[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62160-62161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1533]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Establishment of a Tobacco User Panel

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 the establishment of a probability-based 
panel of tobacco users.

DATES: Submit either electronic or written comments on the collection 
of information by December 15, 2014.

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, <a href="/cdn-cgi/l/email-protection#540406150720353232143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="07575546547366616147616366296f6f7429606871">[email protected]</span></a>.

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, including 
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.

Establishment of a Tobacco User Panel--(OMB Control Number 0910-NEW)

    The Food and Drug Administration's Center for Tobacco Products 
(CTP) proposes to establish a high quality, probability-based, 
primarily Web-based panel of 4,000 tobacco users. The panel will 
include individuals who can participate in up to 8 studies over a 3-
year period to assess consumers' responses to tobacco marketing, 
warning statements, product labels, and other communications about 
tobacco products. CTP proposed the establishment of the panel of 
consumers because currently existing Web-based panels have a number of 
significant limitations. First, most existing consumer panels are drawn 
from convenience samples that limit the generalizability of study 
findings (Baker et al., 2010). Second, although at least two 
probability-based panels of consumers exist in the United States, there 
is a concern that responses to the studies using tobacco users in these 
panels may be biased due to panel conditioning effects (e.g., Coen, 
Lorch and Piekarski, 2005; Nancarrow and Catwright, 2007). That is, 
consumers in these panels complete surveys so frequently that their 
responses may not adequately represent the population as a whole. Panel 
conditioning has been associated with repeated measurement on the same 
topic (e.g., Kruse et al., 2009), panel tenure (e.g., Coen, Lorch and 
Piekarski, 2005), and frequency of the survey request (e.g., Nancarrow 
and Catwright, 2007). This issue is of particular concern for tobacco 
users who represent a minority of the members in the panels, and so may 
be more likely to be selected for participation in experiments and/or 
surveys related to tobacco products. Third, a key benefit of the Web 
panel approach is that the surveys can include multimedia, such as 
images of tobacco product packages, tobacco advertising, new and 
existing warning statements and labels, and potential reduced harm 
claims in the form of labels and print advertisements. Establishing a 
primarily Web-based panel of tobacco users through in-person 
probability-based recruitment of eligible adults and limiting the 
number of times individuals participate in tobacco-related studies will 
result in nationally representative and unbiased data collection on 
matters of importance for FDA.
    With this submission, the FDA seeks approval from OMB to establish 
the Tobacco User Panel, a nationally representative, primarily web-
based panel of 4,000 current tobacco users. Data collection activities 
will involve pilot testing of panel recruitment and management 
procedures and systems, mail and in-person household screening, in-
person recruitment of tobacco users, enrollment of selected household 
members, administration of a baseline survey, and panel maintenance 
surveys, following all required informed consent procedures for panel 
members. Once the panel is established, panel members will be asked to 
participate in up to eight experimental and observational studies over 
the 3-year panel commitment period. The first of these studies (Study 
1) is included in this information collection request; approval for the 
remainder of the studies will be appear in future requests. The current 
request also seeks approval to conduct up to two rounds of cognitive 
testing of new survey items and up to two focus groups to further 
refine study protocols, as needed. With this clearance, study 
investigators will be able to use the OMB approved data collection 
methods where appropriate to plan and implement the national panel.
    The overall purpose of the proposed data collection is to collect 
information from a representative sample of tobacco users to provide 
data that may be used

[[Page 62161]]

to develop and support FDA's policies related to tobacco products, 
including their labels, labeling, and advertising. Data will be 
collected from the panel primarily through the use of randomized 
experimental designs, however, there may be data collected through the 
use of other methods, such as surveys, interviews, or online group 
discussions. Given the limitations on the existing Web-based panels, it 
is important to develop a new panel of tobacco users that balances the 
need to conduct experiments while limiting the number of tobacco-
related studies per year so as to not bias study results.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
        Activity or type of respondent            Number of     responses per   Total annual         Average  burden per  response          Total hours
                                                 respondents     respondent       responses
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Household Screening Respondent...............          29,385            0.33           9,697  0.16 (10 minutes)........................           1,552
Panel Member Enrollment Survey...............           4,000            0.33           1,320  0.25 (15 minutes)........................             330
Panel Member Baseline Survey.................  ..............            0.33           1,320  0.25 (15 minutes)........................             330
Panel Maintenance/Bi-annual Update Surveys...  ..............             3.0          12,000  0.08 (5 minutes).........................             960
Experimental/Observational Studies *.........  ..............             2.7          10,800  0.33 (20 minutes)........................           3,564
Panel Replenishment Screening Respondent.....          10,285            0.50           5,143  0.16 (10 minutes)........................             823
Panel Replenishment Enrollment Survey **.....           2,800            0.33             924  0.25 (15 minutes)........................             231
Panel Replenishment Baseline Survey **.......           2,800            0.33             924  0.25 (15 minutes)........................             231
Cognitive Interview Subjects.................              20            0.33               7  1.0......................................               7
Focus Group Subjects.........................              20            0.33               7  1.5......................................              10
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................          49,310  ..............  ..............  .........................................           8,038
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\1\ There are no capital or operating and maintenance costs or associated with this collection of information.
\*\ Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the time of
  each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task orders but are
  included in this table to present an overall estimate of the burden for each participating panel member.
\**\ Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort.

    The burden above was estimated using data from timed-readings of 
each instrument, including the mail and field screeners, enrollment 
survey, baseline survey, panel maintenance questionnaires, and Study 1 
questionnaire.

    Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24538 Filed 10-15-14; 8:45 am]
BILLING CODE 4164-01-P


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