[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48988-48989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0871]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Studies on Consumer Responses to Nutrient 
Content Claims on Fortified Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Experimental Studies on 
Consumer Responses to Nutrient Content Claims on Fortified Foods.''

DATES: Submit either electronic or written comments on the collection 
of information by October 15, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Experimental Studies on Consumer Responses to Nutrient Content Claims 
on Fortified Foods (OMB Control Number 0910-NEW)

I. Background

    The Nutrition Labeling and Education Act gave FDA the authority to 
promulgate regulations which require almost all packaged foods to bear 
nutrition labeling. The law also allows manufacturers to provide other 
nutrition information on labels in the form of various types of 
statements, including claims, as long as such statements comply with 
the regulatory limits that govern the use of each type of statement. 
There are three types of claims that the food industry can voluntarily 
use on food labels: (1) Health claims, (2) nutrient content claims, and 
(3) structure/function claims. All claims must be truthful and not 
misleading (Ref. 1).
    The FDA's policy on fortification (21 CFR 104.20) establishes a set 
of principles that serve as a model for the rational addition of 
nutrients to foods. The FDA has an interest in the American public 
achieving and maintaining diets with optimal levels of nutritional 
quality, wherein healthy diets are composed of foods from a variety of 
nutrient sources. The FDA does not encourage the addition of nutrients 
to certain food products (including sugars or snack foods such as 
[cookies] candies, and carbonated beverages). FDA is interested in 
studying whether fortification of these foods could cause consumers to 
believe that substituting fortified snack foods for more nutritious 
foods would ensure a nutritionally sound diet.
    Research suggests consumer product perceptions and purchase 
decisions can be influenced by labeling statements and different 
labeling statements may have different influences (Refs. 2 through 5). 
The FDA, as part of its effort to promote public health, proposes to 
conduct two related studies to explore consumer responses to expressed 
and implied nutrient content claims on the labels of snack foods such 
as cookies, carbonated beverages, and candy. Both studies will be 
controlled, randomized experiments. Study 1 will use a 15-minute Web-
based questionnaire to collect information from 4,000 English-speaking 
adult members of an online consumer panel maintained by a contractor. 
Study 2 will use the same questionnaire and draw a sample of 1,000 
English-speaking adult participants from the same online consumer panel 
to test a subset of the experimental conditions employed in Study 1. 
Participants in Study 2 will also access the survey on the Web but will 
use a grocery-shopping simulation software program to participate in 
the study. Study 2 is expected to last 15 minutes as well.
    The purpose for using both the regular Web-based application and 
the simulated shopping program is to be able to compare the two modes 
of data collection. One critique of experimental studies is that they 
may lack external validity--the ability to generalize the findings 
beyond the study setting because the study is very different from real 
life (Ref. 6). The grocery-shopping simulation software program may 
more closely mimic consumers' real-life shopping experiences compared 
to the regular Web-based application and would therefore be expected to 
elicit survey responses similar to real-life food shopping. One study 
comparing simulated shopping with actual behavior concluded that 
consumers' simulated purchase behaviors are highly predictive of their 
actual behavior (Ref. 7). If proposed Study 1 and Study 2 results are 
comparable, this will lend support to the external validity of online 
experimental study results. Researchers will endeavor to collect 
samples that reflect the U.S. Census on gender,

[[Page 48989]]

education, age, and ethnicity/race for both modes of administration.
    Potential conditions for the studies include the following: (1) A 
mock snack product with a claim similar to ``[a]s much [nutrient] as a 
serving of [food product];'' (2) a mock candy with the claim ``[g]ood 
source of [nutrient];'' and (3) a mock carbonated beverage with the 
claim, ``product name] plus [nutrient].'' Each participant in each 
study will be randomly assigned to view a label image. Each participant 
in each study will also be randomly allowed or disallowed to access the 
Nutrition Facts label of the product. All label images will be mock 
products resembling actual food labels found in the marketplace.
    Participants will view label images and answer questions about 
their perceptions and reactions to the label. Product perceptions 
(e.g., healthiness, potential health benefits, levels of nutrients), 
label perceptions (e.g., helpfulness and credibility), and purchase/
choice questions will constitute the measures of response in the 
experiment. To help understand the data, the survey will also collect 
information about participants' background, such as purchase and 
consumption of similar products; nutrition knowledge; dietary 
interests; motivation regarding label use; health status and 
demographic characteristics.
    The studies are part of the Agency's continuing effort to enable 
consumers to make informed dietary choices and construct healthful 
diets. Results of the studies will be used primarily to inform the 
Agency's understanding of how claims on the packages of fortified food 
may affect how consumers perceive a product or a label, which may in 
turn affect their dietary choices. The results of the studies will 
neither be used to develop population estimates nor be directly used to 
inform policy.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                            Number of
                Activity                    Number of    Responses  per   Total annual             Average burden per response              Total hours
                                           respondents      respondent      responses
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Study 1 Cognitive interview screener...              75               1              75  0.083 (5 minutes)..............................               6
Study 2 Cognitive interview screener...              75               1              75  0.083 (5 minutes)..............................               6
Study 1 Cognitive interview............               9               1               9  1 hour (60 minutes)............................               9
Study 2 Cognitive interview............               9               1               9  1 hour (60 minutes)............................               9
Study 1 Pretest invitation.............           1,600               1           1,600  0.033 (2 minutes)..............................              53
Study 2 Pretest invitation.............             800               1             800  0.033 (2 minutes)..............................              26
Study 1 Pretest........................             200               1             200  0.25 (15 minutes)..............................              50
Study 2 Pretest........................             100               1             100  0.25 (15 minutes)..............................              25
Study 1 Survey invitation..............          32,000               1          32,000  0.033 (2 minutes)..............................           1,056
Study 2 Survey invitation..............           8,000               1           8,000  0.033 (2 minutes)..............................             264
Study 1 Survey.........................           4,000               1           4,000  0.25 (15 minutes)..............................           1,000
Study 2 Survey.........................           1,000               1           1,000  0.25 (15 minutes)..............................             250
    Total..............................  ..............  ..............  ..............  ...............................................           2,754
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references have been placed on display in the 
division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. U.S. Food and Drug Administration, ``Claims That Can Be Made for 
Conventional Foods and Dietary Supplements,'' September 2003. 
Available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.
2. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers' Use 
of Nutritional Labels: A Review of Research Studies and Issues,'' 
Academy of Marketing Science Review, 2006(9), 2006. Available at 
http://www.amsreview.org/articles/drichoutis09-2006.pdf.
3. L[auml]hteenm[auml]ki, L., P. Lampila, K. Grunert, et.al, 
``Impact of Health-Related Claims on the Perception of Other Product 
Attributes,'' Food Policy, 23: 230-239, 2010.
4. Labiner-Wolfe, J., C.-T. J. Lin, and L. Verrill, ``Effect of Low 
Carbohydrate Claims on Consumer Perceptions About Food Products' 
Healthfulness and Helpfulness for Weight Management,'' Journal of 
Nutrition Education and Behavior, 42(5): 315-320, 2010.
5. Roe, B., A.S. Levy, and B.M. Derby, ``The Impact of Health Claims 
on Consumer Search and Product Evaluation Outcomes: Evidence From 
FDA Experimental Data,'' Journal of Public Policy and Marketing, 
18(1): 89-105, 1999.
6. Campbell, D.T. and J.C. Stanley, ``Experimental and Quasi-
Experimental Designs for Research,'' Chicago: Rand McNally. 1966.
7. Sharpe, KM., R. Staelin, and J. Huber, ``Using Extremeness 
Aversion to Fight Obesity: Policy Implications of Context Dependent 
Demand,'' Journal of Consumer Research, 35:406-422, 2008.

    Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19991 Filed 8-14-12; 8:45 am]
BILLING CODE 4160-01-P