Notice of Intent to Publish the Reissuance of RFA-OD-20-008, Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed)
Notice Number:
NOT-OD-22-081

Key Dates

Release Date:
June 14, 2022
Estimated Publication Date of Funding Opportunity Announcement:
November 01, 2022
First Estimated Application Due Date:
February 01, 2023
Earliest Estimated Award Date:
December 01, 2023
Earliest Estimated Start Date:
December 01, 2023
Related Announcements

RFA-OD-20-008- Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed)

Issued by

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)

Purpose

This Notice is to inform the research community of the intent to reissue, RFA-OD-20-008, Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed). This FOA will continue to utilize the K01 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

Research Initiative Details

The purpose of the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01) 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.
Funding Information

TBD

Estimated Total Funding

FDA CTP intends to fund up to 3 K01's, corresponding to a total of up to $ 500,000 in FY 2024. Future year amounts will depend on the availability of funds.

Expected Number of Awards

3

Estimated Award Ceiling

FDA CTP intends to contribute up to $90,000 per year toward the salary of the career award recipient and $60,000 per year toward research development costs.

Primary Assistance Listing Number(s)

93.077

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

NCI Contact for Matters Concerning the K01 Mechanism

Sergey Radaev, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: sergei.radaev@nih.gov

NCI Contact for Scientific Questions

Rachel Grana Mayne, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: rachel.mayne@nih.gov

NIEHS Contact for Matters Concerning the K01 Mechanism

Carol Shreffler, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3322
Email: carol.shreffler@nih.gov

NIEHS Contact for Scientific Questions

Fred Tyson, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3334
Email: fred.tyson@nih.gov

NHLBI Contact for Matters Concerning the K01 Mechanism

Qing Lu, DVM, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-9158
Email: qing.lu@nih.gov

NHLBI Contact for Scientific Questions

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-877-7843
Email: lisa.postow@nih.gov

NIDA Contact for Matters Concerning the K01 Mechanism

Albert Avila, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8804
Email: NIDA_Training@nida.nih.gov

NIDA Contact for Scientific Questions

Mary Kautz, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: NIDATRSprogram@nida.nih.gov