
[Federal Register: December 1, 2009 (Volume 229, Number 74)]
[Notices]               
[Page 62786-62792]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de09-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0220]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Studies 
of Nutrition Symbols on Food Packages

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (PRA).

DATES: Fax written comments on the collection of information by 
December 31, 2009.

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Experimental Studies of Nutrition Symbols on Food Packages.'' 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794, Jonna.Capezzuto@fda.hhs.gov.

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 Studies of Nutrition Symbols on Food Packages

    With the increased interest in healthier foods, U.S. food 
processors and retailers have been adding nutrition information, 
particularly nutrition quality icons (e.g., Smart Choices Program) and 
selected nutrient level disclosures (e.g., Guideline Daily Amounts), in 
addition to other labeling statements (e.g., nutrient content claims), 
to the front of the package (FOP). This type of nutrition labeling 
scheme is seen in other countries (e.g., United Kingdom, Sweden, and 
Australia) as well. FDA believes the proliferation of these nutrition 
labeling schemes in the domestic market and the various nutrition 
criteria they use make it necessary for the agency to exercise the 
responsibility that Congress gave it to, among other things, carefully 
examine consumer understanding and use of the various schemes to 
evaluate how well they impart useful nutrition information to U.S. 
consumers and which schemes or types of schemes are better to impart 
the information. The agency held a public hearing in September 2007 and 
completed a focus group study in April 2008 to obtain comments and 
information about many consumer issues related to FOP nutrition 
labeling schemes. We are also aware of recent consumer research 
conducted by foreign governments, non-governmental organizations, and 
academics (e.g., Refs. 1 to 4). The existing information, however, does 
not fill many of the gaps in our understanding of the impacts of FOP 
nutrition labeling schemes on U.S. consumers. Most importantly, there 
is a lack of publicly available quantitative consumer research on the 
relative effectiveness of existing and alternative labeling schemes in 
helping U.S. consumers make better dietary decisions. Therefore, the 
agency is proposing to conduct two experimental studies to assess 
quantitatively consumer reactions to various FOP nutrition labeling 
schemes. The studies will provide critical input to ensure the 
usefulness of FOP nutrition information provided to U.S. consumers.
    FDA conducts research and educational and public information 
programs relating to food safety under its broad statutory authority, 
set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 393(b)(2)), 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

[[Page 62787]]

relating to foods, drugs, cosmetics and devices in carrying out the 
act.
    The purpose of the studies is to help enhance FDA's understanding 
of consumer understanding and use of a selected sample of nutrition 
labeling schemes currently in use in the domestic market, and to 
examine whether certain schemes are better ways to impart useful 
nutrition information to U.S. consumers. The studies are part of the 
agency's continuing effort to enable consumers to make informed dietary 
choices and construct healthful diets.
    The experimental studies will be conducted by two different 
contractors using two different Web-based surveys to collect 
information. Study participants will come from two independent 
convenience samples of adult members recruited from two separate online 
consumer panels; the demographic characteristics of each sample will be 
matched to that of the respective consumer panel.

A. Study 1

    Study 1 will examine five labeling conditions: (1) a Smart Choices 
Program scheme (currently used in the U.S. market); (2) a Guideline 
Daily Amounts scheme (currently used in the U.S. market); (3) a scheme 
similar to the Multiple Traffic Light, which is currently used in the 
United Kingdom; (4) a control that shows only the Nutrition Facts 
label; and (5) a control that shows no FOP nutrition information. The 
study will randomly assign each of its 2,400 participants to view four 
labels from a set of 40 FOP food labels that vary in the presence and 
type of labeling information, the type of food product, and the 
nutritional qualities of the product. The study will make the Nutrition 
Facts (NF) label for each of these food labels available to all 
participants. The study will focus on the following types of consumer 
reaction: (1) Identification of the healthier product in a pair of 
products; (2) judgments about a food product in terms of its 
nutritional qualities, overall healthfulness, health benefits, and 
other characteristics such as taste; (3) judgments about a nutrition 
information scheme in terms of its credibility and helpfulness in 
conveying the product's nutritional qualities and in assisting intake 
decisions; (4) impact of the labeling conditions (1) to (3) on the use 
of the Nutrition Facts label; and (5) time spent on product 
identification and judgment. To help understand consumer reaction, the 
study will also collect information on participants' background, 
including but not limited to consumption and perceptions of food 
products, nutrition attitudes and practice, food label use, and health 
status.
    In addition, Study 1 will include a separate face-to-face eye-
tracking research using a separate sample of 30 adult consumers to 
examine their label viewing patterns when they are asked to judge 
product attributes and to compare products. This research is included 
in Study 1 to explore the usefulness of the methodology of eye-tracking 
for future consumer research. Eye-tracking participants will be 
recruited by a contractor from members of a commercial database of 
consumers who express interest in participation and meet the selection 
criteria.
    Study 1 will help the agency primarily in understanding how U.S. 
consumers would choose and perceive products in response to the five 
labeling conditions. The study will also enhance the agency's 
understanding of the relationships between consumer background and 
reaction to FOP information. This information will help the agency in 
its future deliberation of FOP related labeling actions, such as 
regulations and consumer education, to provide better information to 
consumers to assist their dietary choices. Because this is an 
experimental study, its results will not be used to develop population 
estimates.
    In the Federal Register of June 1, 2009 (74 FR 26244), FDA 
published a 60-day notice requesting public comment on the Experimental 
Study of Nutrition Symbols on Food Packages (Study 1). The agency 
received seven responses, some of them containing multiple comments. 
Two comments raised issues that were outside the scope of the comment 
request on the information collection provisions and will not be 
discussed here. Among the relevant comments, all supported the proposed 
research. The following is a summary of the relevant comments and the 
agency's response to the comments:
    (Comment 1) One comment questioned the inclusion in the study of 
questions about perceived taste and health benefits of products, 
dietary supplement use, and functional health literacy, stating that 
these questions do not seem to focus on the study objective of 
discerning consumer use and understanding of nutrition symbols on food 
packages. Another comment stated that ``diabetes or high blood sugar'' 
and ``obesity or overweight'' should be removed from perceived health 
benefits because FDA has not approved health claims for these 
conditions.
    (Response 1) First, we disagree that questions about perceived 
health benefits and, perceived taste are outside the scope of the 
study. The purpose of the study is to understand consumer response to a 
sample of existing FOP nutrition labeling schemes. The study will help 
the agency evaluate the current situation and will provide information 
that will be important to any future deliberations of the agency's 
response to the various nutrition information schemes. Product 
perceptions (including nutrient levels, health benefits, and taste) are 
inferences consumers often make from labeling information. It is well 
known that some consumers perceive a tradeoff between nutrition and 
taste. Hence, it is within the scope of the study to collect such 
information to obtain a more complete understanding of consumer 
response to nutrition information schemes and to use it to tease out 
the effects of these schemes on product choices and perceptions. In 
addition, such information will enhance our understanding of consumer 
response to food labeling in general. We note that we have decided to 
remove the questions on use of dietary supplements and functional 
health literacy due to the length of the questionnaire.
    Second, we disagree that ''diabetes or high blood sugar'' and 
``obesity or overweight'' should be removed from the list of possible 
perceived health benefits because the agency has not approved health 
claims for these conditions. Diabetes and obesity are health conditions 
that have been linked to dietary quality, which is influenced by 
consumer choices and perceptions of food products. Furthermore, 
perception of the relationships between a food product and the risk of 
these two health conditions are part of inferences consumers often make 
from labeling information. Whether there exist health claims for these 
conditions is irrelevant.
    (Comment 2) One comment noted that the questions seem to be testing 
specific symbols, rather than the concept of FOP nutrition information 
schemes. The comment also noted along the same lines that the it was 
not clear how FDA decided which symbols to test but noted that the 
symbols to be tested include symbols that are used in labeling (e.g., 
store shelf), rather than on the FOP. Another comment suggested that 
the Guiding Stars symbol would be an important element in the proposed 
study.
    (Response 2) The comment is correct that the questions in this 
study are designed to test specific symbols used on packages, rather 
than the concept of FOP symbols. Smart Choices Program and Guideline 
Daily Amounts symbols have been selected because they are among the 
most widely used FOP symbols in the United States. The

[[Page 62788]]

Traffic Light type symbol has been selected because it is one of the 
FOP symbols used in the United Kingdom. The other two symbol schemes, 
NF only and no FOP scheme, have been selected to examine how product 
choice and perceptions would differ if consumers ignore the front 
package and turn to the NF label for product information or are not 
provided any nutrition information on the FOP. We have decided to focus 
at the present time exclusively on FOP symbols rather than on FOP and 
shelf tag symbols because consumers are more likely to see FOP symbols 
on nationally distributed products than shelf-tag symbols that can only 
be found in limited locations. Therefore, we have omitted the Guiding 
Stars and NuVal symbols from the study.
    (Comment 3) One comment suggested that a question series could be 
developed to compare consumer response to three versions of labeling 
approaches: With no nutrition symbol, with a nutrition symbol, and with 
an FDA authorized health claim appropriate to the food.
    (Response 3) We appreciate the suggestion to compare consumer 
responses to different versions of labeling approaches: With no 
nutrition symbol, with a nutrition symbol, and with claims that can be 
used under current regulatory framework, e.g., authorized health claims 
and nutrient content claims. Such research may be useful in the future. 
Nevertheless, due to the scarcity of information regarding consumer 
understanding and use of existing nutrition symbols in the domestic 
market, we consider it most useful at this time to conduct the planned 
research, which does include a comparison between no nutrition symbol 
and the presence of a nutrition symbol.
    (Comment 4) A comment recommended that the study focus more broadly 
on consumer research issues that have not yet been fully answered by 
the limited research conducted to date. These issues include: 
Consumers' focus on nutrition symbols; the nutrition symbols that are 
most helpful to consumers; the nutritional elements that a symbol 
should reflect; the ideal placement of a symbol on the package; the 
effects of multiple symbols on consumer decision-making; the effects of 
the presence of a health claim on consumer use of nutrition symbols or 
the NF label; whether public or private sector oversight has any impact 
on the effect on consumers of a nutrition symbol program; use of 
symbols and behavioral changes; and consumer interpretation of symbols.
    (Response 4) We agree that these issues are important for 
understanding the impacts of nutrition symbols on consumers. In fact, 
the proposed study has been designed to help provide information on 
several of the recommended issues, such as whether consumers focus in 
on nutrition symbols (using the eye-tracking study) and how consumers 
interpret symbols (using the experimental study). In addition, we note 
that we have added Study 2 to examine which of a wide range of symbol 
schemes may be most helpful to consumers. We agree, however, that 
further research will be needed.
    (Comment 5) A comment questioned whether a comparison between a 
pair of products of the same product category and same type of symbol, 
but with different nutritional profiles, can be used to assess the 
various symbol systems and front-of-package v. shelf-tag systems. The 
comment stated that different systems present different information on 
the label or tag.
    (Response 5) We appreciate the comment. One of the objectives of 
the study is to examine identification of the more nutritious product 
in a pair of products. It is precisely because different systems 
present different information on the front of package that we want to 
use this comparison to examine whether and how much respondents can 
discern two nutritionally different products when they see FOP symbols 
of different content/design. We hope to reject the hypothesis that 
there is no difference between different systems, e.g., product choices 
and perceptions are the same regardless of the type of symbol that 
shows on a product package. We also note that we have decided to omit 
shelf-tag symbols in this study.
    (Comment 6) A comment questioned whether a comparison between a 
pair of products of different product categories but with the same type 
of symbol and different nutritional profiles, can be used to assess the 
symbol systems to be examined in this study. The comment stated that 
these symbol systems are designed to allow comparisons between products 
within a category rather than comparisons of products between 
categories.
    (Response 6) We disagree that the comparison in question cannot be 
used to assess the target symbol systems. Though these systems are 
designed for within-category product comparisons, it is unknown whether 
consumers are aware of the intent. If consumers see the same type of 
symbol on various products, e.g., yogurt and cereal, some of them may 
infer these products possess the same or similar nutritional 
characteristics. In addition, the pair of products that will be 
compared have been selected because they are possible substitutes for 
each other for an eating occasion, e.g., yogurt and cereal. Unless 
these possibilities can be ruled out, it is within the scope of this 
study to include the comparison in question because it will provide 
information about consumer understanding of these symbols.
    (Comment 7) One comment raised the issue of the representativeness 
of the study. It stated that the online sample should be balanced to 
reflect U.S. population demographics and controlled for grocery shopper 
status, category purchase and use status; that each test cell should be 
balanced accordingly; and that the study should be conducted in both 
English and Spanish so not to underrepresent non-English speaking 
demographics of the U.S. population.
    (Response 7) We disagree that the study sample as well as each test 
cell should be balanced to reflect the U.S. population. The study is an 
experimental study aimed at establishing valid comparisons of 
respondents' reactions to different symbols and foods, rather than 
generating reliable population estimates. Furthermore, balancing a non-
probability sample (such as the sample used in this study and most 
other online samples) or each test cell generated from the sample, does 
not necessarily make the study results representative. Because the 
study is not intended to generate population estimates, we also 
disagree that the study should control for grocery shopper status, 
category purchase, and use status. We recognize the usefulness in and 
importance of understanding non-English speaking consumers' response to 
food labeling and will consider addressing this need in future studies.
    (Comment 8) A comment recommended that the study consider asking 
about perceived levels of nutrients-to-encourage separately from 
perceived levels of nutrients-to-limit, and about how symbols reinforce 
basic information such as food groups and servings.
    (Response 8) We agree that it is useful to examine consumer 
perceptions of nutrients-to-encourage in addition to nutrients-to-
limit, and have included four nutrients-to encourage (calcium, fiber, 
Vitamin A, and Vitamin C) in the revised questionnaire. We also agree 
that it would be useful to examine in future research how symbols 
reinforce basic information such as food groups and servings.

[[Page 62789]]

    (Comment 9) A comment stated that FDA should apply science and 
transparency in its research intentions and study design.
    (Response 9) We appreciate the comment that FDA should apply 
science and transparency in its research intentions and study design. 
We hope Responses 1 to 6 in this document will help clarify some of the 
critical elements in the agency's rationale behind the purpose of the 
study and the study design.
    (Comment 10) A comment suggested that the word ``nutritious'' 
rather than ``healthy'' should be used because the latter could be 
associated by respondents with considerations other than nutrition and 
has a regulatory meaning.
    (Response 10) We disagree that the word ``healthy'' should not be 
used because it has a regulatory meaning. We are not aware of any 
research that suggests consumers are aware that the word ``healthy'' 
has a specific regulatory definition when used in food labeling. We 
agree that ``healthy'' may be less precise than ``nutritious'' for what 
the study intends to measure. Existing consumer research, however, 
indicates that consumers associate ``healthy'' more with nutritional 
qualities of a food product than with other considerations such as 
freshness. Therefore, we will retain the word ``healthy'' in this 
study.
    (Comment 11) A comment stated that the study plan of ``showing 
front panels which are full-color, three-dimensional, and patterned 
after existing labels in the market'' would not remove the effects of 
brands on responses but would confound the analysis.
    (Response 11) We disagree with this comment. We have taken a great 
deal of care in developing the mock front panels by (1) Omitting any 
pictures or words that may provide clues to the brand name of a 
product; (2) mixing graphic components from different existing labels 
or creating original graphics in an attempt to disassociate the mock 
label with any existing brands; and (3) using fictitious names and 
addresses of the manufacturer. We believe these actions will minimize 
potential confounding effects, if any, caused by brands.
    (Comment 12) A comment suggested that the test symbols should be 
accurately represented and have NF declarations that support the 
symbol-product combinations; if a symbol is used on a product for study 
purposes, but not necessarily in the market, the comment states that 
the difference should be explained in the analysis.
    (Response 12) We understand the concern. In designing the symbols 
for this study, the agency has used available information from symbol 
schemes' Web sites, created certain label information, and omitted 
symbols in some experimental conditions for the purpose the study. The 
agency will inform respondents that the labels they see in this study 
may or may not be the same as the ones they see in the marketplace and 
mention this in the analysis.
    (Comment 13) A comment stated that some questions could be answered 
not because of one's understanding of the nutrition symbol but because 
of the respondent's previous knowledge or perception of the product or 
product category, and that some of the prior knowledge questions may 
prime symbol responses and should be moved to later in the 
questionnaire to minimize potential bias.
    (Response 13) We agree that there is a possibility that some 
respondents may be able to answer some questions by drawing on their 
own previous knowledge or perception of the product or product 
category, rather than on their perception and understanding of the 
nutrition symbol on a test product. The study asks questions about 
respondents' previous knowledge or perception of the product or product 
category precisely because we want to minimize the risk for confounding 
as a result of previous knowledge.
    We disagree that some of the prior knowledge questions should be 
moved to later in the questionnaire. Moving prior knowledge questions 
to follow symbol response questions can cause respondents to choose 
knowledge responses considered consistent with their symbol responses, 
thus increasing potential measurement errors in knowledge response. To 
minimize potential biases caused by asking prior knowledge before 
symbols response, we will have the two phases of the study (Phase 1 on 
prior knowledge and Phase 2 on label response and other topics) 
administered separately and a week apart from each other to the same 
respondents. The agency has implemented this strategy in one of its 
previous experimental studies.
    (Comment 14) A comment questioned whether forced exposure to test 
symbols would make the study results not representative of in-market 
realities.
    (Response 14) We recognize that forced exposure sometimes can 
restrict the applicability of the results to actual consumer responses 
in the store. Nonetheless, the objective of the study is to understand 
consumer reactions to one specific piece of labeling information, the 
nutrition symbol, rather than to all or other pieces of labeling 
information. We think that using forced exposure in a controlled 
environment increases the likelihood that observed outcomes are caused 
by symbols rather than prior knowledge and individual characteristics. 
Otherwise, it would be difficult to ascertain whether respondents have 
noticed the test symbols, which in turn would raise questions about the 
validity of the results. On the other hand, if the objective of the 
study was to gather market-representative results, then alternative 
methodologies such as modeling sales data may be more appropriate.
    (Comment 15) A comment stated that the proposed product categories 
(cereal, savory snack, and frozen meal) would not be appropriate for 
product comparison tasks because they are not substitutes for each 
other in the diet.
    (Response 15) We disagree that these product categories are not 
appropriate. We will use two similar products in a given category, 
e.g., chips and crackers in the savory snack category, for within-
category product comparison; we will use two substitute products, e.g., 
cereal and yogurt, for between-category product comparison.
    (Comment 16) A comment recommended that product consumption and 
purchase questions be moved from the beginning to a later section of 
the questionnaire and that these questions focus on at-home practices 
only.
    (Response 16) We disagree that these questions need to be moved 
from the beginning of the questionnaire. They are relatively easy to 
answer and can serve as a warm-up to focus respondents' attention on 
the food products in question. We have revised the questionnaire to 
help respondents understand that the questions ask about grocery 
shopping rather than food purchases at away-from-home eating 
establishments.
    (Comment 17) A comment stated that it would be important to record 
label reading practices for the food categories included in the study.
    (Response 17) We agree that it would be important to record label 
reading practices for the food categories included in the study. We 
have added two questions to collect this information.
    (Comment 18) A comment offered suggestions on simplifying 
questions, improving response types, scales and response formats, and 
ways to distinguish responses to the front and back of a label.
    (Response 18) We appreciate the comment and suggestions. We have 
incorporated many of the helpful suggestions in the revised 
questionnaire

[[Page 62790]]

and will make other necessary and appropriate revisions to the 
questionnaire based on cognitive interviews and pretests.
    (Comment 19) A comment stated that the proposed study is more 
likely to require close to 30 minutes, rather than the proposed 15 
minutes, to complete. Another comment stated that the commenter's 
experience with a 20-minute online survey similar to the proposed study 
suggested there was no negative feedback on the burden of data 
collection.
    (Response 19) We agree that the original estimate (15 minutes) was 
relatively low and has adjusted the content of the study so it will be 
completed in 20 minutes.
    (Comment 20) One comment asked the agency to publish the revised 
questionnaire for public comment prior to initiating the study.
    (Response 20) We appreciate the suggestion for the agency to 
publish the revised questionnaire for public comment prior to 
initiating the study. Per the PRA, a copy of the revised questionnaire 
is attached to the supporting statement for public comment.
    (Comment 21) A comment suggested that the agency should increase 
the sample size of the eye tracking study from 30 individuals to 100 to 
200 individuals to provide results that are more reliable.
    (Response 21) We appreciate the suggestion to increase the sample 
size of the eye tracking study from 30 individuals to 100 to 200 
individuals to provide results that are more reliable. As stated 
previously, the purpose of the eye-tracking component in this study is 
exploratory. We do not intend to use the information from this study to 
generate any reliable estimates of consumer labeling viewing behaviors. 
We will consider a larger eye-tracking study when resources become 
available and we have the need to collect reliable estimates of the 
behaviors.
    (Comment 22) Another comment recommended that the study consider 
using conjoint analysis to determine how consumers value different 
features of a given symbol.
    (Response 22) We appreciate the suggestion to use conjoint analysis 
for this study. The purpose of the proposed study is to investigate how 
consumers understand various FOP labeling schemes. In contrast, 
conjoint analyses are employed in most studies to examine consumer 
preferences toward different objects, which may include FOP labeling 
schemes. Therefore, despite the wide use of conjoint analysis in 
academic and industry research, the agency will need to establish the 
appropriateness and feasibility of conjoint analysis for research with 
similar objectives as the proposed study before it adopts the 
methodology.

B. Study 2

    Study 2 will examine nine FOP nutrition labeling schemes in 
addition to two controls: (1) The presence of a ``Nutrition Tips'' 
scheme on the FOP that shows: (a) Per-serving amounts of calories, 
total fat, saturated fat, sugar, sodium; and (b) interpretive words and 
colors of the amounts (high-red, medium-yellow, and low-green), with 
each word wrapped in a colored rectangle; (2) same as (1) but in black 
and white; (3) the presence of a ``Nutrition Tips'' scheme on the FOP 
that shows: (a) Per-serving amount of calories and % Daily Values (DV) 
of calories, total fat, saturated fat, sugar, sodium; (b) interpretive 
words of the % DV (high, medium, and low); and (c) is in black and 
white; (4) the presence of a ``Nutrition Tips'' scheme on the FOP, 
patterned after one variant of the U.K. Multiple Traffic Light scheme, 
that shows: (a) per-serving amounts of calories, total fat, saturated 
fat, sugar, sodium; (b) interpretive words and colors of the amounts 
(high-red, medium-yellow, and low-green) with each word wrapped in a 
colored circle; and (c) the measure of a serving (e.g., 1 cup); (5) 
same as (4) except that a different set of colors is used (high-pastel 
red, medium-pastel green, and low-pastel blue); (6) the presence of a 
``Calorie Count'' scheme on the FOP that shows the amount of calories 
per serving and total amount of calories in the package; (7) the 
presence of a ``Calorie Count'' scheme on the FOP that shows the amount 
of calories per serving and the number of servings per package; (8) the 
presence of a ``Nutrition Rating'' scheme on the FOP that shows: (a) 
The numerical value and number of stars (out of five stars) 
representing the overall nutritional quality of the product; and (b) 
the amount of calories per serving; (9) the presence of a green 
``Healthy Check'' scheme on the FOP that includes the word ``healthy'' 
and a separate box showing the amount of calories per serving and the 
number of servings per package; (10) a control that shows only the 
Nutrition Facts label; and (11) a control that shows no FOP nutrition 
information.
    Study 2 will randomly assign each of its 4,800 participants to the 
88 experimental conditions (11 labeling conditions x 4 product 
categories x 2 levels of choice difficulty). The study will focus on 
the following types of consumer reaction: (1) Accuracy and speed in a 
two product choice task that requires selection of the healthier 
product; (2) relevancy given for choice based on thematic coding of 
open-ended responses; (3) perceptions of long term consequences of 
regularly including the chosen product in one's diet; (4) perceptions 
of selected nutrient levels in the chosen product; (5) likelihood of 
truncated information search when answering product perception 
questions; and (6) perceptions of credibility and helpfulness of the 
labeling scheme. To help understand consumer reaction, the study will 
also collect information on participants' nutrition consciousness.
    The purpose of Study 2 is to help the agency compare the relative 
effectiveness of a wide range of nutrition labeling schemes along with 
certain specific design features (e.g., color, presentation of calorie 
and serving size information) in helping consumers make healthier food 
choices. The results of the study will not be used to develop 
population estimates.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 62791]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                         No. of           Annual       Total Annual        Hours per                      Total  Capital    Operating &
             Activity                 Respondents      Frequency per     Responses         Response         Total Hours        Costs        Maintenance
                                                         Response                                                                              Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1 and Study 2)                            288               1             288               0.083              24               0               0
Cognitive interview screener
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1 and Study 2)                             36               1              36               1                  36               0               0
Cognitive interview
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1 and Study 2)                          3,200               1           3,200               0.033             106               0               0
Pretest invitation
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1) Pretest                                200               1             200               0.33               66               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 2) Pretest                                200               1             200               0.25               50               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1 and Study 2)                         38,400               1          38,400               0.033           1,267               0               0
Survey invitation
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1) Survey                               2,400               1           2,400                .33              792               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 2) Survey                               4,800               1           4,800               0.25            1,200               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1) Eye-tracking screener                  240               1             240               0.083              20               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Study 1) Eye-tracking                            30               1              30               1                  30               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                              .................  ..............  ..............  ..................           3,591               0               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the 60-day notice that published on June 1, 2009, we estimated a 
total burden of 1,417 hours for Study 1. In this document, table 1 has 
been modified to add the estimated burden hours associated with new 
Study 2 and to reflect our re-evaluation of the time it takes to 
complete the questionnaire in Study 1. The new total estimated burden 
is 3,591 hours.
    To help design and refine the questionnaires to be used for the 
experimental studies, we will conduct cognitive interviews by screening 
288 adult consumers in order to obtain 36 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 60 hours (24 hours + 36 hours). 
Subsequently, we will conduct pretests of the survey questionnaires 
before they are administered. We expect that 3,200 invitations, each 
taking 2 minutes (0.033 hours), will need to be sent to adult members 
of two online consumer panels to have 400 of them complete a 20-minute 
(0.33 hours) and a 15-minute (0.25 hours) pretest, respectively. The 
total for the pretest activities is 223 hours (106 hours + 66 hours + 
50 hours). For the survey, we estimate that 38,400 invitations, each 
taking 2 minutes (0.033 hours), will need to be sent to adult members 
of two online consumer panels to have 2,400 of them complete a 20-
minute (0.33 hours) questionnaire for Study 1 and 4,800 of them 
complete a 15-minute (0.25 hours) questionnaire for Study 2, 
respectively. The total for the survey activities is 3,259 hours (1,267 
hours + 792 hours + 1,200 hours). To conduct the eye-tracking study, we 
expect to screen 240 adult consumers, each taking 5 minutes (0.083 
hours), to have 30 of them participate in a 1-hour interview. The total 
for the eye-tracking activities is 50 hours (20 hours + 30 hours). 
Thus, the total estimated burden is 3,591 hours. FDA's burden estimate 
is based on prior experience with research that is similar to this 
proposed study.

II. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday. (FDA has verified all Web site addresses, 
but FDA is not responsible for any subsequent changes

[[Page 62792]]

to the Web sites after this document publishes in the Federal 
Register.)
    1. Malam, S., S. Clegg, S. Kirwan, and S. McGinigal, 
``Comprehension and Use of UK Nutrition Signpost Labelling 
Schemes,'' report prepared for Food Standards Agency, May 2009.
    2. Borgmeier, I, and J. Westenhoefer, ``Impact of Different Food 
Label Formats on Healthiness Evaluation and Food Choice of 
Consumers: a Randomized-Controlled Study,'' BMC Public Health, 9: 
184, 2009, accessed online at http://www.biomedcentral.com/content/
pdf/1471-2458-9-184.pdf.
    3. Kelly, B, C. Hughes, K. Chapman, J.C.-Y. Louie, H. Dixon, J. 
Crawford, L. King, M. Daube, T. Slevin, ``Consumer Testing of the 
Acceptability and Effectiveness of Front-of-Pack Food Labelling 
Systems for the Australian Grocery Market,'' Health Promotion 
International 24(2):120-9, 2009.
    4. Feunekes, G.I.J., I.A. Gortemaker, A.A. Willems, R. Lion, and 
M. van den Kommer, ``Front-of-pack Nutrition Labelling: Testing 
Effectiveness of Different Nutrition Labelling Formats Front-of-pack 
in Four European Countries,'' Appetite, 50:57-70, 2008.

    Dated: November 24, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28699 Filed 11-30-09; 8:45 am]

BILLING CODE 4160-01-S
