Att 2 - 60 day FRN

Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Clearance Officer.
[FR Doc. 2010–28925 Filed 11–16–10; 8:45 am]
BILLING CODE 4150–03–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–11–11AC]

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
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 404–639–5960 or send
comments to Carol E. Walker, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an e-mail 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
be received within 60 days of this
notice.

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Proposed Project
Using Traditional Foods and
Sustainable Ecological Approaches for
Health Promotion and Diabetes
Prevention in American Indian/Alaska
Native Communities—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Type 2 Diabetes was rare among
American Indians until the 1950s. Since

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that time, diabetes has become one of
the most common and serious illnesses
among American Indians and Alaska
Natives (AI/AN). From 1994 to 2004, the
age-adjusted prevalence of diagnosed
diabetes doubled (from 8.5 to 17.1 per
1,000 population) among AI/ANs less
than 35 years of age who used Indian
Health Service healthcare services.
However, dietary management and
physical activity can help to prevent or
control Type 2 diabetes.
In 2008, the CDC’s Native Diabetes
Wellness Program (NDWP), in
consultation with American Indian/
Alaska Native Tribal elders, issued a
cooperative agreement entitled, ‘‘Using
Traditional Foods and Sustainable
Ecological Approaches for Health
Promotion and Diabetes Prevention in
American Indian/Alaska Native
Communities.’’ The Traditional Foods
program seeks to build on what is
known about traditional ways in order
to inform culturally relevant,
contemporary approaches to diabetes
prevention for AI/AN communities. The
program supports activities that
enhance or re-introduce indigenous
foods and practices drawn from each
grantee’s landscape, history, and
culture. Example activities include the
cultivation of community gardens,
organization of local farmers’ markets,
and the dissemination of culturally
appropriate health messages through
storytelling, audio and video recordings,
and printed materials.
CDC requests OMB approval to collect
standardized information, called
Traditional Foods Shared Data Elements
(SDE), from grantees over a three-year
period. The SDE will be organized in
three domains: Traditional Local
Healthy Foods, Physical Activity, and
Social Support for Healthy Lifestyle
Change and Maintenance. Since each
grantee currently maintains activity data
for local program improvement,
reporting summary information to CDC
in SDE format is not expected to entail
significant burden to respondents.
The SDE will allow CDC to compile
a systematic, quantifiable inventory of
activities, products, and outcomes
associated with the Traditional Foods
program. The SDE will also allow CDC
to analyze aggregate data for improved
technical assistance and overall program
evaluation, reporting, and identification
of outcomes; allow CDC and grantees to
create a comprehensive inventory/
resource library of diabetes primary
prevention ideas and approaches for AI/
AN communities and identify emerging
best practices; and improve
dissemination of success stories. The
SDE will supplement the narrative

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progress report that grantees submit to
CDC in conjunction with the annual
continuation application for funding.
Although these reports provide
important contextual information and
are useful for local program monitoring,
they do not support the production of
statistical reports that are needed to
fully describe the Traditional Foods
program and to respond to inquiries.
Respondents will be 17 Tribes and
Tribal organizations that receive
funding through the Traditional Foods
program. The SDE will be routinely
submitted to CDC semi-annually using
Survey Monkey, an electronic Webbased interface. The estimated burden
per response is two hours. Each grantee
will receive a personalized advance
notification letter, followed by an e-mail
with a link to the Survey Monkey site.
One of the two required SDE
submissions will coincide
approximately with submission of the
continuation application for funding in
the Spring. The second SDE submission
will be scheduled annually in the Fall,
at approximately the midpoint between
the Spring submissions.
CDC anticipates that routine
information collection will begin in
April 2011 and will describe activities
conducted during the period October
2010–March 2011. CDC also requests
OMB approval to conduct one
additional cycle of retrospective data
collection during the first year of this
three-year information collection
request. The retrospective information
collection will provide baseline SDE
information about grantee activities
conducted prior to October 2010, which
is needed for comparison purposes and
optimal overall program evaluation.
Inclusion of the retrospective data will
enable CDC and grantees to have a
clearer, more quantifiable view of the
growth of Traditional Foods activities
over the five-year funding cycle for the
cooperative agreement.
The total estimated burden for the
one-time retrospective data collection is
34 hours (17 respondents × 2 hours/
response). Annualizing this collection
over three years results in an estimated
annualized burden of 12 hours (6
respondents per year). The annualized
figures slightly over-estimate the actual
burden, due to rounding of the number
of respondents for even allocation over
the three-year clearance period. Second,
some of the information could be
collected through pre-testing the SDE
collection system during Fall/Winter
2010.
There are no costs to respondents
other than their time.

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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
responses per
respondent

Avg. burden
per response
(in hrs)

Total burden
(in hrs)

Form name

AI/AN Tribal Grantees ...

Traditional Foods Shared Data Elements ...........
One-Time Retrospective Data Collection ............

17
6

2
1

2
2

68
12

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

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

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

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

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

80

Dated: November 10, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–28930 Filed 11–16–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0532]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Nutrition Facts Label Formats
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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
(the PRA).
DATES: Fax written comments on the
collection of information by December
17, 2010.
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 e-mailed to
[email protected]. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘Experimental Study of Nutrition
Facts Label Formats.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., 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
SUMMARY:

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No. of
respondents

Type of respondents

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has submitted the following proposed
collection of information to OMB for
review and clearance.
I. Experimental Study of Nutrition
Facts Label Format—(OMB Control No.
0910—New)
Nutrition information is required on
most packaged foods and this
information must be provided in a
specific format as defined in 21 CFR
101.9. When FDA was determining
which Nutrition Facts label format to
require, the Agency undertook
consumer research to evaluate
alternatives (Refs. 1, 2, and 3). More
recently, FDA conducted qualitative
consumer research on the format of the
Nutrition Facts label on behalf of the
Agency’s Obesity Working Group
(OWG) (Ref. 4), which was formed in
2003 and tasked with outlining a plan
to help confront the problem of obesity
in the United States (Ref. 5). In addition
to conducting consumer research, in
response to the OWG plan FDA issued
two advance notices of proposed
rulemaking (ANPRM) requesting
comments on format changes to the
Nutrition Facts label. One ANPRM
requested comments on whether and, if
so, how to give greater emphasis to
calories on the Nutrition Facts label
(Ref. 6) and the other requested
comments on whether and, if so, how to
amend the Agency’s serving size
regulations (Ref. 7). In 2007, FDA issued
an ANPRM requesting comments on
whether the Agency should require that
certain nutrients be added or removed
from the Nutrition Facts label (Ref. 8).
FDA conducts consumer research
under its broad statutory authority, set
forth in section 903(b)(2)(A) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(b)(2)(A),
to protect the public health by ensuring
that ‘‘foods are safe, wholesome,
sanitary, and properly labeled;’’, and in
section 903(d)(2)(C) (21 U.S.C.
393(d)(2)(C)), to conduct research
relating to foods, drugs, cosmetics and
devices in carrying out the FD&C Act.
FDA is proposing to conduct an
experimental study to quantitatively
assess consumer reactions to potential
options for modifying the Nutrition

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Facts label format. The purpose of the
study is to help enhance FDA’s
understanding of consumer
comprehension and acceptance of
modifications to the Nutrition Facts
label format. The study is part of the
Agency’s continuing effort to enable
consumers to make informed dietary
choices and construct healthful diets.
The proposed study will use a Webbased experiment to collect information
from a sample of adult members in an
online consumer panel established by a
contractor. The study plans to randomly
assign each of 10,000 participants to
view Nutrition Facts labels from a set of
Nutrition Facts labels that vary by the
format, the type of food product, and the
quality of nutritional attributes of the
product. The study will focus on the
following types of consumer reactions:
(1) Judgments about a food product in
terms of its nutritional attributes and
overall healthfulness and (2) ability to
use the Nutrition Facts label to, for
example, calculate calories and estimate
serving sizes needed to meet objectives.
To help understand consumer reactions,
the study will also collect information
on participants’ background, including
but not limited to use of the Nutrition
Facts label and health status.
The study results will be used to help
the Agency to understand whether
modifications to the Nutrition Facts
label format could help consumers make
informed food choices. The results of
the experimental study will not be used
to develop population estimates.
In the Federal Register of November
18, 2009 (74 FR 59553), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. The Agency received 36
responses, some of them containing
multiple comments. The comments, and
the Agency’s responses, are discussed in
the following paragraphs. Some of the
comments received were not responsive
to the comment request on the four
topics of the collection of information.
These non-responsive comments are not
addressed.
(Comment 1) Several comments cited
the importance of studying ways to
improve the Nutrition Facts label on

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