIH IC will be considered not acceptable to this NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project Narrative
- Biographical Sketch(es)
- Budget and Budget Narrative
- Research Strategy (including Significance, Innovation, Approach)
- Other Support documents
- Letters of Support (if applicable)
- IRB/IACUC approval documentation (if applicable)
Program contact
- 👤 Office of Research Infrastructure Programs (ORIP)
- 📧 ORIPDCM@mail.nih.gov
- 📞 301-435-0744
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
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$203,025,735
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$201,841,608
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$191,271,017
-
$167,023,331
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$150,172,413
-
$143,135,086
-
$129,717,894
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$41,295,933
-
$37,946,246
-
$33,594,411
Top States by Funding
- OR 7 awards $291.7M
- CA 9 awards $272.7M
- TX 10 awards $235.4M
- WA 2 awards $234.1M
- LA 6 awards $201.4M
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
Can I apply if my research focuses on a single disease?
No. Applications must explore multiple body systems or disease categories with broad applicability across NIH.
What counts as a "new approach methodology" (NAM)?
NAMs are novel technologies or approaches for studying models. They should advance research methods beyond traditional techniques.
Who can submit an application?
Academic institutions, research hospitals, nonprofits, and government agencies can apply. PIs must be at eligible organizations.
Is cost-sharing required?
No. This grant does not require cost-sharing or matching funds from your organization.
What is the typical award amount and project duration?
Awards range from $190,000 to $500,000. Project duration typically spans 2-3 years.
💡 Tips for applicants
- Focus on broad applicability. Demonstrate how your models or methods benefit multiple NIH Institutes, not just one.
- Show impact across systems. Propose research exploring multiple body systems or disease categories to meet eligibility.
- Develop strong preliminary data. Present evidence that your approach improves on existing models or methodologies.
- Explain preserving value. If preserving biological materials or models, justify why they are scientifically important.
- Address confounding factors. Discuss how your work reduces variables that interfere with model reliability in research.
⚠️ Common mistakes
Applications focused on single diseases, narrow research areas, or one body system get rejected. Projects with relevance only to a single NIH Institute fail to meet the broad applicability requirement. Weak preliminary data or unclear methodological innovation reduces competitiveness.
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