[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19673-19675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08466]
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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) 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, PRAStaff@ 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\
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Number of
Type of respondent Activity Number of responses per Total annual Average burden per response Total
respondents respondent responses hours
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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
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Total........................... ....................... 134,528 .............. .............. .............................. 14,208
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\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