Cooperative AgreementPostedDiscretionary

BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)

National Institutes of Health
RFA-NS-25-021
Application Deadline
Sep 28, 2026
198 days left
Days Remaining
198
Until deadline
Award Ceiling
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) has announced a funding opportunity under the BRAIN Initiative, aimed at advancing the development of next-generation devices for recording and modulation in the human central nervous system (CNS). This initiative encourages investigators to engage in translational activities and small clinical studies that focus on therapeutic and diagnostic devices for CNS disorders, particularly those requiring an Investigational Device Exemption (IDE) from the FDA. The program is structured in two phases: the UG3 phase for regulatory activities and the UH3 phase for conducting clinical studies, with a total project period not exceeding five years. NIH anticipates allocating approximately $10 million per year to fund 5 to 7 awards, with applications due by September 28, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

Eligible Applicants

Others
Additional Eligibility Information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Grant Documents

2 Files
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RFA-NS-25-021.html
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AI Summary
The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) under the BRAIN Initiative, aimed at fostering the development of next-generation devices for recording and modulation in the human central nervous system (CNS). This funding opportunity encourages investigators to advance translational activities and small clinical studies focused on treating CNS disorders, explicitly supporting projects that require an Investigational Device Exemption (IDE) from the FDA. The program is structured in two phases: the UG3 phase for regulatory activities and the UH3 phase for conducting clinical studies, with a total project period not exceeding five years. A Plan for Enhancing Diverse Perspectives (PEDP) is mandatory, promoting inclusivity within research teams and populations served. The NIH anticipates allocating approximately $10 million per year to fund 5 to 7 awards, with specific budget limits set for each phase. Eligible applicants include a variety of institutions and organizations, with instructions provided for the application process, milestone tracking, and regulatory compliance. As part of the broader goals of the BRAIN Initiative, this NOFO aims to accelerate the understanding and treatment of brain disorders through innovative technologies and collaboration with private sector partners.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedNov 5, 2024
deadlineApplication DeadlineSep 28, 2026
expiryArchive DateNov 3, 2026

Funding Details

No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Income Security and Social Services
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.867

Official Sources