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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 70267 

packaged foods and commended FDA 

for doing it. 

(Response 1) FDA agrees that the 

study will help FDA learn how 

consumers react and respond to 

Nutrition Facts label modification 

options presented. 

(Comment 2) One comment suggested 

adding questions about product 

purchase intent, amount the consumer 

would likely eat, and impression of the 

product’s taste and safety. 

(Response 2) FDA agrees that these 

questions are worthwhile and has 

included questions on product purchase 

intent. However, given the study 

designs focus solely on the nutrition 

label for use to choose healthier and 

lower calorie products and mode of data 

collection (Internet), questions on 

amount of product likely to be eaten and 

on taste are not meaningful to include. 

(Comment 3) One comment suggested 

that the study include various formats 

with different methods of presenting 

nutrition information be tested so that 

the format can be found which helps 

consumers understand the total 

nutrition package without causing 

confusion regarding the other properties 

of the product. 

(Response 3) FDA agrees that various 

formats should be tested that help 

consumers make more informed 

decisions about the healthfulness of the 

product. We will include questions 

about the product to test how 

consumers use the Nutrition Facts label 

for making those evaluations. 

(Comment 4) One comment suggested 

the inclusion of real-time, one-on-one 

chats between live moderators and 

respondents during the fielding of the 

study to enhance the quality of the 

quantitative data collected. 

(Response 4) FDA disagrees with this 

suggestion. FDA has already conducted 

a series of eight focus groups to learn 

how and why consumers react to the 

formats being tested. Also, prior to 

conducting the on-line experiment, FDA 

will conduct at least nine one-on-one 

interviews where we observe 

respondents taking the questionnaire, 

and get their feedback about what they 

were thinking as they answered each 

question. We believe that, taken 

together, the focus groups and the oneon-one interviews will give us a good 

feel as to why respondents answer the 

questions as they do. 

(Comment 5) A number of comments 

asked the Agency to publish the revised 

instrument and mock stimuli for public 

comment prior to initiating the study. 

They had questions and 

recommendations about the design of 

the experiment, for example, whether 

there will be a control group and how 

many designs will be shown to the 

consumers and how many label formats 

will be tested and whether the subjects 

will be asked to rank the different 

formats in terms of preference. 

(Response 5) We appreciate the 

suggestion for the Agency to publish the 

instrument and stimuli for public 

comment prior to initiating the study. 

Per the PRA, a copy of the revised 

instrument is attached to the supporting 

statement for public comment. We will 

also include examples of stimuli as an 

appendix of the supporting document. 

FDA will have a control group for this 

experiment. Ten different label formats 

will be tested. Each subject will only 

perform two tasks—an evaluation of a 

single label and a label comparison task. 

(Comment 6) Several comments were 

about who should be included in the 

study. One comment said that FDA 

should give careful consideration to the 

gender and age distribution of the study 

subjects and that older subjects may 

have difficulty in using the Web. One 

comment said it was important to 

include people with special health 

concerns, those that do the majority of 

grocery shopping or food preparation for 

their households, and groups that may 

be underrepresented online. 

(Response 6) FDA agrees that 

demographic factors such as age and 

gender, health concerns, grocery 

shopping, and food preparation 

experiences are important factors. FDA 

will collect the previously mentioned 

information and include them in the 

analyses. FDA will aim to have a sample 

resemble the American adult 

population. FDA will do pre-tests to 

make sure everyone can read and 

understand the survey. 

(Comment 7) One comment suggested 

that FDA should consider as part of the 

proposed study how consumers 

interpret the Nutrition Facts label in the 

context of all the other information on 

the package, and raised the question of 

whether the information on the 

Nutrition Facts label would be lost, 

diluted, or confounded by all of the 

other information that appears on the 

package. The comment suggested that, 

as part of the study design, FDA could 

present the Nutrition Facts label by 

itself and also how it would appear 

alongside the other package 

information, to see if consumers view or 

interpret the Nutrition Facts label 

differently in light of the total package. 

(Response 7) While FDA agrees that 

the Nutrition Facts label is perceived in 

the context of the entire package, the 

goal of this study is to test various 

modifications to the Nutrition Facts 

label that would be suitable for all food 

products regardless of the context of the 

package. The study design proposes to 

test different options of modified 

Nutrition Facts label without other 

aspects of the food package. 

(Comment 8) One comment stated 

that, in selecting the final sample for the 

experimental study, FDA should 

consider whether a certain percentage of 

the subjects should be recruited based 

on their concerns about allergy 

information. The comment stated that 

although most of the information on the 

Nutrition Facts label has relevance to all 

consumers, label information about 

allergens may be of interest only to a 

relatively small number of subjects who 

have food allergies. The comment 

suggested that the responses from this 

group could be analyzed separately, in 

addition as part of the total sample. 

(Response 8) It is estimated that the 

prevalence of food allergies ranges from 

approximately 1 to 10 percent of the 

population (Ref. 9). The study will use 

a convenience sample (not a 

representative sample) consisting of 

members of an online panel, 18 years of 

age or older. Therefore, the number of 

respondents who have food allergies or 

are caretakers of children who have food 

allergies would be too small for the 

purpose of statistically sound analysis. 

(Comment 9) One comment asked that 

FDA consider ways to minimize the 

burden of the collection of information 

on respondents, including the use of 

automated collection techniques, when 

appropriate, and other forms of 

information technology. 

(Response 9) FDA has taken steps to 

minimize the burden of data collection 

on respondents. Participants of the 

study will be members of the existing 

online panel and data will be collected 

through the Internet. Respondents will 

be sent e-mail invitations to participate 

in the study. 

(Comment 10) One comment asked 

whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility. 

(Response 10) FDA believes that 

collecting this information is necessary 

for FDA’s regulatory oversight of the 

Nutrition Facts label. Because one of the 

purposes for initially developing and 

implementing the Nutrition Facts label 

was to help consumers make informed 

food choices, it is important for FDA to 

be able to evaluate whether consumers 

understand how to properly interpret 

the label, especially for health purposes. 

(Comment 11) One comment 

requested that FDA consider using some 

or all of the label format changes 

suggested by the Center for Science in 

the Public Interest (CSPI) (Ref. 10). 

mstockstill on DSKH9S0YB1PROD with NOTICES

70268 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

(Response 11) CSPI suggested 

extensive changes to the Nutrition Facts 

label that affect many parts of the label. 

In this research, the Agency is focused 

on how consumers use labels for 

products that are customarily consumed 

at one eating occasion but may contain 

more than one serving per container as 

well as on how consumers react to 

different ways that calorie information 

is declared on the label. FDA believes 

these changes have the potential to be 

among the most useful changes to help 

consumers make informed choices. 

Therefore, FDA identified and chose the 

proposed formats, such as dual column 

formats and prominence of calorie 

formats, for this study. The variety of 

different experimental conditions for 

just these changes requires a very large 

number of respondents. It is not feasible 

to test the additional extensive changes 

such as those suggested by CSPI in this 

study because the number of 

respondents needed would become 

unmanageable. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Annual frequency 

per response 

Total annual 

responses Hours per response Total hours 

Cognitive interview screener ...... 96 1 96 0 .083 8 

Cognitive interview ..................... 12 1 12 1 12 

Pretest invitation ........................ 1,000 1 1,000 0 .033 33 

Pretest ........................................ 150 1 150 0 .25 38 

Experiment invitation .................. 50,000 1 50,000 0 .033 1,650 

Experiment ................................. 10,000 1 10,000 0 .25 2,500 

Total .................................... ................................ ................................ ................................ .................................. 4,241 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In the 60-day notice that published in 

the Federal Register of November 18, 

2009, we estimated a total burden of 

1,595 hours for the study. In this 

document, table 1 has been modified to 

reflect our re-evaluation of the original 

study design. The new total estimated 

burden is 4,241 hours. 

To help design and refine the 

questionnaire to be used for the 

experimental study, we plan to conduct 

cognitive interviews by screening 96 

adult consumers in order to obtain 12 

participants in the interviews. Each 

screening is expected to take 5 minutes 

(0.083 hours) and each cognitive 

interview is expected to take 1 hour. 

The total for cognitive interview 

activities is 20 hours (8 hours + 12 

hours). Subsequently, we plan to 

conduct pretests of the questionnaire 

before it is administered in the study. 

We expect that 1,000 invitations, each 

taking 2 minutes (0.033 hours), will 

need to be sent to adult members of an 

online consumer panel to have 150 of 

them complete a 15-minute (0.25 hours) 

pretest. The total for the pretest 

activities is 71 hours (33 hours + 38 

hours). For the experiment, we estimate 

that 50,000 invitations, each taking 2 

minutes (0.033 hours), will need to be 

sent to adult members of an online 

consumer panel to have 10,000 of them 

complete a 15-minute (0.25 hours) 

questionnaire. The total for the 

experiment activities is 4,150 hours 

(1,650 hours + 2,500 hours). Thus, the 

total estimated burden is 4,241 hours. 

FDA’s burden estimate is based on prior 

experience with research that is similar 

to this proposed study. 

II. References 

1. Levy A., S. Fein, and R. Schucker, 

‘‘Nutrition Labeling Formats: 

Performance and Preference,’’ Food 

Technology 45: 116–121, 1991. 

2. Levy A., S. Fein, and R. Schucker, 

‘‘More Effective Nutrition Label 

Formats Are Not Necessarily 

Preferred,’’ Journal of the American 

Dietetic Association 92: 1230–1234, 

1992. 

3. Levy A., S. Fein, and R. Schucker, 

‘‘Performance Characteristics of 

Seven Nutrition Label Formats,’’ 

Journal of Public Policy and 

Marketing 15: 1–15, 1996. 

4. Lando A. and J. Labiner-Wolfe, 

‘‘Helping Consumers to Make More 

Healthful Food Choices: Consumer 

Views on Modifying Food Labels 

and Providing Point-of-Purchase 

Nutrition Information at QuickService Restaurants,’’ Journal of 

Nutrition Education and Behavior 

39: 157–163, 2007. 

5. U.S. Food and Drug Administration, 

Calories Count: Report of the 

Working Group on Obesity, 2004, 

(http://www.fda.gov/Food/ 

LabelingNutrition/ReportsResearch/ 

ucm081696.htm). 

6. 70 FR 17008, April 4 2005. 

7. 70 FR 17010, April 4 2005. 

8. 72 FR 62149, November 2 2007. 

9. Schnieder Chafer, J.J., S.J. Newbery, 

M.A. Riedl, et al., ‘‘Diagnosing and 

Managing Common Food Allergies: 

A Systematic Review,’’ Journal of 

the American Medical Association 

303(18): 1848–1856. 

10. Silverglade, B and I.R. Heller, ‘‘Food 

Labeling Chaos: The Case for 

Reform,’’ Center for Science in the 

Public Interest, March 2010, 

available at: http:// 

www.cspinet.org/new/pdf/ 

food_labeling_chaos_report.pdf. 

Dated: November 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28966 Filed 11–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; NIH NCI Central 

Institutional Review Board (CIRB) 

Initiative (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on August 16, 2010 (75 FR 

49938) and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

mstockstill on DSKH9S0YB1PROD with NOTICES