Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for U.S. small business concerns (SBCs) developing biomedical technologies. Applicants must have research capabilities and technological expertise aligned with NIH institute missions. Cost-sharing requirement: applicants must demonstrate at least 100% matching funds. The grant supports R&D efforts advancing technologies toward commercialization, particularly those requiring regulatory approval, complex instrumentation development, clinical research tools, or behavioral interventions.
Collaborative applications combining multiple investigator expertise are encouraged. Businesses developing products in medical biotechnology, diagnostics, devices, or related fields are strong candidates. The technology should be moving toward the "Valley of Death" phase where additional bridge funding is critical.
Geographic scope is national—any U.S. small business is eligible. Prior Phase II SBIR completion is typical for Phase IIB applicants, though not explicitly stated here.
⚖️ Cost sharing / matching required — applicants must contribute their own funds.
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Key dates
- May 28, 2026 Applications open
- Mar 1, 2027 Award announced
- Apr 1, 2027 Project start
- Apr 5, 2029 Application deadline in 993 days
Program description
The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): NCI, NEI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDDK, NIGMS, NIMH, NIMHD, NINDS, NCATS, ORIP, and ORWH, intends to publish a Notice of Funding Opportunity (NOFO) to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough grant applications. The main objective of a SBIR/STTR Phase II award is to continue R&D efforts to advance a technology toward commercialization. If the technology is not available for sale or use by the end of the SBIR/STTR Phase II award, the SBC must use non-SBIR/STTR funds to reach market access. This funding gap, between the end of the SBIR/STTR Phase II award and customer access, which affects most medical biotechnology products, is known as the “Valley of Death.” The NIH Phase IIB Strategic Breakthrough award provides additional support to mitigate this funding gap for projects that require extraordinary time and effort, including those requiring regulatory approval or are developing complex instrumentation, clinical research tools, or behavioral interventions.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R44 activity code. United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise will be encouraged and these investigators should also begin considering applying for this application. Prospective applicants should keep in mind that they must demonstrate not less than 100 percent matching funds to be considered for a Phase IIB Strategic Breakthrough award.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- R44 grant application form (SF-424)
- Project narrative and aims
- Budget and budget justification
- Commercialization plan and market analysis
- Letters of support (customers, partners, or investors)
- Evidence of cost-sharing commitment
- Biographical sketches of key personnel
- NIH-format CV for PI and key team members
Program contact
- 👤 NIH SEED (Small business Education and Entrepreneurial Development)
- 📧 SEEDinfo@nih.gov
- 📞 301-827-8595
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$56,144,651
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$40,959,789
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$35,655,349
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$35,655,116
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$35,335,145
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$34,183,297
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$32,294,153
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$32,234,840
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$31,739,294
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$27,282,286
Top States by Funding
- MA 5 awards $123.9M
- OH 4 awards $112.5M
- CA 4 awards $101.3M
- FL 3 awards $100.3M
- MI 3 awards $85.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this Phase IIB award?
U.S. small business concerns with research capabilities matching NIH institute missions. Businesses must have completed or be nearing completion of Phase II SBIR work.
What is the cost-sharing requirement?
Applicants must demonstrate at least 100% matching funds. This means matching the NIH award dollar-for-dollar with your own resources.
What types of projects are funded?
Projects requiring extraordinary time and effort to reach commercialization, including those needing regulatory approval, complex instrumentation, clinical research tools, or behavioral interventions.
When is the deadline?
This is a fixed deadline grant. The specific deadline is September 5, 2026.
Can I apply if my business is at an early commercialization stage?
This is a bridge-funding program for projects past Phase II but not yet market-ready. Your project must show clear path to commercialization within a reasonable timeframe.
💡 Tips for applicants
- Show how matching funds will be secured and committed. Vague commitments weaken competitiveness significantly.
- Clearly articulate the "Valley of Death" problem your project faces. Explain why Phase IIB support is essential to reach customers.
- Include letters of support from potential customers, partners, or investors. These validate market demand and commercialization feasibility.
- Develop a realistic commercialization timeline and strategy. Reviewers will scrutinize whether bridge funding will truly enable market launch.
- Consider collaboration early. Multi-institutional teams with complementary expertise often score higher than single-company applications.
⚠️ Common mistakes
Underestimating matching fund requirements. Many applicants propose insufficient cost-sharing or present uncommitted pledges instead of firm commitments. Poor commercialization plans. Vague timelines and unclear paths to market access waste reviewer attention and invite rejection. Overlooking regulatory pathway—applications weak on FDA/other approval strategy often fail.
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