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, 39675-39677 [2016-14352]
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Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
II. The 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This draft guidance refers to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
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in investigational new drug
applications is approved under OMB
control number 0910–0014; the
collection of information (including
prescription drug labeling) in new drug
applications and abbreviated new drug
applications, as well as supplements to
these applications, is approved under
OMB control number 0910–0001; the
collection of biologics license
applications is approved under OMB
control number 0910–0338; and the
format and content of prescription drug
labeling is approved under OMB control
number 0910–0572.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14354 Filed 6–16–16; 8:45 am]
BILLING CODE 4164–01–P
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.
sradovich on DSK3TPTVN1PROD with NOTICES
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.
SUMMARY:
VerDate Sep<11>2014
16:48 Jun 16, 2016
Jkt 238001
Fax written comments on the
collection of information by July 18,
2016.
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 0910–0753. 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
DATES:
Evaluation of FDA’s General Market
Youth Tobacco Prevention
Campaigns—OMB Control Number
0910–0753—Revision
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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
39675
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
E:\FR\FM\17JNN1.SGM
17JNN1
39676
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
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
We expect 20,000 participants to
complete screener for a total of 60,000
participants (including 40,000
previously approved). At 2 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 annualized
participants (328 annualized burden
hours at 30 minutes per questionnaire)
for the baseline questionnaire and 1,281
annualized participants (961 annualized
burden hours at 0.75 hours per
questionnaire).
In the Federal Register of February
19, 2016 (81 FR 8511), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Two burden items have been revised
since the publication of the 60-day
notice. First, number of respondents
planned for the General Population
Screener and Consent Process has been
corrected to annualize the new
screening participants over the 3-year
extension. Second, the burden per
response for the Cohort 2 Youth
Baseline has been increased to 45
minutes to better reflect the actual time
required for completion as assessed
during the previous data collection
rounds.
FDA estimates the burden of this
collection of information as follows:
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
second cohort will involve screening
17,467 individuals in the general
population for a total of 30,880
participants, including 13,413
previously approved. At 10 minutes per
screening, this adds 2,970 burden hours
to the already approved 2,280 hours for
a total of 5,250 annualized burden
hours.
We expect this screening to yield
2,667 youth annually who will complete
the baseline survey for the new cohort
at 45 minutes per survey, resulting in a
total of 2,000 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.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Activity
General Population ................................
sradovich on DSK3TPTVN1PROD with NOTICES
Type of respondent
Screener and Consent Process (Youth
and Parent).
Parent Baseline Questionnaire .............
30,880
1
30,880
0.17 (10 minutes) ......
5,250
6,009
1
6,009
0.17 (10 minutes) ......
1,022
Youth Baseline Questionnaire (Experimenters & Non-Triers).
Youth 1st, 2nd, 3rd, 4th Follow-up
Questionnaire (Experimenters and
Non-Triers)
Media Tracking Screener ......................
Media Tracking Questionnaires 1st,
2nd, and 3rd
2,288
1
2,288
0.50 (30 minutes) ......
1,144
6,666
1
6,666
0.75 (45 minutes) ......
5,000
60,000
6,000
1
1
60,000
6,000
0.03 (2 minutes) ........
0.50 (30 minutes) ......
1,800
3,000
Parent of Youth Baseline Survey Participants.
Youth Aged 11 to 18 (Experimenters
and Non-Triers).
Youth Aged 13 to 17 .............................
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Total hours
39677
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Type of respondent
Activity
Male Youth Aged 11 to 18 in U.S.
Rural Markets (Male Rural Smokeless).
Youth Baseline Questionnaire (Male
Rural Smokeless).
656
1
656
0.50 (30 minutes) ......
328
Youth 1st, 2nd, 3rd (Male, Rural
Smokeless) Follow-up Questionnaire
Cohort 2—Youth Baseline Questionnaire.
Cohort 2—Youth 1st, 2nd, 3rd FollowUp Questionnaire
1,281
1
1,281
0.75 (45 minutes) ......
961
2,667
1
2,667
0.75 (45 minutes) ......
2,000
6,270
1
6,270
0.75 (45 minutes) ......
4,703
Cohort 2—Youth Aged 11 to 18 ...........
Total ...............................................
1 There
122,717
25,208
are no capital costs or operating and maintenance costs associated with this collection of information.
one film badge or TLD dosimeter) during the
period from March 1, 1970, through
December 31, 1974, and were employed for
a number of work days aggregating at least
250 work days, occurring either solely under
employment during the period from March 1,
1970, through December 31, 1974, or in
combination with work days within the
parameters established for one or more other
classes of employees in the Special Exposure
Cohort.
Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14352 Filed 6–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice of a
decision to designate a class of
employees from the Idaho National
Laboratory site in Scoville, Idaho, as an
addition to the Special Exposure Cohort
(SEC) under the Energy Employees
Occupational Illness Compensation
Program Act of 2000.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 1–877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
7384l(14)(C).
sradovich on DSK3TPTVN1PROD with NOTICES
Total hours
Jkt 238001
Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
7384l(14)(C).
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2016–14327 Filed 6–16–16; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
AGENCY:
Notice.
HHS gives notice of a
decision to designate a class of
employees from the Lawrence
Livermore National Laboratory site in
Livermore, California, as an addition to
the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000.
SUMMARY:
All employees of the Department of
Energy, its predecessor agencies, and their
contractors and subcontractors who worked
at the Idaho National Laboratory (INL) in
Scoville, Idaho, and were monitored for
external radiation at INL (e.g., having at least
16:48 Jun 16, 2016
This designation will become
effective on July 3, 2016, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
ACTION:
On June 3, 2016, as provided for
under 42 U.S.C. 7384l(14)(C),the
Secretary of HHS designated the
following class of employees as an
addition to the SEC:
VerDate Sep<11>2014
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 1–877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
On June 3, 2016, as provided for
under 42 U.S.C. 73841(14)(C), the
Secretary of HHS designated the
following class of employees as an
addition to the SEC:
All employees of the Department of
Energy, its predecessor agencies, and their
contractors and subcontractors who worked
in any area at the Lawrence Livermore
National Laboratory in Livermore, California,
during the period from January 1, 1974,
through December 31, 1989, for a number of
work days aggregating at least 250 work days,
occurring either solely under this
employment, or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation will become
effective on July 3, 2016, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2016–14326 Filed 6–16–16; 8:45 am]
BILLING CODE 4163–19–P
E:\FR\FM\17JNN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39675-39677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14352]
-----------------------------------------------------------------------
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 July
18, 2016.
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 0910-0753.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 0910-0753--Revision
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
[[Page 39676]]
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 second cohort will
involve screening 17,467 individuals in the general population for a
total of 30,880 participants, including 13,413 previously approved. At
10 minutes per screening, this adds 2,970 burden hours to the already
approved 2,280 hours for a total of 5,250 annualized burden hours.
We expect this screening to yield 2,667 youth annually who will
complete the baseline survey for the new cohort at 45 minutes per
survey, resulting in a total of 2,000 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 2 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 annualized participants (328 annualized burden hours at 30
minutes per questionnaire) for the baseline questionnaire and 1,281
annualized participants (961 annualized burden hours at 0.75 hours per
questionnaire).
In the Federal Register of February 19, 2016 (81 FR 8511), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Two burden items have been revised since the publication of the 60-
day notice. First, number of respondents planned for the General
Population Screener and Consent Process has been corrected to annualize
the new screening participants over the 3-year extension. Second, the
burden per response for the Cohort 2 Youth Baseline has been increased
to 45 minutes to better reflect the actual time required for completion
as assessed during the previous data collection rounds.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of responses Total
Type of respondent Activity respondents per annual Average burden per response Total hours
respondent responses
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General Population.................... Screener and Consent 30,880 1 30,880 0.17 (10 minutes)................ 5,250
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 (Experimenters and Youth Baseline 2,288 1 2,288 0.50 (30 minutes)................ 1,144
Non-Triers). Questionnaire
(Experimenters & Non-
Triers).
Youth 1st, 2nd, 3rd, 4th 6,666 1 6,666 0.75 (45 minutes)................ 5,000
Follow-up Questionnaire
(Experimenters and Non-
Triers)
Youth Aged 13 to 17................... Media Tracking Screener.. 60,000 1 60,000 0.03 (2 minutes)................. 1,800
Media Tracking 6,000 1 6,000 0.50 (30 minutes)................ 3,000
Questionnaires 1st, 2nd,
and 3rd
[[Page 39677]]
Male Youth Aged 11 to 18 in U.S. Rural Youth Baseline 656 1 656 0.50 (30 minutes)................ 328
Markets (Male Rural Smokeless). Questionnaire (Male
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 Baseline 2,667 1 2,667 0.75 (45 minutes)................ 2,000
Questionnaire.
Cohort 2--Youth 1st, 2nd, 6,270 1 6,270 0.75 (45 minutes)................ 4,703
3rd Follow-Up
Questionnaire
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Total............................. 122,717 25,208
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14352 Filed 6-16-16; 8:45 am]
BILLING CODE 4164-01-P
