NIH SBIR

NIH SBIR Direct-to-Phase II (Omnibus)

Funds United States small businesses moving directly into major development when early biomedical feasibility is already established.

The NIH SBIR Direct-to-Phase II (D2PII) Omnibus allows U.S. small businesses to apply directly for Phase II-level funding without a prior NIH Phase I award, provided the company can demonstrate that Phase I-equivalent feasibility has already been established through other means. Issued under activity code R44 as a "New" application (not a renewal), D2PII awards carry the same cap as standard Phase II — up to $2,045,816 in total costs over one to three years — and access the same approximately $80 million annual pool allocated to this mechanism across participating NIH institutes and centers.

Eligibility is identical to standard Phase II: U.S. small business concerns of 500 or fewer employees, majority U.S.-owned, with the company performing at least 50% of the funded effort. Not all NIH institutes and centers offer D2PII; applicants must verify availability in the parent NOFO and IC-specific guidance before applying. Critically, the application must include data and documentation equivalent in scope and rigor to what a completed NIH Phase I would have produced — typically published research results, prior federal agency awards (e.g., DOD SBIR, DOE, NSF), internal proof-of-concept studies, or funded academic collaborations. The burden of demonstrating prior feasibility is on the applicant and is rigorously evaluated by reviewers.

FY25 D2PII success rates were approximately 12%, modestly higher than standard Phase I (8%) and reflecting the smaller, more pre-selected applicant pool. Standard receipt dates mirror all NIH SBIR mechanisms: September 5, January 5, and April 5; successor NOFOs are expected before the September 2026 cycle following the April 2026 reauthorization. D2PII is best suited to spinouts from academic labs, companies that received non-NIH federal SBIR awards, or organizations that built feasibility data through foundation grants or internal corporate R&D — where the technology readiness is genuinely at Phase I-completion level but the company never entered the NIH SBIR Phase I queue.