Key Dates

PAR-22-247 - Development of Animal Models and Related Biological Materials for Down Syndrome Research (R24 Clinical Trials Not-Allowed)

NOT-OD-22-011 - Notice of Intent to Publish a Funding Opportunity Announcement for the Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54 Clinical Trial Not Allowed)

NOT-OD-21-175 - Notice of Intent to Publish a Funding Opportunity Announcement for the Center for Rapid Surveillance of Tobacco (CRST) to Assess Changes in Use Behaviors, Product Marketing, and the Marketplace (U01 Clinical Trial Optional)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Cancer Institute (NCI)

The National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP), participating NIH Institutes and Centers (ICs), and the United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to reissue the Funding Opportunity Announcement (FOA) RFA-OD-17-006 Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54). This Notice is being provided now to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Modifications to this FOA will be the inclusion of new and revised scientific domains. In addition, Rapid Response Projects (RRPs) have been removed from this FOA.

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 directly relevant in informing the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

The FOA is expected to be published in Winter 2022 with an expected application due date in Summer 2022. The NIH anticipates holding a pre-application web-based webinar open to all interested prospective applicants.

The overall Tobacco Centers of Regulatory Science (TCORS) cooperative agreement research program will inform FDA’s tobacco product regulatory activities. The TCORS program will lead the establishment of a broad national scientific base of tobacco regulatory research. Essential elements of TCORS applications will include at least three discrete hypothesis-driven Research Projects with a scientific integrative theme, an Administrative Core, a Career Enhancement Core, and optional cores as needed and justified. Research integrated across projects, where findings from one major project inform or complement those in another, is required.

Disciplinary integration within a TCORS, and within projects (where feasible) is also encouraged. Disciplinary diversity in a TCORS must support the objectives of the science and not merely reflect the training of the scientists. Meaningful collaboration is permitted across geographically separate sites within a funded TCORS. Each TCORS funded under this announcement is expected to work with NIH and FDA staff to collaborate with other TCORS, a designated Coordinating Center, and a Center for Rapid Surveillance of Tobacco (CRST), on a regular basis to share information, assess scientific progress in the field, identify new research opportunities, participate in one or more cross-site scientific working groups, address research gaps, and resolve areas of scientific disagreement.

NOTE: Applicant institutions may submit multiple applications in response to this FOA and NOT-OD-21-175 (CRST) and NOT-OD-22-011 (CASEL). The TCORS PD/PI recipient, however, cannot serve as PD/PI of a CRST awardee nor as key personnel of a CASEL recipient.

Applicants will be required to identify an overall Integrative Theme for their proposed TCORS. The level of specialization in different dimensions of regulatory tobacco research will vary with each TCORS, e.g., topics, populations, levels of analysis, and types of research. However, TCORS should focus thematically on areas in which there are significant gaps in knowledge--where focused, collective, interdisciplinary efforts could make the greatest difference in reducing tobacco use and its adverse health consequences through the regulation of the manufacture, distribution, and marketing of tobacco products.

Individual TCORS may vary in their breadth or concentration across research foci. Integrative Themes may coalesce around a research gap that is tobacco product- or constituent-specific that addresses Scientific Domains, or may represent an integrative approach to generating data needed to regulate tobacco in a way that reduces use and harm in populations that experience greater tobacco-related health disparities.

It is expected that the TCORS will facilitate more rapid advances in knowledge than would be possible by depending on individual investigators working in relative isolation.

FDA encourages research studies to include, where appropriate to the research question, vulnerable populations, including (but not limited to): Youth and young adults, those from lower socioeconomic backgrounds (e.g., those with lower household incomes or lower educational attainment), racial or ethnic minorities, sexual and/or gender minorities, rural populations, those pregnant or trying to become pregnant, active-duty military or veterans, those who are or have been incarcerated, and those with mental health conditions or substance use disorders. If a vulnerable population will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health. Health disparity considerations can be incorporated into all the topics below.

A goal of the TCORS program will be to support a portfolio that is balanced across the Scientific Domains below. Any single project can focus on one or more of these domains. However, applications must propose a program that includes two or more of the following Scientific Domains across all projects.

Note: Addressing many/all Scientific Domains in an individual TCORS is not advantageous. What is important regarding Scientific Domains is to demonstrate how the research proposed integrates with the center’s overall theme to inform tobacco regulatory activities.

The scope of the CTP-funded research program focuses on the following scientific domains:

• Product Composition and Design Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics*.
• Toxicity Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in users and nonusers through secondary exposure; including animal (in vivo) and cell culture (in vitro) models, as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke (other than cigarette), aerosols, or specific constituents in tobacco and the tobacco product.
• Addiction Understanding the effect of tobacco product characteristics* on addiction and abuse liability across populations.
• Health Effects Understanding the short- and long-term health effects of tobacco products (excluding conventional cigarettes) with priority on longitudinal data. Areas of interest include cardiovascular, cancer, neurological (e.g., seizures), oral, reproductive, and respiratory health effects [including inflammation and lung disorders (e.g., asthma, COPD)].
• Behavior Understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use and the impact of tobacco product characteristics* on behaviors across populations, as appropriate.
• Communications Understanding how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media.
• Marketing Influences Understanding the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations. Topics may include marketing such as advertising, digital media, and promotions.
• Impact Analysis Understanding the potential or actual impact of FDA regulatory actions.

*The term characteristic encompasses materials, ingredients (including additives, nicotine formulations, and flavors), design, composition, heating source, and other features of a tobacco product, including harmful and potentially harmful constituents. Product characteristics can be incorporated into all of the above topics.

Non-Responsive Research

Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they will not be included in the FOA and will be deemed non-responsive:

• Studies of short-term health effects and/or acute topography/clinical pharmacology testing of early generation Electronic Nicotine Delivery Systems (ENDS) products
• Mechanistic studies (i.e., basic science of disease development) unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
• Studies developing or testing graphic health warnings for cigarette packages and advertisements
• Communicating harmful and potentially harmful constituents to the public
• Impacts of marketing restrictions on adults except for studies on newly authorized products
• Descriptive studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors
• Studies of retailer compliance to the tobacco product regulations not associated with user behaviors or marketing strategies
• Studies of physician or other health professional knowledge, attitudes, perception, and behaviors toward the use of ENDS or other tobacco products.