[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]
BILLING CODE 4160-01-P