Notice Number: NOT-OD-16-151
Key Dates
Release Date: September 16, 2016
Estimated Publication Date of Announcement: February 2017
First Estimated Application Due Date: July 2017
Earliest Estimated Award Date: June 2018
Earliest Estimated Start Date: July 2018
Issued by
National Institutes of Health (NIH)
U.S. Food and Drug Administration, Center for Tobacco Products (CTP)
Purpose
The National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to reissue a Funding Opportunity Announcement (FOA) for its Tobacco Centers of Regulatory Science (TCORS) program. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
This FOA will utilize the U54 activity code for cooperative agreements, which will allow substantial NIH and FDA involvement with the awardees. A separate FOA will solicit cooperative agreement applications for a U54 Coordinating Center for this program.
The overall TCORS program objective is to conduct programs of multidisciplinary research that will inform the manufacture, distribution, and marketing of tobacco products related to the regulatory authorities of FDA CTP. The research findings that will be generated from this FOA are expected to provide additional scientific data to inform the regulation of tobacco products to protect public health.
The FOA is expected to be published in February 2017 with an expected application due date in July 2017. The NIH anticipates holding a pre-application web-based teleconference to which all interested prospective applicants are invited. Information about this pre-application web-based teleconference call will be available at (https://prevention.nih.gov/tobacco-regulatory-science-program).
Details of the planned TCORS FOA are provided below. Details regarding the Coordinating Center FOA can be found in NOT OD-16-150.
Research Initiative Details
The TCORS cooperative agreement program will lead the establishment of a broad national scientific base of tobacco regulatory research and aid in providing new research for FDA to consider as it implements the Family Smoking Prevention and Tobacco Control Act (FSPTCA). Essential elements of TCORS applications will include at least 3 hypothesis driven research projects with a specialized integrative theme, an Administrative Core and other cores as needed and justified, use of set aside funds for rapid response projects, and a program for career development and training. Research integrated across projects, where findings from one major project inform or complement those in another, is strongly encouraged.
Disciplinary integration within a Center and within projects (where feasible) is also encouraged. Disciplinary diversity in a Center 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 Center. Each Center funded under this announcement will be expected to collaborate with other TCORS and a designated coordinating center 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.
In a departure from the current TCORS program, investigators will be asked to respond to solicitations for time sensitive topics for rapid response projects. Research questions for these projects will be identified by NIH and FDA in collaboration with a coordinating center and TCORS Steering Committee.
A TCORS application must propose a program of multidisciplinary research around two to four of the seven research domains outlined below that will aid the development and evaluation of tobacco product regulations. Applications that choose fewer than two or more than four scientific domains will be deemed non-responsive.
TCORS should have an integrative theme that focuses the center. Each project must have goals and objectives that focus on the common unifying theme that integrates the projects. Although a TCORS may choose an integrative theme that includes multiple disciplinary approaches, it is not necessarily an advantage for a TCORS to include both basic and applied research. The scientific domains chosen should play to the strengths of the research team. A goal of the TCORS program will be to support a portfolio that is balanced across the following scientific domains:
Toxicity - Understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality, including animal and cell culture models as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke, aerosols, or specific constituents in tobacco.
Priorities include toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class including electronic nicotine delivery systems (ENDS), cigars, waterpipes and smokeless tobacco; how product design characteristics (and changes in those characteristics) impact constituent exposure and toxicity from tobacco products; biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of non-cigarette tobacco products, including ENDS
Addiction - Understanding the effect of tobacco product characteristics on addiction and abuse liability.
Priorities include the amounts of nicotine delivered to ENDS users during experimentation, regular ENDS use, dual use of ENDS and cigarettes, and cigarette smoking quit attempts; correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other HPHCs delivered by ENDS; impact of changes in tobacco product characteristics (such as flavors, product design) on dependence; differences in dependence and tobacco use patterns with use of low nicotine content cigarettes in context with other tobacco products
Health Effects - Understanding the short- and long-term health effects of tobacco products. Highest priority areas include cardiovascular or respiratory health effects, including inflammation. Other health effects including cancer, oral health or reproductive health may be included within projects but should not be the primary focus of the center.
Priorities include impact of changes in tobacco product characteristics (such as flavors, product design) on human health; biomarkers to assess short and long-term effects of non-cigarette tobacco products; clinical evaluations to distinguish changes in cell function/physiology specific to tobacco exposure (e.g., ENDS aerosol exposure) known to indicate longer term disease development and progression
Behavior - Understanding the knowledge, attitudes, and behaviors related to tobacco product use and changes in tobacco product characteristics.
Priorities include changes in tobacco product characteristics (such as flavors, product design, packaging) impact on tobacco use behaviors including experimentation, initiation, dual/poly use, transition to non-flavored products, and cessation; innovative methods and measures to assess tobacco use behaviors; measures, methods, or study designs to assess the likely impact of novel and/or potential modified risk tobacco products on tobacco behavior, including perceptions, susceptibility, experimentation, adoption, switching, and use (including dual use); measures (e.g., attitudes, perceptions, intentions) to best predict future behaviors of non-cigarette tobacco product use, including current and established users of cigars, waterpipe, and ENDS
Communications Understanding how to effectively communicate to the public and vulnerable populations regarding nicotine and the health effects of tobacco products, including media campaigns, and digital media.
Priorities include messages to effectively communicate about nicotine and the harms of non-cigarette tobacco product use; methods and messages for communicating complex scientific concepts to the general public, including risk and harms of tobacco use taking into account unintended consequences; effectiveness of text and graphic warnings for tobacco products other than cigarettes
Marketing Influences Understanding why people become susceptible to using tobacco products (both classes of products and products within classes) and transitions from experimentation, initiation to regular use and dual use, including tobacco industry marketing such as advertising, point-of-sale, digital media, and promotions.
Priorities include methods, measures, and study designs to best assess the impact of tobacco product advertising, and promotion restrictions on users and non-users of tobacco including marketing of novel and/or potential modified risk tobacco products; impact of potential marketing restrictions on youth experimentation, initiation, use and cessation
Impact Analysis Understanding impact of potential FDA regulatory actions
Priorities include evaluation of policies at the state and community level that fall within CTP regulatory authorities; methods and measures (e.g., behavioral economics, population modeling) to estimate the range of potential impacts on behavior and health of potential FDA regulatory actions such as products standards addressing toxicity, appeal, and addiction
The term "characteristic" encompasses materials, ingredients (including additives 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.
Although the following research topics may be within CTP’s regulatory authorities to fund, they are not planned to be included in the FOA and will be deemed out of scope:
- Studies of short-term health effects and/or acute topography/clinical pharmacology testing of first generation ENDS products
- Mechanistic studies/basic science of disease development unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
- Short-term studies of the acute effects of reduced nicotine content cigarettes
- Graphic health warnings for cigarette packages and advertisements
- Communicating harmful and potentially harmful constituents to the public
- Impacts of marketing restrictions on adults
- Descriptive studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Tobacco Regulatory Science Program
Office of Disease Prevention
Telephone: 301-451-7464
Email: [email protected]
and Human Services (HHS)
