Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 20, 2026
Can you apply?
This grant is for academic researchers and biotech companies partnering to advance bioengineering innovation with commercial potential. Eligible applicants include universities, colleges, research institutions, and small businesses (including minority-owned and woman-owned enterprises). Partnerships between academia and industry are required or strongly preferred. Applicants must have institutional capacity to conduct clinical research if choosing the clinical trial option. Funding supports bioengineering research, product development, and validation studies.
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Program description
This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to accelerate the development and adoption of promising bioengineering tools and technologies that can address important biomedical problems. The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies. The goal of the program is to support technological innovations that deliver new capabilities which can realize meaningful solutions within 5 10 years.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Cover Sheet
- Project Narrative (Research Plan)
- Budget Justification
- Institutional Biosafety Committee Approval (if applicable)
- Industry Letter of Support
- IRB Protocol (if clinical trial option selected)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$463,372,200
-
$199,819,363
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$148,130,300
-
$113,990,692
-
$109,670,101
-
$102,150,671
-
$89,954,729
-
$85,658,817
-
$81,449,732
-
$80,730,785
Top States by Funding
- CA 10 awards $673.7M
- MI 2 awards $528.1M
- MO 8 awards $476.4M
- IN 4 awards $328.1M
- PA 6 awards $323.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
Who can apply for this grant?
Universities, research institutes, colleges, and small businesses. Industry-academic partnerships are expected. Applicants must have relevant research expertise and institutional support.
What is the deadline?
The fixed deadline is September 7, 2027. Applications open November 6, 2024. Check with NIH for submission cutoff times on deadline day.
Can I include a clinical trial component?
Yes, this grant allows the clinical trial option (U01). However, clinical components are optional, not required.
How competitive is this grant?
NIH grants are highly competitive, typically funding 15-25% of applications. Strong preliminary data and clear commercial pathways increase competitiveness.
How much funding can I request?
Funding amounts vary; typical NIH U01 awards range from $400K to $1M+ annually. Check the program announcement for specific guidance limits.
💡 Tips for applicants
- Start building industry partnerships early—this grant strongly emphasizes academic-industry collaboration as central to success.
- Include clear commercialization timelines and market potential. Reviewers want to see how your innovation will reach real-world applications.
- If pursuing the clinical trial option, ensure your institution has IRB capacity and relevant regulatory experience before applying.
- Gather strong preliminary data showing technical feasibility. NIH reviewers expect proof-of-concept work.
- Develop detailed budget narratives linking costs to milestones. NIH scrutinizes budgets for bioengineering projects closely.
⚠️ Common mistakes
Weak industry partnerships or no documented commitment from commercial partners. Vague commercialization plans with unrealistic timelines. Insufficient preliminary data to support feasibility claims.
Similar grants
- OPEN Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) — National Institutes of Health
- OPEN Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Optional) — National Institutes of Health
- OPEN Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional) — National Institutes of Health
- OPEN Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Optional) — National Institutes of Health