Grant✓ Small businesses may apply
BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
National Institutes of Health
- Opportunity #
- RFA-NS-25-021
- Agency
- National Institutes of Health
- ALN (CFDA)
- 93.866, 93.867, 93.242, 93.213, 93.865, 93.173, 93.853, 93.286, 93.273, 93.279
- Status
- posted
- Posted
- Nov 5, 2024
- Closes
- Sep 28, 2026
- Funding instrument
- Cooperative Agreement
- Category
- Education, Health, Income Security and Social Services
- Cost sharing required
- No
Who can apply
- •Public housing authorities/Indian housing authorities
- •City or township governments
- •Native American tribal organizations (other than Federally recognized tribal governments)
- •Others (see text field entitled "Additional Information on Eligibility" for clarification)
- •For profit organizations other than small businesses
- •State governments
- •Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- •Public and State controlled institutions of higher education
- •Small businesses
- •Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- •Independent school districts
- •County governments
- •Private institutions of higher education
- •Native American tribal governments (Federally recognized)
- •Special district governments
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.
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.
Contact
National Institutes of Health · grantsinfo@nih.gov