BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) 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).

Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants.

The clinical trial should provide data to answer key questions about the function or final design of a device.

This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval.

The clinical trial is expected to provide information 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.

Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.

As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.

In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data.

For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm
Related Programs

Research Related to Deafness and Communication Disorders

Department of Health and Human Services


Research and Training in Complementary and Alternative Medicine

Department of Health and Human Services


Mental Health Research Grants

Department of Health and Human Services


Alcohol Research Programs

Department of Health and Human Services


Drug Abuse and Addiction Research Programs

Department of Health and Human Services


Discovery and Applied Research for Technological Innovations to Improve Human Health

Department of Health and Human Services


Extramural Research Programs in the Neurosciences and Neurological Disorders

Department of Health and Human Services


Child Health and Human Development Extramural Research

Department of Health and Human Services


Aging Research

Department of Health and Human Services


Vision Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: National Institutes of Health

Estimated Funding: $10,000,000


Who's Eligible





Obtain Full Opportunity Text:
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-024.html

Additional Information of 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 Institutions) 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.

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-024.html

Contact:


Agency Email Description:
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Agency Email:


Date Posted:
2021-05-07

Application Due Date:


Archive Date:
2024-03-27


Millennials often get flak for being picky, narcissistic and fickle, especially when it comes to doing business. While unemployment struggles often reach more people in younger generations, these seven millennial entrepreneurs featured in the Huffington Post are too busy creating positive social impact, changing other people’s lives and theirs.




Social Services Jobs

  Fundraising & Development Jobs
  Education Jobs
  Program Director Jobs
  Executive Director Jobs
  Social Services Jobs





More Federal Domestic Assistance Programs


Conservation Activities by Youth Service Organizations | Emergency Food and Shelter National Board Program | National Prison Rape Statistics Program | Boating Safety Financial Assistance | Affordable Care Act - Teaching Health Center Graduate Medical Education Payments Program |  Site Style by YAML | Grants.gov | Grants | Grants News | Sitemap | Privacy Policy


Edited by: Michael Saunders

© 2004-2024 Copyright Michael Saunders