The NIH BRAIN Initiative is offering a grant to support small clinical studies aimed at advancing recording and stimulating devices for treating central nervous system disorders and enhancing understanding of the human brain. The studies should provide crucial data to inform the development of next-generation devices, including those requiring Investigational Device Exemption, and address key questions about device functionality. These clinical studies are essential for progressing towards advanced trials and market approval, particularly for novel devices. The funding supports activities that cannot be feasibly achieved through non-clinical assessments, focusing on the unique aspects of the device and its intended applications. Closing Date: October 18, 2017.
Opportunity ID: 289235
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-17-006 |
| Funding Opportunity Title: | BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.173 — Research Related to Deafness and Communication Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 29, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 18, 2017 |
| Current Closing Date for Applications: | Oct 18, 2017 |
| Archive Date: | Nov 18, 2017 |
| Estimated Total Program Funding: | $10,000,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State governments Independent school districts Special district governments Native American tribal governments (Federally recognized) Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical study 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 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 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 study to answer key questions about the function or final design of a device. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-17-006.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00228330 | Nov 21, 2016 | Oct 18, 2017 | View |
Package 1
Mandatory forms
289235 RR_SF424_2_0-2.0.pdf
289235 PHS398_CoverPageSupplement_3_0-3.0.pdf
289235 RR_OtherProjectInfo_1_3-1.3.pdf
289235 PerformanceSite_2_0-2.0.pdf
289235 RR_KeyPersonExpanded_2_0-2.0.pdf
289235 RR_Budget_1_3-1.3.pdf
289235 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
289235 RR_SubawardBudget30_1_3-1.3.pdf
289235 PHS_Inclusion_Enrollment_Report-1.0.pdf
289235 PHS_AssignmentRequestForm-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
