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

ID: RFA-NS-21-023 • Type: Posted
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Description

The purpose of this Funding Opportunity Announcement (FOA) 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.

Overview

On 5/7/21 the National Institutes of Health posted grant opportunity RFA-NS-21-023 for BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) with funding of $10.0 million. The grant will be issued under grant program 93.173 Research Related to Deafness and Communication Disorders.

Timing

Posted Date
May 7, 2021, 12:00 a.m. EDT
Closing Date
Feb. 20, 2024, 12:00 a.m. EST Past Due
Last Updated
May 7, 2021, 1:48 p.m. EDT
Version
1
Archive Date
March 27, 2024

Eligibility

Eligible Applicants
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Native American tribal governments (Federally recognized)
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
County governments
Small businesses
Special district governments
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Private institutions of higher education
Additional Info
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); 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.

Award Sizing

Ceiling
$1,000,000
Floor
Not Listed
Estimated Program Funding
$10,000,000
Estimated Number of Grants
Not Listed

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
Contact Phone
(301) 402-2541

Documents

Posted documents for RFA-NS-21-023

Grant Awards

Grants awarded through RFA-NS-21-023

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