[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26284-26287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10659]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0867]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Review; Experimental Study on
the Public Display of Lists of Harmful and Potentially Harmful Tobacco
Constituents
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed 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 June 7,
2012.
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-NEW and
title ``Experimental Study on the Public Display of Lists of Harmful
and Potentially Harmful Tobacco Constituents.'' 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
[[Page 26285]]
has submitted the following proposed collection of information to OMB
for review and clearance.
Experimental Study on the Public Display of Lists of Harmful and
Potentially Harmful Tobacco Constituents--(OMB Control Number 0910-NEW)
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. Section 904(d)(1) of the FD&C Act (21 U.S.C. 387d(d)(1))
states, ``Not later than 3 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, and annually
thereafter, the Secretary shall publish in a format that is
understandable and not misleading to a lay person, and place on public
display (in a manner determined by the Secretary) the list [of harmful
or potentially harmful constituents] established under [section
904(e)]'' of the FD&C Act. Section 904(e) of the FD&C Act (21 U.S.C.
387d(e)) directs FDA to establish ``a list of harmful and potentially
harmful constituents, including smoke constituents, to health in each
tobacco product by brand, and by quantity in each brand and subbrand.''
On January 31, 2011, FDA announced the availability of a final guidance
representing the Agency's current thinking on the meaning of the term
``harmful and potentially harmful constituent'' (see 76 FR 5387,
January 31, 2011). On April 3, 2012, FDA published a notice in the
Federal Register establishing a list of the harmful and potentially
harmful constituents (HPHCs) in tobacco products and tobacco smoke (see
77 FR 20034) as required by section 904(e) of the FD&C Act.
FDA intends to conduct research with consumers to help inform
decisions about how to implement section 904(d)(1) of the FD&C Act and
to provide information about how consumers understand information about
HPHCs. The primary research goal is to evaluate the impact of different
list formats on the public's ability to understand HPHC information.
The impact of different list formats will be measured by evaluating
respondents' understanding of certain communication objectives
addressed in this document. Secondary outcomes of interest include
measuring effects of different list formats upon respondents'
susceptibility to initiation of tobacco use, motivation and confidence
to quit tobacco use, and risk perceptions about tobacco use.
FDA proposes to conduct an experimental study with current smokers
aged 13 years and older, smokeless tobacco users aged 18 years and
older, and nonsmokers aged between 13 and 17 years who may be
susceptible to initiation of smoking. Data will be collected from
members of an Internet panel. Participation in the experimental study
is voluntary. The information collected from the study is necessary to
inform the Agency's efforts to implement the requirement of the FD&C
Act to place on public display a list of HPHCs in tobacco products and
tobacco smoke in a format that is understandable and not misleading to
a lay person, and is expected to provide information that may inform
Agency communications about HPHCs. The data obtained from this study is
one factor that will be used to inform FDA's decisionmaking regarding
the public display of the list of HPHCs required under section
904(d)(1). By evaluating respondents' understanding of the concepts
listed in this document we do not intend to imply that consumer
understanding of all concepts is needed to comply with these
requirements.
In the Federal Register of December 14, 2011 (76 FR 77837), FDA
published a 60-day notice requesting public comment on its proposed
collection of information. FDA received eight comments that were PRA
related, which required a total of 10 responses.
(Comment 1) One comment recommended that the study examine the
effects of HPHC lists for smokeless tobacco products as well as for
cigarettes.
(Response) FDA agrees. The proposed study will assess the impact of
different HPHC list formats for three classes of tobacco products
(cigarettes, smokeless tobacco products, and roll-your-own tobacco) on
consumer comprehension, beliefs, perceptions, and other precursors to
behavior.
(Comment 2) One comment encouraged FDA to recruit participants from
multiple demographic groups.
(Response) FDA agrees that it is important to include a diverse
group of individuals in the study and plans to include a
demographically diverse sample of respondents drawn from four primary
groups: Adult smoker, young adult smoker, youth smoker, and youth at
risk for tobacco initiation.
(Comment 3) One comment recommended that FDA compare consumer
responses to the HPHC lists against those that do not view an HPHC
list. This would facilitate an evaluation of what consumers may
understand, believe, perceive, or do in the absence of the HPHC list.
(Response) FDA agrees. Within each sample group, respondents will
be randomly assigned to one of the treatment groups that view an HPHC
list format or to a control group that does not view a list. Some of
the formats will include additional information to provide context for
the HPHC lists to the consumer. The effects of each list will be
determined during analysis through a comparison of responses between
treatment and control groups.
(Comment 4) One comment cautioned FDA to consider the utility of
including underage nonsmokers in the experimental study.
(Response) FDA has considered the utility of including under age
nonsmokers in the study. FDA believes it is important to consider the
risks and benefits of the HPHC lists to the population as a whole,
including users and nonusers of the tobacco product, and taking into
account the increased or decreased likelihood that existing users of
tobacco products will stop using such products, and the increased or
decreased likelihood that those who do not use tobacco products will
start using such products. Although FDA does not believe that there is
any information on the HPHC list that would encourage nonusers to
initiate tobacco use, one of the secondary outcomes it is to assess the
effects of the provision of HPHC lists on youth that do not currently
use tobacco products but who may be at risk of initiating the use of
tobacco products.
(Comment 5) One comment recommended that the data collected from
the users of smokeless tobacco products be analyzed separately from
cigarette smokers.
(Response) FDA agrees. FDA will collect data on the use of tobacco
products. The study now includes a sample of adult smokeless tobacco
users aged 18 years and older. The data from those who use smokeless
products will be analyzed separately.
(Comment 6) Three comments provided recommendations on pretesting
the information provided in the lists with target audiences prior to
implementation. One of these comments suggested that FDA use open-ended
questions to allow respondents to say/type what they understand each
statement to mean.
(Response) FDA agrees. FDA intends to conduct cognitive interviews
with individuals to assess comprehension of the test instrument and
certain aspects of the list formats prior to conducting the study.
Individuals will be asked open-ended questions during the
[[Page 26286]]
cognitive testing of the list formats and the survey questions.
(Comment 7) Two comments encouraged FDA to provide additional
information for public comment during the development of the study
including the list formats, study design, and measurement plans for the
listed unintended consequences.
(Response) The study protocol, list formats, and the survey
questionnaire are available for review and public comment upon request.
To request this information see the FOR FURTHER INFORMATION CONTACT
section of this document.
(Comment 8) One commenter stated that the HPHC list could not fully
inform consumers because the list is not complete, and the consumer
would not understand that the listed quantity of the chemicals were
based on machine testing and therefore are not necessarily a reflection
of human use. Other comments argued there was a high likelihood that
consumers will conclude that lower numbers or fewer constituents means
a product is less risky. They also suggested the need to have
disclaimers that provide information to counter potential
misunderstandings.
(Response) FDA agrees that the list format may have the potential
to mislead consumers, which is why FDA plans to conduct an experiment
with consumers to assess the impact of various formats of the HPHC
lists on consumer comprehension and precursors to behavior, such as
beliefs, attitudes, and intentions. Some of the list formats to be
included in the study will contain additional text and graphics to
convey other information to consumers that may not be evident from a
list of chemicals and numerical values. The study will assess various
formats for conveying the communication goals enumerated in this
document, such as uncertainty about the information contained in the
list; that other relationships between the constituents in tobacco
products and health problems may be discovered in the future; that the
values are the results of machine testing; and that exposure to the
chemicals also depends on other factors, such as the variability of
human use.
FDA's proposed study will also assess each list's potential for
increasing the likelihood that consumers will conclude that lower
numbers or fewer constituents imply that a tobacco product is less
risky. To evaluate whether the lists encourage consumers to compare the
relative risks of products, the study will include measures, such as
whether consumers comprehend that the amount of a chemical listed for a
specific tobacco product does not necessarily indicate the likelihood
of experiencing a health problem, and the number of chemicals listed
for a specific tobacco product does not necessarily indicate the
likelihood of experiencing a health problem.
(Comment 9) Two comments stressed the importance of using clear
language with one suggesting that information be written at a fifth
grade reading level. They also recommended FDA consider the impact of
color, font type, and font size on consumer comprehension.
(Response) FDA intends to use plain language, where additional
information is provided, and to select colors, font type, and font size
that are likely to improve consumer comprehension.
(Comment 10) One commenter suggested FDA prioritize the
communication objectives to facilitate evaluation of study results.
(Response) FDA agrees that a prioritization of the communication
objectives may facilitate the evaluation of the results. At this time,
FDA proposes a study to test the impact of various HPHC list formats on
consumer comprehension of the communication objectives, although it is
unlikely that a single format will be completely successful at meeting
all of those objectives.
Based on comments received and preliminary qualitative research,\1\
FDA has refined the communication objectives listed in the Federal
Register of December 14, 2011 (76 FR 77837) to the following: (1) The
chemicals come from the tobacco leaf itself and different parts of a
tobacco product, such as the tobacco smoke, glues, inks, paper, and
additives; (2) for smokeless products, many of the chemicals come from
the tobacco leaf itself; for smoked products, many of the chemicals
come from burning the tobacco leaf; (3) tobacco companies are required
to test their tobacco products and smoke for the chemicals on the list
and report the amounts to FDA; (4) science has linked the chemicals on
these lists to health problems or potential health problems; (5) these
lists do not necessarily identify all of the health problems that may
be caused by the tobacco product; (6) these lists do not necessarily
include all of the chemicals in the tobacco product that may be
harmful; (7) the amount of a chemical listed for a specific tobacco
product does not necessarily indicate the likelihood of experiencing a
health problem; (8) the number of chemicals listed for a specific
tobacco product does not necessarily indicate the likelihood of
experiencing a health problem; and (9) when a chemical is listed
without a quantity it may mean that the chemical was not detected or
the information is not currently available.
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\1\ OMB control number 0910-0674.
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The remaining comments were unresponsive to the 60-day Federal
Register notice. These comments were related to the development of an
accompanying education campaign; the development of a Web site for
consumers to get additional information; the provision of HPHC
information on the packages of tobacco products; the use of claims by
tobacco manufacturers, such as ``all natural'' or ``no additives''; and
the conformance of tobacco manufacturers and retailers to section 911
of the FD&C Act (21 U.S.C. 387k) regarding modified risk claims.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Pretest....................................................... 60 1 60 0.5 30
Screener...................................................... 10,000 1 10,000 0.0167 167
Experimental Survey........................................... 3,150 1 3,150 0.5 1,575
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Total..................................................... ................ ................ ................ ................ 1,772
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 26287]]
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 10,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.0167 hours),
for a total of 167 hours. Three thousand one hundred and fifty
respondents will complete the full study, estimated to last 30 minutes
(0.5 hours), for a total of 1,575 hours. The total estimated burden is
1,772 hours.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10659 Filed 5-2-12; 8:45 am]
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