Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
Can you apply?
This grant is for researchers and research institutions seeking to plan and implement clinical trials testing drug, biologic, device, and/or procedure interventions in the oral health and craniofacial research space. Eligible applicants include institutions with research capabilities and investigators who meet NIH standards for conducting federally-funded clinical research. The cooperative agreement structure (UG3/UH3) provides two phases: the UG3 phase supports planning and protocol development activities, while the UH3 phase supports full trial implementation. Applicants must have institutional infrastructure to support clinical research, including IRB oversight and quality assurance capabilities. This program is open to domestic and international organizations with established research capacity.
This grant is for researchers and research institutions seeking to plan and implement clinical trials testing drug, biologic, device, and/or procedure interventions in the oral health and craniofacial research space. Eligible applicants include institutions with research capabilities and investigators who meet NIH standards for conducting federally-funded clinical research. The cooperative agreement structure (UG3/UH3) provides two phases: the UG3 phase supports planning and protocol development activities, while the UH3 phase supports full trial implementation. Applicants must have institutional infrastructure to support clinical research, including IRB oversight and quality assurance capabilities. This program is open to domestic and international organizations with established research capacity.
Program description
To support UG3/UH3 phased, cooperative agreement research applications to plan and implement clinical trials within the mission of the National Institute of Dental and Craniofacial Research (NIDCR)
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers and research institutions seeking to plan and implement clinical trials testing drug, biologic, device, and/or procedure interventions in the oral health and craniofacial research space. Eligible applicants include institutions with research capabilities and investigators who meet NIH standards for conducting federally-funded clinical research. The cooperative agreement structure (UG3/UH3) provides two phases: the UG3 phase supports planning and protocol development activities, while the UH3 phase supports full trial implementation. Applicants must have institutional infrastructure to support clinical research, including IRB oversight and quality assurance capabilities. This program is open to domestic and international organizations with established research capacity.
How to apply
Application links
Required documents
- SF-424 (R&R) application form
- Project narrative (typically 15 pages for UG3/UH3)
- Detailed study protocol and statistical analysis plan
- Budget and budget justification
- Biosketch of key personnel (NIH format)
- Institutional Review Board approval letter or evidence of pending review
- Letters of support from collaborating institutions/sites
- Data and safety monitoring plan
- Human subjects protection documentation
- Facilities and equipment information
- Bibliography and references
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
-
$31,252,186
-
$29,535,192
-
$23,987,187
-
$23,513,241
-
$18,362,716
-
$16,829,492
-
$15,691,075
-
$14,460,130
Top States by Funding
- WA 2 awards $451.4M
- CA 13 awards $134.6M
- MI 4 awards $75.8M
- PA 4 awards $67.6M
- 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 grant?
Institutions with research capability and investigators qualified to conduct NIH-funded clinical research, including universities, medical centers, research hospitals, and other research organizations. Individuals must hold appropriate research degrees and institutional affiliations.
What is the UG3/UH3 structure?
This is a two-phase cooperative agreement. The UG3 phase (typically 1-2 years) supports planning activities including protocol development and feasibility assessment. The UH3 phase (typically 3-4 years) funds the implementation and conduct of the full clinical trial.
What types of interventions can be studied?
The program supports clinical trials testing drugs, biologics, devices, and/or procedures relevant to oral health and craniofacial research. Interventions must have sufficient preliminary data to justify a clinical trial.
How competitive is this funding opportunity?
NIH clinical trial grants are highly competitive. Your application must demonstrate scientific merit, a well-designed protocol, appropriate statistical power calculations, and a qualified research team with relevant expertise.
What is the typical funding level?
NIH clinical trial budgets vary widely based on trial complexity, duration, sample size, and study sites. Budget requests should be fully justified with detailed cost breakdowns for personnel, participant compensation, equipment, and other direct costs.
💡 Tips for applicants
- Begin with a strong preliminary data section that demonstrates the scientific rationale for moving your intervention into a clinical trial phase. Include relevant preclinical or pilot study findings.
- Develop a detailed statistical analysis plan and power calculation before submitting. Reviewers will scrutinize sample size justification and methods for handling missing data or dropout.
- Invest time in the study protocol itself—it should be comprehensive, address potential safety concerns, and include clear inclusion/exclusion criteria. The protocol often becomes a major review focus.
- Include a realistic recruitment and retention plan with evidence from similar trials or populations. Detail your strategies for participant engagement and adherence monitoring.
- Assemble a strong multidisciplinary team with relevant clinical expertise, biostatistical support, regulatory knowledge, and clinical trial management experience. Letters of support from collaborating sites strengthen applications.
⚠️ Common mistakes
Applications often fail due to insufficient preliminary data or unclear scientific rationale for the proposed intervention. Reviewers also frequently identify weaknesses in study design, such as inadequate statistical power, unrealistic recruitment timelines, or insufficient consideration of safety and adverse event monitoring. Many applicants underestimate the complexity of multi-site clinical trials and provide inadequate detail in their regulatory and quality assurance plans.
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