EXPIRED
December 9, 2021
NOT-OD-22-024 - Notice of Early Expiration of NOT-OD-21-127 “Notice of Special Interest (NOSI): Electronic Nicotine Delivery Systems (ENDS) and Alternative Nicotine and Tobacco Delivery Systems: Basic Mechanisms of Health Effects”
PA-20-146 - NIDA Small Research Grant Program (R03 Clinical Trial Required)
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-21-071 - Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
PAR-19-282 - Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional)
PAR-20-052 - NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Cancer Institute (NCI)
The Office of Disease Prevention and participating ICOs are issuing this Notice to communicate our interest in research examining how electronic nicotine delivery systems (ENDS) affect normal and disease states relevant to human cells, tissues, organs, and behaviors. Research on alternative nicotine and tobacco delivery systems [e.g., heated tobacco products (also called heat-not-burn)] will also be considered. Studies exclusively examining smokeless tobacco or combustible tobacco products (e.g., cigarettes, cigars) will be considered non-responsive.
Background:
Electronic Nicotine Delivery Systems (ENDS) are designed to heat a liquid solution, typically containing nicotine, into an aerosol to be inhaled by a user. ENDS represent a diverse class of products that include e-cigarettes, vapes, vaporizers, vape pens, hookah pens, and pods. In recent years, heated tobacco products, which do not involve combustion and are sometimes called “heat-not-burn", have become available in the United States. For the purposes of this Notice, research examining products within the entire class of ENDS and heated tobacco products is sought. Other emerging non-combustible products will be considered on a case-by-case basis.
Adult prevalence of ENDS in 2019 was 4.5%, with young adults having the highest prevalence among all age groups (2020 Morbidity and Mortality Weekly Report). Current electronic cigarette use among young adults aged 18-24 increased from 7.6% in 2018 to 9.3% in 2019 (2019 Morbidity and Mortality Weekly Report). Youth ENDS use is also a significant concern. According to the 2020 National Youth Tobacco Survey, 20% (3 million) of high school students and 4.7% (550,000) of middle school students reported current e-cigarette use.
The tobacco product landscape is continuously changing. Despite rapidly accumulating research, significant gaps remain in our understanding of the public health effects posed by ENDS and heated tobacco products. More information is needed to understand the risk profile of the various devices or products and the aerosols they generate. The constantly changing landscape presents additional challenges for understanding how variable patterns of use and exposure to ENDS aerosol affect biological, physiological, and behavioral health outcomes.
Research is needed to understand how ENDS product characteristics, product user characteristics, as well as the communication and policy environment interact to affect ENDS use patterns (e.g., exclusive use vs. dual use with combustible cigarettes). For example, although many adult smokers report using ENDS to help them quit smoking or to reduce their cigarette consumption, as noted in the 2020 Surgeon General’s Report on Smoking Cessation, there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation.
The degree to which changes in the devices, products, or aerosols affect nicotine delivery is unknown. Furthermore, questions about their effect on human physiology and behavior still exist. For example, while many of the flavoring chemicals used in the liquids are approved for use in foods, there is incomplete information on their effects when inhaled. Such gaps in our understanding around ENDS and heated tobacco products indicate the need for further investigation at the molecular, cellular, physiological, and behavioral levels to increase our understanding of the risks and potential benefits. These and other research gaps introduce challenges for accurate and meaningful communication about ENDS and heated tobacco products’ impact on an individual’s health.
Research Objectives:
This NOSI encourages research on ENDS and heated tobacco products related to:
This NOSI encourages feasibility and pilot research, as well as efficacy and effectiveness research on new or adapted interventions. Investigators must carefully review the specific research interests of NIH Institutes, Centers, and Offices that are participating in this NOSI. Responsive studies should make use of human cells or specimens, and where appropriate, may utilize cell or animal models that are relevant to humans and well justified. Research with a focus on other non-combustible nicotine and tobacco products will be considered on a case-by-case basis. Specific Research areas of interest for participating NIH institutes are listed below.
Where appropriate, the standardized research e-cigarette (https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig) should be considered for use in addressing specific research questions, or as a comparator for commercially available ENDS.
IC Specific Application and Submission Information:
Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.
National Cancer Institute (NCI)
The National Cancer Institute encourages submission of applications that investigate potential mechanisms of toxicity and carcinogenicity of ENDS and heated tobacco products. Examples of specific topics of interest to NCI include but are not limited to:
NCI’s FOAs for this NOSI include the following or their subsequent reissued equivalents:
Activity Code |
FOA |
First Available Application Due Date |
R03 |
PAR-20-052: NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional) |
February 24, 2022 |
National Institute of Dental and Craniofacial Research (NIDCR)
The NIDCR is interested in all applications that are relevant to the NIDCR mission and strategic plan. Applications that propose to prove causal pathways between ENDS (specifically e-cigarettes) and dental, oral, and/or craniofacial diseases and conditions are of higher priority. Those applications that demonstrate correlations are of lower priority.
NIDCR supports research that examines the basic mechanisms of effects in pre-clinical investigations.
NIDCR is interested in investigations that include, but are not limited to:
Potential applicants are encouraged to speak with a NIDCR program official to discuss the relevance of proposed research topic(s). For additional information on the NIDCR mission and strategic plan please see the NIDCR website: http://www.nidcr.nih.gov.
National Institute on Drug Abuse (NIDA)
NIDA is interested in supporting pre-clinical and clinical research that examines the basic mechanisms of effects by ENDS, and alternative novel nicotine and tobacco delivery systems, such as heated tobacco products (also called heat-not-burn), as they relate to addiction. Investigations that explore the interaction with genetics or epigenetics are of interest. The Institute also encourages research on the effects of flavoring via in vitro or in vivo investigations. Further, NIDA is interested in investigations that explore neuronal mechanisms, such as function of neurons, astrocytes, microglia, or brain circuitry, associated with the use and exposure to the aerosol constituents. How sex differences might impact the effects of use are also of interest. Potential applicants are advised to speak with a NIDA program official to discuss the relevance and priority to NIDA of potential research topic(s).
NIDA is interested in studies that include, but are not limited to:
NIDA’s FOAs for this NOSI include the following or their subsequent reissued equivalents:
Activity Code |
FOA |
First Available Application Due Date |
R03 |
PA-20-146: NIDA Small Research Grant Program (R03 Clinical Trial Required) |
February 16, 2022 |
R61/R33 |
PAR-19-282: Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional) |
July 11, 2022 |
National Institute on Environmental Health Sciences (NIEHS)
NIEHS is most interested in supporting research that examines basic mechanisms of effects related to substances used in ENDS. NIEHS seeks to support studies that examine potential relationships between ENDS flavorings and exposure to toxicants. The Institute is also interested in studies that examine the relationship between secondary and tertiary ENDS aerosol exposures and genetic and physiological outcomes.
NIEHS invites applications that include, but are not limited to:
Application and Submission Information
This notice applies to due dates on or after December 2, 2021 and subsequent receipt dates through May 09, 2023.
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 nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific Contacts:
Ron Johnson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6250
Email: rjohnso2@mail.nih.gov
Mary Kautz, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: kautzm@nida.nih.gov
Zhong Chen, M.D., Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-529-7083
Email: zhong.chen@nih.gov
Frederick L. Tyson, Ph.D.
National Institute of Environmental Health Sciences(NIEHS)
Telephone: 919-541-0176
Email: tyson2@niehs.nih.gov
Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-480-1161
Email: melissa.greenparker@nih.gov