2011-4459. 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 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

Portion of study	No. of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
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.