This grant from the Department of Health and Human Services aims to support Small Business Concerns in conducting rigorous clinical validation of a candidate biomarker for neurological disease. The grant requires the use of retrospective and/or prospective methods to validate an already identified biomarker using validated analytical methods. The ultimate goal is to advance reliable biomarkers for neurological diseases to be used in multi-site clinical trials and clinical practice. Closing date for applications is September 7, 2020.
Opportunity ID: 299661
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-548 |
| Funding Opportunity Title: | Clinical Validation of a Candidate Biomarker for Neurological Disease (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: | Dec 22, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | Sep 07, 2020 |
| Archive Date: | Oct 13, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| 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 encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-548.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-E | Use for due dates on or before May 24, 2020 | PKG00237286 | Feb 14, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260213 | Feb 14, 2018 | Sep 07, 2020 | View |
Package 1
Mandatory forms
299661 RR_SF424_2_0-2.0.pdf
299661 PHS398_CoverPageSupplement_4_0-4.0.pdf
299661 RR_OtherProjectInfo_1_4-1.4.pdf
299661 PerformanceSite_2_0-2.0.pdf
299661 RR_KeyPersonExpanded_2_0-2.0.pdf
299661 RR_Budget_1_4-1.4.pdf
299661 PHS398_ResearchPlan_4_0-4.0.pdf
299661 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
299661 RR_SubawardBudget30_1_4-1.4.pdf
299661 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
299661 RR_SF424_2_0-2.0.pdf
299661 PHS398_CoverPageSupplement_5_0-5.0.pdf
299661 RR_OtherProjectInfo_1_4-1.4.pdf
299661 PerformanceSite_2_0-2.0.pdf
299661 RR_KeyPersonExpanded_2_0-2.0.pdf
299661 RR_Budget_1_4-1.4.pdf
299661 PHS398_ResearchPlan_4_0-4.0.pdf
299661 SBIR_STTR_Information_1_3-1.3.pdf
299661 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
299661 RR_SubawardBudget30_1_4-1.4.pdf
299661 PHS_AssignmentRequestForm_3_0-3.0.pdf
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