2012-474. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call [phone] or send comments to Kimberly Lane, CDC Reports Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, GA 30333 or send an email to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

National Adult Tobacco Survey (NATS) (OMB No. 0920-0828, exp. 10/31/2010)—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 non-smokers. Moreover, cigarette smoking costs more than $193 billion; $97 billion in lost productivity plus $96 billion in health care expenditures. Although the prevalence of current smoking among adults in the United States has declined significantly since 1964, in more recent years (2004 to 2010) these declines have slowed or stalled with 1 in 5 adults reporting current smoking. In addition, promotion of non-cigarette tobacco products is leading to increased diversity of tobacco product usage, including the use of multiple products.

With passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, the Food and Drug Administration is legally mandated to regulate tobacco products for the protection of public health. Congress passed the FSPTCA to discourage tobacco use among minors and young adults, to encourage cessation among adult smokers and to reduce the public health burden of tobacco related disease in the U.S. Under the Tobacco Control Act, FDA has been granted broad authority to use the best available science to develop and implement effective strategies to protect the public's health. FDA authority includes setting and enforcing standards for tobacco product ingredients and design, establishing good manufacturing practices, instituting tobacco product labeling and health warnings; prohibiting marketing that is misleading to consumers and developing enforcement authorities to act quickly and effectively to remove violating products. In addition, the FSPTCA gives FDA the authority to assert jurisdiction over cigars and other currently unregulated tobacco products. Finally, FDA's regulatory authority involves considering whether the marketing of tobacco products might encourage people who don't use tobacco products to begin using them, encourage people who might otherwise quit to continue using tobacco, or 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. The FDA must regularly monitor patterns of tobacco product usage—novel tobacco products as well as 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 National Adult Tobacco Survey (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. In addition, to include the growing population of households that exclusively use cell phones and would be missed in a survey relying only on land-lines, information will be collected from 18,750 cell phone respondents who do not have a landline. To obtain the target number of completed telephone interviews, approximately 166,000 respondents will be contacted for initial eligibility screening.

Response is voluntary. Study 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. There are no costs to respondents except their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Adults ages 18 or older	Screener for land-line users (pp 67-78 of the NATS)	125,000	1	2/60	4,167
	Screener for cell phone users (pp 79-86 of the NATS)	41,000	1	1/60	683
	National Adult Tobacco Survey (pp 5-66 of the NATS)—landline	56,250	1	20/60	18,750
	National Adult Tobacco Survey (pp 5-66 of the NATS)—cell phone	18,750	1	20/60	6,250
Total					29,850

Dated: January 6, 2012.

Kimberly Lane,

Reports Clearance Officer, Centers for Disease Control and Prevention.