Opportunity Information: Apply for RFA OD 25 001
The High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional) funding opportunity (RFA-OD-25-001) supports new biomedical and behavioral research projects that can directly inform how the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) regulates tobacco products to protect public health. The program uses the NIH R01 grant mechanism, and projects may include clinical trials but are not required to do so. The central emphasis is on generating solid scientific evidence that maps clearly onto FDA CTP's regulatory responsibilities, meaning applicants should frame their aims and outcomes in terms of how the results could guide decisions about tobacco product manufacture, distribution, and marketing.
This opportunity is specifically aimed at "high-priority" topics within tobacco regulatory science, so proposals need to align with current priority research areas tied to FDA CTP's legal authority under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). In practical terms, the research is expected to produce data that regulators can actually use, such as evidence related to product characteristics, patterns of use, exposure and health impacts, addiction and dependence, perceptions and behaviors, population-level effects, and other factors that bear on the public health standard used in tobacco regulation. While the notice text in the provided excerpt does not list the exact topic areas, it makes clear that responsiveness to FDA CTP's active priority questions is a core review and fit requirement, not a secondary consideration.
Funding is administered by the National Institutes of Health (NIH), but the dollars come from FDA CTP through the authorities created by the Tobacco Control Act. That arrangement is important because it signals the program's applied regulatory purpose: the expected endpoint is not only academic publication, but also findings that can be translated into regulatory evidence. Applicants should therefore plan for clear measures, strong study design, and deliverables that are interpretable for regulatory decision-making, including transparent methods and outcomes that can help assess potential impacts on initiation, cessation, relapse, and overall population health.
Eligibility is broad and includes many types of U.S. organizations and governments, such as state, county, city/township, and 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; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The opportunity also explicitly highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal government agencies; faith-based or community-based organizations; regional organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations). This wide eligibility suggests the sponsor is open to multidisciplinary and community-relevant research capacity, including work that reaches priority populations or addresses disparities, as long as the research remains tightly linked to FDA CTP regulatory needs.
Administratively, this is a discretionary grant in the health category, associated with CFDA/Assistance Listing number 93.077. The opportunity was created on 2024-12-05, and the original closing date listed is 2025-06-06. The excerpt provided does not specify an award ceiling or the expected number of awards, so applicants would need to consult the full announcement for budget constraints, project period limits, and any institute- or mechanism-specific requirements.
Overall, this NOFO is best understood as an applied research pipeline for tobacco regulation: it funds R01-level studies that answer high-impact questions the FDA needs to evaluate tobacco products and their marketing in ways that reduce harm at the population level. Competitive applications will typically be those that clearly define a regulatory-relevant question, use rigorous and appropriate methods (clinical trial or non-trial), and produce outcomes that can be translated into evidence for FDA decision-making.Apply for RFA OD 25 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "High-Priority Research in 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 2024-12-05.
- Applicants must submit their applications by 2025-06-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional) with funding opportunity number RFA-OD-25-001.
What is the main purpose of this grant?
The purpose is to support new biomedical and behavioral research that can directly inform how the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) regulates tobacco products to protect public health. The emphasis is on producing scientific evidence that maps clearly onto FDA CTP regulatory responsibilities, with aims and outcomes framed around how results could guide decisions about tobacco product manufacture, distribution, and marketing.
What grant mechanism is used for this opportunity?
This program uses the NIH R01 grant mechanism.
Are clinical trials required?
No. Clinical trials are optional. Projects may include a clinical trial, but they are not required to do so.
Who administers the funding, and where do the funds come from?
The funding is administered by the National Institutes of Health (NIH), but the funding dollars come from FDA CTP through authorities created by the Family Smoking Prevention and Tobacco Control Act. This arrangement signals that the program is designed to generate evidence that can be translated into regulatory decision-making, not only academic outputs.
What does "high-priority" tobacco regulatory science mean in this NOFO?
"High-priority" means proposed research must align with FDA CTP's current priority research areas tied to FDA CTP's legal authority under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Responsiveness to FDA CTP's active priority questions is described as a core fit requirement, not a minor consideration.
Does the provided excerpt list the exact priority topic areas?
No. The excerpt states that alignment with FDA CTP priority questions is essential, but it does not list the exact topic areas. Applicants would need to consult the full announcement to confirm the specific priority areas and how they are described.
What kinds of research outputs are expected?
The program emphasizes generating solid, interpretable scientific evidence that regulators can use. While publication may result, the expected endpoint includes findings that can be translated into regulatory evidence to inform FDA CTP decisions. Applicants are encouraged (by the intent described) to plan for clear measures, strong study design, transparent methods, and outcomes usable for regulatory decision-making.
What types of research questions are considered relevant to FDA CTP regulation under this opportunity?
The excerpt indicates that responsive studies are those producing data relevant to tobacco regulation, such as evidence related to:
- Product characteristics
- Patterns of use
- Exposure and health impacts
- Addiction and dependence
- Perceptions and behaviors
- Population-level effects
- Other factors tied to the public health standard used in tobacco regulation
How should applicants frame their research aims to be competitive?
Based on the excerpt, applicants should frame aims and outcomes in terms of how the results could guide FDA CTP decisions about tobacco product regulation, including manufacture, distribution, and marketing. The program description highlights the need for outcomes that help evaluate potential impacts on initiation, cessation, relapse, and overall population health.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S. organizations and governments, including:
- State, county, city/township, and 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
- Tribal organizations that are not federally recognized governments
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
- Other entities
Are minority-serving institutions and community-based organizations eligible?
Yes. The opportunity explicitly highlights additional eligible applicants, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Eligible federal government agencies
- Faith-based or community-based organizations
- Regional organizations
- U.S. territories or possessions
- Non-U.S. entities (foreign organizations)
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The excerpt explicitly includes non-U.S. entities (foreign organizations) among eligible applicants.
What is the Assistance Listing (CFDA) number for this program?
The program is associated with CFDA/Assistance Listing number 93.077.
What category of grant is this described as?
It is described as a discretionary grant in the health category.
What are the key dates included in the provided information?
The opportunity was created on 2024-12-05, and the original closing date listed is 2025-06-06.
Does the excerpt specify the maximum award amount or the expected number of awards?
No. The excerpt does not specify an award ceiling or the expected number of awards. It notes that applicants would need to consult the full announcement for budget constraints, project period limits, and any institute- or mechanism-specific requirements.
What makes this opportunity different from a purely academic research program?
The excerpt characterizes this NOFO as an applied research pipeline for tobacco regulation. It emphasizes that results should be interpretable for regulatory decision-making and tied to FDA CTP responsibilities, rather than being aimed only at academic publication.
What kinds of study designs are implied to be important for this program?
The excerpt stresses the need for rigorous and appropriate methods, whether the project is a clinical trial or non-trial study. It also highlights planning for transparent methods and clear outcomes that can inform regulatory decisions.
What law is referenced as the basis for FDA CTP authority in this program?
The excerpt references the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31) as the basis for FDA CTP legal authority relevant to the program's priority areas.
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