[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Notices]
[Pages 1938-1939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-12-0828]


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 (404) 639-7570 
or send comments to Kimberly Lane, CDC Reports Clearance Officer, 1600 
Clifton Road, MS D-74, Atlanta, GA 30333 or send an email to 
<a href="/cdn-cgi/l/email-protection#adc2c0cfedcec9ce83cac2db"><span class="__cf_email__" data-cfemail="bcd3d1defcdfd8df92dbd3ca">[email protected]</span></a>.
    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).

[[Page 1939]]

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


    Dated: January 6, 2012.
Kimberly Lane,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2012-474 Filed 1-11-12; 8:45 am]
BILLING CODE 4163-18-P


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