Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Experimental Study of Trans Fat Claims on Foods, 6076-6077 [E6-1517]
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6076
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1516 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Proposed
Experimental Study of Trans Fat
Claims on Foods
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES1
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, including each proposed
reinstatement of an existing collection
of information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a proposed experimental study of trans
fat claims on foods to evaluate the
effects of various possible disclosure
requirements intended to help
consumers understand and apply trans
fat claims they might see on food
products. The proposed experimental
study will estimate the communication
effectiveness of these disclosure
requirements in realistic label usage
situations for a range of products that
may bear trans fat claims.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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.
VerDate Aug<31>2005
14:55 Feb 03, 2006
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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,
including each proposed reinstatement
of an existing 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.
Proposed Experimental Study of Trans
Fat Claims on Foods (OMB Control
Number 0910–0533)—Reinstatement
FDA is requesting OMB approval of a
proposed experimental study of trans fat
claims on food products intended to
help FDA’s Center for Food Safety and
Applied Nutrition formulate decisions
and policies affecting labeling
requirements for trans fat claims on
foods.
In the Federal Register of July 11,
2003 (68 FR 41507), FDA 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,’’
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
which requested comments about
possible disclosure requirements to
accompany nutrient content claims
about trans fatty acids that could help
consumers make heart-healthy food
choices. The proposed experimental
study will evaluate the ability of several
such disclosure requirements to help
consumers make heart-healthy food
choices. The results of the proposed
experimental study will provide
empirical support for possible policy
decisions about the need for such
disclosures and the appropriate form
they should take.
FDA or its contractor will collect and
use information gathered from Internet
panel samples to evaluate how
consumers understand and respond to
possible disclosure requirements for
trans fat content claims. The distinctive
features of Internet panel and shopping
mall methodologies for the purpose of
the proposed 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 disclosure
requirements while controlling for
individual differences. 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 treatment effect size.
The proposed study will be conducted
from a sample drawn from a large,
nationally representative consumer
panel with 800,000 households. The
sample size and population pool are
adequate to ensure that results can be
generalized.
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
one of the 144 experimental conditions
consisting of fully crossing 8 disclosure
conditions, 3 product types, 3 fatty acid
profiles and 2 prior knowledge
conditions.
FDA will use the information from the
proposed experimental study to
evaluate regulatory 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 proposed
experimental study will be used by the
agency to assess likely consumer
responses to various disclosure
E:\FR\FM\06FEN1.SGM
06FEN1
6077
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
requirements for nutrient content
claims.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Type of survey
Annual frequency
per response
Number of respondents
Internet Survey
2880
Total annual responses
Hours per response
Total hours
2880
.25
720
1
Total
720
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
approval expires on January 31, 2009. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1517 Filed 2–3–06; 8:45 am]
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1518 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Record Retention Requirements for the
Soy Protein and Risk of Coronary
Heart Disease Health Claim
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 15, 2005
(FR 70 69344), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0428. The
rmajette on PROD1PC67 with NOTICES1
SUMMARY:
VerDate Aug<31>2005
14:55 Feb 03, 2006
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1519 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. 2005N–0317]
AGENCY:
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0572. The
approval expires on January 31, 2009. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Jkt 208001
[Docket No. 2000N–1269] (formerly Docket
No. 00N–1269)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Requirements on Content and Format
of Labeling for Human Prescription
Drugs and Biologics; Requirements for
Prescription Drug Product Labels
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Requirements on Content and Format
of Labeling for Human Prescription
Drugs and Biologics; Requirements for
Prescription Drug Product Labels’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In the
Federal Register of December 22, 2000
(65 FR 81082), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
[Docket No. 2006N–0029]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Impact of Coupons
on Consumer Perceptions of Products
in Prescription Drugs in Direct-toConsumer Prescription Drug Print
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on a
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 of the impact of coupons (such
as price incentives or rebate offers) on
consumers’ perceptions of product risks
and benefits in direct-to-consumer
(DTC) print ads.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 2006.
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6076-6077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0037]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Proposed Experimental Study of Trans Fat Claims on
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,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on a proposed experimental study
of trans fat claims on foods to evaluate the effects of various
possible disclosure requirements intended to help consumers understand
and apply trans fat claims they might see on food products. The
proposed experimental study will estimate the communication
effectiveness of these disclosure requirements in realistic label usage
situations for a range of products that may bear trans fat claims.
DATES: Submit written or electronic comments on the collection of
information by April 7, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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, including
each proposed reinstatement of an existing 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.
Proposed Experimental Study of Trans Fat Claims on Foods (OMB Control
Number 0910-0533)--Reinstatement
FDA is requesting OMB approval of a proposed experimental study of
trans fat claims on food products intended to help FDA's Center for
Food Safety and Applied Nutrition formulate decisions and policies
affecting labeling requirements for trans fat claims on foods.
In the Federal Register of July 11, 2003 (68 FR 41507), FDA 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,'' which requested comments about possible disclosure
requirements to accompany nutrient content claims about trans fatty
acids that could help consumers make heart-healthy food choices. The
proposed experimental study will evaluate the ability of several such
disclosure requirements to help consumers make heart-healthy food
choices. The results of the proposed experimental study will provide
empirical support for possible policy decisions about the need for such
disclosures and the appropriate form they should take.
FDA or its contractor will collect and use information gathered
from Internet panel samples to evaluate how consumers understand and
respond to possible disclosure requirements for trans fat content
claims. The distinctive features of Internet panel and shopping mall
methodologies for the purpose of the proposed 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 disclosure requirements while
controlling for individual differences. 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 treatment effect size. The proposed
study will be conducted from a sample drawn from a large, nationally
representative consumer panel with 800,000 households. The sample size
and population pool are adequate to ensure that results can be
generalized.
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 one of the 144 experimental conditions consisting
of fully crossing 8 disclosure conditions, 3 product types, 3 fatty
acid profiles and 2 prior knowledge conditions.
FDA will use the information from the proposed experimental study
to evaluate regulatory 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
proposed experimental study will be used by the agency to assess likely
consumer responses to various disclosure
[[Page 6077]]
requirements for nutrient content claims.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual frequency Total annual
Type of survey Number of respondents per response responses Hours per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Internet Survey 2880 1 2880 .25 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1517 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S
