Forecasted · 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, Department of Health and Human Services
Key facts
Copied from the official Grants.gov record. Last verified October 29, 2026.
- Program name
- BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
- Issuing agency
- National Institutes of Health (Department of Health and Human Services)
- Opportunity number
- RFA-NS-28-006
- Funding type
- Cooperative Agreement
- Funding purpose
- Health
- Status
- Forecasted
- Application deadline
- Forecasted · estimated close January 28, 2027 (agency estimate)
- Agency estimates
- Estimated posting: December 10, 2026. Estimated award date: December 1, 2027. Estimates can change.
- Published award range
- Not published by the agency
- Estimated total program funding
- $10,000,000
- Expected number of awards
- 3
- Cost sharing or match required
- No
- Eligible applicants (official categories)
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Others (see Additional Information on Eligibility)
- Relevant to
- Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.
- Geographic restrictions
- None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.
- Assistance Listing (CFDA)
- 93.372, 93.853
- Official source
- View on Grants.gov ↗
- Application URL
- www.grants.gov/search-results-detail/363840 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.
- Source identifier
- Grants.gov opportunity ID 363840 · Funding opportunity number RFA-NS-28-006
- Posted
- September 10, 2026 · Source last updated September 10, 2026
- Last verified
- October 29, 2026 (against Grants.gov)
- Data completeness
- 92% of key fields published by the sourceNot published: published funding range.
- Record confidence
- mediumforecast — dates and amounts are agency estimates.
Eligibility details (from the agency)
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).
Description (from the official listing)
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…
Read the full description
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 intended use. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Agency contact
BRAIN Initiative Devices
NINDS-Devices@nih.gov