[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22499-22502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10320]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing 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 July 16, 2019.

[[Page 22500]]


ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 16, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
Insert docket number FDA-2013-N-0717 for ``Evaluation of the Food and 
Drug Administration's General Market Youth Tobacco Prevention 
Campaigns.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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, including 
each proposed extension of an existing 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 the Food and Drug Administration's General Market Youth 
Tobacco Prevention Campaigns

OMB Control Number 0910-0753--Extension

Rationale for and 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 (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

[[Page 22501]]

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 the information collected is integral to that evaluation.
    FDA is 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. The outcome evaluation of the smokeless tobacco campaign is 
now complete, while the other two studies are 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 data collection for the second cohort. We are 
planning three followup surveys of youth in the second cohort.

The Rural Male Youth Smokeless Tobacco Campaign

    The Rural Male Youth Smokeless Campaign is also a longitudinal 
study. Baseline data for this evaluation were collected in January 
2016. Followup surveys were conducted in September 2016, May 2017, 
January 2018, and September 2018. This portion of the study is now 
complete.

Media Tracking Survey

    The Media Tracking Survey consists of assessments of youth aged 13 
to 17 conducted periodically during the campaign period. The tracking 
survey assesses awareness of the campaign and 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.

Methods Used for the Evaluation Studies

    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.

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 
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 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.

Request To Collect Information for the Evaluation

    FDA requests an extension of the study OMB control number 0910-0753 
to continue collecting data for the General Market outcome evaluation. 
No additional burden is requested for this portion of the information 
collection. FDA also requests approval for additional burden for the 
Media Tracking Survey. This is 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 80,000 participants 
(including 60,000 previously approved). At 2 minutes per screener, this 
adds 600 burden hours to the previously approved 1,800 hours for a 
total of 2,400 annualized burden hours. We expect the screening process 
to yield 2,000 participants, for a total of 8,000 including 6,000 
previously approved. At 30 minutes per survey, this adds 1,000 burden 
hours to the already-approved 3,000 for a total of 4,000 annualized 
burden hours.
    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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General Population................  Screener and Consent           17,467               1          17,467  0.17 (10 minutes)............           2,969
                                     Process (Youth and
                                     Parent).
Parent of Youth Baseline Survey     Parent Baseline                 2,667               1           2,667  0.17 (10 minutes)............             453
 Participants.                       Questionnaire.
Youth Aged 13 to 17...............  Media Tracking                 80,000               1          80,000  0.03 (2 minutes).............           2,400
                                     Screener.
                                    Media Tracking                  8,000               1           8,000  0.5 (30 minutes).............           4,000
                                     Questionnaires 1st,
                                     2nd, and 3rd.

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Cohort 2--Youth Aged 11 to 18.....  Cohort 2--Youth                 2,667               1           2,667  0.75 (45 minutes)............           2,000
                                     Baseline
                                     Questionnaire.
                                    Cohort 2--Youth 1st,            6,270               1           6,270  0.75 (45 minutes)............           4,703
                                     2nd, 3rd Followup
                                     Questionnaire.
                                                          ----------------------------------------------------------------------------------------------
    Totals........................  .....................  ..............  ..............  ..............  .............................          16,525
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To accommodate the additional data collection for media tracking, 
FDA requests approval to increase the number of burden hours under the 
existing control number. The previous number of approved screener 
responses for media tracking was 60,000 and the associated burden was 
1,800 hours. The previous burden for the media tracking questionnaires 
was 6,000 and the associated burden was 3,000 hours. We are requesting 
an additional 20,000 screener responses and 2,000 questionnaire 
completions, which adds 600 burden hours and 1,000 burden hours 
respectively. Deducting the responses and burden for the completed 
evaluation components associated with Cohort 1 (general population 
screening (13,413 responses, 2,281 hours), parent interviews (3,342 
responses, 569 hours), youth questionnaires (8,954 responses, 6,144 
hours)) and for the rural smokeless evaluation (2,610 responses, 1,794 
hours) results in a decrease of 6,319 annual responses and 9,187 hours.

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10320 Filed 5-16-19; 8:45 am]
BILLING CODE 4164-01-P