Document ID: FDA-2011-N-0099-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Followup Study for Infant Feeding Practices Study II
Posted Date: 2011-07-14T04:00Z

[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41501-41502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17676]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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.

DATES: Fax written comments on the collection of information by August 
15, 2011.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Followup Study for Infant Feeding Practices Study II.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

[[Page 41502]]

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.

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 he or she 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 and weight; 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's or child's participation in certain government 
programs; and the child's potential exposure to certain environmental 
contaminants including cigarette smoke and pesticides. Although all 
sample members were consumer opinion panel members when the IFPS II was 
conducted, many will no longer participate on the panel. Therefore, a 
demographic questionnaire will be mailed to respondents who are no 
longer a panel member to update current demographic information. 
Participation in the study is voluntary.
    In the Federal Register of March 1, 2011 (76 FR 11251), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
              Portion of study                   Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Pilot study mailed questionnaire............              91               1              91  0.42 (25 minutes).........................              38
Pilot study telephone interview.............               9               1               9  0.42 (25 minutes).........................               4
Main study mailed questionnaire.............           1,538               1           1,538  0.33 (20 minutes).........................             508
Main study telephone interview..............             522               1             522  0.33 (20 minutes).........................             172
Demographic questionnaire...................           1,380               1           1,380  0.08 (5 minutes)..........................             110
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             832
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To refine the questionnaire used in the study, a pilot study will 
be conducted with 100 participants, 91 by mailed questionnaire and 9 by 
telephone interview. We estimate that it will take a respondent 25 
minutes (0.42 hours) to complete the survey and debriefing questions by 
either method for a total of 38 hours for the mailed and 4 hours for 
the interview pretest. The sample for the pilot study will be panel 
members who are mothers of 6-year-old children and 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 an average of 20 minutes (0.33 hours) 
to complete the questionnaire, for a total of 508 hours. An additional 
522 mothers are expected to complete the telephone interview of 20 
minutes (0.33 hours) for a total of 172 hours. Sample members who are 
no longer a panel member will be asked to complete a questionnaire to 
update their demographic information. 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 832 hours. FDA's burden estimate is based on prior 
experience with consumer surveys that are similar to this proposed data 
collection.

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: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17676 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P