[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Pages 37546-37548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14809]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation 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 the Evaluation of FDA's General Market 
Youth Tobacco Prevention Campaigns.

DATES: Submit either electronic or written comments on the collection 
of information by August 20, 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.

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

[[Page 37547]]

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 
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 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 18 conducted at 4 months, 12 months, and 20 months postlaunch. 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 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, 55,695 youth 
respondents and their parent or legal guardian will be contacted 
through a screening and consent process. The estimated burden per 
response is 5 minutes (0.083), for a total of 4,623 hours. An estimated 
12,940 youth will complete the Youth Baseline Questionnaire in order to 
yield 10,352 completes at the first followup, 8,281 completes at the 
second followup, and 6,625 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 6,470 hours. The estimated 
burden per response is 30 minutes (0.5) for each followup 
questionnaire, for a total of 5,176 burden hours for the first Followup 
Questionnaire, 4,141 hours for the second Followup Questionnaire, and 
3,313 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 
2,200 hours.
    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 youth 
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 
respondents is 238,833. The total estimated burden is 35,523 hours. OMB 
approval is requested for 3 years.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
         Type of respondent                 Activity            Number of     responses per   Total annual   Average burden per response    Total hours
                                                               respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Population.................  Screener and Consent            55,695               1          55,695  0.083 (5 min.).............           4,623
                                      Process (Youth and
                                      Parent).
Youth aged 11-18 in the United       Outcome Evaluation              12,940               1          12,940  0.5 (30 min.)..............           6,470
 States.                              Youth Baseline
                                      Questionnaire.
                                     Outcome Evaluation              10,352               1          10,352  0.5 (30 min.)..............           5,176
                                      Youth 1st Followup
                                      Questionnaire.
                                     Outcome Evaluation               8,281               1           8,281  0.5 (30 min.)..............           4,141
                                      Youth 2nd Followup
                                      Questionnaire.
                                     Outcome Evaluation               6,625               1           6,625  0.5 (30 min.)..............           3,313
                                      Youth 3rd Followup
                                      Questionnaire.

[[Page 37548]]

 
Parent of Youth Baseline Survey      Outcome Evaluation              12,940               1          12,940  0.17 (10 min.).............           2,200
 Participants.                        Parent Baseline
                                      Questionnaire.
Youth aged 13-18 in the United       Screener..............          40,000               1          40,000  0.03 (2 min.)..............           1,200
 States.                             1st Media Tracking               4,000               1           4,000  0.5 (30 min.)..............           2,000
                                      Questionnaire.
                                     Screener..............          40,000  ..............          40,000  0.03 (2 min.)..............           1,200
                                     2nd Media Tracking               4,000               1           4,000  0.5 (30 min.)..............           2,000
                                      Questionnaire.
                                     Screener..............          40,000               1          40,000  0.03 (2 min.)..............           1,200
                                     3rd Media Tracking               4,000               1           4,000  0.5 (30 min.)..............           2,000
                                      Questionnaire.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ......................         238,833  ..............  ..............  ...........................         35,523
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14809 Filed 6-20-13; 8:45 am]
BILLING CODE 4160-01-P