The National Institute of Neurological Disorders and Stroke (NINDS) is offering the CREATE Devices grant for translational and clinical studies on therapeutic devices for neurological disorders. This grant supports activities such as prototypes development, safety testing, and pursuit of regulatory approval. Applicants will work towards submitting Investigational Device Exemption (IDE) or IRB approval for a clinical study leading to a 510(k)/510(k) De Novo submission. The goal is to advance devices through clinical trials for neurological disorder treatments. Closing date for applications is May 07, 2017.
Opportunity ID: 260434
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-14-295 |
| Funding Opportunity Title: | NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (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: | Public housing authorities/Indian housing authorities Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments For profit organizations other than small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education State governments |
| 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 the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. 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-14-295.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 | PKG00201885 | Sep 21, 2014 | Jun 07, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00223976 | Jul 11, 2016 | May 07, 2017 | View |
Package 1
Mandatory forms
260434 RR_SF424_2_0-2.0.pdf
260434 PHS398_ResearchPlan_2_0-2.0.pdf
260434 PHS398_CoverPageSupplement_2_0-2.0.pdf
260434 RR_Budget_1_3-1.3.pdf
260434 RR_KeyPersonExpanded_2_0-2.0.pdf
260434 RR_OtherProjectInfo_1_3-1.3.pdf
260434 PerformanceSite_2_0-2.0.pdf
Optional forms
260434 PlannedReport-1.0.pdf
260434 PHS398_CumulativeInclusionReport-1.0.pdf
260434 RR_SubawardBudget30_1_3-1.3.pdf
Package 2
Mandatory forms
260434 RR_SF424_2_0-2.0.pdf
260434 PHS398_CoverPageSupplement_3_0-3.0.pdf
260434 RR_OtherProjectInfo_1_3-1.3.pdf
260434 PerformanceSite_2_0-2.0.pdf
260434 RR_KeyPersonExpanded_2_0-2.0.pdf
260434 RR_Budget_1_3-1.3.pdf
260434 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
260434 RR_SubawardBudget30_1_3-1.3.pdf
260434 PHS_Inclusion_Enrollment_Report-1.0.pdf
260434 PHS_AssignmentRequestForm-1.0.pdf
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