Open · 121 days left D National Institutes of Health

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

Funding
Not specified
Deadline
--
Days
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Hrs
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Min
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Sec
Jun 22, 2026
Posted Oct 2, 2024 (506 days ago)
Closes Jun 22, 2026 (in 121 days)

Grant Details

Opportunity Number
PAR-25-055
CFDA / ALN
93.853
Opportunity Category
Discretionary (D)
Funding Category
Health (HL)
Funding Instrument
Cooperative Agreement (CA)
Cost Sharing
No Cost Sharing (No)

Eligibility

State governments (00) County governments (01) City or township governments (02) Special district governments (04) Independent school districts (05) Public and State controlled institutions of higher education (06) Native American tribal governments (Federally recognized) (07) Public housing authorities / Indian housing authorities (08) Native American tribal organizations (11) Nonprofits having a 501(c)(3) status with the IRS (12) Nonprofits without 501(c)(3) status (13) Private institutions of higher education (20) For-profit organizations other than small businesses (22) Small businesses (23) Others (25)

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.

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.