[Federal Register: April 21, 2004 (Volume 69, Number 77)]
[Page 21548-21549]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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) 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a voluntary consumer survey 
about infant feeding and diet of pregnant women and new mothers.

DATES: Submit written or electronic comments on the collection of 
information by June 21, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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:  Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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, including 
each proposed extension of a 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.

Infant Feeding Practices Study II

    Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 393(d)(2)), FDA is authorized to conduct research and 
educational and public information programs relating to foods and 
devices. Under this authority, FDA is planning to conduct a consumer 
study about infant feeding and the diet of pregnant women and new 
mothers. The study will provide detailed information about foods fed to 
infants, including breast milk and infant formula; factors that may 
contribute to infant feeding choices and to breastfeeding success, 
including intrapartum hospital experiences, mother's employment status, 
mother's self confidence, postpartum depression, infant sleeping 
arrangements; and other issues of interest to FDA, including infant 
food allergy, and experiences with breast pumps. The study will measure 
dietary intake of pregnant women and new mothers. It will also be used 
as one component of an evaluation of the Department of Health and Human

[[Page 21549]]

 Services (HHS) National Breastfeeding Awareness Campaign.
    A sample of pregnant women will be drawn from a commercial consumer 
opinion panel for a longitudinal study in which almost all data will be 
collected by mailed questionnaires. The sample design was chosen to 
maximize the response rate, which is critical for the success of a 
longitudinal study. Almost all of the sample will be members of the 
consumer opinion panel from which the sample will be drawn, while a few 
will be household members but not the panel member. All participants 
will be asked to complete one questionnaire during pregnancy, a short 
telephone interview shortly after delivery, a neonatal questionnaire 
sent a few weeks after the birth, and nine postnatal questionnaires 
sent approximately monthly from infant age 2 to 12 months. The 
postnatal questionnaires consist of various combinations of nine 
modules, some of which will be sent at 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 the other two will take 
about 15 minutes.
    A subset of the sample will be asked to complete a modified Diet 
History Questionnaire (from National Institutes of Health, National 
Cancer Institute) during pregnancy and again when the infants are about 
3 months old. Pregnant women who reside in a panel member's home but 
are not themselves the panel member will be sent a short additional 
questionnaire to collect basic demographic information.
    The expected sample size is about 3,500 pregnant women, of whom 
about 2,250 are expected to complete questionnaires in the later infant 
ages. The sample will be well distributed throughout the United States. 
Only women who give birth to a full-term, healthy, singleton infant 
will be included in the study. An estimated 12 percent of the original 
3,500 women will be ineligible for the study by these criteria. Many of 
the questions are identical to ones asked in a previous Infant Feeding 
Practices Study conducted by the FDA in 1993 to 1994. Use of the same 
questions in both time periods will enable comparison between the two 
data collections. Because the previous data are a decade old, and 
research suggests that significant changes in infant feeding issues 
have occurred in the past ten years, it is likely that consumer 
attitudes and practices have changed since the first data collection. 
FDA needs current information to support consumer education programs 
and to describe the policy context of current issues related to infant 
feeding. In addition, HHS and its agencies need data to evaluate 
various outreach efforts about child and maternal nutrition.
    FDA estimates the burden of this collection of information as 

                                     Table 1.--Estimated Reporting Burden\1\
                                        No. of        Frequency per       Total         Hours per
          Questionnaire              Respondents        Response        Responses       Response     Total Hours
Prenatal                               3,500               1              3,500             .25          875
Prenatal diet history                    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 history                   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 and maintenance costs associated with the collection of information.

    The burden estimate is based on FDA's experience with the 1993 to 
1994 survey mentioned in the previous paragraph and information 
available for the diet history questionnaire.

    Dated: April 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8995 Filed 4-20-04; 8:45 am]