BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Forecasted Federal grant Posted
- Opportunity number
- RFA-NS-28-006
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications expected due
- Award size
- Not on record
Opportunity facts
- Expected posting
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
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- Health
- Eligible applicants
-
- State Governments
- Higher Education Inst. (Private)
- Tribal Organizations (Not Federally Recognized)
- Independent School Districts
- Higher Education Inst. (Public)
- County Governments
- Small Businesses
- For Profit Organizations
- Other
- 501(c)(3) Nonprofits
- Non-501(c)(3) Nonprofits
- City/Township Governments
- Special District Governments
- Public or Indian Housing Auth.
- Tribal Governments (Federally Recognized)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is forecasting a Notice of Funding Opportunity under the BRAIN Initiative to encourage first-in-human or early-stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders; applications are not being solicited at this time, and the source does not specify a hard deadline date.
Eligible applicants include state and local governments, federally recognized and non-federally recognized Indian tribes, public and private higher education institutions, small businesses, for-profit organizations, 501(c)(3) and non-501(c)(3) nonprofits, special district governments, public or Indian housing authorities, independent school districts, U.S. territories, faith-based or community-based organizations, regional organizations, and non-domestic entities.
This will be a cooperative agreement involving milestone-driven collaboration between funded investigators and assigned NIH program officers post-award. The NOFO will enable participation in the NIH BRAIN Initiative Public Private Partnership Program, facilitating partnerships between clinical investigators and device manufacturers to conduct CNS clinical research. Applications may pursue Non-Significant Risk devices (such as non-invasive devices) or Significant Risk devices requiring FDA Investigational Device Exemption (IDE), such as chronic implants. Clinical studies must provide data answering key questions about device function or final design that cannot be practically obtained through non-clinical assessments (bench-top or animal studies) due to device novelty or intended use.
Evaluation criteria include scientific merit and significance, technical adequacy of experimental design and approach, investigator competency, adequacy of facilities and resources, budget necessity, and relevance to announced program objectives. The opportunity falls under CFDA 93.372 (21st Century Cures Act—Brain Research through Advancing Innovative Neurotechnologies) and CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The source does not specify cost share requirements, award ceiling, floor, or expected number of awards.
Forecast synopsis
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.
Eligibility
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).
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