Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults, 63799-63802 [2015-26671]
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
63799
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 U.S.C. section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Dietary supplement adverse event records (21
U.S.C. 379aa–1(e)(1)).
1,700
74
125,800
0.5 (30 minutes) ........
62,900
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement
manufacturers, packers, or distributors
are subject to serious adverse event
recordkeeping. We estimate that there
are 1,700 such respondents, based on
the figure 1,460 as provided in our final
rule of June 25, 2007 (72 FR 34751) on
the ‘‘Current Good Manufacturing
Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for
Dietary Supplements,’’ and factoring a
two percent annual growth rate.
Estimating that each recordkeeper will
keep approximately 74 records per year
results in an annual burden of 125,800
records. Estimating that assembling and
filing these records, including any
necessary photocopying, will take
approximately 30 minutes, or 0.5 hours,
per record, results in an annual burden
of 62,900 hours (125,800 records × 0.50
hours = 62,900 total hours.
Once the documents pertaining to an
adverse event report have been
assembled and filed in accordance with
the safety reporting portal, we expect
the records retention burden to be
minimal, as we believe most
establishments would normally keep
this kind of record for at least several
years after receiving the report, as a
matter of usual and customary business
practice.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26673 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2015–N–2126]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Food and Drug Administration’s
Campaign To Reduce Tobacco Use
Among Lesbian, Gay, Bisexual, and
Transgender Young Adults
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
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 November
20, 2015.
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
title ‘‘Evaluation of the Food and Drug
Administration’s Campaign to Reduce
Tobacco Use Among Lesbian, Gay,
Bisexual, and Transgender Young
Adults’’. 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.
SUMMARY:
Evaluation of FDA’s Campaign To
Reduce Tobacco Use Among Lesbian,
Gay, Bisexual, and Transgender Young
Adults—OMB Control Number 0910—
New
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amended
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
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related to tobacco use. Accordingly,
FDA is currently developing and
implementing public education
campaigns to help prevent and reduce
tobacco use among lesbian, gay,
bisexual, and transgender (LGBT) young
adults and thereby reduce the public
health burden of tobacco. Overall the
campaigns will feature events;
advertisements on television and radio
and in print; digital communications
including social media; and 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, FDA requests OMB
approval to collect information needed
to evaluate FDA’s campaign to reduce
tobacco use among LGBT young adults.
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 LGBT
young adult tobacco prevention
campaign: (1) An outcome evaluation
study to evaluate the effectiveness of its
LGBT young adult tobacco prevention
campaign, and (2) a media tracking
questionnaire to assess awareness of and
receptivity to campaign messages. The
timing of these studies will be designed
to follow the multiple, discrete waves of
media advertising planned for the
campaigns.
I. Outcome Evaluation Study
Before the beginning of data
collection for the outcome evaluation
study, the 5-minute screening
instrument will be tested in a small
pilot study of LGBT young adults aged
18 to 24. The outcome evaluation study
will then begin with a baseline survey
of LGBT young adults aged 18 to 24
before the campaign launch. The
baseline will be followed by three
followup surveys of the target audience
of young adults at approximately 6month intervals after the campaign’s
launch. Information will be collected
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
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about young adult awareness of and
exposure to campaign events and
advertisements and about tobaccorelated knowledge, attitudes, beliefs,
intentions and use, as well as use of
other tobacco products (e-cigarettes,
hookah, cigars, smokeless tobacco),
marijuana and alcohol. Information will
also be collected on demographic
variables including sexual orientation,
age, sex, race/ethnicity, education, and
primary language.
All information will be collected
through in-person and Web-based
questionnaires. Young adult
respondents will be recruited in 24 U.S.
cities (12 campaign and 12 comparison
cities) from two sources: (1) Intercept
surveys in LGBT social venues (e.g.,
bars and nightclubs) and (2) through
social media advertisements (e.g. on
Facebook and Twitter) targeted at LGBT
18 to 24-year-olds, living in the same 24
U.S. cities. Participation in the study is
voluntary.
II. Media Tracking Survey
The media tracking survey consists of
assessments of LGBT young adults aged
18 to 24 conducted in the periods in
between the primary outcome
evaluation survey waves to monitor the
target audience’s awareness of and
receptivity to campaign activities. The
media tracking survey will assess
awareness of the campaign 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 events
and media advertising and variation in
exposure to allow for mid-campaign
refinements. For the media tracking
surveys, we will recruit LGBT young
adults aged 18 to 24 from all campaign
cities through social media.
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 surveys will be
used to estimate awareness of and
exposure to the campaigns among young
adults in target markets where the
campaigns are active. Data from the
outcome evaluation study will be used
to examine statistical associations
between awareness of and exposure to
the campaigns and subsequent changes
in specific outcomes of interest, which
will include knowledge, attitudes,
beliefs, and intentions related to tobacco
use.
FDA’s burden estimate is based on
prior experience with in-person studies
similar to the Agency’s plan presented
in this document, as well as previous
research using social media advertising
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to recruit young adult participants.
Since the 60-day notice was published,
FDA has revised the estimated burden.
The estimated burden has been revised
to account for both participant
eligibility and response rates among
participants to be recruited via inperson intercept screening in LGBT bars
and night clubs as only response rates
were estimated in the 60-day notice. In
addition, the burden table presented in
this document now reports the annual
burden estimate, which has been
corrected from the 60-day notice, which
reported total burden (rather than
annual burden).
To reduce overall burden hours,
participants who screen and complete
the baseline outcome evaluation
questionnaire will be re-contacted to
complete the first followup campaign
evaluation questionnaire; those who
complete the first followup campaign
evaluation questionnaire will be recontacted to complete the second
followup campaign evaluation
questionnaire; and so on. Re-contacted
individuals will not need to complete
the screener again. We expect a 65
percent eligibility rate and 50 percent
response rate for individuals recruited
in person and a combined eligibility and
response rate of 30 percent for
individuals recruited via social media.
In each successive round of data
collection, we expect 50 percent of recontacted individuals to complete the
followup questionnaire; therefore,
additional screenings will be conducted
for each followup in order to maintain
the target sample size for each followup
questionnaire.
In-person recruitment will take place
in a variety of LGBT venues (e.g., bars,
nightclubs). The owners or managers of
potential recruitment sites will be asked
a series of questions to determine the
appropriateness of its clientele for
participation in the study.
Approximately 1,920 venues (640
annualized) will be assessed at 5
minutes per assessment for a total of 159
hours (53 annualized).
To obtain the target number of
completed questionnaires (‘‘completes’’)
for the outcome evaluation study,
24,744 (8,248 annualized, or annually
over the 3-year approval period) young
adults (18,177 (6,059 annualized)
recruited in person and 6,567 (2,189
annualized) recruited via social media)
will participate in a screening process
(‘‘screener’’). The estimated burden per
screener is 5 minutes (0.083 hour), for
a total of 2,055 hours (685 annualized)
(1,512 hours (504 annualized) for
participants recruited in person and 543
hours (181 annualized) for persons
recruited via social media). Before the
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beginning of data collection, the 5minute screener will be tested in a small
pilot study of 81 young adults (27
annualized) for a total of 6 hours (2
hours annualized).
A total of 12,612 (4,204 annualized)
LGBT young adults (9,456 (3,152
annualized) of those screened in person
and 3,156 (1,052 annualized) of those
screened through social media) will
complete questionnaires in four rounds
of data collection (baseline and three
post-campaign rounds). The estimated
burden per complete is 30 minutes (0.5
hour) for the baseline questionnaire and
40 minutes (0.667 hour) for each
followup complete, for a total of 7,884
hours (2,628 annualized) (5,916 hours
(1,972 annualized) for those recruited in
person and 1,968 hours (656
annualized) for those recruited via
social media).
To obtain the target number of
completes (1,503 completes (501
annualized)) for the media tracking
survey, 5,004 (1,668 annualized) young
adults will be recruited via social media
ads to complete a screener for all three
waves of the media tracking survey. The
estimated burden per screener response
is 5 minutes (0.083 hour), for a total of
415 (138 annualized) hours for all waves
of media tracking screener. An
estimated 501 (167 annualized) LGBT
young adults will complete each of the
three waves of the media tracking
survey (assuming a 30 percent
combined eligibility and response rate
to screeners via social media). The
estimated burden per completed media
tracking questionnaire is 40 minutes
(0.667 hour), for a total of 999 (333
annualized) hours for the three waves.
The total burden for the media tracking
survey (screeners and completes) is
1,413 hours (471 annualized).
The target number of completed
campaign questionnaires (i.e., screeners
and questionnaires for both the outcome
evaluation and media tracking survey)
for all respondents is 45,864 (15,288
annualized). The total estimated burden
is 11,517 (3,839 annualized).
In the Federal Register of June 30,
2015 (80 FR 37270), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments; however only one was PRA
related.
(Comment) The commenter did not
believe the amount of hours was
justified for learning about the LGBT
population. Additionally, the
commenter did not see an explanation
of the value of collecting this
information.
(Response) FDA disagrees with this
comment. The Tobacco Control Act
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
authorized FDA to develop and
implement several public health
education campaigns about the dangers
of using tobacco products. Through
literature reviews and analysis of
national survey data, FDA identified
groups that are uniquely at-risk of
tobacco initiation due to a variety of
factors, and who would benefit from an
innovative education campaign
designed to prevent tobacco use. One
such group is young adults who identify
as LGBT who, according to recent data,
smoke at approximately two times the
rate of the general adult population.
FDA is currently developing a
national campaign targeting LGBT
young adults ages 18–24 years. The
purpose of the proposed study is to
evaluate the campaign’s reach and its
effectiveness in changing their
knowledge, beliefs, and attitudes
regarding tobacco. FDA’s public health
education campaigns are a necessary
and worthwhile investment to reduce
the significant burden of tobacco use
and ultimately make tobacco a part of
America’s past, not its future.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of respondent
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total annual
hours
Venue owners and managers.
Venue recruitment assessment.
640
1
640
0.083
53
Total Venue Recruitment.
General Population: Pilot
test of recruitment social
media recruitment.
.............................................
640
1
640
........................
53
Screener—Pilot study ........
27
1
27
0.083
2
.............................................
Screener—Baseline, outcome study.
Screener—First followup,
outcome study.
Screener—Second followup, outcome study.
Screener—Third followup,
outcome study.
.............................................
Screener—Baseline, outcome study.
Screener—First followup,
outcome study.
Screener—Second followup, outcome study.
Screener—Third followup,
outcome study.
.............................................
27
1
27
0.083
2
2,423
1
2,423
0.083
201
1,212
1
1,212
0.083
101
1,212
1
1,212
0.083
101
1,212
6,059
1
........................
1,212
6,059
0.083
........................
101
504
875
1
875
0.083
73
438
1
438
0.083
36
438
1
438
0.083
36
438
2,189
1
........................
438
2,189
0.083
........................
36
181
8,248
........................
8,248
........................
685
788
1
788
0.5
394
788
1
788
0.667
526
788
1
788
0.667
526
788
3,152
1
........................
788
3,152
0.667
........................
526
1,972
263
1
263
0.5
131
263
1
263
0.667
175
263
1
263
0.667
175
263
1,052
1
........................
263
1,052
0.667
........................
175
656
4,204
........................
4,204
........................
2,628
Total Screener Pilot .....
Screener: General population—Recruited in person (65% screen as eligible).
Screeners: In person ..........
Screener: General population—Recruited via social media.
Screeners: Social media .....
tkelley on DSK3SPTVN1PROD with NOTICES
Total screeners ............
Outcome Study LGBT
young adults aged 18–24
in select media markets—
Recruited in person (50%
response rate).
.............................................
Questionnaire—Baseline
outcome study.
Questionnaire—First followup, outcome study.
Questionnaire—Second followup, outcome study.
Questionnaire—Third followup, outcome study.
.............................................
Completes: Screened in
person.
Outcome Evaluation: LGBT
Questionnaire—Baseline
young adults aged 18–24
outcome study.
in select media markets— Questionnaire—First folRecruited via social
lowup, outcome study.
media (30% combined eli- Questionnaire—Second folgibility and response rate).
lowup, outcome study.
Questionnaire—Third followup, outcome study.
Completes: Recruited online .............................................
Total completes (recruited in person and
recruited online).
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Type of respondent
Activity
LGBT young adults aged
18–24 in the select media
markets—Recruited via
social media (30% combined eligibility and response rate).
Media tracking screeners ....
LGBT young adults aged
18–24 in the select media
markets—Recruited via
social media (30% combined eligibility and response rate).
Media tracking questionnaires.
Screener—First media
tracking.
Screener—Second media
tracking.
Screener—Third media
tracking.
.............................................
Questionnaire—First media
tracking.
Questionnaire—Second
media tracking.
Questionnaire—Third media
tracking.
.............................................
Total media tracking
(screeners and questionnaires).
Totals Across All
Study Components.
1 There
Total annual
hours
556
1
556
0.083
46
556
1
556
0.083
46
556
1,668
1
........................
556
1,668
0.083
........................
46
138
167
0.667
111
167
167
0.667
111
167
501
1
........................
167
501
0.667
........................
111
333
.............................................
2,169
........................
2,169
........................
471
.............................................
15,288
........................
15,288
........................
3,839
are no capital costs or operating and maintenance costs associated with this collection of information.
intends to consider to determine
whether a preapproval inspection is
necessary before approval of the PMA
supplement. This draft guidance is not
final nor is it in effect at this time.
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 of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 19,
2016.
ADDRESSES: You may submit comments
as follows:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3454]
Manufacturing Site Change
Supplements: Content and
Submission; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Manufacturing Site Change
Supplements: Content and
Submission’’. This draft guidance
describes the decision-making steps that
FDA recommends to determine whether
a premarket approval application (PMA)
supplement should be submitted when
a manufacturer intends to change the
manufacturing site (including a change
to the processing, packaging, or
sterilization site) of its legally marketed
PMA-approved device. This guidance
also discusses the general factors FDA
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
Average
burden per
response
(in hours)
1
[FR Doc. 2015–26671 Filed 10–20–15; 8:45 am]
ACTION:
Total annual
responses
167
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
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E:\FR\FM\21OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63799-63802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26671]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2126]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Food and Drug Administration's Campaign To Reduce Tobacco Use Among
Lesbian, Gay, Bisexual, and Transgender Young Adults
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
November 20, 2015.
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 title ``Evaluation of the Food
and Drug Administration's Campaign to Reduce Tobacco Use Among Lesbian,
Gay, Bisexual, and Transgender Young Adults''. 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 Campaign To Reduce Tobacco Use Among Lesbian, Gay,
Bisexual, and Transgender Young Adults--OMB Control Number 0910--New
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) amended 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 public education campaigns to help prevent and reduce
tobacco use among lesbian, gay, bisexual, and transgender (LGBT) young
adults and thereby reduce the public health burden of tobacco. Overall
the campaigns will feature events; advertisements on television and
radio and in print; digital communications including social media; and
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, FDA
requests OMB approval to collect information needed to evaluate FDA's
campaign to reduce tobacco use among LGBT young adults. 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 LGBT young adult tobacco prevention campaign: (1) An outcome
evaluation study to evaluate the effectiveness of its LGBT young adult
tobacco prevention campaign, and (2) a media tracking questionnaire to
assess awareness of and receptivity to campaign messages. The timing of
these studies will be designed to follow the multiple, discrete waves
of media advertising planned for the campaigns.
I. Outcome Evaluation Study
Before the beginning of data collection for the outcome evaluation
study, the 5-minute screening instrument will be tested in a small
pilot study of LGBT young adults aged 18 to 24. The outcome evaluation
study will then begin with a baseline survey of LGBT young adults aged
18 to 24 before the campaign launch. The baseline will be followed by
three followup surveys of the target audience of young adults at
approximately 6-month intervals after the campaign's launch.
Information will be collected
[[Page 63800]]
about young adult awareness of and exposure to campaign events and
advertisements and about tobacco-related knowledge, attitudes, beliefs,
intentions and use, as well as use of other tobacco products (e-
cigarettes, hookah, cigars, smokeless tobacco), marijuana and alcohol.
Information will also be collected on demographic variables including
sexual orientation, age, sex, race/ethnicity, education, and primary
language.
All information will be collected through in-person and Web-based
questionnaires. Young adult respondents will be recruited in 24 U.S.
cities (12 campaign and 12 comparison cities) from two sources: (1)
Intercept surveys in LGBT social venues (e.g., bars and nightclubs) and
(2) through social media advertisements (e.g. on Facebook and Twitter)
targeted at LGBT 18 to 24-year-olds, living in the same 24 U.S. cities.
Participation in the study is voluntary.
II. Media Tracking Survey
The media tracking survey consists of assessments of LGBT young
adults aged 18 to 24 conducted in the periods in between the primary
outcome evaluation survey waves to monitor the target audience's
awareness of and receptivity to campaign activities. The media tracking
survey will assess awareness of the campaign 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 events and media advertising and
variation in exposure to allow for mid-campaign refinements. For the
media tracking surveys, we will recruit LGBT young adults aged 18 to 24
from all campaign cities through social media.
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 surveys will be used to estimate awareness
of and exposure to the campaigns among young adults in target markets
where the campaigns are active. Data from the outcome evaluation study
will be used to examine statistical associations between awareness of
and exposure to the campaigns and subsequent changes in specific
outcomes of interest, which will include knowledge, attitudes, beliefs,
and intentions related to tobacco use.
FDA's burden estimate is based on prior experience with in-person
studies similar to the Agency's plan presented in this document, as
well as previous research using social media advertising to recruit
young adult participants. Since the 60-day notice was published, FDA
has revised the estimated burden. The estimated burden has been revised
to account for both participant eligibility and response rates among
participants to be recruited via in-person intercept screening in LGBT
bars and night clubs as only response rates were estimated in the 60-
day notice. In addition, the burden table presented in this document
now reports the annual burden estimate, which has been corrected from
the 60-day notice, which reported total burden (rather than annual
burden).
To reduce overall burden hours, participants who screen and
complete the baseline outcome evaluation questionnaire will be re-
contacted to complete the first followup campaign evaluation
questionnaire; those who complete the first followup campaign
evaluation questionnaire will be re-contacted to complete the second
followup campaign evaluation questionnaire; and so on. Re-contacted
individuals will not need to complete the screener again. We expect a
65 percent eligibility rate and 50 percent response rate for
individuals recruited in person and a combined eligibility and response
rate of 30 percent for individuals recruited via social media. In each
successive round of data collection, we expect 50 percent of re-
contacted individuals to complete the followup questionnaire;
therefore, additional screenings will be conducted for each followup in
order to maintain the target sample size for each followup
questionnaire.
In-person recruitment will take place in a variety of LGBT venues
(e.g., bars, nightclubs). The owners or managers of potential
recruitment sites will be asked a series of questions to determine the
appropriateness of its clientele for participation in the study.
Approximately 1,920 venues (640 annualized) will be assessed at 5
minutes per assessment for a total of 159 hours (53 annualized).
To obtain the target number of completed questionnaires
(``completes'') for the outcome evaluation study, 24,744 (8,248
annualized, or annually over the 3-year approval period) young adults
(18,177 (6,059 annualized) recruited in person and 6,567 (2,189
annualized) recruited via social media) will participate in a screening
process (``screener''). The estimated burden per screener is 5 minutes
(0.083 hour), for a total of 2,055 hours (685 annualized) (1,512 hours
(504 annualized) for participants recruited in person and 543 hours
(181 annualized) for persons recruited via social media). Before the
beginning of data collection, the 5-minute screener will be tested in a
small pilot study of 81 young adults (27 annualized) for a total of 6
hours (2 hours annualized).
A total of 12,612 (4,204 annualized) LGBT young adults (9,456
(3,152 annualized) of those screened in person and 3,156 (1,052
annualized) of those screened through social media) will complete
questionnaires in four rounds of data collection (baseline and three
post-campaign rounds). The estimated burden per complete is 30 minutes
(0.5 hour) for the baseline questionnaire and 40 minutes (0.667 hour)
for each followup complete, for a total of 7,884 hours (2,628
annualized) (5,916 hours (1,972 annualized) for those recruited in
person and 1,968 hours (656 annualized) for those recruited via social
media).
To obtain the target number of completes (1,503 completes (501
annualized)) for the media tracking survey, 5,004 (1,668 annualized)
young adults will be recruited via social media ads to complete a
screener for all three waves of the media tracking survey. The
estimated burden per screener response is 5 minutes (0.083 hour), for a
total of 415 (138 annualized) hours for all waves of media tracking
screener. An estimated 501 (167 annualized) LGBT young adults will
complete each of the three waves of the media tracking survey (assuming
a 30 percent combined eligibility and response rate to screeners via
social media). The estimated burden per completed media tracking
questionnaire is 40 minutes (0.667 hour), for a total of 999 (333
annualized) hours for the three waves. The total burden for the media
tracking survey (screeners and completes) is 1,413 hours (471
annualized).
The target number of completed campaign questionnaires (i.e.,
screeners and questionnaires for both the outcome evaluation and media
tracking survey) for all respondents is 45,864 (15,288 annualized). The
total estimated burden is 11,517 (3,839 annualized).
In the Federal Register of June 30, 2015 (80 FR 37270), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments; however only one
was PRA related.
(Comment) The commenter did not believe the amount of hours was
justified for learning about the LGBT population. Additionally, the
commenter did not see an explanation of the value of collecting this
information.
(Response) FDA disagrees with this comment. The Tobacco Control Act
[[Page 63801]]
authorized FDA to develop and implement several public health education
campaigns about the dangers of using tobacco products. Through
literature reviews and analysis of national survey data, FDA identified
groups that are uniquely at-risk of tobacco initiation due to a variety
of factors, and who would benefit from an innovative education campaign
designed to prevent tobacco use. One such group is young adults who
identify as LGBT who, according to recent data, smoke at approximately
two times the rate of the general adult population.
FDA is currently developing a national campaign targeting LGBT
young adults ages 18-24 years. The purpose of the proposed study is to
evaluate the campaign's reach and its effectiveness in changing their
knowledge, beliefs, and attitudes regarding tobacco. FDA's public
health education campaigns are a necessary and worthwhile investment to
reduce the significant burden of tobacco use and ultimately make
tobacco a part of America's past, not its future.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per Total annual
Type of respondent Activity respondents responses per responses response (in hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Venue owners and managers................. Venue recruitment assessment 640 1 640 0.083 53
-------------------------------------------------------------------------------
Total Venue Recruitment............... ............................ 640 1 640 .............. 53
General Population: Pilot test of Screener--Pilot study....... 27 1 27 0.083 2
recruitment social media recruitment.
-------------------------------------------------------------------------------
Total Screener Pilot.................. ............................ 27 1 27 0.083 2
Screener: General population--Recruited in Screener--Baseline, outcome
person (65% screen as eligible). study. 2,423 1 2,423 0.083 201
Screener--First followup, .............. .............. .............. .............. ..............
outcome study. 1,212 1 1,212 0.083 101
Screener--Second followup, .............. .............. .............. .............. ..............
outcome study. 1,212 1 1,212 0.083 101
Screener--Third followup, .............. .............. .............. .............. ..............
outcome study. 1,212 1 1,212 0.083 101
Screeners: In person...................... ............................ 6,059 .............. 6,059 .............. 504
Screener: General population--Recruited Screener--Baseline, outcome
via social media. study. 875 1 875 0.083 73
Screener--First followup, .............. .............. .............. .............. ..............
outcome study. 438 1 438 0.083 36
Screener--Second followup, .............. .............. .............. .............. ..............
outcome study. 438 1 438 0.083 36
Screener--Third followup, .............. .............. .............. .............. ..............
outcome study. 438 1 438 0.083 36
Screeners: Social media................... ............................ 2,189 .............. 2,189 .............. 181
-------------------------------------------------------------------------------
Total screeners....................... ............................ 8,248 .............. 8,248 .............. 685
Outcome Study LGBT young adults aged 18-24 Questionnaire--Baseline
in select media markets--Recruited in outcome study. 788 1 788 0.5 394
person (50% response rate). Questionnaire--First .............. .............. .............. .............. ..............
followup, outcome study. 788 1 788 0.667 526
Questionnaire--Second .............. .............. .............. .............. ..............
followup, outcome study. 788 1 788 0.667 526
Questionnaire--Third .............. .............. .............. .............. ..............
followup, outcome study. 788 1 788 0.667 526
Completes: Screened in person............. ............................ 3,152 .............. 3,152 .............. 1,972
Outcome Evaluation: LGBT young adults aged Questionnaire--Baseline
18-24 in select media markets--Recruited outcome study. 263 1 263 0.5 131
via social media (30% combined Questionnaire--First .............. .............. .............. .............. ..............
eligibility and response rate). followup, outcome study. 263 1 263 0.667 175
Questionnaire--Second .............. .............. .............. .............. ..............
followup, outcome study. 263 1 263 0.667 175
Questionnaire--Third .............. .............. .............. .............. ..............
followup, outcome study. 263 1 263 0.667 175
Completes: Recruited online............... ............................ 1,052 .............. 1,052 .............. 656
-------------------------------------------------------------------------------
Total completes (recruited in person ............................ 4,204 .............. 4,204 .............. 2,628
and recruited online).
[[Page 63802]]
LGBT young adults aged 18-24 in the select Screener--First media
media markets--Recruited via social media tracking. 556 1 556 0.083 46
(30% combined eligibility and response Screener--Second media .............. .............. .............. .............. ..............
rate). tracking. 556 1 556 0.083 46
Screener--Third media .............. .............. .............. .............. ..............
tracking. 556 1 556 0.083 46
Media tracking screeners.................. ............................ 1,668 .............. 1,668 .............. 138
LGBT young adults aged 18-24 in the select Questionnaire--First media
media markets--Recruited via social media tracking. 167 .............. 167 0.667 111
(30% combined eligibility and response Questionnaire--Second media .............. .............. .............. .............. ..............
rate). tracking. 167 1 167 0.667 111
Questionnaire--Third media .............. .............. .............. .............. ..............
tracking. 167 1 167 0.667 111
Media tracking questionnaires............. ............................ 501 .............. 501 .............. 333
-------------------------------------------------------------------------------
Total media tracking (screeners and ............................ 2,169 .............. 2,169 .............. 471
questionnaires).
-------------------------------------------------------------------------------
Totals Across All Study Components ............................ 15,288 .............. 15,288 .............. 3,839
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26671 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P
