[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37270-37273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16020]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2126]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on

[[Page 37271]]

the Evaluation of FDA's Multicultural Youth Tobacco Prevention 
Campaigns.

DATES: Submit either electronic or written comments on the collection 
of information by August 31, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Evaluation of 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) 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 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.
 Outcome Evaluation Study
    The outcome evaluation study begins with a baseline survey of LGBT 
young adults aged 18 to 24 before the campaign launch. The baseline 
will be followed by three follow-up surveys of the target audience of 
young adults at approximately 6-month intervals after the campaign's 
launch. Information will be collected 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 30 U.S. 
cities (15 campaign and 15 comparison cities) from two sources: (1) 
Intercept surveys in LGBT social venues (e.g., bars and nightclubs) 
identified using a time location sampling approach, and (2) through 
social media advertisements on Facebook and Twitter targeted at LGBT 18 
to 24-year-olds, living in the same 30 U.S. cities. Participation in 
the study is voluntary.
 Media Tracking Survey
    The media tracking survey consists of assessments of LGBT young 
adults aged 18 to 24 conducted once yearly post campaign launch--timing 
that complements the outcome evaluation's timing. 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

[[Page 37272]]

research using social media advertising to recruit young adult 
participants. To reduce overall burden hours, participants who screen 
and complete the baseline outcome evaluation questionnaire will be re-
contacted to complete the first follow up campaign evaluation 
questionnaire, those who complete the first follow up campaign 
evaluation questionnaire will be re-contacted to complete the second 
follow up campaign evaluation questionnaire, and so on. Re-contacted 
individuals will not need to complete the screener again. We expect a 
50 percent response rate for individuals recruited in person and a 30 
percent rate for individuals recruited via social media. In each 
successive round of data collection, we expect 50 percent of re-
contacted individuals to complete the follow up questionnaire, 
therefore, additional screenings will be conducted for each follow up 
in order to maintain the target sample size for each follow up 
questionnaire.
    To obtain the target number of completed questionnaires 
(``completes'') for the outcome evaluation study, 18,376 young adults 
(11,810 recruited in person and 6,566 recruited via social media) will 
participate in a screening process (``screener''). The estimated burden 
per screener is 5 minutes (0.083), for a total of 1,525 hours (980 
hours for participants recruited in person and 545 hours for persons 
recruited via social media). A total of 12,600 LGBT young adults (9,448 
of those screened in person and 3,152 of those screened through social 
media) will complete questionnaires in 4 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 follow up complete, for a total of 7,878 
hours (5,906 hours for those recruited in person and 1,972 hours for 
those recruited via social media).
    To obtain the target number of completes for the media tracking 
survey, 5,000 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 414 hours for all waves of media tracking screener. An 
estimated 500 LGBT young adults will complete each of the three waves 
of the media tracking survey (assuming a 30 percent 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 1,002 
hours for the three waves. The total burden for the media tracking 
survey (screeners and completes) is 1,416 hours.
    The target number of completed campaign questionnaires (screeners 
and questionnaires for both the outcome evaluation and media tracking 
survey) for all respondents is 37,477. The total estimated burden is 
10,819 hours.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
         Type of respondent                 Activity           Number of     responses per   Total annual        Average  burden per        Total hours
                                                              respondents     respondent       responses              response
--------------------------------------------------------------------------------------------------------------------------------------------------------
General population--Recruited in     Screener--Baseline--o           4,724               1           4,724  0.083 (5 min.)..............             392
 person (50% response rate).          utcome study.
                                     Screener--First                 2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
                                     Screener--Second                2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
                                     Screener--Third                 2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
LGBT young adults aged 18-24 in      Baseline--outcome               2,362               1           2,362  0.5 (30 min.)...............            1181
 select media markets--Recruited in   evaluation
 person.                              questionnaire.
                                     First follow up young           2,362               1           2,362  0.667 (40 min.).............            1575
                                      adult outcome
                                      evaluation
                                      questionnaire.
                                     Second follow up                2,362               1           2,362  0.667 (40 min.).............            1575
                                      young adult outcome
                                      evaluation
                                      questionnaire.
                                     Third follow up young           2,362               1           2,362  0.667 (40 min.).............            1575
                                      adult outcome
                                      evaluation
                                      questionnaire.
General population--Recruited via    Screener--Baseline--o           2,627               1           2,627  0.083 (5 min.)..............             218
 social media (30% response rate).    utcome study.
                                     Screener--First                 1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
                                     Screener--Second                1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
                                     Screener--Third                 1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
LGBT young adults aged 18-24 in      Baseline--outcome                 788               1             788  0.5 (30 min.)...............             394
 select media markets--Recruited      evaluation
 via social media.                    questionnaire.
                                     First follow up young             788               1             788  0.667 (40 min.).............             526
                                      adult outcome
                                      evaluation
                                      questionnaire.

[[Page 37273]]

 
                                     Second follow up                  788               1             788  0.667 (40 min.).............             526
                                      young adult outcome
                                      evaluation
                                      questionnaire.
                                     Third follow up young             788               1             788  0.667 (40 min.).............             526
                                      adult outcome
                                      evaluation
                                      questionnaire.
LGBT young adults aged 18-24 in the  1st media tracking               1667               1            1667  0.083 (5 min.)..............             138
 select media markets--Recruited      screener.
 via social media.
                                     1st media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                     2nd media tracking               1667               1            1667  0.083 (5 min.)..............             138
                                      screener.
                                     2nd media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                     3rd media tracking               1667               1            1667  0.083 (5 min.)..............             138
                                      screener.
                                     3rd media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                                           ------------------------------------------------                              ---------------
    Total..........................  .....................          37,477  ..............  ..............  ............................          10,819
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16020 Filed 6-29-15; 8:45 am]
BILLING CODE 4164-01-P