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

Closed Posted

Opportunity number
RFA-NS-25-021
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Categories
  • Income Security and Social Services
  • Health
  • Education
Eligible applicants
  • Non-501(c)(3) Nonprofits
  • Higher Education Inst. (Private)
  • Other
  • Tribal Organizations (Not Federally Recognized)
  • Special District Governments
  • Higher Education Inst. (Public)
  • For Profit Organizations
  • County Governments
  • Independent School Districts
  • City/Township Governments
  • Public or Indian Housing Auth.
  • 501(c)(3) Nonprofits
  • Small Businesses
  • Tribal Governments (Federally Recognized)
  • State Governments
Points of contact
Full announcement

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health is soliciting applications for the BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional), a milestone-driven cooperative agreement program, with applications due September 28, 2026. Non-domestic entities and foreign components of U.S. organizations are ineligible; however, a broad spectrum of domestic applicant types may apply, including nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, higher education institutions (public and private), small businesses, tribal governments (federally recognized), state and local governments, and special district governments. Other eligible applicants include faith-based and community-based organizations, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and AANAPISIs.

The program supports translational activities and small clinical studies advancing therapeutic and diagnostic device development for disorders affecting the nervous or neuromuscular systems. Eligible activities include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation, obtaining an Investigational Device Exemption for Significant Risk studies, and conducting a subsequent small clinical study. The clinical study must provide information about device function or final design that cannot be obtained through non-clinical assessment because of device novelty or intended use.

This is a milestone-driven cooperative agreement requiring NIH program staff participation in negotiating the final project plan before award and monitoring research progress throughout the performance period. No award ceiling, award floor, or number of awards is specified in the source material. Cost share requirements are not stated. The period of performance and specific evaluation criteria are not detailed in the source.

Assistance Listing numbers 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), 93.279 (Drug Use and Addiction Research Programs), 93.865 (Child Health and Human Development Extramural Research), 93.173 (Research Related to Deafness and Communication Disorders), 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), 93.213 (Research and Training in Complementary and Integrative Health), and 93.866 (Aging Research) are listed as parent grant programs.

Synopsis

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.

Eligibility

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.

Files

File Type Posted
RFA-NS-25-021-Full-Announcement.html HTML file
PKG00288476.pdf PDF

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