[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Pages 11251-11252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4459]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
Portion of study No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 839
----------------------------------------------------------------------------------------------------------------
\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