Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Panel of Tobacco Consumer Studies, 22862-22864 [2019-10359]
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Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
2016, including experimental products
and developmental products intended
for introduction into the market for
consumer use. For cigarettes, cigarette
tobacco, RYO, and smokeless tobacco,
FDA understands ‘‘current or future
tobacco products’’ to refer to products
commercially distributed on or after
June 23, 2009, or products in any stage
of research or development at any time
after June 23, 2009, including
experimental products and
developmental products intended for
introduction into the market for
consumer use.
All manufacturers and importers of
tobacco products are now subject to the
FD&C Act and are required to comply
with section 904(a)(4), which requires
immediate and ongoing submission of
health documents developed after June
22, 2009 (the date of enactment of the
Tobacco Control Act). However, FDA
generally does not intend to enforce the
requirement at this time with respect to
all such health documents relating to
the deemed tobacco products, so long as
a specified set of documents, those
developed between June 23, 2009, and
December 31, 2009, were submitted by
February 8, 2017, or in the case of smallscale deemed tobacco product
manufacturers (small-scale
manufacturers), by November 8, 2017
(81 FR 28974 at 29008–09).
Additionally, FDA extended the
compliance deadlines by an additional
6 months to May 8, 2018, for small-scale
manufacturers in the areas impacted by
recent natural disasters. Thereafter,
FDA’s compliance plan requests
deemed manufacturers provide tobacco
health document submissions from the
specified period at least 90 days prior to
the delivery for introduction into
interstate commerce of tobacco products
to which the health documents relate.
Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless
tobacco products must provide all
health documents developed between
June 23, 2009, and December 31, 2009,
at least 90 days prior to the delivery for
introduction of tobacco products into
interstate commerce.
In the Federal Register of August 23,
2018 (83 FR 42664), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that was PRA related.
(Comment) FDA received one
comment requesting that FDA exercise
enforcement discretion by suspending
the collection and utilizing the Agency’s
other authorities to inform regulatory
decisions due to the associated burden
of manufacturers to retain documents
for future submission to FDA.
Additionally, the commenter requests
FDA to narrow the scope of the
collection by defining key terms.
(Response) At this time, FDA does not
intend to suspend the collection as
respondents have the option to submit
documents directly to FDA independent
of the compliance policy. Additionally,
at this time, FDA believes narrowly
defining health effects could potentially
exclude relevant scientific information
from being retained by industry and
subsequently submitted as part of future
health document submissions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Tobacco Health Document Submissions and Form FDA
3743 ..................................................................................
10
3.2
32
50
1,600
khammond on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of documents received
each year since the original collection
period has fallen to less than 5 percent
of what was received in the original
collection period. FDA expects this is
because documents created within the
specified period should have already
been submitted. The Agency bases this
estimate on the total number of tobacco
firms it is aware of and its experience
with document production and the
number of additional documents that
have been reported each year since the
original estimate of the reporting
burden.
FDA estimates that a tobacco health
document submission for cigars, pipe
and waterpipe tobacco, electronic
nicotine delivery systems (ENDS), and
other tobacco products as required by
section 904(a)(4) of the FD&C Act, will
take approximately 50 hours per
submission based on the existing
collection that applies to tobacco
products currently subject to the FD&C
Act and FDA experience. To derive the
number of respondents for this
provision, FDA assumes that very few
VerDate Sep<11>2014
16:41 May 17, 2019
Jkt 247001
manufacturers or importers of deemed
tobacco products, or agents thereof,
would have health documents to
submit. In addition to the existing 4
respondents, the Agency estimates that
approximately 6 submissions (2 for cigar
manufacturers, 1 for pipe and waterpipe
tobacco manufacturers, 1 for other
tobacco product manufacturers, 1 for
tobacco importers, and 1 for importers
of ENDS that are considered
manufacturers) will be submitted on an
annual basis for a total of 10
respondents. FDA estimates the total
annual reporting burden to be 1,600
hours.
Based on a review of the information
collection of our current OMB approval,
we have made no adjustments to our
burden estimate.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10402 Filed 5–17–19; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1533]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; National Panel of
Tobacco Consumer Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 19,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
ADDRESSES:
Sfmt 4703
E:\FR\FM\20MYN1.SGM
20MYN1
Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0815. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
National Panel of Tobacco Consumer
Studies
OMB Control Number 0910–0815—
Extension
khammond on DSKBBV9HB2PROD with NOTICES
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
VerDate Sep<11>2014
16:41 May 17, 2019
Jkt 247001
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 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 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
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Frm 00058
Fmt 4703
Sfmt 4703
22863
tobacco use behavioral intentions. Study
D will be an experimental study using
behavioral economic methods that seeks
to understand how the availability or
lack of availability of menthol cigarettes
potentially impacts adult cigarette
smokers’ product purchasing choices.
The current request also seeks approval
to update the estimated burden for an
additional year of panel replenishment.
The overall purpose of the data
collection is to collect information from
a national sample of tobacco users to
provide data that may be used to
develop and support FDA’s policies
related to tobacco products, including
their labels, labeling, and advertising.
The target population for the panel is
tobacco users aged 18 years and older in
housing units and in
noninstitutionalized group quarters in
the 50 states and the District of
Columbia. A stratified four-stage sample
design was used, with a goal of
recruiting 4,000 adult tobacco users into
the sample panel. The sample is
designed to allow in-depth analysis of
subgroups of interest and to the extent
possible, provide insight into tobacco
users more generally. Replenishment
will be conducted to maintain the panel
with a constant number of members
following existing panel recruitment
and enrollment methods.
In the Federal Register of October 23,
2018 (83 FR 53485), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received 10
comments; however, only 1 was PRA
related.
(Comment) One commenter supports
FDA’s establishment of a tobacco user
panel, adding that high-quality research
is critical to successful implementation
of many provisions of tobacco policy.
The commenter further stated that the
research panel can provide FDA with
critical information on how adult
tobacco users respond to tobacco
marketing, product labels, warning
statements, and other communications
about tobacco products. The commenter
also noted the ability to have its own
panel of tobacco users will allow FDA
to gather more reliable information in a
more efficient manner.
(Response) FDA agrees with this
comment and believes the panel will be
a valuable tool for conducting new
observational and experimental studies.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20MYN1.SGM
20MYN1
22864
Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/respondent
Household Screening Respondent ..........................
Panel Member Enrollment Survey ...........................
Panel Member Baseline Survey ..............................
Study A ....................................................................
Study B ....................................................................
Study C ....................................................................
Study D ....................................................................
Panel Replenishment Household Screening Respondent 4.
Panel Replenishment Enrollment Survey 4 ..............
Panel Replenishment Baseline Survey 4 .................
Total ..................................................................
Number of
responses per
respondent 2
35,885
4,000
Total annual
responses 3
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
11,007
4,600
0.33
0.33
........................
........................
33,355
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
1,431
1,518
1,518
0.25 (15 minutes) ......
0.25 (15 minutes) ......
380
380
........................
....................................
6,134
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 Assumes an estimated 10,285 mail and field household screening respondents during yearly panel replenishment and 1,400 additional panel
members will be recruited annually as part of the panel replenishment effort, as well as an additional 2,500 household screening respondents
during replenishment and an additional 400 panel replenishment enrollment and baseline survey respondents should annual attrition rates be
higher than expected.
khammond on DSKBBV9HB2PROD with NOTICES
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 through D questionnaires. Of
the total screening respondents, we
expect 25 percent will respond only in
the mail screening (household deemed
ineligible), 65 percent will respond only
in the field screening (mail screening
nonrespondents), and the remaining 10
percent will respond in both the mail
screening and the field screening. The
latter includes eligible households from
the mail screening that are subsequently
field screened to sample the panel
member, and the 10 percent quality
control sample of households whose
mail screening ineligibility is verified
through in-person screening. The
estimated burden published in the 60day notice assumed an estimated 10,285
household screening respondent during
yearly panel replenishment (30,855
total) and 1,400 additional panel
members recruited annually (4,200
total). In this notice, we included 2,500
additional household screening
respondents during replenishment, and
an additional 400 panel replenishment
enrollment and baseline survey
respondents as part of the panel
replenishment effort (should annual
attrition rates be higher than expected).
The new total is 33,355 household
screening respondents and a total of
4,600 panel members recruited.
Replenishment panel members replace
original panel members and become
part of the 4,000-member panel that
receives experimental/observational and
panel maintenance surveys. Overall,
this extension reflects an increase of
VerDate Sep<11>2014
16:41 May 17, 2019
Jkt 247001
1,700 hours due to an additional year of
panel replenishment and fielding of
studies B, C, and D.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
II. References
[FR Doc. 2019–10359 Filed 5–17–19; 8:45 am]
BILLING CODE 4164–01–P
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Baker, R., Blumberg, S., Brick, M., et al.,
2010, ‘‘American Association for Public
Opinion Research Report on Online
Panels,’’ Public Opinion Quarterly, 74(4),
pp. 711–781.
2. Coen, T., Lorch, J., and Piekarski, L., 2005,
‘‘The Effects of Survey Frequency on
Panelists’ Responses. Worldwide Panel
Research: Developments and Progress,’’
Amsterdam, European Society for
Opinion and Marketing Research.
3. Nancarrow, C. and Cartwright, T., 2007,
‘‘Online Access Panels and Tracking
Research, The Conditioning Issue,’’
International Journal of Market
Research, 49(5), pp. 435–447.
4. Kruse, Y., Callegaro, M., Dennis, J. M., et
al., 2009, ‘‘Panel Conditioning and
Attrition in the AP-Yahoo! News
Election Panel Study,’’ paper presented
at the American Association for Public
Opinion Research 64th Annual
Conference.
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–4040–0002]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 19, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, ed.calimag@hhs.gov or (202)
690–7569. When submitting comments
or requesting information, please
include the document identifier 4040–
0002–30D and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
SUMMARY:
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22862-22864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1533]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; National Panel of
Tobacco Consumer Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
19, 2019.
ADDRESSES: To ensure that comments on the information collection are
received,
[[Page 22863]]
OMB recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax:
202-395-7285, or emailed to [email protected]. All comments
should be identified with the OMB control number 0910-0815. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
National Panel of Tobacco Consumer Studies
OMB Control Number 0910-0815--Extension
I. Background
FDA's Center for Tobacco Products (CTP) established a national,
primarily web-based panel of about 4,000 tobacco users. The panel
includes individuals who can participate in up to eight studies over a
3-year period to assess consumers' responses to tobacco marketing,
warning statements, product labels, and other communications about
tobacco products. CTP established the panel of consumers because
currently existing panels have a number of significant limitations.
First, many existing consumer panels are drawn from convenience samples
that limit the generalizability of study findings (Ref. 1). Second,
although at least two probability-based panels of consumers exist in
the United States, there is a concern that responses to the studies
using tobacco users in these panels may be biased due to panel
conditioning effects (Refs. 2 and 3). That is, consumers in these
panels complete surveys so frequently that their responses may not
adequately represent the population as a whole. Panel conditioning has
been associated with repeated measurement on the same topic (Ref. 4),
panel tenure (Ref. 2), and frequency of the survey request (Ref. 3).
This issue is of particular concern for tobacco users who represent a
minority of the members in the panels, and so may be more likely to be
selected for participation in experiments and/or surveys related to
tobacco products. Third, a key benefit of the web panel approach is
that the surveys can include multimedia, such as images of tobacco
product packages, tobacco advertising, new and existing warning
statements and labels, and potential reduced harm claims in the form of
labels and print advertisements. Establishing a primarily web-based
panel of tobacco users through in-person probability-based recruitment
of eligible adults and limiting the number of times individuals
participate in tobacco-related studies will result in nationally
representative and unbiased data collection on matters of importance
for FDA.
With this submission, FDA seeks an extension on the currently
approved information collection request from OMB for remaining planned
panel maintenance and replenishment activities for the National Panel
of Tobacco Consumer Studies. Data collection activities will involve
mail and in-person household screening, in-person recruitment of
tobacco users, enrollment of selected household members, and
administration of a baseline survey, following all required informed
consent procedures for panel members. Panel members will be asked to
participate in up to eight experimental and observational studies over
the 3-year panel commitment period. The first of these panel studies,
study A ``Brands and Purchasing Behavior,'' was included in the
currently approved information collection request. Approval for study B
``Coupons and Free Samples,'' study C ``Consumer Perceptions of Product
Standards,'' and study D ``Hypothetical Purchasing of Tobacco
Products'' are included in this request for extension. Study B will be
an observational study offered to all panelists that will provide a
more in-depth examination of tobacco product promotions, namely free
samples and coupons, after the ban on distribution of free samples of
tobacco products (with the exception of certain smokeless tobacco
exemptions) that went into effect when FDA finalized the ``Deeming
Rule'' on August 8, 2016 (published May 10, 2016 (81 FR 28973)), that
extended FDA's regulatory authority to all tobacco products. Study C
will be an experimental study examining how a hypothetical tobacco
product standard may impact consumers' perceptions, attitudes, and
tobacco use behavioral intentions. Study D will be an experimental
study using behavioral economic methods that seeks to understand how
the availability or lack of availability of menthol cigarettes
potentially impacts adult cigarette smokers' product purchasing
choices. The current request also seeks approval to update the
estimated burden for an additional year of panel replenishment. The
overall purpose of the data collection is to collect information from a
national sample of tobacco users to provide data that may be used to
develop and support FDA's policies related to tobacco products,
including their labels, labeling, and advertising.
The target population for the panel is tobacco users aged 18 years
and older in housing units and in noninstitutionalized group quarters
in the 50 states and the District of Columbia. A stratified four-stage
sample design was used, with a goal of recruiting 4,000 adult tobacco
users into the sample panel. The sample is designed to allow in-depth
analysis of subgroups of interest and to the extent possible, provide
insight into tobacco users more generally. Replenishment will be
conducted to maintain the panel with a constant number of members
following existing panel recruitment and enrollment methods.
In the Federal Register of October 23, 2018 (83 FR 53485), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 10 comments; however, only 1
was PRA related.
(Comment) One commenter supports FDA's establishment of a tobacco
user panel, adding that high-quality research is critical to successful
implementation of many provisions of tobacco policy. The commenter
further stated that the research panel can provide FDA with critical
information on how adult tobacco users respond to tobacco marketing,
product labels, warning statements, and other communications about
tobacco products. The commenter also noted the ability to have its own
panel of tobacco users will allow FDA to gather more reliable
information in a more efficient manner.
(Response) FDA agrees with this comment and believes the panel will
be a valuable tool for conducting new observational and experimental
studies.
FDA estimates the burden of this collection of information as
follows:
[[Page 22864]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/respondent Number of responses per Total annual Average burden per response Total hours
respondents respondent \2\ responses \3\ \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Household Screening Respondent.............. 35,885 0.33 11,842 0.13 (8 minutes).......................... 1,539
Panel Member Enrollment Survey.............. 4,000 0.33 1,320 0.25 (15 minutes)......................... 330
Panel Member Baseline Survey................ 0.33 1,320 0.25 (15 minutes)......................... 330
Study A..................................... 0.33 1,320 0.33 (20 minutes)......................... 436
Study B..................................... 0.33 1,320 0.33 (20 minutes)......................... 436
Study C..................................... 0.33 1,320 0.33 (20 minutes)......................... 436
Study D..................................... 0.33 1,320 0.33 (20 minutes)......................... 436
Panel Replenishment Household Screening 33,355 0.33 11,007 0.13 (8 minutes).......................... 1,431
Respondent \4\.
Panel Replenishment Enrollment Survey \4\... 4,600 0.33 1,518 0.25 (15 minutes)......................... 380
Panel Replenishment Baseline Survey \4\..... 0.33 1,518 0.25 (15 minutes)......................... 380
------------------------------------------------ ---------------
Total................................... .............. .............. .............. .......................................... 6,134
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Assumes respondents will participate once over a 3-year period, or 0.33 responses annually.
\3\ Amounts are rounded to the nearest whole number.
\4\ Assumes an estimated 10,285 mail and field household screening respondents during yearly panel replenishment and 1,400 additional panel members will
be recruited annually as part of the panel replenishment effort, as well as an additional 2,500 household screening respondents during replenishment
and an additional 400 panel replenishment enrollment and baseline survey respondents should annual attrition rates be higher than expected.
FDA's burden estimate is based on timed readings of each
instrument, including the mail and field screeners, enrollment survey,
baseline survey, and study A through D questionnaires. Of the total
screening respondents, we expect 25 percent will respond only in the
mail screening (household deemed ineligible), 65 percent will respond
only in the field screening (mail screening nonrespondents), and the
remaining 10 percent will respond in both the mail screening and the
field screening. The latter includes eligible households from the mail
screening that are subsequently field screened to sample the panel
member, and the 10 percent quality control sample of households whose
mail screening ineligibility is verified through in-person screening.
The estimated burden published in the 60-day notice assumed an
estimated 10,285 household screening respondent during yearly panel
replenishment (30,855 total) and 1,400 additional panel members
recruited annually (4,200 total). In this notice, we included 2,500
additional household screening respondents during replenishment, and an
additional 400 panel replenishment enrollment and baseline survey
respondents as part of the panel replenishment effort (should annual
attrition rates be higher than expected). The new total is 33,355
household screening respondents and a total of 4,600 panel members
recruited. Replenishment panel members replace original panel members
and become part of the 4,000-member panel that receives experimental/
observational and panel maintenance surveys. Overall, this extension
reflects an increase of 1,700 hours due to an additional year of panel
replenishment and fielding of studies B, C, and D.
II. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Baker, R., Blumberg, S., Brick, M., et al., 2010, ``American
Association for Public Opinion Research Report on Online Panels,''
Public Opinion Quarterly, 74(4), pp. 711-781.
2. Coen, T., Lorch, J., and Piekarski, L., 2005, ``The Effects of
Survey Frequency on Panelists' Responses. Worldwide Panel Research:
Developments and Progress,'' Amsterdam, European Society for Opinion
and Marketing Research.
3. Nancarrow, C. and Cartwright, T., 2007, ``Online Access Panels
and Tracking Research, The Conditioning Issue,'' International
Journal of Market Research, 49(5), pp. 435-447.
4. Kruse, Y., Callegaro, M., Dennis, J. M., et al., 2009, ``Panel
Conditioning and Attrition in the AP-Yahoo! News Election Panel
Study,'' paper presented at the American Association for Public
Opinion Research 64th Annual Conference.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10359 Filed 5-17-19; 8:45 am]
BILLING CODE 4164-01-P
