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

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.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions). Non-domestic (non-U.S.) components of U.S. OrganizationsForeign components, as defined in the NIH Grants Policy Statement

Funding decisions are based on scientific merit (42 CFR 52h) and program relevance. Scientific merit review encompasses: the peer review criteria detailed in the specific funding announcement, as well as the significance, approach, and innovation of the proposed research; the competency of the principal investigator; the adequacy of the resources and environment; the proposed budget and requested period of support; and, where applicable, the adequacy of the measures for protecting against adverse effects upon humans, animals, or the environment. Relevance to Tobacco Control Regulatory Research program priorities will also be taken into consideration.