[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Pages 18250-18251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7289]



Food and Drug Administration

[Docket No. FDA-2012-N-0273]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Graphic Cigarette Warning Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the Experimental Study of 
Graphic Cigarette Warning Labels that is being conducted in support of 
the graphic label provision of the Family Smoking Prevention and 
Tobacco Control Act (the Tobacco Control Act).

DATES: Submit either electronic or written comments on the collection 
of information by May 29, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Experimental Study of Graphic Cigarette Warning Labels--(OMB Control 
Number 0910-0668)--Extension

    Tobacco products are responsible for more than 400,000 deaths each 
year. The Centers for Disease Control and Prevention report that 
approximately 46 million 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. One way to do this is 
through health warnings that describe and graphically depict the harm 
caused by cigarette use causing individuals to think harder about the 
choice to use tobacco.
    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 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).'' FDA 
conducts research relating to tobacco products under its statutory 
authority in section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 393(d)(2)(C)), as amended by the Tobacco 
Control Act, to conduct research ``relating to foods, drugs, cosmetics, 
devices, and tobacco products in carrying out the act.'' 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 Federal Register 
of June 22, 2011 (76 FR 36628) entitled ``Required Warnings for 
Cigarette Packages and Advertisements,'' which specified nine graphic 
images to accompany the new textual warnings for cigarettes. Although 
the rule was scheduled to become effective 15 months after it issued, a 
federal district court has permanently enjoined FDA from implementing 
the rule in its current form. FDA has appealed this decision to the 
U.S. Court of Appeals of the District of Columbia. FDA expects that the 
information that FDA proposes to collect will be relevant to FDA's 
regulation of cigarette warnings no matter the outcome of the current 
    The 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

[[Page 18251]]

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 Tobacco Control Act for 
achieving each of the communication goals. The information collected 
from the study is necessary to inform the Agency's efforts to implement 
the mandatory graphic warnings required by the Tobacco Control Act.
    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 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of
        Portion of study             Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
Pretest.........................              60               1              60           0.5                30
Screener........................          15,000               1          15,000           0.016             240
Experimental Survey.............           5,400               1           5,400           0.5             2,700
    Total.......................  ..............  ..............  ..............  ..............           2,970
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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, for a total of 2,700 
hours. The total estimated burden is 2,970 hours (30 hours plus 240 
hours plus 2,700 hours).

    Dated: March 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7289 Filed 3-26-12; 8:45 am]