Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for institutions and researchers conducting prospective observational or biomarker validation studies in dental, oral, and craniofacial health. Eligible organizations typically include universities, medical centers, research institutes, and nonprofit organizations with research capacity. The grant supports studies with prospective data/biospecimen collection, longitudinal cohort studies, and clinical biomarker validation work. This is a federal cooperative agreement program with national scope.
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Key dates
- Jun 16, 2026 Applications open
- Dec 1, 2026 Award announced
- Dec 1, 2026 Project start
- Jul 5, 2029 Application deadline in 1085 days
Program description
The National Institute of Dental and Craniofacial Research (NIDCR) intends to reissue a Notice of Funding Opportunity (NOFO) to solicit applications for observational or biomarker validation studies that require prospective collection or continued analysis of data/biospecimens. Well-designed, adequately powered, and well-executed clinical studies that prospectively collect data and/or biospecimens have the potential to generate robust results and advance the knowledge base to improve dental, oral and craniofacial health. Longitudinal studies allow for exposure assessment and its relation to disease development. A biomarker validation study aims to confirm the utility of strong candidate biomarker measures or endpoints—supported by robust preliminary data—for diagnosis, prognosis, monitoring, and/or predicting response to treatment. Study design examples 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. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical research or biomarker validation studies are encouraged to consider applying for this new NOFO. NIDCR is authorized to forecast this opportunity under the Public Health Service Act (42 U.S.C §§ 241 and 284) and federal regulations (42 CFR Part 52 and 2 CFR Part 200).
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biographical Sketches of Key Personnel
- Letters of Support from Collaborating Institutions
- Preliminary Data (if applicable)
Program contact
- 👤 Lorena Baccaglini, DDS, MS, PhD National Institute of Dental and Craniofacial Research (NIDCR)
- 📧 lorena.baccaglini@nih.gov
- 📞 301-435-7908
Funding track record
Recent awards under CFDA 93.121 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$443,702,768
-
$32,310,944
-
$31,252,186
-
$29,535,192
-
$23,987,187
-
$23,513,241
-
$18,362,716
-
$16,829,492
-
$15,991,067
-
$14,460,130
Top States by Funding
- WA 2 awards $451.6M
- CA 14 awards $145.2M
- MI 4 awards $75.8M
- PA 4 awards $68.3M
- MA 5 awards $39.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.121). How funding has trended year over year.
| 2024 | $319,987,302 | |
| 2025 | $332,151,837 | |
| 2026 est. | $337,316,521 |
FAQ
What types of studies are eligible?
Prospective cohort studies, multi-site studies, post-trial follow-ups, and biomarker validation studies. Applications must include prospective data or biospecimen collection.
Who can apply for this grant?
Research institutions, universities, medical centers, and nonprofit organizations with clinical research or biomarker validation expertise. Individual researchers typically apply through their institution.
When is the deadline?
The deadline is February 5, 2026. This is a fixed deadline, not rolling. Check the NIDCR website for any updates before applying.
What makes a competitive application?
Strong preliminary data, well-powered study design, clear clinical significance, and experienced research teams. Biomarker studies need robust candidate measures backed by preliminary evidence.
How much funding is available?
Award amounts are not specified in the notice. Contact NIDCR program officer for typical funding ranges for cooperative agreements.
💡 Tips for applicants
- Start collaborations now. The notice emphasizes allowing time for meaningful partnerships before applications open.
- Focus on prospective design. Studies with forward-looking data collection are stronger than retrospective analyses.
- Include strong preliminary data, especially for biomarker validation studies. Robust candidate biomarkers backed by evidence are essential.
- Involve clinical expertise. Include researchers with demonstrated experience in clinical studies or biomarker validation.
- Address clinical significance. Clearly explain how results will improve dental, oral, or craniofacial health outcomes.
⚠️ Common mistakes
Submitting retrospective studies instead of prospective designs. Lacking strong preliminary data for biomarker validation claims. Weak or underdeveloped team collaboration and research infrastructure.
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