NIEHS SBIR Phase II
Supports United States. small businesses scaling environmental health technologies toward full development.
The NIEHS SBIR Phase II award, made under the R44 mechanism, provides approximately $2,000,000 over two years for full research and development and early commercialization of environmental health technologies. Phase II is the development and scale-up stage of the NIH SBIR pathway; applicants must have successfully completed a Phase I SBIR award before applying, as direct-to-Phase-II applications are rare exceptions. The companion STTR Phase II mechanism (R42) follows the same budget and duration structure but requires a continuing formal subcontract with the original research-institution partner, who must retain an active role in the Phase II work. NIEHS participates in NIH omnibus SBIR solicitations on grants.gov and applies standard NIH-wide rules.
Eligibility mirrors Phase I requirements: the applicant must be a U.S.-based for-profit small business with fewer than 500 employees, majority U.S.-owned and independently operated. Nonprofits, universities, and research organizations are not eligible as lead applicants. Venture-capital-majority companies may apply through NIH's special opt-in SBIR pathway. Phase II applications are expected to build directly on Phase I results, demonstrate that Phase I objectives were met, and present a credible plan for full development and commercialization. The scientific and commercial potential of the technology is evaluated during peer review.
NIEHS's SBIR portfolio spans exposure monitoring tools, environmental toxicity assays, occupational health devices, and related commercial technologies. The Phase II period of two years is intended to carry the project from demonstrated feasibility to a prototype or product ready for regulatory or commercial pathways. NIEHS program staff are available for pre-submission consultation to confirm that the proposed Phase II scope and commercialization plan align with institute priorities. Submission windows follow standard NIH omnibus SBIR deadlines, typically three cycles per year.
Continued development and commercialization of technologies addressing environmental health challenges; follows Phase I feasibility.
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