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FORECAST · COOPERATIVE AGREEMENT

BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System

National Institutes of Health · Health

Forecast. The agency expects to post this grant around Dec 10, 2026 (fiscal year 2028). Dates and amounts are estimates until the notice posts.
Expected deadline
Not stated
Who can apply
Others
Award range
Not stated
Expected awards
3
Total program funding
$10 million
Your own money required
No cost sharing or matching required
Opportunity number
RFA-NS-28-006
Posted
Sep 10, 2026
Assistance listing
93.853

More on who can apply

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

What it funds

The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative along with other NIH Institutes and Centers (ICs) intends to publish a Notice of Funding Opportunity (NOFO) to encourage investigators to pursue first-in-human or early-stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. This NOFO will be a part of a milestone-driven program, involving collaborative activities with the program officer(s)/director(s) assigned to the funded projects and joint responsibility for the successful management of the program post-award. This NOFO will allow participation in the NIH BRAIN Initiative Public Private Partnership Program which aims to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices to conduct clinical research in the CNS. Through the PPP, the BRAIN Initiative is interested in reducing barriers to negotiating such partnerships and ensuring that new clinical studies leverage manufacturers' existing data. Data demonstrating safety and utility of these devices are very costly to obtain and pose a substantial barrier to research progress.Applications may be Non-Significant Risk (NSR), such as non-invasive devices, or Significant Risk (SR) requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study is expected to provide data to answer key questions about the function or final design of a device and 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 inte…

Open the official notice on Grants.gov ↗

What to do next

  1. This is a forecast: the agency expects to post the full notice later. Open it on Grants.gov and subscribe there to be told when it posts.
  2. Get your SAM.gov registration ("all awards") and Grants.gov account active now; both take time.
  3. Use the forecast's award range and eligibility to decide whether to prepare.
  4. Watch for the notice; the dates here are estimates and can change.

New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: NINDS-Devices@nih.gov

From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.

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