PAR-25-188
NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
Summary
NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (PAR-25-188)
Research Focus
This funding opportunity supports planning and implementation of rigorously designed behavioral and biopsychosocial intervention clinical trials addressing dental, oral, and craniofacial (DOC) health and associated medical or mental health comorbidities. The National Institute of Dental and Craniofacial Research (NIDCR) seeks research that targets DOC conditions including dental caries, periodontal diseases, temporomandibular joint and muscle disorders (TMDs), salivary disorders, craniofacial abnormalities, and oral manifestations of autoimmune/rheumatologic conditions such as Sjögrens syndrome. Interventions may address patients with developmental disabilities, comorbid conditions (diabetes, cardiovascular disease, cancer, obesity, xerostomia), or health disparities in women. The program welcomes traditional and novel approaches including mobile health applications, telehealth, responsive health system records, and advanced designs such as Sequential Multiple Assignment Randomized Trials (SMART). Interventions may target patients, practitioners, health systems, or non-clinical populations, and may involve stakeholders from clinical and community sectors.
At-a-Glance
- Who can apply: U.S. and international institutions (specific eligibility details not stated in excerpt)
- Funding & project length: Two-phase award: UG3 planning phase (1 year) followed by UH3 implementation phase (up to 5 years); amounts not stated
- Award mechanism: UG3/UH3 Exploratory/Developmental Phased Cooperative Agreement (single application required)
- Key dates: Open January 7, 2025; rolling due dates through January 7, 2028; earliest start February–July 2025 depending on submission cycle
- Best fit for: Behavioral health researchers, oral health scientists, and implementation scientists designing clinical trials in dental/craniofacial health with rigorous methodology and clear milestones
Key Facts
Deadline
Thu, January 6, 2028
Posted
Mon, December 2, 2024
Award Range
— – $500,000
Max Duration
6 years
Keywords
Research Areas
Gotchas (6)
Study Timeline and Milestone Plan is mandatory and applications without it will be considered incomplete and not reviewed. This is a hard gate requirement that could result in desk rejection.
98%
Source Text
“A Study Timeline and Milestone Plan must be included in the application to cover both the UG3 and UH3 time-periods... Applications submitted without a Study Timeline and Milestone Plan will be considered incomplete and will not be reviewed.”
Annual milestones must be objective, measurable, and achievable. If project fails to meet annual milestones at any time, NIDCR will consider ending support and negotiating orderly close-out. This is a
95%
Source Text
“Annual milestones must be objective, measurable, achievable, and serve as scientific and/or operational accomplishments. If at any time the project fails to meet annual milestones, NIDCR will consider ending support and negotiating an orderly close-out of the project.”
A full pilot of the UH3 planned intervention is explicitly prohibited during the UG3 planning phase. This is a programmatic constraint that could disqualify applications proposing pilot work.
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Source Text
“Note: A full pilot of the UH3 planned intervention is prohibited in the UG3 planning phase.”
This NOFO explicitly will not support testing of drugs, devices, or biologics regulated by the FDA. Applicants proposing such interventions will be ineligible.
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Source Text
“This NOFO will not support the testing of drugs, devices, or biologics regulated by the FDA; the corresponding NOFO for clinical trials in these areas is PAR-25-057.”
UG3/UH3 application must be submitted as a single application with both phases clearly integrated, requiring meticulous clarity on how UG3 planning informs UH3 implementation—this is a structural requ
95%
Source Text
“The UG3/UH3 application must be submitted as a single application. Clarity and organization in the application should be meticulous in order to support understanding each of the two phases, how information from the UG3 phase is planned to inform the UH3 phase, and an operational framework to account for uncertainties that could arise from proposing, in one application, both phases.”
UG3 award does not guarantee subsequent UH3 funding; transition to UH3 is subject to administrative review and funding availability, creating uncertainty for applicants planning a 6-year project.
95%
Source Text
“An administrative review will determine whether the UH3 phase award will be issued, subject to funding availability. Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding.”