Document ID: FDA-2011-N-0099-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Followup Study for Infant Feeding Practices Study II
Posted Date: 2011-03-01T05:00Z

[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Pages 11251-11252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0099]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Followup Study for Infant Feeding Practices Study II

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 ``Followup Study for 
Infant Feeding Practices Study II.''

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.

Followup Study for Infant Feeding Practices Study II (OMB Control 
Number 0910-NEW)

I. Background

    FDA is planning to conduct a survey of the mothers who participated 
in the Infant Feeding Practices Study II (IFPS II) (Ref. 1). The IFPS 
II sample was drawn from a commercial consumer opinion panel, and so 
participants are expected to be easier to re-contact than would be the 
case for a random sample of the population. Some participants will 
still be panel members. The purpose of the study is to enhance FDA's 
understanding of the associations between infant feeding practices and 
diet quality, food allergy, overweight and obesity, and other health 
and development outcomes in young children.
    The study results will be used to help the Agency to understand the 
possible role of infant feeding practices in the development and 
progression of food allergy and childhood overweight and obesity, in 
addition to resistance to infection and other health and development 
outcomes. The results of the study will not be used to develop 
population estimates.
    The data will be collected by a mailed questionnaire from most 
respondents and by telephone from those who do not respond to the 
mailed questionnaire. The study will focus on the following types of 
information: The child's consumption of various food groups; the 
child's other consumption practices (such as how often the child eats 
dinner with a parent and how often the child eats from fast food 
restaurants); the mother's control over the child's eating patterns; 
the child's physical activity and time spent watching a screen (TV or 
computer); the child's sleep patterns; extent of the child's cognitive 
stimulation at home; the child's height, weight, and waist 
circumference; the child's visits to a dentist and number of cavities; 
number of the child's recent physician visits; number of various types 
of infections the child had in the past year; whether the child has 
various health conditions including digestive problems, eczema, food 
allergy, respiratory allergy, attention deficit disorder, developmental 
delay, anxiety problems, depression, or asthma; the child's social 
development; the child's family medical history; the mother's height 
and weight, physical activity, depression, pregnancies subsequent to 
the sample child and whether subsequent children were breastfed, and 
employment conditions; the mother or child's participation in certain 
government programs; and the child's potential exposure to certain 
environmental contaminants including cigarette smoke and pesticides. A 
demographic questionnaire will also be mailed to respondents for whom 
current information is not available through the consumer opinion 
panel. Participation in the study is voluntary.
    To refine the questionnaire used in the study, a pretest will be 
conducted with 100 participants, 91 by mailed questionnaire and 9 by 
telephone interview. We estimate that it will take a respondent 20 
minutes (0.33 hours) to complete the survey and 5 minutes (0.08 hours) 
to complete debriefing questions for the pretest, for a total of 25 
minutes (0.42 hours) per respondent and a total of 38 hours for the 
mailed and 4 hours for the interview pretest. The sample for the 
pretest will be panel members who are mothers of children 5 to 7 years 
old

[[Page 11252]]

who did not participate in the IFPS II. All IFPS II participants who 
completed at least two surveys after their infants were born and for 
whom current contact information can be found will be sent the mailed 
questionnaire. This is expected to be about 2,562 participants. We 
estimate that 1,538 respondents will return it and that it will take a 
respondent 20 minutes (0.33 hours) to complete the questionnaire, for a 
total of 513 hours. An additional 522 mothers are expected to complete 
the telephone interview of 20 minutes (0.33 hours) for a total of 174 
hours. An estimated 1,380 participants will return the demographic 
questionnaire, which will require 5 minutes (0.08 hours) to complete 
for a total of 110 hours. Thus, the total estimated burden is 839 
hours. FDA's burden estimate is based on prior experience with consumer 
surveys that are similar to this proposed data collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
        Portion of study              No. of      frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Pretest mailed questionnaire....              91               1              91            0.42              38
Pretest telephone interview.....               9               1               9            0.42               4
Main study mailed questionnaire.           1,538               1           1,538            0.33             513
Main study telephone interview..             522               1             522            0.33             174
Demographic questionnaire.......           1,380               1           1,380            0.08             110
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    Total.......................  ..............  ..............  ..............  ..............             839
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Fein, Sara B., Judith Labiner-Wolfe, Katherine Shealy, et al., 
``Infant Feeding Practices Study II: Study Methods,'' Pediatrics 2008; 
122(suppl 2): S28-S35.

    Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4459 Filed 2-28-11; 8:45 am]
BILLING CODE 4160-01-P