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NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

US · MD · Bethesda National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH) grant open #PAR-25-057
Response due Jan 06, 2028 · 00:00 UTC

Summary

The National Institute of Dental and Craniofacial Research (NIDCR), part of NIH/HHS, is soliciting cooperative agreement applications (UG3/UH3 mechanism) to support the planning and implementation of clinical trials involving drug, biologic, device, and/or procedure interventions. The UG3 phase covers trial planning and the UH3 phase covers full implementation. A clinical trial is required under this funding opportunity announcement (FOA). The opportunity is open for multiple submission cycles through early 2028.

What they want

Applicants must propose and carry out a two-phase cooperative agreement: (1) UG3 – a planning phase for a clinical trial involving drug, biologic, device, and/or procedure interventions in dental/craniofacial/oral health research; and (2) UH3 – a full clinical trial implementation phase contingent on satisfactory completion of UG3 milestones. NIDCR staff will have substantial programmatic involvement throughout both phases. A clinical trial is explicitly required.
Deliverables
  • UG3 phase: clinical trial planning protocol and milestone completion
  • UH3 phase: full clinical trial implementation and results reporting
Technical requirements
  • Clinical trial is required (not optional)
  • Two-phase structure: UG3 (planning) followed by UH3 (implementation)
  • Interventions must involve drug, biologic, device, and/or procedure
  • NIDCR staff will have substantial programmatic involvement (cooperative agreement terms)
  • Progression from UG3 to UH3 contingent on milestone achievement

How they evaluate

Submission: Electronic submission via Grants.gov (federal grants portal); FOA number PAR-25-057

Risks & flags

  • Multi-year open window (Oct 2024 – Jan 2028) suggests rolling submission cycles — applicants should check NIH Guide for specific due dates
  • No budget ceiling or floor stated in the synopsis, making cost planning difficult without the full FOA
  • Cooperative agreement mechanism implies significant NIH programmatic control, which may constrain PI autonomy

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
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 Drug, Biologic, Device and/or Proced…
Due Jan 06
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