Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed) | RFA OD 19 022

Opportunity Information: Apply for RFA OD 19 022

The grant opportunity "Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-OD-19-022) is a discretionary NIH research grant designed to support innovative, short-term projects that reanalyze existing data to answer new questions about tobacco use and health. The emphasis is on secondary analyses rather than collecting new data or running a clinical trial, and it uses the NIH R21 mechanism, which typically backs early-stage, exploratory, or high-impact ideas that can move a field forward quickly. The overall goal is to produce evidence that is directly useful for U.S. tobacco regulation, specifically to inform the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as it regulates the manufacture, distribution, and marketing of tobacco products to protect public health under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31).

The FOA prioritizes projects that analyze publicly available, nationally representative U.S. datasets, including both cross-sectional and longitudinal sources. In practical terms, this means applications are strongest when they use large U.S. datasets designed to represent the national population and allow population-level inference, trend estimation, subgroup comparisons, and policy-relevant modeling. While the announcement allows for other publicly available datasets, those alternatives must be justified clearly. If an applicant proposes to use a dataset that is not nationally representative, they are expected to explain why that dataset is uniquely suited to the research question and why the same question cannot be answered using an available nationally representative public-use dataset. The review and funding priorities therefore strongly favor analyses with broad generalizability to the U.S. population, unless there is a compelling reason to deviate.

From a scientific standpoint, the FOA is looking for more than routine descriptive statistics. It invites proposals that test novel scientific ideas or develop new models, systems, tools, methods, or technologies that could significantly affect biomedical or biobehavioral tobacco research aligned with FDA CTP needs. That can include innovative modeling approaches, new analytic frameworks for assessing use patterns or transitions across products, improved measurement strategies using existing survey items, or methods that better estimate the public health impact of product characteristics, marketing exposure, or regulatory scenarios. The key is that the work must remain grounded in existing data and produce outputs that regulators and the tobacco control research community can use.

A central feature of this opportunity is its explicitly regulatory focus. The NIH administers the awards, but the funding comes through FDA CTP, and the expected outputs are intended to help support tobacco regulatory actions in the United States. In other words, investigators are expected to connect their analytic aims to the types of evidence FDA relies on when evaluating population health impacts, understanding patterns of initiation and cessation, tracking product switching, assessing disparities, and anticipating how marketing, availability, and product attributes may influence behavior. Applications are expected to address research priorities that fall within FDA CTP's regulatory authority, so proposals should make a clear case that the findings will be directly relevant to decisions about tobacco product oversight and public health protection.

In terms of basic logistics, the sponsoring agency is the Department of Health and Human Services, National Institutes of Health, and the activity category is health (CFDA 93.077). The opportunity had an award ceiling of $200,000 and anticipated making about 5 awards. The original posting date was July 8, 2019, with an original closing date of March 8, 2021. The eligible applicant pool is broad and includes state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; special district governments and independent school districts; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility language.

Overall, this FOA is best understood as an opportunity for researchers with strong quantitative and methodological expertise to leverage existing public-use U.S. datasets to generate timely, policy-relevant evidence about tobacco use and its health consequences. The strongest applications are likely to be those that (1) use nationally representative datasets when possible, (2) propose clearly innovative analytic approaches rather than incremental reanalysis, and (3) make an explicit, credible connection between the expected results and FDA CTP regulatory decision-making.

• The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Secondary Analyses of Existing Datasets of Tobacco Use and Health (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 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).

Apply for RFA OD 19 022

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: