Opportunity Information: Apply for RFA OD 21 004
This grant opportunity, titled "Maximizing the Scientific Value of Existing Biospecimen Collections (R21 Clinical Trial Not Allowed)" (RFA OD 21 004), supports short-term, exploratory research projects that make new scientific use of biospecimens that have already been collected and are publicly available through established US repositories. The central idea is to help investigators unlock additional value from stored specimens by asking new questions, applying newer laboratory or analytic methods, or linking biospecimen-based measures to existing health and behavior data, especially in ways that align with the regulatory science mission of the FDA Center for Tobacco Products (CTP). Because it is an R21 mechanism, the emphasis is on generating early, proof-of-concept findings and preliminary data that can justify and strengthen a later, larger follow-on study rather than completing a full-scale, definitive research program in one award.
A key feature of the program is its focus on using existing biospecimens rather than collecting new samples. The FOA highlights several major repositories and studies as examples of the kinds of resources applicants may draw from, including 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. Projects can also propose to use other publicly available repositories, but the announcement makes clear that priority will go to analyses that are nationally representative when that is relevant to the research question. In practical terms, this means proposals that can produce findings generalizable to the US population (or another broad, representative frame) are especially responsive, provided they also fit the tobacco-related regulatory science focus.
The scientific scope is intentionally broad as long as it is relevant to FDA CTP interests and leverages existing stored biospecimens. Applicants are expected to frame questions that can be answered by testing or analyzing these specimens, often in combination with associated participant data that may include demographics, health outcomes, exposures, or tobacco-use behaviors. The underlying goal is to "maximize scientific value," which typically means extracting new information from specimens that were collected for earlier purposes, using improved assays, evaluating emerging biomarkers, exploring novel exposure-response relationships, or conducting exploratory comparisons among tobacco product use patterns and biologic measures that were not previously examined.
The FOA also sets an important expectation around the choice of repository and dataset. If an applicant proposes a resource that is not publicly available and nationally representative, they must justify why that dataset is uniquely suited to the proposed aims and why the same research questions cannot be answered using a publicly available, nationally representative dataset. In other words, the proposal must make a convincing case that the selected biospecimen collection is not just convenient, but necessary for the science. This requirement is meant to keep projects tightly focused on questions that truly require the specific specimens, metadata, or study design features available in the chosen repository.
Administratively, this is a discretionary grant funded under CFDA 93.077 by the Department of Health and Human Services through the National Institutes of Health, with research aligned to FDA CTP priorities. The award uses the R21 exploratory/developmental grant mechanism and explicitly does not allow clinical trials. The maximum award amount listed is an award ceiling of $200,000, and the opportunity anticipated making about five awards. Eligible applicants span a wide range of organizations, including public and private higher education institutions, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special districts), as well as eligible tribal governments and tribal organizations and certain housing authorities. The opportunity was created on March 10, 2021, with an original closing date of March 8, 2023.
Overall, the opportunity is designed for researchers who can take advantage of high-value existing US biospecimen collections to produce actionable, early-stage findings relevant to tobacco-related public health and regulation. Strong applications will typically be those that (1) clearly align with FDA CTP mission needs, (2) demonstrate that the proposed aims are feasible within an R21 scope using available specimens and accompanying data, (3) explain why the chosen repository is uniquely appropriate, and (4) show how the resulting data will position the research team for a subsequent, more definitive project or application.Apply for RFA OD 21 004
- 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 (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 Mar 10, 2021.
- Applicants must submit their applications by Mar 08, 2023. (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 5 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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