The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications to stimulate exploratory research relevant to the mission of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP) using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but not be limited to, collections associated with the Population Assessment of Tobacco and Health (PATH) Study, the National Health and Nutrition Examination Survey (NHANES), the National Heart, Lung and Blood Institute’s (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), and the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Proposed research should seek to maximize the scientific value of these stored collections and to provide researchers with an opportunity to generate preliminary data for subsequent research proposals. While other publicly available repositories would be considered, depending on analyses to be conducted, nationally representative analyses will receive priority. These applications need to provide justification why the data set is unique, and the research questions cannot be answered from a publicly available, nationally representative, data set.
The awards under this FOA will be administered by NIH using funds that have been made available through FDA-CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP).