Document ID: FDA-2011-N-0098-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Infant Formula Label Statements Experimental Study
Posted Date: 2011-03-03T05:00Z

[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11788-11789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4740]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0098]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Infant Formula Label Statements Experimental Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Infant Formula Label 
Statements Experimental Study.''

DATES: Submit either electronic or written comments on the collection 
of information by May 2, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3793.

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 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.

Infant Formula Label Statements Experimental Study--(OMB Control Number 
0910-NEW)

    FDA is planning to conduct an experimental study about certain 
types of label statements on infant formula, such as those that are 
either structure function claims or similar to such claims. An example 
of the type of statements that are of interest is: ``Supports brain and 
eye development.'' The Infant Formula Label Statements Experimental 
Study will collect information from four groups: Pregnant women, 
mothers of infants less than 12 months old, mothers of children older 
than 1 year but younger than 5 years old, and women of childbearing age 
who do not have a child younger than 5 years. The purpose of the study 
is to assess women's understanding of and response to various 
statements on infant formula labels. The study results will be used to 
help the Agency to understand the role that certain types of statements 
on infant formula labels have in influencing formula choice.
    The data will be collected over the Internet from a sample of 5,000 
adult women selected from an online consumer panel. Participants will 
be randomly assigned to an experimental condition. The study will show 
participants one of five explanations of the regulatory, scientific, or 
marketing context (or none of these) of infant formula marketing in the 
United States and will ask them to compare two sets of two experimental 
infant formula labels. One label will always be a control label with no 
statement similar to a structure function claim. The other label will 
include one of the statements of interest to the study. The study will 
focus on purchase choice, perceived similarity of the formula to breast 
milk, and perceived likelihood that the formula has certain health 
benefits. In addition, information about certain covariates will be 
collected, depending on the group the participant is in. Covariate 
information will include, as appropriate, month of pregnancy, plans for 
feeding the infant, number of children, age of youngest child, whether 
the youngest child was fed infant formula, whether the youngest child 
was ever breast fed, whether the mother bought infant formula for her 
youngest child, priorities used to select the formula purchased, and 
attitudes about the differences between breast milk and formula. 
Participation in the study is voluntary.
    Approximately 10,000 women will be screened. We estimate that it 
will take a respondent 20 seconds (0.0055 hours) to complete the 
screening questions, for a total of 55 hours. A pretest will be 
conducted with 150 participants. We estimate that it will take a 
respondent 15 minutes (0.25 hours) to complete the experiment and 10 
minutes (0.167 hours) to complete debriefing questions for the pretest, 
for a total of 25 minutes (0.42 hours) per respondent and a total of 63 
hours for the pretest. Five thousand (5,000) adult women will complete 
the experiment. We estimate that it will take a respondent 15 minutes 
(0.25 hours) to complete the entire experiment, for a total of 1,250 
hours. Thus, the total estimated burden is 1,368 hours. FDA's burden 
estimate is based on prior experience with consumer experiments that 
are similar to this proposed experiment.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 11789]]

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                       Annual
         Portion of study             Number of     frequency per   Total annual     Hours per      Total hours
                                     respondents      response        responses       response
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Screener.........................          10,000               1          10,000         0.0055              55
Pretest..........................             150               1             150         0.42                63
Experiment.......................           5,000               1           5,000         0.25             1,250
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    Total........................  ..............  ..............  ..............  .............           1,368
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4740 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P