BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility Study). The small clinical study 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 study is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study.
General information about this opportunity
Last Known Status
Active
Program Number
RFA-NS-16-009
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Cooperative Agreement
Who is eligible to apply/benefit from this assistance?
Applicant 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); 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.
What is the process for applying and being award this assistance?
Deadlines
04/26/2016
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Headquarters Office
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-009.html
E-mail Address
FBOWebmaster@OD.NIH.GOV
Financial Information
Obligations
$13,500,000.00
Range and Average of Financial Assistance
Awards up to $2,000,000.00
