Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
- Posted
- January 22, 2024
- Closed
- November 17, 2025
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.853
- Category
- Health
- Archives
- November 18, 2025
Program funding history
Awards made under Assistance Listing 93.853 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $1.8B
- FY2026 obligated
- $2B
- FY2027 (to date) obligated
- $0
- Awards in window
- 8,124
Top recipients: The General Hospital Corporation, Regents of the University of California, San Francisco, the, The Johns Hopkins University, Regents of the University of Michigan, Washington University, the
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
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
- County governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- City or township governments
- Independent school districts
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public and State controlled institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- State governments
- For profit organizations other than small businesses
- Special district 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.
The official record
Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.
View on Grants.gov Full announcement
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