Key Dates

NOT-OD-22-017 - Notice of Intent to Publish a Funding Opportunity Announcement for Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional )

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 Institute on Drug Abuse (NIDA)

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-17-002 Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

When reissued, this FOA will continue to utilize the U54 grant mechanism for cooperative agreements, which allow substantial NIH and FDA involvement with the recipients . NIH is also proposing separate FOAs to solicit cooperative agreement applications for Tobacco Centers of Regulatory Science (TCORS) and a Center for Rapid Surveillance (CRST). Details regarding the proposed can be found in NOT-OD-22-017 for TCORS and NOT-OD-21-175 for CRST. Recipients will be expected to collaborate with the TCORS and CRST on a regular basis, share information, facilitate collaborative scientific progress in the field, address identified research gaps, and resolve areas of scientific disagreement. Applicant institutions may submit multiple applications in response to this FOA and NOT-OD-22-017 (TCORS) and NOT-OD-21-175 (CRST). Key personnel of CASEL awardee team, however, cannot include key personnel from the research team of a TCORS nor CRST recipients.

CASEL is expected to provide scientific coordination for the broad portfolio of tobacco regulatory research funded by FDA CTP to inform their regulatory activities to reduce tobacco-related disease, disability, and death in the United States. In cooperation with NIH and FDA CTP, CASEL will help build a broad base of knowledge and resources for the advancement, dissemination, and translation of tobacco regulatory science. Key goals will be to provide leadership in fostering excellence in tobacco regulatory research and supporting career enhancement efforts in tobacco regulatory science.

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 date in Summer 2022.

The NIH anticipates holding a pre-application web-based webinar open to all interested prospective applicants.

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The overarching objective of the CTP-funded research program is to conduct research that will inform tobacco product regulatory activities and address the research priorities related to the regulatory activities of the FDA CTP. CASEL, in conjunction with the NIH and the FDA CTP, will facilitate communication, scientific coordination, and collaboration among the CTP-funded research programs and 1) provide logistical support and coordination across CTP-funded research, 2) conduct scientific synthesis and facilitate collaborative research, including support for projects that address the high priority, time-sensitive needs of the FDA CTP, 3) facilitate career enhancement of tobacco regulatory scientists and 4) support dissemination of research results.

CASEL will be expected to provide intellectual and scientific leadership and logistical support infrastructure for the entire FDA CTP-funded research program and encourage and support research networks among FDA CTP-funded tobacco regulatory scientists that foster communication, collaboration, and research that address FDA CTP’s scientific priorities. CASEL also will have an important role in coordinating research generated by the Tobacco Centers of Regulatory Science (TCORS), including the TCORS career enhancement activities, and enabling collaboration among other FDA CTP-funded recipients and investigators conducting tobacco regulatory research.

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 the above topics.

All work proposed by or through CASEL must be within scope of the regulatory authority of the FDA CTP in order to be considered responsive to this FOA.