(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application. Total funding support (direct costs, indirect costs, fee) normally may not exceed $295,924 for Phase I awards and $1,972,828 for Phase II awards. NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics. The current list of approved topics can be found at https://sbir.nih.gov/funding.

Applications should not exceed $700,000 in total cost for Phase I, with no more than $500,000 total costs in any year, and $3,000,000 total costs for Phase II with no more $1,500,000 in total cost in any year.