[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8511-8513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03458]


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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) 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 a 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 (1) an extension of the study conducted 
with the original longitudinal youth cohort developed and surveyed for 
the outcome evaluation of FDA's General Market Youth Tobacco Prevention 
Campaign, (2) the development of a second longitudinal cohort for the 
purpose of continuing the evaluation, (3) an extension of the time 
period for the outcome evaluation of the Rural Male Youth Smokeless 
Tobacco Campaign, (4) and an extension of the media tracking survey.

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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. 
FDA-2013-N-0717 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Evaluation of the Food and Drug 
Administration's General Market Youth Tobacco Prevention Campaigns''. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: 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

[[Page 8512]]

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 FDA's General Market Youth Tobacco Prevention Campaigns--
OMB Control Number 0910-0753--Extension

    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 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

[[Page 8513]]

second cohort will involve screening 52,401 individuals in the general 
population for a total of 65,814 participants, including 13,413 
previously approved. At 10 minutes per screening, this adds 8,908 
burden hours to the already approved 2,280 hours for a total of 11,188 
annualized burden hours.
    We expect this screening to yield 2,667 youth annually who will 
complete the baseline survey for the new cohort, resulting in a total 
of 1,334 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 two 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 participants (328 burden hours at 30 minutes per 
questionnaire) for the baseline questionnaire and 1,281 participants 
(961 burden hours at 0.75 hours per questionnaire).

                                                     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          65,814               1          65,814  0.17 (10 minutes)..............          11,188
                                    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                Youth Baseline                 2,288               1           2,288  0.50 (30 minutes)..............           1,144
 (Experimenters and Non-Triers).    Questionnaire
                                    (Experimenters &
                                    Non-Triers).
                                   Youth 1st, 2nd, 3rd,           6,666               1           6,666  0.75 (45 minutes)..............           5,000
                                    4th Follow-up
                                    Questionnaire
                                    (Experimenters and
                                    Non-Triers).
Youth Aged 13 to 17..............  Media Tracking                60,000               1          60,000  0.03 (2 minutes)...............           1,800
                                    Screener.
                                   Media Tracking                 6,000               1           6,000  0.50 (30 minutes)..............           3,000
                                    Questionnaires 1st,
                                    2nd, and 3rd.
Male Youth Aged 11 to 18 in U.S.   Youth Baseline                   656               1             656  0.50 (30 minutes)..............             328
 Rural Markets (Male Rural          Questionnaire (Male
 Smokeless).                        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                2,667               1           2,667  0.50 (30 minutes)..............           1,334
                                    Baseline
                                    Questionnaire.
                                   Cohort 2--Youth 1st,           6,270               1           6,270  0.75 (45 minutes)..............           4,703
                                    2nd, 3rd Follow-Up
                                    Questionnaire.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals.......................  ....................  ..............  ..............         157,651  ...............................          30,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03458 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P