Tobacco Regulatory Science Research Program
What Is the Tobacco Regulatory Science Program?
The Tobacco Regulatory Science Program (TRSP) is an interagency partnership between the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and the National Institutes of Health (NIH) and the to foster tobacco regulatory research.
With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Within the framework of the Tobacco Control Act, TRSP provides scientific evidence and data to inform FDA’s regulatory actions.
Through this partnership, FDA and NIH establish a comprehensive research agenda in tobacco regulatory science. The FDA provides the expertise, authority, and resources to support research responsive to FDA’s regulatory authority. NIH provides the infrastructure for the solicitation, review, and management of scientific research, and several NIH Institutes and Centers have long supported tobacco-related research as part of their missions.
TRSP brings together scientists from diverse fields, such as epidemiology, chemistry, toxicology, addiction, and psychology, to shed light on why people try and continue to use tobacco, how tobacco use affects health, and which policies might help reduce the risk of harm. TRSP-supported biomedical, behavioral, and social sciences research helps FDA better understand tobacco use and associated risks in order to reduce the public health burden of tobacco in the United States.
How are Grants Reviewed and Awarded?
The NIH peer review process forms the cornerstone of the NIH extramural research program. Through this process, NIH seeks to ensure that applications for funding receive fair, independent, expert, and timely scientific reviews—free from inappropriate influences—so that NIH can fund the most promising research.
NIH’s funding decisions are made through a rigorous dual-level peer review process that emphasizes fairness and accountability and prioritizes support of scientific ideas with the greatest potential impact to improve human health or otherwise advance biomedical research. During the peer review process, NIH relies on individuals with expertise in various scientific and technical fields who volunteer their time to assist the agency in rigorously evaluating grant applications for their scientific and technical merit during the first stage of peer review. This process is followed by a second-level review for mission relevance by members of national advisory councils for NIH institutes and centers (IC) and the NIH Office of the Director. Final funding decisions are made by IC directors, taking into consideration the research program priorities of their ICs in the context of the existing funding portfolio.
During the first stage of peer review, research project grant (RPG) applications are evaluated based on five criteria (42 C.F.R. Part 52h.8): Significance, Investigators, Innovation, Approach, and Environment. In current review practice (for applications with due dates before January 25, 2025), each of the five criteria is given a numerical score by assigned reviewers. These five scored criteria, along with several non-scored Additional Review Criteria, contribute to an application’s final, Overall Impact score. For additional details on the peer review process, see Peer Review.