Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
The purpose of this submission is to request OMB approval to conduct Web-based surveys to evaluate the relative effectiveness of various graphic health warnings on cigarette packs, which will inform the Agency's efforts to implement the mandatory graphic warnings required by the Tobacco Control Act.
The current approval for this information collection expired October 31, 2012. FDA seeks to reinstate the collection and to reflect that there is no change in the reporting burden. At this time, the Agency is not collecting the information, but awaits OMB review and approval, and therefore believes that we are not in violation of the PRA.
Tobacco products are responsible for more than 400,000 deaths each year. The Centers for Disease Control and Prevention report that approximately 46 million U.S. adults smoke cigarettes in the United States, even though this behavior will result in death or disability for half of all regular users. Paralleling this enormous health burden is the economic burden of tobacco use, which is estimated to total $193 billion annually in medical expenditures and lost productivity. Curbing the significant adverse consequences of tobacco use is one of the most important public health goals of our time.
On June 22, 2009, the President signed the Tobacco Control Act (Pub. L. 111-31) into law. The Tobacco Control Act granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act, which amends section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), requires FDA to issue “regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1).” The study proposed here is an effort by FDA to collect data concerning graphic warnings on cigarette packages and their impact on consumer perceptions, attitudes, and behavior with respect to smoking.
On June 22, 2011, FDA issued a final rule in the
This study, the Experimental Study of Graphic Cigarette Warning Labels, is a voluntary annual experimental survey of consumers. The purpose of the study is to assess the effectiveness of various graphic warnings on cigarette packs for achieving three communication goals: (1) Conveying information about various health risks of smoking; (2) encouraging cessation of smoking among current smokers; and (3) discouraging initiation of smoking among youth and former smokers. The study will collect data from various groups of consumers, including current smokers aged 13 years and older, former smokers aged 13 years and older, and non-smokers aged between 13 and 25 years who may be susceptible to initiation of smoking. The study goals are to: (1) Measure consumer attitudes, beliefs, and intended behaviors related to cigarette smoking in response to graphic warning labels; (2) determine whether consumer responses to graphic warning labels differ across various groups based on smoking status, age, or other demographic variables; and (3) evaluate the relative effectiveness of various graphic images associated with each of the nine warning statements specified in
The experimental study data will be collected from participants of an Internet panel of approximately 43,000 people. Participation in the experimental study is voluntary.
FDA estimates the burden of this collection of information as follows:
FDA's burden estimate is based on prior experience with Internet panel experiments similar to the study proposed here. Sixty panel members will take part in a pretest of the study, estimated to last 30 minutes (0.5 hours), for a total of 30 hours. Approximately 15,000 respondents will complete a screener to determine eligibility for participation in the study, estimated to take 1 minute (0.016 hours), for a total of 240 hours. Fifty-four hundred respondents will complete the full study, estimated to last 30 minutes (0.5 hours), for a total of 2,700 hours. The total estimated burden is 2,970 hours (30 hours plus 240 hours plus 2,700 hours).