The National Institute of Neurological Disorders and Stroke (NINDS) is offering a grant for translational and clinical studies on therapeutic devices for neurological disorders. This grant aims to support the development of devices through clinical studies that inform the final device design, leading to IDE or IRB approval. Additionally, the program enables the testing of scientific hypotheses not feasible in animal models and supports preclinical testing, design verification, regulatory approval, and small clinical studies. Applications for this grant must be submitted before the closing date on May 07, 2017.
Opportunity ID: 260436
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-297 |
| Funding Opportunity Title: | NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 28, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 07, 2017 |
| Current Closing Date for Applications: | May 07, 2017 |
| Archive Date: | Jun 07, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments City or township governments Private institutions of higher education 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 Native American tribal governments (Federally recognized) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Special district governments 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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-14-297.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 | PKG00201887 | Sep 21, 2014 | Jun 07, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00223978 | Jul 11, 2016 | May 07, 2017 | View |
Package 1
Mandatory forms
260436 RR_SF424_2_0-2.0.pdf
260436 PHS398_ResearchPlan_2_0-2.0.pdf
260436 PHS398_CoverPageSupplement_2_0-2.0.pdf
260436 RR_Budget_1_3-1.3.pdf
260436 RR_KeyPersonExpanded_2_0-2.0.pdf
260436 RR_OtherProjectInfo_1_3-1.3.pdf
260436 PerformanceSite_2_0-2.0.pdf
Optional forms
260436 PlannedReport-1.0.pdf
260436 PHS398_CumulativeInclusionReport-1.0.pdf
260436 RR_SubawardBudget30_1_3-1.3.pdf
Package 2
Mandatory forms
260436 RR_SF424_2_0-2.0.pdf
260436 PHS398_CoverPageSupplement_3_0-3.0.pdf
260436 RR_OtherProjectInfo_1_3-1.3.pdf
260436 PerformanceSite_2_0-2.0.pdf
260436 RR_KeyPersonExpanded_2_0-2.0.pdf
260436 RR_Budget_1_3-1.3.pdf
260436 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
260436 RR_SubawardBudget30_1_3-1.3.pdf
260436 PHS_Inclusion_Enrollment_Report-1.0.pdf
260436 PHS_AssignmentRequestForm-1.0.pdf
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