This NIH grant is offered to facilitate the rigorous analytical validation of strong candidate biomarkers for neurological and neuromuscular disorders. Its purpose is to validate analytical methods for biomarker measurements, ensuring reproducibility and accuracy per FDA guidelines. This involves evaluating detection methods, their performance characteristics, and establishing optimal conditions. This grant is for researchers who have already identified a candidate biomarker, developed the detection technology, and established the research or clinical need with its potential context of use. The initiative supports crucial work to prepare established biomarkers for clinical utility.
Opportunity ID: 351914
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-098 |
| Funding Opportunity Title: | Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (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: | Jan 22, 2024 |
| Last Updated Date: | Jan 22, 2024 |
| Original Closing Date for Applications: | Jun 25, 2026 |
| Current Closing Date for Applications: | Jun 25, 2026 |
| Archive Date: | Jul 31, 2026 |
| 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 Organizations) 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: | (Reissue PAR-21-057) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-098.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information 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-H | Use for due dates on or before January 24, 2025 | PKG00284506 | Feb 22, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289246 | Nov 27, 2024 | Jun 25, 2026 | View |
Package 1
Mandatory forms
351914 RR_SF424_5_0-5.0.pdf
351914 PHS398_CoverPageSupplement_5_0-5.0.pdf
351914 RR_OtherProjectInfo_1_4-1.4.pdf
351914 PerformanceSite_4_0-4.0.pdf
351914 RR_KeyPersonExpanded_4_0-4.0.pdf
351914 RR_Budget_3_0-3.0.pdf
351914 PHS398_ResearchPlan_5_0-5.0.pdf
351914 SBIR_STTR_Information_3_0-3.0.pdf
351914 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351914 RR_SubawardBudget30_3_0-3.0.pdf
351914 PHS_AssignmentRequestForm_4_0-4.0.pdf
Package 2
Mandatory forms
351914 RR_SF424_5_0-5.0.pdf
351914 PHS398_CoverPageSupplement_5_0-5.0.pdf
351914 RR_OtherProjectInfo_1_4-1.4.pdf
351914 PerformanceSite_4_0-4.0.pdf
351914 RR_KeyPersonExpanded_4_0-4.0.pdf
351914 RR_Budget_3_0-3.0.pdf
351914 PHS398_ResearchPlan_5_0-5.0.pdf
351914 SBIR_STTR_Information_3_0-3.0.pdf
351914 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351914 RR_SubawardBudget30_3_0-3.0.pdf
351914 PHS_AssignmentRequestForm_3_0-3.0.pdf
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