NOT-OD-21-044: Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections (R21 Clinical Trial Not Allowed)

Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections (R21 Clinical Trial Not Allowed)

Notice Number:

NOT-OD-21-044

Key Dates

Release Date:

December 23, 2020

Estimated Publication Date of Funding Opportunity Announcement:

March 08, 2021

First Estimated Application Due Date:

October 08, 2021

Earliest Estimated Award Date:

July 08, 2022

Earliest Estimated Start Date:

July 08, 2022

Related Announcements

RFA-OD-21-004

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)

Purpose

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-19-021 "Maximizing the Scientific Value of Existing Biospecimen Collections (R21 Clinical Trial Not Allowed)." When reissued, this FOA will continue to utilize the R21 grant mechanism.

Modifications to this FOA include funding as NIH, via NIH support from the FDA Center for Tobacco Products (CTP), intends to fund up to 5 R21s, corresponding to a total of up to $1.0 million, for fiscal year 2021. Future year amounts will depend on availability of funds.

This Notice is being provided to allow potential eligible applicants sufficient time to develop competitive and responsive projects.

The FOA is expected to be published in Spring 2021. Details of the planned FOA are provided below.

Research Initiative Details

The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications to stimulate exploratory research relevant to the mission of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP) using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but not be limited to, collections associated with the Population Assessment of Tobacco and Health (PATH) Study, the National Health and Nutrition Examination Survey (NHANES), the National Heart, Lung and Blood Institute’s (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), and the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Proposed research should seek to maximize the scientific value of these stored collections and to provide researchers with an opportunity to generate preliminary data for subsequent research proposals. Other publicly available repositories would be considered, depending on analyses to be conducted. These applications need to provide justification why the data set is unique, and the research questions cannot be answered from a publicly available, nationally representative, data set.

Funding Information

Estimated Total Funding

NIH, via support from the FDA Center for Tobacco products (CTP), intends to fund up to 5 R21s, corresponding to a total of up to $1 million, for fiscal year 2021. Future year amounts will depend on availability of funds.

Expected Number of Awards

Estimated Award Ceiling

The combined budget for direct costs for the entire project period may not exceed $275,000. No more than $200,000 in direct cost may be requested in any single year.

Primary CFDA Numbers

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
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Tobacco Regulatory Science Program

Office of Disease Prevention

301-451-7464

[email protected]