High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional)
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The National Institutes of Health and the FDA Center for Tobacco Products are issuing a Notice of Funding Opportunity for High-Priority Research Projects in Tobacco Regulatory Science. This initiative seeks to gather additional scientific data to support the FDA's regulatory authorities and the implementation of the Family Smoking Prevention and Tobacco Control Act to protect public health. Clinical trials are optional for these projects. To be eligible, research must fall within the regulatory authority of the FDA CTP and address specific topics including addiction, behavior, communications, health effects, product composition and design, or toxicity. Awards will be administered by the NIH using funds from the FDA CTP and the Family Smoking Prevention and Tobacco Control Act.
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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.
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