The National Institute of Neurological Disorders and Stroke is offering a grant for small clinical studies that focus on advancing recording and stimulating devices to treat central nervous system disorders and enhance understanding of the human brain. These studies can involve acute or short-term procedures classified as Non-Significant Risk or Significant Risk by IRB, potentially requiring an IDE from the FDA. The goal is to gather vital data on device function and design, crucial for progressing to advanced clinical trials and eventual market approval. This grant aims to provide insights not feasible through nonclinical assessments due to device novelty or intended use. Closing date: Apr 14, 2015.
Opportunity ID: 272928
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-15-008 |
| 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: | Feb 03, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 14, 2015 |
| Current Closing Date for Applications: | Apr 14, 2015 |
| Archive Date: | May 15, 2015 |
| Estimated Total Program Funding: | $3,000,000 |
| Award Ceiling: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments City or township governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) State governments Small businesses 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); 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 not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this FOA is to encourage applications 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, 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-15-008.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 | PKG00213203 | Mar 14, 2015 | Apr 14, 2015 | View |
Package 1
Mandatory forms
272928 RR_SF424_2_0-2.0.pdf
272928 PHS398_ResearchPlan_2_0-2.0.pdf
272928 PHS398_CoverPageSupplement_2_0-2.0.pdf
272928 RR_Budget_1_3-1.3.pdf
272928 RR_KeyPersonExpanded_2_0-2.0.pdf
272928 RR_OtherProjectInfo_1_3-1.3.pdf
272928 PerformanceSite_2_0-2.0.pdf
Optional forms
272928 PlannedReport-1.0.pdf
272928 PHS398_CumulativeInclusionReport-1.0.pdf
272928 RR_SubawardBudget30_1_3-1.3.pdf
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