2012-11096. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

National Adult Tobacco Survey (NATS)—Reinstatement with Changes—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC) and the Center for Tobacco Products (CTP), Food and Drug Administration (FDA).

Background and Brief Description

Tobacco use remains the leading preventable cause of disease and death in the United States, resulting in approximately 440,000 deaths annually. Smokers die an average of 14 years earlier than nonsmokers. Moreover, cigarette smoking costs more than $193 billion; $97 billion in lost productivity plus $96 billion in health care expenditures.

With passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in 2009, the FDA is legally mandated to regulate tobacco products for the protection of public health. Such authority involves considering whether the marketing of tobacco products might encourage people who don't use tobacco products to begin using them, to encourage people who might otherwise quit to continue using tobacco, or to encourage former users to relapse.

In order to ensure that FDA is in compliance with the Tobacco Control Act's mandate to protect the public health, annual data collection is needed at least initially to monitor the benefits and potential adverse consequences of FDA's regulatory actions, as the regulatory framework is being established. As novel tobacco products are introduced onto the market, the FDA must regularly monitor patterns of all tobacco product usage—not just cigarettes—to identify changes in susceptibility and rates of tobacco use initiation, perceptions regarding tobacco use, and rates of tobacco use cessation.

Rather than develop a completely new system to monitor measures critical to FDA, and thereby increasing burden to the population, FDA has partnered with CDC to leverage the existing NATS system. While NATS has been re-designed to meet the critical data needs of the FDA, many of the measures are relevant to CDC's National Tobacco Control Program (NTCP), and CDC also will use the NATS data to evaluate the NTCP. Many of the NATS questions reflect CDC's key outcome indicators for evaluating tobacco control programs.

CDC proposes to conduct three annual cycles of the NATS to collect data necessary to evaluate the effectiveness of FDA's initial regulatory actions. The NATS will be a stratified, random-digit dialed telephone survey of non-institutionalized adults 18 years of age and older. To yield results that are representative nationally, information will be collected from 56,250 landline respondents and 18,750 cell phone respondents who do not have a landline to include the growing population of households that exclusively use cell phones and would be missed in a survey relying only on land-lines. To obtain the target number of completed telephone interviews, approximately 166,000 respondents will be contacted for initial eligibility screening and consent.

The burden per response for the proposed NATS remains the same by design as the 2009/2010 NATS. However, the number of respondents is smaller because the current NATS seeks to develop national estimates, whereas the 2009/2010 NATS sought to develop state-level estimates. Therefore, the total respondent burden for the new NATS cycle is substantially lower than the prior NATS. The 2009/2010 NATS involved a total respondent burden of 38,303 hours. The revised 2012/2013 NATS involves a total respondent burden of 29,850 hours, which amounts to 8,453 fewer hours, or 22.1% fewer hours, than the 2009/2010 NATS.

Results will have significant implications for the development and periodic adjustment of policies and programs aimed at preventing and reducing tobacco use in the United States.

Participation in the NATS is voluntary. There are no costs to respondents except their time. The total estimated annualized burden hours are 29,850.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Adults ages 18 or older	Screener for land-line users (pp. 3-8 of the NATS)	125,000	1	2/60
	Screener for cell phone users (pp. 9-11 of the NATS)	41,000	1	1/60
	National Adult Tobacco Survey for landline users (pp. 12-end of the NATS)	56,250	1	20/60
	National Adult Tobacco Survey for cell phone users (pp. 12-end of the NATS)	18,750	1	20/60

Kimberly S. Lane,

Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.