The National Institutes of Health (NIH) is offering a grant to support translational and clinical studies focusing on recording and stimulating devices to treat nervous system disorders and enhance understanding of the human brain. This grant aims to facilitate Investigational Device Exemption (IDE) submission for clinical studies and advance device designs through small clinical trials. Funding will cover clinical prototype implementation, safety testing, design validation, and regulatory approval processes. This opportunity targets innovations that require clinical data to progress beyond nonclinical assessments, offering a pathway towards advanced trials and market clearance.
Opportunity ID: 272909
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-15-006 |
| Funding Opportunity Title: | BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/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: | $9,000,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Special district governments County governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal governments (Federally recognized) Private institutions of higher education City or township governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities |
| 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 Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-15-006.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 | PKG00213185 | Mar 14, 2015 | Apr 14, 2015 | View |
Package 1
Mandatory forms
272909 RR_SF424_2_0-2.0.pdf
272909 PHS398_ResearchPlan_2_0-2.0.pdf
272909 PHS398_CoverPageSupplement_2_0-2.0.pdf
272909 RR_Budget_1_3-1.3.pdf
272909 RR_KeyPersonExpanded_2_0-2.0.pdf
272909 RR_OtherProjectInfo_1_3-1.3.pdf
272909 PerformanceSite_2_0-2.0.pdf
Optional forms
272909 PlannedReport-1.0.pdf
272909 PHS398_CumulativeInclusionReport-1.0.pdf
272909 RR_SubawardBudget30_1_3-1.3.pdf
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