Opportunity Information: Apply for RFA OD 19 028
The Tobacco Regulatory Science (R01 Clinical Trial Optional) funding opportunity (RFA-OD-19-028) is a discretionary grant program administered by the National Institutes of Health (NIH) using funds provided through the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Its central aim is to support R01-level biomedical and behavioral research that produces solid scientific evidence directly useful for FDA decision-making about tobacco product regulation, with the overarching goal of protecting public health. In practical terms, the FOA is looking for research that can generate data the FDA can apply when regulating how tobacco products are made, distributed, and marketed.
Applications must align with the FDA CTPs regulatory authority and research priorities, meaning projects should be framed around questions that affect product standards, product characteristics, user behavior, population health impacts, marketing influences, and other factors that inform regulatory actions. While the announcement is broad in describing research areas (biomedical and behavioral), the common thread is that the work should be clearly and explicitly tied to regulatory relevance rather than purely exploratory tobacco research. The mechanism is an R01, and clinical trials are optional, so proposals may include clinical trial components if they are appropriate for answering a regulatory science question, but they do not have to.
A wide range of applicants are eligible, reflecting the intent to draw on diverse scientific, community, and institutional capacities. Eligible applicants include state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits both with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations (other than small businesses) and small businesses; and other miscellaneous eligible entities. The FOA also explicitly highlights additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. (foreign) organizations.
From an administrative and funding standpoint, the opportunity falls under the health funding activity category and is associated with CFDA number 93.077. The source listing notes an award ceiling of $300,000, and it originally closed on 2021-02-13, with the FOA created on 2019-09-24. The expected number of awards is not specified in the provided text. Overall, the program is designed for investigators and institutions that can produce actionable, policy-relevant evidence that helps the FDA CTP evaluate tobacco products and implement science-based regulations aimed at reducing harm at the population level.Apply for RFA OD 19 028
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Tobacco Regulatory Science (R01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.077.
- This funding opportunity was created on 2019-09-24.
- Applicants must submit their applications by 2021-02-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Tobacco Regulatory Science (R01 Clinical Trial Optional)" and is identified as RFA-OD-19-028.
What type of grant mechanism does this program use?
This funding opportunity uses the NIH R01 research project grant mechanism.
Are clinical trials required under this FOA?
No. Clinical trials are optional. Applications may include a clinical trial component if it is appropriate for answering a tobacco regulatory science question, but a clinical trial is not required.
Who administers this grant program?
The program is administered by the National Institutes of Health (NIH).
Where do the funds for this program come from?
The funds are provided through the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31), and NIH administers the discretionary grant program using those funds.
What is the main purpose of this funding opportunity?
The central aim is to support R01-level biomedical and behavioral research that produces solid scientific evidence that is directly useful for FDA decision-making about tobacco product regulation, with the overarching goal of protecting public health.
What does "tobacco regulatory science" mean in the context of this FOA?
In this FOA, tobacco regulatory science refers to research designed to generate evidence the FDA can apply when regulating how tobacco products are made, distributed, and marketed. The emphasis is on actionable, policy-relevant evidence rather than purely exploratory tobacco research.
What kinds of research topics are expected to be responsive?
Applications should be framed around questions that affect FDA CTP regulatory actions. The provided description points to topics such as product standards, product characteristics, user behavior, population health impacts, marketing influences, distribution, and other factors that inform regulatory decisions.
What is the key requirement for the research focus?
The work should be clearly and explicitly tied to regulatory relevance and FDA CTP decision-making. Projects should align with FDA CTP regulatory authority and research priorities.
Is the FOA limited to biomedical research only?
No. The announcement describes both biomedical and behavioral research as within scope, as long as the work is directly useful for tobacco product regulatory decision-making.
What is the overarching public health goal of the program?
The overarching goal is protecting public health by supporting science-based tobacco product regulations aimed at reducing harm at the population level.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.077.
What funding activity category does this opportunity fall under?
The opportunity falls under the health funding activity category.
What is the listed award ceiling?
The source listing notes an award ceiling of $300,000.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided information.
When was the FOA created?
The FOA was created on 2019-09-24.
What is the closing date shown for this opportunity?
The opportunity is noted as originally closed on 2021-02-13.
Which organizations are eligible to apply?
The FOA lists a wide range of eligible applicants, including state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits (with or without 501(c)(3) status, as long as they are not institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses) and small businesses; and other miscellaneous eligible entities.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible applicants.
Are community-based or faith-based organizations eligible?
Yes. The FOA explicitly highlights faith-based or community-based organizations among the additional eligible groups.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA explicitly highlights eligibility for institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Are U.S. territories and regional organizations eligible?
Yes. The FOA explicitly highlights U.S. territories or possessions and regional organizations as eligible.
Are federal agencies eligible to apply?
Yes. The FOA mentions eligible federal agencies among the additional eligible groups.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA explicitly notes that non-U.S. (foreign) organizations are eligible.
What type of applicant is this opportunity trying to attract?
The opportunity is designed for investigators and institutions that can produce actionable evidence that helps the FDA CTP evaluate tobacco products and implement science-based regulations.
How should applicants describe the significance of their work?
Based on the provided description, applicants should make the regulatory relevance explicit by explaining how the proposed research will generate evidence that can be used in FDA CTP decision-making related to tobacco product regulation.
What kinds of real-world decisions could this research inform?
The FOA description indicates the research should be useful for regulating how tobacco products are made, distributed, and marketed, and for informing regulatory actions related to product standards, product characteristics, marketing influences, user behavior, and population health impacts.
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