At a glance
This program funds milestone-driven regulatory work and a small early clinical study for next-generation recording and/or stimulating devices for central nervous system disorders and human brain research. Applicants may be institutions or businesses, including companies and researchers with existing collaborations, and projects must focus on a single CNS condition within the mission of a participating BRAIN Initiative institute. Each project has a one-year UG3 phase and a UH3 phase of one to four years, with a total project period of no more than five years. The notice does not state the award size or number of awards, and it does not mention cost-share requirements. Applications proposing only non-significant-risk studies, animal studies, basic research, healthy-person augmentation, or technologies for non-CNS uses are not responsive.
What it funds
Official description from grants.gov
The purpose of this announcement is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments