NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
About
This Notice of Funding Opportunity (NOFO) will support, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens.
The NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) is designed for researchers and investigator-initiated teams seeking federal funding to conduct observational studies or validate biomarkers in oral and dental health research. This funding mechanism supports projects that require prospective collection of data and biospecimens or continued analysis of previously collected materials. Unlike clinical trial-focused grants, this opportunity specifically excludes clinical trial designs, making it ideal for exploratory and validation research that builds the scientific foundation for future studies. Researchers from U.S.-based institutions, including academic medical centers, research institutes, and eligible organizations, can apply to advance their oral health research agendas. The cooperative agreement model emphasizes collaborative partnership between investigators and the National Institute of Dental and Craniofacial Research (NIDCR), providing not only funding but also scientific guidance and support. This grant is particularly valuable for researchers looking to establish preliminary data, identify and validate biomarkers, understand disease mechanisms through observation, and develop robust evidence that supports future clinical investigations. If your research involves longitudinal data collection, biospecimen analysis, or biomarker validation in the dental and oral health field, this funding opportunity represents a significant resource to advance your scientific goals.
Funding Facts
● Applications openDeadline
July 5, 2029
Award Amount
Up to $500K
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $500K
Deadline
2029-07-05
Grant Type
federal
Application Cycle
Annual - Refer to official NOFO for specific submission deadlines
Best For
Academic institutions, research centers, and U.S.-based organizations conducting observational oral health research or biomarker validation studies
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-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 not allowed.
Frequently Asked Questions
Who is eligible for NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)?
U.S.-based organizations and institutions are eligible to apply. Foreign organizations and non-domestic components of U.S. organizations are not eligible. Foreign collaborations and international components are not allowed under this funding mechanism. For complete eligibility details, including specific institutional requirements and investigator qualifications, refer to Section III of the official Notice of Funding Opportunity (NOFO) on the NIH website.
How much funding does NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) provide?
Funding ranges up to $500,000 per award. The specific amount available in each funding cycle may vary. Applicants should consult the current NOFO and contact NIDCR program staff for details on funding levels for the specific cycle in which they plan to apply.
How do I apply for NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)?
Applications are submitted through the NIH grants portal using the standard federal application process. You will need to develop a research proposal that aligns with observational study or biomarker validation objectives, assemble your team, and submit through Grants.gov or the NIH eRA system. Visit the official NIDCR website and review the current NOFO for specific application instructions, required forms, submission deadlines, and program-specific guidelines.
What can NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) funding be used for?
Funding supports investigator-initiated observational studies and biomarker validation studies that involve prospective collection of data and biospecimens, or continued analysis of previously collected data and biospecimens. This includes research personnel, equipment, biospecimen collection and analysis, data management, and other costs directly related to conducting observational research or validating biomarkers in oral and dental health. Clinical trials are not permitted under this mechanism. Consult the NOFO for detailed budget guidelines and allowable costs.
Last updated: July 5, 2026