Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel, 6079-6081 [E6-1522]
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6079
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
advertisements. To justify future
regulatory changes, we need to have
better empirical data about consumers’
perceptions of the information in both
types of ads and how inclusion of such
promotional devices can impact
consumers’ perceptions of the risks and
benefits of advertised prescription
drugs.
Design Overview: This study will
employ a between-subjects crossed
factorial design and will focus on
consumer print advertising. Fifteen
print advertisements will be created
using three levels of ad type and five
levels of promotional offer. Thus, the
factors will be ad type (DTC print
reminder; DTC print full product; overthe-counter print full product) and offer
type (free trial offer; buy one, get one
free; money off prescription/purchase
cost; money back guarantee; no
promotion). Product name and
indication will be constant across
conditions. Side effect and risk
information will be constant across full
product DTC ad conditions. Participants
will be asked to read a single print
advertisement for a new drug. After
reading the advertisement, they will be
asked questions about their evaluation
of the information presented in the
advertisement.
Factors: (1) Participants. Consumers
will be screened and recruited by the
contractor to be currently diagnosed
with insomnia or at risk of developing
insomnia. Participants will be randomly
assigned to experimental cells. Each
one, get one free, these are promotional
variations that have been used in drug
advertising. We ask for comment on
other promotional types that could be
tested.
Procedure: Participants will be shown
one ad, for example, a reminder ad for
a prescription drug with a free-trial offer
coupon attached. Then the participant
will be asked to answer questions
examining a number of important
perceptions about the product,
including perceived riskiness of the
drug, likelihood of benefits, and
behavioral intent (talking to doctor,
product purchase). Finally,
demographic and health care utilization
information will be collected.
Interviews are expected to last
approximately 15 minutes. A total of
1,350 participants will be involved. This
will be a one time (rather than annual)
collection of information.
FDA estimates the burden of this
collection of information as follows:
FDA estimates that 2,025 individuals
will need to be screened to obtain a
respondent sample of 1,350. The
screener is expected to take 30 seconds,
for a total screener burden of 17 hours.
The 1,350 respondents will then be
asked to respond to a series of questions
about the advertisement. We estimate
the response burden for the consumer
part of the survey to be 15 minutes, for
a burden of 337.5 hours. The estimated
total burden for this data collection
effort is 354.5 hours. The respondent
burden chart is listed below:
condition will be balanced with respect
to gender.
Because this is the first investigation
of this issue with DTC ads, we chose to
limit our investigation to one disease
condition. We chose to accept this
decrease in generality to maximize our
ability to detect a subtle difference
between promotion types. Participants
will be screened to represent a range of
education levels (some college or less
vs. completed college or more). Because
the task presumes basic reading
abilities, all participants will have
English as their primary language and,
as appropriate, be required to have
reading glasses when participating in
the study.
(2) Type of Ad. Three types of ads will
be tested: A full-product ad for a
prescription drug, a reminder ad for a
prescription drug, and an ad for an overthe-counter (OTC) drug. An ad for an
OTC drug, which typically includes
benefit but not risk information, is
included to see if prior research findings
in the area of consumer package goods
can be replicated. It is expected that
consumer processing of information in
the ad may vary by presence of a
promotion. For instance, consumers
may assign more weight to benefit
claims in cases where a promotional
coupon is included.
(3) Type of Promotion. Five types of
promotion will be tested: Free trial offer,
buy one, get one free, money-off
prescription/purchase cost, money back
guarantee, and a no promotion
condition. With the exception of buy
ESTIMATED ANNUAL REPORTING BURDEN
Annual frequency
per response
No. of respondents
Total annual
responses
Hours per
response
Total hours
2,025 (screener)
1
2,025
.008
17
1,350 (questionnaire)
1
1,350
.25
337.5
Total
3,375
354.5
Footnote: there are no capital costs or operating and maintenance costs associated with this data collection.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
rmajette on PROD1PC67 with NOTICES1
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1521 Filed 2–3–06; 8:45 am]
[Docket No. 2006N–0036]
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
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.
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14:55 Feb 03, 2006
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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
E:\FR\FM\06FEN1.SGM
06FEN1
rmajette on PROD1PC67 with NOTICES1
6080
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
an experimental study of possible
footnotes and cueing schemes intended
to help consumers understand and
apply quantitative trans fat information
they might see on the Nutrition Facts
Panel of a food product. The
experimental study will estimate the
communication effectiveness of
quantitative trans fat information in
terms of its ability to help consumers
make heart-healthy product decisions in
realistic label usage situations for a
range of products.
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
VerDate Aug<31>2005
14:55 Feb 03, 2006
Jkt 208001
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 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 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
Nutrition Facts Panel 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
Nutrition Facts Panel 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
PO 00000
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Sfmt 4703
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 wellknown techniques such as analysis of
variance or regression analysis to yield
statistically valid estimates of effect
size. The 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 42 experimental conditions
derived from fully crossing 7 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 600,000
people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this
collection of information as follows:
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6081
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
Type of survey
Internet survey
Annual frequency
per response
3,240
Total annual
responses
1
Hours per
response
3,240
Total hours
.25
Total
810
1There
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 in this document.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1522 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–0032]
Referral of ZINECARD (dexrazoxane)
and RELPAX (eletriptan) Written
Requests for the Conduct of Pediatric
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
referral of ZINECARD (dexrazoxane)
and RELPAX (eletriptan) Written
Requests for the conduct of pediatric
studies to the Foundation for the
National Institutes of Health (the
Foundation). FDA referred the
ZINECARD (dexrazoxane) and RELPAX
(eletriptan) Written Requests to the
Foundation on August 29, 2005, and is
publishing this notice of the referrals in
accordance with the Best
Pharmaceuticals for Children Act
(BPCA).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 1613,
Silver Spring, MD 20993–0002, 301–
796–2200, e-mail:
carmouzeg@cder.fda.gov.
In
accordance with section 4 of the BPCA
(Public Law 107–109), FDA is
announcing the referral to the
Foundation of the written requests for
the conduct of pediatric studies for
ZINECARD (dexrazoxane) and RELPAX
(eletriptan). Enacted on January 4, 2002,
SUPPLEMENTARY INFORMATION:
rmajette on PROD1PC67 with NOTICES1
810
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16:32 Feb 03, 2006
Jkt 205001
the BPCA reauthorizes, with certain
important changes, the exclusivity
incentive program described in section
505A of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 355a).
Section 505A of the act permits certain
applications to obtain 6 months of
exclusivity if, in accordance with the
requirements of the statute, the sponsor
submits requested information relating
to the use of the drug in the pediatric
population.
The BPCA established additional
mechanisms for obtaining information
on the safe and effective use of drugs in
pediatric patients. Specifically, section
4 of the BPCA amends section 505A(d)
of the act to create a referral process to
obtain studies for drugs that have patent
or exclusivity protection, but for which
the sponsor has declined to conduct the
pediatric studies in response to a
written request by FDA. Under section
4 of the BPCA, if the Secretary of Health
and Human Services (the Secretary)
determines that there is a continuing
need for the pediatric studies described
in the written request and the sponsors
of the products with patent or
exclusivity protection have declined to
conduct the studies, the Secretary shall
refer the drug to the Foundation,
established under section 499 of the
Public Health Service Act (42 U.S.C.
290(b)), for the conduct of the pediatric
studies described in the written request
(21 U.S.C. 355a(d)(4)(B)(i)). In addition,
the BPCA requires public notice of the
name of the drug, name of the
manufacturer, and indications to be
studied under the referrals (21 U.S.C.
355a(d)(4)(B)(ii)).
In accordance with section 4 of the
BPCA, FDA is announcing that on
August 29, 2005, it referred to the
Foundation the written requests for
pediatric studies for ZINECARD
(dexrazoxane) and RELPAX (eletriptan).
On July 14, 2004, FDA issued a written
request for pediatric studies to Pfizer,
Inc., the holder of approved
applications for RELPAX (eletriptan)
that have market exclusivity. The
studies described in the written request
were for the acute treatment of
migraines in adolescents. Pfizer, Inc.,
declined to conduct the requested
studies. FDA has determined that there
PO 00000
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is a continuing need for information
relating to the use of RELPAX
(eletriptan) in the pediatric population.
On June 17, 2004, FDA issued a
written request for pediatric studies to
Pfizer, Inc., the holder of approved
applications for ZINECARD
(dexrazoxane) that have market
exclusivity. The studies described in the
written request were for
cardioprotection in children receiving
doxorubicin therapy. Pfizer, Inc.,
declined to conduct the requested
studies. FDA has determined that there
is a continuing need for information
relating to the use of ZINECARD
(dexrazoxane) in the pediatric
population.
Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1520 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6079-6081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0036]
Agency Information Collection Activities; Proposed Collection;
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 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
[[Page 6080]]
an experimental study of possible footnotes and cueing schemes intended
to help consumers understand and apply quantitative trans fat
information they might see on the Nutrition Facts Panel of a food
product. The experimental study will estimate the communication
effectiveness of quantitative trans fat information in terms of its
ability to help consumers make heart-healthy product decisions in
realistic label usage situations for a range of products.
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.
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 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 Nutrition Facts Panel 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
Nutrition Facts Panel 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 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 42 experimental conditions derived from
fully crossing 7 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 600,000 people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this collection of information as
follows:
[[Page 6081]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual frequency Total annual Hours per
Type of survey respondents per response responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Internet survey 3,240 1 3,240 .25 810
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 810
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 in this document.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1522 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S
