Published 60 Day FRN

Appendix B1. 60-day FRN 2 27 2012.pdf

Use of Smartphones to Collect Information about Health Behaviors: Feasibility Study

Published 60 Day FRN

OMB: 0920-0972

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11545

Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
assessed; the estimated burden for this
as needed assessment is 375 hours. The
costs of sponsored activities for 50
community and clinical partners; the
estimated burden for this yearly
assessment is 125 hours.
All information can be reported to
CDC through an interactive web-based
system, ‘‘iGTO,’’ that awardees can use
to manage their general organizational
information and to support and track
the implementation of strategies to
prevent teen pregnancy. Respondents
who prefer not to use the iGTO system
will be able to export the assessment

immediate, targeted technical assistance
as needed. The assessment information,
performance measures and training and
technical assistance information to be
collected are critical to understanding
(1) the teen pregnancy prevention needs
of each target community, (2) quality
implementation practices associated
with evidence-based programs and
contraceptive access, and (3) the impact
of implemented strategies.
OMB approval is requested for three
years. There are no costs to respondents
other than their time.

tools, complete them, and return their
reports to CDC by electronic mail.
Assessment and performance
information will be reported to CDC
annually. In addition, CDC will collect
information about costs and awardee
needs for training and technical
assistance. To ensure high data quality,
cost information will be submitted as
soon as it becomes available. CDC
estimates that each state or community
awardee will submit 10 cost data reports
per year. Training and technical
assistance needs will be reported
monthly so that CDC can provide

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

State and Community Awardees ......

Project Director/Coordinator Needs
Assessment.
Performance Measure Assessment
Tool.
Staff Assessment .............................
Training and Technical Assistance
Tool.
Cost Reporting Form For Sponsored
Activities.
Training and Technical Assistance
Tool.
Clinical Provider Needs Assessment
Tool.
Program Implementation Partner
Needs Assessment Tool.
Partner Cost Reporting Form for
Participants.
Cost Reporting Form For Sponsored
Activities.

National Organization Awardees ......
Community and Clinical Partners .....

Total ...........................................

...........................................................

Kimberly S. Lane,
Chief Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2012–4550 Filed 2–24–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

srobinson on DSK4SPTVN1PROD with NOTICES

[60Day–12–12EG]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic

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Number of
responses per
respondent

Number of
respondents

Type of respondent

Frm 00066

Fmt 4703

Total burden
(hr)

9

1

45/60

7

50

1

4

200

50
50

1
12

45/60
1

38
600

50

10

15/60

125

15

112

........................

180

50

1

1

50

100

1

45/60

75

150

10

15/60

375

50

10

15/60

125

........................

........................

........................

1,775

summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Kimberly Lane, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS D–74, Atlanta, GA 30333 or
send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should

PO 00000

Average
burden per
response
(hr)

Sfmt 4703

be received within 60 days of this
notice.
Proposed Project
Use of Smartphones to Collect
Information about Health Behaviors:
Feasibility Study—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Despite the high level of public
knowledge about the adverse effects of
smoking, tobacco use remains the
leading preventable cause of disease and
death in the U.S., resulting in
approximately 443,000 deaths annually.
During 2005–2010, the overall
proportion of U.S. adults who were
current smokers declined from 20.9% to
19.3%. Despite this decrease, smoking
rates are still well above Healthy People
2010 targets for reducing adult smoking

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Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices

prevalence to 12%, and the decline in
prevalence was not uniform across the
population.
One of the highest priorities
emanating from the American Recovery
and Reinvestment Act of 2009 is tobacco
control and cessation programs. In
addition, the Family Smoking
Prevention and Tobacco Control Act
gave the Food and Drug Administration
new authority to regulate tobacco
products, and the Children’s Health
Insurance Program Reauthorization Act
of 2009 included increases in Federal
excise taxes on tobacco products. These
developments reinforce the importance
of timely collection of data related to
tobacco usage.
The evolution of new
communications technologies that are
completely mobile provides a unique
opportunity for innovation in public
health. Text messaging and smartphone
web access are immediate, accessible,
and anonymous, a combination of
features that could make smartphones
ideal for the ongoing research,
surveillance, and evaluation of risk
behaviors and health conditions, as well
as targeted dissemination of
information.

respondents who agree will receive
invitations to participate by text
message, which will include a link to
the survey. Non-smartphone
respondents who agree will receive a
text message inviting them to
participate; respondents opting in will
be texted survey questions one at a time.
This study will evaluate: (1) Response
bias of a smartphone health survey by
comparing data collected via CATI to
data collected via smartphones/text
messages, and data collected via
smartphones to data collected via text
messages, (2) relative cost-effectiveness
of data collected via CATI to data
collected via smartphones/text
messages; (3) coverage bias associated
with restricting the sample to
smartphone users; and (4) the utility of
smartphones for completing frequent,
short interviews (i.e. diary studies to
track activities or events).
OMB approval is requested for one
year. Participation is voluntary and
respondents can choose not to
participate at any time. There are no
costs to respondents other than their
time.

CDC proposes to conduct a feasibility
study to identify and evaluate the
process of conducting surveys by text
message and smartphone, the outcomes
of the surveys, and the value of the
surveys. Before initiating the feasibility
study, CDC will conduct a brief pre-test
of information collection forms and
procedures. The universe for this study
is English-speaking U.S. residents aged
18–65. The sample frame will consist of
a national random digit dial sample of
telephone numbers from a frame of
known cell phone exchanges.
Respondents will be recruited from this
sample frame by calling cell phones
numbers and asking respondents to
complete an initial CATI survey
consisting of a short series of simple
demographic questions, general health
questions, and questions about tobacco
and alcohol use. At the conclusion of
this brief survey, all respondents who
have smartphones and a subset of
respondents who do not have
smartphones will be asked to participate
in the follow-up portion of the
feasibility study consisting of a first
follow-up survey and, a week later, a
second follow-up survey. Smartphone

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

Smartphone and non-smartphone users aged 18–65 .........

Pre-test of
CATI
Screener/Initial
CATI Survey
CATI Screener
Initial CATI
Survey
First Web
Survey Followup for
Smartphone
Users
Second Web
Survey Followup for
Smartphone
Users
First Text
Message
Survey Followup for nonSmartphone
Users
Second Text
Message
Survey Followup for nonSmartphone
Users

Smartphone Users aged 18–65 ...........................................

srobinson on DSK4SPTVN1PROD with NOTICES

Non-smartphone Users aged 18–65 ...................................

Total ..............................................................................

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PO 00000

........................

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Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hr)

Total burden
(in hr)

20

1

8/60

3

1,990
995

1
1

1/60
7/60

33
116

697

1

3/60

35

592

1

3/60

30

200

1

3/60

10

170

1

3/60

9

........................

........................

........................

236

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Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
Kimberly Lane,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2012–4549 Filed 2–24–12; 8:45 am]

Food and Drug Administration

BILLING CODE 4163–18–P

[Docket No. FDA–2011–N–0320]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Consumer Responses to
Whole Grain Labeling Statements on
Food Packages

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)

AGENCY:
ACTION:

Theodore Katz, M.P.A., Executive
Secretary, NIOSH, CDC, 1600 Clifton
Road, NE., MS E–20, Atlanta, Georgia
30333, Telephone: (513) 533–6800, toll
free: 1–800–CDC–INFO, email:
[email protected].
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 17, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–4569 Filed 2–24–12; 8:45 am]

Notice.

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 March 28,
2012.
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 ‘‘Experimental Study on Consumer
Responses to Whole Grain Labeling
Statements on Food Packages.’’ Please
also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, II, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
SUMMARY:

CONTACT PERSON FOR MORE INFORMATION:

BILLING CODE 4163–18–P

Food and Drug Administration,

HHS

The meeting scheduled to convene on
February 28–29, 2012 was published in
the Federal Register on February 16,
2012, Volume 77, Number 32, Pages
9254–9255. This notice was put on
display for 12 days in advance of the
meeting instead of the 15 calendar days
required in accordance with section
10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92–463), and
pursuant to the requirements of 42 CFR
83.15(a).

srobinson on DSK4SPTVN1PROD with NOTICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Experimental Study on Consumer
Responses to Whole Grain Labeling
Statements on Food Packages—(OMB
Control Number 0910–New)
I. Background
The Nutrition Labeling and Education
Act, which amended the Federal Food,
Drug, and Cosmetic Act, requires most
foods to bear nutrition labeling (i.e., the
Nutrition Facts) and requires food labels
that bear nutrient content claims and
certain health messages to comply with

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specific requirements. There are three
different types of claims (health claims,
nutrient content claims, and structure/
function claims) that the food industry
can voluntarily use on food labels.
Although they are regulated differently,
they all must be truthful and not
misleading (Ref. 1).
In the past 30 years, whole-grain
consumption has been greatly promoted
by government agencies and scientific
communities as an important part of a
healthy diet (Refs. 2 and 3). For
example, the newly released ‘‘Dietary
Guidelines for Americans 2010’’
recommends Americans eat fewer
refined grains and consume more
nutrient-dense whole grains instead
(Ref. 4). At the same time, whole grain
labeling statements, such as ‘‘Made
With Whole Grain’’, on food products
have also become more prevalent in
recent years (Ref. 5). Given the variety
of whole-grain statements on food
products and the importance of whole
grains in maintaining a healthy diet, it
is important for policy makers to gain a
better understanding of how consumers
interpret these statements.
Several studies indicate that
consumers may have difficulties in
understanding the meaning of whole
grains or recognizing whole-grain foods
(Refs. 6 to 8). Research also suggests
consumer product perceptions and
purchase decisions can be influenced by
labeling statements, and different
labeling statements may have different
influences (Refs. 9 and 10). The majority
of existing studies focus on whole grain
intake or the relationships between
whole grain and disease prevention.
There is a lack of systematic
investigation of consumers’
understanding of different whole-grain
labeling statements. We are aware of at
least one existing study related to the
statements (Ref. 11). However, the study
did not compare consumer reactions to
various whole-grain statements.
Therefore, FDA, as part of its effort to
promote public health, plans to use the
proposed study to explore and compare
consumer responses to food labels that
use whole-grain labeling statements.
Specifically, the study plans to
examine: (1) Consumer judgments about
a food product including its nutritional
attributes, overall healthiness, and
health benefits; (2) consumer judgments
about a labeling statement in terms of its
credibility, helpfulness, and other
attributes; (3) consumer interpretations
of different terms and statements, such
as ‘‘Made with Whole Grain’’, ‘‘MultiGrain’’, and ‘‘100% Whole Wheat’’; (4)
consumer extrapolation of whole grain
statements beyond the scope of the
statements themselves (i.e., halo effects);

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