Notice of Intent to Publish a Request for Applications for Centers of Excellence for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (P50)

Notice Number: NOT-DA-12-007

Release Date: February 13, 2012
Estimated Publication Date of Announcement: Spring 2012
First Estimated Application Due Date: Fall 2012
Earliest Estimated Award Date: July 2013
Earliest Estimated Start Date: July 2013

National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
National Institute of Environmental Health Sciences (NIEHS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS), in conjunction with other IC partners, intends to publish a Funding Opportunity Announcement (FOA) to establish Centers for tobacco regulatory science to conduct programs of multidisciplinary research that will aid the development and evaluation of tobacco product regulations. The Centers program will conduct research that addresses research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). Support for the Centers will come from funds provided to NIH through the FDA CTP to support tobacco regulatory science as per the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster regulatory science. Within the framework of the Tobacco Control Act, the FDA and NIH share interest in supporting science that can assist the FDA in the development and evaluation of tobacco product regulations. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data needed to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Consistent with the FDA CTP mission, this FOA seeks research centers that address such topics as: the diversity of tobacco products, reducing addiction, reducing toxicity and carcinogenicity, adverse health consequences, communications, marketing of tobacco products, and economics and policies. See the NIH Web site for additional information http://cancercontrol.cancer.gov/nih-fda

This Notice is provided to allow prospective applicants sufficient time to develop essential collaborations and plans prior to submitting an application in response to the published FOA. 

The FOA is expected to be published in the NIH Guide for Grants and Contracts in Spring 2012 with an expected receipt date in Fall 2012.

The FOA will utilize the Specialized Center (P50) funding mechanism for research centers. NIH and FDA intend to make 8-10 research center awards, with a maximum of 5 years of funding; NIH and FDA intend to make one coordinating center award; the coordinating center mechanism is to be determined.

Centers resulting from this FOA are expected to demonstrate research excellence and leadership to accelerate the pace of science that will guide FDA actions to reduce the public health toll from tobacco products in the United States. A Center application must propose a program of multidisciplinary research around a unifying or well-defined goal or targeted area of research that will aid the development and evaluation of tobacco product regulations. The research Center is required to have a minimum of three component research projects that are judged to have independent scientific merit and to contribute to the overall research theme of the center.

The goal of this FOA is to fund research relevant to FSPTCA. With the passage of FSPTCA in June 2009, the FDA has authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for FDA to consider as it implements the FSPTCA. Research and pilot studies supported by this notice will be used to provide scientific evidence in seven areas as follows.

• Diversity of Tobacco Products - understanding the constituents, components, ingredients, additives, and design features; use behaviors; perceptions, attitudes and beliefs of conventional and new and emerging tobacco products
• Reducing Addiction - understanding dependence in relation to nicotine level; how reductions in nicotine affect use behaviors; other constituents and components beyond nicotine that affect addiction of combustible and non-combustible tobacco products
• Reducing Toxicity and Carcinogenicity - understanding how reductions in toxicity of tobacco products affect use behaviors and perceptions; what level of reduction in harmful and potentially harmful constituents result in decreased disease risk; what assays best compare toxicity between different tobacco products
• Adverse Health Consequences - understanding health risks of multiple tobacco types; what biomarkers of disease risk can be associated with measures of tobacco exposure; what novel biological and physiological markers are predictive of tobacco-related adverse health outcomes
• Communications - understanding how to effectively convey information regarding risks associated with tobacco product use and FDA's regulatory authority over tobacco products  
• Marketing of Tobacco Products - understanding the impact of tobacco product marketing on use behaviors, perception, attitudes and beliefs  
• Economics and Policies - estimating the economic impact of FDA regulatory actions; understanding the impact of FDA regulatory actions on tobacco use and on overall morbidity and mortality

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Please direct all inquiries to:

Kay Wanke, PhD, MPH
Epidemiology Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
(301) 402-0036 (Direct)
(301) 443-6504 (Main)
(301) 443-2636 (Fax)
Email: [email protected]

Stacey Vandor
Division of Cancer Control and Population Sciences
National Cancer Institute
(301) 594-6786 (Direct)
(301) 594-6776 (Main)
(301) 594-6787(Fax)
Email: [email protected]

Srikanth’s Nadadur, M.Sc., Ph.D.
Cellular, Organs and Systems Pathobiology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
(919) 541-5327 (Direct)
(919) 541-1919 (Main)
(919) 541-0462 (Fax)
Email: [email protected]

Caroline Signore, MD, MPH
Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of
Child Health and Human Development
(301) 496-5577 (Direct)
(301) 496-5575 (Main)
(301) 496-3790 (Fax)
Email: [email protected]

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
(301) 443-1638 (Direct)
(301) 443-4045 (Fax)
Email: [email protected]

Randall R. Stewart, Ph.D.
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
(301) 496-6460 (Direct)
(301) 496-1917 (Main)
(301) 402-1501 (Fax)
E-mail: [email protected]