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	N/a
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

Native American tribal governments (Federally recognized), 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, County governments, Special district governments, Small businesses, Public and State controlled institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, City or township governments, Independent school districts, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, State governments, Public housing authorities/Indian housing authorities

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

CFDA Program(s)

• 93.173: Research Related to Deafness and Communication Disorders
• 93.213: Research and Training in Complementary and Integrative Health
• 93.242: Mental Health Research Grants
• 93.273: Alcohol Research Programs
• 93.279: Drug Use and Addiction Research Programs
• 93.286: Discovery and Applied Research for Technological Innovations to Improve Human Health
• 93.853: Extramural Research Programs in the Neurosciences and Neurological Disorders
• 93.865: Child Health and Human Development Extramural Research
• 93.866: Aging Research
• 93.867: Vision Research