Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages, 30725-30727 [2011-13060]
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30725
Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
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, in the Federal Register of
April 29, 2010 (75 FR 22599), FDA
published a notice of availability of the
draft guidance document providing a
60-day public comment period on the
proposed collection of information
provisions.
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.
Title: Draft Guidance for Industry and
FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests
for Information Under the Federal Food,
Drug, and Cosmetic Act.
Description: Section 513(g) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c(g))
provides a means for obtaining the
Agency’s views about the classification
and regulatory requirements that may be
applicable to your particular device.
Section 513(g) provides that within 60
days of the receipt of a written request
of any person for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
Section 513(g) of the FD&C Act
provides a means for obtaining FDA’s
views about the classification and the
regulatory requirements that may be
applicable to a particular device. The
purpose of this draft guidance is to
establish procedures for submitting,
reviewing, and responding to requests
for information respecting the class in
which a device has been classified or
the requirements applicable to a device
under the FD&C Act that are submitted
in accordance with section 513(g) of the
FD&C Act. FDA does not review data
related to substantial equivalence or
safety and effectiveness in a 513(g)
request for information. FDA’s
responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act. Additionally, the FD&C
Act, as amended by the FDA
Amendments Act of 2007 (Pub. L. 110–
85), requires FDA to collect user fees for
513(g) requests for information.
In the Federal Register of April 29,
2010, FDA published a 60-day notice
requesting public comment on the
proposed collection of information. No
comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act 513(g)
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
Center for Devices and Radiological Health (CDRH) .........
Center for Biologics Evaluation and Research (CBER) ......
110
4
1
1
110
4
12
12
1,320
48
Total ..............................................................................
........................
........................
........................
........................
1,368
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
Respondents to this collection of
information are mostly device
manufacturers; however, anyone may
submit a 513(g) request for information.
The total number of annual responses is
based on the average number of 513(g)
requests received each year by the
Agency. FDA based its estimates on the
number of 513(g) requests for
information received by both CDRH and
CBER from 2007 to 2009.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0320]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study on Consumer Responses to
Whole Grain Labeling Statements on
Food Packages
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2011–13058 Filed 5–25–11; 8:45 am]
ACTION:
BILLING CODE 4160–01–P
SUMMARY:
VerDate Mar<15>2010
20:04 May 25, 2011
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
Jkt 223001
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
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 Whole Grain
Labeling Statements on Food Packages.’’
Submit either electronic or
written comments on the collection of
information by July 25, 2011.
DATES:
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
ADDRESSES:
E:\FR\FM\26MYN1.SGM
26MYN1
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Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
docket number found in brackets in the
heading of this document. For access to
the docket to read background
documents or comments received, go to
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3793.
I. Background
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Experimental Study on Consumer
Responses to Whole Grain Labeling
Statements on Food Packages, 21 U.S.C.
393(d)(2)(C)—(OMB Control Number
0910—New)
The Nutrition Labeling and Education
Act (NLEA), which amended the Food,
Drug and Cosmetic Act, requires most
foods to bear nutrition labeling (i.e., the
VerDate Mar<15>2010
20:04 May 25, 2011
Jkt 223001
Nutrition Facts), and requires food
labels that bear nutrient content claims
and certain health messages to comply
with specific requirements. There are
three different types of claims (health
claims, nutrient content claims, and
structure/function claims) that the food
industry can voluntarily use on food
labels. Although they are regulated
differently, they all must be truthful and
not misleading (Ref. 1).
In the past 30 years, whole-grain
consumption has been greatly promoted
by government agencies and scientific
communities as an important part of a
healthy diet (Refs. 2 and 3). For
example, the newly-released ‘‘Dietary
Guidelines for Americans 2010’’
recommends Americans eat fewer
refined grains, and consume more
nutrient-dense whole grains instead
(Ref. 4). At the same time, whole grain
labeling statements, such as ‘‘Made With
Whole Grain,’’ on food products have
also become more prevalent in recent
years (Ref. 5). Given the variety of
whole-grain statements on food
products and the importance of whole
grains in maintaining a healthy diet, it
is important for policy makers to gain a
better understanding of how consumers
interpret these statements.
Several studies indicate that
consumers may have difficulties in
understanding the meaning of whole
grains or recognizing whole-grain foods
(Refs. 6 to 8). Research also suggests
consumer product perceptions and
purchase decisions can be influenced by
labeling statements and different
labeling statements may have different
influences (Refs. 9 and 10). The majority
of existing studies focus on whole grain
intake or the relationships between
whole grain and disease prevention.
There is a lack of systematic
investigation of consumers’
understanding of different whole-grain
labeling statements. We are aware of at
least one existing study related to the
statements (Ref. 11). However, the study
did not compare consumer reactions to
various whole-grain statements.
Therefore, the FDA, as part of its effort
to promote public health, plans to use
the proposed study to explore and
compare consumer responses to food
labels that use whole grains labeling
statements.
Specifically, the study plans to
examine: (1) Consumer judgments about
a food product including its nutritional
attributes, overall healthiness, and
health benefits; (2) consumer judgments
about a label in terms of its credibility
in conveying the product’s nutritional
attributes and its helpfulness in making
product purchasing decisions; (3)
consumer perceptions about differences
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
between different statements, such as
‘‘Made with Whole Grain,’’ ‘‘Contains
Whole Grain,’’ and ‘‘Whole Grain;’’ (4)
consumer extrapolation of whole grain
statements beyond the scope of the
statements themselves (i.e., halo effects);
and (5) how whole grain statements
influence consumer use of the Nutrition
Facts.
The proposed collection of
information is a controlled randomized
experimental study. The study will use
a 15-minute Web-based survey to collect
information from 2,700 Englishspeaking adult members of an online
consumer panel maintained by a
contractor. The study will aim to
produce a sample that reflects the U.S.
Census on gender, education, age, and
ethnicity/race.
The study will randomly assign each
participant to view two label images
from a set of food labels that will be
created for the study and systematically
varied in the: (1) Whole grain labeling
statements; (2) nutritional profiles
(differing by the amount of fiber); (3)
ingredient lists (differing by the ranking
order of whole grain wheat on the list);
and (4) featured product (e.g., bread,
cereal, and breakfast bars). With regard
to claims, the study will focus on
examples of whole grain statements that
can be found on food packages. All label
images will be mock-ups resembling
food labels that may be found in the
marketplace. Images will show product
identity (e.g., bread), but not any real or
fictitious brand name. The study will
provide interested participants access to
the Nutrition Facts, but not together
with a product image.
The survey will ask its participants to
view two label images one at a time and
answer questions about their
perceptions and reactions related to
each of the products and labels. Product
perceptions (e.g., healthiness, potential
health benefits, levels of whole grains
and fiber amount) and label perceptions
(e.g., helpfulness and credibility) will
constitute the measures of responses in
the experiment. To help understand the
data, the survey will also collect
information about participants’
backgrounds, such as consumption,
purchase history, perception, and
familiarity with a category of food;
awareness and knowledge of nutrients
and substances; health literacy; and
health status and demographic
characteristics.
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
whole grains claims and other related
E:\FR\FM\26MYN1.SGM
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Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
labeling statements on food packages
may affect how consumers perceive a
product or a label, 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 one 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
21,600 invitations, each taking 2
minutes (0.033 hour) to complete, will
need to be sent to the consumer panel
to have 2,700 of its members complete
a 15-minute (0.25 hour) questionnaire.
The total for the survey activities is
1,388 hours (713 hours + 675 hours).
Thus, the total estimated burden is
1,506 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
Number of
respondents
Portion of study
Number of
responses
per
respondent
Average
burden
per response
(in hours) 2
Total annual
responses
Total hours
Cognitive interview screener ................................................
Cognitive interview ...............................................................
Pretest invitation ..................................................................
Pretest ..................................................................................
Survey invitation ...................................................................
Survey ..................................................................................
72
9
1,600
200
21,600
2,700
1
1
1
1
1
1
72
9
1,600
200
21,600
2,700
5/60
1
2/60
15/60
2/60
15/60
6
9
53
50
713
675
Total ..............................................................................
........................
........................
........................
........................
1,506
1 There
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
mstockstill on DSK4VPTVN1PROD with NOTICES
II. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20857, under
Docket No. FDA–2011–N–0320 and may
be seen by interested persons between
9 a.m. and 4 p.m., Monday through
Friday. We have verified all 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 https://www.fda.gov/Food/
LabelingNutrition/LabelClaims/
ucm111447.htm.
2. Cleveland, L. E., A.J. Moshfegh, A.M.
Albertson, and J.D. Goldman, ‘‘Dietary
intake of whole grains,’’ Journal of the
American College of Nutrition, 19, 331S–
338S, 2000.
3. Kantor, L. S., J.N. Variyam, J.E. Allshouse,
J.J. Putnam, and B.H. Lin, ‘‘Choose a
variety of grains daily, especially whole
grains: A challenge for consumers,’’
Journal of Nutrition, 131, 473S–486S,
2001.
4. U.S. Department of Agriculture and U.S.
Department of Health and Human
Services. ‘‘Executive Summary of Dietary
Guidelines for Americans, 2010,’’
January 2011, available at https://
www.cnpp.usda.gov/Publications/
DietaryGuidelines/2010/PolicyDoc/
VerDate Mar<15>2010
20:04 May 25, 2011
Jkt 223001
ExecSumm.pdf.
5. Supermarket News, ‘‘Report: Whole Grains
Gain Momentum,’’ September 2010,
available at https://
supermarketnews.com/news/whole_
grains_0917/#.
¨
¨
6. Arvola, A., L.Lahteenmaki, M. Dean, M.
Vassallo, M. Winkelmann, E. Claupein,
A. Saba, and R. Shepherd, ‘‘Consumers’
beliefs about whole and refined grain
products in the UK, Italy and Finland,’’
Journal of Cereal Science, 46, 197–206,
2007.
7. Kantor, L. S., J.N. Variyam, J.E. Allshouse,
J.J. Putnam, and B.H.Lin, ‘‘Choose a
variety of grains daily, especially whole
grains: A challenge for consumers,’’
Journal of Nutrition, 131, 473S–486S,
2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, and
B.Jacob, ‘‘Whole grain health claims in
the U.S.A. and other efforts to increase
whole-grain consumption,’’ Proceedings
of the Nutrition Society, 62, 151–159,
2003.
9. 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.
10. Willis, Josephine M., and K.G. Grunert,
‘‘A Review of Research on Consumer
Response to Nutrition Information on
Food Packaging,’’ 2007.
11. Kellogg Co. ‘‘A Survey of Consumers’
Whole Grain & Fiber Consumption
Behaviors, and the Perception of Whole
Grain Foods as a Source of Dietary
Fiber,’’ 2010. FDA Docket No. 2006–D–
0298, July 2010, available at https://
www.regulations.gov/
#!documentDetail;D=FDA-2006-D-0298-
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
0016.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13060 Filed 5–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0366]
Food and Drug Administration Food
Safety Modernization Act: Focus on
Inspections and Compliance
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘FDA Food
Safety Modernization Act: Focus on
Inspections and Compliance.’’ The
purpose of the public meeting is to
provide interested persons an
opportunity to discuss implementation
of inspections and compliance under
the recently enacted FDA Food Safety
Modernization Act (FSMA). More
specifically, the public will have an
opportunity to provide information and
share views that will inform FDA’s
SUMMARY:
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30725-30727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0320]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study on Consumer Responses to Whole
Grain Labeling Statements on Food Packages
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 Whole Grain Labeling Statements on Food
Packages.''
DATES: Submit either electronic or written comments on the collection
of information by July 25, 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
[[Page 30726]]
docket number found in brackets in the heading of this document. For
access to the docket to read background documents or comments received,
go to https://www.regulations.gov and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3793.
I. Background
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 on Consumer Responses to Whole Grain Labeling
Statements on Food Packages, 21 U.S.C. 393(d)(2)(C)--(OMB Control
Number 0910--New)
The Nutrition Labeling and Education Act (NLEA), which amended the
Food, Drug and Cosmetic Act, requires most foods to bear nutrition
labeling (i.e., the Nutrition Facts), and requires food labels that
bear nutrient content claims and certain health messages to comply with
specific requirements. There are three different types of claims
(health claims, nutrient content claims, and structure/function claims)
that the food industry can voluntarily use on food labels. Although
they are regulated differently, they all must be truthful and not
misleading (Ref. 1).
In the past 30 years, whole-grain consumption has been greatly
promoted by government agencies and scientific communities as an
important part of a healthy diet (Refs. 2 and 3). For example, the
newly-released ``Dietary Guidelines for Americans 2010'' recommends
Americans eat fewer refined grains, and consume more nutrient-dense
whole grains instead (Ref. 4). At the same time, whole grain labeling
statements, such as ``Made With Whole Grain,'' on food products have
also become more prevalent in recent years (Ref. 5). Given the variety
of whole-grain statements on food products and the importance of whole
grains in maintaining a healthy diet, it is important for policy makers
to gain a better understanding of how consumers interpret these
statements.
Several studies indicate that consumers may have difficulties in
understanding the meaning of whole grains or recognizing whole-grain
foods (Refs. 6 to 8). Research also suggests consumer product
perceptions and purchase decisions can be influenced by labeling
statements and different labeling statements may have different
influences (Refs. 9 and 10). The majority of existing studies focus on
whole grain intake or the relationships between whole grain and disease
prevention. There is a lack of systematic investigation of consumers'
understanding of different whole-grain labeling statements. We are
aware of at least one existing study related to the statements (Ref.
11). However, the study did not compare consumer reactions to various
whole-grain statements. Therefore, the FDA, as part of its effort to
promote public health, plans to use the proposed study to explore and
compare consumer responses to food labels that use whole grains
labeling statements.
Specifically, the study plans to examine: (1) Consumer judgments
about a food product including its nutritional attributes, overall
healthiness, and health benefits; (2) consumer judgments about a label
in terms of its credibility in conveying the product's nutritional
attributes and its helpfulness in making product purchasing decisions;
(3) consumer perceptions about differences between different
statements, such as ``Made with Whole Grain,'' ``Contains Whole
Grain,'' and ``Whole Grain;'' (4) consumer extrapolation of whole grain
statements beyond the scope of the statements themselves (i.e., halo
effects); and (5) how whole grain statements influence consumer use of
the Nutrition Facts.
The proposed collection of information is a controlled randomized
experimental study. The study will use a 15-minute Web-based survey to
collect information from 2,700 English-speaking adult members of an
online consumer panel maintained by a contractor. The study will aim to
produce a sample that reflects the U.S. Census on gender, education,
age, and ethnicity/race.
The study will randomly assign each participant to view two label
images from a set of food labels that will be created for the study and
systematically varied in the: (1) Whole grain labeling statements; (2)
nutritional profiles (differing by the amount of fiber); (3) ingredient
lists (differing by the ranking order of whole grain wheat on the
list); and (4) featured product (e.g., bread, cereal, and breakfast
bars). With regard to claims, the study will focus on examples of whole
grain statements that can be found on food packages. All label images
will be mock-ups resembling food labels that may be found in the
marketplace. Images will show product identity (e.g., bread), but not
any real or fictitious brand name. The study will provide interested
participants access to the Nutrition Facts, but not together with a
product image.
The survey will ask its participants to view two label images one
at a time and answer questions about their perceptions and reactions
related to each of the products and labels. Product perceptions (e.g.,
healthiness, potential health benefits, levels of whole grains and
fiber amount) and label perceptions (e.g., helpfulness and credibility)
will constitute the measures of responses in the experiment. To help
understand the data, the survey will also collect information about
participants' backgrounds, such as consumption, purchase history,
perception, and familiarity with a category of food; awareness and
knowledge of nutrients and substances; health literacy; and health
status and demographic characteristics.
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 whole grains claims and other related
[[Page 30727]]
labeling statements on food packages may affect how consumers perceive
a product or a label, 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
one 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 21,600 invitations, each
taking 2 minutes (0.033 hour) to complete, will need to be sent to the
consumer panel to have 2,700 of its members complete a 15-minute (0.25
hour) questionnaire. The total for the survey activities is 1,388 hours
(713 hours + 675 hours). Thus, the total estimated burden is 1,506
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
Portion of study 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............... 21,600 1 21,600 2/60 713
Survey.......................... 2,700 1 2,700 15/60 675
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,506
----------------------------------------------------------------------------------------------------------------
\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857, under Docket No. FDA-2011-N-0320 and may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday. We have verified all 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 https://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.
2. Cleveland, L. E., A.J. Moshfegh, A.M. Albertson, and J.D.
Goldman, ``Dietary intake of whole grains,'' Journal of the American
College of Nutrition, 19, 331S-338S, 2000.
3. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and
B.H. Lin, ``Choose a variety of grains daily, especially whole
grains: A challenge for consumers,'' Journal of Nutrition, 131,
473S-486S, 2001.
4. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. ``Executive Summary of Dietary Guidelines for
Americans, 2010,'' January 2011, available at https://www.cnpp.usda.gov/Publications/DietaryGuidelines/2010/PolicyDoc/ExecSumm.pdf.
5. Supermarket News, ``Report: Whole Grains Gain Momentum,''
September 2010, available at https://supermarketnews.com/news/whole_grains_0917/#.
6. Arvola, A., L.L[auml]hteenm[auml]ki, M. Dean, M. Vassallo, M.
Winkelmann, E. Claupein, A. Saba, and R. Shepherd, ``Consumers'
beliefs about whole and refined grain products in the UK, Italy and
Finland,'' Journal of Cereal Science, 46, 197-206, 2007.
7. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and
B.H.Lin, ``Choose a variety of grains daily, especially whole
grains: A challenge for consumers,'' Journal of Nutrition, 131,
473S-486S, 2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, and B.Jacob, ``Whole grain
health claims in the U.S.A. and other efforts to increase whole-
grain consumption,'' Proceedings of the Nutrition Society, 62, 151-
159, 2003.
9. 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.
10. Willis, Josephine M., and K.G. Grunert, ``A Review of Research
on Consumer Response to Nutrition Information on Food Packaging,''
2007.
11. Kellogg Co. ``A Survey of Consumers' Whole Grain & Fiber
Consumption Behaviors, and the Perception of Whole Grain Foods as a
Source of Dietary Fiber,'' 2010. FDA Docket No. 2006-D-0298, July
2010, available at https://www.regulations.gov/#!documentDetail;D=FDA-2006-D-0298-0016.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13060 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P
