80 FR 32963 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment of a Tobacco User Panel

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 111 (June 10, 2015)

Page Range		32963-32966
FR Document		2015-14125
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.
Federal Register, Volume 80 Issue 111 (Wednesday, June 10, 2015)
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32963-32966]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected]. 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, [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.

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

[[Page 32964]]

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

[[Page 32965]]

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

[[Page 32966]]

 
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 http://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
Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices 32963

Spring, MD 20993–0002, PRAStaff@ Administration, 5630 Fishers Lane, rm. DEPARTMENT OF HEALTH AND
fda.hhs.gov. 1061, Rockville, MD 20852. HUMAN SERVICES
SUPPLEMENTARY INFORMATION: On April FOR FURTHER INFORMATION CONTACT: John Food and Drug Administration
23, 2015, the Agency submitted a Harshman, Center for Veterinary
proposed collection of information Medicine, Food and Drug [Docket No. FDA–2014–N–1533]
entitled, ‘‘Comparative Price Administration, HFV–170, MPN2, 7500
Information in Direct-to-Consumer and Agency Information Collection
Standish Pl., Rockville, MD 20855, 240– Activities; Submission for Office of
Professional Prescription Drug 402–0845.
Advertisements’’ to OMB for review and Management and Budget Review;
clearance under 44 U.S.C. 3507. An SUPPLEMENTARY INFORMATION: Comment Request; Establishment of a
Agency may not conduct or sponsor, Tobacco User Panel
I. Background
and a person is not required to respond AGENCY: Food and Drug Administration,
to, a collection of information unless it In the Federal Register of March 18, HHS.
displays a currently valid OMB control 2015 (80 FR 14146), FDA announced a ACTION: Notice.
number. OMB has now approved the public meeting to discuss the use of in
information collection and has assigned vitro methods as a mechanism for SUMMARY: The Food and Drug
OMB control number 0910–0791. The assessing the in vivo product Administration (FDA) is announcing
approval expires on May 31, 2018. A bioequivalence (BE) of nonsystemically that a proposed collection of
copy of the supporting statement for this absorbed drug products intended for use information has been submitted to the
information collection is available on Office of Management and Budget
in veterinary species. In the same
the Internet at http://www.reginfo.gov/ (OMB) for review and clearance under
notice, FDA said that it is seeking
public/do/PRAMain. the Paperwork Reduction Act of 1995.
additional public comment to the
Dated: June 4, 2015. DATES: Fax written comments on the
docket. Interested persons were
Leslie Kux, originally given until May 18, 2015, to collection of information by July 10,
Associate Commissioner for Policy. 2015.
comment on this issue.
[FR Doc. 2015–14122 Filed 6–9–15; 8:45 am] ADDRESSES: To ensure that comments on
II. Request for Comments the information collection are received,
BILLING CODE 4164–01–P

Following publication of the March OMB recommends that written
comments be faxed to the Office of
18, 2015, notification of public meeting
DEPARTMENT OF HEALTH AND Information and Regulatory Affairs,
and request for comments, FDA
HUMAN SERVICES OMB, Attn: FDA Desk Officer, FAX:
received a request to allow interested 202–395–7285, or emailed to oira_
Food and Drug Administration persons additional time to comment. submission@omb.eop.gov. All
The requester asserted that the time comments should be identified with the
[Docket No. FDA–2015–N–0684] period of 60 days was insufficient to OMB control number 0910–NEW and
respond fully to FDA’s specific requests title ‘‘Establishment of a Tobacco User
Identification of Alternative In Vitro for comments and to allow potential
Bioequivalence Pathways Which Can Panel’’. Also include the FDA docket
respondents to thoroughly evaluate and number found in brackets in the
Reliably Ensure In Vivo Bioequivalence
address pertinent issues. heading of this document.
of Product Performance and Quality of
Non-Systemically Absorbed Drug III. How To Submit Comments FOR FURTHER INFORMATION CONTACT: FDA
Products for Animals; Reopening of PRA Staff, Office of Operations, Food
the Comment Period Interested persons may submit either and Drug Administration, 8455
electronic comments regarding this Colesville Rd., COLE–14526, Silver
AGENCY: Food and Drug Administration, document to http://www.regulations.gov Spring, MD 20993–0002, PRAStaff@
HHS. or written comments to the Division of fda.hhs.gov.
ACTION:Request for comments; Dockets Management (see ADDRESSES). It SUPPLEMENTARY INFORMATION: In
reopening of the comment period. is only necessary to send one set of compliance with 44 U.S.C. 3507, FDA
comments. Identify comments with the has submitted the following proposed
SUMMARY: The Food and Drug
docket number found in brackets in the collection of information to OMB for
Administration (FDA) is reopening the
comment period related to the use of in heading of this document. Received review and clearance.
vitro methods as a mechanism for comments may be seen in the Division Establishment of a Tobacco User
assessing the in vivo product of Dockets Management between 9 a.m. Panel—(OMB Control Number 0910–
bioequivalence (BE) of nonsystemically and 4 p.m., Monday through Friday, and NEW)
absorbed drug products intended for use will be posted to the docket at http://
www.regulations.gov. The Food and Drug Administration’s
in veterinary species, published in the Center for Tobacco Products (CTP)
Federal Register of March 18, 2015 (80 Dated: June 4, 2015. proposes to establish a high quality,
FR 14146). FDA is reopening the Leslie Kux, probability-based, primarily Web-based,
comment period to update comments panel of 4,000 tobacco users. The panel
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Associate Commissioner for Policy.
and to receive any new information. will include individuals who can
[FR Doc. 2015–14101 Filed 6–9–15; 8:45 am]
DATES: Submit either electronic or participate in up to 8 studies over a 3-
BILLING CODE 4164–01–P
written comments by August 10, 2015. year period to assess consumers’
ADDRESSES: Submit electronic responses to tobacco marketing, warning
comments to http:// statements, product labels, and other
www.regulations.gov. Submit written communications about tobacco
comments to the Division of Dockets products. CTP proposed the
Management (HFA–305), Food and Drug establishment of the panel of consumers

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32964 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices

because currently existing Web-based to conduct up to two rounds of and the overall selection probability)
panels have a number of significant cognitive testing of new survey items will be measurable at each stage.
limitations. and up to two focus groups to further The issues of non-response and
First, most existing consumer panels refine study protocols, as needed. With conditioning effects are real challenges
are drawn from convenience samples this clearance, study investigators will but they should be considered
that limit the generalizability of study be able to use the OMB approved data separately from the sample design.
findings (Ref. 1). Second, although at collection methods where appropriate to These are issues faced in the field once
least two probability-based panels of plan and implement the national panel. the sample has been selected and
consumers exist in the United States, The overall purpose of the proposed contacted. We have proposed several
there is a concern that responses to the data collection is to collect information strategies for reducing non-response in
studies using tobacco users in these from a representative sample of tobacco the recruitment of panel members, the
panels may be biased due to panel users to provide data that may be used primary one being in-person
conditioning effects (Refs. 2 and 3). That to develop and support FDA’s policies recruitment which we believe will lead
is, consumers in these panels complete related to tobacco products, including to significantly larger recruitment rates
surveys so frequently that their their labels, labeling, and advertising. than we would achieve if we contacted
responses may not adequately represent Data will be collected from the panel sample members via mail, telephone, or
the population as a whole. Panel primarily through the use of web. We will describe our plans to
conditioning has been associated with randomized experimental designs, reduce the non-response bias in future
repeated measurement on the same however, there may be data collected individual studies as part of the OMB
topic (Ref. 4), panel tenure (Ref. 2), and through the use of other methods, such submissions for these studies. We
frequency of the survey request (Ref. 3). as surveys, interviews, or online group consider the issue of conditioning
This issue is of particular concern for discussions. Given the limitations on effects as part of our overall panel
tobacco users who represent a minority the existing Web-based panels, it is management plan, which is described in
of the members in the panels, and so important to develop a new panel of Supporting Statement, Part A.
may be more likely to be selected for tobacco users that balances the need to (Comment) One comment stated that
participation in experiments and/or conduct experiments while limiting the FDA suggests that not every panelist
surveys related to tobacco products. number of tobacco-related studies per will be eligible to participate in every
Third, a key benefit of the Web panel year so as to not bias study results. study to minimize the potential for
approach is that the surveys can include FDA estimates the burden of this
‘‘conditioning’’ effects. However, this
multimedia, such as images of tobacco collection of information as follows:
In the Federal Register of October 16, approach to participation is inconsistent
product packages, tobacco advertising,
2014 (79 FR 62160), FDA published a with the requirement that every
new and existing warning statements
60-day notice requesting public individual in the population has a non-
and labels, and potential reduced harm
comment on the proposed collection of zero probability of being in the sample.
claims in the form of labels and print
information. FDA received three FDA will need to make trade-offs to
advertisements. Establishing a primarily
comments, however only two were PRA balance these two interests. FDA could
Web-based panel of tobacco users
related. Within those submissions, FDA consider drawing data from similar
through in-person probability-based
received multiple comments which the respondents, as long as FDA knows that
recruitment of eligible adults and
Agency has addressed. there are no important hidden
limiting the number of times
individuals participate in tobacco- (Comment) One comment asked FDA differences between the respondents
related studies will result in nationally for the opportunity to review the data that may affect their responses.
representative and unbiased data collection plans and instruments (Response) We will draw the original
collection on matters of importance for including the sample design, data sample with known, non-zero, and, to
FDA. collection methodology, and panel the extent possible, equal probabilities.
With this submission, FDA seeks performance evaluation plan. The same will apply to any additional
approval from OMB to establish the (Response) All the instruments and samples drawn for the panel to replace
Tobacco User Panel, a nationally background documents including our attrition. Furthermore, any subsample
representative, primarily Web-based plan for evaluating panel performance drawn from the panel for specific
panel of 4,000 current tobacco users. have been uploaded to the docket for studies will also result in known
Data collection activities will involve easy access. The documents included probabilities of selection. We will derive
pilot testing of panel recruitment and are the data collection plans and a strategy of spreading the survey-taking
management procedures and systems, methodology (Supporting Statement load over all panel members to avoid
mail and in-person household Part A), copies of the survey excessive burden on any single member
screening, in-person recruitment of instruments used to screen and recruit or group of members. We will
tobacco users, enrollment of selected panel members, as well as the first implement this strategy by randomly
household members, administration of a experimental or observation study selecting each subsample, but at the
baseline survey, and panel maintenance (Study 1), and the proposed sample same time keeping track of each
surveys, following all required informed design (Supporting Statement Part B). member’s survey-taking activity. As the
consent procedures for panel members. (Comment) One comment asked FDA number and frequency of survey-taking
Once the panel is established, panel to provide additional details about the for a given member increases, their
members will be asked to participate in proposed sample design and FDA’s probability of selection will decrease, a
asabaliauskas on DSK5VPTVN1PROD with NOTICES

up to eight experimental and approach to issues such as nonresponse strategy that we will implement using
observational studies over the 3-year of subjects and conditioning effects. probability proportion to size sampling.
panel commitment period. The first of (Response) The proposed sample This strategy will lead to known and
these studies (Study 1) is included in design is described in detail in measurable selection probabilities for
this information collection request; Supporting Statement, Part B. Briefly, each specific subsample.
approval for the remainder of the we propose a multi-stage area sample (Comment) One comment stated FDA
studies will appear in future requests. based on an address-based sampling should consider, whether in some
The current request also seeks approval frame. The probabilities (single, joint, instances, collecting fresh data from

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32966 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity or type of respondent responses per burden per Total hours
respondents responses
respondent response

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 or-
ders 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 and Tompson, T., 2009, Panel Dextrose in 32 mg single IV doses. The
using data from timed-readings of each Conditioning and Attrition in the AP- holders of these applications have
instrument, including the mail and field Yahoo! News Election Panel Study, voluntarily requested that FDA
Paper presented at the American
screeners, enrollment survey, baseline withdraw approval of their applications
Association for Public Opinion Research
survey, panel maintenance 64th Annual Conference. and have waived their opportunity for a
questionnaires, and Study 1 hearing.
questionnaire. Dated: June 4, 2015.
DATES: Effective June 10, 2015.
References Leslie Kux,
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
The following references have been Emily Helms Williams, Center for Drug
[FR Doc. 2015–14125 Filed 6–9–15; 8:45 am]
placed on display in the Division of Evaluation and Research, Food and
BILLING CODE 4164–01–P
Dockets Management (HFA–305), Food Drug Administration, 10903 New
and Drug Administration, 5630 Fishers Hampshire Ave., Bldg. 51, Rm. 6280,
Lane, rm. 1061, Rockville, MD 20852, Silver Spring, MD 20993–0002, 301–
DEPARTMENT OF HEALTH AND
and may be seen by interested persons 796–3381.
HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday
through Friday, and are available SUPPLEMENTARY INFORMATION: On June
Food and Drug Administration
electronically at http:// 29, 2012, FDA issued a Drug Safety
www.regulations.gov. [Docket No. FDA–2015–N–1702] Communication to notify health care
1. Baker, R., Blumberg, S., Brick, M., Couper,
professionals that the 32 mg, single IV
Baxter Healthcare Corporation et al.; dose of ondansetron HCl, indicated for
M., Courtright, M., Dennis, J. M.,
Withdrawal of Approval of One New prevention of nausea and vomiting
Dillman, D., Frankel, M., Garland, P.,
Groves, R., Kennedy, C., Krosnick, J. and Drug Application and Four Abbreviated associated with initial and repeat
Lavrakas, P., 2010, American Association New Drug Applications courses of emetogenic cancer
for Public Opinion Research Report on chemotherapy in adult patients, should
AGENCY: Food and Drug Administration,
Online Panels. Public Opinion Quarterly, be avoided due to the risk of a specific
74 (4), pp. 711–781. HHS.
2. Coen, T., Lorch, J. and Piekarski, L., 2005, ACTION: Notice. type of irregular heart rhythm called QT
The Effects of Survey Frequency on interval prolongation, which can lead to
Panelists’ Responses, Worldwide Panel SUMMARY: The Food and Drug Torsades de Pointes, an abnormal,
Research: Developments and Progress, Administration (FDA) is withdrawing potentially fatal heart rhythm.
Amsterdam, European Society for approval of one new drug application Subsequently, FDA contacted the
Opinion and Marketing Research. (NDA) for Ondansetron (ondansetron holders of the following applications
3. Nancarrow, C. and Catwright, T., 2007, hydrochloride (HCl)) Injection, USP in and informed them that the Agency
Online Access Panels and Tracking PL 2408 Plastic Container, 32 believes that in light of the safety
Research, The Conditioning Issue,
International Journal of Market milligrams (mg) in 50 milliliters (mL), concern associated with ondansetron
Research, 49(5), pp. 435–447. single intravenous (IV) dose, and four HCl in the 32 mg, single IV dose, the
4. Kruse, Y., Callegaro, M., Dennis, J. M., abbreviated new drug applications following drug products should be
DiSogra, C., Subias, S., Lawrence, M., (ANDAs) for ondansetron HCl and removed from the market:

Application number Drug Applicant

NDA 021915 ........................ Ondansetron Hydrochloride Injection, USP premix in Baxter Healthcare Corporation (Baxter), 32650 N. Wil-
Intravia Plastic Container. son Rd., Round Lake, IL 60073.
ANDA 077348 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Hospira, Inc. (Hospira), 275 North Field Dr., Depart-
Container. ment 389, Bldg. H2–2, Lake Forest, IL 60045.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ANDA 077480 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Teva Pharmaceuticals USA (Teva), 400 Chestnut
Container. Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 078291 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Bedford Labs (Bedford), 300 Northfield Rd., Bedford,
Container. OH 44146.
ANDA 078308 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Claris Lifesciences Ltd. (Claris), 2325 Camino Vida
Container. Roble, Suite A, Carlsbad, CA 92011.

VerDate Sep<11>2014 16:46 Jun 09, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1
Document Created: 2015-12-15 15:17:40
Document Modified: 2015-12-15 15:17:40
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by July 10, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 32963
80 FR 32963 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment of a Tobacco User Panel

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 111 (June 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
