Opportunity Information: Apply for RFA OD 19 021

Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed) is a U.S. Department of Health and Human Services funding opportunity administered through the National Institutes of Health (NIH) using funds provided by the FDA Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). It supports short, exploratory projects under the NIH R21 mechanism, with the clear intent of helping investigators produce early, decision-relevant findings that can inform FDA regulation of tobacco product manufacturing, distribution, and marketing in ways that protect public health.

The central idea is to unlock additional scientific and regulatory value from biospecimens that have already been collected and are currently stored in U.S. repositories, particularly collections that are publicly available and already linked to rich participant data. Rather than paying for new specimen collection, the program encourages researchers to use existing resources efficiently and creatively, leveraging established repositories to answer new questions, test novel hypotheses, or validate emerging biomarkers relevant to tobacco use and its health impacts. The FOA highlights several major sources as examples, including biospecimens tied to the Population Assessment of Tobacco and Health (PATH) Study, the National Health and Nutrition Examination Survey (NHANES), the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), and the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Other publicly available biospecimen datasets can also be proposed, but applicants need to make a strong case for why the alternative dataset is uniquely necessary for the proposed work.

A key priority is analyses that are nationally representative, meaning studies that can produce findings generalizable to the U.S. population will receive preference. If an applicant proposes to use a dataset that is not nationally representative, the application is expected to explain why the scientific question cannot be answered using an available nationally representative resource. In practice, that justification should connect the research aims to the unique features of the chosen biospecimen collection, such as specific specimen types, timing of collection, longitudinal follow-up, linked behavioral or exposure measures, demographic coverage, or the availability of particular tobacco-related variables.

This opportunity is specifically for exploratory research and is not intended to support clinical trials, as indicated by the "Clinical Trial Not Allowed" designation. The R21 structure also signals that reviewers will be looking for projects that are innovative and feasible but may still be at an early stage, where the main deliverable is strong preliminary data, proof-of-concept analyses, or pilot results that can justify larger follow-on studies. The FOA explicitly frames these awards as a way to generate preliminary evidence and datasets that can support subsequent research proposals, while still producing outputs relevant to FDA-CTP regulatory science needs.

Eligibility is broad and includes many types of U.S.-based organizations: 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The opportunity is categorized as a discretionary grant in the health area (CFDA 93.077), reflecting its public health and regulatory science orientation.

From an administrative standpoint, the funding opportunity number is RFA-OD-19-021, with a creation date of July 8, 2019, and an original closing date of March 8, 2021. The posted award ceiling is $200,000, and the FOA anticipated approximately seven awards. Taken together, these details suggest a competitive, targeted program designed to fund a limited number of tightly aligned projects that can move quickly, make strong use of existing national biospecimen resources, and produce findings that can directly support FDA-CTP decision-making about tobacco products and population health.

  • The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 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): 93.077.
  • This funding opportunity was created on Jul 08, 2019.
  • Applicants must submit their applications by Mar 08, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • The number of recipients for this funding is limited to 7 candidate(s).
  • 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 (see text field entitled Additional Information on Eligibility for clarification).
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