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

National Institutes of Health Nonprofit eligible

Administered by National Institutes of Health, this health grant invites applications from nonprofits and other eligible applicants, with applications due Jun 22, 2026.

Open the official Grants.gov listing
Deadline
Jun 22, 2026
Posted
Oct 2, 2024
Opportunity number
PAR-25-055
CFDA
93.853

Opportunity 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.

Who can apply

  • Private institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Special district governments
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Public and State controlled institutions of higher education
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Native American tribal governments (Federally recognized)
  • City or township governments
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Small businesses
  • For profit organizations other than small businesses
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Independent school districts
  • County governments
  • State governments

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.

Agency contact

National Institutes of Health

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

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