The Department of Neurology is offering this grant to facilitate small clinical studies and translational activities for developing therapeutic and diagnostic devices targeting nervous or neuromuscular disorders. The funded projects will focus on activities like translational bench and animal studies, leading to the submission of an Investigational Device Exemption (IDE) and small clinical studies. The grant aims to gather safety and effectiveness data necessary for marketing applications or final device design, with a closing date of Dec 20, 2022.
Opportunity ID: 333155
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-022 |
| Funding Opportunity Title: | Translational Neural Devices (U44 Clinical Trial Optional) |
| 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 2 |
| Posted Date: | Apr 28, 2021 |
| Last Updated Date: | Jan 06, 2023 |
| Original Closing Date for Applications: | Feb 20, 2024 |
| Current Closing Date for Applications: | Dec 20, 2022 |
| Archive Date: | Jan 19, 2023 |
| Estimated Total Program Funding: | $4,000,000 |
| Award Ceiling: | $1,000,000 |
| 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 applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-022.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated close date | Jan 06, 2023 | |
| Apr 28, 2021 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-022 |
| Funding Opportunity Title: | Translational Neural Devices (U44 Clinical Trial Optional) |
| 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 2 |
| Posted Date: | Apr 28, 2021 |
| Last Updated Date: | Jan 06, 2023 |
| Original Closing Date for Applications: | Feb 20, 2024 |
| Current Closing Date for Applications: | Dec 20, 2022 |
| Archive Date: | Jan 19, 2023 |
| Estimated Total Program Funding: | $4,000,000 |
| Award Ceiling: | $1,000,000 |
| 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 applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-022.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-022 |
| Funding Opportunity Title: | Translational Neural Devices (U44 Clinical Trial Optional) |
| 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: | Apr 28, 2021 |
| Last Updated Date: | Apr 28, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 20, 2024 |
| Archive Date: | Mar 27, 2024 |
| Estimated Total Program Funding: | $4,000,000 |
| Award Ceiling: | $1,000,000 |
| 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 applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-022.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
Folder 333155 Full Announcement-RFA-NS-21-022 -> RFA-NS-21-022-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00266798 | Jun 01, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270965 | Dec 16, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278471 | Nov 15, 2022 | Jan 07, 2023 | View |
Package 1
Mandatory forms
333155 RR_SF424_2_0-2.0.pdf
333155 PHS398_CoverPageSupplement_5_0-5.0.pdf
333155 RR_OtherProjectInfo_1_4-1.4.pdf
333155 PerformanceSite_2_0-2.0.pdf
333155 RR_KeyPersonExpanded_2_0-2.0.pdf
333155 RR_Budget_1_4-1.4.pdf
333155 PHS398_ResearchPlan_4_0-4.0.pdf
333155 SBIR_STTR_Information_1_3-1.3.pdf
333155 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
333155 RR_SubawardBudget30_1_4-1.4.pdf
333155 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
333155 RR_SF424_5_0-5.0.pdf
333155 PHS398_CoverPageSupplement_5_0-5.0.pdf
333155 RR_OtherProjectInfo_1_4-1.4.pdf
333155 PerformanceSite_4_0-4.0.pdf
333155 RR_KeyPersonExpanded_4_0-4.0.pdf
333155 RR_Budget_3_0-3.0.pdf
333155 PHS398_ResearchPlan_4_0-4.0.pdf
333155 SBIR_STTR_Information_3_0-3.0.pdf
333155 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333155 RR_SubawardBudget30_3_0-3.0.pdf
333155 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
333155 RR_SF424_5_0-5.0.pdf
333155 PHS398_CoverPageSupplement_5_0-5.0.pdf
333155 RR_OtherProjectInfo_1_4-1.4.pdf
333155 PerformanceSite_4_0-4.0.pdf
333155 RR_KeyPersonExpanded_4_0-4.0.pdf
333155 RR_Budget_3_0-3.0.pdf
333155 PHS398_ResearchPlan_5_0-5.0.pdf
333155 SBIR_STTR_Information_3_0-3.0.pdf
333155 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333155 RR_SubawardBudget30_3_0-3.0.pdf
333155 PHS_AssignmentRequestForm_3_0-3.0.pdf
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