[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53485-53487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23060]


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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; 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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the National Panel of Tobacco 
Consumer Studies.

DATES: Submit either electronic or written comments on the collection 
of information by December 24, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 24, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1533 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; National Panel of Tobacco 
Consumer Studies.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available

[[Page 53486]]

for public viewing and posted on https://www.regulations.gov. Submit 
both copies to the Dockets Management Staff. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

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 extension of an existing 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.

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 Studies 
B, C, and D are included in this extension request. The first of these 
panel studies, Study A ``Brands and Purchasing Behavior,'' was included 
in the currently approved information collection request. 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

[[Page 53487]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                   No. of
                                   No. of       responses per   Total annual     Average burden    Total hours 3
     Activity/respondent         respondents    respondent 2     responses 3      per response
 
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Household Screening                    35,885            0.33          11,842  0.13 (8 minutes).           1,539
 Respondent 4.
Panel Member Enrollment                 4,000            0.33           1,320  0.25 (15 minutes)             330
 Survey.
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          30,855            0.33          10,182  0.13 (8 minutes).           1,324
 Screening Respondent.
Panel Replenishment                     4,200            0.33           1,386  0.25 (15 minutes)             347
 Enrollment Survey 5.
Panel Replenishment Baseline   ..............            0.33           1,386  0.25 (15 minutes)             347
 Survey 5.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................           5,961
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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 Includes both mail and field screening.
5 Assumes 1,400 additional panel members will be recruited annually (4,200 total) as part of the panel
  replenishment effort.

    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-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. 
This assumes an estimated 10,285 household screening respondent during 
yearly panel replenishment (30,855 total). Replenishment panel members 
replace original panel members and become part of the 4,000-member 
panel that receives experimental/observational and panel maintenance 
surveys. This extension reflects an increase of 1,527 hours due to an 
additional year of panel replenishment and fielding of Studies B, C, 
and D. The estimated burden assumes 10,285 household screening 
respondents during yearly panel replenishment (30,855 total) and 1,400 
additional panel members recruited annually (4,200 total) as part of 
the panel replenishment effort.

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; they are also 
available electronically at https://www.regulations.gov. 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 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., 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: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23060 Filed 10-22-18; 8:45 am]
 BILLING CODE 4164-01-P