RFA-NS-25-021-Full-Announcement.html

This document is a Request for Applications (RFA) for the BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) federal grant opportunity.

The purpose of this RFA is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders affecting the nervous or neuromuscular systems. Eligible applicants include non-501(c)(3) nonprofits, government entities, small businesses, and higher education institutions. The funding instrument is a cooperative agreement, and the anticipated award budget is unspecified. Key focus areas include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification, obtaining Investigational Device Exemption (IDE), and conducting a subsequent small clinical study. This RFA is a milestone-driven program involving NIH program staff participation. The federal grant programs associated with this opportunity span mental health, alcohol research, drug use and addiction, child health, deafness/communication disorders, biomedical technology, neurosciences, aging, and complementary/integrative health.