Opportunity Information: Apply for RFA OD 18 003
The Tobacco Regulatory Science (R21 Clinical Trial Optional) opportunity (RFA-OD-18-003) is a discretionary grant program run through the Department of Health and Human Services (HHS), administered by the National Institutes of Health (NIH), and funded with money made available through the FDA Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31). Its core goal is to support biomedical and behavioral research that produces solid scientific evidence the FDA can use when regulating tobacco products in ways that protect public health. In practical terms, the work proposed is expected to generate data that directly helps inform FDA decision-making about how tobacco products are manufactured, distributed, and marketed.
A central requirement of the FOA is that proposed projects align with research priorities tied to FDA CTP's regulatory authority. That means the research cannot be purely academic or only loosely connected to tobacco control; it needs to produce results that are relevant to regulatory questions the FDA faces, such as understanding product characteristics, user behavior, exposure and risk, public perceptions, marketing impacts, and population-level effects in ways that can feed into regulation. The announcement frames the purpose clearly: generate findings and datasets that are actionable for regulation, rather than general public health advocacy or unrelated basic science.
This is an R21 mechanism, which typically supports exploratory and developmental research. The FOA explicitly notes that clinical trials are optional, meaning applicants may propose either clinical trial or non-clinical trial designs, depending on what is necessary to answer the regulatory science question. The maximum award amount (award ceiling) is listed as $200,000, and the opportunity anticipated making about 14 awards, indicating a competitive program with a defined number of funded projects.
Eligibility is broad and includes many types of applicants that can conduct high-quality research. Eligible organizations include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those specific categories); for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with additional eligibility details referenced in the full FOA.
From an administrative standpoint, the listing identifies the program under CFDA number 93.077 and categorizes it within the Health funding activity area. The FOA was created on November 20, 2017, with an original closing date of February 13, 2019. While those dates indicate the specific posted cycle for this announcement, the summary purpose remains useful for understanding what NIH and FDA CTP were seeking to fund: targeted tobacco regulatory science that yields evidence directly relevant to FDA oversight of tobacco products and the broader goal of protecting public health.Apply for RFA OD 18 003
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Tobacco Regulatory Science (R21 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 Nov 20, 2017.
- Applicants must submit their applications by Feb 13, 2019. (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 $200,000.00 in funding.
- The number of recipients for this funding is limited to 14 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the Tobacco Regulatory Science (R21 Clinical Trial Optional) opportunity (RFA-OD-18-003)?
It is a discretionary government grant opportunity run through the U.S. Department of Health and Human Services (HHS), administered by the National Institutes of Health (NIH), and funded with money made available through the FDA Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31). The program supports research intended to produce scientific evidence the FDA can use when regulating tobacco products to protect public health.
What is the main purpose of this funding opportunity?
The core goal is to support biomedical and behavioral research that generates solid scientific evidence and datasets that are directly usable by the FDA for tobacco product regulation. The work is expected to produce data that helps inform FDA decision-making about how tobacco products are manufactured, distributed, and marketed.
What does "tobacco regulatory science" mean in the context of this FOA?
In this announcement, tobacco regulatory science refers to research designed to answer regulatory questions the FDA faces about tobacco products. The emphasis is on producing results that can feed into regulation, rather than research that is purely academic, only loosely connected to tobacco control, or aimed primarily at general public health advocacy without a clear regulatory connection.
What kinds of research topics are considered aligned with FDA CTP regulatory authority?
The FOA highlights regulatory-relevant areas such as product characteristics, user behavior, exposure and risk, public perceptions, marketing impacts, and population-level effects, as long as the project is structured to generate evidence that can inform FDA regulatory decisions.
Does the project have to be directly tied to FDA decision-making?
Yes. A central requirement is alignment with research priorities tied to FDA CTP's regulatory authority. Proposed studies are expected to generate findings and datasets that are actionable for tobacco product regulation and can be used to inform FDA oversight.
Can an applicant propose a project that is primarily academic or only generally related to tobacco control?
The program description indicates that research should not be purely academic or only loosely connected to tobacco control. Projects should be designed to produce results relevant to the specific regulatory questions the FDA faces.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH R21 mechanism, which typically supports exploratory and developmental research.
Are clinical trials required under this FOA?
No. The FOA states that clinical trials are optional. Applicants may propose either clinical trial or non-clinical trial designs, depending on what is needed to answer the regulatory science question being addressed.
What is the maximum award amount for this opportunity?
The listed award ceiling is $200,000.
How many awards were anticipated?
The opportunity anticipated making about 14 awards, suggesting a competitive program with a defined expected number of funded projects.
Which federal agencies are involved in running and funding this program?
HHS is identified as the overarching department. NIH administers the opportunity. Funding is made available through the FDA Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act.
What law is referenced as the basis for the funding source?
The funding source is tied to the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31).
Who is eligible to apply?
Eligibility is broad and includes state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations (501(c)(3) and non-501(c)(3), excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; and small businesses. The listing also mentions an "Others" category with additional eligibility details referenced in the full FOA.
Are colleges and universities eligible?
Yes. The eligible organization types include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. The eligible organization types include nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status (excluding institutions of higher education in those specific categories, as noted in the listing).
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it also separately includes small businesses.
Are tribal governments or tribal organizations eligible?
Yes. The eligible organization types include federally recognized Native American tribal governments and other Native American tribal organizations.
Are government entities eligible to apply?
Yes. The eligibility list includes state governments, county governments, local governments, and special district governments. Independent school districts are also listed as eligible.
Are housing authorities eligible?
Yes. The eligibility list includes public housing authorities and Indian housing authorities.
What is the CFDA number associated with this program?
The listing identifies CFDA number 93.077.
What funding activity area is this opportunity associated with?
It is categorized within the Health funding activity area.
When was the FOA created and what was the original closing date?
The FOA was created on November 20, 2017, and the original closing date was February 13, 2019.
Does the posted closing date affect the overall description of what the program funds?
The dates reflect the specific posted cycle for this announcement. The summary still describes what NIH and FDA CTP were seeking to fund under this opportunity: targeted tobacco regulatory science intended to yield evidence directly relevant to FDA oversight of tobacco products and the goal of protecting public health.
What should applicants emphasize in their project design based on this description?
Based on the stated requirements, applicants should emphasize a clear connection between the proposed research and FDA CTP regulatory priorities, and show how the project will produce actionable findings or datasets that can inform FDA regulation of tobacco products (including aspects such as manufacturing, distribution, and marketing).
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