Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil, and Green Tea, 29340-29342 [E6-7692]
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29340
Federal Register / Vol. 71, No. 98 / Monday, May 22, 2006 / Notices
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
individuals who are familiar with the
enrollees could, because of the small
size, use this information to deduce the
identity of the individual).
STORAGE:
All records are stored electronically
and in hard copy.
RETRIEVABILITY:
The complaint data are retrieved by
an individual identifier i.e., name of
complainant.
cchase on PROD1PC60 with NOTICES
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: The Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
CMS will retain complaint
information for a total period not to
exceed 25 years.
VerDate Aug<31>2005
20:16 May 19, 2006
Jkt 208001
Director, Division of Continuing Care
Providers, Survey and Certification
Group, Center for Medicaid and State
Operations, CMS, 7500 Security
Boulevard, Mail Stop S2–01–16,
Baltimore, Maryland 21244–1849.
NOTIFICATION PROCEDURE:
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
RETENTION AND DISPOSAL:
SYSTEM MANAGER AND ADDRESS:
This system is exempt under the
provisions of 5 U.S.C. 552a(k)(2) of the
Privacy Act. However, portions of this
system notice are non-exempt and
consideration will be given to requests
addressed to the system manager for
those portions. For general inquiries, it
would be helpful if the request included
the system name, address, age, sex, and
for verification purposes, the subject
individual’s name (woman’s maiden
name, if applicable) and complaint
tracking identification number.
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2).)
CONTESTING RECORDS PROCEDURES:
The subject individual should contact
the system manager named above and
reasonably identify the records and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
Procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
CMS investigative files maintained in
OPOS are either received as electronic
documents or paper records that are
compiled for administrative, civil, and
law enforcement purposes. In the course
of investigations, CMS often has a need
to obtain confidential information
involving individuals other than the
complainant.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
HHS claims exemption of certain
records (case files on active fraud
investigations) in the system from
notification and access procedures
under 5 U.S.C. 552a(k)(2) inasmuch as
these records are investigatory materials
compiled for program, administrative,
and law enforcement in anticipation of
a criminal or administrative
proceedings. (See Department
Regulation (45 CFR 5b.11)).
[FR Doc. E6–7690 Filed 5–19–06; 8:45 am]
BILLING CODE 4120–03–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0097]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Qualified Health Claims:
Consumer Inferences About Omega-3
Fatty Acids, Monounsaturated Fatty
Acids From Olive Oil, and Green Tea
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
(the PRA).
DATES: Fax written comments on the
collection of information by June 21,
2006.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
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
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Experimental Study of Qualified Health
Claims: Consumer Inferences About
Omega-3 Fatty Acids, Monounsaturated
Fatty Acids From Olive Oil, and Green
Tea
FDA regulates health claims in the
labeling of food products under the
Nutrition Labeling and Education Act of
1990 (NLEA). NLEA regulations
establish general requirements for
health claims in food labeling. A
manufacturer is required to provide a
description of the scientific evidence
supporting a proposed health claim to
FDA for review before the claim may
appear in labeling (§§ 101.14(c) and (d),
E:\FR\FM\22MYN1.SGM
22MYN1
cchase on PROD1PC60 with NOTICES
Federal Register / Vol. 71, No. 98 / Monday, May 22, 2006 / Notices
101.70 (21 CFR 101.14(c) and (d),
101.70)). If FDA determines that there is
significant scientific agreement among
experts that the proposed health claim
is supported by the totality of publicly
available evidence, FDA issues a
regulation authorizing the claim. Health
claims must be ‘‘complete, truthful, and
not misleading’’ (§101.14(d)(2)(iii)) and
must ‘‘enable the public to comprehend
the information provided and to
understand the relative significance of
such information in the context of a
total daily diet’’ (§ 101.14 (d)(2)(v)).
In 2003, an FDA Task Force on
Consumer Health Information for Better
Nutrition issued a report that provided
guidance on an interim review process
for health claims that do not meet the
significant scientific agreement (SSA)
standard for the issuance of a regulation
authorizing the claim. These claims,
referred to as ‘‘qualified health claims,’’
are evaluated according to an interim
evidence-based ranking system for
scientific data and include a disclaimer
or other qualifying language to
distinguish them from claims that meet
the SSA standard. The report also
identified the need for consumer
research to examine ways to
communicate the level of scientific
support associated with qualified health
claims.
In the fall of 2004, FDA issued letters
of enforcement discretion for two
qualified health claims about the
relationship between risk of coronary
heart disease and consumption of
monounsaturated fatty acids from olive
oil and omega-3 fatty acids,
respectively. The qualified health
claims appear below:
1. Limited and not conclusive
scientific evidence suggests that eating
about 2 tablespoons (23 grams) of olive
oil daily may reduce the risk of coronary
heart disease due to the
monounsaturated fat in olive oil. To
achieve this possible benefit, olive oil is
to replace a similar amount of saturated
fat and not increase the total number of
calories you eat in a day. One serving
of this product [Name of food] contains
[x] grams of olive oil.
2. Supportive but not conclusive
research shows that consumption of
EPA and DHA omega-3 fatty acids may
reduce the risk of coronary heart
disease. One serving of [name of food]
provides [x] grams of EPA and DHA
omega-3 fatty acids. [See nutrition
information for total fat, saturated fat
and cholesterol content.]
In June 2005, FDA issued a letter of
enforcement discretion for two qualified
health claims about the relationship
between risk of breast and prostate
VerDate Aug<31>2005
20:16 May 19, 2006
Jkt 208001
cancers and consumption of green tea.
The qualified claims appear below:
1. Two studies do not show that
drinking green tea reduces the risk of
breast cancer in women, but one
weaker, more limited study suggests
that drinking green tea may reduce this
risk. Based on these studies, FDA
concludes that it is highly unlikely that
green tea reduces the risk of breast
cancer.
2. One weak and limited study does
not show that drinking green tea
reduces the risk of prostate cancer, but
another weak and limited study suggests
that drinking green tea may reduce this
risk. Based on the studies, FDA
concludes that it is highly unlikely that
green tea reduces the risk of prostate
cancer.
In November 2005, FDA released the
results of a prior study of qualified
health claims to assess the effectiveness
of claim language and grading schemes
for conveying the level of scientific
evidence supporting the claim. The
study showed that report card schemes
helped consumers distinguish between
various levels of scientific support.
However, the report card scheme
inadvertently conveyed other nutrient
and product attributes to consumers. In
particular, report card schemes resulted
in ‘‘halo effects’’ and other
misperceptions concerning the general
healthfulness and quality of the
product. In addition, the study showed
that consumers attributed higher levels
of scientific support to certain qualified
health claims bearing a grade of ‘‘B’’
than to non-graded claims that meet
FDA’s standard of ‘‘SSA’’. Thus, the
study proposed here will further explore
the report card grading scheme by
modifying it in two ways. First, the
study will test the ability of grade
disclaimers to correct for some of the
misperceptions created by report card
schemes observed in the earlier study.
Second, the study will include SSA
claims as ‘‘A’’ grade claims within the
report card grade scheme.
The study proposed here is part of an
ongoing effort by FDA to collect data
concerning qualified health claims and
their impact on consumer perceptions
and behavior. Previous FDA studies
have examined hypothetical qualified
health claims to evaluate ways to
communicate the strength of scientific
evidence supporting a claim. This study
will examine four qualified health
claims and two SSA claims to evaluate
whether consumers comprehend the
information in the claim and whether
consumers understand the relative
significance of the information in the
context of a total diet. In addition, the
study will broaden FDA’s
PO 00000
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29341
understanding about how consumers
interpret qualified health claims,
particularly as they pertain to the level
of scientific evidence conveyed by the
message and to any differences there
may be between qualified health claims
on dietary supplements versus foods.
The experimental study data will be
collected using participants of an
Internet panel. Participation in the
experimental study is voluntary.
In the Federal Register of March 30,
2005 (70 FR 16291), FDA published a
60-day notice requesting public
comment on the information collection
provisions. At that time, the
experimental study was titled
‘‘Experimental Study of Qualified
Health Claims: Consumer Inferences
about Omega-3 Fatty Acids and
Monounsaturated Fatty Acids from
Olive Oil.’’ Previously, it did not
include the two qualified health claims
for green tea or the two SSA health
claims, and the study also did not
include further exploration of the report
card grading scheme for health claims.
The study is now renamed to indicate
the inclusion of the green tea claims.
Burden estimates have also been
adjusted to account for the increase in
respondents necessary to make these
changes in the study.
FDA received four letters in response
to the notice, each containing one or
more comments. One of the letters and
portions of another letter contained
comments that were not responsive to
the four PRA questions for which
comments were requested. One of these
comments was about the presence of
monounsaturated fatty acids in oils
other than olive oil, while the others
raised legal issues outside the scope of
the PRA. These comments will not be
addressed in this document, which is
intended to summarize and respond to
comments about PRA issues. The
comments that addressed the four PRA
questions and our responses follow.
One comment expressed concern that
the proposed collection of information
is unnecessary for the proper
performance of the agency’s functions
and that the information will have no
practical utility. The comment asserted
that the information to be collected will
be inadequate for the agency to assess
whether consumer confusion will arise
from the claims.
FDA disagrees. The study is part of an
ongoing effort by FDA to collect data
concerning the communications effects
of qualified health claims on consumer
perceptions and judgments. The
purpose of the study is to assess how
some claim language compares to other
claim language in conveying
information to consumers. The study
E:\FR\FM\22MYN1.SGM
22MYN1
29342
Federal Register / Vol. 71, No. 98 / Monday, May 22, 2006 / Notices
uses an experimental design to assess
consumer reactions to health claim
language intended to convey both the
potential health benefits and the level of
scientific support for the health claim.
The comment also suggested that the
information will not be useful if it is the
agency’s intent to alter or restrict the
wording of qualified health claims
because, according to the comment,
consumers have the right to receive
truthful information, regardless of
whether they understand that
information.
FDA disagrees. The agency has a
responsibility to ensure that disclaimers
and other qualifying language intended
to prevent consumer deception are
effective in serving that purpose. The
study is designed to evaluate whether
certain variants of the qualified health
claims are more effective than others at
conveying to consumers the potential
health benefits and the level of scientific
support for the health claim. FDA
expects this study to be useful in
determining language that effectively
conveys this information to consumers.
The comment suggested that there
might be ways to improve the quality or
utility of the information collection, yet
did not offer specific recommendations
to modify the study and analysis. In
particular, the comment expressed
concern that an Internet survey cannot
be used to measure consumer confusion.
FDA responds that the experimental
study that is the basis of this
information collection request is an
Internet-based experiment, not an
Internet survey. The experimental study
is intended to assess the communication
effects, in a large sample of study
participants, of both existing health
claim language that appears on dietary
supplements and conventional food
products and variants of such language.
The study is not intended to measure
consumer confusion per se.
One comment recommended that, to
help maximize the quality, utility and
accuracy of the data to be collected in
the study, FDA should test the qualified
claim language exactly as stated in the
Federal Register notice published
March 30, 2005.
FDA agrees. The experimental study
will test the qualified claim language
exactly as it appears in the notice, in
addition to variants of the claim
language.
A comment urged FDA to takes steps
to ensure that using electronic data
collection is reliable and verifiable for
the study.
FDA is confident that the
methodology is reliable and verifiable
for this type of study. FDA will closely
monitor the contractor that implements
the experiment to ensure the validity
and accuracy of the collected data.
Another comment supported FDA’s
efforts to understand consumer
responses to food and dietary
supplement labels, but expressed
concern that FDA has not supplied
sufficient information to evaluate
whether the estimated burden of the
proposed collection is accurate.
FDA believes that the estimate of
burden is accurate because the estimate
is based on past experience with
Internet panel experiments similar in
complexity and duration to the one
proposed here. The study protocol will
be available for public viewing when
this 30-day notice is published. FDA has
followed the procedures for public
notice and comment about this
information collection set out in the
PRA (44 U.S.C. 3501–3520) and OMB
regulations (5 CFR part 1320).
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency per
Response
No. of Respondents
30 (pre-test)
7,440 (experiment)
TOTAL
1There
Total Annual Responses
1
1
30
7,440
‘‘Focus Groups as Used by the Food and
Drug Administration’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
BILLING CODE 4160–01–S
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Focus Groups as Used by the Food
and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
SUMMARY:
VerDate Aug<31>2005
20:16 May 19, 2006
In the
Federal Register of February 27, 2006
(71 FR 9828), 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 0910–0497. The
approval expires on November 30, 2007.
A copy of the supporting statement for
SUPPLEMENTARY INFORMATION:
[Docket No. 2005N–0443]
cchase on PROD1PC60 with NOTICES
Total Hours
.16
.16
5
1,191
1,196
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7692 Filed 5–19–06; 8:45 am]
ACTION:
Hours per Response
Jkt 208001
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Frm 00056
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Sfmt 4703
this information collection is available
on the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7698 Filed 5–19–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0183]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\22MYN1.SGM
Notice.
22MYN1
]]>Agencies
[Federal Register Volume 71, Number 98 (Monday, May 22, 2006)]
[Notices]
[Pages 29340-29342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0097]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids,
Monounsaturated Fatty Acids From Olive Oil, and Green Tea
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 (the PRA).
DATES: Fax written comments on the collection of information by June
21, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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 compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Experimental Study of Qualified Health Claims: Consumer Inferences
About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil,
and Green Tea
FDA regulates health claims in the labeling of food products under
the Nutrition Labeling and Education Act of 1990 (NLEA). NLEA
regulations establish general requirements for health claims in food
labeling. A manufacturer is required to provide a description of the
scientific evidence supporting a proposed health claim to FDA for
review before the claim may appear in labeling (Sec. Sec. 101.14(c)
and (d),
[[Page 29341]]
101.70 (21 CFR 101.14(c) and (d), 101.70)). If FDA determines that
there is significant scientific agreement among experts that the
proposed health claim is supported by the totality of publicly
available evidence, FDA issues a regulation authorizing the claim.
Health claims must be ``complete, truthful, and not misleading''
(Sec. 101.14(d)(2)(iii)) and must ``enable the public to comprehend the
information provided and to understand the relative significance of
such information in the context of a total daily diet'' (Sec. 101.14
(d)(2)(v)).
In 2003, an FDA Task Force on Consumer Health Information for
Better Nutrition issued a report that provided guidance on an interim
review process for health claims that do not meet the significant
scientific agreement (SSA) standard for the issuance of a regulation
authorizing the claim. These claims, referred to as ``qualified health
claims,'' are evaluated according to an interim evidence-based ranking
system for scientific data and include a disclaimer or other qualifying
language to distinguish them from claims that meet the SSA standard.
The report also identified the need for consumer research to examine
ways to communicate the level of scientific support associated with
qualified health claims.
In the fall of 2004, FDA issued letters of enforcement discretion
for two qualified health claims about the relationship between risk of
coronary heart disease and consumption of monounsaturated fatty acids
from olive oil and omega-3 fatty acids, respectively. The qualified
health claims appear below:
1. Limited and not conclusive scientific evidence suggests that
eating about 2 tablespoons (23 grams) of olive oil daily may reduce the
risk of coronary heart disease due to the monounsaturated fat in olive
oil. To achieve this possible benefit, olive oil is to replace a
similar amount of saturated fat and not increase the total number of
calories you eat in a day. One serving of this product [Name of food]
contains [x] grams of olive oil.
2. Supportive but not conclusive research shows that consumption of
EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart
disease. One serving of [name of food] provides [x] grams of EPA and
DHA omega-3 fatty acids. [See nutrition information for total fat,
saturated fat and cholesterol content.]
In June 2005, FDA issued a letter of enforcement discretion for two
qualified health claims about the relationship between risk of breast
and prostate cancers and consumption of green tea. The qualified claims
appear below:
1. Two studies do not show that drinking green tea reduces the risk
of breast cancer in women, but one weaker, more limited study suggests
that drinking green tea may reduce this risk. Based on these studies,
FDA concludes that it is highly unlikely that green tea reduces the
risk of breast cancer.
2. One weak and limited study does not show that drinking green tea
reduces the risk of prostate cancer, but another weak and limited study
suggests that drinking green tea may reduce this risk. Based on the
studies, FDA concludes that it is highly unlikely that green tea
reduces the risk of prostate cancer.
In November 2005, FDA released the results of a prior study of
qualified health claims to assess the effectiveness of claim language
and grading schemes for conveying the level of scientific evidence
supporting the claim. The study showed that report card schemes helped
consumers distinguish between various levels of scientific support.
However, the report card scheme inadvertently conveyed other nutrient
and product attributes to consumers. In particular, report card schemes
resulted in ``halo effects'' and other misperceptions concerning the
general healthfulness and quality of the product. In addition, the
study showed that consumers attributed higher levels of scientific
support to certain qualified health claims bearing a grade of ``B''
than to non-graded claims that meet FDA's standard of ``SSA''. Thus,
the study proposed here will further explore the report card grading
scheme by modifying it in two ways. First, the study will test the
ability of grade disclaimers to correct for some of the misperceptions
created by report card schemes observed in the earlier study. Second,
the study will include SSA claims as ``A'' grade claims within the
report card grade scheme.
The study proposed here is part of an ongoing effort by FDA to
collect data concerning qualified health claims and their impact on
consumer perceptions and behavior. Previous FDA studies have examined
hypothetical qualified health claims to evaluate ways to communicate
the strength of scientific evidence supporting a claim. This study will
examine four qualified health claims and two SSA claims to evaluate
whether consumers comprehend the information in the claim and whether
consumers understand the relative significance of the information in
the context of a total diet. In addition, the study will broaden FDA's
understanding about how consumers interpret qualified health claims,
particularly as they pertain to the level of scientific evidence
conveyed by the message and to any differences there may be between
qualified health claims on dietary supplements versus foods.
The experimental study data will be collected using participants of
an Internet panel. Participation in the experimental study is
voluntary.
In the Federal Register of March 30, 2005 (70 FR 16291), FDA
published a 60-day notice requesting public comment on the information
collection provisions. At that time, the experimental study was titled
``Experimental Study of Qualified Health Claims: Consumer Inferences
about Omega-3 Fatty Acids and Monounsaturated Fatty Acids from Olive
Oil.'' Previously, it did not include the two qualified health claims
for green tea or the two SSA health claims, and the study also did not
include further exploration of the report card grading scheme for
health claims. The study is now renamed to indicate the inclusion of
the green tea claims. Burden estimates have also been adjusted to
account for the increase in respondents necessary to make these changes
in the study.
FDA received four letters in response to the notice, each
containing one or more comments. One of the letters and portions of
another letter contained comments that were not responsive to the four
PRA questions for which comments were requested. One of these comments
was about the presence of monounsaturated fatty acids in oils other
than olive oil, while the others raised legal issues outside the scope
of the PRA. These comments will not be addressed in this document,
which is intended to summarize and respond to comments about PRA
issues. The comments that addressed the four PRA questions and our
responses follow.
One comment expressed concern that the proposed collection of
information is unnecessary for the proper performance of the agency's
functions and that the information will have no practical utility. The
comment asserted that the information to be collected will be
inadequate for the agency to assess whether consumer confusion will
arise from the claims.
FDA disagrees. The study is part of an ongoing effort by FDA to
collect data concerning the communications effects of qualified health
claims on consumer perceptions and judgments. The purpose of the study
is to assess how some claim language compares to other claim language
in conveying information to consumers. The study
[[Page 29342]]
uses an experimental design to assess consumer reactions to health
claim language intended to convey both the potential health benefits
and the level of scientific support for the health claim.
The comment also suggested that the information will not be useful
if it is the agency's intent to alter or restrict the wording of
qualified health claims because, according to the comment, consumers
have the right to receive truthful information, regardless of whether
they understand that information.
FDA disagrees. The agency has a responsibility to ensure that
disclaimers and other qualifying language intended to prevent consumer
deception are effective in serving that purpose. The study is designed
to evaluate whether certain variants of the qualified health claims are
more effective than others at conveying to consumers the potential
health benefits and the level of scientific support for the health
claim. FDA expects this study to be useful in determining language that
effectively conveys this information to consumers.
The comment suggested that there might be ways to improve the
quality or utility of the information collection, yet did not offer
specific recommendations to modify the study and analysis. In
particular, the comment expressed concern that an Internet survey
cannot be used to measure consumer confusion.
FDA responds that the experimental study that is the basis of this
information collection request is an Internet-based experiment, not an
Internet survey. The experimental study is intended to assess the
communication effects, in a large sample of study participants, of both
existing health claim language that appears on dietary supplements and
conventional food products and variants of such language. The study is
not intended to measure consumer confusion per se.
One comment recommended that, to help maximize the quality, utility
and accuracy of the data to be collected in the study, FDA should test
the qualified claim language exactly as stated in the Federal Register
notice published March 30, 2005.
FDA agrees. The experimental study will test the qualified claim
language exactly as it appears in the notice, in addition to variants
of the claim language.
A comment urged FDA to takes steps to ensure that using electronic
data collection is reliable and verifiable for the study.
FDA is confident that the methodology is reliable and verifiable
for this type of study. FDA will closely monitor the contractor that
implements the experiment to ensure the validity and accuracy of the
collected data.
Another comment supported FDA's efforts to understand consumer
responses to food and dietary supplement labels, but expressed concern
that FDA has not supplied sufficient information to evaluate whether
the estimated burden of the proposed collection is accurate.
FDA believes that the estimate of burden is accurate because the
estimate is based on past experience with Internet panel experiments
similar in complexity and duration to the one proposed here. The study
protocol will be available for public viewing when this 30-day notice
is published. FDA has followed the procedures for public notice and
comment about this information collection set out in the PRA (44 U.S.C.
3501-3520) and OMB regulations (5 CFR part 1320).
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
30 (pre-test) 1 30 .16 5
7,440 (experiment) 1 7,440 .16 1,191
TOTAL .................... ......................... .................... 1,196
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7692 Filed 5-19-06; 8:45 am]
BILLING CODE 4160-01-S
