[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.
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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
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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.
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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