
[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55725-55727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0717]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Evaluation 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 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 October 
11, 2013.

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-New and 
title ``Evaluation of FDA's General Market Youth Tobacco Prevention 
Campaigns''. 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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.

Evaluation 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) (Pub. L. 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.
    In support of the provisions of the Tobacco Control Act that 
require FDA to protect the public health and to reduce tobacco use by 
minors, FDA requests OMB approval to collect information needed to 
evaluate FDA's general market youth tobacco prevention campaigns. 
Comprehensive evaluation of FDA's public education campaigns is needed 
to ensure campaign messages are effectively received, understood, and 
accepted by those for whom they are intended. Evaluation is an 
essential organizational practice in public health and a systematic way 
to account for and improve public health actions.
    FDA plans to conduct two studies to evaluate the effectiveness of 
its youth tobacco prevention campaigns: (1) An outcome evaluation study 
consisting of a youth experimenter and non-trier initiative and a male 
only youth rural smokeless initiative and (2) a media tracking survey. 
The timing of these studies will be designed to follow the multiple, 
discrete waves of media advertising planned for the campaigns.
     Outcome Evaluation Study. The outcome evaluation study 
consists of an initial baseline survey of youth aged 11 to 16 before 
the campaigns launch. The baseline will be followed by three 
longitudinal followup surveys of the same youth, aged 11 to 16, at 
approximate 8-month intervals after the campaigns launch. As the cohort 
will be aging over this time period, the data collected throughout the 
study will reflect information from youth aged 11 to 18. Information 
will be collected about youth awareness of and exposure to campaign 
advertisements and about youth knowledge, attitudes, and beliefs 
related to tobacco use. In addition, the surveys will measure tobacco 
use susceptibility and current use. Information will also be collected 
on demographic variables including age, sex, race/ethnicity, grade 
level, and primary language. Finally, a baseline survey will also be 
conducted with the parent or legal guardian of each youth baseline 
survey participant in order to collect data on household 
characteristics and media use.
     Media Tracking Survey. The media tracking survey consists 
of assessments of youth aged 13 to 17 conducted at 4 months, 12 months, 
and 20 months post launch. The tracking survey will assess awareness of 
the campaigns and receptivity to campaign messages. These data will 
provide critical evaluation feedback to the campaigns and will be 
conducted with sufficient frequency to match the cyclical patterns of 
media advertising and variation in exposure to allow for mid-campaign 
refinements.
    All information will be collected through in-person and Web-based 
questionnaires. Youth respondents will be recruited from two sources: 
(1) A probability sample drawn from 90 U.S. media markets gathered 
using an address-based postal mail sampling of U.S. households for the 
outcome evaluation study and (2) an Internet

[[Page 55726]]

panel for the media tracking survey. Participation in the studies is 
voluntary.
    The information collected is necessary to inform FDA's efforts and 
measure the effectiveness and public health impact of the campaigns. 
Data from the media tracking survey will be used to estimate awareness 
of and exposure to the campaigns among youth nationally as well as 
among youth in geographic areas targeted by the campaign. Data from the 
outcome evaluation study will be used to examine statistical 
associations between exposure to the campaigns and subsequent changes 
in specific outcomes of interest, which will include knowledge, 
attitudes, beliefs, and intentions related to tobacco use, as well as 
behavioral outcomes including tobacco use.
    FDA's burden estimate is based on prior experience with in-person 
and Internet panel studies similar to the Agency's plan presented in 
this document. To obtain the target number of completed surveys 
(``completes'') for the outcome evaluation study, 40,238 youth 
respondents and their parent or legal guardian will be contacted 
through a screening and consent process. The estimated burden per 
response is 10 minutes (0.17), for a total of 6,840 hours. An estimated 
8,057 youth will complete the Youth Baseline Questionnaire in order to 
yield 6,445 completes at the first followup; 5,156 completes at the 
second followup; and 4,125 completes at the third followup survey 
waves. The estimated burden per response is 30 minutes (0.5) for the 
baseline questionnaire, for a total of 4,029 hours. The estimated 
burden per response is 45 minutes (0.75) for each followup 
questionnaire, for a total of 4,834 burden hours for the first Followup 
Questionnaire; 3,867 hours for the second Followup Questionnaire; and 
3,094 hours for the third Followup Questionnaire. The parent or legal 
guardian of youth recruited to complete the Youth Baseline 
Questionnaire will also complete a Parent Baseline Questionnaire with 
an estimate burden per response of 10 minutes (0.17), for a total of 
1,704 hours. Additionally for clarity, FDA has added male youth, aged 
11-18, to the burden chart. This is not a new component to the 
information collection as they were already a component of the study 
that falls within the group of youth aged 11-18. The rural smokeless 
campaign component of the evaluation differs from the experimenter and 
non-trier campaigns component in one major way--only males in the age 
range will be considered eligible.
    To obtain the target number of completes for the media tracking 
survey, 40,000 respondents will be contacted for each survey wave 
through an online invitation. The estimated burden per response is 2 
minutes (0.03), for a total of 1,200 hours for the first Media Tracking 
Screener; 1,200 hours for the second Media Tracking Screener; and 1,200 
hours for the third Media Tracking Screener. An estimated 4,000 youths 
will be recruited to complete each of the three waves of the media 
tracking survey. The estimated burden per response is 30 minutes for 
each questionnaire, for a total of 2,000 hours for the first Media 
Tracking Questionnaire; 2,000 hours for the second Media Tracking 
Questionnaire; and 2,000 hours for the third Media Tracking 
Questionnaire.
    The target number of completed campaign questionnaires for all 
responses is 211,859. The total estimated burden is 37,836 hours. After 
further review of the burden estimates, the Agency has revised the 
interview hourly burden in table 1, which was based on the number of 
samples needed to assess the campaigns in the final data collection 
request. The estimates are reflective of a decrease in the expected 
sample size and an increase in the timing for the screener followup 
surveys. The estimates of the sample size for the youth outcome 
baseline interviews in the 60-day Federal Register notice was an 
estimate for the general market population. The survey timing increased 
slightly for screeners and for followups because it was considered more 
realistic based on the instrument length.
    In the Federal Register of June 21, 2013 (78 FR 37546), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received, which were not 
PRA related, and are beyond the scope of this collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
        Type of respondent/activity             Number of      responses per     Total annual          Average burden per response          Total hours
                                               respondents       respondent       responses
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Outcome Evaluation Study General Population/          40,238                1           40,238  0.17 (10 minutes).......................           6,840
 Screener and Consent Process (Youth and
 Parent).
United States Youth aged 11 to 16/Youth                8,057                1            8,057  0.5 (30 minutes)........................           4,029
 Baseline Questionnaire (Experimenter and
 Non-Trier).
United States Youth aged 11 to 18/Youth                6,445                1            6,445  0.75 (45 minutes).......................           4,834
 First Followup Questionnaire (Experimenter
 and Non-Trier).
United States Youth aged 11 to 18/Youth                5,156                1            5,156  0.75 (45 minutes).......................           3,867
 Second Followup Questionnaire
 (Experimenter and Non-Trier).
United States Youth aged 11 to 18/Youth                4,125                1            4,125  0.75 (45 minutes).......................           3,094
 Third Followup Questionnaire (Experimenter
 and Non-Trier).
United States Rural Markets Male Youth aged            1,969                1            1,969  0.50 (30 minutes).......................             985
 11 to 18/Youth Baseline Questionnaire.
United States Rural Markets Male Youth aged            1,575                1            1,575  0.75 (45 minutes).......................           1,182
 11 to 18/Youth First Followup
 Questionnaire.
United States Rural Markets Male Youth aged            1,260                1            1,260  0.75 (45 minutes).......................             945
 11 to 18/Youth Second Followup
 Questionnaire.
United States Rural Markets Male Youth aged            1,008                1            1,008  0.75 (45 minutes).......................             756
 11 to 18/Youth Third Followup
 Questionnaire.

[[Page 55727]]

 
Parent of Youth Baseline Survey                       10,026                1           10,026  0.17 (10 minutes).......................           1,704
 Participants/Parent Baseline Questionnaire.
United States Youth aged 13 to 17/First               40,000                1           40,000  0.03 (2 minutes)........................           1,200
 Media Tracking Screener.
United States Youth aged 13 to 17/First                4,000                1            4,000  0.5 (30 minutes)........................           2,000
 Media Tracking Questionnaire.
United States Youth aged 13 to 17/Second              40,000                1           40,000  0.03 (2 minutes)........................           1,200
 Media Tracking Screener.
United States Youth aged 13 to 17/Second               4,000                1            4,000  0.5 (30 minutes)........................           2,000
 Media Tracking Questionnaire.
United States Youth aged 13 to 17/Third               40,000                1           40,000  0.03 (2 minutes)........................           1,200
 Media Tracking Screener.
United States Youth aged 13 to 17/Third                4,000                1            4,000  0.5 (30 minutes)........................           2,000
 Media Tracking Questionnaire.
                                            ---------------------------------------------------                                          ---------------
    Total Hours............................  ...............  ...............  ...............  ........................................          37,836
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22014 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P


