80 FR 19673 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 70 (April 13, 2015)

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.

[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19673-19675]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08466]


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

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.

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

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 May 13, 
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 OMB control number 0910-NEW and 
title ``Evaluation of the Food and Drug Administration's `Fresh Empire' 
Multicultural Youth Tobacco Prevention Campaign.'' 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] fda.hhs.gov.

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 the Food and Drug Administration's `Fresh Empire' 
Multicultural Youth Tobacco Prevention Campaign (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 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 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 by 
minors, FDA requests OMB approval to collect information needed to 
evaluate FDA's `Fresh Empire' multicultural youth tobacco prevention 
campaign. 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 evaluate the effectiveness of its multicultural youth 
tobacco prevention campaign through an outcome evaluation study that 
will be designed to follow the multiple, discrete waves of media 
advertising planned for the campaign.
    The outcome evaluation study consists of a pre-test survey of 
multicultural youth aged 12 to 17 before campaign launch. The pre-test 
survey will be followed by ongoing cross-sectional surveys of the 
target audience of youth beginning approximately 3 months following 
campaign launch. Information will be collected about youth awareness of 
and exposure to campaign events and advertisements and about tobacco-
related knowledge, attitudes, beliefs, intentions, and use. Information 
will also be collected on demographic variables including age, sex, 
race/ethnicity, grade level, and primary language.
    All information will be collected through in-person and Web-based 
questionnaires. Youth respondents will be 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 studies and (2) targeted social media

[[Page 19674]]

(e.g., Facebook). Participation in the study is voluntary.
    The information collected is necessary to inform FDA's efforts and 
measure the effectiveness and public health impact of the campaign. 
Data will be used to estimate awareness of and exposure to the campaign 
among youth in target markets where the campaign is active. Data will 
also be used to examine statistical associations between exposure to 
the campaign and subsequent changes in specific outcomes of interest, 
which will include knowledge, attitudes, and beliefs, related to 
tobacco use.
    FDA's burden estimate is based on prior experience with in-person 
and Internet panel studies similar to the Agency's plan presented in 
this document. Since the 60-day notice published, FDA has revised the 
estimated burden. The original burden estimate accounted for evaluation 
of more than one FDA multicultural campaign. The current burden 
estimate accounts for the evaluation of one campaign, FDA's `Fresh 
Empire' Youth Tobacco Prevention Campaign.
    A mail-based screener will be one of the methods used to identify 
eligible youth. Parents or guardians will be asked to provide consent 
and their contact information on this form. For the pre-launch survey, 
the 5-minute screener will be completed by 13,816 households for a 
total of 1,151 burden hours for youth and an additional 230 hours for 
the parents or guardians. For the pre-test survey, 2,100 youth will 
complete a questionnaire with an estimated burden of 30 minutes per 
respondent, for an annualized total of 1,050 hours. For the post-test 
screening survey, the estimated burden is 3,453 hours for youth and 691 
hours for adults. For the post-test surveys, the estimated burden is 45 
minutes per respondent, for a total of 4,725 burden hours.
    We will also recruit youth through social media (e.g., Facebook, 
Twitter) as a secondary strategy to recruit youth 13 to 17. An online 
version of the screener described above will be used to identify 
eligible youth (included in Attachment 3). Eligible youth will be asked 
to provide their parents' or guardians' contact information. The 
screener will take 5 minutes and will be completed by 2,500 youth for 
the pre-test survey for a total of 208 burden hours. Of these, 500 will 
be eligible and complete the pre-test survey for a total of 250 burden 
hours. For the post-test survey, 10,500 youth will complete the 5-
minute screener, for 875 burden hours. Of these, 2,100 will be eligible 
and complete the post-test survey online (up to 45 minutes), for a 
total of 1,575 burden hours.
    The target number of completed campaign questionnaires for all 
respondents is 134,528, and the annualized response burden is estimated 
at 14,208 hours.
    In the Federal Register of January 5, 2015 (80 FR 230), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received, however, only 
one was PRA related.
    Comment: One comment stated that the media tracking survey and the 
outcome evaluation study proposed by FDA are critical to FDA's efforts 
to develop and implement an effective multicultural youth tobacco 
prevention campaign.
    Response: FDA agrees that this collection of information is 
necessary to the Agency's efforts to promote and improve public health.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
         Type of respondent                   Activity            Number of     responses per   Total annual     Average burden per response     Total
                                                                 respondents     respondent       responses                                      hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth aged 12 to 17 in the United     Screener and Consent             13,816               1          13,816  0.0833 (5 min.)...............      1,151
 States.                               Process--Pre-test
                                       outcome survey.
Adults 18 and older in the United     Screener and Consent             13,816               1          13,816  0.0166 (1 min.)...............        230
 States.                               Process--Pre-test
                                       outcome survey.
Youth aged 12 to 17 in the United     Screener and Consent             41,448               1          41,448  0.0833 (5 min.)...............      3,453
 States.                               Process--post-test
                                       outcome survey.
Adults 18 and older in the United     Screener and Consent             41,448               1          41,448  0.01666 (1 min.)..............        691
 States.                               Process--post-test
                                       outcome survey.
Multicultural Youth aged 12-17 in     Pre-test outcome                  2,100               1           2,100  0.5 (30 min.).................      1,050
 select media markets.                 evaluation survey.
                                      Post-test evaluation              6,300               1           6,300  0.75 (45 min.)................      4,725
                                       survey.
Multicultural youth aged 13-17 in     Pre-test online                   2,500               1           2,500  0.0833 (5 min.)...............        208
 the select media markets recruiting   screener.
 through social media.
                                      Pre-test online survey.             500               1             500  0.5 (30 min.).................        250
                                      Post-test online                 10,500               1          10,500  0.0833 (5 min.)...............        875
                                       screener.
                                      Post-test online survey           2,100               1           2,100  0.75 (45 min.)................      1,575
                                                              ------------------------------------------------------------------------------------------
    Total...........................  .......................         134,528  ..............  ..............  ..............................     14,208
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 19675]]

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08466 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P