[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59553-59554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0532]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Nutrition Facts Label Formats

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 an experimental study of Nutrition Facts 
label formats.

DATES: Submit written or electronic comments on the collection of 
information by January 19, 2010.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 Study of Nutrition Facts Label Formats--(Section 
903(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
393(d)(2)(C))) (OMB Control Number 0910-NEW)

I. Description

    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).

[[Page 59554]]

    FDA conducts consumer research under its broad statutory authority, 
set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic 
Act (the act), to protect the public health by ensuring that foods are 
``safe, wholesome, sanitary, and properly labeled,'' and in section 
903(d)(2)(C) of the act, to conduct research relating to foods, drugs, 
cosmetics, and devices in carrying out the 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 Web-based 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 
3,600 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 to make informed food choices. The results of the 
experimental study will not be used to develop population estimates.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
                     Portion of Study                         Respondents        per Response        Responses           Response         Total Hours
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Cognitive interview screener                                              96                  1                 96              0.083                  8
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Cognitive interview                                                       12                  1                 12                  1                 12
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Pretest invitation                                                     1,000                  1              1,000              0.033                 33
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Pretest                                                                  150                  1                150               0.20                 30
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Experiment invitation                                                 24,000                  1             24,000              0.033                792
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Experiment                                                             3,600                  1              3,600               0.20                720
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Total                                                      .................  .................  .................  .................              1,595
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 12-minute 
(0.20 hours) pretest. The total for the pretest activities is 63 hours 
(33 hours + 30 hours). For the experiment, we estimate that 24,000 
invitations, each taking 2 minutes (0.033 hours), will need to be sent 
to adult members of an online consumer panel to have 3,600 of them 
complete a 12-minute (0.20 hours) questionnaire. The total for the 
experiment activities is 1,512 hours (792 hours + 720 hours). Thus, the 
total estimated burden is 1,595 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 (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    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 Quick-
Service 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.

    Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27720 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S