Agency Information Collection Activities; Proposed Collection; Comment Request; Copy Testing of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns, 40156-40157 [2013-16000]
Download as PDF
<![CDATA[
40156
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices
3. van Herpen, E. and H. C. M. van Trijp,
‘‘Front-of-Pack Nutrition Labels, Their Effect
on Attention and Choices When Consumers
Have Varying Goals and Time Constraints,’’
Appetite, vol. 57, pp. 148–160, 2011.
4. Fox, R. J., D. M. Krugman, J. E. Fletcher,
and P. M. Fischer, ‘‘Adolescents’ Attention to
Beer and Cigarette Print Ads and Associated
Product Warnings,’’ Journal of Advertising,
vol. 27, pp. 57–68, 1998.
5. Galesic, M., R. Tourangeau, M. P.
Couper, and F. G. Conrad, ‘‘Eye-Tracking
Data: New Insights on Response Order Effects
and Other Cognitive Shortcuts in Survey
Responding,’’ Public Opinion Quarterly, vol.
72, pp. 892–913, 2008.
6. Graesser, A. C., Z. Cai, M. M. Louwerse,
and F. Daniel, ‘‘Question Understanding Aid
(QUAID): A Web Facility That Tests Question
Comprehensibility,’’ Public Opinion
Quarterly, vol. 70, pp. 3–22, 2006.
7. Reutskaja, E., R. Nagel, C. F. Camerer,
and A. Rangel, ‘‘Search Dynamics in
Consumer Choice Under Time Pressure: An
Eye-Tracking Study,’’ American Economic
Review, vol. 101, pp. 900–926, 2011.
8. FDA, ‘‘What We Do.’’ Available at
https://www.fda.gov/AboutFDA/WhatWeDo/
default.htm.
9. FDA, ‘‘Strengthen Social and Behavioral
Science to Help Consumers and Professionals
Make Informed Decisions About Regulated
Products,’’ Section 8 in Strategic Plan for
Regulatory Science. Available at https://
www.fda.gov/ScienceResearch/
SpecialTopics/RegulatoryScience/
ucm268150.htm.
Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16001 Filed 7–2–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0778]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Copy Testing of
the Food and Drug Administration’s
General Market Youth Tobacco
Prevention Campaigns
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 a notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:48 Jul 02, 2013
Jkt 229001
notice. This notice solicits comments on
Copy Testing of FDA’s General Market
Youth Tobacco Prevention Campaigns.
Copy Testing of FDA’s General Market
Youth Tobacco Prevention Campaigns
(OMB Control Number—0910—New)
Submit either electronic or
written comments on the collection of
information by September 3, 2013.
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Public Law 111–31)
amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to grant
FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect public health and to reduce
tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21
U.S.C. 393(d)(2)(D)) supports the
development and implementation of
FDA public education campaigns
related to tobacco use. Accordingly,
FDA is currently developing and
implementing youth-targeted public
education campaigns to help prevent
tobacco use among youth and thereby
reduce the public health burden of
tobacco. The campaigns will feature
televised advertisements along with
complementary ads on radio, on the
Internet, in print, and through other
forms of media.
FDA requests OMB approval to collect
information needed to assess the
potential effectiveness of draft (or
‘‘rough-cut’’) youth tobacco prevention
campaign advertisements prior to
launch. This information will be
collected through copy testing as part of
the message development phase. Copy
testing involves showing rough-cut
versions of campaign advertisements to
a small sample of the campaign target
audience to ensure understanding of
messages and assess any potential
unintended consequences. Copy testing
of FDA’s rough-cut general market
youth tobacco prevention campaign
advertisements is needed to ensure
development and execution of
meaningful and effective public
education tactics.
FDA plans to conduct three voluntary
cross-sectional studies involving youth
ages 12 to 17 to copy test the Agency’s
general market youth tobacco
prevention campaign advertisements:
1. Youth Experimenter Copy Testing:
The study will be designed to obtain
insights into potential effectiveness and
unintended consequences of
advertisements designed to target
general market youth ages 12–17 who
are currently experimenting with
tobacco products (i.e., have smoked
between 1 and 100 cigarettes).
2. Youth Non-Trier Copy Testing: The
study will be designed to obtain insights
into potential effectiveness and
unintended consequences of
advertisements designed to target
general market youth ages 12–17 who
DATES:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
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
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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\03JYN1.SGM
03JYN1
40157
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices
have not tried tobacco but are most at
risk of initiation.
3. Youth Rural Smokeless Copy
Testing: The study will be designed to
obtain insights into potential
effectiveness and unintended
consequences of advertisements
designed to target general market youth
ages 12–15 who reside in rural areas,
with a focus on males at risk of
smokeless tobacco initiation.
In each study, each study participant
will view a maximum of two rough cut
tobacco prevention advertisements.
After reviewing the advertisements,
each participant will respond to
questions traditionally used in
formative testing of advertisements to
assess his or her receptivity to the
advertisements. Study data will be used
to refine rough-cut television
advertisements prior to campaign
launch. The study data will be collected
from participants of an Internet panel.
FDA’s burden estimate is based on
prior experience with Internet panel
studies similar to the Agency’s plan
presented in this document. To obtain
the target number of completed surveys
(‘‘completes’’) for the Youth
Experimenter Copy Testing, 3,600 youth
respondents and their parent or legal
guardian will be contacted through a
screening and consent process. The
estimated burden per response for the
screening and consent is 5 minutes
(0.083 hours) per respondent, for a total
of 300 hours. An estimated 1,200 youth
respondents will then complete the
copy test survey. The estimated burden
per response is 10 minutes (0.17 hours)
for the Youth Experimenter Copy
Testing survey, for a total of 200 hours.
To obtain the target number of
completes for the Youth Non-Trier Copy
Testing, 1,800 youth respondents and
their parent or legal guardian will be
contacted through a screening and
consent process. The estimated burden
per response for screening and consent
is 5 minutes (0.083 hours) per
respondent, for a total of 150 hours. An
estimated 600 youth respondents will
then complete the copy test survey. The
estimated burden per response is 10
minutes (0.17 hours) for the Youth
Experimenter Copy Testing survey, for a
total of 100 hours.
To obtain the target number of
completes for the Youth Rural
Smokeless Copy Testing, 1,800 youth
respondents and their parent or legal
guardian will be contacted through a
screening and consent process. The
estimated burden per response for
screening and consent is 5 minutes
(0.083 hours) per respondent, for a total
of 150 hours. An estimated 600 youth
respondents will then complete the
copy test survey. The estimated burden
per response is 10 minutes (0.17 hours)
for the Youth Rural Smokeless Copy
Testing survey, for a total of 100 hours.
The target number of completed copy
testing surveys for all respondents is
2,400. The total estimated burden is
1,000 hours.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Youth
Youth
Youth
Youth
Youth
Youth
Number of
responses per
respondent
Total annual
responses
Experimenter Screener and Consent ........................
Experimenter Copy Testing .......................................
Non-Trier Screener and Consent ..............................
Non-Trier Copy Testing .............................................
Rural Smokeless Screener and Consent ..................
Rural Smokeless Copy Testing .................................
3,600
1,200
1,800
600
1,800
600
1
1
1
1
1
1
3,600
1,200
1,800
600
1,800
600
Total ..............................................................................
9,600
........................
........................
1 There
0.083 (5
0.17 (10
0.083 (5
0.17 (10
0.083 (5
0.17 (10
Total hours
min.)
min.)
min.)
min.)
min.)
min.)
300
200
150
100
150
100
........................
1,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16000 Filed 7–2–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2013–0012; OMB No.
1660–NEW]
emcdonald on DSK67QTVN1PROD with NOTICES
Average
burden per
response
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
The Federal Emergency
Management Agency (FEMA) will
submit the information collection
SUMMARY:
VerDate Mar<15>2010
17:48 Jul 02, 2013
Jkt 229001
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
will describe the nature of the
information collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
the actual data collection instruments
FEMA will use.
DATES: Comments must be submitted on
or before August 2, 2013.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to
oira.submission@omb.eop.gov or faxed
to (202) 395–5806.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address FEMA-InformationCollections-Management@dhs.gov.
SUPPLEMENTARY INFORMATION:
Collection of Information
Title: Community Drill Day
Registration.
OMB Control Number: 1660–NEW.
Type of information collection: New
information collection.
Form Titles and Numbers: FEMA
Form 008–0–8, Community Drill Day.
Abstract: FEMA’s Individual and
Community Preparedness Division is
requesting comments on a new
information collection for its
registration of individuals and
organizations for the Community Drill
Day. The registration process allows for
E:\FR\FM\03JYN1.SGM
03JYN1
]]>Agencies
[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40156-40157]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0778]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Copy Testing of the Food and Drug Administration's
General Market Youth Tobacco Prevention Campaigns
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 a 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 Copy Testing of FDA's General Market Youth
Tobacco Prevention Campaigns.
DATES: Submit either electronic or written comments on the collection
of information by September 3, 2013.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@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 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.
Copy Testing of FDA's General Market Youth Tobacco Prevention Campaigns
(OMB Control Number--0910--New)
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Public Law 111-31) amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health and to reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the
development and implementation of FDA public education campaigns
related to tobacco use. Accordingly, FDA is currently developing and
implementing youth-targeted public education campaigns to help prevent
tobacco use among youth and thereby reduce the public health burden of
tobacco. The campaigns will feature televised advertisements along with
complementary ads on radio, on the Internet, in print, and through
other forms of media.
FDA requests OMB approval to collect information needed to assess
the potential effectiveness of draft (or ``rough-cut'') youth tobacco
prevention campaign advertisements prior to launch. This information
will be collected through copy testing as part of the message
development phase. Copy testing involves showing rough-cut versions of
campaign advertisements to a small sample of the campaign target
audience to ensure understanding of messages and assess any potential
unintended consequences. Copy testing of FDA's rough-cut general market
youth tobacco prevention campaign advertisements is needed to ensure
development and execution of meaningful and effective public education
tactics.
FDA plans to conduct three voluntary cross-sectional studies
involving youth ages 12 to 17 to copy test the Agency's general market
youth tobacco prevention campaign advertisements:
1. Youth Experimenter Copy Testing: The study will be designed to
obtain insights into potential effectiveness and unintended
consequences of advertisements designed to target general market youth
ages 12-17 who are currently experimenting with tobacco products (i.e.,
have smoked between 1 and 100 cigarettes).
2. Youth Non-Trier Copy Testing: The study will be designed to
obtain insights into potential effectiveness and unintended
consequences of advertisements designed to target general market youth
ages 12-17 who
[[Page 40157]]
have not tried tobacco but are most at risk of initiation.
3. Youth Rural Smokeless Copy Testing: The study will be designed
to obtain insights into potential effectiveness and unintended
consequences of advertisements designed to target general market youth
ages 12-15 who reside in rural areas, with a focus on males at risk of
smokeless tobacco initiation.
In each study, each study participant will view a maximum of two
rough cut tobacco prevention advertisements. After reviewing the
advertisements, each participant will respond to questions
traditionally used in formative testing of advertisements to assess his
or her receptivity to the advertisements. Study data will be used to
refine rough-cut television advertisements prior to campaign launch.
The study data will be collected from participants of an Internet
panel.
FDA's burden estimate is based on prior experience with Internet
panel studies similar to the Agency's plan presented in this document.
To obtain the target number of completed surveys (``completes'') for
the Youth Experimenter Copy Testing, 3,600 youth respondents and their
parent or legal guardian will be contacted through a screening and
consent process. The estimated burden per response for the screening
and consent is 5 minutes (0.083 hours) per respondent, for a total of
300 hours. An estimated 1,200 youth respondents will then complete the
copy test survey. The estimated burden per response is 10 minutes (0.17
hours) for the Youth Experimenter Copy Testing survey, for a total of
200 hours.
To obtain the target number of completes for the Youth Non-Trier
Copy Testing, 1,800 youth respondents and their parent or legal
guardian will be contacted through a screening and consent process. The
estimated burden per response for screening and consent is 5 minutes
(0.083 hours) per respondent, for a total of 150 hours. An estimated
600 youth respondents will then complete the copy test survey. The
estimated burden per response is 10 minutes (0.17 hours) for the Youth
Experimenter Copy Testing survey, for a total of 100 hours.
To obtain the target number of completes for the Youth Rural
Smokeless Copy Testing, 1,800 youth respondents and their parent or
legal guardian will be contacted through a screening and consent
process. The estimated burden per response for screening and consent is
5 minutes (0.083 hours) per respondent, for a total of 150 hours. An
estimated 600 youth respondents will then complete the copy test
survey. The estimated burden per response is 10 minutes (0.17 hours)
for the Youth Rural Smokeless Copy Testing survey, for a total of 100
hours.
The target number of completed copy testing surveys for all
respondents is 2,400. The total estimated burden is 1,000 hours.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Youth Experimenter Screener and 3,600 1 3,600 0.083 (5 min.) 300
Consent........................
Youth Experimenter Copy Testing. 1,200 1 1,200 0.17 (10 min.) 200
Youth Non-Trier Screener and 1,800 1 1,800 0.083 (5 min.) 150
Consent........................
Youth Non-Trier Copy Testing.... 600 1 600 0.17 (10 min.) 100
Youth Rural Smokeless Screener 1,800 1 1,800 0.083 (5 min.) 150
and Consent....................
Youth Rural Smokeless Copy 600 1 600 0.17 (10 min.) 100
Testing........................
-------------------------------------------------------------------------------
Total....................... 9,600 .............. .............. .............. 1,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16000 Filed 7-2-13; 8:45 am]
BILLING CODE 4160-01-P
