This grant is for the clinical validation of strong candidate biomarkers crucial for neurological and neuromuscular disorders. The core purpose is to enable rigorous validation of biomarker measurements within the specific clinical population of interest. This validation aims to meticulously establish the positive and negative predictive values of the candidate biomarker, ensuring consistency with FDA guidelines for potential clinical application. Applicants should note that this program assumes a candidate biomarker has already been identified, its detection method technology is fully developed and analytically validated, and its research or clinical need along with potential context of use has been clearly defined. This opportunity specifically supports the critical final stages of biomarker development.
Opportunity ID: 356621
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-055 |
| Funding Opportunity Title: | Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 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: | Oct 02, 2024 |
| Last Updated Date: | Oct 02, 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: | Public and State controlled institutions of higher education Private institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses County governments Independent school districts |
| 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-25-055.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 356621 Full Announcement-PAR-25-055 -> PAR-25-055-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-I | Use for due dates on or after January 25, 2025 | PKG00288390 | Jan 21, 2025 | Jun 22, 2026 | View |
Package 1
Mandatory forms
356621 RR_SF424_5_0-5.0.pdf
356621 PHS398_CoverPageSupplement_5_0-5.0.pdf
356621 RR_OtherProjectInfo_1_4-1.4.pdf
356621 PerformanceSite_4_0-4.0.pdf
356621 RR_KeyPersonExpanded_4_0-4.0.pdf
356621 PHS398_ResearchPlan_5_0-5.0.pdf
356621 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356621 RR_Budget_3_0-3.0.pdf
356621 RR_SubawardBudget30_3_0-3.0.pdf
356621 PHS398_ModularBudget_1_2-1.2.pdf
356621 PHS_AssignmentRequestForm_4_0-4.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
