[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39675-39677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14352]


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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 July 
18, 2016.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0753. 
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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 0910-0753--Revision

    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 feature televised advertisements along with 
complementary ads on radio, on the Internet, in print, and through 
other forms of media.
    Evaluation is an essential organizational practice in public health 
and a systematic way to account for and improve public health actions. 
Comprehensive evaluation of FDA's public education campaigns will be 
used to document whether the intended audience is aware of and 
understands campaign messages; and whether campaign exposure influences 
beliefs about tobacco, susceptibility to tobacco use, and tobacco use 
behavior. All of the information collected is integral to that 
evaluation.
    FDA is in the process of conducting three studies to evaluate the 
effectiveness of its youth tobacco prevention campaigns: (1) An outcome 
evaluation study of its General Market Youth Tobacco Prevention 
Campaign, (2) an outcome evaluation of the Rural Male Youth Smokeless 
Tobacco Campaign, and (3) a media tracking survey. The timing of these 
studies follows the multiple, discrete waves of media advertising 
planned for the campaigns.

Evaluation of the General Market Youth Tobacco Prevention Campaign

    The General Market Youth Tobacco Prevention Campaign targets youth 
who are at-risk for smoking, or who have experimented with but not 
progressed to regular smoking. The outcome evaluation of the campaign 
consists of an initial baseline survey of youth aged 11 to 16 before 
campaigns launch, followed by a number of longitudinal follow-up 
surveys of the same youth at approximate 8 month intervals. To date, 
the baseline and three follow-up surveys have been conducted. A 
baseline survey was also conducted with the parent or legal guardian of 
each youth, to collect data on household characteristics and media use. 
Because the cohort aged over the study period, data have been collected 
from youth aged 11 to 18. Information has been 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 have measured tobacco use susceptibility and current use. 
Information has been collected on demographic variables including age, 
sex, race/ethnicity, grade level, and primary language.

Evaluation of the Rural Male Youth Smokeless Tobacco Campaign

    Baseline data collection for the Rural Male Youth Smokeless 
Campaign evaluation will begin in January 2016. The three follow up 
surveys will begin in August 2016, March 2017, and October 2017. The 
evaluation of the Rural Male Youth Smokeless Campaign differs from the 
General Market Campaign evaluation, in that only males in the age range 
will be considered eligible.

Media Tracking Survey

    The media tracking survey consists of assessments of youth aged 13 
to 18 conducted periodically during the campaign period. The tracking 
survey assesses awareness of the campaign and

[[Page 39676]]

receptivity to campaign messages. These data provide critical 
evaluation feedback to the campaigns and are conducted with sufficient 
frequency to match the cyclical patterns of media advertising and 
variation in exposure to allow for mid-campaign refinements.
    All information is being collected through in-person and web-based 
questionnaires. Youth respondents were 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 
evaluations, and (2) an Internet panel for the media tracking survey. 
Participation in the studies is voluntary.
    The studies are being conducted in support of the provisions of the 
Tobacco Control Act, which require FDA to protect the public health and 
to reduce tobacco use by minors. The information being collected is 
necessary to inform FDA's efforts towards those goals and to measure 
the effectiveness and public health impact of the campaigns. Data from 
the outcome evaluation of the General Market and Rural Male Youth 
Smokeless campaigns is being 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. Data from the media tracking survey is being 
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.
    FDA requests OMB approval to collect additional information for the 
purpose of extending the evaluation of FDA's general market youth 
tobacco prevention campaign. Specifically, FDA requests approval to 
conduct a fourth follow-up survey with youth who are part of the first 
longitudinal cohort, and who participated in the baseline and first 
through third follow-up surveys. Based on earlier response rates, we 
estimate that 1,607 will participate in this survey, for a total of 
6,666 annualized participants (including 5,059 previously approved). At 
0.75 hours per survey, this adds 1,205 annualized burden hours to the 
3,794 previously approved hours for a total of 5,000 annualized burden 
hours. Baseline data collection for this cohort, approved for 2,288 
participants (1,144 burden hours at 30 minutes per survey) is complete.
    FDA also requests approval to develop and survey a second 
longitudinal cohort which will consist of an entirely new sample of 
youth, ages 11-16 at baseline. Development of the second cohort will 
involve screening 17,467 individuals in the general population for a 
total of 30,880 participants, including 13,413 previously approved. At 
10 minutes per screening, this adds 2,970 burden hours to the already 
approved 2,280 hours for a total of 5,250 annualized burden hours.
    We expect this screening to yield 2,667 youth annually who will 
complete the baseline survey for the new cohort at 45 minutes per 
survey, resulting in a total of 2,000 burden hours for youth. Three 
follow up surveys are planned for this cohort. We expect a total of 
6,270 participants to complete follow up surveys for a total burden of 
4,703 annualized burden hours. As was done with the first cohort, 
parents of the 2,667 youth will also complete surveys for a total of 
6,009 parent surveys including the 3,342 previously approved. At 10 
minutes per survey, this adds 453 hours to the previously approved 568 
hours for a total of 1,021 annualized burden hours.
    FDA also requests approval to extend the media tracking survey. 
This survey is cross sectional and thus necessitates brief screening 
prior to data collection. We expect 20,000 participants to complete 
screener for a total of 60,000 participants (including 40,000 
previously approved). At 2 minutes per screener, this adds 600 burden 
hours to the previously approved 1,200 hours for a total of 1,800 
annualized burden hours. We expect the screening process to yield 2,000 
participants, for a total of 6,000 including 4,000 previously approved. 
At 30 minutes per survey, this adds 1,000 burden hours to the already-
approved 2,000 for a total of 3,000 annualized burden hours.
    FDA also requests approval to extend the time period of the 
evaluation of the Male Rural Youth Smokeless Campaign. No new burden 
hours will be required to complete this study. Previously approved 
burden for the evaluation of the Rural Male Youth Smokeless Campaign 
include 656 annualized participants (328 annualized burden hours at 30 
minutes per questionnaire) for the baseline questionnaire and 1,281 
annualized participants (961 annualized burden hours at 0.75 hours per 
questionnaire).
    In the Federal Register of February 19, 2016 (81 FR 8511), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Two burden items have been revised since the publication of the 60-
day notice. First, number of respondents planned for the General 
Population Screener and Consent Process has been corrected to annualize 
the new screening participants over the 3-year extension. Second, the 
burden per response for the Cohort 2 Youth Baseline has been increased 
to 45 minutes to better reflect the actual time required for completion 
as assessed during the previous data collection rounds.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                 Number of
                                                                    Number of    responses      Total
          Type of respondent                     Activity          respondents      per         annual      Average  burden per  response    Total hours
                                                                                 respondent   responses
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General Population....................  Screener and Consent            30,880            1       30,880  0.17 (10 minutes)................        5,250
                                         Process (Youth and
                                         Parent).
Parent of Youth Baseline Survey         Parent Baseline                  6,009            1        6,009  0.17 (10 minutes)................        1,022
 Participants.                           Questionnaire.
Youth Aged 11 to 18 (Experimenters and  Youth Baseline                   2,288            1        2,288  0.50 (30 minutes)................        1,144
 Non-Triers).                            Questionnaire
                                         (Experimenters & Non-
                                         Triers).
                                        Youth 1st, 2nd, 3rd, 4th         6,666            1        6,666  0.75 (45 minutes)................        5,000
                                         Follow-up Questionnaire
                                         (Experimenters and Non-
                                         Triers)
Youth Aged 13 to 17...................  Media Tracking Screener..       60,000            1       60,000  0.03 (2 minutes).................        1,800
                                        Media Tracking                   6,000            1        6,000  0.50 (30 minutes)................        3,000
                                         Questionnaires 1st, 2nd,
                                         and 3rd

[[Page 39677]]

 
Male Youth Aged 11 to 18 in U.S. Rural  Youth Baseline                     656            1          656  0.50 (30 minutes)................          328
 Markets (Male Rural Smokeless).         Questionnaire (Male
                                         Rural Smokeless).
                                        Youth 1st, 2nd, 3rd              1,281            1        1,281  0.75 (45 minutes)................          961
                                         (Male, Rural Smokeless)
                                         Follow-up Questionnaire
Cohort 2--Youth Aged 11 to 18.........  Cohort 2--Youth Baseline         2,667            1        2,667  0.75 (45 minutes)................        2,000
                                         Questionnaire.
                                        Cohort 2--Youth 1st, 2nd,        6,270            1        6,270  0.75 (45 minutes)................        4,703
                                         3rd Follow-Up
                                         Questionnaire
                                                                  ---------------------------------------                                   ------------
    Total.............................                                                           122,717                                          25,208
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14352 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-P