Key Dates

NOT-OD-22-011

NOT-OD-22-017

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

National Cancer Institute (NCI)

This Notice is to inform the research community that the National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP), the National Cancer Institute (NCI), and the United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to issue a Funding Opportunity Announcement (FOA) seeking (U01) applications for a Center for Rapid Surveillance of Tobacco (CRST) to support time-sensitive data acquisition strategies, data harmonization, data synthesis and analysis, and reporting activities on emerging and current tobacco use across the United States. Applications should focus on rapid surveillance, real-time signals, and reporting of information on emerging tobacco use patterns, factors that contribute to their use, including social media and tobacco product marketing, and changes in the tobacco marketplace.

The award 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 must address the research priorities related to the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) regulatory authorities.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaboration and responsive projects. The FOA is expected to be published in Fall/Winter 2021, with an expected application due date in May of 2022. This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

The Funding Opportunity Announcement (FOA) will invite applications for a U01 Center for Rapid Surveillance of Tobacco (CRST) to better understand the rapidly evolving tobacco landscape in the United States. The goal is to complement existing surveillance systems by providing data and information to the FDA CTP and federal partners on a more frequent basis and shorter timeline than typical surveillance methods. Areas of interest include the rapid surveillance of changing tobacco use patterns among tobacco product user groups and the factors that contribute to these changing patterns; rapid surveillance of tobacco product marketing; and the rapid surveillance of changes in the tobacco marketplace, including emerging products and tobacco products that are modified by the user.

Research Objectives

Applicants will be encouraged to submit strategies for time-sensitive data collection, data harmonization, data synthesis and analysis, and reporting. Of particular interest are proposals that take advantage of existing cohorts, panels, focus groups, social media data, observational studies, environmental scanning, or ecological momentary assessments that can provide real-time or boots on the ground information on a more frequent basis than traditional research or reporting. In addition, partnerships may be formed with community or public health partners (e.g., school and education systems, local departments of health, health care providers, public mental health/substance abuse or health care systems, child welfare agencies) who monitor or address challenges with tobacco products and their use. Data should be geographically diverse and account for relevant subpopulations, and when available and appropriate, nationally representative. The CRST will maximize data sources that can serve as a signal detection system for findings that traditional data sources can help validate. Moreover, rapid or sentinel data sources are more able to adapt data collection methods or instruments to capture the current tobacco landscape.

The CRST will work collaboratively with NIH and FDA CTP to implement a model that utilizes multiple data sources to identify emerging tobacco use issues, and to track tobacco use trends through regular monitoring of key data from sentinel sites. Varying approaches to collecting data, such as web-based surveys, data mining (e.g., social media or marketing data), crowdsourcing, and development of strategies for the timely and effective reporting of findings should serve as central functions performed by the CRST. The network of sentinel sites may consist of community experts and data from other sources, to complement the core functions of the CRST.

Data from the CRST will have a substantial public health impact and will inform the regulation of tobacco products by providing timely and potentially actionable information about changes in tobacco product use patterns, tobacco products and the factors that contribute to their use, and changes in the tobacco marketplace before more traditional data collection mechanisms have information available.

The FOA will seek innovation and direction from the scientific community in devising and implementing an optimal rapid surveillance program -- including approaches to data collection, forming collaborative networks, data harmonization, analysis, and reporting -- while maintaining NIH and FDA scientific input to assure consistency with CTP priorities and regulatory authorities.

Topic Areas

The CRST must address the following:

Rapid surveillance of changes in tobacco product use behaviors:

• Changes in tobacco use behaviors among youth, young adults, and other populations with tobacco-related disparities such as racial/ethnic minorities, people with mental health comorbidities, and LGBTQ+ population and factors that contribute to their use, e.g., access, labeled product characteristics (e.g., brand, packaging, nicotine concentration, flavors, components, design features), price promotions, advertising, social media marketing, social media discussions
• Changes in how youth, young adults, and populations with tobacco-related disparities access or obtain tobacco products
• Emerging use behaviors such as:
  • Users adjusting the components, ingredients, or features of their products (including devices and/or contents) and the result of those modifications
  • Users producing their own flavored tobacco products (including mixing their own flavors into ENDS liquids or refilling e-liquid cartridges with their own mixtures)
  • Shifts in tobacco product use behaviors in terms of type, quantity, and frequency among populations of special relevance, including (but not limited to): youth, young adults, those with lower socioeconomic status, certain races or ethnicities, sexual or gender minorities, underserved rural populations, those pregnant or trying to become pregnant, those in the military or veterans, and those with mental health conditions or substance use disorders.

Rapid surveillance of tobacco product marketing:

• Describe recent changes in the mechanisms or platforms of current tobacco product marketing in traditional and non-traditional communication channels, including owned or earned media, social media influencers, brand ambassadors, outreach events, or other digital marketing of tobacco products.
• Describe recent changes in industry tobacco product marketing strategies, including retailer (online or brick and mortar), promotional practices, such as point-of-sale marketing, price promotions, coupons, and/or affiliate marketing. Is there evidence that these marketing strategies have disparate effects on populations of special relevance?

Rapid surveillance of tobacco product marketplace:

• Describe recent changes in the tobacco retail environment for existing and/or emerging tobacco products including traditional stores such as grocery, convenient, and big-box stores, and gas stations; as well as tobacco specialty shops such as vape shops, head shops, cigar bars and hookah bars.
• Describe recent changes and/or trends in tobacco product sales in tobacco specialty shops (e.g., vape shops, cigar bars, hookah bars), as well as online retailers, for deemed tobacco products (e.g., ENDS, cigars, hookah/waterpipe) and products that have recently obtained a marketing authorization.

Applications are not being solicited at this time.

Please direct all inquiries to:

Maria Roditis PhD, MPH

National Cancer Institute (NCI)

(240) 276-5326

[email protected]