Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 70265 

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 

omb@cdc.gov. 

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. 

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 

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 

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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70266 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name No. of 

respondents 

No. of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs) 

Total burden 

(in hrs) 

AI/AN Tribal Grantees ... Traditional Foods Shared Data Elements ........... 17 2 2 68 

One-Time Retrospective Data Collection ............ 6 1 2 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. 

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 

(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 

oira_submission@omb.eop.gov. 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 

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 

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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