NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) | PAR 25 239

Opportunity Information: Apply for PAR 25 239

The NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) is a National Institutes of Health funding opportunity that supports investigator-initiated research focused on observational studies or biomarker validation work in dental, oral, and craniofacial health. The central aim is to fund projects that either (1) prospectively collect new data and/or biospecimens moving forward, or (2) continue analyzing data and/or biospecimens that were previously collected under an earlier NIDCR cooperative agreement. In practical terms, this means the opportunity is designed for research teams that need a structured, forward-looking data or specimen collection component for an observational or validation purpose, or teams that have valuable existing cooperative-agreement data/specimens and want to extend the scientific yield through further planned analyses. Because it is explicitly labeled "Clinical Trial Not Allowed," applications must stay within observational and validation boundaries rather than proposing interventional clinical trials.

This funding opportunity uses the cooperative agreement mechanism (U01), which typically signals substantial scientific or programmatic involvement by NIH staff compared with a standard research grant. While the specific day-to-day responsibilities depend on the terms laid out in the full announcement, applicants should generally expect a more collaborative relationship with NIDCR, with NIH program staff potentially playing an active role in coordination, oversight, and alignment with program goals. This structure is commonly used when a project benefits from close coordination, consistent study conduct across sites, harmonized methods, or other features where NIH involvement helps ensure rigor and usability of the resulting datasets and biospecimens.

The announcement is identified as PAR-25-239, categorized as a discretionary grant opportunity under the Health funding activity category, and associated with CFDA (Assistance Listing) 93.121. The sponsoring agency is the National Institutes of Health. The opportunity was created on December 5, 2024, and the original closing date listed is May 7, 2026. The excerpt provided does not state an award ceiling or the expected number of awards, so applicants would need to consult the full NOFO text for budget limits, project period expectations, and any NIDCR-specific caps or constraints.

Eligibility is broad and includes many standard U.S.-based applicant types, spanning 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; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofits with and without 501(c)(3) status (excluding institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The NOFO also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Indian/Native American Tribal Governments other than federally recognized entities, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions.

At the same time, the announcement draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicants, 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, which typically means a U.S. applicant organization may include a foreign component in the project when it is scientifically justified and consistent with NIH policy, even though a foreign organization cannot be the primary applicant.

Overall, this NOFO is best suited for teams proposing well-designed prospective observational efforts or rigorous biomarker validation studies where the value comes from systematic data and biospecimen collection and/or continued exploitation of high-quality resources generated under earlier NIDCR cooperative agreements. Applicants should shape their aims to fit non-interventional research (since clinical trials are not allowed), clearly justify the need for prospective collection or continued analysis of cooperative-agreement resources, and be prepared for the collaborative expectations that come with the U01 cooperative agreement structure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)" 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 2024-12-05.
• Applicants must submit their applications by 2026-05-07. (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 25 239

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