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

National Institutes of Health Nonprofit eligible

National Institutes of Health is funding education projects through this opportunity, which is open to nonprofits and other eligible applicants, with applications due Sep 28, 2026.

View & apply on Grants.gov
Deadline
Sep 28, 2026
Posted
Nov 5, 2024
Opportunity number
RFA-NS-25-021
CFDA
93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867

Opportunity description

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.

Who can apply

  • Small businesses
  • Private institutions of higher education
  • For profit organizations other than small businesses
  • State governments
  • County governments
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Special district governments
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • City or township governments
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

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.

Agency contact

National Institutes of Health

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Next steps to apply

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Official Grants.gov listing

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