Funding Opportunity Number: RFA-NS-25-021
Issuing agency: National Institutes of Health BRAIN Initiative, led by participating NIH Institutes and Centers.
Application deadline: September 28, 2026 at 5:00 PM local time of the applicant organization.
Funding: NIH anticipates approximately $10 million per year for an estimated 5 to 7 awards. Applicants must not exceed $500,000 in direct costs per year during the UG3 phase and should rarely exceed $1,500,000 in direct costs per year during the UH3 phase. UG3 may not exceed one year, UH3 may not exceed four years, and total duration may not exceed five years. Cost sharing is not required.
Purpose: This milestone-driven UG3/UH3 cooperative agreement supports translational activities and small clinical studies for next-generation recording and/or stimulating devices intended to treat central nervous system disorders or advance understanding of the human brain. It includes regulatory work needed to obtain an FDA Investigational Device Exemption for Significant Risk studies and a subsequent small first-in-human or early-stage clinical study.
Program requirements: Only Significant Risk clinical studies that require an FDA IDE, such as chronic implants, are supported when a clinical study is proposed. Projects must use quantitative milestones and go/no-go criteria. NIH strongly encourages consultation with program staff when planning an application, preferably well before the receipt date. Device developers may apply directly or collaborate with manufacturers, including through the BRAIN Public-Private Partnership where appropriate.
Eligibility: Eligible domestic organizations include public and private institutions of higher education, nonprofit organizations, small businesses and other for-profit organizations, state and local governments, Tribal governments and organizations, eligible federal agencies and U.S. territories, independent school districts, public and Indian housing authorities, faith-based and community-based organizations, and regional organizations. Foreign organizations and non-U.S. components of U.S. organizations are not eligible; foreign components are allowed subject to NIH policy.
Atlas assessment: Very strong medical-device, neuroscience, neurotechnology, regulatory, and translational-development relevance. Structural for-profit eligibility creates a possible direct-vendor path only if Dr. Miltie can independently demonstrate a qualifying CNS device program, IP or manufacturer collaboration, FDA/IDE strategy, engineering and clinical expertise, milestone plan, and compliant institutional research infrastructure. Absent that evidence, the recommended posture is Partner-Led / Neurotechnology Device Development Team.
Atlas score: 96/100.