[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16863-16865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2294]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Evaluation of the 
Fresh Empire Campaign on Tobacco

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 (the PRA).

DATES: Fax written comments on the collection of information by May 17, 
2018.

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 0910-0788. 
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

[[Page 16864]]

collection of information to OMB for review and clearance.

Evaluation of the Food and Drug Administration's `Fresh Empire' 
Multicultural Youth Tobacco Prevention Campaign

OMB Control Number 0910-0788--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. Accordingly, FDA is currently developing and 
implementing a youth-targeted public education campaign (`Fresh 
Empire') to help prevent tobacco use among multicultural youth and 
thereby reduce the public health burden of tobacco. The campaign 
features events, advertisements on television and radio and in print, 
digital communications including social media, and other forms of 
media.
    Evaluation is an essential organizational practice in public health 
and a systematic way to account for and improve public health actions. 
Comprehensive evaluation of FDA's multicultural public education 
campaign will be used to document whether the intended audience is 
aware of and understands campaign messages, and whether campaign 
exposure influences specific cognitive outcomes related to tobacco use 
that are targeted by the campaign.
    FDA is in the process of evaluating the effectiveness of its 
multicultural youth tobacco prevention campaign through an outcome 
evaluation study that follows the multiple, discrete waves of media 
advertising planned for the campaign. All information collected is 
integral to that evaluation.
    FDA's Fresh Empire youth tobacco public education campaign aims to 
reduce tobacco use among youth who affiliate with a hip-hop peer crowd, 
predominantly among African American, Hispanic, and Asian/Pacific 
Islander youth. The outcome evaluation of the campaign consists of a 
pre-test survey of youth aged 12 to 17 before campaign launch followed 
by a series of post-test surveys beginning approximately 6 months after 
the campaign launch. The post-test surveys are conducted among youth 
who participated in one or more surveys (the embedded longitudinal 
cohort) and new participants who are recruited to make up for 
attrition. Eligible youth were initially 12 to 17 years old and 
influenced by the hip-hop peer crowd. Youth in the embedded 
longitudinal cohort may reach the age of 18 over the course of the 
evaluation.
    To date, the pre-test and three post-test surveys have been 
conducted. Information has been collected about youth awareness of and 
exposure to campaign events and advertisements and about tobacco-
related knowledge, attitudes, beliefs, intentions, and use. Information 
has also been collected on demographic variables including age, sex, 
race/ethnicity, grade level, and primary language.
    All information is voluntarily provided and is being collected 
through in-person and web-based questionnaires. Youth respondents were 
recruited from two sources: (1) A sample drawn from 30 U.S. media 
markets gathered using an address-based postal mail sampling of U.S. 
households for the outcome evaluation, and (2) targeted social media 
(e.g., Facebook, Instagram).
    This study is being conducted in support of the provisions of the 
Tobacco Control Act that require FDA to protect the public health and 
to educate the population about the risks and potential risks of 
tobacco use. The information being collected is necessary to inform 
FDA's efforts towards these goals and to measure the effectiveness and 
public health impact of the campaign. Data from the outcome evaluation 
are being used to estimate awareness of and exposure to the campaign 
among youth in target markets where the campaign is active. Data are 
also being used to examine statistical associations between exposure to 
the campaign and subsequent changes in specific outcomes of interest, 
which include knowledge, attitudes, and beliefs related to tobacco use.
    FDA requests OMB approval to extend OMB approval of the evaluation 
of FDA's multicultural youth tobacco public education campaign and to 
add two additional waves of data collection with existing youth in the 
study. To accommodate these two additional surveys, FDA requests 
approval to increase the number of burden hours under the existing 
control number. The fourth post-test survey will begin in July 2018. 
The fifth post-test survey will begin in February 2019. As was done in 
earlier post-test surveys, new youth will be recruited to participate 
to make up for attrition.
    A total of 2,100 youth will voluntarily complete questionnaires for 
the fourth post-test survey, and the same number will complete 
questionnaires for the fifth post-test survey. These respondents will 
include existing youth who have participated in one or more surveys 
previously (``Longitudinal Cohort'') and new youth recruited via a 
mail-based screener or social media ads (``Cross-Sectional Refresher 
Sample''). Based on earlier response rates and longitudinal respondents 
aging out of the eligibility criteria (over the age of 18), we expect 
to need to recruit a larger number of cross-sectional respondents than 
in previous waves. We estimate that approximately 600 longitudinal 
youth and 1,500 cross-sectional youth will voluntarily participate in 
each of the fourth and fifth post-test surveys. With an estimated 
burden of 45 minutes per respondent, this adds 450 hours for 
longitudinal respondents and 1,125 hours for cross-sectional 
respondents for each of the fourth and fifth post-test evaluation 
surveys.
    A mail-based screener was one of the methods used to identify 
eligible youth for the pre-test survey. This method will be used during 
the fourth post-test survey to recruit new youth aged 12 to 17 to 
ensure that the sample composition is similar across rounds of data 
collection. As was done during the pre-test survey, parents or 
guardians will be asked to provide consent and their contact 
information on this form. For the fourth post-test survey, the 5-minute 
youth screener and the 1-minute parental consent will be completed by 
9,869 households for a total of 822 burden hours for youth and an 
additional 164 hours for the parents or guardians. This method will not 
be used during the fifth post-test survey, for which new participants 
will be recruited only via social media.
    We will continue to recruit new youth through social media (e.g., 
Facebook, Instagram) as a secondary strategy to recruit youth aged 13 
to 17. An online version of the screener described above will continue 
to be used to identify eligible youth. The screener will take 5 minutes 
to complete and will be taken by an additional 4,000 youth during each 
of the fourth and fifth post-test surveys, for a total of 8,000 
additional youth respondents and 666 total additional burden hours. The 
new total number of voluntary participants for the youth online post-
test screener will be 32,000 and the total burden will be 2,666 hours. 
This includes the originally approved 24,000 participants and 2,000 
burden hours.
    As was done previously, eligible youth aged 13 to 14 who complete 
the

[[Page 16865]]

online screener will be asked to provide their parents' or guardians' 
contact information to provide parental consent for the main survey. 
The process of parents and guardians providing consent for eligible 
youth will take approximately 1 minute. For the fourth and fifth post-
test surveys, we estimate that an additional 700 adults will be 
contacted to provide consent for eligible youth for a total of 11 
additional burden hours. Added to the original 6,000 parents and 100 
burden hours, the total number of parental online screeners and 
consents will be 6,700 and the total burden will be 111 hours.
    With these additions, the estimated number of voluntary 
respondents/responses for all waves of data collection for the study is 
107,743, and the total burden is estimated at 15,135 hours--an 
estimated increase of 4,813 hours from the last approval.
    In the Federal Register of December 26, 2017 (82 FR 61003), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received; however, this 
comment was not PRA related.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
         Type of respondent/activity             Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Youth Mail screener-outcome survey..........          23,685               1          23,685  0.0833 (5 minutes)........................           1,973
Cross-Sectional Youth Refresher Sample, Post-          4,920               1           4,920  0.75 (45 minutes).........................           3,690
 test and assent/consent process-outcome
 surveys 1-5.
Youth Pre-test and assent/consent process-             2,194               1           2,194  0.50 (30 minutes).........................           1,097
 outcome survey.
Longitudinal Youth Cohort, Post-test and               6,039               1           6,039  0.75 (45 minutes).........................           4,530
 assent/consent process-outcome surveys 1-5.
Youth Online screener-outcome survey........          40,000               1          40,000  0.0833 (5 minutes)........................           3,332
Adult parental permission process-outcome             30,905               1          30,905  0.0166 (1 minute).........................             513
 survey.
                                             ------------------------------------------------                                            ---------------
    Total...................................         107,743  ..............  ..............  ..........................................          15,135
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07971 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P`


