NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)
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The National Institutes of Health, through various institutes and centers including NCI, NIAID, and NIMH, is issuing a Notice of Funding Opportunity for Small Business Innovation Research SBIR Phase IIB Strategic Breakthrough awards under activity code R44. This initiative is specifically designed to support United States small business concerns in bridging the funding gap between Phase II R&D and full commercialization, often referred to as the Valley of Death. The award targets projects requiring extraordinary time and effort, such as those involving complex instrumentation, behavioral interventions, or the pursuit of regulatory approvals. Eligible small businesses must demonstrate at least 100 percent matching funds to be considered for this award. While the forecast was posted in June 2025, the formal notice PA-27-101 is scheduled for posting on May 28, 2026, with an opening date of August 5, 2026. Application deadlines will extend through 2029, with the program officially expiring on April 6, 2029. This opportunity encourages collaborative investigations and is intended for entities with the technological expertise to advance the R&D missions of the participating NIH components.
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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.
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