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

The summary for the BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.
BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required): 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 trial (e.g., Early Feasibility Study). The small 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 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 trial. 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/.
Federal Grant Title: BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required)
Federal Agency Name: National Institutes of Health (HHS-NIH11)
Grant Categories: Education Health Income Security and Social Services
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-NS-18-021
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867
CFDA Descriptions: Information not provided
Current Application Deadline: October 21st, 2020
Original Application Deadline: October 21st, 2020
Posted Date: December 21st, 2017
Creation Date: December 21st, 2017
Archive Date: November 26th, 2020
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching: No
Last Updated: December 21st, 2017
Applicants Eligible for this Grant
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 text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on 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.
Link to Full Grant Announcement
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-021.html
Grant Announcement Contact
NIH OER Webmaster
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