NIDCR Prospective Observational or Biomarker Clinical Validation Study Cooperative Agreement (U01) | PAR 17 154

Opportunity Information: Apply for PAR 17 154

The NIDCR Prospective Observational or Biomarker Clinical Validation Study Cooperative Agreement (U01) (Funding Opportunity Number PAR-17-154) is a National Institutes of Health discretionary funding opportunity in the health category (CFDA 93.121) that uses the cooperative agreement mechanism. In practical terms, a U01 means the funded project is still investigator-initiated and led, but it is carried out with substantial NIH program involvement compared to a standard research project grant. This FOA is designed to support clinical research efforts that either (1) prospectively collect new clinical data and/or biospecimens in an observational framework or for biomarker clinical validation, or (2) continue analyzing data and/or biospecimens that were originally gathered under a previous NIDCR cooperative agreement award. The emphasis is on prospective collection or structured continuation of analysis tied to prior NIDCR cooperative agreement-supported resources, rather than purely retrospective studies that do not involve continued follow-up or planned forward-looking data collection.

The scientific scope centers on observational studies and biomarker validation studies. Observational studies typically follow participants over time without assigning interventions, aiming to understand disease natural history, risk factors, outcomes, or associations between exposures and oral or craniofacial health endpoints. Biomarker clinical validation studies focus on testing whether a candidate biomarker performs reliably and meaningfully in a clinical context, such as predicting disease presence, progression, prognosis, or response, using well-defined clinical endpoints and standardized collection and processing methods for specimens and data. A key point in this FOA is that the work must require prospective data or biospecimen collection, or a continued, structured analysis of previously collected materials from an earlier NIDCR cooperative agreement, which signals that NIDCR is prioritizing studies with rigorous clinical characterization, robust sample handling, and strong linkage to clinically relevant outcomes.

Eligibility is broad across government, academic, nonprofit, and industry sectors. Eligible applicants listed include state, county, city/township, and 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 (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. This structure reflects NIH's common approach of allowing many organizational forms to lead projects, as long as they can meet the scientific, ethical, and operational requirements of clinical observational or validation research.

At the same time, there are clear restrictions regarding foreign organizations. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the primary applicant organization, 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, meaning a U.S.-based applicant may include certain foreign performance sites or collaborations when they are justified and appropriately structured under NIH policy, even though a foreign institution cannot be the direct applicant.

The opportunity was created on 2017-02-03, and the original closing date listed is 2019-11-19. The notice does not provide an award ceiling or an expected number of awards in the excerpted source data, which usually means applicants would need to consult the full FOA and any associated notices for budget expectations, project period limits, and program-specific guidance. Overall, this FOA is best understood as a pathway for teams capable of executing well-controlled prospective observational research or clinically meaningful biomarker validation work in dental, oral, and craniofacial health domains, with the added feature of NIH staff collaboration typical of U01 cooperative agreements and a particular interest in leveraging or extending resources built under prior NIDCR cooperative agreement awards.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Prospective Observational or Biomarker Clinical Validation Study Cooperative Agreement (U01)" 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 2017-02-03.
• Applicants must submit their applications by 2019-11-19. (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.

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