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U.S. Federal Drug Administration Awards $40 Million Tobacco Product Policy Research Contract to SciMetrika

Population Health Consulting Firm’s Findings May Influence Regulation of Popular Tobacco Products Like Electronic Cigarettes.

Durham, NC, October 02, 2013 --( SciMetrika, LLC, a population health consulting firm, has announced that the company has been awarded a $40 million, Indefinite Delivery/Indefinite Quantity (IDIQ) single-award contract by the Federal Drug Administration (FDA) to research and analyze the feasibility of various policy options for regulating certain tobacco products. SciMetrika’s research findings could influence a range of policies, including regulations related to electronic cigarettes or flavored tobacco products.

Under the terms of the contract, SciMetrika will be responsible for assembling a team of multidisciplinary public health professionals who will collect and synthesize evidence concerning tobacco products and inform the development of regulatory policy options to the FDA’s Center for Tobacco Products (CTP).

The contract will span five years. Project work began in September 2013.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority to regulate tobacco products. CTP’s responsibilities for implementing the Family Smoking Prevention and Tobacco Control Act include:

- Setting performance standards
- Reviewing premarket applications for new and modified-risk tobacco products
- Proposing and implementing new cigarette pack warning labels
- Eliminating flavor additives (except menthol) in cigarettes
- Investigating and ruling on the possible elimination of menthol flavoring in cigarettes
- Proposing a plan to regulate other tobacco products, such as cigars and smokeless tobacco
- Establishing and enforcing advertising and promotion restrictions

SciMetrika will consult with other companies as well as subject matter experts from schools of public health at leading universities to offer augmented expertise and services in specialized areas. The organizations include Gesellschaft für Konsumforschung (Society for Consumer Research), Abt SRBI, the University of North Carolina at Greensboro and JBS International, Inc.

“We are excited to work with the FDA’s Center for Tobacco Products to assist in the development of regulatory policy options,” said Dr. Michael Samuhel, SciMetrika director of population health sciences. “We are looking forward to sharing our findings with the FDA and CTP and to doing our part in eliminating tobacco-related disease and mortality.”

“We are excited for the opportunity to provide research and present evidence to the FDA Center for Tobacco Products on this project,” said SciMetrika CEO Dr. Jean Orelien. “SciMetrika’s staff understands the special attention required for an initiative as important as the regulation of tobacco products. We look forward to serving the FDA using our deep knowledge of population health.”

About SciMetrika:
SciMetrika, LLC is a fast-growing, privately held business with a singular focus on advancing human health. Founded in 2001, the company serves public and private sector clients seeking to understand and influence population health outcomes. SciMetrika's multidisciplinary teams, mature business processes and unwavering focus on advancing human health allow SciMetrika to offer wide-ranging services that are unmatched by other businesses in this market space. For more information, please visit or call (919) 354-5200.
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