NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

The National Institute of Dental and Craniofacial Research, a component of the National Institutes of Health within the U.S. Department of Health and Human Services, funds investigator-initiated studies to advance knowledge of dental, oral, and craniofacial health. Through this cooperative agreement program, the Institute supports large-scale prospective observational or biomarker validation research that does not constitute a clinical trial. The mechanism allows significant federal scientific participation while maintaining scientific leadership by the awardee institutions. NIDCR seeks to strengthen evidence bases for disease prevention, diagnosis, and treatment by promoting rigorously designed studies that generate reliable data to improve population oral health outcomes. The opportunity invites applications for epidemiologic, cohort, or biomarker analytic and clinical validation studies requiring prospective collection or continued analysis of data or biospecimens. Projects may examine disease prevalence, risk factors, treatment outcomes, or long-term follow-up of prior interventions. Biomarker studies should move beyond discovery to analytic and clinical validation, demonstrating measurable accuracy, reproducibility, and correlation with disease pathophysiology or clinical response. Examples include large multicenter cohorts assessing oral disease progression, genomic and -omics investigations, or cross-sectional studies developing predictive tools for prevention or therapy. Discovery-phase biomarker work is outside the program scope. Applications are expected to demonstrate strong design, robust statistical planning, and access to appropriately powered participant populations. Investigators must provide Quality Management and Clinical Data Management Plans detailing standardized study processes, data validation, and confidentiality procedures. Prospective data collection studies must also include a schedule of participant events. The cooperative agreement structure entails active NIDCR program staff engagement throughout study conduct, quality oversight, and data coordination. Projects may request up to five years of support with budgets reflecting actual research needs; there are no fixed funding limits. Eligible applicants include public and private higher education institutions, nonprofit and for-profit organizations, small businesses, state, local, special district, and tribal governments, and public housing authorities. Foreign organizations are not eligible to apply, though foreign components of U.S. institutions are permitted. Cost sharing is not required. Applicant organizations must complete registrations in SAM.gov, eRA Commons, and Grants.gov, and principal investigators must hold active Commons IDs. Letters of intent are due thirty days before the chosen application due date. Applications must follow the NIH SF424 (R&R) format and the Research Instructions in the Application Guide. NIH standard due dates apply: February 5, June 5, and October 5 each year for new submissions, with corresponding resubmission and AIDS-related cycles. Applications are accepted beginning January 5, 2025, and the announcement remains active through May 8, 2026. Reviews follow the NIH dual-level peer-review process assessing significance, rigor, feasibility, investigator expertise, and alignment with NIDCR priorities. Awards are expected to start in the December, April, or July periods following council review. Projects are governed by standard NIH policy and the NIDCR Clinical Terms of Award, including data management, human subject protection, and public dissemination requirements. Program inquiries may be directed to scientific staff Lorena Baccaglini (301-435-7908, lorena.baccaglini@nih.gov) or Dena Fischer (301-594-4876, dena.fischer@nih.gov). Peer-review questions go to Yasaman Shirazi (301-594-5593, yasaman.shirazi@nih.gov), and financial matters to Gabriel Hidalgo (301-827-4630, hidalgoge@mail.nih.gov). This recurring federal opportunity provides sustained support for high-impact, rigorously designed observational and biomarker validation research that advances the scientific foundation of oral and craniofacial health.