High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional)
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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Tobacco Regulatory Science Program, in collaboration with participating NIH Institutes and Centers and the FDA Center for Tobacco Products, plans to release a funding opportunity focused on high-priority research projects in tobacco regulatory science. This initiative aims to support research that will provide critical scientific data to inform FDA’s regulation of tobacco products, enhancing public health protection under the Family Smoking Prevention and Tobacco Control Act. While existing research forms a strong foundation, the program seeks additional high-impact studies addressing key areas such as addiction, behavior, communications, health effects, product composition and design, and toxicity. Eligible research must fall within the FDA CTP’s regulatory authority and thoroughly address all components within the chosen subtopics. The funding will be administered by NIH using resources from the FDA CTP and the FSPTCA, with authorization under the Public Health Service Act. Applicants have the option to include clinical trials as part of their proposals. For further details or inquiries, contact Erik Rodriquez, Ph.D., M.P.H. via the provided NIH contacts.
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Full Description
The Tobacco Regulatory Science Program, participating NIH Institutes and Centers (ICs), and the United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to issue a Notice of Funding Opportunity (NOFO) soliciting applications for High-Priority Research Projects in Tobacco Regulatory Science (Clinical Trial Optional).
The FDA and NIH share an interest in supporting research that could inform FDA's tobacco regulatory authorities. High-priority research encouraged by this NOFO is expected to provide additional scientific data to the research base to inform the regulation of tobacco products to protect public health. Although a vast and sound science base exists related to the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31, the NOFO will seek high-priority research that will provide additional science for the FDA to consider as it implements the FSPTCA.
In order to be considered responsive, research must (1) be within the regulatory authority of FDA CTP, (2) address one or more of the following topics: Addiction, Behavior, Communications, Health Effects, Product Composition and Design, and/or Toxicity; and (3) address all components within the subtopic(s) of the selected topic(s).
Awards will be administered by NIH using funds made available through FDA CTP and the FSPTCA. TRSP is authorized to forecast this opportunity under The Public Health Service Act and the FSPTCA, Public Law 111-31, 42 US Code 300u-3.