[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63176-63178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26555]


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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; Food and Drug 
Administration's Research and Evaluation Survey for the Public 
Education Campaign on Tobacco Among the Lesbian Gay Bisexual 
Transgender Community

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 January 
7, 2019.

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 OMB control number 0910-0808. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

Food and Drug Administration's (FDA's) Research and Evaluation Survey 
for the Public Education Campaign on Tobacco (RESPECT) Among the LGBT 
Community

OMB Control Number 0910-0808--Extension

    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and 
Cosmetic Act (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. In May 2016, FDA began implementing a public 
education campaign 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. The campaign continues to 
be implemented in 12 U.S. cities and features events, television and 
radio and print advertisements, digital communications, including 
videos, social media, and other forms of media. For the purpose of this 
notice, these campaign elements will be referred to as 
``advertisements'' or ``ads.''
    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.
    To evaluate the effectiveness of FDA's RESPECT at reducing tobacco 
use among LGBT young adults aged 18 to 24, FDA contracted with RTI 
International to conduct Web-based surveys with the target population 
in the 12 campaign cities and 12 comparison cities. The surveys include 
measures of tobacco-related knowledge, attitudes, beliefs, intentions, 
and use as well as measures of audience awareness of and exposure to 
campaign events and advertisements. The voluntary surveys also collect 
information on demographic variables, including sexual orientation, 
age, sex, race/ethnicity, education, and

[[Page 63177]]

primary language. Baseline data collection for RESPECT was conducted 
between February and May 2016. Four subsequent waves of data collection 
were conducted with new (cross-sectional) and returning (longitudinal) 
respondents. This design facilitated analysis of relationships between 
individuals' exposure to campaign activities and baseline to followup 
changes in outcomes of interest between campaign and comparison cities. 
Information collection for baseline and the first four followups was 
reviewed and approved by OMB.
    FDA will continue to implement RESPECT in 12 U.S. cities through 
April 2019. To complete the evaluation of RESPECT, FDA is requesting an 
extension of the previously approved information collection in order to 
conduct two additional waves of data collection with the target 
population. The proposed sixth and seventh waves of data collection 
(i.e., fifth and sixth followups after baseline) will coincide with the 
official end of the campaign, and will serve as an assessment of the 
campaign at completion. Continued evaluation is necessary in order to 
determine the campaign's impact on outcomes of interest.
    As in previous waves, new and returning survey respondents will be 
invited to complete the online questionnaire. New (or cross-sectional) 
respondents will be recruited at LGBT social venues and via social 
media (i.e., Facebook and Twitter). In-person recruitment will take 
place in a variety of LGBT venues. 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. For 
the fifth and sixth followups, an estimated 60 new venues (20 
annualized) will be assessed at 5 minutes per assessment, for an 
additional 5 hours (1.67 annualized). A total of 1,980 venues (660 
annualized) will be assessed during the evaluation study, for a total 
of 165 hours (55 annualized).
    Our goal is to recruit 75 percent of the sample via intercept 
interviews and 25 percent via social media. To obtain the target number 
of completed fifth and sixth followup questionnaires, an additional 
11,904 adults (3,968 annualized) recruited in person and 2,736 adults 
(912 annualized) recruited via social media will complete screening 
questionnaires. For the entire evaluation study, a total of 33,717 
adults (11,239 annualized) recruited in person will complete screening 
questionnaires along with 10,617 adults (3,539 annualized) recruited 
via social media. The estimated burden to complete the screening 
questionnaire is 5 minutes (0.083 hour), for a total of 2,799 hours 
(933 annualized) for in-person recruits and 881 hours (294 annualized) 
for social media recruits.
    Based on analysis of response rates from prior waves of data 
collection, we expect 65 percent of intercept respondents will be 
deemed eligible and 50 percent of those will complete the fifth 
followup questionnaire. We expect 30 percent of those recruited via 
social media will be deemed eligible and complete the fifth followup 
questionnaire. Lastly, we expect 50 percent of returning (or 
longitudinal) respondents to complete the fifth and sixth followup 
questionnaires. We estimate that approximately 2,100 new respondents 
(700 annualized) and 6,678 returning (2,226 annualized) respondents 
will complete the fifth and sixth followup questionnaires, for a total 
of 8,778 responses (2,926 annualized).
    OMB previously approved 3,156 (1,052 annualized) respondents 
recruited via social media and 9,456 (3,152 annualized) respondents 
recruited in person to complete the first four followup questionnaires. 
Adding the fifth and sixth followups brings the total estimated number 
of followup questionnaires completed by social media recruits to 5,256 
(1,752 annualized) and by in-person recruits to 16,134 (5,378 
annualized). At 40 minutes per completed questionnaire, the total 
burden is 3,507 hours (1,169 annualized) for social media respondents 
and 10,761 hours (3,587 annualized) for in-person respondents.
    OMB also previously approved 393 hours (approximately 132 
annualized) for social media respondents and 1,182 hours (394 
annualized) for in-person respondents to complete baseline 
questionnaires. OMB also approved the pilot test of procedures in bars 
(6 hours (2 annualized)). As these study components are complete, the 
corresponding burden will not change. Lastly, the original study design 
included a media tracking component, which included a burden of 414 
hours (138 annualized) for completing a 5-minute screening 
questionnaire and 999 hours (333 annualized) for completing the media 
tracking questionnaire. However, this component was dropped from the 
study; hence, the related burden has been deducted from the total study 
burden.
    In the Federal Register of August 2, 2018 (83 FR 37817), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received a total of nine comments from 
the public, of which five were PRA-related.
    (Comment) Two commenters indicated support for FDA's efforts to 
evaluate media campaigns targeting smoking within the LGBT community.
    (Response) FDA appreciates the public's support of its efforts to 
meet its mission to promote and protect public health.
    (Comment) One commenter questioned the need for further data 
collection on this topic.
    (Response) FDA disagrees. This collection of information is 
necessary for FDA to meet its mission to promote and protect public, 
and in its implementation of the Tobacco Control Act.
    (Comment) One commenter questioned whether the evaluation is 
collecting sufficient data on the campaign's impact on the target 
population's thinking about smoking.
    (Response) The campaign is intended to influence the target 
population's attitude towards smoking. To evaluate the effectiveness of 
the campaign, FDA is asking questions about the target population's 
tobacco use-related knowledge, attitudes, beliefs, and intentions 
before and after seeing the campaign's ads to test whether those have 
changed over time as a result of exposure to the campaign.
    (Comment) One commenter questioned the utility of collecting data 
on smoking among LGBT young adults without first gathering information 
on smoking rates in this population, and also suggested specific modes 
for participant recruitment.
    (Response) Multiple peer-reviewed studies have found that LGBT 
populations of all age groups are significantly more likely to smoke 
cigarettes and use other tobacco products compared to non-LGBT 
populations. FDA appreciates the detailed review of the evaluation's 
recruitment approach. Consistent with the commenter's recommendation, 
this information collection recruits participants both online via 
social media platforms and in person at LGBT social venues. This 
information collection does not recruit on the street or advertise via 
television.
    (Comment) Several comments raised questions about the 
appropriateness of the target population and implementation approach of 
the public education campaigns being conducted by FDA.
    (Response) FDA notes that these comments address the content, 
focus, or implementation of an existing public education campaign, and 
are therefore outside the scope of this information

[[Page 63178]]

collection, which is being conducted to evaluate the campaign.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
       Respondent type and activity            Number of     responses per   Total annual           Average  burden per  response           Total hours
                                              respondents     respondent       responses
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Venue Owners and Managers.................             660               1             660  0.083 (5 minutes)...........................              55
General Population: Pilot test of                       27               1              27  0.083 (5 minutes)...........................               2
 Procedures in Bars.
General population--outcome screener (in            11,239               1          11,239  0.083 (5 minutes)...........................             933
 person).
General population--outcome screener                 3,539               1           3,539  0.083 (5 minutes)...........................             294
 (social media).
LGBT young adults outcome baseline (social             263               1             263  0.5 (30 minutes)............................             132
 media).
LGBT young adults outcome baseline (in                 788               1             788  0.5 (30 minutes)............................             394
 person).
LGBT young adults outcome followup                   1,752               1           1,752  0.667 (40 minutes)..........................           1,169
 questionnaire (social media).
LGBT young adults outcome followup                   5,378               1           5,378  0.667 (40 minutes)..........................           3,587
 questionnaire (in person).
                                           -------------------------------------------------------------------------------------------------------------
    Totals................................  ..............  ..............  ..............  ............................................           6,566
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To accommodate the additional waves of data collection, FDA 
requests approval to increase the number of burden hours under the 
existing control number. The previous number of approved responses was 
53,967 (17,989 annualized), and the previous burden was 14,031 hours 
(4,677 annualized). The fifth and sixth followups add 23,478 responses 
(7,826 annualized), which include responses to new venues assessments, 
screening questionnaires, and the followup questionnaires, for a total 
of 7,074 additional burden hours (2,357 annualized). Removing the media 
tracking component deducts 6,507 responses (2,169 annualized) and 1,413 
burden hours (471 annualized). The totals for the entire evaluation 
study are increasing by 16,971 responses (5,657 annualized) and 5,661 
hours (1,887 annualized) for a new total of 70,938 responses (23,646 
annualized) and 19,692 burden hours (approximately 6,566 annualized).

    Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26555 Filed 12-6-18; 8:45 am]
BILLING CODE 4164-01-P