Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement (UH3 Clinical Trial Required) | PAR 22 068

Opportunity Information: Apply for PAR 22 068

The Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement (UH3 Clinical Trial Required) grant opportunity, PAR 22 068, is a National Institutes of Health (NIH) Funding Opportunity Announcement run by the National Institute of Dental and Craniofacial Research (NIDCR). It is designed specifically for projects that are already being supported by NIDCR as ongoing clinical trials and now need either additional time or a justified change in direction. The mechanism is a cooperative agreement (UH3), which generally means NIDCR program staff are expected to have substantial involvement during the project period, not just a hands-off sponsor role. The activity area is health (CFDA 93.121), and it is categorized as discretionary funding.

This FOA is narrowly focused on two types of requests tied to an existing NIDCR-supported clinical trial. First, it supports competing renewals, which are essentially extensions of the current trial through a new competitive application. NIDCR indicates it will consider renewals when the trial genuinely needs more time to finish planned work, or when there is a strong scientific rationale for extending follow-up to capture longer-term outcomes that cannot be adequately assessed within the original award period. Second, it supports competitive revisions, which are requests to modify the scope of an ongoing trial. These revisions are not meant for minor tweaks; they are expected to be justified by compelling reasons to change what the trial is doing, such as a substantial, well-supported need to alter objectives, procedures, or other scope-defining elements.

A key practical expectation in the announcement is early communication with NIDCR. Applicants are strongly encouraged to contact the relevant Scientific/Research contact for the specific ongoing clinical trial before submitting a renewal or revision application under this FOA. In practice, that pre-submission conversation helps ensure the proposed renewal or scope change matches NIDCR expectations for the parent award, aligns with institute priorities, and is appropriate for the UH3 clinical trial implementation stage.

Eligibility is broad across U.S.-based organization types typically allowed under NIH policies, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education, where that is separately listed); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out several additional eligible applicant categories that NIH often highlights for outreach and inclusivity, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the FOA draws clear boundaries around non-U.S. applicants. Non-domestic (non-U.S.) entities and non-U.S. foreign institutions 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 in the NIH Grants Policy Statement, meaning a U.S. applicant organization may include certain elements of the work conducted abroad if they meet NIH’s definition and requirements for a foreign component (for example, a substantial portion of the project being performed outside the United States), subject to NIH rules and approval.

The listed original closing date for this opportunity is 2025-01-08, and the FOA record shows no award ceiling and no expected awards number specified in the summary data provided. Overall, this opportunity is best understood as a targeted pathway for NIDCR-funded clinical trial teams to either finish what they started when timelines prove insufficient or to make a well-justified, significant adjustment to the trial’s scope, with NIDCR remaining an active partner through the cooperative agreement structure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Continuation or Revision of NIDCR Clinical Trial 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 2021-12-01.
• Applicants must submit their applications by 2025-01-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 22 068

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