Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Disclosure of Amounts of Vitamins and Minerals, 29758-29760 [2011-12556]
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Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
and help consumers adopt healthy
lifestyles. The information will also
help FDA and other Federal Agencies
evaluate and track consumer awareness
and behavior as outcome measures of
their achievement in improving public
health.
Description of Respondents: The
respondents are adults, age 18 and
older, drawn from the 50 States and the
District of Columbia. Participation will
be voluntary.
FDA bases its estimate of the number
of respondents and the hours per
response on its experience with
previous Health and Diet Surveys. Prior
to the administration of the Health and
Diet Survey—General Topics, the
Agency plans to conduct a pretest to
identify and resolve potential problems.
The pretest will be conducted with 27
participants; we estimate that it will
take a respondent 15 minutes (0.25
hours) to complete the pretest, for a total
of 6.75 hours, rounded to 7. The Agency
will use a screener to select an eligible
adult respondent in each household to
participate in the survey. For the Health
and Diet Survey—General Topics data
collection activity, a total of 10,000
individuals in the 50 States and the
District of Columbia will be screened by
telephone. We estimate that it will take
a respondent 1 minute (0.02 hours) to
complete the screening, for a total of 200
hours. We estimate that 3,000 eligible
adults will participate in the survey,
each taking 15 minutes (0.25 hours), for
a total of 750 hours. For the Health and
Diet Survey—Dietary Guidelines
Supplement data collection activity,
4,000 individuals in the 50 States and
the District of Columbia will be
screened by telephone. We estimate that
it will take a respondent 1 minute (0.02
hours) to complete the screening
questions, for a total of 80 hours. Of
these respondents, 1,200 will complete
the survey. We estimate that it will take
a respondent 13 minutes (0.22 hours) to
complete the entire survey, for a total of
264 hours. Thus, the total estimated
burden is 1,301 hours.
In the Federal Register of January 7,
2011 (76 FR 1168), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received two
comments in response to the 30-day
notice. The letters contained comments
outside the scope of the four collection
of information topics on which the
notice solicits comments and, thus, will
not be addressed here.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average burden
per response
(in hours) 2
Total annual
responses
Total hours
General Topics: Pretest .............................................
General Topics: Screener ..........................................
General Topics: Survey .............................................
Dietary Guidelines Supplement: Screener ................
Dietary Guidelines Supplement: Survey ....................
27
10,000
3,000
4,000
1,200
1
1
1
1
1
27
10,000
3,000
4,000
1,200
15/60
1/60
15/60
1/60
13/60
7
200
750
80
264
Total ....................................................................
..........................
..........................
..........................
..........................
1,301
1 There
2
are no capital costs or operating and maintenance costs associated with this collection of information.
Burden estimates of less than 1 hour are expressed as a fraction of an hour in the form ‘‘[number of minutes per response]/60’’.
Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12554 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0345]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study on Consumer Responses to
Nutrition Facts Labels With Various
Footnote Formats and Disclosure of
Amounts of Vitamins and Minerals
srobinson on DSK4SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
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 Study on
Consumer Responses to Nutrition Facts
Labels With Various Footnote Formats
and Disclosure of Amounts of Vitamins
and Minerals.’’
DATES: Submit either electronic or
written comments on the collection of
information by July 22, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23MYN1.SGM
23MYN1
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
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.
I. Experimental Study on Consumer
Responses to Nutrition Facts Labels
With Various Footnote Formats and
Disclosure of Amounts of Vitamins and
Minerals—(OMB Control Number 0910New)
Under the Nutrition Labeling and
Education Act of 1990 (Pub. L. 101–
535), the Nutrition Facts label is
required on most packaged foods, and
this information must be provided in a
specific format in accordance with the
provisions of § 101.9 (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
through 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 (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 the Federal
Register of November 2, 2007 (72 FR
62149) FDA issued an advance notice of
proposed rulemaking (ANPRM) entitled,
‘‘Food Labeling: Revision of Reference
Values and Mandatory Nutrients’’ (the
2007 ANPRM), which requested
comments on a variety of topics related
to a future proposed rule to update the
presentation of nutrients and content of
nutrient values on food labels. In the
2007 ANPRM, the Agency included a
request for comments on how
consumers use the percent Daily Value
in the Nutrition Facts label when
evaluating the nutritional content of
food items and making purchases.
Research has suggested that
consumers use the Nutrition Facts label
in various ways, including, but not
limited to, using the Nutrition Facts
label to determine if products are high
or low in a specific nutrient and to
compare products (Ref. 6). One
component of the Nutrition Facts label
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
that serves as an aid in these uses is the
percent Daily Value. Early consumer
research indicated that the percent Daily
Value format improved consumers’
abilities to make correct dietary
judgments about a food in the context of
a total daily diet (Ref. 3), which led FDA
to require both quantitative and
percentage declarations of nutrient daily
values in the Nutrition Facts label in the
1993 Nutrition Labeling final rule (58
FR 2079, January 6, 1993).
Research in subsequent years,
however, suggested that consumers’
understanding and use of percent Daily
Value may be somewhat inconsistent
(Refs. 7 and 8). Additionally, FDA has
received several public comments
suggesting that further research on
percent Daily Values may be warranted,
along with research on other
modifications to the Nutrition Facts
label. Suggested research on potential
modifications includes research on: (1)
The removal of the statements, ‘‘Percent
Daily Values are based on a 2,000
calorie diet. Your daily values may be
higher or lower depending on your
calorie needs’’; (2) the removal of the
table in the footnote that lists the Daily
Values for total fat, saturated fat,
cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and
2,500 calorie diets as described in
§ 101.9(d)(9); and (3) changes to the
presentation of and amount of
information provided in the Nutrition
Facts label. Therefore, FDA, as part of
its effort to promote public health,
proposes to use this study to explore
consumer responses to various food
label formats for the footnote area of the
Nutrition Facts label, including those
that exhibit information such as various
definitions for percent Daily Value and
general guidelines for high and low
nutrient levels. In addition, the Agency
will use this study to explore consumer
responses to inclusion of weight amount
information in the declaration of
vitamins and minerals described in
§ 101.9(c)(8)(ii) (i.e., vitamin A, vitamin
C, calcium, and iron), which may have
potential health value to consumers
(Ref. 9).
The proposed collection of
information is a controlled, randomized,
experimental study. The study will use
a Web-based survey, which will take
about 15 minutes to complete, to collect
information from 10,000 Englishspeaking adult members of an online
consumer panel maintained by a
contractor. The study will aim to recruit
a sample that reflects the U.S. Census on
gender, education, age, and ethnicity/
race.
The study will randomly assign each
of its participants to view a total of three
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
29759
label images from a set of food labels
that will be created for the study and
systematically varied in the presence or
absence of the following items: (1) A
definition for percent Daily Value, (2) a
general guideline for ‘‘high’’ and ‘‘low’’
nutrient levels, and (3) weight amounts
for vitamins and minerals. Various
definitions for percent Daily Value may
include, for example, ‘‘The percent Daily
Value is the amount of a nutrient listed
above that one serving of this product
contributes to the daily diet’’; ‘‘The
percent Daily Value is the amount of a
nutrient listed above that one serving of
this product contributes to what you eat
in a day’’; and ‘‘The percent Daily Value
is the amount of a nutrient listed above
that one serving of this product
contributes to a 2,000 calorie diet.’’ A
sample guideline for high and low
nutrient levels may include, for
example, ‘‘A percent Daily Value that is
5 percent or less is low, and 20 percent
or more is high.’’ To correspond with
FDA’s other experimental study of
Nutrition Facts label formats described
in the November 17, 2010, Federal
Register (75 FR 70266), this study will
evaluate performance of the footnote
statements in combination with single
and dual column labeling. Finally, the
study will also examine effects of
including reference to FDA within the
Nutrition Facts footnote. All label
images will be mock-ups resembling
food labels that may be found in the
marketplace. Images will show product
identity (e.g., potato chips), but not any
real or fictitious brand name.
The survey will ask its participants to
view label images and answer questions
about their understanding, perceptions,
and reactions related to the viewed
label. 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 healthiness; (2) ability to use the
Nutrition Facts label to, for example,
compare products and calculate the
number of servings of a product needed
to meet nutritional objectives; and (3)
label perceptions (e.g., helpfulness and
credibility). 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 is part of the Agency’s
continuing effort to enable consumers to
make informed dietary choices and
construct healthful diets. Results of the
study will be used primarily to enhance
the Agency’s understanding of how
various potential modifications to the
Nutrition Facts label may affect how
consumers perceive a product or a label,
E:\FR\FM\23MYN1.SGM
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29760
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
which may in turn affect their dietary
choices. Results of the study will not be
used to develop population estimates.
To help design and refine the
questionnaire, FDA plans to conduct
cognitive interviews by screening 72
panelists in order to obtain 9
participants in the interviews. Each
screening is expected to take 5 minutes
(0.083 hour) and each cognitive
interview is expected to take 1 hour.
The total for cognitive interview
activities is 15 hours (6 hours + 9
hours). Subsequently, we plan to
conduct pretests of the questionnaire
before it is administered in the study.
We expect that 1,600 invitations, each
taking 2 minutes (0.033 hour), will need
to be sent to panelists to have 200 of
them complete a 15-minute (0.25 hour)
pretest. The total for the pretest
activities is 103 hours (53 hours + 50
hours). For the survey, we estimate that
80,000 invitations, each taking 2
minutes (0.033 hour) to complete, will
need to be sent to the consumer panel
to have 10,000 of its members complete
a 15-minute (0.25 hour) questionnaire.
The total for the survey activities is
5,140 hours (2,640 hours + 2,500 hours).
Thus, the total estimated burden is
5,258 hours. FDA’s burden estimate is
based on prior experience with research
that is similar to this proposed study.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Cognitive interview screener ................................................
Cognitive interview ...............................................................
Pretest invitation ..................................................................
Pretest ..................................................................................
Survey invitation ...................................................................
Survey ..................................................................................
Total ..............................................................................
72
9
1,600
200
80,000
10,000
........................
1
1
1
1
1
1
........................
72
9
1,600
200
80,000
10,000
........................
5/60
1
2/60
15/60
2/60
15/60
........................
1 There
Total hours
6
9
53
50
2,640
2,500
5,258
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
srobinson on DSK4SPTVN1PROD with NOTICES
II. References
The following references are 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, S.B., and Schucker, R.E.
‘‘Nutrition Labeling Formats:
Performance and Preference,’’ Food
Technology, 45: 116–121, 1991.
2. Levy, A.S., Fein, S.B., and Schucker, R.E.
‘‘More Effective Nutrition Label Formats
Are Not Necessarily Preferred,’’ Journal
of the American Dietetic Association, 92:
1230–1234, 1992.
3. Levy, A.S., Fein, S.B., and Schucker, R.E.
‘‘Performance Characteristics of Seven
Nutrition Label Formats,’’ Journal of
Public Policy and Marketing, 15: 1–15,
1996.
4. Lando, A.M. and Labiner-Wolfe, J.
‘‘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, available at
https://www.fda.gov/Food/
LabelingNutrition/ReportsResearch/
ucm081696.htm.
6. U.S. Food and Drug Administration. ‘‘2008
Health and Diet Survey—Preliminary
Topline Frequencies (Weighted),’’ 2010,
available at https://www.fda.gov/Food/
ScienceResearch/ResearchAreas/
ConsumerResearch/ucm193895.htm.
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16:22 May 20, 2011
Jkt 223001
7. Li, F., Miniard, P.W., and Barone, M.J.
‘‘The Facilitating Influence of Consumer
Knowledge on the Effectiveness of Daily
Value Reference Information,’’ Journal of
the Academy of Marketing Science, 28:
425–436, 2000.
8. Levy, L., Patterson, R.E., Kristal, A.R., and
Li, S.S. ‘‘How Well Do Consumers
Understand Percentage Daily Value on
Food Labels?’’ American Journal of
Health Promotion, 14: 157–160, 2000.
9. Institute of Medicine. Dietary Reference
Intakes: Guiding Principles for Nutrition
Labeling and Fortification. Washington,
DC: National Academies Press, 2003.
Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12556 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0640]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Food and Nutrition Product
Communications, as Used by the Food
and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00041
Fmt 4703
Sfmt 4703
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.
SUMMARY:
Fax written comments on the
collection of information by June 22,
2011.
DATES:
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 ‘‘Data to Support Food and
Nutrition Product Communications, as
Used by the Food and Drug
Administration.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29758-29760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0345]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study on Consumer Responses to Nutrition
Facts Labels With Various Footnote Formats and Disclosure of Amounts of
Vitamins and Minerals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Study on
Consumer Responses to Nutrition Facts Labels With Various Footnote
Formats and Disclosure of Amounts of Vitamins and Minerals.''
DATES: Submit either electronic or written comments on the collection
of information by July 22, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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
[[Page 29759]]
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.
I. Experimental Study on Consumer Responses to Nutrition Facts Labels
With Various Footnote Formats and Disclosure of Amounts of Vitamins and
Minerals--(OMB Control Number 0910-New)
Under the Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535), the Nutrition Facts label is required on most packaged foods,
and this information must be provided in a specific format in
accordance with the provisions of Sec. 101.9 (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
through 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 (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
the Federal Register of November 2, 2007 (72 FR 62149) FDA issued an
advance notice of proposed rulemaking (ANPRM) entitled, ``Food
Labeling: Revision of Reference Values and Mandatory Nutrients'' (the
2007 ANPRM), which requested comments on a variety of topics related to
a future proposed rule to update the presentation of nutrients and
content of nutrient values on food labels. In the 2007 ANPRM, the
Agency included a request for comments on how consumers use the percent
Daily Value in the Nutrition Facts label when evaluating the
nutritional content of food items and making purchases.
Research has suggested that consumers use the Nutrition Facts label
in various ways, including, but not limited to, using the Nutrition
Facts label to determine if products are high or low in a specific
nutrient and to compare products (Ref. 6). One component of the
Nutrition Facts label that serves as an aid in these uses is the
percent Daily Value. Early consumer research indicated that the percent
Daily Value format improved consumers' abilities to make correct
dietary judgments about a food in the context of a total daily diet
(Ref. 3), which led FDA to require both quantitative and percentage
declarations of nutrient daily values in the Nutrition Facts label in
the 1993 Nutrition Labeling final rule (58 FR 2079, January 6, 1993).
Research in subsequent years, however, suggested that consumers'
understanding and use of percent Daily Value may be somewhat
inconsistent (Refs. 7 and 8). Additionally, FDA has received several
public comments suggesting that further research on percent Daily
Values may be warranted, along with research on other modifications to
the Nutrition Facts label. Suggested research on potential
modifications includes research on: (1) The removal of the statements,
``Percent Daily Values are based on a 2,000 calorie diet. Your daily
values may be higher or lower depending on your calorie needs''; (2)
the removal of the table in the footnote that lists the Daily Values
for total fat, saturated fat, cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and 2,500 calorie diets as described
in Sec. 101.9(d)(9); and (3) changes to the presentation of and amount
of information provided in the Nutrition Facts label. Therefore, FDA,
as part of its effort to promote public health, proposes to use this
study to explore consumer responses to various food label formats for
the footnote area of the Nutrition Facts label, including those that
exhibit information such as various definitions for percent Daily Value
and general guidelines for high and low nutrient levels. In addition,
the Agency will use this study to explore consumer responses to
inclusion of weight amount information in the declaration of vitamins
and minerals described in Sec. 101.9(c)(8)(ii) (i.e., vitamin A,
vitamin C, calcium, and iron), which may have potential health value to
consumers (Ref. 9).
The proposed collection of information is a controlled, randomized,
experimental study. The study will use a Web-based survey, which will
take about 15 minutes to complete, to collect information from 10,000
English-speaking adult members of an online consumer panel maintained
by a contractor. The study will aim to recruit a sample that reflects
the U.S. Census on gender, education, age, and ethnicity/race.
The study will randomly assign each of its participants to view a
total of three label images from a set of food labels that will be
created for the study and systematically varied in the presence or
absence of the following items: (1) A definition for percent Daily
Value, (2) a general guideline for ``high'' and ``low'' nutrient
levels, and (3) weight amounts for vitamins and minerals. Various
definitions for percent Daily Value may include, for example, ``The
percent Daily Value is the amount of a nutrient listed above that one
serving of this product contributes to the daily diet''; ``The percent
Daily Value is the amount of a nutrient listed above that one serving
of this product contributes to what you eat in a day''; and ``The
percent Daily Value is the amount of a nutrient listed above that one
serving of this product contributes to a 2,000 calorie diet.'' A sample
guideline for high and low nutrient levels may include, for example,
``A percent Daily Value that is 5 percent or less is low, and 20
percent or more is high.'' To correspond with FDA's other experimental
study of Nutrition Facts label formats described in the November 17,
2010, Federal Register (75 FR 70266), this study will evaluate
performance of the footnote statements in combination with single and
dual column labeling. Finally, the study will also examine effects of
including reference to FDA within the Nutrition Facts footnote. All
label images will be mock-ups resembling food labels that may be found
in the marketplace. Images will show product identity (e.g., potato
chips), but not any real or fictitious brand name.
The survey will ask its participants to view label images and
answer questions about their understanding, perceptions, and reactions
related to the viewed label. 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 healthiness; (2)
ability to use the Nutrition Facts label to, for example, compare
products and calculate the number of servings of a product needed to
meet nutritional objectives; and (3) label perceptions (e.g.,
helpfulness and credibility). 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 is part of the Agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets. Results of the study will be used primarily to enhance the
Agency's understanding of how various potential modifications to the
Nutrition Facts label may affect how consumers perceive a product or a
label,
[[Page 29760]]
which may in turn affect their dietary choices. Results of the study
will not be used to develop population estimates.
To help design and refine the questionnaire, FDA plans to conduct
cognitive interviews by screening 72 panelists in order to obtain 9
participants in the interviews. Each screening is expected to take 5
minutes (0.083 hour) and each cognitive interview is expected to take 1
hour. The total for cognitive interview activities is 15 hours (6 hours
+ 9 hours). Subsequently, we plan to conduct pretests of the
questionnaire before it is administered in the study. We expect that
1,600 invitations, each taking 2 minutes (0.033 hour), will need to be
sent to panelists to have 200 of them complete a 15-minute (0.25 hour)
pretest. The total for the pretest activities is 103 hours (53 hours +
50 hours). For the survey, we estimate that 80,000 invitations, each
taking 2 minutes (0.033 hour) to complete, will need to be sent to the
consumer panel to have 10,000 of its members complete a 15-minute (0.25
hour) questionnaire. The total for the survey activities is 5,140 hours
(2,640 hours + 2,500 hours). Thus, the total estimated burden is 5,258
hours. FDA's burden estimate is based on prior experience with research
that is similar to this proposed study.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours) \2\
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener.... 72 1 72 5/60 6
Cognitive interview............. 9 1 9 1 9
Pretest invitation.............. 1,600 1 1,600 2/60 53
Pretest......................... 200 1 200 15/60 50
Survey invitation............... 80,000 1 80,000 2/60 2,640
Survey.......................... 10,000 1 10,000 15/60 2,500
Total....................... .............. .............. .............. .............. 5,258
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60''.
II. References
The following references are 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, S.B., and Schucker, R.E. ``Nutrition Labeling
Formats: Performance and Preference,'' Food Technology, 45: 116-121,
1991.
2. Levy, A.S., Fein, S.B., and Schucker, R.E. ``More Effective
Nutrition Label Formats Are Not Necessarily Preferred,'' Journal of
the American Dietetic Association, 92: 1230-1234, 1992.
3. Levy, A.S., Fein, S.B., and Schucker, R.E. ``Performance
Characteristics of Seven Nutrition Label Formats,'' Journal of
Public Policy and Marketing, 15: 1-15, 1996.
4. Lando, A.M. and Labiner-Wolfe, J. ``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, available at https://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm.
6. U.S. Food and Drug Administration. ``2008 Health and Diet
Survey--Preliminary Topline Frequencies (Weighted),'' 2010,
available at https://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
7. Li, F., Miniard, P.W., and Barone, M.J. ``The Facilitating
Influence of Consumer Knowledge on the Effectiveness of Daily Value
Reference Information,'' Journal of the Academy of Marketing
Science, 28: 425-436, 2000.
8. Levy, L., Patterson, R.E., Kristal, A.R., and Li, S.S. ``How Well
Do Consumers Understand Percentage Daily Value on Food Labels?''
American Journal of Health Promotion, 14: 157-160, 2000.
9. Institute of Medicine. Dietary Reference Intakes: Guiding
Principles for Nutrition Labeling and Fortification. Washington, DC:
National Academies Press, 2003.
Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12556 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P
