The National Institutes of Health (NIH) is offering a grant to support small businesses in developing recording and stimulation devices for treating nervous system disorders. This grant aims to facilitate translational non-clinical and clinical studies to enhance understanding of the human brain. The funding will assist in device prototype implementation, safety testing, design validation, regulatory approval, and conducting a small clinical study. The research outcomes are expected to provide valuable insights not achievable through traditional non-clinical assessments, ultimately advancing towards advanced clinical trials and market approval. Applications are due by April 26, 2016.
Opportunity ID: 280641
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-16-011 |
| 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: | Dec 18, 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: | $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-16-011.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 | PKG00220213 | Mar 26, 2016 | Apr 26, 2016 | View |
Package 1
Mandatory forms
280641 RR_SF424_2_0-2.0.pdf
280641 PHS398_ResearchPlan_2_0-2.0.pdf
280641 SBIR_STTR_Information_1_1-1.1.pdf
280641 RR_KeyPersonExpanded_2_0-2.0.pdf
280641 RR_OtherProjectInfo_1_3-1.3.pdf
280641 RR_Budget_1_3-1.3.pdf
280641 PerformanceSite_2_0-2.0.pdf
280641 PHS398_CoverPageSupplement_2_0-2.0.pdf
Optional forms
280641 RR_SubawardBudget30_1_3-1.3.pdf
280641 PlannedReport-1.0.pdf
280641 PHS398_CumulativeInclusionReport-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
