The National Institutes of Health is offering this grant to enable the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders. This grant is for the specific purpose of rigorously validating biomarker measurements within clinical populations. Its goal is to establish the positive and negative predictive values of the candidate biomarker, consistent with FDA guidelines. This program assumes a candidate biomarker is already identified, detection method technology developed and analytically validated, and the research/clinical need and potential context of use defined. It supports moving identified biomarkers towards clinical utility.
Opportunity ID: 351913
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-096 |
| Funding Opportunity Title: | Clinical 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 22, 2026 |
| Current Closing Date for Applications: | Jun 22, 2026 |
| Archive Date: | Jul 28, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses State governments Public and State controlled institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities |
| 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 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, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker 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 analytically validated, 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-24-096.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
Folder 351913 Full Announcement-PAR-24-096 -> PAR-24-096-Full-Announcement.pdf
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 | PKG00284505 | Feb 22, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289245 | Nov 27, 2024 | Jun 22, 2026 | View |
Package 1
Mandatory forms
351913 RR_SF424_5_0-5.0.pdf
351913 PHS398_CoverPageSupplement_5_0-5.0.pdf
351913 RR_OtherProjectInfo_1_4-1.4.pdf
351913 PerformanceSite_4_0-4.0.pdf
351913 RR_KeyPersonExpanded_4_0-4.0.pdf
351913 RR_Budget_3_0-3.0.pdf
351913 PHS398_ResearchPlan_5_0-5.0.pdf
351913 SBIR_STTR_Information_3_0-3.0.pdf
351913 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351913 RR_SubawardBudget30_3_0-3.0.pdf
351913 PHS_AssignmentRequestForm_4_0-4.0.pdf
Package 2
Mandatory forms
351913 RR_SF424_5_0-5.0.pdf
351913 PHS398_CoverPageSupplement_5_0-5.0.pdf
351913 RR_OtherProjectInfo_1_4-1.4.pdf
351913 PerformanceSite_4_0-4.0.pdf
351913 RR_KeyPersonExpanded_4_0-4.0.pdf
351913 RR_Budget_3_0-3.0.pdf
351913 PHS398_ResearchPlan_5_0-5.0.pdf
351913 SBIR_STTR_Information_3_0-3.0.pdf
351913 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351913 RR_SubawardBudget30_3_0-3.0.pdf
351913 PHS_AssignmentRequestForm_3_0-3.0.pdf
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