Archived

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

Federal funding opportunity PAR-25-055 from National Institutes of Health (Department of Health and Human Services).

Posted: October 2, 2024
Closed: June 22, 2026
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.853
Category: Health
Archives: July 28, 2026

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 →

This opportunity is archived. Applications are no longer accepted. Similar grants are listed below, and the free Tuesday digest carries the next ones like it.

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

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

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

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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