Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and research institutions seeking to continue, extend, or revise existing NIDCR (National Institute of Dental and Craniofacial Research) clinical trial planning and implementation work through a UH3 cooperative agreement mechanism. Eligible applicants typically include academic medical centers, dental schools, research hospitals, and established research institutions with demonstrated capacity to conduct rigorous clinical trials in oral health, dental, and craniofacial research. The grant supports the full-scale implementation and conduct of clinical trials that have undergone planning and feasibility phases. Applicants must have institutional infrastructure, access to appropriate patient populations, and experience managing federally-funded research. This is a continuation/revision mechanism, meaning prior NIDCR funding and successful planning activities are typically expected.
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Program description
To support competing renewal or competitive revision of ongoing clinical trials supported by the National Institute of Dental and Craniofacial Research (NIDCR)
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Federal Application for Federal Assistance) and SF-424 Supplement
- Project Narrative (includes specific aims, background, clinical trial protocol, recruitment plan, data management, statistical analysis plan)
- Detailed Budget and Budget Narrative (includes personnel, participant costs, regulatory/IRB costs, monitoring)
- NIH Biosketch(es) for key personnel (updated format)
- Institutional Support Letter and signed assurance of institutional resources
- Clinical Trial Protocol (detailed methodology, inclusion/exclusion criteria, endpoints)
- Letters of Support from participating sites and recruitment partners
- Data Management and Monitoring Plan, including plans for adverse event reporting
- Evidence of prior planning phase success (if applicable) or feasibility data
- Regulatory and compliance documentation (IRB approval status, regulatory strategy)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
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
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$31,252,186
-
$29,535,192
-
$23,987,187
-
$23,513,241
-
$18,362,716
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$16,829,492
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$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
Who is eligible to apply for this continuation/revision UH3 grant?
Primarily institutions with existing NIDCR clinical trial planning awards (such as prior UH2 or planning phase grants) seeking to transition to full implementation. Institutions must have strong research infrastructure and clinical trial management capacity.
What is the typical focus of UH3 grants compared to UH2 planning grants?
UH3 grants support full-scale clinical trial implementation, enrollment, and conduct, whereas UH2 funding focuses on planning, feasibility, and optimization before moving to the implementation phase.
What does "cooperative agreement" mean in this context?
A cooperative agreement indicates substantial, ongoing NIH involvement in the research through monitoring, technical input, and regular communication with program officers throughout the grant period.
What clinical trial areas does NIDCR prioritize?
NIDCR focuses on oral health, dental diseases, craniofacial research, and related conditions. Trials may address prevention, treatment, rehabilitation, and health equity in dental and craniofacial health.
What is the typical funding range and budget period?
Federal clinical trial grants typically range from $300,000 to $2+ million in annual costs depending on trial scope and complexity. Budget periods are often 1-2 years with a total project period of 5 years or more.
💡 Tips for applicants
- Emphasize the successful completion of prior planning phases (UH2 or similar) and demonstrate that your team is ready for full implementation. Reviewers want evidence of preparation and feasibility studies that justify moving forward.
- Provide detailed descriptions of your clinical trial protocol, statistical power calculations, recruitment strategies, and patient retention plans. NIH clinical trial reviews are rigorous and require strong methodological rigor.
- Include letters of support from participating clinical sites, recruitment partners, and key collaborators. For cooperative agreements, showing strong institutional commitment and infrastructure is critical.
- Develop a comprehensive budget narrative that clearly itemizes all trial-related costs: participant compensation, regulatory/monitoring costs, personnel, equipment, and overhead. Clinical trials are expensive and must be justifiable.
- Engage early with your NIH program officer at NIDCR. As a continuation/revision mechanism, proactive communication about your resubmission plans, any changes to the protocol, or scientific direction can strengthen your application significantly.
⚠️ Common mistakes
Applicants often submit continuation applications without clearly articulating how they addressed previous critique panels' feedback or reviewer concerns from the planning phase. Additionally, weak recruitment and retention plans are frequently cited reasons for UH3 clinical trial applications being rejected—reviewers need realistic, evidence-based strategies for enrolling and maintaining the target sample size. Finally, insufficient institutional budget support, unclear lines of authority for trial conduct, or lack of demonstrated infrastructure for regulatory compliance and data management are common deficiencies.
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