Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
Status: Forecasted
Posted date: January 22, 2024
Archive date: July 28, 2026
Close date: June 22, 2026
Opportunity ID: 351913
Opportunity number: PAR-24-096
Opportunity category: Discretionary
Agency name: National Institutes of Health
Agency code: HHS-NIH11
Award floor: $0
Award ceiling: $0
Cost sharing required: No
Funding Instrument Types
- Cooperative Agreement
Category of Funding Activity
- Health
Eligible Applicants
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities/Indian housing authorities
- Small businesses
- Special district governments
- State governments
Categories (use these for quoted searches)
- agency_code:hhs_nih11
- category_of_funding_activity:health
- cost_sharing_or_matching_requirement:false
- eligible_applicants:city_or_township_governments
- eligible_applicants:county_governments
- eligible_applicants:for_profit_organizations_other_than_small_businesses
- eligible_applicants:independent_school_districts
- eligible_applicants:native_american_tribal_governments_federally_recognized
- eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
- eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:others
- eligible_applicants:private_institutions_of_higher_education
- eligible_applicants:public_and_state_controlled_institutions_of_higher_education
- eligible_applicants:public_housing_authoritiesindian_housing_authorities
- eligible_applicants:small_businesses
- eligible_applicants:special_district_governments
- eligible_applicants:state_governments
- funding_instrument_type:cooperative_agreement
- opportunity_category:discretionary
- status:forecasted
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.