Agency Information Collection Activities; Proposed Collection; Comment Request; National Panel of Tobacco Consumer Studies, 53485-53487 [2018-23060]
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VI. Duration of the OCT 510(k) Pilot
Program
FDA intends to accept requests for
participation in the voluntary OCT
510(k) Pilot Program from the date of
publication in the Federal Register
through one year, or until the time when
a total of nine participants have been
enrolled.
VII. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in FDA regulations and guidance.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120. The
collections of information in ‘‘Requests
for Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756.
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VIII. References
The following references are on
display at the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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. MDUFA IV Commitment Letter, available
at https://www.fda.gov/downloads/
ForIndustry/UserFees/
MedicalDeviceUserFee/UCM535548.pdf.
2. FDA Guidance for Industry and FDA Staff
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
dated September 29, 2017, available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM311176.
3. FDA Guidance for Industry and FDA Staff
‘‘Refuse to Accept Policy for 510(k)s’’
dated January 30, 2018, available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM315014.
4. FDA Guidance for Industry and FDA Staff
‘‘The 510(k) Program: Evaluating
Substantial Equivalence in Premarket
Notifications [510(k)]’’ dated July 28,
2014, available at: https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
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GuidanceDocuments/UCM284443.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23059 Filed 10–22–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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
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53485
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
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53486
Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
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Jkt 247001
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
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individuals participate in tobaccorelated 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, inperson 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 indepth 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
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Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices
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
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:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
responses per
respondent 2
Activity/respondent
No. of
respondents
Total annual
responses 3
Household Screening Respondent 4 .......
Panel Member Enrollment Survey ..........
Panel Member Baseline Survey ..............
Study A ....................................................
Study B ....................................................
Study C ....................................................
Study D ....................................................
Panel
Replenishment
Household
Screening Respondent.
Panel Replenishment Enrollment Survey 5.
Panel Replenishment Baseline Survey 5
35,885
4,000
........................
........................
........................
........................
........................
30,855
0.33
0.33
0.33
0.33
0.33
0.33
0.33
0.33
11,842
1,320
1,320
1,320
1,320
1,320
1,320
10,182
4,200
0.33
........................
Total .................................................
........................
Average burden per response
0.13
0.25
0.25
0.33
0.33
0.33
0.33
0.13
Total hours 3
(8 minutes) .........................
(15 minutes) .......................
(15 minutes) .......................
(20 minutes) .......................
(20 minutes) .......................
(20 minutes) .......................
(20 minutes) .......................
(8 minutes) .........................
1,539
330
330
436
436
436
436
1,324
1,386
0.25 (15 minutes) .......................
347
0.33
1,386
0.25 (15 minutes) .......................
347
........................
........................
....................................................
5,961
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
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2 Assumes
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
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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
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Children’s
Graduate Medical Education Quality
Bonus System (QBS) Initiative
Response Form, OMB No. 0906–xxxx–
New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.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
----------------------------------------------------------------------------------------------------------------
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
