Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel, 10220-10222 [E7-3904]
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10220
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices
Dated: February 28, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–3986 Filed 3–6–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Statement of Organization, Functions
and Delegation of Authority;
Republication
Editorial Note: FR Doc. E7–3306 originally
published at page 8742 in the issue of
Tuesday, February 27, 2007. The original
publication contained erroneous text. As a
result, the corrected document is being
republished in its entirety.
Notice is hereby given that I have
delegated to the Director, Office of Head
Start, the following authority vested in
me by the Secretary of Health and
Human Services in a memorandum
dated August 20, 1991, pertaining to the
Head Start Program and the Child
Development Associate Scholarship
Assistance Grants Program.
(a) Authority Delegated
Authority to administer the Head
Start Program under the Head Start Act,
42 U.S.C. 9801 et seq., and as amended
now and hereafter. (This includes
authority to administer the Early Head
Start program.)
sroberts on PROD1PC70 with NOTICES
(b) Limitations
1. This delegation of authority shall
be exercised under the Department’s
existing policies on delegations and
regulations.
2. This delegation of authority does
not include the authority to submit
reports to Congress and shall be
exercised under financial and
administrative requirements applicable
to all Administration for Children and
Families’ authorities.
3. The approval or disapproval of
grant applications including refunding
applications, the making of grant
awards, the waiver of non-Federal share
under 42 U.S.C. 9835(b), the waiver of
fifteen percent administrative cost
limitations under 42 U.S.C. 9839(b), and
the approval of interim grantees under
42 U.S.C. 9836(e) requires concurrence
of the appropriate Grants Officer. The
approval or disapproval of contract
proposals and awards is subject to the
requirements of the Federal Acquisition
Regulations and requires the
concurrence of the Contracting Officer.
VerDate Aug<31>2005
18:25 Mar 06, 2007
Jkt 211001
4. This delegation of authority does
not include the authority to approve or
disapprove awards for grants or
contracts for research, demonstration, or
evaluation under section 649 of the
Head Start Act.
5. This delegation of authority does
not include the authority to appoint
Central Office or Regional Office Grant
Officers for the administration of the
Head Start Program.
6. This delegation of authority does
not include the authority to appoint
Action Officials for Audit Resolution.
7. This delegation of authority does
not include the authority to sign and
issue notices of grant awards.
8. This delegation of authority does
not include the authority to hold
hearings. This limitation does not
include the ‘‘informal meetings’’
authorized in 45 CFR part 1303.
9. Any redelegation shall be in writing
and prompt notification must be
provided to all affected managers,
supervisors, and other personnel, and
requires the concurrence of the Deputy
Assistant Secretary for Administration.
(c) Effect on Existing Delegations
As related to this delegation of
authority, this delegation supersedes all
previous delegations of authority
involving the Head Start Program except
the September 25, 2002, delegation to
the Director, Office of Planning,
Research and Evaluation relating to
section 649 of the Head Start Act.
(d) Effective Date
This delegation is effective upon the
date of signature.
I hereby affirm and ratify any actions
taken by the Director, Office of Head
Start, which involved the exercise of the
authority delegated herein prior to the
effective date of this delegation.
Dated: February 16, 2007.
Wade F. Horn,
Assistant Secretary for Children and Families.
[FR Doc. E7–3306 Filed 2–26–07; 8:45 am]
Editorial Note: FR Doc. E7–3306 originally
published at page 8742 in the issue of
Tuesday, February 27, 2007. The original
publication contained erroneous text. As a
result, the corrected document is being
republished in its entirety.
[FR Doc. R7–3306 Filed 3–6–07; 8:45 am]
BILLING CODE 1505–01–D
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0036]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Possible Footnotes and
Cueing Schemes to Help Consumers
Interpret Quantitative Trans Fat
Disclosure on the Nutrition Facts Panel
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: 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.
Fax written comments on the
collection of information by April 6,
2007.
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:
202–395–6974.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. In the Federal
Register of December 18, 2006 (71 FR
75762), FDA published a notice entitled
‘‘Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental Study
of Possible Footnotes and Cueing
Schemes to Help Consumers Interpret
Quantitative Trans Fat Disclosure on the
Nutrition Facts Panel.’’ This notice
contained an incorrect deadline for
comments on the proposed collection of
information in the DATES section. FDA
is republishing the notice and providing
a full 30-day comment period. Any
comments previously submitted
regarding this notice will be considered
and do not need to be re-submitted.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07MRN1.SGM
07MRN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices
Experimental Study of Possible
Footnotes and Cueing Schemes to Help
Consumers Interpret Quantitative
Trans Fat Disclosure on the Nutrition
Facts Panel—(OMB Control Number
0910–0532)—Reinstatement
FDA is requesting OMB approval of
an experimental study of possible
footnotes and cueing schemes intended
to help consumers interpret quantitative
trans fat information on the Nutrition
Facts Panel (NFP) of a food product. The
purpose of the experimental study is to
help FDA’s Center for Food Safety and
Applied Nutrition formulate decisions
and policies affecting labeling
requirements for trans fat disclosure.
In the Federal Register of July 11,
2003 (68 FR 41434), FDA issued a final
rule requiring disclosure on the NFP of
quantitative trans fat information on a
separate line without any accompanying
footnote. At the same time, the agency
issued an advance notice of proposed
rulemaking entitled ‘‘Food Labeling:
Trans Fatty Acids in Nutrition Labeling;
Consumer Research to Consider
Nutrient Content and Health Claims and
Possible Footnote or Disclosure
Statements’’ (68 FR 41507) which
requested comments about possible
footnotes to help consumers better
understand trans fat declarations on the
product label. The agency sought
comments about whether it should
consider requiring statements about
trans fat, either alone or in combination
with saturated fat and cholesterol, as a
footnote on the NFP to enhance
consumers’ understanding about such
cholesterol-raising lipids and how to
use information on the label to make
healthy food choices. Comments
received in response to the notice
contained suggested footnotes and
cueing schemes. The proposed
experimental study will evaluate the
ability of several possible footnotes and
cueing schemes to help consumers make
heart-healthy food choices. The results
of the experimental study will provide
empirical support for possible policy
decisions about the need for such
requirements and the appropriate form
they should take.
FDA or its contractor will use
information gathered from Internet
panel samples to evaluate how
consumers understand and respond to
possible footnote and cueing schemes.
The distinctive features of Internet
panels for the purpose of the
experimental study are that they allow
for controlled visual presentation of
study materials, experimental
manipulation of study materials, and
the random assignment of subjects to
condition. Experimental manipulation
VerDate Aug<31>2005
18:25 Mar 06, 2007
Jkt 211001
of labels and random assignment to
condition makes it possible to estimate
the effects of the various possible
footnotes and cueing schemes while
controlling for individual differences
between subjects. Random assignment
ensures that mean differences between
conditions can be tested using wellknown techniques such as analysis of
variance or regression analysis to yield
statistically valid estimates of effect
size. The study will be conducted using
a convenience sample drawn from a
large, national consumer panel of about
one million households.
Participants will be adults, age 18 and
older, who are recruited for a study
about foods and food labels. Each
participant will be randomly assigned to
1 of the 54 experimental conditions
derived from fully crossing 8 possible
footnotes/cueing schemes, 3 product
types, and 2 prior knowledge
conditions.
FDA will use the information from the
experimental study to evaluate
regulatory and policy options. The
agency often lacks empirical data about
how consumers understand and
respond to statements they might see in
product labeling. The information
gathered from this experimental study
will be used to estimate consumer
comprehension and the behavioral
impact of various footnotes and cueing
schemes intended to help consumers
better understand quantitative trans fat
information.
The experimental study data will be
collected using participants of an
Internet panel of approximately one
million people. Participation in the
experimental study is voluntary.
In the Federal Register of February 6,
2006 (71 FR 6079), FDA published a 60day notice requesting public comment
on the information collection that will
take place as part of the experimental
study. FDA received two letters in
response to the notice, each containing
multiple comments.
(Comment 1) One comment stated
that the organization concurs with the
objectives of the study and believes the
information from this study will be
useful to FDA in developing labeling
policy to assist consumers with
interpretation of trans fat claims in food
labeling. Another comment expressed
concern that the NFP of only one of the
three product pairs (margarine) showed
polyunsaturated fat and
monounsaturated fat content and
recommended that the NFPs for all three
products tested in the study show the
fuller fat profile.
(Response) FDA disagrees with the
recommendation that the NFPs for all
three products tested in the study
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
10221
disclose a fuller fat profile. Most NFPs
do not include the optional
polyunsaturated fat and
monounsaturated fat content. Typically,
this information is disclosed on NFPs
for products that are entirely or largely
composed of fat (e.g., butter, margarine,
and cooking oils). In these cases, the fat
profile may be shown in greater detail
because consumers may use this
information to select among alternative
food products. The NFPs for the product
pairs tested in the study are consistent
with actual donut, margarine, and
frozen lasagna labels. Because the
recommended change would limit
products tested in the study to those
such as butter, margarine, and cooking
oils, FDA will retain the NFPs as
proposed.
(Comment 2) One comment suggested
that the NFPs should not reflect
rounding, to minimize potential
consumer confusion. The comment
specifically recommended that FDA edit
the study NFPs containing declarations
of polyunsaturated and
monounsaturated fats (i.e., for the
margarine product pair) to declare total
fat grams in an amount equal to the sum
of the four listed fatty acids.
(Response) FDA agrees that for the
margarine labels, which include the four
fatty acids under total fat, the fatty acids
gram (g) amounts declared should add
up to the total fat gram amount to avoid
raising questions or distracting the
participants in the margarine
conditions. We made the requested
change.
(Comment 3) One comment suggested
that, for the margarine labels, FDA
should edit the polyunsaturated and
monounsaturated values to be as equal
as possible in the product pairings to
ensure that the focus is on the saturated
fat and trans fat content.
(Response) FDA disagrees with the
suggested change to the NFPs for the
margarine product pairs. In order to
keep the values for the polyunsaturated
and monounsaturated fats identical in
the margarine pairs, the saturated fat
content would become unrealistically
high in one label because it is the only
fat component that could increase when
trans fat equals zero. FDA will retain the
NFPs as proposed.
(Comment 4) One comment noted that
only one of the NFPs for the three
products tested in the study showed
some cholesterol present in the product;
the other two products disclosed
cholesterol as zero. In particular, the
comment identified lasagna as unlikely
to contain 0 milligrams of cholesterol.
(Response) FDA agrees that zero
cholesterol is not likely to be a realistic
amount of cholesterol disclosed on a
E:\FR\FM\07MRN1.SGM
07MRN1
10222
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices
NFP for a lasagna product and has
revised the NFPs for the lasagna pairs.
In addition, FDA changed a product
category from cookies to donuts edited
and the NFPs for the new donut product
pair to add a disclosure of cholesterol.
(Comment 5) One comment critiqued
the draft Full Information treatment
language. The comment criticized the
one-page summary because: (1) It did
not identify calories in the discussion of
fat as a major source of energy and (2)
it did not relate the calorie contribution
of fat to that of carbohydrates and
protein. The comment also criticized the
information about sources of trans fat
because it omitted mention of natural
sources of trans fat in the diet, which
the comment suggested would help
ensure factually correct and balanced
information about sources of trans in the
diet. The comment questioned the value
of stating that trans fat extends shelflife
and has desirable taste characteristics
since many saturated fat sources are
relatively shelf stable and have desirable
taste characteristics.
(Response) FDA agrees and has
revised the Full Information treatment
in response to these concerns. Calories
and other sources of energy are now
mentioned in the introductory passage.
Natural sources of trans fat are now
mentioned and the similarity between
trans fat and saturated fat in terms of
shelflife and taste are now addressed.
The revised draft will be included in the
study pretest and further revisions will
be made if FDA determines they are
needed based upon pretest results.
(Comment 6) One comment suggested
consumer confusion may be caused
when a NFP for a product discloses 0g
of trans fat but the ingredient list
discloses an ingredient that contains
trans fat, as is permitted by the trans fat
labeling regulations. The comment
concluded that FDA should add
experimental conditions in which this
occurs. The comment suggested that for
this situation the study should test
language for a footnote to the ingredient
list to explain that there may be a trans
fat ingredient in the product when the
NFP shows trans fat as zero.
(Response) FDA disagrees with the
proposed addition to the study’s
experimental conditions. Under existing
trans fat labeling regulations, food
manufacturers are allowed to list
amounts of trans fat less than 0.5 g per
serving as zero on the NFP. While such
situations occur in the marketplace and
are permitted by the trans fat labeling
regulations, whether this causes
consumer confusion is an issue outside
the scope of the proposed research,
which focuses on the effects of NFP
footnotes and alternative presentations
of trans fat information in the NFP on
consumers’ ability to correctly identify
more healthful food products. The
Office of Nutritional Products, Labeling,
and Dietary Supplements has received
and responded to a separate letter on
this topic from the commenter.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
40
1
40
.25
10
3,240
Study
1
3,240
.25
810
Total
820
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 28, 2007.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E7–3904 Filed 3–6–07; 8:45 am]
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by April 6,
2007.
DATES:
BILLING CODE 4160–01–S
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:
202–395–6974.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0357]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Total Hours
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
VerDate Aug<31>2005
18:25 Mar 06, 2007
Jkt 211001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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:
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—21 CFR Part 123
(OMB Control Number 0910–0354)—
Extension
FDA regulations in part 123 (21 CFR
part 123) mandate the application of
hazard analysis and critical control
point (HACCP) principles to the
processing of seafood. HACCP is a
preventive system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety, including section
402(a)(1) and (a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (a)(4)), and became
effective on December 18, 1997.
Certain provisions in part 123 require
that processors and importers of seafood
collect and record information. The
HACCP records compiled and
maintained by a seafood processor
primarily consist of the periodic
observations recorded at selected
monitoring points during processing
and packaging operations, as called for
in a processor’s HACCP plan (e.g., the
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 72, Number 44 (Wednesday, March 7, 2007)]
[Notices]
[Pages 10220-10222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0036]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Possible Footnotes and Cueing Schemes to Help Consumers Interpret
Quantitative Trans Fat Disclosure on the Nutrition Facts Panel
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Fax written comments on the collection of information by April
6, 2007.
ADDRESSES: 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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. In the Federal Register of December 18, 2006 (71
FR 75762), FDA published a notice entitled ``Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Experimental Study of Possible Footnotes and
Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat
Disclosure on the Nutrition Facts Panel.'' This notice contained an
incorrect deadline for comments on the proposed collection of
information in the DATES section. FDA is republishing the notice and
providing a full 30-day comment period. Any comments previously
submitted regarding this notice will be considered and do not need to
be re-submitted.
[[Page 10221]]
Experimental Study of Possible Footnotes and Cueing Schemes to Help
Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition
Facts Panel--(OMB Control Number 0910-0532)--Reinstatement
FDA is requesting OMB approval of an experimental study of possible
footnotes and cueing schemes intended to help consumers interpret
quantitative trans fat information on the Nutrition Facts Panel (NFP)
of a food product. The purpose of the experimental study is to help
FDA's Center for Food Safety and Applied Nutrition formulate decisions
and policies affecting labeling requirements for trans fat disclosure.
In the Federal Register of July 11, 2003 (68 FR 41434), FDA issued
a final rule requiring disclosure on the NFP of quantitative trans fat
information on a separate line without any accompanying footnote. At
the same time, the agency issued an advance notice of proposed
rulemaking entitled ``Food Labeling: Trans Fatty Acids in Nutrition
Labeling; Consumer Research to Consider Nutrient Content and Health
Claims and Possible Footnote or Disclosure Statements'' (68 FR 41507)
which requested comments about possible footnotes to help consumers
better understand trans fat declarations on the product label. The
agency sought comments about whether it should consider requiring
statements about trans fat, either alone or in combination with
saturated fat and cholesterol, as a footnote on the NFP to enhance
consumers' understanding about such cholesterol-raising lipids and how
to use information on the label to make healthy food choices. Comments
received in response to the notice contained suggested footnotes and
cueing schemes. The proposed experimental study will evaluate the
ability of several possible footnotes and cueing schemes to help
consumers make heart-healthy food choices. The results of the
experimental study will provide empirical support for possible policy
decisions about the need for such requirements and the appropriate form
they should take.
FDA or its contractor will use information gathered from Internet
panel samples to evaluate how consumers understand and respond to
possible footnote and cueing schemes. The distinctive features of
Internet panels for the purpose of the experimental study are that they
allow for controlled visual presentation of study materials,
experimental manipulation of study materials, and the random assignment
of subjects to condition. Experimental manipulation of labels and
random assignment to condition makes it possible to estimate the
effects of the various possible footnotes and cueing schemes while
controlling for individual differences between subjects. Random
assignment ensures that mean differences between conditions can be
tested using well-known techniques such as analysis of variance or
regression analysis to yield statistically valid estimates of effect
size. The study will be conducted using a convenience sample drawn from
a large, national consumer panel of about one million households.
Participants will be adults, age 18 and older, who are recruited
for a study about foods and food labels. Each participant will be
randomly assigned to 1 of the 54 experimental conditions derived from
fully crossing 8 possible footnotes/cueing schemes, 3 product types,
and 2 prior knowledge conditions.
FDA will use the information from the experimental study to
evaluate regulatory and policy options. The agency often lacks
empirical data about how consumers understand and respond to statements
they might see in product labeling. The information gathered from this
experimental study will be used to estimate consumer comprehension and
the behavioral impact of various footnotes and cueing schemes intended
to help consumers better understand quantitative trans fat information.
The experimental study data will be collected using participants of
an Internet panel of approximately one million people. Participation in
the experimental study is voluntary.
In the Federal Register of February 6, 2006 (71 FR 6079), FDA
published a 60-day notice requesting public comment on the information
collection that will take place as part of the experimental study. FDA
received two letters in response to the notice, each containing
multiple comments.
(Comment 1) One comment stated that the organization concurs with
the objectives of the study and believes the information from this
study will be useful to FDA in developing labeling policy to assist
consumers with interpretation of trans fat claims in food labeling.
Another comment expressed concern that the NFP of only one of the three
product pairs (margarine) showed polyunsaturated fat and
monounsaturated fat content and recommended that the NFPs for all three
products tested in the study show the fuller fat profile.
(Response) FDA disagrees with the recommendation that the NFPs for
all three products tested in the study disclose a fuller fat profile.
Most NFPs do not include the optional polyunsaturated fat and
monounsaturated fat content. Typically, this information is disclosed
on NFPs for products that are entirely or largely composed of fat
(e.g., butter, margarine, and cooking oils). In these cases, the fat
profile may be shown in greater detail because consumers may use this
information to select among alternative food products. The NFPs for the
product pairs tested in the study are consistent with actual donut,
margarine, and frozen lasagna labels. Because the recommended change
would limit products tested in the study to those such as butter,
margarine, and cooking oils, FDA will retain the NFPs as proposed.
(Comment 2) One comment suggested that the NFPs should not reflect
rounding, to minimize potential consumer confusion. The comment
specifically recommended that FDA edit the study NFPs containing
declarations of polyunsaturated and monounsaturated fats (i.e., for the
margarine product pair) to declare total fat grams in an amount equal
to the sum of the four listed fatty acids.
(Response) FDA agrees that for the margarine labels, which include
the four fatty acids under total fat, the fatty acids gram (g) amounts
declared should add up to the total fat gram amount to avoid raising
questions or distracting the participants in the margarine conditions.
We made the requested change.
(Comment 3) One comment suggested that, for the margarine labels,
FDA should edit the polyunsaturated and monounsaturated values to be as
equal as possible in the product pairings to ensure that the focus is
on the saturated fat and trans fat content.
(Response) FDA disagrees with the suggested change to the NFPs for
the margarine product pairs. In order to keep the values for the
polyunsaturated and monounsaturated fats identical in the margarine
pairs, the saturated fat content would become unrealistically high in
one label because it is the only fat component that could increase when
trans fat equals zero. FDA will retain the NFPs as proposed.
(Comment 4) One comment noted that only one of the NFPs for the
three products tested in the study showed some cholesterol present in
the product; the other two products disclosed cholesterol as zero. In
particular, the comment identified lasagna as unlikely to contain 0
milligrams of cholesterol.
(Response) FDA agrees that zero cholesterol is not likely to be a
realistic amount of cholesterol disclosed on a
[[Page 10222]]
NFP for a lasagna product and has revised the NFPs for the lasagna
pairs. In addition, FDA changed a product category from cookies to
donuts edited and the NFPs for the new donut product pair to add a
disclosure of cholesterol.
(Comment 5) One comment critiqued the draft Full Information
treatment language. The comment criticized the one-page summary
because: (1) It did not identify calories in the discussion of fat as a
major source of energy and (2) it did not relate the calorie
contribution of fat to that of carbohydrates and protein. The comment
also criticized the information about sources of trans fat because it
omitted mention of natural sources of trans fat in the diet, which the
comment suggested would help ensure factually correct and balanced
information about sources of trans in the diet. The comment questioned
the value of stating that trans fat extends shelflife and has desirable
taste characteristics since many saturated fat sources are relatively
shelf stable and have desirable taste characteristics.
(Response) FDA agrees and has revised the Full Information
treatment in response to these concerns. Calories and other sources of
energy are now mentioned in the introductory passage. Natural sources
of trans fat are now mentioned and the similarity between trans fat and
saturated fat in terms of shelflife and taste are now addressed. The
revised draft will be included in the study pretest and further
revisions will be made if FDA determines they are needed based upon
pretest results.
(Comment 6) One comment suggested consumer confusion may be caused
when a NFP for a product discloses 0g of trans fat but the ingredient
list discloses an ingredient that contains trans fat, as is permitted
by the trans fat labeling regulations. The comment concluded that FDA
should add experimental conditions in which this occurs. The comment
suggested that for this situation the study should test language for a
footnote to the ingredient list to explain that there may be a trans
fat ingredient in the product when the NFP shows trans fat as zero.
(Response) FDA disagrees with the proposed addition to the study's
experimental conditions. Under existing trans fat labeling regulations,
food manufacturers are allowed to list amounts of trans fat less than
0.5 g per serving as zero on the NFP. While such situations occur in
the marketplace and are permitted by the trans fat labeling
regulations, whether this causes consumer confusion is an issue outside
the scope of the proposed research, which focuses on the effects of NFP
footnotes and alternative presentations of trans fat information in the
NFP on consumers' ability to correctly identify more healthful food
products. The Office of Nutritional Products, Labeling, and Dietary
Supplements has received and responded to a separate letter on this
topic from the commenter.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Pretest 40 1 40 .25 10
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Study 3,240 1 3,240 .25 810
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Total 820
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 28, 2007.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E7-3904 Filed 3-6-07; 8:45 am]
BILLING CODE 4160-01-S
