Notice Number: NOT-OD-20-081
Release Date: March 25, 2020
First Available Due Date: July 17, 2020
Expiration Date: February 13, 2021
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Cancer Institute (NCI)
U.S. Food and Drug Administration, Center for Tobacco Products (CTP)
The purpose of this Notice is to invite applications focused on Tobacco Product Pharmacokinetic Research to support biomedical and behavioral research that will provide scientific data to inform the regulation of tobacco products to protect public health.
The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by the President in June 2009, created the FDA Center for Tobacco Products and granted it authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Under the law, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. The law also gave FDA the ability to regulate additional tobacco products, commonly referred to as "deeming" them through rulemaking. A full description of the FSPTCA can be found at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm.
FDA finalized the "deeming" rule, effective August 8, 2016 "to regulate all tobacco products that were not under its jurisdiction that meets the statutory definition of "tobacco product", including Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products, but not including accessories of newly deemed products." Products deemed under this rule are subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, including but not limited to: (1) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (2) prohibition against use of modified risk descriptors (e.g., "light," "low," and "mild" descriptors) and claims unless FDA issues an order permitting their use; and (3) premarket review requirements. These actions will improve the public health by affording FDA information regarding the health risks of such products, evaluating whether marketing of new products would be appropriate for the protection of public health or are substantially equivalent to an identified predicate product, and preventing misleading claims about the relative risk of tobacco products. In addition, FDA has the authority to develop product standards, when appropriate for the protection of public health.
The awards under this Notice 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.
Topics to be addressed by this NOSI include areas where knowledge gaps exist, and research is needed - in particular, the following questions regarding the pharmacokinetics of tobacco products. The Institutes listed above are issuing this Notice to highlight interest in receiving grant applications addressing the following questions:
Nicotine salt (of varying types) vs. free-base nicotine e-liquids
E-liquid nicotine and menthol concentrations (i.e., dose-dependent effects)
Product power, temperature, double coils
Application and Submission Information
This notice applies to due dates on or after July 17, 2020 and subsequent receipt dates through February 13, 2021.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications non responsive to terms of this NOSI will be not be considered for the NOSI initiative. Applications proposing work outside of FDA-CTP's regulatory authority or outside of the scope of RFA-OD-19-028 will not be reviewed.
Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.