Research Priorities

Science will guide all FDA actions to reduce the public health toll from tobacco products in the United States. Science will help FDA understand tobacco and its ingredients and constituents, tobacco addiction, tobacco marketing and labeling, and childhood tobacco use.

FDA Center for Tobacco Products Research Interest Areas

The Family Smoking Prevention and Tobacco Control Act (TCA) gives the Food and Drug Administration (FDA) broad authority to regulate tobacco product manufacturing, distribution and marketing. Although a vast and sound science base exists with regard to numerous areas of the TCA, new research will provide scientific evidence in several areas. Research areas include:

1. understanding the diversity of tobacco products
2. reducing addiction to tobacco products
3. reducing toxicity and carcinogenicity of tobacco products and smoke
4. understanding the adverse health consequences of tobacco use
5. understanding communications about tobacco products
6. understanding tobacco product marketing
7. understanding how economics and policies affect tobacco product use

FDA has identified 56 research priorities under the 7 research interest areas. The 56 research questions can be viewed by visiting http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM293998.pdf (pdf – 37KB, updated January 2012).

Vulnerable populations referenced in research questions include, but are not limited to age, gender, race, ethnicity, income, occupation, geographic location, people with mental health or medical co-morbidities, the military/veterans, the lesbian, gay, bi-sexual, transgendered, questioning (LGBTQ) community, and pregnant women/women of reproductive age.

FDA Center for Tobacco Products Review Criteria

Applicants should note the specific section(s) of the Tobacco Control Act that are relevant to their research plan and why.

Review Criteria
As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria: Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

• Significance: Does the project address an important issue or a critical barrier in regulatory authority over tobacco products? If the aims of the project are achieved, how will regulatory science research be informed or regulation affected? How will successful completion of the aims have affect on the concepts, methods, technologies, or regulation of tobacco products?
  
  
• Investigator(s): Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
  
  
• Innovation: Will the project aid in advancement of developing and evaluating regulations pertaining to the manufacture, distribution, and marketing of tobacco products in order to protect public health? Will the outcomes of the project provide new information addressing regulatory authority over tobacco products?
  
  
• Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Is the project directly relevant to a specific section in the Family Smoking Prevention and Tobacco Control Act? If the project is in the early stages of development, will the strategy establish feasibility and are risky aspects addressed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
  
  
• Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items: Protection of Human Subjects; Inclusion of Women, Minorities, and Children; Vertebrate Animals; and Biohazards.

For information about funding opportunities and how to apply, visit the Funding Opportunities section.