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. By providing awards to SBCs, the SBIR program supports the commercialization of innovative technologies and strengthens U.S. small businesses. The National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) use these programs to help US-owned and operated small businesses develop promising technologies and products that support their missions to enhance the health and well-being of all Americans. NIH, CDC and FDA are required to set-aside 3.2% of their extramural research budget for the SBIR program.
What this NOFO supports
This NOFO supports a small business to do the research and development (R&D) needed to develop a commercial product. The small business should propose to do the majority of the research or analytical effort, and the Program Director/Principal investigator (PD/PI) should be primarily employed by the small business. SBIR projects allow for limited research or analytical effort to be done by research partners or consultants. See eligibility requirements in Section III.
Small businesses should apply to STTR NOFO PA-27-102 if the project depends on a formal collaboration with a nonprofit research institution, such as a university. STTRs also allow the PD/PI of the project to be primarily employed by either the small business or nonprofit research partner. In both the SBIR and STTR programs, the award goes to the small business. Applicants are strongly encouraged to contact program staff prior to applying to help choose the best funding opportunity for their project.
The SBIR Program supports 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).
This NOFO accepts SBIR Phase I, Phase II, Direct to Phase II (NIH only), and Fast-Track (NIH only), grant applications from eligible United States SBCs.
NIH Fast-Track: The NIH Fast-Track allows both Phase I and Phase II of a project to be submitted and reviewed together as one application to reduce or eliminate the funding gap between phases.
NIH Direct to Phase II: 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, can apply for a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the 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.
Small businesses that are eligible to submit a Phase II application 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. SBIR Phase IIB Strategic Breakthrough grant applications should be submitted to PA-27-101.
Scientific and Technical Scope
Applications from eligible United States SBCs should propose a feasibility and/or R&D study that contributes to the missions of any NIH, CDC or FDA 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," the CDC Director's Statement of Priorities (https://www.cdc.gov/about/cdc/index.html), entitled "CDC Priorities," and the FDA's Mission Statement (https://www.fda.gov/about-fda/what-we-do#mission), entitled "FDA Mission."
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.
Staff within the NIH's Center for Scientific Review (CSR) office, the single receiving point for all NIH grant applications, will assign all applications to the most appropriate participating component. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form. Applicants are encouraged to contact the appropriate NIH Institute, Center, or Office they believe is the best fit for their proposed research prior to submission.
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 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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
All participating components of the Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER/FDA)
Center for Drug Evaluation and Research (CDER/FDA)
Human Foods Program (HFP/FDA)
Center for Devices and Radiological Health (CDRH/FDA)
Center for Veterinary Medicine (CVM/FDA)
