The National Institutes of Health (NIH) is offering a grant to assist small businesses in developing advanced invasive devices for recording and stimulating the human central nervous system. This grant supports non-clinical and clinical studies to address nervous system disorders and enhance understanding of the human brain. Funding will cover activities such as prototype development, safety testing, regulatory approval, and a small clinical study to gather crucial data for device improvement. The final device design resulting from this grant will pave the way for more extensive clinical trials and market endorsement. Applications close on October 18, 2017, at 12:00 AM EDT.
Opportunity ID: 289234
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-17-007 |
| Funding Opportunity Title: | BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44) |
| 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: | 5 |
| 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: | $6,500,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: 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, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical study (e.g., Early Feasibility Study). 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. 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 non-clinical 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-17-007.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 | PKG00228328 | Nov 21, 2016 | Oct 18, 2017 | View |
Package 1
Mandatory forms
289234 RR_SF424_2_0-2.0.pdf
289234 PHS398_CoverPageSupplement_3_0-3.0.pdf
289234 RR_OtherProjectInfo_1_3-1.3.pdf
289234 PerformanceSite_2_0-2.0.pdf
289234 RR_KeyPersonExpanded_2_0-2.0.pdf
289234 RR_Budget_1_3-1.3.pdf
289234 PHS398_ResearchPlan_3_0-3.0.pdf
289234 SBIR_STTR_Information_1_1-1.1.pdf
Optional forms
289234 RR_SubawardBudget30_1_3-1.3.pdf
289234 PHS_Inclusion_Enrollment_Report-1.0.pdf
289234 PHS_AssignmentRequestForm-1.0.pdf
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