83_FR_53690 83 FR 53485 - Agency Information Collection Activities; Proposed Collection; Comment Request; National Panel of Tobacco Consumer Studies

83 FR 53485 - Agency Information Collection Activities; Proposed Collection; Comment Request; National Panel of Tobacco Consumer Studies

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 205 (October 23, 2018)

Page Range53485-53487
FR Document2018-23060

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.

Federal Register, Volume 83 Issue 205 (Tuesday, October 23, 2018)
[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53485-53487]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23060]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.thefederalregister.org/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
----------------------------------------------------------------------------------------------------------------
                                                   No. of
                                   No. of       responses per   Total annual     Average burden    Total hours 3
     Activity/respondent         respondents    respondent 2     responses 3      per response
 
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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



                                                                            Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices                                         53485

                                               VI. Duration of the OCT 510(k) Pilot                          GuidanceDocuments/UCM284443.                    comment will be made public, you are
                                               Program                                                   Dated: October 17, 2018.                            solely responsible for ensuring that your
                                                  FDA intends to accept requests for                   Leslie Kux,                                           comment does not include any
                                               participation in the voluntary OCT                      Associate Commissioner for Policy.
                                                                                                                                                             confidential information that you or a
                                               510(k) Pilot Program from the date of                                                                         third party may not wish to be posted,
                                                                                                       [FR Doc. 2018–23059 Filed 10–22–18; 8:45 am]
                                               publication in the Federal Register                                                                           such as medical information, your or
                                                                                                       BILLING CODE 4164–01–P
                                               through one year, or until the time when                                                                      anyone else’s Social Security number, or
                                               a total of nine participants have been                                                                        confidential business information, such
                                               enrolled.                                                                                                     as a manufacturing process. Please note
                                                                                                       DEPARTMENT OF HEALTH AND
                                                                                                                                                             that if you include your name, contact
                                               VII. Paperwork Reduction Act of 1995                    HUMAN SERVICES
                                                                                                                                                             information, or other information that
                                                 This notice refers to previously                      Food and Drug Administration                          identifies you in the body of your
                                               approved collections of information                                                                           comments, that information will be
                                                                                                       [Docket No. FDA–2014–N–1533]                          posted on https://www.regulations.gov.
                                               found in FDA regulations and guidance.
                                               These collections of information are                                                                            • If you want to submit a comment
                                                                                                       Agency Information Collection                         with confidential information that you
                                               subject to review by the Office of                      Activities; Proposed Collection;
                                               Management and Budget (OMB) under                                                                             do not wish to be made available to the
                                                                                                       Comment Request; National Panel of                    public, submit the comment as a
                                               the Paperwork Reduction Act of 1995                     Tobacco Consumer Studies
                                               (44 U.S.C. 3501–3520). The collections                                                                        written/paper submission and in the
                                               of information in 21 CFR part 807,                      AGENCY:    Food and Drug Administration,              manner detailed (see ‘‘Written/Paper
                                               subpart E have been approved under                      HHS.                                                  Submissions’’ and ‘‘Instructions’’).
                                               OMB control number 0910–0120. The                       ACTION:   Notice.                                     Written/Paper Submissions
                                               collections of information in ‘‘Requests                                                                         Submit written/paper submissions as
                                               for Feedback on Medical Device                          SUMMARY:    The Food and Drug
                                                                                                       Administration (FDA, Agency, or we) is                follows:
                                               Submissions: The Pre-Submission                                                                                  • Mail/Hand delivery/Courier (for
                                               Program and Meetings with Food and                      announcing an opportunity for public
                                                                                                                                                             written/paper submissions): Dockets
                                               Drug Administration Staff’’ have been                   comment on the proposed collection of
                                                                                                                                                             Management Staff (HFA–305), Food and
                                               approved under OMB control number                       certain information by the Agency.
                                                                                                                                                             Drug Administration, 5630 Fishers
                                               0910–0756.                                              Under the Paperwork Reduction Act of
                                                                                                                                                             Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                       1995 (PRA), Federal Agencies are                         • For written/paper comments
                                               VIII. References                                        required to publish notice in the                     submitted to the Dockets Management
                                                 The following references are on                       Federal Register concerning each                      Staff, FDA will post your comment, as
                                               display at the Dockets Management Staff                 proposed collection of information,                   well as any attachments, except for
                                               (HFA–305), Food and Drug                                including each proposed extension of an               information submitted, marked and
                                               Administration, 5630 Fishers Lane, Rm.                  existing collection of information, and               identified, as confidential, if submitted
                                               1061, Rockville, MD 20852, and are                      to allow 60 days for public comment in                as detailed in ‘‘Instructions.’’
                                               available for viewing by interested                     response to the notice. This notice                      Instructions: All submissions received
                                               persons between 9 a.m. and 4 p.m.,                      solicits comments on the National Panel               must include the Docket No. FDA–
                                               Monday through Friday; they are also                    of Tobacco Consumer Studies.                          2014–N–1533 for ‘‘Agency Information
                                               available electronically at https://                    DATES: Submit either electronic or                    Collection Activities; Proposed
                                               www.regulations.gov. FDA has verified                   written comments on the collection of                 Collection; Comment Request; National
                                               the website addresses, as of the date this              information by December 24, 2018.                     Panel of Tobacco Consumer Studies.’’
                                               document publishes in the Federal                       ADDRESSES: You may submit comments                    Received comments, those filed in a
                                               Register, but websites are subject to                   as follows. Please note that late,                    timely manner (see ADDRESSES), will be
                                               change over time.                                       untimely filed comments will not be                   placed in the docket and, except for
                                               1. MDUFA IV Commitment Letter, available                considered. Electronic comments must                  those submitted as ‘‘Confidential
                                                   at https://www.fda.gov/downloads/                   be submitted on or before December 24,                Submissions,’’ publicly viewable at
                                                   ForIndustry/UserFees/                               2018. The https://www.regulations.gov                 https://www.regulations.gov or at the
                                                   MedicalDeviceUserFee/UCM535548.pdf.
                                               2. FDA Guidance for Industry and FDA Staff
                                                                                                       electronic filing system will accept                  Dockets Management Staff between 9
                                                   ‘‘Requests for Feedback on Medical                  comments until 11:59 p.m. Eastern Time                a.m. and 4 p.m., Monday through
                                                   Device Submissions: The Pre-                        at the end of December 24, 2018.                      Friday.
                                                   Submission Program and Meetings with                Comments received by mail/hand                           • Confidential Submissions—To
                                                   Food and Drug Administration Staff’’                delivery/courier (for written/paper                   submit a comment with confidential
                                                   dated September 29, 2017, available at              submissions) will be considered timely                information that you do not wish to be
                                                   https://www.fda.gov/MedicalDevices/                 if they are postmarked or the delivery                made publicly available, submit your
                                                   DeviceRegulationandGuidance/                                                                              comments only as a written/paper
                                                   GuidanceDocuments/UCM311176.
                                                                                                       service acceptance receipt is on or
                                               3. FDA Guidance for Industry and FDA Staff              before that date.                                     submission. You should submit two
                                                   ‘‘Refuse to Accept Policy for 510(k)s’’                                                                   copies total. One copy will include the
                                                                                                       Electronic Submissions                                information you claim to be confidential
                                                   dated January 30, 2018, available at
                                                   https://www.fda.gov/MedicalDevices/                   Submit electronic comments in the                   with a heading or cover note that states
                                                   DeviceRegulationandGuidance/                        following way:                                        ‘‘THIS DOCUMENT CONTAINS
khammond on DSK30JT082PROD with NOTICES




                                                   GuidanceDocuments/UCM315014.                          • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                               4. FDA Guidance for Industry and FDA Staff              https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                   ‘‘The 510(k) Program: Evaluating                    instructions for submitting comments.                 the claimed confidential information, in
                                                   Substantial Equivalence in Premarket
                                                   Notifications [510(k)]’’ dated July 28,             Comments submitted electronically,                    its consideration of comments. The
                                                   2014, available at: https://www.fda.gov/            including attachments, to https://                    second copy, which will have the
                                                   MedicalDevices/                                     www.regulations.gov will be posted to                 claimed confidential information
                                                   DeviceRegulationandGuidance/                        the docket unchanged. Because your                    redacted/blacked out, will be available


                                          VerDate Sep<11>2014   20:20 Oct 22, 2018   Jkt 247001   PO 00000   Frm 00044   Fmt 4703   Sfmt 4703   E:\FR\FM\23OCN1.SGM   23OCN1


                                               53486                        Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices

                                               for public viewing and posted on                        utility; (2) the accuracy of FDA’s                    individuals participate in tobacco-
                                               https://www.regulations.gov. Submit                     estimate of the burden of the proposed                related studies will result in nationally
                                               both copies to the Dockets Management                   collection of information, including the              representative and unbiased data
                                               Staff. If you do not wish your name and                 validity of the methodology and                       collection on matters of importance for
                                               contact information to be made publicly                 assumptions used; (3) ways to enhance                 FDA.
                                               available, you can provide this                         the quality, utility, and clarity of the                 With this submission, FDA seeks an
                                               information on the cover sheet and not                  information to be collected; and (4)                  extension on the currently approved
                                               in the body of your comments and you                    ways to minimize the burden of the                    information collection request from
                                               must identify this information as                       collection of information on                          OMB for remaining planned panel
                                               ‘‘confidential.’’ Any information marked                respondents, including through the use                maintenance and replenishment
                                               as ‘‘confidential’’ will not be disclosed               of automated collection techniques,                   activities for the National Panel of
                                               except in accordance with 21 CFR 10.20                  when appropriate, and other forms of                  Tobacco Consumer Studies. Data
                                               and other applicable disclosure law. For                information technology.                               collection activities will involve mail
                                               more information about FDA’s posting                    National Panel of Tobacco Consumer                    and in-person household screening, in-
                                               of comments to public dockets, see 80                   Studies                                               person recruitment of tobacco users,
                                               FR 56469, September 18, 2015, or access                                                                       enrollment of selected household
                                               the information at: https://www.gpo.gov/                OMB Control Number 0910–0815—
                                                                                                                                                             members, and administration of a
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                       Extension
                                                                                                                                                             baseline survey, following all required
                                               23389.pdf.                                              I. Background                                         informed consent procedures for panel
                                                  Docket: For access to the docket to                                                                        members. Panel members will be asked
                                               read background documents or the                           FDA’s Center for Tobacco Products
                                                                                                       (CTP) established a national, primarily               to participate in up to eight
                                               electronic and written/paper comments                                                                         experimental and observational studies
                                               received, go to https://                                web-based panel of about 4,000 tobacco
                                                                                                       users. The panel includes individuals                 over the 3-year panel commitment
                                               www.regulations.gov and insert the                                                                            period. The first of these panel studies,
                                                                                                       who can participate in up to eight
                                               docket number, found in brackets in the                                                                       Study A ‘‘Brands and Purchasing
                                                                                                       studies over a 3-year period to assess
                                               heading of this document, into the                                                                            Behavior,’’ was included in the
                                                                                                       consumers’ responses to tobacco
                                               ‘‘Search’’ box and follow the prompts                                                                         currently approved information
                                                                                                       marketing, warning statements, product
                                               and/or go to the Dockets Management                                                                           collection request; approval for Studies
                                                                                                       labels, and other communications about
                                               Staff, 5630 Fishers Lane, Rm. 1061,                                                                           B, C, and D are included in this
                                                                                                       tobacco products. CTP established the
                                               Rockville, MD 20852.                                                                                          extension request. The first of these
                                                                                                       panel of consumers because currently
                                               FOR FURTHER INFORMATION CONTACT:                        existing panels have a number of                      panel studies, Study A ‘‘Brands and
                                               Amber Sanford, Office of Operations,                    significant limitations. First, many                  Purchasing Behavior,’’ was included in
                                               Food and Drug Administration, Three                     existing consumer panels are drawn                    the currently approved information
                                               White Flint North, 10A–12M, 11601                       from convenience samples that limit the               collection request. Study B ‘‘Coupons
                                               Landsdown St., North Bethesda, MD                       generalizability of study findings (Ref.              and Free Samples,’’ Study C ‘‘Consumer
                                               20852, 301–796–8867, PRAStaff@                          1). Second, although at least two                     Perceptions of Product Standards,’’ and
                                               fda.hhs.gov.                                            probability-based panels of consumers                 Study D ‘‘Hypothetical Purchasing of
                                               SUPPLEMENTARY INFORMATION: Under the                    exist in the United States, there is a                Tobacco Products’’ are included in this
                                               PRA (44 U.S.C. 3501–3520), Federal                      concern that responses to the studies                 request for extension. Study B will be an
                                               Agencies must obtain approval from the                  using tobacco users in these panels may               observational study offered to all
                                               Office of Management and Budget                         be biased due to panel conditioning                   panelists that will provide a more in-
                                               (OMB) for each collection of                            effects (Refs. 2 and 3). That is,                     depth examination of tobacco product
                                               information they conduct or sponsor.                    consumers in these panels complete                    promotions, namely free samples and
                                               ‘‘Collection of information’’ is defined                surveys so frequently that their                      coupons, after the ban on distribution of
                                               in 44 U.S.C. 3502(3) and 5 CFR                          responses may not adequately represent                free samples of tobacco products (with
                                               1320.3(c) and includes Agency requests                  the population as a whole. Panel                      the exception of certain smokeless
                                               or requirements that members of the                     conditioning has been associated with                 tobacco exemptions) that went into
                                               public submit reports, keep records, or                 repeated measurement on the same                      effect when FDA finalized the ‘‘Deeming
                                               provide information to a third party.                   topic (Ref. 4), panel tenure (Ref. 2), and            Rule’’ on August 8, 2016 (published
                                               Section 3506(c)(2)(A) of the PRA (44                    frequency of the survey request (Ref. 3).             May 10, 2016 (81 FR 28973)) that
                                               U.S.C. 3506(c)(2)(A)) requires Federal                  This issue is of particular concern for               extended FDA’s regulatory authority to
                                               Agencies to provide a 60-day notice in                  tobacco users who represent a minority                all tobacco products. Study C will be an
                                               the Federal Register concerning each                    of the members in the panels, and so                  experimental study examining how a
                                               proposed collection of information,                     may be more likely to be selected for                 hypothetical tobacco product standard
                                               including each proposed extension of an                 participation in experiments and/or                   may impact consumers’ perceptions,
                                               existing collection of information,                     surveys related to tobacco products.                  attitudes, and tobacco use behavioral
                                               before submitting the collection to OMB                 Third, a key benefit of the web panel                 intentions. Study D will be an
                                               for approval. To comply with this                       approach is that the surveys can include              experimental study using behavioral
                                               requirement, FDA is publishing notice                   multimedia, such as images of tobacco                 economic methods that seeks to
                                               of the proposed collection of                           product packages, tobacco advertising,                understand how the availability or lack
                                                                                                       new and existing warning statements                   of availability of menthol cigarettes
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                                               information set forth in this document.
                                                  With respect to the following                        and labels, and potential reduced harm                potentially impacts adult cigarette
                                               collection of information, FDA invites                  claims in the form of labels and print                smokers’ product purchasing choices.
                                               comments on these topics: (1) Whether                   advertisements. Establishing a primarily              The current request also seeks approval
                                               the proposed collection of information                  web-based panel of tobacco users                      to update the estimated burden for an
                                               is necessary for the proper performance                 through in-person probability-based                   additional year of panel replenishment.
                                               of FDA’s functions, including whether                   recruitment of eligible adults and                    The overall purpose of the data
                                               the information will have practical                     limiting the number of times                          collection is to collect information from


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                                                                                    Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices                                                                                                53487

                                               a national sample of tobacco users to                                     noninstitutionalized group quarters in                                      possible, provide insight into tobacco
                                               provide data that may be used to                                          the 50 states and the District of                                           users more generally. Replenishment
                                               develop and support FDA’s policies                                        Columbia. A stratified four-stage sample                                    will be conducted to maintain the panel
                                               related to tobacco products, including                                    design was used, with a goal of                                             with a constant number of members
                                               their labels, labeling, and advertising.                                  recruiting 4,000 adult tobacco users into                                   following existing panel recruitment
                                                 The target population for the panel is                                  the sample panel. The sample is                                             and enrollment methods.
                                               tobacco users aged 18 years and older in                                  designed to allow in-depth analysis of                                        FDA estimates the burden of this
                                               housing units and in                                                      subgroups of interest and to the extent                                     collection of information as follows:

                                                                                                               TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                               No. of
                                                                                                                    No. of                                             Total annual
                                                               Activity/respondent                                                         responses per                                          Average burden per response                           Total hours 3
                                                                                                                 respondents                                           responses 3
                                                                                                                                            respondent 2

                                               Household Screening Respondent 4 .......                                      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                          30,855                        0.33                    10,182        0.13   (8 minutes) .........................                   1,324
                                                 Screening Respondent.
                                               Panel Replenishment Enrollment Sur-                                            4,200                         0.33                    1,386        0.25 (15 minutes) .......................                        347
                                                 vey 5.
                                               Panel Replenishment Baseline Survey 5                            ........................                    0.33                     1,386       0.25 (15 minutes) .......................                        347

                                                     Total .................................................    ........................   ........................   ........................   ....................................................           5,961
                                                  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                                      additional panel members recruited                                                 the American Association for Public
                                               timed-readings of each instrument,                                        annually (4,200 total) as part of the                                              Opinion Research 64th Annual
                                               including the mail and field screeners,                                   panel replenishment effort.                                                        Conference.
                                               enrollment survey, baseline survey, and                                                                                                                 Dated: October 17, 2018.
                                                                                                                         II. References
                                               Study A–D questionnaires. Of the total                                                                                                                Leslie Kux,
                                               screening respondents, we expect 25                                          The following references are on                                          Associate Commissioner for Policy.
                                               percent will respond only in the mail                                     display at the Dockets Management Staff
                                                                                                                                                                                                     [FR Doc. 2018–23060 Filed 10–22–18; 8:45 am]
                                               screening (household deemed                                               (see ADDRESSES) and are available for
                                                                                                                                                                                                     BILLING CODE 4164–01–P
                                               ineligible), 65 percent will respond only                                 viewing by interested persons between
                                               in the field screening (mail screening                                    9 a.m. and 4 p.m., Monday through
                                               nonrespondents), and the remaining 10                                     Friday; they are also available                                             DEPARTMENT OF HEALTH AND
                                               percent will respond in both the mail                                     electronically at https://                                                  HUMAN SERVICES
                                               screening and the field screening. The                                    www.regulations.gov. FDA has verified
                                               latter includes eligible households from                                  the website addresses, as of the date this                                  Health Resources and Services
                                               the mail screening that are subsequently                                  document publishes in the Federal                                           Administration
                                               field-screened to sample the panel                                        Register, but websites are subject to
                                               member, and the 10 percent quality                                        change over time.                                                           Agency Information Collection
                                               control sample of households whose                                        1. Baker, R., Blumberg, S., Brick, M., et al.,                              Activities: Proposed Collection: Public
                                               mail screening ineligibility is verified                                      2010, ‘‘American Association for Public                                 Comment Request; Information
                                               through in-person screening. This                                             Opinion Research Report on Online                                       Collection Request Title: Children’s
                                               assumes an estimated 10,285 household                                         Panels.’’ Public Opinion Quarterly, 74(4),                              Graduate Medical Education Quality
                                                                                                                             pp. 711–781.                                                            Bonus System (QBS) Initiative
                                               screening respondent during yearly                                        2. Coen, T., Lorch, J. and Piekarski, L., 2005,
                                               panel replenishment (30,855 total).                                                                                                                   Response Form, OMB No. 0906–xxxx–
                                                                                                                             ‘‘The Effects of Survey Frequency on                                    New
                                               Replenishment panel members replace                                           Panelists’ Responses. Worldwide Panel
                                               original panel members and become                                             Research: Developments and Progress,’’                                  AGENCY: Health Resources and Services
                                               part of the 4,000-member panel that                                           Amsterdam, European Society for                                         Administration (HRSA), Department of
                                               receives experimental/observational and                                       Opinion and Marketing Research.                                         Health and Human Services (HHS).
                                               panel maintenance surveys. This                                           3. Nancarrow, C. and Catwright, T., 2007,
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                                                                                                                             ‘‘Online Access Panels and Tracking                                     ACTION: Notice.
                                               extension reflects an increase of 1,527
                                               hours due to an additional year of panel                                      Research, The Conditioning Issue,’’
                                                                                                                                                                                                     SUMMARY:   In compliance with the
                                                                                                                             International Journal of Market
                                               replenishment and fielding of Studies B,                                      Research, 49(5), pp. 435–447.                                           requirement for opportunity for public
                                               C, and D. The estimated burden assumes                                    4. Kruse, Y., Callegaro, M., Dennis, J. M., et                              comment on proposed data collection
                                               10,285 household screening                                                    al., 2009, Panel Conditioning and                                       projects of the Paperwork Reduction Act
                                               respondents during yearly panel                                               Attrition in the AP-Yahoo! News                                         of 1995, HRSA announces plans to
                                               replenishment (30,855 total) and 1,400                                        Election Panel Study, Paper presented at                                submit an Information Collection


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Document Created: 2018-10-23 04:14:31
Document Modified: 2018-10-23 04:14:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by December 24, 2018.
ContactAmber 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]
FR Citation83 FR 53485 

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