[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61003-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27712]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on an extension of the time period for the 
outcome evaluation of FDA's multicultural youth tobacco public 
education campaign, the addition of two rounds of data collection with 
the original youth surveyed for the outcome evaluation, and recruitment 
of new youth to participate in those two additional surveys.

DATES: Submit either electronic or written comments on the collection 
of information by February 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 26, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

[[Page 61004]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2294 for ``Evaluation of the Food and Drug Administration's 
`Fresh Empire' Multicultural Youth Tobacco Prevention Campaign'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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, including 
each proposed extension of an existing 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 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 (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 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.

[[Page 61005]]

    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-year-old youth who 
are 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 two post-test surveys have been 
conducted. A third post-test survey is currently underway. 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 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).
    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 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 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 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 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 and 
will be completed 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 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 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 screener and consents 
will be 6,700 and the total burden will be 111 hours.
    With these additions, the estimated number of 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 increase of 4,813 hours 
from the last approval.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 61006]]



                                                     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    Total hours
                                                                            respondents     respondent       responses     per response
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Youth aged 12 to 17 in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0833           1,151
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0833             822
                                             Process--Post-test outcome
                                             survey.
Adults 18 and older in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0166             229
                                             Process--Pre-test outcome
                                             survey.
                                            Online Screener and Consent              520               1             520          0.0166               9
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0166             164
                                             Process--Post-test outcome
                                             survey.
                                            Online Screener and Consent            6,700               1           6,700          0.0166             111
                                             Process--Post-test outcome
                                             survey.
Multicultural Youth aged 12 to 17 in        Pre-test outcome evaluation            2,194               1           2,194             0.5           1,097
 select media markets.                       survey.
Longitudinal Cohort, age 13 to 18 years...  First post-test evaluation             1,722               1           1,722            0.75           1,292
                                             survey.
                                            Second post-test evaluation            1,752               1           1,752            0.75           1,314
                                             survey.
                                            Third post-test evaluation             1,365               1           1,365            0.75           1,024
                                             survey.
                                            Fourth post-test evaluation              600               1             600            0.75             450
                                             survey.
                                            Fifth post-test evaluation               600               1             600            0.75             450
                                             survey.
Cross-Sectional Refresher Sample, age 13    First post-test evaluation               682               1             682            0.75             512
 to 17 years.                                survey.                                 503               1             503            0.75             377
                                            Second post-test evaluation              735               1             735            0.75             551
                                             survey.                               1,500               1           1,500            0.75           1,125
                                            Third post-test evaluation             1,500               1           1,500            0.75           1,125
                                             survey.
                                            Fourth post-test evaluation
                                             survey.
                                            Fifth post-test evaluation
                                             survey.
Multicultural youth aged 13 to 17 in the    Pre-test online screener....           8,000               1           8,000          0.0833             666
 select media markets recruiting through    Post-test online screener...          32,000               1          32,000          0.0833           2,666
 social media and online panels.
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    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: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27712 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P


