[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6076-6077]
From the Federal Register Online via the Government Publishing 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: http://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