
[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68888-68890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on Experimental Studies on Consumer 
Perceptions of Modified Risk Tobacco Products (MRTPs).

[[Page 68889]]


DATES: Submit either electronic or written comments on the collection 
of information by January 20, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 (i.e., product adoption), 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 measures for 
gathering such information from consumers.
    The impact of different claims pertaining to modified risk or 
exposure on understanding, perceptions, and potential product adoption 
(i.e., intention to try) 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: Comprehension of the modified risk 
information in the claims, perceived benefits of the product, 
perceptions of harm and risk, misbeliefs about the product, quit 
intentions, and willingness to try or purchase the product.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 68890]]



                                   Table 1--Estimated Annual Reporting Burden
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Adult Screener................          24,000               1          24,000  0.03 (2 minutes)             720
Study 1 (Adults)..............           1,800               1           1,800  0.333 (20                    599
                                                                                 minutes).
Study 2 (Adults)..............             600               1             600  0.333 (20                    200
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total adult hours.........  ..............  ..............  ..............  ................           1,519
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Youth Screener................           6,000               1           6,000  0.03 (2 minutes)             180
Study 3 (Youth)...............             600               1             600  0.333 (20                    200
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total youth hours.........  ..............  ..............  ..............  ................             380
                               =================================================================================
        Total Hours...........  ..............  ..............  ..............  ................           1,899
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    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 one youth study. The estimated total hour burden of 
the collection of information is 1,899 hours.

    Dated: November 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27283 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P


