[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46021-46022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18938]


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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 
3, 2019.

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 0910-0753. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 the Food and Drug Administration's General Market Youth 
Tobacco Prevention Campaigns

OMB Control Number 0910-0753--Extension

Overview of the Evaluation Studies
    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) amended 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

[[Page 46022]]

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 the 
information collected is integral to that evaluation.
    FDA conducted 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. The outcome evaluation of the smokeless tobacco campaign and 
the media tracking survey are now complete, while evaluation of the 
General Market Youth Tobacco Prevention campaign is ongoing.
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 smoking but 
not progressed to regular smoking. The campaign evaluation consists of 
surveys conducted with two cohorts of youth and their parents or 
guardians. Each cohort consists of an initial baseline survey of youth 
aged 11 to 16, and followup surveys of the same youth at approximate 8-
month intervals. At baseline, surveys are also conducted with the 
parent or legal guardian of each youth to collect data on household 
characteristics and media use. Because youth age over the study period, 
the age range of youth and young adults among whom we collect data over 
the study period are aged 11 to 18.
    Data collection associated with the first cohort, including a 
baseline survey and four followup surveys, is complete. We have also 
completed baseline and first followup data collection for the second 
cohort. We are planning two additional followup surveys of youth in the 
second cohort.
Methods Used for the Evaluation Study
    All information for the General Market campaign evaluation is being 
collected through in-person and web-based questionnaires. Youth 
respondents were recruited from a probability sample drawn from 90 U.S. 
media markets gathered using an address-based postal mail sampling of 
U.S. households. Participation in the study is voluntary.
Purpose of the Evaluation Studies
    The studies are being conducted in support of the provisions of the 
Tobacco Control Act, which require FDA to protect the public health and 
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 are being used to examine statistical associations 
between exposure to the campaigns and subsequent changes in specific 
outcomes of interest, which include knowledge, attitudes, beliefs, and 
intentions related to tobacco use, as well as behavioral outcomes 
including tobacco use. Data from the media tracking survey are 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.
    In the Federal Register of May 17, 2019 (84 FR 22499), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received that were not 
PRA related.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                  Number of       Total
         Type of respondent                    Activity            Number of    responses per     annual      Average burden per response    Total hours
                                                                  respondents    respondent     responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Population.................  Screener and Consent               6,270               1        6,270  .125 (7.5 minutes).............          784
                                      Process (Parent
                                      Permission).
Parent of Youth Baseline Survey....  Telephone Verification               627               1          627  .1333 (8 minutes)..............           84
                                      Survey.
 Participants......................  Recruitment Materials--            6,270               1        6,270  .20 (12 minutes)...............        1,254
                                      Panel Maintenance Letter,
                                      Lead Letter, Survey
                                      Invitation Email, Q&As
                                      Study Description; Email
                                      Reminders, Reminder
                                      Letter, Notifications.
Cohort 2 Youth Assent..............  Youth Assent under 18......        5,874               1        5,874  .08 (5 minutes)................          470
Cohort 2--Youth Aged 11 to 18......  Youth Consent 18 and up....          396               1          396  .08 (5 minutes)................           32
                                     Cohort 2--Youth 1st, 2nd,          6,270               1        6,270  0.75 (45 minutes)..............        4,703
                                      3rd Followup Questionnaire.
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................  ...........................  ...........  ..............       25,707  ...............................        7,327
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has revised the burden since publication of the 60-day notice 
due to the decision to complete data collection for the Media Tracking 
Survey earlier than originally planned. Therefore, the estimated burden 
hours for the: (1) Screener and Consent Process, (2) Parent Baseline 
Questionnaire, (3) Media Tracking Screener, and (4) three waves of 
Media Tracking Questionnaires are no longer needed or requested. In 
addition, we have completed the baseline and first wave of followup 
data collection for Cohort 2 of the General Market campaign evaluation.
    The new estimated burden for this collection is 25,707 responses 
and 7,327 hours. This is a decrease of 117,120 responses and 21,010 
hours from the current approved information collection.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18938 Filed 8-30-19; 8:45 am]
 BILLING CODE 4164-01-P


