Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment of a Tobacco User Panel, 32963-32966 [2015-14125]
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
32963
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
On April
23, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Comparative Price
Information in Direct-to-Consumer and
Professional Prescription Drug
Advertisements’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0791. The
approval expires on May 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
FOR FURTHER INFORMATION CONTACT:
John
Harshman, Center for Veterinary
Medicine, Food and Drug
Administration, HFV–170, MPN2, 7500
Standish Pl., Rockville, MD 20855, 240–
402–0845.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14122 Filed 6–9–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0684]
Identification of Alternative In Vitro
Bioequivalence Pathways Which Can
Reliably Ensure In Vivo Bioequivalence
of Product Performance and Quality of
Non-Systemically Absorbed Drug
Products for Animals; Reopening of
the Comment Period
Food and Drug Administration,
HHS.
Request for comments;
reopening of the comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period related to the use of in
vitro methods as a mechanism for
assessing the in vivo product
bioequivalence (BE) of nonsystemically
absorbed drug products intended for use
in veterinary species, published in the
Federal Register of March 18, 2015 (80
FR 14146). FDA is reopening the
comment period to update comments
and to receive any new information.
DATES: Submit either electronic or
written comments by August 10, 2015.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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I. Background
Following publication of the March
18, 2015, notification of public meeting
and request for comments, FDA
received a request to allow interested
persons additional time to comment.
The requester asserted that the time
period of 60 days was insufficient to
respond fully to FDA’s specific requests
for comments and to allow potential
respondents to thoroughly evaluate and
address pertinent issues.
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14101 Filed 6–9–15; 8:45 am]
BILLING CODE 4164–01–P
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Establishment of a
Tobacco User Panel
AGENCY:
In the Federal Register of March 18,
2015 (80 FR 14146), FDA announced a
public meeting to discuss the use of in
vitro methods as a mechanism for
assessing the in vivo product
bioequivalence (BE) of nonsystemically
absorbed drug products intended for use
in veterinary species. In the same
notice, FDA said that it is seeking
additional public comment to the
docket. Interested persons were
originally given until May 18, 2015, to
comment on this issue.
II. Request for Comments
BILLING CODE 4164–01–P
AGENCY:
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2014–N–1533]
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 July 10,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
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–NEW and
title ‘‘Establishment of a Tobacco User
Panel’’. Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Establishment of a Tobacco User
Panel—(OMB Control Number 0910–
NEW)
The Food and Drug Administration’s
Center for Tobacco Products (CTP)
proposes to establish a high quality,
probability-based, primarily Web-based,
panel of 4,000 tobacco users. The panel
will include individuals who can
participate in up to 8 studies over a 3year period to assess consumers’
responses to tobacco marketing, warning
statements, product labels, and other
communications about tobacco
products. CTP proposed the
establishment of the panel of consumers
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
because currently existing Web-based
panels have a number of significant
limitations.
First, most 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 tobaccorelated studies will result in nationally
representative and unbiased data
collection on matters of importance for
FDA.
With this submission, FDA seeks
approval from OMB to establish the
Tobacco User Panel, a nationally
representative, primarily Web-based
panel of 4,000 current tobacco users.
Data collection activities will involve
pilot testing of panel recruitment and
management procedures and systems,
mail and in-person household
screening, in-person recruitment of
tobacco users, enrollment of selected
household members, administration of a
baseline survey, and panel maintenance
surveys, following all required informed
consent procedures for panel members.
Once the panel is established, 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 studies (Study 1) is included in
this information collection request;
approval for the remainder of the
studies will appear in future requests.
The current request also seeks approval
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to conduct up to two rounds of
cognitive testing of new survey items
and up to two focus groups to further
refine study protocols, as needed. With
this clearance, study investigators will
be able to use the OMB approved data
collection methods where appropriate to
plan and implement the national panel.
The overall purpose of the proposed
data collection is to collect information
from a representative 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.
Data will be collected from the panel
primarily through the use of
randomized experimental designs,
however, there may be data collected
through the use of other methods, such
as surveys, interviews, or online group
discussions. Given the limitations on
the existing Web-based panels, it is
important to develop a new panel of
tobacco users that balances the need to
conduct experiments while limiting the
number of tobacco-related studies per
year so as to not bias study results.
FDA estimates the burden of this
collection of information as follows:
In the Federal Register of October 16,
2014 (79 FR 62160), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received three
comments, however only two were PRA
related. Within those submissions, FDA
received multiple comments which the
Agency has addressed.
(Comment) One comment asked FDA
for the opportunity to review the data
collection plans and instruments
including the sample design, data
collection methodology, and panel
performance evaluation plan.
(Response) All the instruments and
background documents including our
plan for evaluating panel performance
have been uploaded to the docket for
easy access. The documents included
are the data collection plans and
methodology (Supporting Statement
Part A), copies of the survey
instruments used to screen and recruit
panel members, as well as the first
experimental or observation study
(Study 1), and the proposed sample
design (Supporting Statement Part B).
(Comment) One comment asked FDA
to provide additional details about the
proposed sample design and FDA’s
approach to issues such as nonresponse
of subjects and conditioning effects.
(Response) The proposed sample
design is described in detail in
Supporting Statement, Part B. Briefly,
we propose a multi-stage area sample
based on an address-based sampling
frame. The probabilities (single, joint,
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and the overall selection probability)
will be measurable at each stage.
The issues of non-response and
conditioning effects are real challenges
but they should be considered
separately from the sample design.
These are issues faced in the field once
the sample has been selected and
contacted. We have proposed several
strategies for reducing non-response in
the recruitment of panel members, the
primary one being in-person
recruitment which we believe will lead
to significantly larger recruitment rates
than we would achieve if we contacted
sample members via mail, telephone, or
web. We will describe our plans to
reduce the non-response bias in future
individual studies as part of the OMB
submissions for these studies. We
consider the issue of conditioning
effects as part of our overall panel
management plan, which is described in
Supporting Statement, Part A.
(Comment) One comment stated that
FDA suggests that not every panelist
will be eligible to participate in every
study to minimize the potential for
‘‘conditioning’’ effects. However, this
approach to participation is inconsistent
with the requirement that every
individual in the population has a nonzero probability of being in the sample.
FDA will need to make trade-offs to
balance these two interests. FDA could
consider drawing data from similar
respondents, as long as FDA knows that
there are no important hidden
differences between the respondents
that may affect their responses.
(Response) We will draw the original
sample with known, non-zero, and, to
the extent possible, equal probabilities.
The same will apply to any additional
samples drawn for the panel to replace
attrition. Furthermore, any subsample
drawn from the panel for specific
studies will also result in known
probabilities of selection. We will derive
a strategy of spreading the survey-taking
load over all panel members to avoid
excessive burden on any single member
or group of members. We will
implement this strategy by randomly
selecting each subsample, but at the
same time keeping track of each
member’s survey-taking activity. As the
number and frequency of survey-taking
for a given member increases, their
probability of selection will decrease, a
strategy that we will implement using
probability proportion to size sampling.
This strategy will lead to known and
measurable selection probabilities for
each specific subsample.
(Comment) One comment stated FDA
should consider, whether in some
instances, collecting fresh data from
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
new samples of tobacco product users
over time may provide better results.
(Response) Our proposed approach
includes replenishment of the sample
over time to address attrition from the
panel. As such, the panel will include
tobacco users with varying tenure
lengths on the panel. We will be in a
position to restrict a specific study
subsample to the more recent panel
members, if desired, and more
generally, the panel will allow FDA to
specify the composition of the sample
with respect to tenure.
(Comment) One comment said FDA
should consider inclusion of nontobacco users or users of specific
tobacco categories (e.g., e-cigarette
users, moist smokeless tobacco users) in
the sample to support comparative
analyses between users and non-users or
subgroup analyses.
(Response) FDA considered including
non-tobacco users early in the planning
process. However, the planned
experimental and observational studies
will examine issues specific to the
tobacco-using population, especially
those with lower socio-economic status.
This includes the underlying
demographics of users as well as their
knowledge, attitudes, practices,
behaviors, and reactions to various
tobacco-related stimuli. Other existing
data sources, including survey panels,
support research with non-users.
Moreover, limiting the panel to users
reduces the overall public burden. Once
the panel is firmly established, we may
consider its expansion.
(Comment) One comment stated FDA
should also consider how well the
sample of 4,000 adult tobacco users will
support the planned investigations.
(Response) The sample size of 4,000
was chosen after a careful review of, on
the one hand, power and subclass
analyses requirements, and on the other
hand, the budgetary implications. After
our careful review, we concluded that a
sample size of 4,000 tobacco users
represents a good balance, at least for
the first iteration of the panel.
We should also mention that the
young adult population (aged 18–25)
and the low-income population
(combined household income less than
$30,000) will be oversampled allowing
for more in-depth study of these two
groups of tobacco users. We also include
a screening feature that will result in
oversampling of the smokeless tobacco
users.
(Comment) One commenter stated
that FDA suggests that the approach
includes a ‘‘3-year panel commitment
period’’. FDA should consider
developing and sharing its plan for
keeping or removing panelists. For
example, will FDA keep or remove a
panelist if he/she decides to quit using
tobacco products? Also, how will FDA
monitor whether incentives are
influencing a panelist’s responses or
behavior? These are only a few
examples of issues that could arise;
therefore, a thoughtful panel
management plan is needed.
(Response) We agree that a detailed
and well-designed panel management
plan is needed to make the panel
successful. The literature on panel
maintenance is growing, but there is
still much to be learned about optimal
strategies for maintaining a strong and
productive panel. Supporting
Statement, Part A outlines our plans for
panel management, including retention
and nonresponse follow-up strategies,
planned incentive experiments,
monitoring of panel conditioning, and
evaluation of the effects of various panel
maintenance strategies on substantive
responses.
Continual monitoring is planned to
study these and other important aspects
of the panel’s health. We will also keep
a close eye on individual panelists, their
participation patterns, and their nonresponse patterns to identify potential
problems requiring intervention. FDA
considered removing panel members
who report they have stopped using
tobacco products. Because of recidivism
rates, it was decided to retain all
enrolled panel members regardless of
32965
changes in their tobacco use patterns.
Subsampling of panelists may be
implemented for specific experimental
or observational studies that are
intended solely for current users of one
or more specific tobacco products.
(Comment) One commenter stated
FDA should consider establishing
mechanisms to evaluate the
performance of the panel as well as the
data derived from it. For example, data
from the panel on measures such as
current or past 30-day cigarette smoking
might be compared against the most
recent data from national surveys and
other published reports.
(Response) We agree that
benchmarking the panel sample
characteristics—demographic,
socioeconomic, and tobacco use—
against other national data sources is
extremely important. We will
continuously check that our panel
matches known underlying population
characteristics. However, we will also
monitor how the panel compares with
the target population with respect to
known patterns of behavior surrounding
tobacco use. Differences will not
necessarily suggest problems with the
panel but they will stimulate further
investigation and explanation.
(Comment) One commenter asked
FDA to provide copies of the survey
instruments for public comment.
(Response) Copies of the survey
instruments used to screen and recruit
panel members, as well as the first
experimental or observation study
(Study 1), are uploaded to the docket.
(Comment) One commenter strongly
supports FDA’s proposed collection of
information. The commenter stated that
this panel is of great utility and the
proposed probability-based panel will
serve as a flexible tool, giving FDA the
opportunity to conduct diverse studies.
(Response) FDA agrees with this
comment and believes the panel will be
a valuable tool for conducting new
experimental studies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Activity or type of respondent
Number of
respondents
Household Screening Respondent .................................
Panel Member Enrollment Survey ..................................
Panel Member Baseline Survey .....................................
Panel Maintenance/Bi-annual Update Surveys ..............
Experimental/Observational Studies * .............................
Panel Replenishment Screening Respondent ................
Panel Replenishment Enrollment Survey ** ....................
Panel Replenishment Baseline Survey ** .......................
Cognitive Interview Subjects ...........................................
Number of
responses per
respondent
29,385
........................
........................
4,000
........................
10,285
2,800
2,800
20
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0.33
0.33
0.33
3.0
2.7
0.50
0.33
0.33
0.33
Sfmt 4703
Average
burden per
response
Total annual
responses
9,697
1,320
1,320
12,000
10,800
5,143
924
924
7
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0.16 (10 minutes)
0.25 (15 minutes)
0.25 (15 minutes)
0.08 (5 minutes)
0.33 (20 minutes)
0.16 (10 minutes)
0.25 (15 minutes)
0.25 (15 minutes)
1.0 ......................
10JNN1
Total hours
1,552
330
330
960
3,564
823
231
231
7
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity or type of respondent
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Focus Group Subjects ....................................................
20
0.33
7
1.5 ......................
10
Total .........................................................................
49,310
........................
........................
............................
8,038
1 There
are no capital or operating and maintenance costs or associated with this collection of information.
* Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the
time of each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task orders but are included in this table to present an overall estimate of the burden for each participating panel member.
** Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort.
The collection burden was estimated
using data from timed-readings of each
instrument, including the mail and field
screeners, enrollment survey, baseline
survey, panel maintenance
questionnaires, and Study 1
questionnaire.
References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Baker, R., Blumberg, S., Brick, M., Couper,
M., Courtright, M., Dennis, J. M.,
Dillman, D., Frankel, M., Garland, P.,
Groves, R., Kennedy, C., Krosnick, J. and
Lavrakas, P., 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.,
DiSogra, C., Subias, S., Lawrence, M.,
and Tompson, T., 2009, Panel
Conditioning and Attrition in the APYahoo! News Election Panel Study,
Paper presented at the American
Association for Public Opinion Research
64th Annual Conference.
Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ANDA 077348 ......................
ANDA 077480 ......................
ANDA 078291 ......................
ANDA 078308 ......................
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Emily Helms Williams, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3381.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–1702]
Baxter Healthcare Corporation et al.;
Withdrawal of Approval of One New
Drug Application and Four Abbreviated
New Drug Applications
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of one new drug application
(NDA) for Ondansetron (ondansetron
hydrochloride (HCl)) Injection, USP in
PL 2408 Plastic Container, 32
milligrams (mg) in 50 milliliters (mL),
single intravenous (IV) dose, and four
abbreviated new drug applications
(ANDAs) for ondansetron HCl and
SUMMARY:
On June
29, 2012, FDA issued a Drug Safety
Communication to notify health care
professionals that the 32 mg, single IV
dose of ondansetron HCl, indicated for
prevention of nausea and vomiting
associated with initial and repeat
courses of emetogenic cancer
chemotherapy in adult patients, should
be avoided due to the risk of a specific
type of irregular heart rhythm called QT
interval prolongation, which can lead to
Torsades de Pointes, an abnormal,
potentially fatal heart rhythm.
Subsequently, FDA contacted the
holders of the following applications
and informed them that the Agency
believes that in light of the safety
concern associated with ondansetron
HCl in the 32 mg, single IV dose, the
following drug products should be
removed from the market:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
ACTION:
Effective June 10, 2015.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Application number
NDA 021915 ........................
DATES:
[FR Doc. 2015–14125 Filed 6–9–15; 8:45 am]
AGENCY:
Dextrose in 32 mg single IV doses. The
holders of these applications have
voluntarily requested that FDA
withdraw approval of their applications
and have waived their opportunity for a
hearing.
Drug
Ondansetron Hydrochloride
Intravia Plastic Container.
Ondansetron Hydrochloride
Container.
Ondansetron Hydrochloride
Container.
Ondansetron Hydrochloride
Container.
Ondansetron Hydrochloride
Container.
Jkt 235001
PO 00000
Applicant
Injection, USP premix in
and Dextrose in Plastic
and Dextrose in Plastic
and Dextrose in Plastic
and Dextrose in Plastic
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Baxter Healthcare Corporation (Baxter), 32650 N. Wilson Rd., Round Lake, IL 60073.
Hospira, Inc. (Hospira), 275 North Field Dr., Department 389, Bldg. H2–2, Lake Forest, IL 60045.
Teva Pharmaceuticals USA (Teva), 400 Chestnut
Ridge Rd., Woodcliff Lake, NJ 07677.
Bedford Labs (Bedford), 300 Northfield Rd., Bedford,
OH 44146.
Claris Lifesciences Ltd. (Claris), 2325 Camino Vida
Roble, Suite A, Carlsbad, CA 92011.
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]]>Agencies
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32963-32966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14125]
-----------------------------------------------------------------------
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; Establishment of a
Tobacco User Panel
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 July
10, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, 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-NEW and
title ``Establishment of a Tobacco User Panel''. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Establishment of a Tobacco User Panel--(OMB Control Number 0910-NEW)
The Food and Drug Administration's Center for Tobacco Products
(CTP) proposes to establish a high quality, probability-based,
primarily Web-based, panel of 4,000 tobacco users. The panel will
include individuals who can participate in up to 8 studies over a 3-
year period to assess consumers' responses to tobacco marketing,
warning statements, product labels, and other communications about
tobacco products. CTP proposed the establishment of the panel of
consumers
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because currently existing Web-based panels have a number of
significant limitations.
First, most 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 approval from OMB to establish the
Tobacco User Panel, a nationally representative, primarily Web-based
panel of 4,000 current tobacco users. Data collection activities will
involve pilot testing of panel recruitment and management procedures
and systems, mail and in-person household screening, in-person
recruitment of tobacco users, enrollment of selected household members,
administration of a baseline survey, and panel maintenance surveys,
following all required informed consent procedures for panel members.
Once the panel is established, 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 studies (Study
1) is included in this information collection request; approval for the
remainder of the studies will appear in future requests. The current
request also seeks approval to conduct up to two rounds of cognitive
testing of new survey items and up to two focus groups to further
refine study protocols, as needed. With this clearance, study
investigators will be able to use the OMB approved data collection
methods where appropriate to plan and implement the national panel.
The overall purpose of the proposed data collection is to collect
information from a representative 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.
Data will be collected from the panel primarily through the use of
randomized experimental designs, however, there may be data collected
through the use of other methods, such as surveys, interviews, or
online group discussions. Given the limitations on the existing Web-
based panels, it is important to develop a new panel of tobacco users
that balances the need to conduct experiments while limiting the number
of tobacco-related studies per year so as to not bias study results.
FDA estimates the burden of this collection of information as
follows:
In the Federal Register of October 16, 2014 (79 FR 62160), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments, however only
two were PRA related. Within those submissions, FDA received multiple
comments which the Agency has addressed.
(Comment) One comment asked FDA for the opportunity to review the
data collection plans and instruments including the sample design, data
collection methodology, and panel performance evaluation plan.
(Response) All the instruments and background documents including
our plan for evaluating panel performance have been uploaded to the
docket for easy access. The documents included are the data collection
plans and methodology (Supporting Statement Part A), copies of the
survey instruments used to screen and recruit panel members, as well as
the first experimental or observation study (Study 1), and the proposed
sample design (Supporting Statement Part B).
(Comment) One comment asked FDA to provide additional details about
the proposed sample design and FDA's approach to issues such as
nonresponse of subjects and conditioning effects.
(Response) The proposed sample design is described in detail in
Supporting Statement, Part B. Briefly, we propose a multi-stage area
sample based on an address-based sampling frame. The probabilities
(single, joint, and the overall selection probability) will be
measurable at each stage.
The issues of non-response and conditioning effects are real
challenges but they should be considered separately from the sample
design. These are issues faced in the field once the sample has been
selected and contacted. We have proposed several strategies for
reducing non-response in the recruitment of panel members, the primary
one being in-person recruitment which we believe will lead to
significantly larger recruitment rates than we would achieve if we
contacted sample members via mail, telephone, or web. We will describe
our plans to reduce the non-response bias in future individual studies
as part of the OMB submissions for these studies. We consider the issue
of conditioning effects as part of our overall panel management plan,
which is described in Supporting Statement, Part A.
(Comment) One comment stated that FDA suggests that not every
panelist will be eligible to participate in every study to minimize the
potential for ``conditioning'' effects. However, this approach to
participation is inconsistent with the requirement that every
individual in the population has a non-zero probability of being in the
sample. FDA will need to make trade-offs to balance these two
interests. FDA could consider drawing data from similar respondents, as
long as FDA knows that there are no important hidden differences
between the respondents that may affect their responses.
(Response) We will draw the original sample with known, non-zero,
and, to the extent possible, equal probabilities. The same will apply
to any additional samples drawn for the panel to replace attrition.
Furthermore, any subsample drawn from the panel for specific studies
will also result in known probabilities of selection. We will derive a
strategy of spreading the survey-taking load over all panel members to
avoid excessive burden on any single member or group of members. We
will implement this strategy by randomly selecting each subsample, but
at the same time keeping track of each member's survey-taking activity.
As the number and frequency of survey-taking for a given member
increases, their probability of selection will decrease, a strategy
that we will implement using probability proportion to size sampling.
This strategy will lead to known and measurable selection probabilities
for each specific subsample.
(Comment) One comment stated FDA should consider, whether in some
instances, collecting fresh data from
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new samples of tobacco product users over time may provide better
results.
(Response) Our proposed approach includes replenishment of the
sample over time to address attrition from the panel. As such, the
panel will include tobacco users with varying tenure lengths on the
panel. We will be in a position to restrict a specific study subsample
to the more recent panel members, if desired, and more generally, the
panel will allow FDA to specify the composition of the sample with
respect to tenure.
(Comment) One comment said FDA should consider inclusion of non-
tobacco users or users of specific tobacco categories (e.g., e-
cigarette users, moist smokeless tobacco users) in the sample to
support comparative analyses between users and non-users or subgroup
analyses.
(Response) FDA considered including non-tobacco users early in the
planning process. However, the planned experimental and observational
studies will examine issues specific to the tobacco-using population,
especially those with lower socio-economic status. This includes the
underlying demographics of users as well as their knowledge, attitudes,
practices, behaviors, and reactions to various tobacco-related stimuli.
Other existing data sources, including survey panels, support research
with non-users. Moreover, limiting the panel to users reduces the
overall public burden. Once the panel is firmly established, we may
consider its expansion.
(Comment) One comment stated FDA should also consider how well the
sample of 4,000 adult tobacco users will support the planned
investigations.
(Response) The sample size of 4,000 was chosen after a careful
review of, on the one hand, power and subclass analyses requirements,
and on the other hand, the budgetary implications. After our careful
review, we concluded that a sample size of 4,000 tobacco users
represents a good balance, at least for the first iteration of the
panel.
We should also mention that the young adult population (aged 18-25)
and the low-income population (combined household income less than
$30,000) will be oversampled allowing for more in-depth study of these
two groups of tobacco users. We also include a screening feature that
will result in oversampling of the smokeless tobacco users.
(Comment) One commenter stated that FDA suggests that the approach
includes a ``3-year panel commitment period''. FDA should consider
developing and sharing its plan for keeping or removing panelists. For
example, will FDA keep or remove a panelist if he/she decides to quit
using tobacco products? Also, how will FDA monitor whether incentives
are influencing a panelist's responses or behavior? These are only a
few examples of issues that could arise; therefore, a thoughtful panel
management plan is needed.
(Response) We agree that a detailed and well-designed panel
management plan is needed to make the panel successful. The literature
on panel maintenance is growing, but there is still much to be learned
about optimal strategies for maintaining a strong and productive panel.
Supporting Statement, Part A outlines our plans for panel management,
including retention and nonresponse follow-up strategies, planned
incentive experiments, monitoring of panel conditioning, and evaluation
of the effects of various panel maintenance strategies on substantive
responses.
Continual monitoring is planned to study these and other important
aspects of the panel's health. We will also keep a close eye on
individual panelists, their participation patterns, and their non-
response patterns to identify potential problems requiring
intervention. FDA considered removing panel members who report they
have stopped using tobacco products. Because of recidivism rates, it
was decided to retain all enrolled panel members regardless of changes
in their tobacco use patterns. Subsampling of panelists may be
implemented for specific experimental or observational studies that are
intended solely for current users of one or more specific tobacco
products.
(Comment) One commenter stated FDA should consider establishing
mechanisms to evaluate the performance of the panel as well as the data
derived from it. For example, data from the panel on measures such as
current or past 30-day cigarette smoking might be compared against the
most recent data from national surveys and other published reports.
(Response) We agree that benchmarking the panel sample
characteristics--demographic, socioeconomic, and tobacco use--against
other national data sources is extremely important. We will
continuously check that our panel matches known underlying population
characteristics. However, we will also monitor how the panel compares
with the target population with respect to known patterns of behavior
surrounding tobacco use. Differences will not necessarily suggest
problems with the panel but they will stimulate further investigation
and explanation.
(Comment) One commenter asked FDA to provide copies of the survey
instruments for public comment.
(Response) Copies of the survey instruments used to screen and
recruit panel members, as well as the first experimental or observation
study (Study 1), are uploaded to the docket.
(Comment) One commenter strongly supports FDA's proposed collection
of information. The commenter stated that this panel is of great
utility and the proposed probability-based panel will serve as a
flexible tool, giving FDA the opportunity to conduct diverse studies.
(Response) FDA agrees with this comment and believes the panel will
be a valuable tool for conducting new experimental studies.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity or type of respondent Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Household Screening Respondent................. 29,385 0.33 9,697 0.16 (10 minutes)...................... 1,552
Panel Member Enrollment Survey................. .............. 0.33 1,320 0.25 (15 minutes)...................... 330
Panel Member Baseline Survey................... .............. 0.33 1,320 0.25 (15 minutes)...................... 330
Panel Maintenance/Bi-annual Update Surveys..... 4,000 3.0 12,000 0.08 (5 minutes)....................... 960
Experimental/Observational Studies *........... .............. 2.7 10,800 0.33 (20 minutes)...................... 3,564
Panel Replenishment Screening Respondent....... 10,285 0.50 5,143 0.16 (10 minutes)...................... 823
Panel Replenishment Enrollment Survey **....... 2,800 0.33 924 0.25 (15 minutes)...................... 231
Panel Replenishment Baseline Survey **......... 2,800 0.33 924 0.25 (15 minutes)...................... 231
Cognitive Interview Subjects................... 20 0.33 7 1.0.................................... 7
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Focus Group Subjects........................... 20 0.33 7 1.5.................................... 10
--------------------------------------------------------------------------------------------------------
Total...................................... 49,310 .............. .............. ....................................... 8,038
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs or associated with this collection of information.
* Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the time of
each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task orders but are
included in this table to present an overall estimate of the burden for each participating panel member.
** Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort.
The collection burden was estimated using data from timed-readings
of each instrument, including the mail and field screeners, enrollment
survey, baseline survey, panel maintenance questionnaires, and Study 1
questionnaire.
References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. Baker, R., Blumberg, S., Brick, M., Couper, M., Courtright, M.,
Dennis, J. M., Dillman, D., Frankel, M., Garland, P., Groves, R.,
Kennedy, C., Krosnick, J. and Lavrakas, P., 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., DiSogra, C., Subias, S.,
Lawrence, M., and Tompson, T., 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: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14125 Filed 6-9-15; 8:45 am]
BILLING CODE 4164-01-P
