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

<p><span style="background-color:white;">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).</span></p><p>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.</p><p>In order to be considered responsive, research must (1) be within the regulatory authority of FDA CTP, (2) address one or <span style="background-color:white;">more of the following topics: Addiction, Behavior, Communications, Health Effects, Product Composition and Design, and/or Toxicity;&nbsp;</span>and (3) address all components within the subtopic(s) of the selected topic(s)<span style="background-color:white;">.</span></p><p><span style="background-color:white;">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.</span></p>