Overview

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. Administered by the National Institutes of Health, this opportunity provides additional support for later-stage research and development (R&D) to help technologies advance toward market, particularly those facing regulatory approval, complex manufacturing, or small-market challenges. Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to apply.

Funding and Matching Requirements

Applicants must secure and demonstrate not less than 100% third-party matching funds for the proposed Phase IIB Strategic Breakthrough award project. Matching funds may come from:

• New private capital (e.g., another company, venture capital firm, or other private investor);
• New funding awarded by a government agency (other than a Phase I or II SBIR or STTR award); or
• Any combination of the above.

No award ceiling or floor is specified for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project.

Eligibility

Eligible applicants are limited to United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award. Non-domestic (non-U.S.) entities and non-domestic 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. This funding opportunity accepts 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.

Phase II recipients that require additional technical assistance or later-stage R&D but do not have third-party matching funding or need to outsource a significant amount of work are encouraged to consider the Commercialization Readiness Pilot (CRP) program instead.

Application Process

Applicants must follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide, except where instructed otherwise in the notice of funding opportunity or in a Notice from the NIH Guide for Grants and Contracts. Conformance to all requirements is required and strictly enforced. Applications that do not comply may be delayed or not accepted for review.

Submission options include:

• NIH ASSIST system to prepare, submit, and track applications online;
• An institutional system-to-system (S2S) solution to prepare and submit applications via Grants.gov and eRA Commons; or
• Grants.gov Workspace to prepare and submit applications, with tracking through eRA Commons.

Deadline and Timeline

Posted Date: May 28, 2026

Open Date (Earliest Submission Date): August 5, 2026

Expiration Date: April 6, 2029

Applications are accepted on standard NIH due dates marked with an asterisk. The following due dates apply for Renewal/Resubmission applications:

• September 5, 2026 *
• January 5, 2027 *
• April 5, 2027 *
• September 5, 2027 *
• January 5, 2028 *
• April 5, 2028 *
• September 5, 2028 *
• January 5, 2029 *
• April 5, 2029 *

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

Contact Information

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