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 often need specialized studies or product development services (for example, market research) to commercialize or attract third-party investment. This additional work is often outsourced to contract research organizations (CROs).
Some NIH Institutes, Centers, and Offices (ICOs) participate in the Phase IIB Strategic Breakthrough program PA-27-101, which provides a second Phase II award to help bridge this gap, but those awards limit the amount of work that can be outsourced and require matching funds.
What this NOFO Supports
The Commercialization Readiness Pilot (CRP) NOFO provides later-stage research and development and technical assistance to NIH SBIR or STTR Phase II recipients. The CRP program can support R&D that requires significant outsourcing and/or is needed during an active Phase II awards. This funding opportunity requires a prior (active or ended) NIH Phase II award. New SBIR Phase I and II grant applications should be submitted to PA-27-100 and STTR Phase I and II grant applications should be submitted to PA-27-102.
Phase II recipients that need significant R&D funding to bridge the gap between the SBIR or STTR Phase II award and commercialization should consider the Phase IIB Strategic Breakthrough. See PA-27-101. 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 New "Type 1" Applications from recipients of NIH SBIR or STTR Phase II awards or an NIH SBIR or STTR Phase IIB Strategic Breakthrough award.
SBCs must meet the eligibility requirements in Section III.
Scientific/Technical Scope
SBCs may propose to do technical assistance, later-stage R&D activities, or both in the application.
Applications from eligible United States SBCs should propose a technical assistance and/or 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.
Some examples of activities within scope include (but are not limited to):
Technical Assistance:
Regulatory strategy and submissions
Intellectual property (IP) strategy
Manufacturing technical assistance
Other third-party technical assistance (e.g. market research)
Late Stage Research and Development Activities:
Independent replication or confirmation of key studies.
Development and optimization or manufacturing methods.
Activities to bring development under Design and Quality Systems Control.
Device, Drug, and Biologic-related pre-clinical product development.
Clinical studies and clinical trials (Note: Not every NIH participating component accepts clinical trials through this NOFO. See "Applications Not Responsive to this NOFO" below.)
Outsourcing and project oversight
Applicants may outsource a significant portion of CRP work. The expert services should fit the work proposed and be well justified in the application. The SBC must perform a substantial role in oversight and management of the proposed work, which should be reflected in the budget. This includes appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.
Costs and requests not allowed
CRP awards cannot pay filing fees or FDA submission filing fees.
CRP applications cannot include separate Technical and Business Assistance (TABA) funding.
Further information about the CRP program 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 Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
