[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32963-32966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 July 
10, 2015.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Establishment of a Tobacco User Panel''. 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, [email protected].

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.

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

[[Page 32964]]

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 (Ref. 1). 
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 (Refs. 2 and 3). 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 (Ref. 4), 
panel tenure (Ref. 2), and frequency of the survey request (Ref. 3). 
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, 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 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 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:
    In the Federal Register of October 16, 2014 (79 FR 62160), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments, however only 
two were PRA related. Within those submissions, FDA received multiple 
comments which the Agency has addressed.
    (Comment) One comment asked FDA for the opportunity to review the 
data collection plans and instruments including the sample design, data 
collection methodology, and panel performance evaluation plan.
    (Response) All the instruments and background documents including 
our plan for evaluating panel performance have been uploaded to the 
docket for easy access. The documents included are the data collection 
plans and methodology (Supporting Statement Part A), copies of the 
survey instruments used to screen and recruit panel members, as well as 
the first experimental or observation study (Study 1), and the proposed 
sample design (Supporting Statement Part B).
    (Comment) One comment asked FDA to provide additional details about 
the proposed sample design and FDA's approach to issues such as 
nonresponse of subjects and conditioning effects.
    (Response) The proposed sample design is described in detail in 
Supporting Statement, Part B. Briefly, we propose a multi-stage area 
sample based on an address-based sampling frame. The probabilities 
(single, joint, and the overall selection probability) will be 
measurable at each stage.
    The issues of non-response and conditioning effects are real 
challenges but they should be considered separately from the sample 
design. These are issues faced in the field once the sample has been 
selected and contacted. We have proposed several strategies for 
reducing non-response in the recruitment of panel members, the primary 
one being in-person recruitment which we believe will lead to 
significantly larger recruitment rates than we would achieve if we 
contacted sample members via mail, telephone, or web. We will describe 
our plans to reduce the non-response bias in future individual studies 
as part of the OMB submissions for these studies. We consider the issue 
of conditioning effects as part of our overall panel management plan, 
which is described in Supporting Statement, Part A.
    (Comment) One comment stated that FDA suggests that not every 
panelist will be eligible to participate in every study to minimize the 
potential for ``conditioning'' effects. However, this approach to 
participation is inconsistent with the requirement that every 
individual in the population has a non-zero probability of being in the 
sample. FDA will need to make trade-offs to balance these two 
interests. FDA could consider drawing data from similar respondents, as 
long as FDA knows that there are no important hidden differences 
between the respondents that may affect their responses.
    (Response) We will draw the original sample with known, non-zero, 
and, to the extent possible, equal probabilities. The same will apply 
to any additional samples drawn for the panel to replace attrition. 
Furthermore, any subsample drawn from the panel for specific studies 
will also result in known probabilities of selection. We will derive a 
strategy of spreading the survey-taking load over all panel members to 
avoid excessive burden on any single member or group of members. We 
will implement this strategy by randomly selecting each subsample, but 
at the same time keeping track of each member's survey-taking activity. 
As the number and frequency of survey-taking for a given member 
increases, their probability of selection will decrease, a strategy 
that we will implement using probability proportion to size sampling. 
This strategy will lead to known and measurable selection probabilities 
for each specific subsample.
    (Comment) One comment stated FDA should consider, whether in some 
instances, collecting fresh data from

[[Page 32965]]

new samples of tobacco product users over time may provide better 
results.
    (Response) Our proposed approach includes replenishment of the 
sample over time to address attrition from the panel. As such, the 
panel will include tobacco users with varying tenure lengths on the 
panel. We will be in a position to restrict a specific study subsample 
to the more recent panel members, if desired, and more generally, the 
panel will allow FDA to specify the composition of the sample with 
respect to tenure.
    (Comment) One comment said FDA should consider inclusion of non-
tobacco users or users of specific tobacco categories (e.g., e-
cigarette users, moist smokeless tobacco users) in the sample to 
support comparative analyses between users and non-users or subgroup 
analyses.
    (Response) FDA considered including non-tobacco users early in the 
planning process. However, the planned experimental and observational 
studies will examine issues specific to the tobacco-using population, 
especially those with lower socio-economic status. This includes the 
underlying demographics of users as well as their knowledge, attitudes, 
practices, behaviors, and reactions to various tobacco-related stimuli. 
Other existing data sources, including survey panels, support research 
with non-users. Moreover, limiting the panel to users reduces the 
overall public burden. Once the panel is firmly established, we may 
consider its expansion.
    (Comment) One comment stated FDA should also consider how well the 
sample of 4,000 adult tobacco users will support the planned 
investigations.
    (Response) The sample size of 4,000 was chosen after a careful 
review of, on the one hand, power and subclass analyses requirements, 
and on the other hand, the budgetary implications. After our careful 
review, we concluded that a sample size of 4,000 tobacco users 
represents a good balance, at least for the first iteration of the 
panel.
    We should also mention that the young adult population (aged 18-25) 
and the low-income population (combined household income less than 
$30,000) will be oversampled allowing for more in-depth study of these 
two groups of tobacco users. We also include a screening feature that 
will result in oversampling of the smokeless tobacco users.
    (Comment) One commenter stated that FDA suggests that the approach 
includes a ``3-year panel commitment period''. FDA should consider 
developing and sharing its plan for keeping or removing panelists. For 
example, will FDA keep or remove a panelist if he/she decides to quit 
using tobacco products? Also, how will FDA monitor whether incentives 
are influencing a panelist's responses or behavior? These are only a 
few examples of issues that could arise; therefore, a thoughtful panel 
management plan is needed.
    (Response) We agree that a detailed and well-designed panel 
management plan is needed to make the panel successful. The literature 
on panel maintenance is growing, but there is still much to be learned 
about optimal strategies for maintaining a strong and productive panel. 
Supporting Statement, Part A outlines our plans for panel management, 
including retention and nonresponse follow-up strategies, planned 
incentive experiments, monitoring of panel conditioning, and evaluation 
of the effects of various panel maintenance strategies on substantive 
responses.
    Continual monitoring is planned to study these and other important 
aspects of the panel's health. We will also keep a close eye on 
individual panelists, their participation patterns, and their non-
response patterns to identify potential problems requiring 
intervention. FDA considered removing panel members who report they 
have stopped using tobacco products. Because of recidivism rates, it 
was decided to retain all enrolled panel members regardless of changes 
in their tobacco use patterns. Subsampling of panelists may be 
implemented for specific experimental or observational studies that are 
intended solely for current users of one or more specific tobacco 
products.
    (Comment) One commenter stated FDA should consider establishing 
mechanisms to evaluate the performance of the panel as well as the data 
derived from it. For example, data from the panel on measures such as 
current or past 30-day cigarette smoking might be compared against the 
most recent data from national surveys and other published reports.
    (Response) We agree that benchmarking the panel sample 
characteristics--demographic, socioeconomic, and tobacco use--against 
other national data sources is extremely important. We will 
continuously check that our panel matches known underlying population 
characteristics. However, we will also monitor how the panel compares 
with the target population with respect to known patterns of behavior 
surrounding tobacco use. Differences will not necessarily suggest 
problems with the panel but they will stimulate further investigation 
and explanation.
    (Comment) One commenter asked FDA to provide copies of the survey 
instruments for public comment.
    (Response) Copies of the survey instruments used to screen and 
recruit panel members, as well as the first experimental or observation 
study (Study 1), are uploaded to the docket.
    (Comment) One commenter strongly supports FDA's proposed collection 
of information. The commenter stated that this panel is of great 
utility and the proposed probability-based panel will serve as a 
flexible tool, giving FDA the opportunity to conduct diverse studies.
    (Response) FDA agrees with this comment and believes the panel will 
be a valuable tool for conducting new experimental studies.
    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 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.................  ..............            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.....           4,000             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

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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 collection burden 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.

References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. Baker, R., Blumberg, S., Brick, M., Couper, M., Courtright, M., 
Dennis, J. M., Dillman, D., Frankel, M., Garland, P., Groves, R., 
Kennedy, C., Krosnick, J. and Lavrakas, P., 2010, American 
Association for Public Opinion Research Report on Online Panels. 
Public Opinion Quarterly, 74 (4), pp. 711-781.
2. Coen, T., Lorch, J. and Piekarski, L., 2005, The Effects of 
Survey Frequency on Panelists' Responses, Worldwide Panel Research: 
Developments and Progress, Amsterdam, European Society for Opinion 
and Marketing Research.
3. Nancarrow, C. and Catwright, T., 2007, Online Access Panels and 
Tracking Research, The Conditioning Issue, International Journal of 
Market Research, 49(5), pp. 435-447.
4. Kruse, Y., Callegaro, M., Dennis, J. M., DiSogra, C., Subias, S., 
Lawrence, M., and Tompson, T., 2009, Panel Conditioning and 
Attrition in the AP-Yahoo! News Election Panel Study, Paper 
presented at the American Association for Public Opinion Research 
64th Annual Conference.


    Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14125 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P