Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns, 55725-55727 [2013-22014]
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Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices
55725
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Activity
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
Glossary ...........................................................
689
1
689
4
2,756
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–22110 Filed 9–10–13; 8:45 am]
BILLING CODE 4160–01–P
Evaluation of FDA’s General Market
Youth Tobacco Prevention
Campaigns—(OMB Control Number
0910–New)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0717]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 11,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Evaluation of FDA’s General
Market Youth Tobacco Prevention
Campaigns’’. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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Jkt 229001
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 will feature
televised advertisements along with
complementary ads on radio, on the
Internet, in print, and through other
forms of media.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use by minors, FDA requests
OMB approval to collect information
needed to evaluate FDA’s general
market youth tobacco prevention
campaigns. Comprehensive evaluation
of FDA’s public education campaigns is
needed to ensure campaign messages
are effectively received, understood, and
accepted by those for whom they are
intended. Evaluation is an essential
organizational practice in public health
and a systematic way to account for and
improve public health actions.
FDA plans to conduct two studies to
evaluate the effectiveness of its youth
tobacco prevention campaigns: (1) An
outcome evaluation study consisting of
a youth experimenter and non-trier
initiative and a male only youth rural
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
smokeless initiative and (2) a media
tracking survey. The timing of these
studies will be designed to follow the
multiple, discrete waves of media
advertising planned for the campaigns.
• Outcome Evaluation Study. The
outcome evaluation study consists of an
initial baseline survey of youth aged 11
to 16 before the campaigns launch. The
baseline will be followed by three
longitudinal followup surveys of the
same youth, aged 11 to 16, at
approximate 8-month intervals after the
campaigns launch. As the cohort will be
aging over this time period, the data
collected throughout the study will
reflect information from youth aged 11
to 18. Information will be 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 will measure tobacco use
susceptibility and current use.
Information will also be collected on
demographic variables including age,
sex, race/ethnicity, grade level, and
primary language. Finally, a baseline
survey will also be conducted with the
parent or legal guardian of each youth
baseline survey participant in order to
collect data on household
characteristics and media use.
• Media Tracking Survey. The media
tracking survey consists of assessments
of youth aged 13 to 17 conducted at 4
months, 12 months, and 20 months post
launch. The tracking survey will assess
awareness of the campaigns and
receptivity to campaign messages. These
data will provide critical evaluation
feedback to the campaigns and will be
conducted with sufficient frequency to
match the cyclical patterns of media
advertising and variation in exposure to
allow for mid-campaign refinements.
All information will be collected
through in-person and Web-based
questionnaires. Youth respondents will
be 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
evaluation study and (2) an Internet
E:\FR\FM\11SEN1.SGM
11SEN1
55726
Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices
panel for the media tracking survey.
Participation in the studies is voluntary.
The information collected is
necessary to inform FDA’s efforts and
measure the effectiveness and public
health impact of the campaigns. Data
from the media tracking survey will be
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. Data from the outcome
evaluation study will be used to
examine statistical associations between
exposure to the campaigns and
subsequent changes in specific
outcomes of interest, which will include
knowledge, attitudes, beliefs, and
intentions related to tobacco use, as well
as behavioral outcomes including
tobacco use.
FDA’s burden estimate is based on
prior experience with in-person and
Internet panel studies similar to the
Agency’s plan presented in this
document. To obtain the target number
of completed surveys (‘‘completes’’) for
the outcome evaluation study, 40,238
youth respondents and their parent or
legal guardian will be contacted through
a screening and consent process. The
estimated burden per response is 10
minutes (0.17), for a total of 6,840 hours.
An estimated 8,057 youth will complete
the Youth Baseline Questionnaire in
order to yield 6,445 completes at the
first followup; 5,156 completes at the
second followup; and 4,125 completes
at the third followup survey waves. The
estimated burden per response is 30
minutes (0.5) for the baseline
questionnaire, for a total of 4,029 hours.
The estimated burden per response is 45
minutes (0.75) for each followup
questionnaire, for a total of 4,834
burden hours for the first Followup
Questionnaire; 3,867 hours for the
second Followup Questionnaire; and
3,094 hours for the third Followup
Questionnaire. The parent or legal
guardian of youth recruited to complete
the Youth Baseline Questionnaire will
also complete a Parent Baseline
Questionnaire with an estimate burden
per response of 10 minutes (0.17), for a
total of 1,704 hours. Additionally for
clarity, FDA has added male youth, aged
11–18, to the burden chart. This is not
a new component to the information
collection as they were already a
component of the study that falls within
the group of youth aged 11–18. The
rural smokeless campaign component of
the evaluation differs from the
experimenter and non-trier campaigns
component in one major way—only
males in the age range will be
considered eligible.
To obtain the target number of
completes for the media tracking survey,
40,000 respondents will be contacted for
each survey wave through an online
invitation. The estimated burden per
response is 2 minutes (0.03), for a total
of 1,200 hours for the first Media
Tracking Screener; 1,200 hours for the
second Media Tracking Screener; and
1,200 hours for the third Media
Tracking Screener. An estimated 4,000
youths will be recruited to complete
each of the three waves of the media
tracking survey. The estimated burden
per response is 30 minutes for each
questionnaire, for a total of 2,000 hours
for the first Media Tracking
Questionnaire; 2,000 hours for the
second Media Tracking Questionnaire;
and 2,000 hours for the third Media
Tracking Questionnaire.
The target number of completed
campaign questionnaires for all
responses is 211,859. The total
estimated burden is 37,836 hours. After
further review of the burden estimates,
the Agency has revised the interview
hourly burden in table 1, which was
based on the number of samples needed
to assess the campaigns in the final data
collection request. The estimates are
reflective of a decrease in the expected
sample size and an increase in the
timing for the screener followup
surveys. The estimates of the sample
size for the youth outcome baseline
interviews in the 60-day Federal
Register notice was an estimate for the
general market population. The survey
timing increased slightly for screeners
and for followups because it was
considered more realistic based on the
instrument length.
In the Federal Register of June 21,
2013 (78 FR 37546), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received, which were not PRA related,
and are beyond the scope of this
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
emcdonald on DSK67QTVN1PROD with NOTICES
Type of respondent/activity
Outcome Evaluation Study General Population/
Screener and Consent Process (Youth and
Parent).
United States Youth aged 11 to 16/Youth Baseline Questionnaire (Experimenter and NonTrier).
United States Youth aged 11 to 18/Youth First
Followup Questionnaire (Experimenter and
Non-Trier).
United States Youth aged 11 to 18/Youth Second Followup Questionnaire (Experimenter
and Non-Trier).
United States Youth aged 11 to 18/Youth Third
Followup Questionnaire (Experimenter and
Non-Trier).
United States Rural Markets Male Youth aged
11 to 18/Youth Baseline Questionnaire.
United States Rural Markets Male Youth aged
11 to 18/Youth First Followup Questionnaire.
United States Rural Markets Male Youth aged
11 to 18/Youth Second Followup Questionnaire.
United States Rural Markets Male Youth aged
11 to 18/Youth Third Followup Questionnaire.
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Jkt 229001
PO 00000
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
40,238
1
40,238
0.17 (10 minutes) ....
6,840
8,057
1
8,057
0.5 (30 minutes) ......
4,029
6,445
1
6,445
0.75 (45 minutes) ....
4,834
5,156
1
5,156
0.75 (45 minutes) ....
3,867
4,125
1
4,125
0.75 (45 minutes) ....
3,094
1,969
1
1,969
0.50 (30 minutes) ....
985
1,575
1
1,575
0.75 (45 minutes) ....
1,182
1,260
1
1,260
0.75 (45 minutes) ....
945
1,008
1
1,008
0.75 (45 minutes) ....
756
Frm 00051
Fmt 4703
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E:\FR\FM\11SEN1.SGM
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Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices
55727
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Type of respondent/activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Parent of Youth Baseline Survey Participants/
Parent Baseline Questionnaire.
United States Youth aged 13 to 17/First Media
Tracking Screener.
United States Youth aged 13 to 17/First Media
Tracking Questionnaire.
United States Youth aged 13 to 17/Second
Media Tracking Screener.
United States Youth aged 13 to 17/Second
Media Tracking Questionnaire.
United States Youth aged 13 to 17/Third Media
Tracking Screener.
United States Youth aged 13 to 17/Third Media
Tracking Questionnaire.
10,026
1
10,026
0.17 (10 minutes) ....
1,704
40,000
1
40,000
0.03 (2 minutes) ......
1,200
4,000
1
4,000
0.5 (30 minutes) ......
2,000
40,000
1
40,000
0.03 (2 minutes) ......
1,200
4,000
1
4,000
0.5 (30 minutes) ......
2,000
40,000
1
40,000
0.03 (2 minutes) ......
1,200
4,000
1
4,000
0.5 (30 minutes) ......
2,000
Total Hours ...................................................
..........................
..........................
..........................
..................................
37,836
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22014 Filed 9–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0928]
Draft Guidance for Industry on
Recommendations for Preparation and
Submission of Animal Food Additive
Petitions; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (GFI #221) entitled
‘‘Recommendations for Preparation and
Submission of Animal Food Additive
Petitions.’’
This draft guidance describes the
types of information that FDA’s Center
for Veterinary Medicine (CVM)
recommends for inclusion in food
additive petitions (FAPs) submitted for
food additives intended for use in food
for animals. It is intended to help the
petitioner submit such FAP information
in a consistent and appropriate manner.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:50 Sep 10, 2013
Jkt 229001
on the draft guidance by November 12,
2013.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sharon Benz, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Place,
Rockville, MD 20855, 240–453–6864,
sharon.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (GFI #221)
entitled ‘‘Recommendations for
Preparation and Submission of Animal
Food Additive Petitions.’’ It is intended
to help petitioners submit FAP
information in a consistent and
appropriate manner.
The requirements for submitting an
animal food additive petition to FDA are
set forth in section 409 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348) and 21 CFR part
571. This draft guidance provides
information for complying with these
requirements.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
This draft guidance includes the
following information:
• How to determine if an animal food
ingredient is already the subject of an
approved FAP.
• Who to contact for more
information about approved food
additives.
• Who to contact for more
information on how to submit an FAP
for approval.
• When and how to request a prepetition consultation with CVM before
submitting an FAP.
• When and how to submit study
designs for CVM review.
• What data CVM considers adequate
to support an FAP.
• Where to find other FDA guidances
that may be helpful when preparing and
submitting an FAP to CVM.
• General recommendations for the
format of an FAP submission.
• Where and how to submit an FAP.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
E:\FR\FM\11SEN1.SGM
11SEN1
]]>Agencies
[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55725-55727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22014]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0717]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
11, 2013.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Evaluation of FDA's General Market Youth Tobacco Prevention
Campaigns''. Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Evaluation of FDA's General Market Youth Tobacco Prevention Campaigns--
(OMB Control Number 0910-New)
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) 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 will feature televised advertisements along with
complementary ads on radio, on the Internet, in print, and through
other forms of media.
In support of the provisions of the Tobacco Control Act that
require FDA to protect the public health and to reduce tobacco use by
minors, FDA requests OMB approval to collect information needed to
evaluate FDA's general market youth tobacco prevention campaigns.
Comprehensive evaluation of FDA's public education campaigns is needed
to ensure campaign messages are effectively received, understood, and
accepted by those for whom they are intended. Evaluation is an
essential organizational practice in public health and a systematic way
to account for and improve public health actions.
FDA plans to conduct two studies to evaluate the effectiveness of
its youth tobacco prevention campaigns: (1) An outcome evaluation study
consisting of a youth experimenter and non-trier initiative and a male
only youth rural smokeless initiative and (2) a media tracking survey.
The timing of these studies will be designed to follow the multiple,
discrete waves of media advertising planned for the campaigns.
Outcome Evaluation Study. The outcome evaluation study
consists of an initial baseline survey of youth aged 11 to 16 before
the campaigns launch. The baseline will be followed by three
longitudinal followup surveys of the same youth, aged 11 to 16, at
approximate 8-month intervals after the campaigns launch. As the cohort
will be aging over this time period, the data collected throughout the
study will reflect information from youth aged 11 to 18. Information
will be 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 will measure tobacco
use susceptibility and current use. Information will also be collected
on demographic variables including age, sex, race/ethnicity, grade
level, and primary language. Finally, a baseline survey will also be
conducted with the parent or legal guardian of each youth baseline
survey participant in order to collect data on household
characteristics and media use.
Media Tracking Survey. The media tracking survey consists
of assessments of youth aged 13 to 17 conducted at 4 months, 12 months,
and 20 months post launch. The tracking survey will assess awareness of
the campaigns and receptivity to campaign messages. These data will
provide critical evaluation feedback to the campaigns and will be
conducted with sufficient frequency to match the cyclical patterns of
media advertising and variation in exposure to allow for mid-campaign
refinements.
All information will be collected through in-person and Web-based
questionnaires. Youth respondents will be 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 evaluation study and (2) an Internet
[[Page 55726]]
panel for the media tracking survey. Participation in the studies is
voluntary.
The information collected is necessary to inform FDA's efforts and
measure the effectiveness and public health impact of the campaigns.
Data from the media tracking survey will be 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. Data from the
outcome evaluation study will be used to examine statistical
associations between exposure to the campaigns and subsequent changes
in specific outcomes of interest, which will include knowledge,
attitudes, beliefs, and intentions related to tobacco use, as well as
behavioral outcomes including tobacco use.
FDA's burden estimate is based on prior experience with in-person
and Internet panel studies similar to the Agency's plan presented in
this document. To obtain the target number of completed surveys
(``completes'') for the outcome evaluation study, 40,238 youth
respondents and their parent or legal guardian will be contacted
through a screening and consent process. The estimated burden per
response is 10 minutes (0.17), for a total of 6,840 hours. An estimated
8,057 youth will complete the Youth Baseline Questionnaire in order to
yield 6,445 completes at the first followup; 5,156 completes at the
second followup; and 4,125 completes at the third followup survey
waves. The estimated burden per response is 30 minutes (0.5) for the
baseline questionnaire, for a total of 4,029 hours. The estimated
burden per response is 45 minutes (0.75) for each followup
questionnaire, for a total of 4,834 burden hours for the first Followup
Questionnaire; 3,867 hours for the second Followup Questionnaire; and
3,094 hours for the third Followup Questionnaire. The parent or legal
guardian of youth recruited to complete the Youth Baseline
Questionnaire will also complete a Parent Baseline Questionnaire with
an estimate burden per response of 10 minutes (0.17), for a total of
1,704 hours. Additionally for clarity, FDA has added male youth, aged
11-18, to the burden chart. This is not a new component to the
information collection as they were already a component of the study
that falls within the group of youth aged 11-18. The rural smokeless
campaign component of the evaluation differs from the experimenter and
non-trier campaigns component in one major way--only males in the age
range will be considered eligible.
To obtain the target number of completes for the media tracking
survey, 40,000 respondents will be contacted for each survey wave
through an online invitation. The estimated burden per response is 2
minutes (0.03), for a total of 1,200 hours for the first Media Tracking
Screener; 1,200 hours for the second Media Tracking Screener; and 1,200
hours for the third Media Tracking Screener. An estimated 4,000 youths
will be recruited to complete each of the three waves of the media
tracking survey. The estimated burden per response is 30 minutes for
each questionnaire, for a total of 2,000 hours for the first Media
Tracking Questionnaire; 2,000 hours for the second Media Tracking
Questionnaire; and 2,000 hours for the third Media Tracking
Questionnaire.
The target number of completed campaign questionnaires for all
responses is 211,859. The total estimated burden is 37,836 hours. After
further review of the burden estimates, the Agency has revised the
interview hourly burden in table 1, which was based on the number of
samples needed to assess the campaigns in the final data collection
request. The estimates are reflective of a decrease in the expected
sample size and an increase in the timing for the screener followup
surveys. The estimates of the sample size for the youth outcome
baseline interviews in the 60-day Federal Register notice was an
estimate for the general market population. The survey timing increased
slightly for screeners and for followups because it was considered more
realistic based on the instrument length.
In the Federal Register of June 21, 2013 (78 FR 37546), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received, which were not
PRA related, and are beyond the scope of this collection.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Outcome Evaluation Study General Population/ 40,238 1 40,238 0.17 (10 minutes)....................... 6,840
Screener and Consent Process (Youth and
Parent).
United States Youth aged 11 to 16/Youth 8,057 1 8,057 0.5 (30 minutes)........................ 4,029
Baseline Questionnaire (Experimenter and
Non-Trier).
United States Youth aged 11 to 18/Youth 6,445 1 6,445 0.75 (45 minutes)....................... 4,834
First Followup Questionnaire (Experimenter
and Non-Trier).
United States Youth aged 11 to 18/Youth 5,156 1 5,156 0.75 (45 minutes)....................... 3,867
Second Followup Questionnaire
(Experimenter and Non-Trier).
United States Youth aged 11 to 18/Youth 4,125 1 4,125 0.75 (45 minutes)....................... 3,094
Third Followup Questionnaire (Experimenter
and Non-Trier).
United States Rural Markets Male Youth aged 1,969 1 1,969 0.50 (30 minutes)....................... 985
11 to 18/Youth Baseline Questionnaire.
United States Rural Markets Male Youth aged 1,575 1 1,575 0.75 (45 minutes)....................... 1,182
11 to 18/Youth First Followup
Questionnaire.
United States Rural Markets Male Youth aged 1,260 1 1,260 0.75 (45 minutes)....................... 945
11 to 18/Youth Second Followup
Questionnaire.
United States Rural Markets Male Youth aged 1,008 1 1,008 0.75 (45 minutes)....................... 756
11 to 18/Youth Third Followup
Questionnaire.
[[Page 55727]]
Parent of Youth Baseline Survey 10,026 1 10,026 0.17 (10 minutes)....................... 1,704
Participants/Parent Baseline Questionnaire.
United States Youth aged 13 to 17/First 40,000 1 40,000 0.03 (2 minutes)........................ 1,200
Media Tracking Screener.
United States Youth aged 13 to 17/First 4,000 1 4,000 0.5 (30 minutes)........................ 2,000
Media Tracking Questionnaire.
United States Youth aged 13 to 17/Second 40,000 1 40,000 0.03 (2 minutes)........................ 1,200
Media Tracking Screener.
United States Youth aged 13 to 17/Second 4,000 1 4,000 0.5 (30 minutes)........................ 2,000
Media Tracking Questionnaire.
United States Youth aged 13 to 17/Third 40,000 1 40,000 0.03 (2 minutes)........................ 1,200
Media Tracking Screener.
United States Youth aged 13 to 17/Third 4,000 1 4,000 0.5 (30 minutes)........................ 2,000
Media Tracking Questionnaire.
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Total Hours............................ ............... ............... ............... ........................................ 37,836
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22014 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P
