NIH BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Funding opportunity: RFA-NS-25-022
Status: Open
Next deadline: September 28, 2026 at 5:00 PM in the applicant organization’s local time.
Funding: NIH anticipates approximately $10 million per year for an estimated 5 to 7 awards. Application budgets are not capped, but NIH states that budgets should rarely exceed $1.5 million in direct costs per year. The total project period may not exceed five years.
Program focus
This BRAIN Initiative UH3 cooperative agreement supports milestone-driven first-in-human and early-stage clinical investigations of next-generation devices with recording and/or stimulation capabilities for central nervous system disorders and human brain research. Only significant-risk studies requiring an FDA Investigational Device Exemption, such as chronic implant studies, are supported. Projects must have completed the nonclinical testing needed to obtain an IDE before entry, and FDA and IRB approvals must be obtained before award issuance.
Eligibility
Eligible U.S. applicants 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, independent school districts, public housing authorities, eligible federal agencies, faith-based and community organizations, and regional organizations. Foreign organizations and foreign components of U.S. organizations are not eligible, although allowable foreign components may participate as defined by NIH policy.
Submission, match, and required planning
No cost sharing is required. Applications may be prepared through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution and must follow the NIH Research instructions plus this NOFO’s program-specific requirements. Required planning materials include a Needs Assessment, Intellectual Property Strategy, Team Management Plan, Gantt chart, and a Long-term Care Plan for Patients. The application must also include a Technology Translation Plan with quantitative, milestone-driven go/no-go criteria and must address design controls and quality systems appropriate to the device and regulatory pathway.
Direct Dr. Miltie path
Small businesses and other for-profit organizations are structurally eligible, and NIH states that institutions or businesses developing their own devices, or those with established device-manufacturer collaborations, may apply directly. However, this is not a submission-ready direct path absent evidence that Dr. Miltie owns, controls, or has a formal collaboration for a qualifying significant-risk CNS recording or stimulation device; has completed the necessary nonclinical testing; has a credible IDE and FDA pathway; and has the required PI, clinical sites, IRB capability, patient recruitment, quality systems, IP strategy, regulatory documentation, long-term patient-care planning, and quantitative milestones. The appropriate current classification is Dr. Miltie Direct / Structural Eligibility Only / Needs Marc Review.
Atlas routing
This is a high-fit healthcare technology and clinical research opportunity. Organization-specific applicant evaluation and any outreach should be handled through the applicable state healthcare and academic-health pathways. Do not initiate a direct federal package until the device, regulatory, scientific, clinical, and organizational prerequisites are independently substantiated.