NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-188
- 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
-
- County Governments
- Special District Governments
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- Small Businesses
- Public or Indian Housing Auth.
- 501(c)(3) Nonprofits
- Other
- Tribal Governments (Federally Recognized)
- Non-501(c)(3) Nonprofits
- State Governments
- Higher Education Inst. (Private)
- Higher Education Inst. (Public)
- For Profit Organizations
- Independent School Districts
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Dental and Craniofacial Research (NIDCR) is soliciting UG3/UH3 phased cooperative agreement applications for behavioral and social intervention clinical trials planning and implementation, with applications due January 6, 2028. The program funds behavior change interventions related to dental, oral, or craniofacial conditions across a broad applicant base including higher education institutions, nonprofits, small businesses, tribal organizations, state and local governments, and faith-based or community-based organizations; foreign organizations and non-domestic components of U.S. organizations are ineligible.
The UG3 planning phase runs up to two years and supports scientific planning (small-scale feasibility and acceptability data collection, intervention and fidelity testing) and operational planning (final protocol development, intervention manual creation, data management systems, safety and quality oversight, recruitment and retention strategies). Only UG3 projects meeting scientific milestones and feasibility requirements may transition to the UH3 implementation phase, which runs up to five years and funds investigator-initiated intervention research from early mechanistic studies (Stages 0/I) through implementation and cost-effectiveness research (Stages IV/V).
The opportunity falls under CFDA 93.121 (Oral Diseases and Disorders Research). Applications must follow NIH FORMS-I research application instructions with both general and research-specific guidance. Evaluation criteria include scientific merit, investigator competency, innovation, technical adequacy of experimental design, facility and resource adequacy, budget necessity and relevance to NIDCR program objectives; human subject protections, demographic inclusion, and animal welfare are evaluated but not scored.
Synopsis
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage UG3/UH3 phased cooperative agreement research applications to plan and implement behavioral and social intervention clinical trials. Studies appropriate for this announcement include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures (e.g., acceptability of study content or mode of delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures). Operational planning activities include, at a minimum, development of: the final clinical protocol; the intervention manual or equivalent; the data management system and other tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stages 0/ I) through implementation and cost-effectiveness research (Stages IV/V).
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-188-Full-Announcement.html | HTML file | |
| PKG00289271.pdf |
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