Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required) | PAR 25 062

Opportunity Information: Apply for PAR 25 062

This funding opportunity, titled "Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required)" (Funding Opportunity Number PAR-25-062), is a National Institutes of Health (NIH) discretionary grant mechanism administered through the National Institute of Dental and Craniofacial Research (NIDCR). It is designed specifically to support either a competing renewal or a competitive revision of clinical trials that are already underway and currently supported by NIDCR. In practical terms, the program is meant for investigators and institutions that have an active NIDCR-supported clinical trial and need additional support to continue the trial into a new competitive segment (renewal) or to make significant, peer-review-worthy changes to the existing study (revision), while keeping the work within the scope of NIDCRs mission in dental, oral, and craniofacial health.

The award mechanism is a cooperative agreement (UH3), which signals that the project is expected to involve substantial programmatic involvement from NIDCR staff compared to a standard research project grant. Under a cooperative agreement, the awardee typically retains primary responsibility for leading and conducting the clinical trial, but NIH/NIDCR may play an active role through collaboration, oversight, and coordination on key aspects such as milestones, monitoring expectations, and other operational elements common to complex clinical research. The listing also clearly indicates "Clinical Trial Required," meaning the application must propose a clinical trial as defined by NIH, and the activity supported is not purely observational or preclinical; it must involve prospective assignment to an intervention and evaluation of outcomes in human participants.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities. Institutions of higher education are eligible, both public/state-controlled and private. Tribal eligibility includes Native American tribal governments that are federally recognized, as well as Native American tribal organizations that are not federally recognized tribal governments. The opportunity is also open to nonprofit organizations, including those with 501(c)(3) status and those without 501(c)(3) status, provided they are not institutions of higher education when applying under those nonprofit categories. For-profit organizations are eligible as well, including entities other than small businesses and small businesses. The announcement also explicitly highlights additional eligible applicant categories that NIH frequently calls out for emphasis, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and applicants located in a U.S. territory or possession.

At the same time, the opportunity draws a clear line on foreign eligibility. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S. applicant organization may include certain well-justified foreign elements (for example, specific performance sites, collaborations, or components needed to accomplish the research aims) if they meet NIH policy requirements and are appropriately described and justified. This distinction matters for multi-site clinical trials that may rely on specialized resources or participant populations outside the U.S., but where the applicant organization and overall award administration remain domestic.

From an administrative standpoint, the funding activity category is health, and the associated CFDA (now commonly referenced through Assistance Listing) number is 93.121. The opportunity was created on 2024-10-10, and the original closing date listed is 2028-01-06, indicating an extended availability window typical of certain NIH program announcements. The provided source data does not specify an award ceiling or the expected number of awards, which often means applicants need to consult the full announcement text and NIH guidance for budget expectations, institute-specific limits (if any), and the likely funding level given the scope of the ongoing trial and the nature of the renewal or revision request.

Overall, the core purpose is continuation or significant modification of existing NIDCR-supported clinical trials using a UH3 cooperative agreement structure, with broad domestic eligibility across governmental, academic, nonprofit, tribal, and for-profit sectors, explicit exclusion of foreign applicant organizations and non-domestic components of U.S. organizations, and allowance for foreign components only under NIH policy definitions and justifications.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2024-10-10.
• Applicants must submit their applications by 2028-01-06.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 062

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