The National Institutes of Health (NIH) is offering a grant to support small clinical studies focusing on advancing invasive devices for recording and stimulating the central nervous system. These studies aim to provide crucial information for the development of devices to treat CNS disorders and enhance understanding of the human brain. Projects may include acute or short-term procedures classified as Non-Significant Risk (NSR) or Significant Risk (SR) studies requiring FDA approval, with a focus on addressing key questions related to device function and design. This grant is ideal for researchers seeking to bridge the gap between non-clinical testing and advanced clinical trials.
Opportunity ID: 279059
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-16-010 |
| 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 17, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 26, 2016 |
| Current Closing Date for Applications: | Apr 26, 2016 |
| Archive Date: | May 27, 2016 |
| Estimated Total Program Funding: | $13,500,000 |
| Award Ceiling: | $2,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities State governments For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education County governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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); 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-16-010.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-C | FORMS-C | PKG00218547 | Mar 26, 2016 | Apr 26, 2016 | View |
Package 1
Mandatory forms
279059 RR_SF424_2_0-2.0.pdf
279059 PHS398_ResearchPlan_2_0-2.0.pdf
279059 PHS398_CoverPageSupplement_2_0-2.0.pdf
279059 RR_Budget_1_3-1.3.pdf
279059 RR_KeyPersonExpanded_2_0-2.0.pdf
279059 RR_OtherProjectInfo_1_3-1.3.pdf
279059 PerformanceSite_2_0-2.0.pdf
Optional forms
279059 PlannedReport-1.0.pdf
279059 PHS398_CumulativeInclusionReport-1.0.pdf
279059 RR_SubawardBudget30_1_3-1.3.pdf
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