NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)
About
The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R&D).
The NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award is designed specifically for U.S. small business concerns that have successfully completed an NIH SBIR or STTR Phase II award. This grant bridges a critical funding gap between the conclusion of Phase II research and the commercialization stage, providing previously funded projects with additional support for later-stage research and development activities. Entrepreneurs and small business leaders should apply if they have an existing NIH SBIR or STTR Phase II award and are ready to advance their innovation toward market. This opportunity is particularly valuable for companies developing biomedical, clinical, or health-related technologies that require substantial investment to move from research into commercial viability. The Phase IIB Strategic Breakthrough Award enables small businesses to de-risk their technology, conduct additional validation studies, prepare for regulatory pathways, and strengthen their commercial potential without waiting for standard funding cycles. If your small business has demonstrated feasibility through Phase II funding and needs resources to bridge to commercialization, this award represents a strategic pathway to accelerate your innovation's transition from laboratory to marketplace.
Funding Facts
● Applications openDeadline
April 5, 2029
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by project and funding cycle
Deadline
2029-04-05
Grant Type
federal
Application Cycle
Annual with specified submission windows for Phase II award recipients
Best For
U.S. small business concerns with completed NIH SBIR or STTR Phase II awards seeking to advance innovations toward commercialization
Eligibility
Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project. This NOFO supports Renewal/Resubmission "Type 2" Applications from recipients with NIH Phase II SBIR/STTR awards that are submitted within th
Frequently Asked Questions
Who is eligible for NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)?
Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to apply. Applicants must submit within the specified timeframe following their Phase II award conclusion. Only one Phase IIB Strategic Breakthrough award is permitted per project. The program supports Renewal/Resubmission applications from recipients with active or recently completed NIH Phase II SBIR/STTR awards. For complete eligibility details and submission windows, visit the official NIH SBIR/STTR website.
How much funding does NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) provide?
Specific funding amounts vary and are not listed in the current program summary. Funding levels are determined on a case-by-case basis and may depend on the scope of proposed research and development activities. Visit the official NIH Small Business Innovation Research program website or the specific Notice of Funding Opportunity (NOFO) for detailed budget information and funding caps for this award cycle.
How do I apply for NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)?
Applications are submitted through the NIH's grants submission portal. Since this is a federal research grant, you will need an active SAM.gov registration, DUNS number, and institutional Grants.gov account. Applicants should review the specific Notice of Funding Opportunity (NOFO) for detailed submission guidelines, required documentation, and application deadlines. The official NIH SBIR/STTR website provides templates, instructions, and support resources for the application process. Begin your application early to allow time for institutional review and submission.
What can NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) funding be used for?
Phase IIB Strategic Breakthrough Award funding supports later-stage research and development activities that advance previously funded SBIR/STTR Phase II projects toward commercialization. Eligible uses typically include continued scientific validation, regulatory preparation, clinical trial activities (where applicable), prototype refinement, manufacturing scale-up planning, and other R&D activities essential to move the innovation closer to market. The 'Clinical Trial Optional' designation indicates flexibility regarding clinical research components. Review the official NOFO and contact the NIH program officer to confirm which specific activities align with your project's commercialization pathway.
Last updated: July 5, 2026