Key Dates

RFA-OD-20-009 - Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Not Allowed)

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)

This Notice is to inform the research community of the intent to reissue RFA-OD-20-009, Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Not Allowed). This FOA will continue to utilize the K99/R00 grant mechanism. Modifications to the existing FOAs will include new and revised research priorities.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and appropriate projects.

This FOA is expected to be published in Fall 2022, with an expected application due date in Spring 2023.

The purpose of the Pathway to Independence Award in Tobacco Regulatory Research (K99/R00) is to increase and maintain a strong cohort of new and talented independent investigators conducting research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored postdoctoral research positions to independent, tenure-track, or equivalent faculty positions. This program will provide independent NIH research support during this transition in order to help awardees launch competitive, independent research careers.

Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31).

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.

Applications are not being solicited at this time. 

Please direct all inquiries to:

NCI Contact for Matters Concerning the K99/R00 Mechanism

Sergey Radaev, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]

NCI Contact for Scientific Questions

Rachel Grana Mayne, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: [email protected]

NIEHS Contact for Matters Concerning the K99/R00 Mechanism

Carol Shreffler, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3322
Email: [email protected]

NIEHS Contact for Scientific Questions

Fred Tyson, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3334
Email: [email protected]

NHLBI Contact for Matters Concerning the K99/R00 Mechanism

Qing Lu, DVM, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-9158
Email: [email protected]

NHLBI Contact for Scientific Questions

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-877-7843
Email: [email protected]

NIDA Contact for Matters Concerning the K99/R00 Mechanism

Albert Avila, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8804
Email: NIDA_[email protected]

NIDA Contact for Scientific Questions

Mary Kautz, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: [email protected]