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

National Institutes of Health

PAR-25-055

HHS-NIH11

General Information

Est. Program Funding:

June 22, 2026

Closing Date:

Expected No. of Awards

Award Ceiling

Opportunity Number:
PAR-25-055

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

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.

Response Date	Jun 22, 2026 12:00:00 AM EDT
Posting Date	Oct 02, 2024 12:00:00 AM EDT
Archive Date	Jul 28, 2026 12:00:00 AM EDT
Award Ceiling
Award Floor
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on Eligibility:

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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

93.853: Extramural Research Programs in the Neurosciences and Neurological Disorders
:

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