NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)
Funds late-stage R&D to advance previously NIH-funded SBIR/STTR Phase II projects toward commercialization, but only for eligible U.S. small business concerns with prior NIH Phase II awards.
RESTRICTED TO: SMALL BUSINESS SBIR STTR
⚑ Only U.S. small business concerns with prior NIH SBIR/STTR Phase II awards may apply. · One award per project. · Renewal/resubmission Type 2 applications only, submitted within the first six due dates after the budget period ends. · Foreign organizations and non-domestic components of U.S. organizations are not eligible.
Unit fits — one characterization, each unit's own rules
| Tom Love Innovation Hub | 100 strong | SBIR/STTR — core Hub pipeline (faculty founders + small-business partners); funds commercialization; prototyping/demonstration stage; deep-tech content |
| IPPRA | 15 none | university cannot apply directly (ineligible) |
| Physical Sciences & Engineering (demo) | 15 none | university cannot apply directly (ineligible) |
Description
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).
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 the first six due dates following the expiration of their budget period. Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <SEEDinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.