The NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) supports previous NIH SBIR or STTR Phase II recipients in bridging the funding gap between the end of a Phase II award and full commercialization. This opportunity, also known as America's Seed Fund, provides additional support for later-stage research and development (R&D) to help technologies overcome the "Valley of Death" that often delays or prevents market entry, particularly for biomedical products requiring regulatory approval, complex manufacturing, or serving small markets.

Overview

Administered by the National Institutes of Health (NIH), this funding opportunity is designed for small business concerns (SBCs) that have already completed an NIH SBIR or STTR Phase II award. The award supports projects that need further R&D before they can attract non-SBIR/STTR funding for full commercialization. The programme accepts Renewal/Resubmission "Type 2" applications from recipients whose NIH Phase II SBIR/STTR awards are submitted within the first six due dates following the expiration of their budget period. Only one Phase IIB Strategic Breakthrough award is permitted per project.

Multiple NIH institutes and centres participate, including the National Cancer Institute, National Heart, Lung, and Blood Institute, National Institute of Allergy and Infectious Diseases, and many others. All applications must fall within the mission of the relevant institute or centre.

Funding and Benefits

Applicants must secure 100% third-party matching funds for the proposed Phase IIB award project. Eligible matching funds may come from:

• New private capital, such as investment from another company, a venture capital firm, or other private investor; or
• New funding awarded by a government agency other than a Phase I or II SBIR or STTR award; or
• Any combination of the above sources.

No award ceiling or floor is specified for this opportunity. The grant uses the R44 activity code (Small Business Innovation Research Grant – Phase II only). Assistance listing numbers include 93.233, 93.837, 93.838, 93.839, 93.840, 93.351, 93.313, 93.866, 93.350, 93.859, 93.855, 93.394, 93.393, 93.395, 93.867, 93.273, 93.865, 93.847, 93.242, 93.307, and 93.853.

For applicants who need additional technical assistance or later-stage R&D but lack third-party matching funds or require significant outsourcing, the Commercialization Readiness Pilot (CRP) programme (PAR-27-098) may be an alternative. The CRP programme can also support small businesses during an active Phase II award.

Eligibility

Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to apply. Non-domestic entities, including foreign organizations and non-domestic components of U.S. organizations, are not eligible to apply. Unfunded international collaborations or unfunded foreign components may be allowed as defined in the NIH Grants Policy Statement. Applicants are strongly encouraged to contact program staff prior to applying for guidance on selecting the most appropriate funding opportunity.

Application Process

Applicants must follow the SBIR/STTR (B) Instructions in the NIH How to Apply – Application Guide, except where instructed otherwise in the full announcement. Conformance to all requirements is strictly enforced. Applications may be submitted through one of the following options:

• NIH ASSIST system for preparing, submitting, and tracking applications online;
• An institutional system-to-system (S2S) solution; or
• Grants.gov Workspace.

All applications must be submitted by 5:00 PM local time of the applicant organization on the applicable due date. Late applications will not be accepted. Applicants are encouraged to apply early to allow time for corrections.

Deadline and Timeline

The opportunity was posted on May 28, 2026. The open date (earliest submission date) is August 05, 2026. Standard NIH due dates apply. Applications are accepted on the following cycles:

• September 05, 2026 – Scientific Merit Review: November 2026; Advisory Council Review: January 2027; Earliest Start Date: April 2027
• January 05, 2027 – Scientific Merit Review: March 2027; Advisory Council Review: May 2027; Earliest Start Date: July 2027
• April 05, 2027 – Scientific Merit Review: July 2027; Advisory Council Review: August 2027; Earliest Start Date: December 2027
• September 05, 2027 – Scientific Merit Review: November 2027; Advisory Council Review: January 2028; Earliest Start Date: April 2028
• January 05, 2028 – Scientific Merit Review: March 2028; Advisory Council Review: May 2028; Earliest Start Date: July 2028
• April 05, 2028 – Scientific Merit Review: July 2028; Advisory Council Review: August 2028; Earliest Start Date: December 2028
• September 05, 2028 – Scientific Merit Review: November 2028; Advisory Council Review: January 2029; Earliest Start Date: April 2029
• January 05, 2029 – Scientific Merit Review: March 2029; Advisory Council Review: May 2029; Earliest Start Date: July 2029
• April 05, 2029 – Scientific Merit Review: July 2029; Advisory Council Review: August 2029; Earliest Start Date: December 2029

The expiration date for this opportunity is April 06, 2029.

Contact: NIH SEED (Small business Education and Entrepreneurial Development) – SEEDinfo@nih.gov | 301-402-2541