NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) | PAR 20 060

Opportunity Information: Apply for PAR 20 060

The NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed), Funding Opportunity Number PAR 20 060, is a National Institutes of Health discretionary funding program administered by the National Institute of Dental and Craniofacial Research (NIDCR). It uses the cooperative agreement funding instrument (U01), which generally means the project is still investigator-initiated, but NIDCR expects to have substantial scientific or programmatic involvement during the life of the award compared with a typical research grant. The activity category is health (CFDA 93.121), and the FOA was created on 2019-11-19 with an original closing date listed as 2023-05-07.

The purpose of the announcement is to support observational research or biomarker validation work that specifically needs prospective collection of data and/or biospecimens, or that continues analyzing data and/or biospecimens that were originally collected under a previous NIDCR award. In practical terms, this is aimed at studies where the central scientific value comes from carefully following participants over time, systematically capturing clinical or behavioral information, and/or collecting and processing samples in a way that allows robust biomarker assessment. It also explicitly accommodates projects that build on existing NIDCR-supported cohorts or repositories, where new analyses or follow-on prospective work can substantially extend what was learned in the earlier NIDCR-funded effort. The "Clinical Trial Not Allowed" designation signals that applications proposing a clinical trial design are not responsive to this FOA; the supported studies should be observational in nature or focused on validating biomarkers rather than testing interventions.

A wide range of applicant organizations can apply. Standard eligible applicant types 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; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations as permitted. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); 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; regional organizations; tribally controlled colleges and universities (TCCUs); and U.S. territories or possessions.

Restrictions related to foreign involvement are specific. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, the FOA allows foreign components under NIH policy definitions, meaning a U.S.-based applicant may include certain foreign activities, collaborations, or performance sites if they meet NIH Grants Policy Statement requirements and are well-justified scientifically.

Overall, the opportunity is best suited for research teams that can demonstrate a strong observational study design or a rigorous biomarker validation plan, along with the infrastructure and governance needed to manage prospective data and biospecimen collection (or to responsibly leverage and analyze existing NIDCR-supported datasets and samples). Because it is a U01 cooperative agreement, applicants should also anticipate a more active relationship with NIDCR staff during project execution, including coordination around study conduct, data/specimen stewardship expectations, and progress oversight consistent with cooperative agreement norms.

• 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 2019-11-19.
• Applicants must submit their applications by 2023-05-07. (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 20 060

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