69 FR 77 pgs. 21548-21549 - Agency Information Collection Activities; Proposed Collection;Comment Request; Infant Feeding Practices Study II
Type: NOTICEVolume: 69Number: 77Pages: 21548 - 21549
Docket number: [Docket No. 2004N-0166]
FR document: [FR Doc. 04-8995 Filed 4-20-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0166]
Agency Information Collection Activities; Proposed Collection;Comment Request; Infant Feeding Practices Study II
AGENCY:
Food and Drug Administration, HHS
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing an opportunity for public comment on the proposed collection ofcertain information by the agency. Under the Paperwork Reduction Act of1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection ofinformation, including each proposed extension of an existing collection ofinformation, and to allow 60 days for public comment in response to thenotice. This notice solicits comments on a voluntary consumer survey aboutinfant feeding and diet of pregnant women and new mothers.
DATES:
Submit written or electronic comments on thecollection of information by June 21, 2004.
ADDRESSES:
Submit electronic comments on the collectionof information to: http://www.fda.gov/dockets/ecomments .Submit written comments on the collection of information to the Division ofDockets Management (HFA-305), Food and Drug Administration, 5630Fishers Lane., rm. 1061, Rockville, MD 20852. All comments should beidentified with the docket number found in brackets in the heading of thisdocument.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtainapproval from the Office of Management and Budget (OMB) for each collectionof information they conduct or sponsor. "Collection ofinformation" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) andincludes agency requests or requirements that members of the public submitreports, keep records, or provide information to a third party. Section3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federalagencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposedextension of a collection of information, before submitting the collectionto OMB for approval. To comply with this requirement, FDA is publishingnotice of the proposed collection of information set forth in thisdocument.
With respect to the following collection of information, FDA invitescomments on these topics: (1) Whether the proposed collection ofinformation is necessary for the proper performance of FDA's functions,including whether the information will have practical utility; (2) theaccuracy of FDA's estimate of the burden of the proposed collection ofinformation, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection of information on respondents, including through the use ofautomated collection techniques, when appropriate, and other forms ofinformation technology.
Infant Feeding Practices Study II
Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 393(d)(2)), FDA is authorized to conduct research and educationaland public information programs relating to foods and devices. Under thisauthority, FDA is planning to conduct a consumer study about infant feedingand the diet of pregnant women and new mothers. The study will providedetailed information about foods fed to infants, including breast milk andinfant formula; factors that may contribute to infant feeding choices andto breastfeeding success, including intrapartum hospital experiences,mother's employment status, mother's self confidence, postpartumdepression, infant sleeping arrangements; and other issues of interest toFDA, including infant food allergy, and experiences with breast pumps. Thestudy will measure dietary intake of pregnant women and new mothers. Itwill also be used as one component of an evaluation of the Department ofHealth and Human Services (HHS) National Breastfeeding AwarenessCampaign.
A sample of pregnant women will be drawn from a commercial consumeropinion panel for a longitudinal study in which almost all data will becollected by mailed questionnaires. The sample design was chosen tomaximize the response rate, which is critical for the success of alongitudinal study. Almost all of the sample will be members of theconsumer opinion panel from which the sample will be drawn, while a fewwill be household members but not the panel member. All participants willbe asked to complete one questionnaire during pregnancy, a short telephoneinterview shortly after delivery, a neonatal questionnaire sent a few weeksafter the birth, and nine postnatal questionnaires sent approximatelymonthly from infant age 2 to 12 months. The postnatal questionnairesconsist of various combinations of nine modules, some of which will be sentat each data collection, while others will be sent only some of the time.Seven of the questionnaires will take about 25 minutes to complete, and theother two will take about 15 minutes.
A subset of the sample will be asked to complete a modified Diet HistoryQuestionnaire (from National Institutes of Health, National CancerInstitute) during pregnancy and again when the infants are about 3 monthsold. Pregnant women who reside in a panel member's home but are notthemselves the panel member will be sent a short additional questionnaireto collect basic demographic information.
The expected sample size is about 3,500 pregnant women, of whom about2,250 are expected to complete questionnaires in the later infant ages.The sample will be well distributed throughout the United States. Onlywomen who give birth to a full-term, healthy, singleton infant will beincluded in the study. An estimated 12 percent of the original 3,500 womenwill be ineligible for the study by these criteria. Many of the questionsare identical to ones asked in a previous Infant Feeding Practices Studyconducted by the FDA in 1993 to 1994. Use of the same questions in bothtime periods will enable comparison between the two data collections.Because the previous data are a decade old, and research suggests thatsignificant changes in infant feeding issues have occurred in the past tenyears, it is likely that consumer attitudes and practices have changedsince the first data collection. FDA needs current information to supportconsumer education programs and to describe the policy context of currentissues related to infant feeding. In addition, HHS and its agencies needdata to evaluate various outreach efforts about child and maternalnutrition.
FDA estimates the burden of this collection of information asfollows:
| Questionnaire | No. of Respondents | Frequency per Response | Total Responses | Hours per Response | Total Hours |
|---|---|---|---|---|---|
| Prenatal | 3,500 | 1 | 3,500 | .25 | 875 |
| Prenatal diet historyquestionnaire | 900 | 1 | 900 | 1.00 | 900 |
| Demographic questionnaire | 140 | 1 | 140 | .17 | 24 |
| Birth screener | 2,772 | 1 | 2,772 | .07 | 194 |
| Neonatal questionnaire | 2,494 | 1 | 2,494 | .25 | 624 |
| Postnatal diet historyquestionnaire | 900 | 1 | 900 | 1.00 | 900 |
| Postnatal questionnaires A | 2,250 | 7 | 15,750 | .42 | 6,615 |
| Postnatal questionnaires B | 2,250 | 2 | 4500 | .25 | 1,125 |
| Total | 11,257 | ||||
| 1 There are no capital costs or operating andmaintenance costs associated with the collection of information. | |||||
The burden estimate is based on FDA's experience with the 1993 to 1994survey mentioned in the previous paragraph and information available forthe diet history questionnaire.
Dated: April 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8995 Filed 4-20-04; 8:45 am]
BILLING CODE 4160-01-S