Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional)

Document Type:Grants NoticeFunding Opportunity Number:PAR-23-258Funding Opportunity Title:Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional)Opportunity Category:DiscretionaryOpportunity Category Explanation: Funding Instrument Type:Cooperative AgreementCategory of Funding Activity:HealthCategory Explanation: Expected Number of Awards: CFDA Number(s):93.866 -- Aging ResearchCost Sharing or Matching Requirement:No Version:Synopsis 1Posted Date:Aug 16, 2023Last Updated Date:Aug 16, 2023Original Closing Date for Applications:Mar 05, 2026 Current Closing Date for Applications:Mar 05, 2026 Archive Date:Apr 10, 2026Estimated Total Program Funding: Award Ceiling: Award Floor: Document Type:Grants NoticeFunding Opportunity Number:PAR-23-258Funding Opportunity Title:Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial

Optional)Opportunity Category:DiscretionaryOpportunity Category Explanation: Funding Instrument Type:Cooperative AgreementCategory of Funding Activity:HealthCategory Explanation: Expected Number of Awards: CFDA Number(s):93.866 -- Aging ResearchCost Sharing or Matching Requirement:No Version:Synopsis 1Posted Date:Aug 16, 2023Last Updated Date:Aug 16, 2023Original Closing Date for Applications:Mar 05, 2026 Current Closing Date for Applications:Mar 05, 2026 Archive Date:Apr 10, 2026Estimated Total Program Funding: Award Ceiling: Award Floor: Eligible Applicants:Small businesses Special district governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Others (see text field entitled "Additional Information on Eligibility" for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher educationAdditional Information 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. Agency Name:National Institutes of HealthDescription:The goal of this Notice of Funding Opportunity (NOFO) is to accelerate the establishment ofeffective and reliable biomarkers of Alzheimers disease (AD) and AD-related dementias (ADRD) for usein therapy/medical product discovery and development, clinical trials and/or clinical practice. Specifically, this NOFO willsupport analytical and/or clinical validationof a biomarker, composite biomarker or biomarker signature, withrigor comparable with the expectations described in the Food and Drug Administration (FDA)Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways.Link to Additional Information:https://grants.nih.gov/grants/guide/pa-files/PAR-23-258.htmlGrantor Contact Information:If you have difficulty accessing the full announcement electronically, please contact: NIH Grants Information grantsinfo@nih.govSee Section VII. Agency Contacts within the full opportunity announcement for all other inquires.