Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional) | RFA OD 25 008

Opportunity Information: Apply for RFA OD 25 008

The Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional), Funding Opportunity Number RFA-OD-25-008, is a discretionary NIH grant opportunity designed to help early-career investigators build an independent research program in tobacco regulatory science. It specifically targets new biomedical, behavioral, and social science researchers who are still in the early stages of establishing themselves as independent investigators and who want to generate evidence that can be used in real-world tobacco regulation. Although NIH will administer the awards, the funding comes from the FDA Center for Tobacco Products (CTP) under the authority of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31, which is the law that expanded FDA authority to regulate tobacco products.

This opportunity uses the NIH R03 small grant mechanism, which is meant for focused, limited-scope projects that can be completed with relatively modest resources. The program is structured to support work such as pilot or feasibility studies, secondary analyses of existing datasets, small self-contained research projects, development or refinement of research methods, and early-stage development of new research technologies. The "clinical trial optional" designation means applicants may propose studies that include a clinical trial component if appropriate, but a clinical trial is not required to be competitive; the key issue is whether the proposed approach fits the question and can produce useful regulatory-relevant evidence.

A central requirement is that the research must address one or more High-Priority Research Topics tied directly to FDA CTP's regulatory authorities. In practical terms, applicants should frame their projects around questions that could inform how FDA regulates the manufacturing, distribution, and marketing of tobacco products, with the overarching goal of protecting public health. The expectation is not simply to advance academic knowledge about tobacco, but to generate findings and data that are directly relevant to FDA decision-making. Successful projects will typically make clear how their outcomes could support regulatory actions or policy development, such as by improving understanding of product characteristics, user behaviors, marketing impacts, population-level effects, or methodological tools that strengthen regulatory science.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education, since higher education institutions are already listed separately); for-profit organizations other than small businesses; and small businesses. The NOFO also notes additional eligible applicant types such as certain eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, the program is explicitly domestic in scope: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

The maximum award amount listed is an award ceiling of $75,000. The original application due date shown is July 14, 2026, and the opportunity was created on June 24, 2025. Overall, this NOFO is best understood as a small, targeted funding option for new investigators to generate early, credible regulatory science results, gather preliminary data, validate tools or methods, or test feasible approaches that can later be scaled into larger studies, all while staying tightly aligned with FDA CTP priorities under the tobacco control law.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)" 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 2025-06-24.
• Applicants must submit their applications by 2026-07-14. (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 $75,000.00 in funding.
• 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 RFA OD 25 008

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