The National Institute of Dental and Craniofacial Research (NIDCR) is offering this grant to encourage UG3/UH3 phased cooperative agreement research for behavioral and social intervention clinical trials related to dental, oral, or craniofacial conditions. The UG3 phase, lasting up to two years, supports milestone-driven planning, including small-scale data collection for feasibility and acceptability assessments, alongside operational activities like protocol and data management system development. Successful UG3 projects meeting scientific milestones can transition to the UH3 phase, which supports up to five years of clinical trial implementation. This phase covers intervention research from early development to implementation and cost-effectiveness studies. Applicants must submit a single UG3/UH3 application.
Opportunity ID: 357462
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-188 |
| Funding Opportunity Title: | NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 02, 2024 |
| Last Updated Date: | Dec 02, 2024 |
| Original Closing Date for Applications: | Jan 06, 2028 |
| Current Closing Date for Applications: | Jan 06, 2028 |
| Archive Date: | Feb 11, 2028 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses |
| Additional Information on 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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). |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-188.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357462 Full Announcement-PAR-25-188 -> PAR-25-188-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289271 | Jan 07, 2025 | Jan 06, 2028 | View |
Package 1
Mandatory forms
357462 RR_SF424_5_0-5.0.pdf
357462 PHS398_CoverPageSupplement_5_0-5.0.pdf
357462 RR_OtherProjectInfo_1_4-1.4.pdf
357462 PerformanceSite_4_0-4.0.pdf
357462 RR_KeyPersonExpanded_4_0-4.0.pdf
357462 RR_Budget10_3_0-3.0.pdf
357462 PHS398_ResearchPlan_5_0-5.0.pdf
357462 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357462 RR_SubawardBudget10_30_3_0-3.0.pdf
357462 PHS_AssignmentRequestForm_4_0-4.0.pdf
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