[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