
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5470-5472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1855]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Studies 
on Consumer Perceptions of Modified Risk Tobacco Products

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.

DATES: Fax written comments on the collection of information by March 
3, 2016.

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 Studies on Consumer Perceptions of Modified Risk 
Tobacco Products.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Experimental Studies on Consumer Perceptions of Modified Risk Tobacco 
Products OMB Control Number 0910-NEW

    FDA's Center for Tobacco Products proposes to conduct experimental 
studies to develop generalizable scientific knowledge to help inform 
its implementation of section 911 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be 
evaluating information submitted to the Agency about how consumers 
understand and perceive tobacco products marketed as modified risk 
tobacco products (MRTPs). Section 911 of the FD&C Act authorizes FDA to 
grant orders to persons to allow the marketing of MRTPs. The term 
``modified risk tobacco product'' means any tobacco product that is 
sold or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco products. 
FDA must issue an order authorizing the marketing of an MRTP if the 
Agency determines that the product, as it is actually used by 
consumers, will significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users and benefit the health of 
the population as a whole taking into account both users of tobacco 
products and persons who do not currently use tobacco products (section 
911(g)(1) of the FD&C Act).
    FDA may also issue an order authorizing the marketing of an MRTP 
that reduces or eliminates exposure to a harmful substance if, among 
other requirements, the Agency determines that the order would be 
appropriate to promote the public health, the issuance of the order is 
expected to benefit the population as a whole taking into account both 
users and nonusers of tobacco products, and the existing evidence 
demonstrates that a measurable and substantial reduction in morbidity 
and mortality among individual tobacco users is reasonably likely to be 
shown in subsequent studies (section 911(g)(2) of the FD&C Act). In 
addition, section 911 requires that any advertising or labeling 
concerning modified risk products enable the public to comprehend the 
information concerning modified risk and to understand the relative 
significance of such information in the context of total health and in 
relation to all of the diseases and health related conditions 
associated with the use of tobacco products (section 911(h)(1) of the 
FD&C Act). The proposed research will inform the Agency's efforts to 
implement the provisions of the FD&C Act related to MRTPs.
    FDA proposes to conduct experimental studies in order to develop 
generalizable scientific information to better understand how consumers 
perceive and understand these products, how exposure to claims about 
modified risk or exposure influence intentions to try or purchase the 
product, and how individual characteristics such as current tobacco use 
and/or brand loyalty might influence these outcomes. Moreover, 
information from the experimental studies may assist FDA to determine 
the appropriate methods and

[[Page 5471]]

measures for gathering such information from consumers.
    The impact of different claims pertaining to modified risk or 
exposure on understanding, perceptions, and use intentions will be 
evaluated by conducting a series of three studies that, in turn, will 
examine: The impact of claims about cigarette (Study 1) or smokeless 
tobacco products (Study 2) among young adult and adult current, former, 
or never users of tobacco; and the impact of claims on adolescents 
currently using, or susceptible to using, tobacco (Study 3). All three 
studies will assess individual-level factors that might influence the 
impact of claims on consumer responses, including: Brand loyalty, 
tobacco use history and behavior, concerns about health risks, and 
openness to new products.
    Across all studies, participants will be randomized to either see 
modified risk claims or not (control condition). In Studies 1 and 2, 
modified risk claims will be displayed on mock tobacco product packages 
and ads. For ethical reasons, adolescents (Study 3) will see modified 
risk claims displayed as statements alone, not attached to product 
packaging or ads. Consumer reactions to claims will be evaluated by 
measuring constructs such as: Understanding of the modified risk 
information in the claims, perceptions of harm and risk, beliefs about 
the product, quit intentions, and intention to try or purchase the 
product.
    In the Federal Register of November 19, 2014 (79 FR 68888), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Three comments were received, however only 
two were PRA related.
    (Comment) One commenter critiqued the inclusion of items assessing 
brand loyalty, asserting such constructs have ``no practical utility'' 
for MRTPA review and is beyond the FDA's statutory authority because it 
is not mentioned in the FD&C Act.
    (Response) FDA does not agree. Although concepts such as ``brand 
loyalty'' are not specifically mentioned in the FD&C Act, FDA seeks 
understanding of how attitudes toward one's preferred brand(s) may 
affect perceptions and understanding of modified risk information 
(section 911(h)(1)). The goal of the present experiments is to 
understand how consumers react to RM and EM claims, in order to inform 
FDA's ability to evaluate MRTPAs. Brand loyalty is widely regarded as 
an important driver of consumer behavior (Ref. 1). Moreover, 
psychological theory and evidence suggests that the source of 
information can affect how that information is processed--including 
whether or not it is perceived as believable and is persuasive (Ref. 
2). Thus, consumers' brand attitudes are highly relevant to 
understanding how they interpret and respond to claims made by that 
brand. To omit this possible influence from our analyses would, in our 
assessment, limit our ability to fully understand consumer perceptions 
of MRTPs.
    (Comment) One commenter suggested that to assess the variable 
``purchase interest,'' FDA should assign a hypothetical price to the 
product being studied.
    (Response) FDA acknowledges that price plays an important role in 
consumers' purchasing decisions. However, examination of the role of 
price is beyond the scope of the present studies. The experimental 
design of this study will enable comparisons between experimental 
conditions on intentions to use the product; thus, rather than 
evaluating absolute levels of interest, results will examine relative 
levels of interest across experimental conditions. Thus, the measure of 
intentions to use the product will assess consumer interest in the 
product without regard to cost.
    (Comment) One commenter noted that Study 1 proposes to focus on 
conventional cigarettes and asks how FDA proposes to address the issue 
of novel devices/products when considering consumer perceptions?
    (Response) FDA agrees that the current studies are not designed to 
assess interest in novel devices/products. Addressing questions related 
to consumer perceptions of novel devices/products, and reactions to 
claims about those products, is beyond the scope of the current set of 
studies.
    (Comment) One commenter asked for specificity regarding how FDA 
will define susceptibility to tobacco use among the adolescents in 
Study 3.
    (Response) FDA plans to use items from Pierce and colleagues (1996) 
to identify adolescents who are susceptible to using tobacco. These 
items are: (1) Do you think that you will smoke a cigarette soon? (2) 
Do you think you will smoke a cigarette at any time in the next year? 
and (3) If one of your best friends were to offer you a cigarette, 
would you smoke it? Response options are: (1) Definitely yes; (2) 
Probably yes; (3) Probably not; and (4) Definitely not. A respondent 
who selects a response of 1, 2, or 3 to any of these items is 
classified as susceptible.
    (Comment) One commenter sought clarification regarding which health 
warnings will be used (on the study stimuli) alongside the claims and 
how FDA intends to address the balance between MRTP claims and 
warnings.
    (Response) Study stimuli-images of tobacco product packages and 
ads-will display the warning labels currently mandated for each product 
category. The warnings will be rotated (between participants) so that 
all mandated warnings are used. Because the current studies are not 
intended to examine the relationship between warnings and claims 
(including potential interactions between the two), warning label 
assignment will not be an experimental factor in the study design. 
Instead, the warnings will be rotated throughout all conditions to 
control for any differences between them (alone or in combination with 
a particular claim).
    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 per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult Screener...............................          24,000               1          24,000  0.03 (2 minutes).........................             720
Study 1 (Adults).............................           1,800               1           1,800  0.333 (20 minutes).......................             599
Study 2 (Adults).............................             600               1             600  0.333 (20 minutes).......................             200
                                              ------------------------------------------------                                           ---------------
    Total Adult Hours........................  ..............  ..............  ..............  .........................................           1,519
Youth Screener...............................           6,000               1           6,000  0.03 (2 minutes).........................             180
                                              ------------------------------------------------                                           ---------------
Study 3 (Youth)..............................             600               1             600  0.333 (20 minutes).......................             200
                                              ------------------------------------------------                                           ---------------

[[Page 5472]]

 
    Total Youth Hours........................  ..............  ..............  ..............  .........................................             380
                                              ------------------------------------------------                                           ---------------
        Total Hours..........................  ..............  ..............  ..............  .........................................           1,899
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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 research 
that is similar to this proposed study. Approximately 30,000 
respondents will complete a screener to determine eligibility for 
participation in a study, estimated to take approximately 2 minutes 
(0.03 hours), for a total of 900 hours for screening activities. Three 
thousand respondents will complete a full study, estimated to last 20 
minutes (0.333 hours), for a total of 999 hours for completion of both 
adult studies and 1 youth study. The estimated total hour burden of the 
collection of information is 1,899 hours.

References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov.

1. Keller, Kevin L. and Donald R. Lehman, ``Brands and Branding: 
Research Findings and Future Priorities,'' Marketing Science, vol. 
25, no. 6, pp. 740-759, 2006.
2. Eagly, Alice H. and Shelly Chaiken, ``Process Theories of 
Attitude Formation and Change: Reception and Cognitive Responding,'' 
The Psychology of Attitudes, Chapter 6, Harcourt Brace Jovanovich 
College Publishers, 1993.


    Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01788 Filed 2-1-16; 8:45 am]
BILLING CODE 4164-01-P


