Solutions to Enable Regional Genomic Medicine eConsult Services (R43/R44 Clinical Trial Optional)

This Notice of Funding Opportunity (NOFO) invites applications from eligible small businesses to develop solutions for commercialization that can be used to enable regional clinician-to-clinician genomic medicine eConsult services. Specifically, we seek products, such as technologies or services, that will allow for the development and sustainment of eConsult services. Eligible United States small business concerns (SBCs) may submit Small Business Innovation Research (SBIR) Phase I, Direct to Phase II, and Fast-Track grant applications. Small business applicants interested in submitting a Small Business Technology Transfer (STTR) grant application should submit to the related funding opportunity, PAR-24-107. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH Fast-Track: An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Direct to Phase II: For small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, NIH can issue a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Direct to Phase II awards should be submitted as “New” applications and not continuations ("Renewal") of Phase I SBIR or STTR projects.