NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-27-058
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $500,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Tribal Governments (Federally Recognized)
- 501(c)(3) Nonprofits
- Non-501(c)(3) Nonprofits
- State Governments
- County Governments
- Small Businesses
- Higher Education Inst. (Public)
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- Independent School Districts
- For Profit Organizations
- Other
- Public or Indian Housing Auth.
- City/Township Governments
- Special District Governments
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Dental and Craniofacial Research (NIDCR) is soliciting applications through cooperative agreement for prospective observational or biomarker validation studies with a rolling application due date of October 5, 2026, and continuing through June 5, 2029. Clinical trials as defined by NIH are not eligible.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal governments and organizations, special district governments, public or Indian housing authorities, independent school districts, and other entity types. Non-domestic entities and foreign components of U.S. organizations are ineligible.
Awards fund investigator-initiated studies requiring prospective collection of data and biospecimens or continued analysis of previously collected specimens. Eligible study designs include prospective cohort or multi-site studies, post-trial follow-up of clinical trial participants to assess long-term adverse events, and advanced analytical or clinical biomarker validation studies. Biomarker validation studies must confirm utility of candidate biomarker measures or endpoints supported by robust preliminary data for diagnosis, prognosis, monitoring, or predicting treatment response.
Cooperative agreements provide up to $500,000 in direct costs per year for project periods up to five years. NIDCR anticipates substantial federal involvement through assigned Project Scientists, Program Officials, and Medical Officers who participate in study oversight, protocol review, and site monitoring. Applications must include mandatory attachments: Quality Management Plan (3 pages), Clinical Data Management Plan (2 pages), and Schedule of Events (2 pages). Applicants must demonstrate study feasibility through recruitment and retention plans, provide statistical analysis plans with power calculations, and include letters of support from clinical partners. Review emphasizes significance and innovation, rigor and feasibility of approach, investigator expertise, and institutional resources. The program operates under CFDA 93.121 (Oral Diseases and Disorders Research).
Synopsis
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.
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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00293321.pdf | ||
| PAR-27-058-Full-Announcement.html | HTML file |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar grant opportunities
- Ask GovTribe AI about this opportunity