
[Federal Register Volume 80, Number 2 (Monday, January 5, 2015)]
[Notices]
[Pages 230-231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30808]



[[Page 230]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2294]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of the Food and Drug Administration's 
Multicultural 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 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 multicultural youth 
tobacco prevention campaigns.

DATES: Submit either electronic or written comments on the collection 
of information by March 6, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 Multicultural 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) 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 multicultural youth and thereby reduce the public 
health burden of tobacco. The campaigns will feature events, 
advertisements on television and radio and in print, digital 
communications including social media, and 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 multicultural 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 
each of its multicultural 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 Studies

    The outcome evaluation studies consist of baseline surveys of 
multicultural youth aged 12 to 18 before each campaign's launch. The 
baseline will be followed by three cross-sectional surveys of the 
target audience of youth at approximate 6-month intervals after the 
campaign's launch. Information will be collected about youth awareness 
of and exposure to campaign events and advertisements and about 
tobacco-related knowledge, attitudes, beliefs, intentions, and use. 
Information will also be collected on demographic variables including 
age, sex, race/ethnicity, grade level, and primary language.

Media Tracking Surveys

    The media tracking surveys consist of assessments of youth aged 13 
to 18 conducted at 3, 9, and 15 months postcampaign launch--timing that 
complements the outcome evaluation's timing. The media tracking surveys 
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 events and media advertising and variation in 
exposure to allow for midcampaign refinements.
    All information will be collected through in-person and Web-based 
questionnaires. Youth respondents will be recruited from four sources: 
(1) A sample drawn from 30 U.S. media markets gathered using an 
address-based postal mail sampling of U.S. households for the outcome 
evaluation studies, (2) an Internet panel for the media tracking 
surveys, (3) intercepts at various locations (e.g., mall, events), and 
(4) targeted social media (e.g., Facebook). 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 surveys will be used to estimate awareness 
of and exposure to the campaigns among youth in target markets where 
the campaigns

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are active. Data from the outcome evaluation studies 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.
    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 studies, 48,000 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, for a total of 4,000 hours. An estimated 16,800 
surveys will be completed in the baseline and 3 postcampaign cross-
sectional surveys. The estimated burden per response is 35 minutes for 
each survey wave, for a total of 9,800 hours.
    To obtain the target number of completes for the media tracking 
survey, a total of 90,000 respondents will be contacted for the 3 
survey waves through an online invitation. The estimated burden per 
response is 2 minutes, for a total of 3,000 hours for all waves of the 
Media Tracking Screener. An estimated 2,000 youth will be recruited to 
complete each of the 3 waves of the media tracking survey. The 
estimated burden per response is 30 minutes for each questionnaire, for 
a total of 3,000 hours for all of the three waves of the Media Tracking 
Questionnaire.
    The total number of respondents is 160,800. The total estimated 
burden is 19,800 hours.

                                                     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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General Population..............  Screener and Consent              12,000               1          12,000  0.0833 (5 min.).............           1,000
                                   Process (Youth and
                                   Parent)--Baseline/Wave
                                   1--outcome study.
General Population..............  Screener and Consent              12,000               1          12,000  0.0833 (5 min.).............           1,000
                                   Process (Youth and
                                   Parent)--Wave 2--
                                   outcome study.
General Population..............  Screener and Consent              12,000               1          12,000  0.0833 (5 min.).............           1,000
                                   Process (Youth and
                                   Parent)--Wave 3--
                                   outcome study.
General Population..............  Screener and Consent              12,000               1          12,000  0.0833 (5 min.).............           1,000
                                   Process (Youth and
                                   Parent)--Wave 4--
                                   outcome study.
Multicultural Youth aged 12-18    Baseline (Wave 1) youth            4,200               1           4,200  0.5833 (35 min.)............           2,450
 in select media markets.          outcome evaluation
                                   questionnaire.
                                  Wave 2 youth outcome               4,200               1           4,200  0.5833 (35 min.)............           2,450
                                   evaluation
                                   questionnaire.
                                  Wave 3 youth outcome               4,200               1           4,200  0.5833 (35 min.)............           2,450
                                   evaluation
                                   questionnaire.
                                  Wave 4 youth outcome               4,200               1           4,200  0.5833 (35 min.)............           2,450
                                   evaluation
                                   questionnaire.
Multicultural youth aged 13-18    1st Media Tracking                30,000               1          30,000  0.03333 (2 min.)............           1,000
 in the select media markets.      Screener.
                                  1st Media Tracking                 2,000               1           2,000  0.5 (30 min.)...............           1,000
                                   Questionnaire.
                                  2nd Media Tracking                30,000               1          30,000  0.03333 (2 min.)............           1,000
                                   Screener.
                                  2nd Media Tracking                 2,000               1           2,000  0.5 (30 min.)...............           1,000
                                   Questionnaire.
                                  3rd Media tracking                30,000               1          30,000  0.03333 (2 min.)............           1,000
                                   Screener.
                                  3rd Media Tracking                 2,000               1           2,000  0.5 (30 min.)...............           1,000
                                   Questionnaire.
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    Total.......................  ........................         160,800  ..............  ..............  ............................          19,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 29, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30808 Filed 1-2-15; 8:45 am]
BILLING CODE 4164-01-P


