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

Background The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs (also known as America's Seed Fund) are major sources of early-stage funding for U.S. technology development and commercialization. NIH SBIR and STTR awards support projects through multiple phases: Phase I: Establish the technical merit and feasibility of the proposed R&D. Phase II: Continue R&D to advance toward commercialization. After Phase II, NIH expects small business concerns (SBCs) to fully commercialize the product or technology using non-SBIR/STTR funds (federal or non-federal). However, biomedical projects may need additional support because of a significant funding gap between Phase II and commercialization (known as the "Valley of Death"). This is a particular challenge for technologies that need regulatory approval, use new complex manufacturing methods, or target small markets. What this NOFO supports This SBIR Phase IIB Strategic Breakthrough NOFO provides previous NIH SBIR or STTR Phase II recipients support to bridge the gap between the Phase II and commercialization. Applicants must secure 100% third-party matching funds for the proposed Phase IIB Strategic Breakthrough award project. SBCs must demonstrate not less than 100% matching funds from: new private capital (e.g. another company, venture capital firm or other private investor) OR new funding awarded by a government agency (other than a Phase I or II SBIR or STTR award) OR any combination of the above Phase II recipients should consider the Commercialization Readiness Pilot (CRP) program when they need additional technical assistance and/or later-stage R&D, but do not have third-party matching funding and/or require a significant amount of the work to be outsourced. The CRP program can also support small businesses that need additional support during an active Phase II award. See PAR-27-098. Applicants are strongly encouraged to contact program staff prior to applying to help choose the best funding opportunity for their project. Note: This NOFO accepts Renewal/Resubmission "Type 2" Applications from previous recipients of NIH SBIR or STTR Phase II awards. SBCs must meet the eligibility requirements in Section III. Scientific and Technical Scope The NIH Phase IIB Strategic Breakthrough award provides a second Phase II award to support follow-on R&D. Applications are encouraged for projects that demonstrate strong commercial potential (i.e., the likelihood that a technology will lead to an effective, successful product), and need extra time, effort and funds after Phase II to succeed. Commercial potential will be emphasized during review and when selecting awards (refer to Section V for details). Applications from eligible United States SBCs should propose a R&D study that contributes to the missions of any NIH components participating in this NOFO. See NIH Institutes, Centers, and Offices and Small Business Funding Considerations and Contacts for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations. See the NIH Director's Statement of Priorities (https://www.nih.gov/about-nih/nih-director/statements/advancing-nihs-mission-through-unified-strategy), entitled "Advancing NIH's Mission Through a Unified Strategy." Applicants and recipients are encouraged to also refer to the Make Our Children Healthy Again Strategy (https://www.whitehouse.gov/maha/) when structuring their applications. Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed: Applications to this Parent NOFO may include clinical trial(s). However, the following organizations, Institutes and Centers DO NOT ACCEPT clinical trials under this NOFO and applications that propose a clinical trial and only align with the mission of one of the following components are not responsive to this NOFO and will not be reviewed: National Center for Advancing Translational Sciences (NCATS) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)