Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment of a Tobacco User Panel, 62160-62161 [2014-24538]
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62160
Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices
regulations and ORR policies and
procedures.
Melody Wayland,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services,
Division of Grants Policy.
[FR Doc. 2014–24555 Filed 10–15–14; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1533]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishment of a
Tobacco User Panel
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the establishment of a probability-based
panel of tobacco users.
DATES: Submit either electronic or
written comments on the collection of
information by December 15, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:19 Oct 15, 2014
Jkt 235001
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed collection of
information, before submitting the
collection to OMB for approval. To
comply with this requirement, FDA is
publishing notice of the proposed
collection of information set forth in
this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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
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 (Baker
et al., 2010). 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 (e.g., Coen, Lorch
and Piekarski, 2005; Nancarrow and
Catwright, 2007). That is, consumers in
these panels complete surveys so
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 (e.g., Kruse et al.,
2009), panel tenure (e.g., Coen, Lorch
and Piekarski, 2005), and frequency of
the survey request (e.g., Nancarrow and
Catwright, 2007). 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, the 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 be 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
E:\FR\FM\16OCN1.SGM
16OCN1
Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices
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
62161
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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
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 .......................................
Focus Group Subjects .................................................
29,385
4,000
........................
........................
........................
10,285
2,800
2,800
20
20
0.33
0.33
0.33
3.0
2.7
0.50
0.33
0.33
0.33
0.33
9,697
1,320
1,320
12,000
10,800
5,143
924
924
7
7
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 ..........................
1.5 ..........................
1,552
330
330
960
3,564
823
231
231
7
10
Total ......................................................................
49,310
........................
........................
................................
8,038
Total hours
1 There
are no capital or operating and maintenance costs or associated with this collection of information.
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.
* Includes
The burden above 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.
Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24538 Filed 10–15–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0555]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
ACTION:
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.
SUMMARY:
17:19 Oct 15, 2014
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:
Medical Devices; Device Tracking—21
CFR part 821 (OMB Control Number
0910–0442)—Extension
Notice.
VerDate Sep<11>2014
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
Fax written comments on the
collection of information by November
17, 2014.
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 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
Jkt 235001
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food,
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360i(e)(1) and (e)(2)) that
were added by the Safe Medical Devices
Act of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA, which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule that
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the FD&C Act, as
amended by FDAMA, provides that
FDA may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62160-62161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1533]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the establishment of a probability-based
panel of tobacco users.
DATES: Submit either electronic or written comments on the collection
of information by December 15, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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 (Baker et al., 2010). 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 (e.g., Coen,
Lorch and Piekarski, 2005; Nancarrow and Catwright, 2007). 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 (e.g., Kruse et al., 2009), panel tenure (e.g., Coen, Lorch and
Piekarski, 2005), and frequency of the survey request (e.g., Nancarrow
and Catwright, 2007). 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, the 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 be 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
[[Page 62161]]
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:
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............... 4,000 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... .............. 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
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 burden above 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.
Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24538 Filed 10-15-14; 8:45 am]
BILLING CODE 4164-01-P
