[Federal Register Volume 80, Number 2 (Monday, January 5, 2015)]
[Notices]
[Pages 230-231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30808]
[[Page 230]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2294]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Evaluation of the Food and Drug Administration's
Multicultural Youth Tobacco Prevention Campaigns
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the evaluation of FDA's multicultural youth
tobacco prevention campaigns.
DATES: Submit either electronic or written comments on the collection
of information by March 6, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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].
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 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 FDA's Multicultural Youth Tobacco Prevention Campaigns
(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 youth-targeted public education campaigns to help prevent
tobacco use among multicultural youth and thereby reduce the public
health burden of tobacco. The campaigns 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 multicultural youth tobacco prevention campaigns.
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 conduct two studies to evaluate the effectiveness of
each of its multicultural youth tobacco prevention campaigns: (1) An
outcome evaluation study and (2) a media tracking survey. The timing of
these studies will be designed to follow the multiple, discrete waves
of media advertising planned for the campaigns.
Outcome Evaluation Studies
The outcome evaluation studies consist of baseline surveys of
multicultural youth aged 12 to 18 before each campaign's launch. The
baseline will be followed by three cross-sectional surveys of the
target audience of youth at approximate 6-month intervals after the
campaign's 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.
Media Tracking Surveys
The media tracking surveys consist of assessments of youth aged 13
to 18 conducted at 3, 9, and 15 months postcampaign launch--timing that
complements the outcome evaluation's timing. The media tracking surveys
will assess awareness of the campaigns and receptivity to campaign
messages. These data will provide critical evaluation feedback to the
campaigns and will be conducted with sufficient frequency to match the
cyclical patterns of events and media advertising and variation in
exposure to allow for midcampaign refinements.
All information will be collected through in-person and Web-based
questionnaires. Youth respondents will be recruited from four 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, (2) an Internet panel for the media tracking
surveys, (3) intercepts at various locations (e.g., mall, events), and
(4) targeted social media (e.g., Facebook). Participation in the
studies is voluntary.
The information collected is necessary to inform FDA's efforts and
measure the effectiveness and public health impact of the campaigns.
Data from the media-tracking surveys will be used to estimate awareness
of and exposure to the campaigns among youth in target markets where
the campaigns
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are active. Data from the outcome evaluation studies will be used to
examine statistical associations between exposure to the campaigns and
subsequent changes in specific outcomes of interest, which will include
knowledge, attitudes, beliefs, and intentions 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. To obtain the target number of completed surveys
(completes) for the outcome evaluation studies, 48,000 youth
respondents and their parent or legal guardian will be contacted
through a screening and consent process. The estimated burden per
response is 5 minutes, for a total of 4,000 hours. An estimated 16,800
surveys will be completed in the baseline and 3 postcampaign cross-
sectional surveys. The estimated burden per response is 35 minutes for
each survey wave, for a total of 9,800 hours.
To obtain the target number of completes for the media tracking
survey, a total of 90,000 respondents will be contacted for the 3
survey waves through an online invitation. The estimated burden per
response is 2 minutes, for a total of 3,000 hours for all waves of the
Media Tracking Screener. An estimated 2,000 youth will be recruited to
complete each of the 3 waves of the media tracking survey. The
estimated burden per response is 30 minutes for each questionnaire, for
a total of 3,000 hours for all of the three waves of the Media Tracking
Questionnaire.
The total number of respondents is 160,800. The total estimated
burden is 19,800 hours.
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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General Population.............. Screener and Consent 12,000 1 12,000 0.0833 (5 min.)............. 1,000
Process (Youth and
Parent)--Baseline/Wave
1--outcome study.
General Population.............. Screener and Consent 12,000 1 12,000 0.0833 (5 min.)............. 1,000
Process (Youth and
Parent)--Wave 2--
outcome study.
General Population.............. Screener and Consent 12,000 1 12,000 0.0833 (5 min.)............. 1,000
Process (Youth and
Parent)--Wave 3--
outcome study.
General Population.............. Screener and Consent 12,000 1 12,000 0.0833 (5 min.)............. 1,000
Process (Youth and
Parent)--Wave 4--
outcome study.
Multicultural Youth aged 12-18 Baseline (Wave 1) youth 4,200 1 4,200 0.5833 (35 min.)............ 2,450
in select media markets. outcome evaluation
questionnaire.
Wave 2 youth outcome 4,200 1 4,200 0.5833 (35 min.)............ 2,450
evaluation
questionnaire.
Wave 3 youth outcome 4,200 1 4,200 0.5833 (35 min.)............ 2,450
evaluation
questionnaire.
Wave 4 youth outcome 4,200 1 4,200 0.5833 (35 min.)............ 2,450
evaluation
questionnaire.
Multicultural youth aged 13-18 1st Media Tracking 30,000 1 30,000 0.03333 (2 min.)............ 1,000
in the select media markets. Screener.
1st Media Tracking 2,000 1 2,000 0.5 (30 min.)............... 1,000
Questionnaire.
2nd Media Tracking 30,000 1 30,000 0.03333 (2 min.)............ 1,000
Screener.
2nd Media Tracking 2,000 1 2,000 0.5 (30 min.)............... 1,000
Questionnaire.
3rd Media tracking 30,000 1 30,000 0.03333 (2 min.)............ 1,000
Screener.
3rd Media Tracking 2,000 1 2,000 0.5 (30 min.)............... 1,000
Questionnaire.
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Total....................... ........................ 160,800 .............. .............. ............................ 19,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 29, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30808 Filed 1-2-15; 8:45 am]
BILLING CODE 4164-01-P