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

National Institutes of Health

Funding

Varies

About

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.

Applicant types

Grants.gov eligibility code 00 Grants.gov eligibility code 01 Grants.gov eligibility code 02 Grants.gov eligibility code 04 Grants.gov eligibility code 05 Grants.gov eligibility code 06 Grants.gov eligibility code 07 Grants.gov eligibility code 08 Grants.gov eligibility code 11 Grants.gov eligibility code 12 Grants.gov eligibility code 13 Grants.gov eligibility code 20 Grants.gov eligibility code 22 Grants.gov eligibility code 23 Grants.gov eligibility code 25

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National Institutes of Health

The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Cl

Notice-specific evidence check

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

Applicant evidence

Applicant type: State governments
Applicant type: County governments
Applicant type: City or township governments
Applicant type: Special district governments
Applicant type: Independent school districts
Applicant type: Public and state-controlled institutions of higher education
Applicant type: Federally recognized tribal governments
Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

Recorded deadline: September 29, 2026; confirm time zone and submission system.
Recorded focus: Education
Recorded focus: Health
Recorded focus: Information and statistics

Do not infer missing fields: award amount. Absence from this directory record is not evidence that a restriction does not exist.

Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

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

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

• Applicant types: Grants.gov eligibility code 00, Grants.gov eligibility code 01, Grants.gov eligibility code 02, Grants.gov eligibility code 04, Grants.gov eligibility code 05, Grants.gov eligibility code 06.
• Geographic scope is not structured in this record.
• Notice summary: 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.

Focus areas: ED, HL, ISS

Recorded deadline

September 28, 2026 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Open official notice →

Last directory verification: Sep 13, 2026.