Notice of Intent to Publish a Funding Opportunity Announcement for Tobacco Regulatory Science (R01 Clinical Trial Optional)
Notice Number:

Key Dates

Release Date:
October 28, 2020
Estimated Publication Date of Funding Opportunity Announcement:
February 2021
First Estimated Application Due Date:
July 14, 2021
Earliest Estimated Award Date:
April 2022
Earliest Estimated Start Date:
April 2022
Related Announcements

RFA-OD-21-002 - Tobacco Regulatory Science (R01 Clinical Trial Optional)

RFA-OD-19-028 - Tobacco Regulatory Science (R01 Clinical Trial Optional)

NOT-OD-21-025 - Notice of Correction to NOT-OD-21-012

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 Alcohol Abuse and Alcoholism (NIAAA)

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 that the National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP), participating NIH Institutes and Centers (ICs) and the United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to reissue the Funding Opportunity Announcement (FOA) RFA-OD-20-028 "Tobacco Regulatory Science (R01 Clinical Trial Optional)." When reissued, this FOA will continue to utilize the R01 grant mechanism. Modifications to this FOA will be the inclusion of new and revised research priorities. This Notice is being published now to inform prospective applicants in advance of this modification. The FOA is expected to be published in Spring 2021.

Research Initiative Details

The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA 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.

Funding Information
Estimated Total Funding

NIH, via support from the FDA Center for Tobacco products (CTP), intends to fund up to 8 R01s, corresponding to a total of up to $4 million, for fiscal year 2021. Future year amounts will depend on availability of funds.

Expected Number of Awards


Estimated Award Ceiling

Application budgets are limited to $500,000 in direct cost per year for up to five years.

Primary CFDA Numbers


Anticipated Eligible Organizations
Public/State Controlled 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

Applications are not being solicited at this time.


Please direct all inquiries to:

Tobacco Regulatory Science Program
Office of Disease Prevention 301-451-7464

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices