[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
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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]
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