Opportunity Information: Apply for PAR 12 267
Apply for PAR 12 267
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Tobacco Control Regulatory Research R01" 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 19, 2013 and posted on Aug 23, 2012.
- Applicants must submit their applications by Jun 18, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Special district governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) 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 R01 grant opportunity (Funding Opportunity Number PAR 12 267) is a discretionary NIH research grant designed to support projects that generate evidence the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) can use when developing, implementing, or evaluating regulations over tobacco products. The focus is squarely on regulatory science, meaning the research is expected to produce data that can directly inform federal decision-making about how tobacco products are manufactured, distributed, and marketed in ways that protect public health. While NIH is the awarding agency and manages the grants, the funding itself is provided through designated FDA CTP tobacco regulatory science funds, reflecting the program's intent to answer questions tied to FDA's legal authorities and practical regulatory needs.
A central requirement of this opportunity is that proposed studies align with the FDA CTP regulatory authority established by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. In practical terms, applicants are expected to target research priorities that help the FDA evaluate tobacco product characteristics and how they influence initiation, addiction, patterns of use, exposure, perceptions of risk, and health outcomes, as well as how marketing and distribution practices shape consumer behavior. The FOA explicitly welcomes biomedical, behavioral, and social science approaches, which signals that competitive applications could range from lab-based or clinical investigations to population-level studies, communications and marketing research, policy evaluation, and other methods that can credibly inform regulation. The underlying expectation is not just general tobacco research, but results that translate into actionable regulatory evidence relevant to product standards, marketing restrictions, labeling and messaging considerations, and other regulatory levers.
This is an R01 mechanism, which typically supports substantial, hypothesis-driven or otherwise well-justified research projects with a defined scope and rigorous methods. The opportunity is categorized under Health as the activity area and is associated with CFDA number 93.077, labeled as Family Smoking Prevention and Tobacco Control Act Regulatory Research. There is no cost sharing or matching requirement, which reduces barriers for applicants by not requiring non-federal funds to be committed as a condition of the award.
Eligibility is broad and spans many types of organizations, indicating the program aims to draw from a wide research community. Eligible applicants include state, county, city or township governments; independent school districts; special district governments; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments as well as other tribal organizations; public and state-controlled institutions of higher education and private institutions of higher education; nonprofits with or without 501(c)(3) status (with the noted exception categories); for-profit organizations other than small businesses; and small businesses. The eligibility language also explicitly includes a range of mission-focused and capacity-building institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs). Faith-based and community-based organizations and certain regional organizations are also listed as eligible, broadening participation beyond traditional academic settings when appropriate expertise and infrastructure exist to conduct the proposed research.
Notably, this FOA allows non-U.S. participation: non-domestic (foreign) institutions may apply, non-domestic components of U.S. organizations may apply, and foreign components as defined in the NIH Grants Policy Statement are allowed. That international eligibility can matter for tobacco regulatory science because tobacco product markets, manufacturing practices, marketing strategies, and product innovations often cross borders, and evidence developed in other settings may still be informative for U.S. regulatory questions when appropriately designed and contextualized.
Key dates included in the source information show the FOA was posted on August 23, 2012, with a creation date of April 19, 2013. The original closing date was January 16, 2015, though the current closing date listed in the record is June 18, 2013, and the archive date is July 18, 2013, indicating the announcement has been closed and archived. For applicants or researchers looking for details, the full announcement was hosted on the NIH grants site under the provided link (http://grants.nih.gov/grants/guide/pa-files/PAR-12-267.html). The contact pathway given is through the NIH Office of Extramural Research (OER) webmaster email for access or linking issues (FBOWebmaster@OD.NIH.GOV), which is an administrative contact rather than a scientific program contact.
Overall, the program can be summarized as a targeted NIH-administered, FDA-funded R01 grant opportunity meant to build a strong evidence base for FDA tobacco regulation under the FSPTCA. The most important takeaway is that proposed work must be clearly tied to FDA CTP regulatory priorities and must be positioned to produce findings that are directly relevant to real-world regulatory decisions about tobacco products and their marketing and distribution, with the broader goal of protecting public health.
Frequently Asked Questions (FAQs)
What is the Tobacco Control Regulatory Research R01 opportunity (PAR 12 267)?
This is a discretionary NIH research grant opportunity using the R01 mechanism to support tobacco regulatory science projects. The intent is to generate evidence the FDA Center for Tobacco Products (CTP) can use when developing, implementing, or evaluating regulations over tobacco products.
What is the main purpose of this funding opportunity?
The purpose is to fund research that produces data directly relevant to federal regulatory decision-making about how tobacco products are manufactured, distributed, and marketed in ways that protect public health. The emphasis is on producing actionable regulatory evidence rather than general tobacco research.
Who administers the grants, and where does the funding come from?
NIH is the awarding agency and administers and manages the grants. The funding itself is provided through designated FDA CTP tobacco regulatory science funds, reflecting that the supported research should address FDA regulatory needs and authorities.
What does "regulatory science" mean in the context of this FOA?
In this FOA, regulatory science refers to research expected to produce evidence that can directly inform FDA actions, such as setting product standards, considering marketing restrictions, evaluating labeling and messaging approaches, and other regulatory levers related to tobacco products.
What law and regulatory authority must proposed studies align with?
Proposed studies are expected to align with FDA CTP authority under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.
What kinds of research topics does the FOA prioritize?
The FOA emphasizes research priorities that help FDA evaluate tobacco product characteristics and how those characteristics influence initiation, addiction, patterns of use, exposure, perceptions of risk, and health outcomes. It also highlights the importance of understanding how marketing and distribution practices shape consumer behavior.
What types of scientific approaches are encouraged?
The FOA explicitly welcomes biomedical, behavioral, and social science approaches. This indicates that a range of methods may be relevant, including laboratory, clinical, population-level, communications/marketing research, and policy evaluation approaches, as long as they credibly inform regulation.
Is this opportunity intended for general tobacco research?
No. The stated expectation is that projects go beyond general tobacco research and are positioned to translate into evidence that is directly relevant to FDA CTP regulatory decisions and practical needs.
What grant mechanism is used, and what does that imply about project scope?
This opportunity uses the NIH R01 mechanism, which typically supports substantial, well-justified research projects with a defined scope and rigorous methods (often hypothesis-driven, though the key expectation here is a strong rationale and regulatory relevance).
What is the activity area and associated CFDA number?
The activity area is Health. The opportunity is associated with CFDA 93.077, labeled "Family Smoking Prevention and Tobacco Control Act Regulatory Research."
Is cost sharing or matching required?
No. The FOA indicates there is no cost sharing or matching requirement, meaning applicants are not required to commit non-federal funds as a condition of award.
What organizations are eligible to apply?
Eligibility is broad. Eligible applicants include various government entities (state, county, city or township; independent school districts; special district governments), public housing authorities/Indian housing authorities, federally recognized Native American tribal governments and other tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (with noted exception categories), for-profit organizations other than small businesses, and small businesses.
Are mission-focused or capacity-building institution types explicitly included?
Yes. The eligibility language explicitly includes institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based and community-based organizations eligible?
Yes. The FOA includes faith-based and community-based organizations among eligible applicants, along with certain regional organizations, suggesting participation is not limited to traditional academic settings when the needed expertise and infrastructure are in place.
Can non-U.S. (foreign) organizations apply?
Yes. The FOA allows non-domestic (foreign) institutions to apply. It also allows non-domestic components of U.S. organizations to apply, and permits foreign components as defined in the NIH Grants Policy Statement.
Why might international eligibility matter for this program?
The FOA notes that tobacco markets, manufacturing practices, marketing strategies, and product innovations often cross borders. Evidence developed in other settings may still be informative for U.S. regulatory questions when appropriately designed and contextualized.
What are the key dates listed for this FOA?
The record indicates the FOA was posted on August 23, 2012, with a creation date of April 19, 2013. It lists an original closing date of January 16, 2015, while also listing a current closing date of June 18, 2013, and an archive date of July 18, 2013.
Is this funding opportunity still open?
No. Based on the dates provided, the announcement is closed and archived (archive date: July 18, 2013).
Where was the full funding announcement hosted?
The full announcement was hosted on the NIH grants site at http://grants.nih.gov/grants/guide/pa-files/PAR-12-267.html.
Who is the listed contact for questions or issues?
The provided contact pathway is the NIH Office of Extramural Research (OER) webmaster email (FBOWebmaster@OD.NIH.GOV) for access or linking issues. This is an administrative contact rather than a scientific program contact.
What is the most important compliance or fit requirement emphasized by the FOA?
The central requirement is that proposed work must be clearly tied to FDA CTP regulatory priorities and to FDA authority under the FSPTCA, and it must be positioned to produce findings that can inform real-world regulatory decisions about tobacco products and their marketing and distribution.
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