[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72355-72356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2012-N-0273]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Review; Experimental Study of 
Graphic Cigarette Warning Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
reinstatement collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by January 
4, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0668. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 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.

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

    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 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 
panel of the U.S. Court of Appeals of the District of Columbia held, on 
August 24, 2012, that the rule in its current form violates the First 
Amendment. FDA expects that the information that FDA proposes to 
collect will be relevant to FDA's regulation of cigarette warnings no 
matter the final outcome of the current litigation.
    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

[[Page 72356]]

the Tobacco Control Act for achieving each of the communication goals. 
The information collected from the study will help inform the Agency's 
efforts to implement the mandatory graphic health 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.
    In the Federal Register of March 27, 2012 (77 FR 18250), FDA 
published a 60-day notice requesting public comment on its proposed 
collection of information. FDA received eight comments that were not 
PRA-related and that were outside the scope of this collection of 
information. FDA also received a comment that asked FDA to provide more 
detail about the design of the proposed consumer research study to 
allow for meaningful public comments. The commenter also encouraged FDA 
to provide additional information for public comment, including details 
of the protocol, screen, questionnaire, and actual graphic warnings 
images to be used with study participants to enhance the quality, 
utility, and clarity of the information to be collected and further the 
goals of the PRA to ensure the greatest possible public benefit from 
and maximize the utility of the information. FDA notes in response to 
this comment that the study and copies of the instruments used to 
collect this information are described in detail as part of the overall 
package submitted to OMB for review. The study and copies of the 
instrument were made available to the public during the original 
information collection period. They will also be available to the 
public at www.reginfo.gov once OMB receives the package for review.
    FDA estimates the burden of this collection of information as 
follows:

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

    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).

    Dated: November 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29321 Filed 12-4-12; 8:45 am]
BILLING CODE 4160-01-P