High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional)

The National Institutes of Health, in partnership with the U.S. Food and Drug Administration’s Center for Tobacco Products, has announced a forecasted funding opportunity titled High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional). This program falls under the authority of the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, and is part of the Tobacco Regulatory Science Program. It is designed to solicit applications that will provide scientific evidence to inform FDA’s regulatory actions related to tobacco products. The focus of this initiative is to strengthen the existing research base in ways that directly support the FDA’s responsibilities under the law, ensuring public health protection through evidence-driven regulation. The purpose of this opportunity is to fund high-priority research projects that expand knowledge relevant to tobacco regulation. Although there is already a significant body of science in this area, the program emphasizes the need for additional research to address emerging issues and strengthen regulatory decisions. Projects funded under this program must align with FDA’s regulatory authority, focusing on one or more of the following topic areas: Addiction, Behavior, Communications, Health Effects, Product Composition and Design, or Toxicity. In addition, applications must comprehensively address all subcomponents of their selected topics to be considered responsive. The estimated total program funding is $7,000,000, with an anticipated eight awards. Each award may be up to $500,000, though no minimum award size has been specified. The awards will be administered by the National Institutes of Health but funded through the FDA’s Center for Tobacco Products. No cost sharing or matching requirement is imposed on applicants. Funds are expected to be used to support research activities directly related to tobacco product regulation and to generate results that are scientifically sound and relevant to the FDA’s mandate. Eligibility for this opportunity is broad, encompassing a wide range of organizations. Eligible applicants include state governments, county governments, city or township governments, special district governments, Native American tribal governments and organizations, public housing authorities, independent school districts, nonprofit organizations with or without 501(c)(3) status, small businesses, other for-profit organizations, and institutions of higher education both public and private. Additional eligible entities include U.S. territories, faith-based or community-based organizations, regional organizations, and foreign institutions. Non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are also eligible. The anticipated timeline for this opportunity begins with a forecast posting date of January 14, 2026. Applications are expected to be due on May 4, 2026, with awards projected to be announced by December 4, 2026. Project start dates are expected to align with the award date in December 2026. Because this is a forecasted notice, details such as final application instructions, required forms, and submission criteria will be made available in the official Notice of Funding Opportunity when posted. Applicants should prepare to apply through Grants.gov once the solicitation is live. Questions regarding this funding opportunity should be directed to Erik Rodriquez, Ph.D., M.P.H., who serves as the primary contact for the Tobacco Regulatory Science Program. He can be reached by phone at 301-827-2830 or by email at TRSP@nih.gov. Interested applicants should monitor Grants.gov for the official release of the Notice of Funding Opportunity to confirm application requirements and any additional details that may affect eligibility, submission, or review.