health · HHS-NIH11

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

National Institutes of Health · PAR-25-055

Closed

Deadline

June 22, 2026

GRANTQUICK SUMMARYPlain-English Overview

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional). National Institutes of Health. 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... Funding amounts not specified.

Who Should Apply

Public universities/colleges, Independent school districts, Federally Recognized Native American Tribal Governments, Nonprofits (non-501c3), Public And Indian Housing Authorities (+10 more)

Who Should NOT Apply

Organizations not matching the eligible applicant types listed above

Key Requirements (Plain English)

•Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Is...
•Deadline: 2026-06-22

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Focus your proposal on clear outcomes, alignment with agency priorities, and demonstrate organizational capacity.

Competitiveness: Moderate to high — federal grants are always competitive

What This Grant Funds

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.

Attachments

PDF

PAR-25-055 Full Announcement Text

PAR-25-055-Full-Announcement.html

Who Can Apply

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.

Eligible Applicant Types

Public Colleges & UniversitiesIndependent School DistrictsFederally Recognized Tribal GovernmentsNonprofits without 501(c)(3)Public And Indian Housing AuthoritiesFor-Profit OrganizationsPrivate Colleges & UniversitiesCounty Governments501(c)(3) NonprofitsCity/Township GovernmentsOther Tribal OrganizationsSmall BusinessesSpecial District GovernmentsOther (see NOFO for details)State Governments

Funding Details

Cost Sharing Required?: No
Funding Instrument: cooperative_agreement

Key Dates

Posted: October 2, 2024

Application Deadline: June 22, 2026 (0 days remaining)

Agency Contact

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov

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