[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]


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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.

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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 [email protected]. 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, [email protected].

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\
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                                                                                                                              Average
                                                                             Number of       Number of     Total annual     burden per     Total annual
            Type of respondent                        Activity              respondents    responses per     responses     response  (in       hours
                                                                                            respondent                        hours)
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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
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\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