Opportunity Information: Apply for RFA OD 15 006

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Abuse Liability Associated with Reduced Nicotine Content Tobacco Products (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 Aug 24, 2015 and posted on Aug 24, 2015.
  • Applicants must submit their applications by Dec 11, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $500,000.00 in funding.
  • The number of recipients for this funding is limited to 10 candidate(s).
  • Eligible applicants include: Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal governments (Federally recognized) City or township governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses.
  • 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.
Apply for RFA OD 15 006

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Opportunity Summary:

The grant opportunity titled "Abuse Liability Associated with Reduced Nicotine Content Tobacco Products (R01)" (Funding Opportunity Number RFA-OD-15-006) is a discretionary federal research grant administered by the National Institutes of Health (NIH) using dedicated funds from the FDA Center for Tobacco Products (CTP). Its central aim is to produce strong, policy-relevant scientific evidence that can help the FDA reduce the addictiveness of tobacco products and, by extension, reduce the public health burden caused by tobacco use in the United States. The announcement is rooted in the FDA's tobacco regulatory responsibilities under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31, meaning the research is expected to directly support regulatory decision-making rather than purely basic science.

The scientific focus is on nicotine as the key driver of cigarette addiction. The opportunity emphasizes that nicotine is the primary chemical that reinforces smoking behavior and makes quitting difficult, which leads to continued smoking and its associated health harms. Because of this, the FOA is specifically interested in research that examines how changing nicotine levels in combusted tobacco products, especially cigarettes, affects use behavior and addiction-related outcomes. The underlying regulatory question is practical: if nicotine content in cigarettes is reduced, how does that change the product's "abuse liability" (its potential to sustain addiction and compulsive use), and what unintended behavioral responses might occur that could undermine public health goals.

Projects proposed under this FOA are expected to study nicotine and combusted tobacco use behaviors in ways that inform FDA action. The announcement highlights several example areas, including reinforcing effects (how strongly the product motivates repeated use), compensation (whether users change their behavior to make up for lower nicotine, such as smoking more cigarettes or puffing more intensely), overall amount used, and dose effects (how different nicotine doses affect behavior and exposure). In practice, this points toward work that carefully measures how smokers respond when nicotine content is reduced, whether reduced-nicotine products reduce dependence and facilitate cessation, and whether users adapt in ways that could increase exposure to other harmful smoke constituents even if nicotine is lower.

From a program and funding standpoint, the FOA planned to make about 10 awards with an estimated total funding pool of $5,000,000, and it listed an award ceiling of $500,000. There was no cost-sharing or matching requirement, which generally lowers barriers to applying and allows institutions to focus their budgets on carrying out the research plan. The activity category is health, and the associated CFDA number is 93.077, tied to regulatory research authorized by the Tobacco Control Act.

Eligibility was broad and included many types of organizations that can conduct rigorous research. Eligible applicants included public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations other than small businesses, small businesses, and multiple levels of government (state, county, city/township, special district governments), as well as tribal governments and tribal organizations. The opportunity also explicitly welcomed a wide range of institution types and communities, including 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 and Native American Pacific Islander-serving institutions (AANAPISIs). It also allowed participation by U.S. territories and possessions and listed non-U.S. entities (foreign organizations) and regional organizations as eligible, signaling an interest in drawing on the best available expertise and potentially leveraging international research capacity where relevant.

The key compliance expectation is that proposed work must align with FDA CTP research priorities and the FDA's regulatory authority under the FSPTCA. In other words, the research is meant to be directly useful for evaluating regulatory options related to nicotine reduction in combusted tobacco products, rather than exploring tobacco-related questions without a clear line to regulatory decisions. Administrative details reflect the timeline of the announcement: it was posted on August 24, 2015, with an original and current closing date of December 11, 2015, and it was archived on January 11, 2016. For additional details, the full announcement was hosted on the NIH grants guide site, and contacts were provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Abuse Liability Associated with Reduced Nicotine Content Tobacco Products (R01)".

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-OD-15-006.

What type of funding is this?

This is a discretionary federal research grant administered by the National Institutes of Health (NIH), using dedicated funds from the FDA Center for Tobacco Products (CTP).

Which federal agency administers the grant?

The grant is administered by the National Institutes of Health (NIH).

Where does the funding for this NIH opportunity come from?

The FOA uses dedicated funds from the FDA Center for Tobacco Products (CTP).

What is the main purpose of this funding opportunity?

The central aim is to generate strong, policy-relevant scientific evidence to help the FDA reduce the addictiveness of tobacco products and reduce the public health burden of tobacco use in the United States.

How is this research tied to FDA regulation?

The announcement is rooted in the FDA's tobacco regulatory responsibilities under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The research is expected to support FDA regulatory decision-making rather than being purely basic science.

What is the scientific focus of the FOA?

The FOA focuses on nicotine as the key driver of cigarette addiction and emphasizes research on how changing nicotine levels in combusted tobacco products, especially cigarettes, affects use behavior and addiction-related outcomes.

What does "abuse liability" mean in the context of this FOA?

In this context, "abuse liability" refers to a tobacco product's potential to sustain addiction and compulsive use, including how strongly it reinforces repeated use and how users may respond behaviorally when nicotine content is reduced.

What kinds of research questions is the FOA trying to answer?

The underlying regulatory question is practical: if nicotine content in cigarettes is reduced, how does that change addiction-related behavior, and what unintended behavioral responses might occur that could undermine public health goals.

Which tobacco products are emphasized in this opportunity?

The FOA emphasizes combusted tobacco products, with particular attention to cigarettes.

What example research areas are highlighted in the announcement?

The FOA highlights example areas such as:

  • Reinforcing effects (how strongly the product motivates repeated use)
  • Compensation (whether users change behavior to make up for lower nicotine, such as smoking more cigarettes or puffing more intensely)
  • Overall amount used
  • Dose effects (how different nicotine doses affect behavior and exposure)

What behavioral responses are applicants expected to consider?

The FOA points to the need to assess whether users compensate for reduced nicotine (for example, by smoking more or puffing harder), including whether such adaptation could increase exposure to other harmful smoke constituents even if nicotine is lower.

Does the FOA anticipate research related to dependence and cessation?

Yes. The description indicates interest in whether reduced-nicotine products reduce dependence, may facilitate cessation, and how behavior changes might affect exposure and public health outcomes.

What is the activity category for this opportunity?

The activity category is health.

What is the CFDA number associated with this opportunity?

The associated CFDA number is 93.077, tied to regulatory research authorized by the Tobacco Control Act.

How many awards were planned?

The FOA planned to make approximately 10 awards.

What was the estimated total funding available?

The estimated total funding pool was $5,000,000.

What was the maximum award amount ("ceiling")?

The FOA listed an award ceiling of $500,000.

Is there a cost-sharing or matching requirement?

No. The FOA stated there was no cost-sharing or matching requirement.

Who was eligible to apply?

Eligibility was broad and included:

  • Public and private institutions of higher education
  • Nonprofits (with or without 501(c)(3) status)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Tribal governments
  • Tribal organizations
  • U.S. territories and possessions
  • Non-U.S. entities (foreign organizations)
  • Regional organizations

Did the FOA encourage applications from specific institution types or communities?

Yes. The FOA explicitly welcomed applications from a wide range of institutions and communities, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs.

Are foreign organizations eligible to apply?

Yes. The opportunity listed non-U.S. entities (foreign organizations) as eligible.

What are the key compliance expectations for proposed projects?

Proposed work must align with FDA CTP research priorities and the FDA's regulatory authority under the FSPTCA. The work should be directly useful for evaluating regulatory options related to nicotine reduction in combusted tobacco products.

Is the FOA intended for purely basic science tobacco research?

No. The description emphasizes that the research is expected to directly support regulatory decision-making, not simply explore tobacco-related questions without a clear connection to FDA regulatory decisions.

When was the funding announcement posted?

The announcement was posted on August 24, 2015.

What was the closing date for applications?

The original and current closing date listed was December 11, 2015.

Is this funding opportunity still active?

No. The FOA was archived on January 11, 2016.

Where was the full announcement hosted?

The full announcement was hosted on the NIH grants guide site.

Who was listed as the contact for access or linking issues?

Contacts were provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.

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