2011-17676. 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.

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: [phone], or e-mailed to [e-mail]. 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.

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

Portion of study	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
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
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.