Opportunity Information: Apply for RFA OD 13 010
Apply for RFA OD 13 010
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Tobacco Control Regulatory Research (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.077 Family Smoking Prevention and Tobacco Control Act Regulatory Research.
- This funding opportunity was created on Apr 8, 2014 and posted on Jun 20, 2013.
- Applicants must submit their applications by Jun 17, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 20 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) State governments Small businesses Independent school districts Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Tobacco Control Regulatory Research (R21) funding opportunity (RFA-OD-13-010) is a discretionary NIH grant program designed to support short, exploratory research projects that can directly inform U.S. tobacco regulation. Its central aim is to encourage biomedical, behavioral, and social science studies that generate practical evidence the Food and Drug Administration (FDA), specifically the Center for Tobacco Products (CTP), can use when developing, implementing, or evaluating rules affecting how tobacco products are manufactured, distributed, and marketed. The work supported under this announcement is expected to produce findings that are not just academically interesting, but immediately relevant to regulatory decision-making intended to protect public health.
A defining feature of this opportunity is that funded projects must align with research priorities tied to FDA CTP's statutory authority under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. In other words, applicants are expected to frame their research questions around issues the FDA can actually regulate, such as product characteristics, labeling and marketing practices, patterns of use and initiation, consumer understanding and risk perceptions, and other factors that affect population-level health outcomes. While the program welcomes multiple scientific approaches, it emphasizes research that can support evidence-based regulation, including the development of stronger regulatory standards and the evaluation of whether regulatory actions achieve intended public health effects.
Although NIH administers the awards, the funds are provided through designated FDA CTP tobacco regulatory science dollars. This arrangement signals that the program is meant to bridge research and policy by producing regulatory-grade evidence. The focus is less on basic science for its own sake and more on actionable data that can help FDA evaluate product risks, marketing impacts, and public health consequences in real-world settings. Projects funded through this mechanism are expected to contribute to the evidence base behind regulatory decisions on tobacco products, including emerging product categories and shifting marketing channels, as long as the work stays within the FDA's regulatory scope.
In terms of scale and structure, the announcement anticipated about 20 awards with an estimated total funding level of $4,000,000. The award ceiling listed is $200,000, consistent with the R21 mechanism, which typically supports early-stage or proof-of-concept research rather than large, multi-year clinical trials or expansive longitudinal studies. There is no cost sharing or matching requirement, which lowers the barrier for organizations that may not have additional resources to contribute. Key dates provided in the source include a posted date of June 20, 2013, with a current closing date shown as June 17, 2014 (with earlier original closing information also noted), and the opportunity later archived.
Eligibility is broad and includes a wide range of domestic and international entities. Eligible applicants span federal, state, local, and tribal governments; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The eligibility language also explicitly includes organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), among others. Foreign organizations and foreign components of U.S. organizations are allowed as well, including non-U.S. institutions and non-U.S. components, consistent with NIH policy definitions, which expands the applicant pool to researchers who can contribute globally relevant evidence that still supports U.S. regulatory needs.
Overall, this FOA is best understood as a targeted research investment intended to produce timely, decision-relevant evidence for tobacco regulation. Applicants are expected to propose focused projects with clear regulatory significance, showing how their results could inform FDA oversight of tobacco product manufacturing standards, marketing restrictions, distribution practices, or related public health protections. The opportunity is administered by NIH, but its purpose and priorities are anchored in FDA CTP's regulatory mission under the Tobacco Control Act, with the expectation that the final outputs can be used to strengthen and evaluate real-world tobacco product regulation.
Frequently Asked Questions (FAQs)
What is the Tobacco Control Regulatory Research (R21) opportunity?
It is an NIH discretionary grant funding opportunity (RFA-OD-13-010) that supports short, exploratory research projects intended to directly inform U.S. tobacco regulation. The goal is to generate practical evidence that the U.S. Food and Drug Administration (FDA), specifically the Center for Tobacco Products (CTP), can use when developing, implementing, or evaluating tobacco-related rules.
What is the main purpose of this funding announcement?
The central purpose is to encourage biomedical, behavioral, and social science research that produces findings with clear, immediate relevance to regulatory decision-making aimed at protecting public health. The emphasis is on actionable, regulatory-grade evidence rather than research that is only academically interesting.
Which federal agencies are involved, and how are roles divided?
NIH administers the awards, but the funds come from designated FDA CTP tobacco regulatory science dollars. This structure is intended to bridge research and policy by producing evidence that can be used in FDA tobacco product regulation.
What makes a project a good fit for this FOA?
A strong fit is a focused, short, exploratory project that clearly explains how its findings could be used by FDA CTP in real regulatory work. Proposed research questions should be tied to issues FDA can regulate and should show clear regulatory significance and practical use for rulemaking, implementation, or evaluation.
What types of research areas does the FOA emphasize?
The FOA emphasizes biomedical, behavioral, and social science studies that can inform evidence-based regulation. Examples of topic areas mentioned include product characteristics, labeling and marketing practices, patterns of use and initiation, consumer understanding and risk perceptions, and other factors that affect population-level health outcomes.
Does the research have to align with a specific law or regulatory authority?
Yes. Funded projects are expected to align with FDA CTP research priorities connected to its statutory authority under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. Applicants are expected to frame their research around issues that fall within FDA's regulatory scope.
What does "regulatory-grade evidence" mean in the context provided?
Based on the description, it refers to evidence that can be used in real-world regulatory decision-making. The FOA stresses actionable data to help FDA evaluate product risks, marketing impacts, and public health consequences, rather than basic science conducted without a clear regulatory application.
Can projects focus on emerging tobacco product categories or new marketing channels?
Yes, the description notes that projects may include emerging product categories and shifting marketing channels, as long as the work stays within FDA's regulatory scope.
How many awards and how much total funding were anticipated?
The announcement anticipated about 20 awards with an estimated total funding level of $4,000,000.
What is the maximum award amount mentioned?
The award ceiling listed is $200,000, consistent with the R21 mechanism, which is typically used for early-stage or proof-of-concept work.
Is this funding intended for large, long-term studies?
No. The R21 mechanism is described as supporting short, exploratory projects rather than large, multi-year clinical trials or expansive longitudinal studies.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad. It includes federal, state, local, and tribal governments; public and private institutions of higher education; nonprofits (with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are specific institution types explicitly included?
Yes. The eligibility language explicitly includes organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), among others.
Are foreign organizations or international components allowed?
Yes. Foreign organizations and foreign components of U.S. organizations are allowed, including non-U.S. institutions and non-U.S. components, consistent with NIH policy definitions.
What is the posted date and the closing date shown?
The posted date listed is June 20, 2013. The current closing date shown is June 17, 2014, with earlier original closing information also noted.
What does it mean that the opportunity was archived?
The source indicates the opportunity was later archived, meaning it is no longer an active, open funding opportunity under the provided listing.
What should applicants emphasize in describing expected results?
Applicants should emphasize how the results can be used to strengthen or evaluate tobacco regulation in practical terms, such as informing FDA oversight of manufacturing standards, marketing restrictions, distribution practices, and other public health protections within FDA's authority.
Is the focus more on basic science or applied regulatory relevance?
The focus is on applied regulatory relevance. The program description highlights actionable evidence for regulatory decisions and de-emphasizes basic science pursued without a clear connection to FDA's regulatory needs.
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