Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods, 48988-48989 [2012-19991]
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48988
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
Dated: August 10, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–20051 Filed 8–14–12; 8:45 am]
BILLING CODE 4120–01–P
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.
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 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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
17:49 Aug 14, 2012
Jkt 226001
‘‘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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 15minute Web-based questionnaire to
collect information from 4,000 Englishspeaking 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,
E:\FR\FM\15AUN1.SGM
15AUN1
48989
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
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
Activity
Number of
respondents
Number of
Responses
per
respondent
Total annual
responses
Average burden per response
Study 1 Cognitive interview screener .........
Study 2 Cognitive interview screener .........
Study 1 Cognitive interview .........................
Study 2 Cognitive interview .........................
Study 1 Pretest invitation ............................
Study 2 Pretest invitation ............................
Study 1 Pretest ............................................
Study 2 Pretest ............................................
Study 1 Survey invitation ............................
Study 2 Survey invitation ............................
Study 1 Survey ............................................
Study 2 Survey ............................................
Total .....................................................
75
75
9
9
1,600
800
200
100
32,000
8,000
4,000
1,000
........................
1
1
1
1
1
1
1
1
1
1
1
1
........................
75
75
9
9
1,600
800
200
100
32,000
8,000
4,000
1,000
........................
0.083 (5 minutes) ...................
0.083 (5 minutes) ...................
1 hour (60 minutes) ...............
1 hour (60 minutes) ...............
0.033 (2 minutes) ...................
0.033 (2 minutes) ...................
0.25 (15 minutes) ...................
0.25 (15 minutes) ...................
0.033 (2 minutes) ...................
0.033 (2 minutes) ...................
0.25 (15 minutes) ...................
0.25 (15 minutes) ...................
................................................
1 There
6
6
9
9
53
26
50
25
1,056
264
1,000
250
2,754
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.)
srobinson on DSK4SPTVN1PROD with NOTICES
Total hours
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. 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 https://www.amsreview.org/articles/
drichoutis09-2006.pdf.
¨
¨
3. Lahteenmaki, 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.
VerDate Mar<15>2010
17:49 Aug 14, 2012
Jkt 226001
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0849]
Draft Guidance for Industry on Suicidal
Ideation and Behavior: Prospective
Assessment of Occurrence in Clinical
Trials; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Suicidal Ideation and
Behavior: Prospective Assessment of
Occurrence in Clinical Trials.’’ The
purpose of this guidance is to assist
sponsors in prospectively assessing the
occurrence of treatment-emergent
suicidal ideation and behavior in
clinical trials of drug and biological
products, including drugs for
psychiatric and nonpsychiatric
indications. This guidance revises and
replaces a previous draft guidance
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48988-48989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19991]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of Responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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
https://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
