The National Institutes of Health BRAIN Initiative aims to support small business concerns in conducting small clinical studies to advance recording and stimulating devices for treating central nervous system disorders. The grant supports studies that provide essential data on device functionality and design, including acute or short-term procedures that are Non-Significant Risk or Significant Risk studies requiring FDA approval. This opportunity is crucial for advancing innovative devices for understanding the human brain and may lead to further clinical trials and market approval. Applications for this grant close on April 26, 2016.
Opportunity ID: 280642
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-16-018 |
| Funding Opportunity Title: | BRAIN Initiative: SBIR Direct to Phase II 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: | 93.213 — Research and Training in Complementary and Integrative Health |
| 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: | $1,500,000 |
| 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 a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and thereby 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-16-018.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 | PKG00220204 | Mar 26, 2016 | Apr 26, 2016 | View |
Package 1
Mandatory forms
280642 RR_SF424_2_0-2.0.pdf
280642 PHS398_ResearchPlan_2_0-2.0.pdf
280642 SBIR_STTR_Information_1_1-1.1.pdf
280642 RR_KeyPersonExpanded_2_0-2.0.pdf
280642 RR_OtherProjectInfo_1_3-1.3.pdf
280642 RR_Budget_1_3-1.3.pdf
280642 PerformanceSite_2_0-2.0.pdf
280642 PHS398_CoverPageSupplement_2_0-2.0.pdf
Optional forms
280642 RR_SubawardBudget30_1_3-1.3.pdf
280642 PlannedReport-1.0.pdf
280642 PHS398_CumulativeInclusionReport-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
