NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement

The National Institute of Dental and Craniofacial Research (NIDCR), part of the U.S. Department of Health and Human Services and administered through the National Institutes of Health (NIH), is preparing to reissue a Notice of Funding Opportunity (NOFO) under the title "NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement." This funding opportunity is part of a broader effort to support innovative and well-executed clinical research focused on oral, dental, and craniofacial health. While applications are not yet being solicited, this forecasted NOFO is being publicly shared to allow sufficient preparation time for potential applicants. The primary goal of the opportunity is to fund prospective observational studies or biomarker validation studies that involve the collection or ongoing analysis of biospecimens and data. These types of clinical studies have the potential to generate reliable and actionable results, helping to identify and validate biomarkers or to understand disease mechanisms through longitudinal data collection. Biomarker validation studies under this opportunity will focus on the diagnostic, prognostic, monitoring, or predictive uses of robust, previously identified candidate biomarkers. Qualifying studies might include multi-site prospective cohort studies, long-term follow-up of clinical trial participants to monitor adverse outcomes, or advanced analytical work supporting clinical biomarker validation. Funding will be awarded through cooperative agreements, reflecting the intention for substantial scientific and programmatic involvement by NIDCR staff. Acceptable study designs may vary, but they must involve strong methodological frameworks and aim for significant contributions to the field of dental, oral, or craniofacial health. Although the total available funding, award ceiling, and award floor are not specified in the current forecast, the assistance listing associated with the opportunity is 93.121, titled "Oral Diseases and Disorders Research." As such, it is expected that applicants align their proposals closely with this research scope. The estimated posting date for the official NOFO is November 3, 2025. Interested applicants should prepare to submit full applications by February 5, 2026. Awards are projected to be announced by December 1, 2026, which is also the anticipated project start date. This places the opportunity within the 2027 fiscal year for federal budgeting purposes. This forecast is authorized under the Public Health Service Act and federal regulations, allowing NIDCR to publish early notifications to foster collaboration and strong proposal development. Eligible applicants include a wide range of organizations such as state and county governments, federally recognized tribal governments, Native American tribal organizations, public and private institutions of higher education, independent school districts, small businesses, nonprofits with IRS 501(c)(3) status (excluding higher education institutions), for-profit organizations (excluding small businesses), and public housing authorities. The opportunity is available nationwide, and no cost-sharing or matching is required from applicants. For questions related to this forecast, the designated point of contact is Dr. Lorena Baccaglini, DDS, MS, PhD, who can be reached at lorena.baccaglini@nih.gov or by phone at 301-435-7908. Applicants are encouraged to begin forming collaborations and aligning their research approaches in anticipation of the NOFO’s release.