Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns, 22499-22502 [2019-10320]
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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
each manufacturer and importer of
tobacco products’’ subject to the tobacco
product provisions of the FD&C Act
(chapter IX of the FD&C Act). The total
amount of user fees to be collected for
each fiscal year is specified in section
919(b)(1) of the FD&C Act, and under
section 919(a) FDA is to assess and
collect a proportionate amount each
quarter of the fiscal year. The FD&C Act
provides for the total assessment to be
allocated among the classes of tobacco
products. The class allocation is based
on each tobacco product class’ volume
of tobacco product removed into
commerce. Within each class of tobacco
products, an individual domestic
manufacturer or importer is assessed a
user fee based on its share of the market
for that tobacco product class.
In the Federal Register of September
11, 2018 (83 FR 45937), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that was not PRA related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
1150.5(a), (b)(1) and (2), and Form FDA 3852; General
identifying information provided by manufacturers and
importers of FDA regulated tobacco products and identification and removal information (monthly) ......................
1150.5(b)(3); Certified copies (monthly) ..............................
1150.13; Submission of user fee information (identifying
information, fee amount, etc.) (quarterly) .........................
1150.15(a); Submission of user fee dispute (annually) .......
1150.15(d); Submission of request for further review of
dispute of user fee (annually) ..........................................
Total ..............................................................................
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1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
658
658
12
12
7,896
7,896
3
1
23,688
7,896
329
5
4
1
1,316
5
1
10
1,316
50
3
1
3
10
30
........................
........................
........................
........................
32,980
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 658 entities will
submit tobacco product user fees. The
entity count was derived from aggregate
data provided by the Alcohol and
Tobacco Tax and Trade Bureau (TTB),
and reflects that in 2017 there were 192
total permitted manufacturers and 466
permitted importers over all tobacco
product types for which TTB collects
excise taxes (including cigarettes, cigars,
snuff, chewing tobacco, pipe tobacco,
and roll-your-own tobacco, excluding
electronic nicotine delivery systems).
The estimate of 658 respondents to
provide the information requested from
§ 1150.5(a), (b)(1) and (2) (21 CFR
1150.5(a), (b)(1) and (2)), and Form FDA
3852 reflects both reports of no removal
of tobacco products into domestic
commerce and reports of removal of
tobacco product into domestic
commerce. FDA estimates it will take 3
hours for each of these submission types
for a total of 23,688 hours. Under
§ 1150.5(b)(3), these respondents are
also expected to provide monthly
certified copies of the returns and forms
that relate to the removal of tobacco
products into domestic commerce and
the payment of Federal excise taxes
imposed under chapter 52 of the
Internal Revenue Code of 1986 to FDA.
We estimate that each monthly report
will take 1 hour for a total of 7,896
hours. The estimate of 329 respondents
to submit payment of user fee
information under § 1150.13 reflects an
average of half the number of domestic
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17:05 May 16, 2019
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manufacturers and importers who may
be subject to fees each fiscal quarter.
FDA estimates the quarterly submission
will take approximately 1 hour for a
total of 1,316 hours.
FDA estimates that five of those
respondents assessed user fees will
dispute the amounts under § 1150.15(a),
for a total amount of 50 hours. FDA also
estimates that three respondents who
dispute their user fees will ask for
further review by FDA under
§ 1150.15(d), for a total amount of 30
hours. FDA has only received one
dispute submission since fiscal year
2015. Based on this data, the Agency
does not believe we will receive more
than five disputes and three requests for
further reviews in the next 3 years.
FDA estimates the total annual
burden for this collection of information
is 32,980 hours. The estimated burden
for the information collection reflects an
overall increase of 16,058 hours. We
attribute this adjustment to an increase
in the number of entities submitting
tobacco user fee information to FDA.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10287 Filed 5–16–19; 8:45 am]
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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.
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.
SUMMARY:
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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
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.
ADDRESSES:
jbell on DSK3GLQ082PROD with NOTICES
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.’’
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17:05 May 16, 2019
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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/201523389.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, 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
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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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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
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
22501
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 crosssectional 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:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of respondent
Activity
General Population .........
Screener and Consent
Process (Youth and
Parent).
Parent Baseline Questionnaire.
Media Tracking Screener
Media Tracking Questionnaires 1st, 2nd,
and 3rd.
Parent of Youth Baseline
Survey Participants.
Youth Aged 13 to 17 ......
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Number of
respondents
Frm 00072
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
17,467
1
17,467
0.17 (10 minutes) ..
2,969
2,667
1
2,667
0.17 (10 minutes) ..
453
80,000
8,000
1
1
80,000
8,000
0.03 (2 minutes) .....
0.5 (30 minutes) .....
2,400
4,000
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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent
Cohort 2—Youth Aged
11 to 18.
Totals .......................
1 There
Cohort 2—Youth Baseline Questionnaire.
Cohort 2—Youth 1st,
2nd, 3rd Followup
Questionnaire.
.........................................
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
2,667
1
2,667
0.75 (45 minutes) ...
2,000
6,270
1
6,270
0.75 (45 minutes) ..
4,703
........................
........................
........................
................................
16,525
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Amended
Notice of Meeting
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Number of
respondents
Activity
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Council of Research Advocates,
May 20, 2019, 9:30 a.m. to 4:00 p.m.,
National Institutes of Health, Building
40, Room 1201/1203, 40 Convent Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
April 11, 2019, 84 FR 14662.
This meeting notice is amended to
change the meeting start time from 9:00
a.m. to 9:30 a.m. on May 20, 2019 at the
National Institutes of Health, Building
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20:15 May 16, 2019
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40, Room 1201/1203, 40 Convent Drive,
Bethesda, MD 20892. This meeting is
open to the public.
Dated: May 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10217 Filed 5–16–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health, Two Democracy
Boulevard, Suite 920, 6707 Democracy Blvd.,
Bethesda, MD 20892, 301–451–4794,
dennis.hlasta@nih.gov.
Dated: May 13, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10235 Filed 5–16–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Resources for
Technology Dissemination (U24) Review
Meeting (2019/08).
Date: June 27, 2019.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging, and Bioengineering,
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: June 6, 2019.
Time: 1:30 p.m. to 2:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive, Room
1206, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National
Advisory Council, Director, Office of
Extramural Activities, National Institute On
Alcohol Abuse And Alcoholism, 6700 B
PO 00000
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
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FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
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[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[[Page 22502]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
