[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40156-40157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16000]
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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.
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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 http://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,
[email protected].
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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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........................
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Total....................... 9,600 .............. .............. .............. 1,000
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\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