Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts Label Formats, 59553-59554 [E9-27720]
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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
59553
ANNUALIZED SUMMARY TABLE
Number of
respondents
Respondents
Total
responses
Total
annualized hour
burden *
Adolescent .................................................................................................................................
Collateral ....................................................................................................................................
Project Coordinator ....................................................................................................................
Telephone Support Volunteer ....................................................................................................
Social Network Site Moderator ..................................................................................................
Family Program Clinician ...........................................................................................................
Support Services Supervisor .....................................................................................................
200
200
4
8
1
4
1
2,000
5,000
1,204
7,608
53
5,604
37
1,450
910
261
2,766
26.25
1,115
30.25
Total ....................................................................................................................................
418
21,506
6,558.50
Written comments and
recommendations concerning the
proposed information collection should
be sent by December 18, 2009 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: November 12, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–27641 Filed 11–17–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0532]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Nutrition Facts Label Formats
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
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
an experimental study of Nutrition Facts
label formats.
* Total Annualized Hour Burden = Total
Responses × Hours per Response.
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
DATES: Submit written or electronic
comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to 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 (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Experimental Study of Nutrition Facts
Label Formats—(Section 903(d)(2)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(C))) (OMB
Control Number 0910–NEW)
I. Description
Nutrition information is required on
most packaged foods and this
information must be provided in a
specific format as defined in 21 CFR
101. 9. When FDA was determining
which Nutrition Facts label format to
require, the agency undertook consumer
research to evaluate alternatives (Refs. 1,
2, and 3). More recently, FDA
conducted qualitative consumer
research on the format of the Nutrition
Facts label on behalf of the agency’s
Obesity Working Group (OWG) (Ref. 4),
which was formed in 2003 and tasked
with outlining a plan to help confront
the problem of obesity in the United
States (Ref. 5). In addition to conducting
consumer research, in response to the
OWG plan FDA issued two Advance
Notices of Proposed Rulemaking
(ANPRM) requesting comments on
format changes to the Nutrition Facts
label. One ANPRM requested comments
on whether and, if so, how to give
greater emphasis to calories on the
Nutrition Facts label (Ref. 6) and the
other requested comments on whether
and, if so, how to amend the agency’s
serving size regulations (Ref. 7). In 2007,
FDA issued an ANPRM requesting
comments on whether the agency
should require that certain nutrients be
added or removed from the Nutrition
Facts label (Ref. 8).
E:\FR\FM\18NON1.SGM
18NON1
59554
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
FDA conducts consumer research
under its broad statutory authority, set
forth in section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (the act),
to protect the public health by ensuring
that foods are ‘‘safe, wholesome,
sanitary, and properly labeled,’’ and in
section 903(d)(2)(C) of the act, to
conduct research relating to foods,
drugs, cosmetics, and devices in
carrying out the act.
FDA is proposing to conduct an
experimental study to quantitatively
assess consumer reactions to potential
options for modifying the Nutrition
Facts label format. The purpose of the
study is to help enhance FDA’s
understanding of consumer
comprehension and acceptance of
modifications to the Nutrition Facts
label format. The study is part of the
agency’s continuing effort to enable
consumers to make informed dietary
choices and construct healthful diets.
The proposed study will use a Webbased experiment to collect information
from a sample of adult members in an
online consumer panel established by a
contractor. The study plans to randomly
assign each of 3,600 participants to view
Nutrition Facts labels from a set of
Nutrition Facts labels that vary by the
format, the type of food product, and the
quality of nutritional attributes of the
product. The study will focus on the
following types of consumer reactions:
(1) Judgments about a food product in
terms of its nutritional attributes and
overall healthfulness and (2) ability to
use the Nutrition Facts label to, for
example, calculate calories and estimate
serving sizes needed to meet objectives.
To help understand consumer reactions,
the study will also collect information
on participants’ background, including
but not limited to use of the Nutrition
Facts label and health status.
The study results will be used to help
the agency to understand whether
modifications to the Nutrition Facts
label format could help consumers to
make informed food choices. The results
of the experimental study will not be
used to develop population estimates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Portion of Study
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Cognitive interview screener
96
1
96
0.083
8
Cognitive interview
12
1
12
1
12
1,000
1
1,000
0.033
33
150
1
150
0.20
30
24,000
1
24,000
0.033
792
3,600
1
3,600
0.20
720
Pretest invitation
Pretest
Experiment invitation
Experiment
Total
mstockstill on DSKH9S0YB1PROD with NOTICES
1There
1,595
are no capital costs or operating and maintenance costs associated with this collection of information.
To help design and refine the
questionnaire to be used for the
experimental study, we plan to conduct
cognitive interviews by screening 96
adult consumers in order to obtain 12
participants in the interviews. Each
screening is expected to take 5 minutes
(0.083 hours) and each cognitive
interview is expected to take 1 hour.
The total for cognitive interview
activities is 20 hours (8 hours + 12
hours). Subsequently, we plan to
conduct pretests of the questionnaire
before it is administered in the study.
We expect that 1,000 invitations, each
taking 2 minutes (0.033 hours), will
need to be sent to adult members of an
online consumer panel to have 150 of
them complete a 12-minute (0.20 hours)
pretest. The total for the pretest
activities is 63 hours (33 hours + 30
hours). For the experiment, we estimate
that 24,000 invitations, each taking 2
minutes (0.033 hours), will need to be
sent to adult members of an online
consumer panel to have 3,600 of them
complete a 12-minute (0.20 hours)
questionnaire. The total for the
experiment activities is 1,512 hours (792
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
hours + 720 hours). Thus, the total
estimated burden is 1,595 hours. FDA’s
burden estimate is based on prior
experience with research that is similar
to this proposed study.
II. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Levy A., S. Fein, and R. Schucker,
‘‘Nutrition Labeling Formats: Performance
and Preference,’’ Food Technology, 45: 116–
121, 1991.
2. Levy A., S. Fein, and R. Schucker, ‘‘More
Effective Nutrition Label Formats Are Not
Necessarily Preferred,’’ Journal of the
American Dietetic Association, 92: 1230–
1234, 1992.
3. Levy A., S. Fein, and R. Schucker,
‘‘Performance Characteristics of Seven
Nutrition Label Formats,’’ Journal of Public
Policy and Marketing, 15: 1–15, 1996.
4. Lando A. and J. Labiner-Wolfe, ‘‘Helping
Consumers to Make More Healthful Food
Choices: Consumer Views on Modifying
Food Labels and Providing Point-of-Purchase
Nutrition Information at Quick-Service
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 (https://www.fda.gov/Food/
LabelingNutrition/ReportsResearch/
ucm081696.htm).
6. 70 FR 17008, April 4, 2005.
7. 70 FR 17010, April 4, 2005.
8. 72 FR 62149, November 2, 2007.
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27720 Filed 11–17–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59553-59554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27720]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0532]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Nutrition Facts Label Formats
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on an experimental study of Nutrition Facts
label formats.
DATES: Submit written or electronic comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to 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 (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study of Nutrition Facts Label Formats--(Section
903(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)(C))) (OMB Control Number 0910-NEW)
I. Description
Nutrition information is required on most packaged foods and this
information must be provided in a specific format as defined in 21 CFR
101. 9. When FDA was determining which Nutrition Facts label format to
require, the agency undertook consumer research to evaluate
alternatives (Refs. 1, 2, and 3). More recently, FDA conducted
qualitative consumer research on the format of the Nutrition Facts
label on behalf of the agency's Obesity Working Group (OWG) (Ref. 4),
which was formed in 2003 and tasked with outlining a plan to help
confront the problem of obesity in the United States (Ref. 5). In
addition to conducting consumer research, in response to the OWG plan
FDA issued two Advance Notices of Proposed Rulemaking (ANPRM)
requesting comments on format changes to the Nutrition Facts label. One
ANPRM requested comments on whether and, if so, how to give greater
emphasis to calories on the Nutrition Facts label (Ref. 6) and the
other requested comments on whether and, if so, how to amend the
agency's serving size regulations (Ref. 7). In 2007, FDA issued an
ANPRM requesting comments on whether the agency should require that
certain nutrients be added or removed from the Nutrition Facts label
(Ref. 8).
[[Page 59554]]
FDA conducts consumer research under its broad statutory authority,
set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic
Act (the act), to protect the public health by ensuring that foods are
``safe, wholesome, sanitary, and properly labeled,'' and in section
903(d)(2)(C) of the act, to conduct research relating to foods, drugs,
cosmetics, and devices in carrying out the act.
FDA is proposing to conduct an experimental study to quantitatively
assess consumer reactions to potential options for modifying the
Nutrition Facts label format. The purpose of the study is to help
enhance FDA's understanding of consumer comprehension and acceptance of
modifications to the Nutrition Facts label format. The study is part of
the agency's continuing effort to enable consumers to make informed
dietary choices and construct healthful diets.
The proposed study will use a Web-based experiment to collect
information from a sample of adult members in an online consumer panel
established by a contractor. The study plans to randomly assign each of
3,600 participants to view Nutrition Facts labels from a set of
Nutrition Facts labels that vary by the format, the type of food
product, and the quality of nutritional attributes of the product. The
study will focus on the following types of consumer reactions: (1)
Judgments about a food product in terms of its nutritional attributes
and overall healthfulness and (2) ability to use the Nutrition Facts
label to, for example, calculate calories and estimate serving sizes
needed to meet objectives. To help understand consumer reactions, the
study will also collect information on participants' background,
including but not limited to use of the Nutrition Facts label and
health status.
The study results will be used to help the agency to understand
whether modifications to the Nutrition Facts label format could help
consumers to make informed food choices. The results of the
experimental study will not be used to develop population estimates.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Portion of Study Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener 96 1 96 0.083 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview 12 1 12 1 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest invitation 1,000 1 1,000 0.033 33
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 150 1 150 0.20 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experiment invitation 24,000 1 24,000 0.033 792
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experiment 3,600 1 3,600 0.20 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 1,595
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
To help design and refine the questionnaire to be used for the
experimental study, we plan to conduct cognitive interviews by
screening 96 adult consumers in order to obtain 12 participants in the
interviews. Each screening is expected to take 5 minutes (0.083 hours)
and each cognitive interview is expected to take 1 hour. The total for
cognitive interview activities is 20 hours (8 hours + 12 hours).
Subsequently, we plan to conduct pretests of the questionnaire before
it is administered in the study. We expect that 1,000 invitations, each
taking 2 minutes (0.033 hours), will need to be sent to adult members
of an online consumer panel to have 150 of them complete a 12-minute
(0.20 hours) pretest. The total for the pretest activities is 63 hours
(33 hours + 30 hours). For the experiment, we estimate that 24,000
invitations, each taking 2 minutes (0.033 hours), will need to be sent
to adult members of an online consumer panel to have 3,600 of them
complete a 12-minute (0.20 hours) questionnaire. The total for the
experiment activities is 1,512 hours (792 hours + 720 hours). Thus, the
total estimated burden is 1,595 hours. FDA's burden estimate is based
on prior experience with research that is similar to this proposed
study.
II. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Levy A., S. Fein, and R. Schucker, ``Nutrition Labeling
Formats: Performance and Preference,'' Food Technology, 45: 116-121,
1991.
2. Levy A., S. Fein, and R. Schucker, ``More Effective Nutrition
Label Formats Are Not Necessarily Preferred,'' Journal of the
American Dietetic Association, 92: 1230-1234, 1992.
3. Levy A., S. Fein, and R. Schucker, ``Performance
Characteristics of Seven Nutrition Label Formats,'' Journal of
Public Policy and Marketing, 15: 1-15, 1996.
4. Lando A. and J. Labiner-Wolfe, ``Helping Consumers to Make
More Healthful Food Choices: Consumer Views on Modifying Food Labels
and Providing Point-of-Purchase Nutrition Information at Quick-
Service Restaurants,'' Journal of Nutrition Education and Behavior,
39: 157-163, 2007.
5. U.S. Food and Drug Administration, Calories Count: Report of
the Working Group on Obesity, 2004 (https://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm).
6. 70 FR 17008, April 4, 2005.
7. 70 FR 17010, April 4, 2005.
8. 72 FR 62149, November 2, 2007.
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27720 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S
