NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): NCI, NEI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDDK, NIGMS, NIMH, NIMHD, NINDS, NCATS, ORIP, and ORWH, intends to publish a Notice of Funding Opportunity (NOFO) to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough grant applications. The main objective of a SBIR/STTR Phase II award is to continue R&D efforts to advance a technology toward commercialization. If the technology is not available for sale or use by the end of the SBIR/STTR Phase II award, the SBC must use non-SBIR/STTR funds to reach market access. This funding gap, between the end of the SBIR/STTR Phase II award and customer access, which affects most medical biotechnology products, is known as the Valley of Death. The NIH Phase IIB Strategic Breakthrough award provides additional support to mitigate this funding gap for projects that require extraordinary time and effort, including those requiring regulatory approval or are developing complex instrumentation, clinical research tools, or behavioral interventions.

Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R44 activity code. United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise will be encouraged and these investigators should also begin considering applying for this application. Prospective applicants should keep in mind that they must demonstrate not less than 100 percent matching funds to be considered for a Phase IIB Strategic Breakthrough award.