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NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

US · MD · Bethesda National Institutes of Health – National Institute of Dental and Craniofacial Research (NIDCR) grant open #PAR-25-188
Response due Jan 06, 2028 · 00:00 UTC

Summary

The National Institute of Dental and Craniofacial Research (NIDCR), part of NIH, is soliciting cooperative agreement applications (UG3/UH3 mechanism) for the planning and implementation of behavioral and social intervention clinical trials. The UG3 phase covers planning/milestone achievement, while the UH3 phase supports full trial implementation. Applicants must design and conduct a clinical trial as a required component of the award. This is a multi-year opportunity open from December 2024 through January 2028.

What they want

Cooperative agreement to support two phased activities: (1) UG3 Planning Phase — development and validation of a behavioral/social intervention protocol, establishment of trial infrastructure, and achievement of pre-specified go/no-go milestones; (2) UH3 Implementation Phase — full execution of the clinical trial upon successful completion of UG3 milestones. A clinical trial is required; applications that do not include a clinical trial will not be accepted. NIDCR staff will have substantial programmatic involvement throughout both phases.
Technical requirements
  • Clinical trial must be included as a required component of the application
  • Two-phase award structure: UG3 (planning) followed by UH3 (implementation)
  • Go/no-go milestone review required between UG3 and UH3 phases
  • Substantial NIH/NIDCR programmatic involvement as cooperative agreement

How they evaluate

  • Scientific and technical merit (peer review)
  • Significance and innovation of behavioral/social intervention
  • Approach and rigor of clinical trial design
  • Investigator qualifications and environment
  • Milestone feasibility for UG3-to-UH3 transition
Submission: Electronic submission via Grants.gov (federal grants portal); NIH ASSIST or institutional systems-to-system submission likely required per standard NIH policy

Eligibility & certifications

SAM.gov registration (standard federal requirement)Institutional assurances for human subjects research (IRB approval at trial launch)NIH compliance with clinical trial registration requirements (ClinicalTrials.gov)

Risks & flags

  • Extremely long open window (~3 years, through Jan 2028) with rolling submission — may favor established research teams with existing NIDCR relationships
  • Cooperative agreement mechanism implies substantial NIH staff involvement, which can disadvantage applicants unfamiliar with NIDCR programmatic priorities

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NIDCR Behavioral and Social Intervention C…
Due Jan 06
Onboard