Funder: National Institutes of Health
Due Dates: June 6, 2025 (New) | July 8, 2025 (Renewal/Resubmission/Revision) | September 4, 2025 (AIDS) | October 7, 2025 (New) | November 6, 2025 (Renewal/Resubmission/Revision) | January 6, 2026 (AIDS) | Additional cycles through January 8, 2028
Funding Amounts: Up to $500,000 direct costs per year; UG3 phase: 1 year; UH3 phase: up to 5 years; budgets must reflect actual project needs
Summary: Supports planning and implementation of behavioral and social intervention clinical trials related to dental, oral, or craniofacial health, using a milestone-driven UG3/UH3 cooperative agreement mechanism.
Key Information: UG3/UH3 application must be submitted as a single application; only projects meeting UG3 milestones may transition to UH3; no support for FDA-regulated drug/device/biologic trials.
Description
This funding opportunity supports the planning and implementation of behavioral and social intervention clinical trials relevant to dental, oral, and craniofacial (DOC) health, including associated medical and mental health comorbidities. The program uses a two-phase, milestone-driven cooperative agreement (UG3/UH3):
- UG3 Phase (Planning): Up to 1 year for scientific and operational planning, including feasibility studies, protocol development, and preparation for trial implementation.
- UH3 Phase (Implementation): Up to 5 years for conducting the clinical trial, contingent on successful completion of UG3 milestones and administrative review.
Projects must address behavior change interventions, and may include a wide range of populations, conditions, and intervention types, provided they are not FDA-regulated drug, device, or biologic trials. Both traditional and innovative methodologies (e.g., mobile health, telehealth, adaptive trial designs) are encouraged.
Due Dates
- New Applications: June 6, 2025 | October 7, 2025 | February 9, 2026 | June 8, 2026 | October 8, 2026 | February 8, 2027 | June 8, 2027 | October 8, 2027 | February 8, 2028
- Renewal/Resubmission/Revision: July 8, 2025 | November 6, 2025 | March 9, 2026 | July 8, 2026 | November 9, 2026 | March 8, 2027 | July 7, 2027 | November 8, 2027 | March 8, 2028
- AIDS-related Applications: September 4, 2025 | January 6, 2026 | May 8, 2026 | September 9, 2026 | January 8, 2027 | May 6, 2027 | September 8, 2027 | January 8, 2028
- Letter of Intent: 30 days prior to application due date
All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- Award Budget: No set limit, but direct costs of $500,000 or more in any year require prior approval. Budgets must reflect actual project needs.
- Project Period: UG3 phase: up to 1 year; UH3 phase: up to 5 years (maximum total: 6 years).
- Funding Mechanism: Cooperative Agreement (UG3/UH3).
- Transition: Only UG3 projects that meet pre-specified milestones may transition to the UH3 phase.
Eligibility
Eligible applicants include:
- Public/State and Private Institutions of Higher Education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Native American tribal governments and organizations
- Independent school districts
- Public housing authorities/Indian housing authorities
- Faith-based and community-based organizations
- Regional organizations
Note: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. Foreign components as defined by NIH policy may be included.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
- Application Guide: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
- Letter of Intent: Strongly encouraged, due 30 days before the application deadline.
- Required Registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov.
- Application Format: The UG3/UH3 must be submitted as a single, clearly organized application, with a detailed Study Timeline and Milestone Plan for both phases.
- Budget: If requesting $500,000 or more in direct costs in any year, contact NIDCR program staff at least 8 weeks before submission.
Additional Information
- Scope: Only applications proposing clinical trials of behavioral or social interventions (not FDA-regulated drugs/devices/biologics) are eligible.
- Milestones: Annual, objective, and measurable milestones are required for both UG3 and UH3 phases. Failure to meet milestones may result in discontinuation of funding.
- Data Management: All applications must include a Data Management and Sharing Plan.
- Human Subjects: Applications must include detailed plans for recruitment, retention, and protection of human subjects, as well as a data and safety monitoring plan.
- Consultation: Early consultation with NIDCR program staff is strongly encouraged.
External Links
Contact Information
See Also