[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22862-22864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10359]


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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; National Panel of 
Tobacco Consumer Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 June 
19, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received,

[[Page 22863]]

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 0910-0815. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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.

National Panel of Tobacco Consumer Studies

OMB Control Number 0910-0815--Extension

I. Background

    FDA's Center for Tobacco Products (CTP) established a national, 
primarily web-based panel of about 4,000 tobacco users. The panel 
includes individuals who can participate in up to eight studies over a 
3-year period to assess consumers' responses to tobacco marketing, 
warning statements, product labels, and other communications about 
tobacco products. CTP established the panel of consumers because 
currently existing panels have a number of significant limitations. 
First, many 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 an extension on the currently 
approved information collection request from OMB for remaining planned 
panel maintenance and replenishment activities for the National Panel 
of Tobacco Consumer Studies. Data collection activities will involve 
mail and in-person household screening, in-person recruitment of 
tobacco users, enrollment of selected household members, and 
administration of a baseline survey, following all required informed 
consent procedures for panel members. 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 panel studies, 
study A ``Brands and Purchasing Behavior,'' was included in the 
currently approved information collection request. Approval for study B 
``Coupons and Free Samples,'' study C ``Consumer Perceptions of Product 
Standards,'' and study D ``Hypothetical Purchasing of Tobacco 
Products'' are included in this request for extension. Study B will be 
an observational study offered to all panelists that will provide a 
more in-depth examination of tobacco product promotions, namely free 
samples and coupons, after the ban on distribution of free samples of 
tobacco products (with the exception of certain smokeless tobacco 
exemptions) that went into effect when FDA finalized the ``Deeming 
Rule'' on August 8, 2016 (published May 10, 2016 (81 FR 28973)), that 
extended FDA's regulatory authority to all tobacco products. Study C 
will be an experimental study examining how a hypothetical tobacco 
product standard may impact consumers' perceptions, attitudes, and 
tobacco use behavioral intentions. Study D will be an experimental 
study using behavioral economic methods that seeks to understand how 
the availability or lack of availability of menthol cigarettes 
potentially impacts adult cigarette smokers' product purchasing 
choices. The current request also seeks approval to update the 
estimated burden for an additional year of panel replenishment. The 
overall purpose of the data collection is to collect information from a 
national 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.
    The target population for the panel is tobacco users aged 18 years 
and older in housing units and in noninstitutionalized group quarters 
in the 50 states and the District of Columbia. A stratified four-stage 
sample design was used, with a goal of recruiting 4,000 adult tobacco 
users into the sample panel. The sample is designed to allow in-depth 
analysis of subgroups of interest and to the extent possible, provide 
insight into tobacco users more generally. Replenishment will be 
conducted to maintain the panel with a constant number of members 
following existing panel recruitment and enrollment methods.
    In the Federal Register of October 23, 2018 (83 FR 53485), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received 10 comments; however, only 1 
was PRA related.
    (Comment) One commenter supports FDA's establishment of a tobacco 
user panel, adding that high-quality research is critical to successful 
implementation of many provisions of tobacco policy. The commenter 
further stated that the research panel can provide FDA with critical 
information on how adult tobacco users respond to tobacco marketing, 
product labels, warning statements, and other communications about 
tobacco products. The commenter also noted the ability to have its own 
panel of tobacco users will allow FDA to gather more reliable 
information in a more efficient manner.
    (Response) FDA agrees with this comment and believes the panel will 
be a valuable tool for conducting new observational and experimental 
studies.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 22864]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
             Activity/respondent                 Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents   respondent \2\   responses \3\                                                    \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Household Screening Respondent..............          35,885            0.33          11,842  0.13 (8 minutes)..........................           1,539
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
Study A.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study B.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study C.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study D.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Panel Replenishment Household Screening               33,355            0.33          11,007  0.13 (8 minutes)..........................           1,431
 Respondent \4\.
Panel Replenishment Enrollment Survey \4\...           4,600            0.33           1,518  0.25 (15 minutes).........................             380
Panel Replenishment Baseline Survey \4\.....                            0.33           1,518  0.25 (15 minutes).........................             380
                                             ------------------------------------------------                                            ---------------
    Total...................................  ..............  ..............  ..............  ..........................................           6,134
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Assumes respondents will participate once over a 3-year period, or 0.33 responses annually.
\3\ Amounts are rounded to the nearest whole number.
\4\ Assumes an estimated 10,285 mail and field household screening respondents during yearly panel replenishment and 1,400 additional panel members will
  be recruited annually as part of the panel replenishment effort, as well as an additional 2,500 household screening respondents during replenishment
  and an additional 400 panel replenishment enrollment and baseline survey respondents should annual attrition rates be higher than expected.

    FDA's burden estimate is based on timed readings of each 
instrument, including the mail and field screeners, enrollment survey, 
baseline survey, and study A through D questionnaires. Of the total 
screening respondents, we expect 25 percent will respond only in the 
mail screening (household deemed ineligible), 65 percent will respond 
only in the field screening (mail screening nonrespondents), and the 
remaining 10 percent will respond in both the mail screening and the 
field screening. The latter includes eligible households from the mail 
screening that are subsequently field screened to sample the panel 
member, and the 10 percent quality control sample of households whose 
mail screening ineligibility is verified through in-person screening. 
The estimated burden published in the 60-day notice assumed an 
estimated 10,285 household screening respondent during yearly panel 
replenishment (30,855 total) and 1,400 additional panel members 
recruited annually (4,200 total). In this notice, we included 2,500 
additional household screening respondents during replenishment, and an 
additional 400 panel replenishment enrollment and baseline survey 
respondents as part of the panel replenishment effort (should annual 
attrition rates be higher than expected). The new total is 33,355 
household screening respondents and a total of 4,600 panel members 
recruited. Replenishment panel members replace original panel members 
and become part of the 4,000-member panel that receives experimental/
observational and panel maintenance surveys. Overall, this extension 
reflects an increase of 1,700 hours due to an additional year of panel 
replenishment and fielding of studies B, C, and D.

II. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not 
available electronically at https://www.regulations.gov as these 
references are copyright protected. Some may be available at the 
website address, if listed. FDA has verified the website addresses, as 
of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

1. Baker, R., Blumberg, S., Brick, M., et al., 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 Cartwright, 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., et al., 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: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10359 Filed 5-17-19; 8:45 am]
BILLING CODE 4164-01-P


