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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

RFA-NS-25-021

HHS-NIH11

General Information

Est. Program Funding:

September 28, 2026

Closing Date:

Expected No. of Awards

Award Ceiling

Opportunity Number:
RFA-NS-25-021

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

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.

Response Date	Sep 28, 2026 12:00:00 AM EDT
Posting Date	Nov 05, 2024 12:00:00 AM EST
Archive Date	Nov 03, 2026 12:00:00 AM EST
Award Ceiling
Award Floor
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on 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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-021.html
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

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