[Federal Register: October 1, 2004 (Volume 69, Number 190)]
[Notices]               
[Page 58915-58928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc04-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0166]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Infant Feeding 
Practices Study II

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 
November 1, 2004.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that comments be faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

I. Background on the 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 
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.

[[Page 58916]]

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 (IFPS) conducted by 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 10 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.
    In the Federal Register of April 21, 2004 (69 FR 21548), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions.
    FDA received five paperwork reduction comments on the proposed 
Infant Feeding Practices Study II; one comment was from a member of the 
public, two from industry groups, one from another government agency, 
and one from a medical center. In the request for comments (69 FR 
21548-21549), the agency invited comments on four topics. Two of the 
comments we received addressed the first topic: whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility. Two comments addressed the second topic: the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used. Two 
comments addressed the third topic: ways to enhance the quality, 
utility, and clarity of the information to be collected. These latter 
two comments were from the infant formula industry and provided 
detailed comments about many aspects of the study, including the 
sampling design, the questionnaire design and specific questions, and 
possible interpretations of results. No comments specifically addressed 
the fourth topic: ways to minimize the burden on the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.

II. Comments on Topic One

    Is the proposed collection of information necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility?
    (Comment 1) One comment from a member of the public states that the 
agency does not need additional information about infant feeding 
practices because there is already a substantial amount of information 
on this topic.
    (Response) The agency is not persuaded that existing information 
will fulfill the agency's needs. We note that detailed, longitudinal 
information about infant feeding has not been collected by anyone in 
over a decade. In the approximate decade since the first IFPS, a number 
of dietary practices related to infants have changed. These changes 
include the availability of new formulations of infant formula 
(specifically the addition of docosahexaenoic acid (DHA) and 
arachidonic acid (ARA)--types of omega-3 and omega-6 fatty acids--to 
some formula), the increased use of breast pumps, and probable 
increased intake by infants and mothers of dietary supplements (i.e., 
vitamins, minerals, herbal, and botanical supplements). Knowledge 
related to infant feeding has also increased, including the possibility 
of preventing or delaying food allergy through early infant diet and 
evidence that certain other diseases, such as diabetes, may be related 
to solid food timing. Furthermore, overall breastfeeding rates have 
risen dramatically over the past decade, creating the need to better 
understand how infant feeding patterns and their determinants have 
changed. Breastfeeding initiation in 2002 was 70 percent, compared with 
54 percent in 1992, and duration to 6 months was 33 percent, compared 
with 19 percent in 1992. Additionally, increased physician education 
related to breastfeeding, improved maternity care practices, and some 
State and Federal laws have altered the barriers that women face in 
making infant feeding decisions. There is a need to understand infant 
feeding in the context of these new environments. Consequently, a need 
exists to update the database with a current description of the 
practices of mothers of infants.
    (Comment 2) One comment from another government unit states that 
staff use the data from the first IFPS and that they are in favor of 
the IFPS II.
    (Response) The agency agrees that information from the IFPS II will 
be useful to many government agencies and their staff.

III. Comments on Topic Two

    What is the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used?
    (Comment 3) One comment from a medical center recommends that the 
data collection be done by an independent contractor and not by a 
formula manufacturer. It states that the contractor should not have any 
affiliation with the formula industry.
    (Response) The agency agrees that the data should not be collected 
by a formula manufacturer. The data will be collected by an independent 
contractor under the direction of FDA employees.
    (Comment 4) One comment from the formula industry states that the 
sample of the IFPS II should be representative of the general 
population of new mothers in the United States. The comment asks what 
steps will be taken to ensure that the proposed data collection is 
truly representative of the general population. The comment also notes, 
however, that the sample of the first IFPS was not representative and

[[Page 58917]]

acknowledges that if the sample of IFPS II is representative of the 
general population, FDA will not be able to validly compare results 
from the two data collections.
    (Response) Although the agency agrees with the principle that a 
nationally representative sample is ideal, it disagrees that this 
characteristic is essential for the IFPS II. The IFPS II sample will 
not be representative of the general population of new mothers in the 
United States. The IFPS II sample will be drawn from the same consumer 
opinion panel (a collection of households throughout the United States 
in which members have agreed to answer questionnaires by mail) from 
which the original study sample was drawn. Before the first infant 
feeding study was conducted, project staff considered many possible 
designs and consulted with several experts. The conclusion was that 
screening costs would be enormous to find a large sample at the 
required stage of pregnancy to assemble a panel, and that subsequent 
nonresponse from a panel composed of the general population would be so 
high that the nonresponse bias would invalidate the study. The people 
most likely to drop out would be those not included in the consumer 
opinion panel, such as those with a low level of education, those from 
unstable households, and those with low English proficiency. Use of the 
consumer opinion panel will provide data primarily on a middle segment 
of the U.S. population, but the segment included is fairly broad. For 
example, 20 percent of the previous study sample participated in the 
Supplemental Feeding Program for Women, Infants, and Children (WIC), 
the same proportion as the general population of mothers of infants at 
the time. In this study, the nature of the bias will be known and the 
data will be truly longitudinal because most of those who begin the 
study will complete it. Panel members who have a low level of education 
and who are of minority race and ethnicity will be oversampled to 
increase the total numbers from these groups. Use of the same sample 
frame as the original study will enable comparison across time on some 
key variables.
    For certain analyses the IFPS II sample will be weighted to the 
distributions of characteristics of new mothers in vital statistics to 
make the results more representative.
    (Comment 5) One comment from industry states that the data 
collection instruments are lengthy and detailed and appear to be 
written for an educated, highly literate population. The comment states 
that this characteristic will make it difficult for the consumer sample 
to be representative of the general population. The comment recommends 
that the agency take steps to make all survey instruments appropriate 
for the general population, including low literacy and minority 
subgroups. The comment also refers to the agency's proposal to have a 
subset of the sample complete a modified National Institutes of Health, 
National Cancer Institute (NIH-NCI) Diet History Questionnaire (DHQ), 
and asks how the DHQ will be modified for use in the IFPS II. The 
comment states that the standard DHQ appears to be based primarily on a 
typical Western diet and collects limited information on ethnic/
culture-specific foods.
    (Response) The agency disagrees that the data collection 
instruments should be appropriate for low literacy subgroups. The 
agency notes that all panel members are, in fact, literate. It would be 
impossible to conduct a mail survey with people who have low literacy. 
As noted earlier, the consumer opinion panel will provide data on a 
fairly broad middle segment of the U.S. population, with oversampling 
of panel members who have a low level of education and who are of 
minority race and ethnicity. Thus, the sample will include a range of 
education and income, including some panel members with no more than a 
high school education and some low income respondents who qualify for 
the WIC program. Based on pretesting and on our experience with the 
first IFPS, we expect that the length and detail of the questionnaires 
will be appropriate for the IFPS II sample.
    Major parts of the instruments were extensively tested and used 
successfully in the previous IFPS. In the previous study, 32 percent of 
the sample had no more than a high school education, and as noted 
above, 20 percent participated in WIC. Some of the previous questions 
and the new questions have been cognitively tested with a small number 
of WIC mothers and mothers from the panel from which the sample will be 
drawn. After OMB approval for the data collection, a pilot test will be 
conducted for additional testing. One finding from the cognitive 
testing is that, for some types of questions, it is easier for the 
mothers to give detailed answers than to answer ``in general'' 
responses.
    In response to the question about modification of the DHQ, the 
original NIH-NCI Diet History Questionnaire asks participants about 
foods consumed during the past year. For the IFPS II, the questionnaire 
was modified to ask about foods consumed in the past month, a more 
appropriate interval for measuring diet in pregnancy and lactation. 
Additionally, foods and dietary supplements of special interest in 
pregnancy and lactation were added to the questionnaire, including 
certain fortified foods, foods relevant to developing messages about 
food safety, prenatal vitamin supplements and herbal and botanical 
preparations known to be used for conditions of pregnancy or 
breastfeeding or known to be taken by pregnant women. The wording of 
the question items is given in our draft modified DHQ, which was 
available for review at the time of our first notice of proposed data 
collection (69 FR 21548-21549) and is again available with the present 
notice.
    The DHQ was designed based on food intake from a general population 
national dietary survey, U.S. Department of Agriculture's (USDA's) 
Continuing Survey of Food Intakes by Individuals 1994 to 1996. These 
reference data are representative of the entire U.S. adult population. 
It is true that the DHQ collects limited information on culture-
specific foods. However, significant portions of the questionnaire 
inquire about consumption of whole foods, such as various fruits, 
vegetables, and grains which are common to many cultures. Because the 
DHQ was developed using nationally representative food intake data, it 
is appropriate for this sample of mothers from a fairly broad middle 
segment of the U.S. population.
    Regarding the comment about length and detail of proposed survey 
instruments, we note that the infant related questionnaires take less 
time to complete than they appear because of skip patterns. All 
questionnaires include some questions that only mothers with certain 
characteristics will answer, and most mothers will skip at least some 
of these sections. In the postnatal questionnaires that are composed of 
various modules, some of the modules will be completed only by select 
mothers. For example, Module B, Stopping Breastfeeding, and Module C, 
Food Allergy, will be skipped by most mothers in most months they are 
sent.
    The NIH-NCI DHQ may appear to be lengthy and detailed, but its 
design emphasizes clarity and ease of use for the respondent. The DHQ, 
developed using extensive cognitive testing, presents food questions 
individually, rather than in the older, ``grid'' format; avoids 
grouping food items that are not conceptually similar (although their 
nutrients may be similar); and uses nested questions about differing 
forms of a food. When compared with an older, grid format questionnaire 
in a

[[Page 58918]]

mailed survey, the DHQ had a better response rate, was rated easier to 
use by participants, and had fewer missing or unusable responses on 
portion size, even though the grid format questionnaire had fewer pages 
and took less time to complete. Other studies have shown that the 
accuracy of dietary intake using the DHQ is similar to or better than 
that for standard grid format questionnaires when compared with 
checklist or 24-hour diet recall criteria.
    (Comment 6) One comment from industry states that use of the IFPS 
II data to evaluate the HHS National Breastfeeding Awareness Campaign 
will not be valid unless the sample is truly representative of the U.S. 
population and has an adequate sample of African-Americans, a group 
that the campaign especially hopes to reach.
    (Response) The agency is not persuaded that this component of the 
campaign evaluation requires a nationally representative sample. A 
separate pre-post design evaluation that has a national probability 
sample will examine the campaign's effect on attitudes related to 
breastfeeding, and most of the questions used in that evaluation have 
been included in the IFPS II. The design of the campaign evaluation 
component of the IFPS II is a prospective post-test only measure using 
statistical controls. The analysis will statistically compare mothers 
who are more and less exposed to the campaign and who are more and less 
aware of the campaign on the dimensions of perceptions and beliefs 
about breastfeeding, breastfeeding confidence, feeding intentions, and 
the breastfeeding behaviors of initiation, duration of exclusive 
breastfeeding, and duration of any breastfeeding. Appropriate control 
variables will be included in the analysis, such as demographic 
characteristics and previous breastfeeding experience. Mother's race 
will be included in the analysis to provide information on the extent 
to which the campaign was effective among African-American mothers. As 
noted above, African-American mothers will be oversampled to ensure an 
adequate number for analysis.
    The IFPS II includes several elements that enhance the evaluation 
design. One strength of the design is the prospective data collection. 
Information about awareness of the campaign will first be obtained 
during pregnancy (in addition to monthly after the infant's birth), and 
the outcome variables will be measured throughout the infant's first 
year. In addition, the data will be collected nationally, which will 
provide geographic variation and therefore the ability to collect data 
in communities with varying degrees of exposure to the campaign.

IV. Comments on Topic Three

    What are the ways to enhance the quality, utility, and clarity of 
the information to be collected?
    (Comment 7) One comment from industry urges FDA not to ask for 
specific formula brand name because this information is not needed for 
the agency purposes and could be misused by researchers outside of the 
agency who analyze the data. It recommends that if brands are asked, 
colored package photos of each brand be provided to respondents to 
improve accuracy.
    (Response) The agency agrees that formula brand information is not 
needed for our purposes, and we have revised response options to obtain 
the information we need without identifying specific brands. Our 
interest is in certain characteristics of the formula, such as whether 
it was milk, soy, or hydrolysate based, and whether it contains DHA and 
ARA. We have determined that a series of questions to obtain formula 
characteristics directly from mothers is not the best option because 
some mothers do not know some of the characteristics of interest and 
because the series of questions required each time formula 
characteristics are asked would increase the length and repetitiveness 
of the survey. Therefore, we will ask mothers what brand of formula 
they are using, but the brands will be grouped so that individual 
brands cannot be identified. For example, all of the milk-based 
formulas, including store brands, without DHA and ARA will be grouped 
together; all of the soy-based formulas, including store brands, 
without DHA and ARA will be grouped together, and so forth. The exact 
groupings are listed in the questionnaire. Because brands are grouped, 
there is no need to use color photos to distinguish different formulas 
with similar names because the most similar ones will be in the same 
group.
    (Comment 8) One comment from industry questions whether the two 
psychological testing scales should be used in a mail survey. 
Particularly regarding the depression scale, the concern is that the 
Federal Government would possess potentially life-saving information 
that cannot be used without violating the promise of respondent 
confidentiality.
    (Response) The agency is confident of the appropriateness of these 
scales for a mail survey. The Edinburgh Postpartum Depression Scale is 
a publicly available instrument and is established in the field as a 
standard screening tool for postpartum depression. The Edinburgh 
Postnatal Depression Scale has been used previously in at least two 
large mail surveys, one of which also assessed the relation between 
breastfeeding and postpartum depression. It is administered as a self-
completed survey when it used in clinics or other settings where face-
to-face interactions are possible. The IFPS II will use a version 
slightly modified for consistency with the conventions of the American 
language, as used in the Listening to Mothers Study.
    The Listening to Mothers Survey (LtMS) was a concurrently 
administered mail and Web survey completed by 1,583 women who had given 
birth in the last 24 months. This survey was developed by the Maternity 
Center Association and Harris Interactive to assess a broad range of 
issues related to birth experiences. The survey included items on 
breastfeeding related to the intrapartum hospital stay and the 
Edinburgh Postpartum Depression Scale. The agency has consulted with 
the principal investigators on the LtMS, who have expertise in 
postpartum depression as well as this particular survey methodology, 
and is convinced that administration of the Edinburgh Postpartum 
Depression Scale survey in this medium is appropriate and does not 
introduce risk to the mothers involved in the IFPS II.
    The comment is correct that the IFPS II will not have procedures to 
refer women for followup evaluation if they score relatively high on 
the depression scale. We note that even a high score does not indicate 
a life-threatening extent of depression. Previous researchers have 
faced this same issue of lack of followup as well, which has been 
reviewed in all cases by the appropriate Institutional Review Board. 
The Institutional Review Boards reviewing prior mail surveys have 
determined this risk to be minimal, and use of this measure has also 
been approved by FDA's Research Involving Human Subjects Committee. The 
Rosenberg Self-Esteem Scale measure was developed to be self-
administered and has high reliability. It measures a stable 
characteristic of adults, and therefore a characteristic unlikely to 
change greatly during pregnancy and the postpartum period. The 
Rosenberg Self-Esteem Scale contains no items that are sensitive. It is 
more scientifically rigorous, as well as efficient for the government 
to use established reliable instruments that are available and 
appropriate than to develop its own.
    (Comment 9) One comment from industry states that the wording and 
order of questions in the 1993

[[Page 58919]]

questionnaire have been changed so much that FDA has lost the ability 
to legitimately compare the two studies and draw conclusions about 
changes over time.
    (Response) The agency is not persuaded that comparisons between all 
question results will be invalid because of the addition of new 
questions and the slight differing in order from the previous study. 
Nearly all repeated surveys add and drop some questions between data 
collections because of the imperative need to address current issues 
while keeping the survey length reasonable. The agency recognizes that 
some of the questions have changed from the 1993 study and that the 
context of some questions has necessarily changed because new questions 
have been added. However, FDA has kept the same order of questions 
relative to the 1993 study to the extent possible, but with some 
modifications to improve but questionnaire flow. In addition, for the 
postnatal questionnaires the modules will be placed in the same order 
as they appeared in the 1993 study. Most of the postnatal modules will 
be sent with the same frequency and at the same infant ages as in the 
previous study. The modules that primarily consist of new questions 
will be placed near the end of each postnatal questionnaire in order to 
minimize a change in context for the questions repeated from the 
previous study.
    (Comment 10) One comment from industry states that the 
questionnaire flow, i.e., the order of topics and the transition 
between topics, needs to be improved. It points out that some of the 
problem with questionnaire flow occurs because of the difficulty of 
accommodating new questions within the order of the old questions.
    (Response) The agency has evaluated the order of topics in some of 
the cognitive testing that has been conducted and will also evaluate it 
in the pilot tests to be conducted after OMB approval of the data 
collection. The comment is correct our addition of new questions and 
deletion of old ones has led to a less smooth questionnaire flow in 
some places. We have sacrificed improvements in order to maintain 
maximum comparability with the previous study except where the flow was 
especially awkward. The agency is convinced that comparability is the 
more important characteristic and that questionnaire flow is sufficient 
to achieve valid data.
    (Comment 11) One comment from industry states that some of the 
questionnaires are extremely long and that some of the repeated 
questions have increased in length and complexity. The comment urges 
FDA to conduct pretests to identify and correct sources of respondent 
fatigue, confusion, or inconsistency.
    (Response) The agency agrees that pretesting the questionnaires is 
important. We have conducted cognitive interviews on some parts of the 
questionnaires, and we plan to conduct larger pretests after OMB 
approval for information collection is granted. We disagree that any of 
the questionnaires are extremely long. None are longer than the 
questionnaires in the original study, for which response rates and data 
quality were very good. As part of the questionnaire development and in 
response to these comments, we will continue to evaluate the effect of 
lengthy questions before the questionnaires are fielded.
    (Comment 12) One comment from industry states that some of the 
questionnaires do not include a WIC participation question.
    (Response) The WIC participation question will appear in all 
questionnaires. It is in Module L, which will be sent in all postnatal 
questionnaires.
    (Comment 13) One comment states that factual information is needed 
on how much influence, if any, infant formula labeling and advertising 
have on a woman's decision to use infant formula. It recommends that 
questions be added that will address formula marketing and use of 
infant formula. A specific question recommended is whether mothers read 
infant formula labels before they decide whether or not to breastfeed, 
and if so, how much influence the information on the labels has on 
their decision.
    (Response) The agency is not persuaded that direct questions about 
the influence of various factors on infant feeding intentions will be 
useful. At the time of the prenatal questionnaire, mothers will have 
intentions for methods of feeding their babies but actual behavior will 
come after the infant is born. We have included questions about sources 
of information, which is an appropriate and related topic.
    (Comment 14) One comment states that an assessment of the impact of 
the National Breastfeeding Awareness Campaign on a woman's 
decisionmaking would be useful.
    (Response) The agency agrees with this comment. We note that the 
questionnaires have been designed to measure the association between 
awareness of and agreement with the campaign messages and breastfeeding 
behaviors promoted by the campaign.

V. Specific Comments on the Prenatal Questionnaire

    (Comment 15) The questionnaire emphasizes breastfeeding, which 
could bias respondents postnatally. The concern is that answering 
questions about breastfeeding prenatally will have an artificial effect 
on behavior.
    (Response) The agency disagrees that any effect on behavior of 
answering questions prenatally will be large. While the agency is 
concerned about the possibility of previous questions influencing 
behavior, it is essential to obtain a description of infant feeding 
intentions and attitudes from the prenatal questionnaire. Most of the 
sources of information about infant feeding that a pregnant woman is 
exposed to probably mention the value of breastfeeding, so that 
answering questions about breastfeeding will not introduce an idea to 
which the mother would not otherwise be exposed. It is unlikely that 
the presence of questions about breastfeeding will affect subsequent 
behavior differently than questions from health care professionals and 
important family members or information already available to pregnant 
women. Additionally, approximately 70 percent of new mothers in the 
United States initiate breastfeeding and the rates are expected to be 
higher in this sample because of the demographic characteristics. 
Therefore, most women in the sample will have thought about 
breastfeeding and will have planned to initiate breastfeeding before 
reading the IFPS II questions.
    (Comment 16) One comment recommends that prenatal questions about 
intended feeding methods appear earlier in the questionnaire, followed 
by questions to elicit the primary influencers of her decision. A 
similar comment states that the prenatal question about exposure to 
breastfeeding and infant formula information from various sources is 
adequate to assess awareness of those sources, but that to assess 
impact, additional questions about how much impact the public 
communication or advertisements had on knowledge, decisionmaking and 
behavior should follow. The comment recommends that the agency ask the 
mother to rate the influence of certain information on her 
decisionmaking.
    (Response) The agency agrees that moving intended feeding methods 
to an earlier part of the questionnaire will substantially improve the 
questionnaire flow and has made this change.
    We are not persuaded that direct questions about the influence of 
labels

[[Page 58920]]

and advertising on infant feeding behavior are as useful as questions 
about exposure to various factors and the subsequent measurement of 
attitudes and behaviors. People are often unaware of the effect of 
specific information. For example, most people report that advertising 
has no effect on their behavior, but research indicates that this is 
not the case. We do ask about the reasons for certain behaviors, 
including stopping breastfeeding, changing formula brands, and choosing 
formula brands. For the first behavior, the mother is not likely to be 
aware of the influence of specific information such as formula 
advertising. For the other two behaviors, it is possible that mothers 
sought information from formula labels and advertising and are 
therefore more likely to be able to report their influence.
    (Comment 17) One comment states that the question about which 
medical conditions the baby's relatives have will confuse the 
respondents, particularly the ``other relatives'' column because it is 
unclear how to answer if some other relatives have the condition, some 
do not, or their conditions are not known. It recommends that the 
question be reduced to ask whether anyone in the family has each 
condition. In addition, the comment states that the terms ``eczema,'' 
``food allergy,'' and ``overweight/obesity'' are not defined, thereby 
allowing for a wide range of interpretations.
    (Response) The agency has completed cognitive testing of this 
question and has found that pregnant women and mothers do not have 
trouble answering it. This type of checklist is commonly completed at 
doctor's offices and in other medical settings. The information is 
important to have for the mother herself because some of the conditions 
may affect breastfeeding. Whether the infant's first degree relatives, 
in contrast to other relatives, have the condition is important. The 
question asks about ``any'' other relatives, not ``all'' other 
relatives, a wording which should help the mother understand the 
meaning of the question.
    As people answer medical condition checklists, they should 
recognize the term if they have the condition. Cognitive tests have 
shown that mothers are not disturbed by encountering unknown conditions 
in this list. The agency has asked whether respondents or their infants 
or children have food allergies in the original IFPS and also in 
general population telephone surveys. It is likely that people who have 
a true food allergy, and especially a severe one, will classify 
themselves correctly so that the category will include nearly all of 
the targeted group, but will also include some that are not actually in 
the classification. That is, the classification will be useful even 
though it is not perfect. Regarding ``overweight/obesity,'' although 
some respondents may misclassify themselves or their relatives, prior 
research has demonstrated that self-report of this condition is 
appropriate for use in this type of research setting.
    (Comment 18) One comment states that the workplace questions ask 
mothers to speculate on workplace receptiveness to breastfeeding but 
that all these questions are vague and should be qualified.
    (Response) The agency is not persuaded that the workplace questions 
are vague nor that they ask for speculation on the part of the mother. 
The pregnant women we have interviewed so far have been aware of 
workplace issues related to breastfeeding because they are in a 
situation that makes the information very relevant to them. A later 
questionnaire asks about specific issues related to workplace and to 
child care support for breastfeeding, and it asks for the mother's 
overall impression using the same questions as in the prenatal 
questionnaire. Cognitive testing on the full set of questions has shown 
that mothers can answer the specific and the general question easily 
and that they see the general question as a summary of all various 
practices and policies of the workplace. The mother's overall 
impression is what the question intends to measure, and it appears to 
work for this purpose. The cognitive interviews suggest that mothers 
give the question a consistent interpretation.
    (Comment 19) Both comments from industry find this question to be 
vague: ``Which of the following statements is closest to your opinion? 
The best way to feed a baby is:'' They state that the age of the baby 
is not specified in the question and that ``best'' is not defined in 
terms of the mother's or child's interest. One comment recommends a 
different question: ``From what you know, which is generally healthier 
for an infant: breastfeeding, formula feeding, both are about the 
same?''
    (Response) The agency is not persuaded that the question is vague 
when asked in the context of the prenatal questionnaire. The question 
was asked on the original IFPS, and it was analytically useful. The 
context of the prenatal questionnaire leads respondents to think of 
very young babies rather than older ones. The question asks for a 
general, overall assessment by the mother, similar to the overall 
assessment we ask regarding the supportiveness of the workplace. We 
have no reason to believe that mothers have varied interpretations of 
this question. If we ask about the best feeding method for different 
interests and different dimensions, such as physical or psychological 
health, many additional questions would be needed, and we would not 
know how important the various aspects are to the mothers. The one 
question provides us with the information we are seeking.
    In addition to these considerations, this question was asked on the 
population survey to assess pre-campaign attitudes toward 
breastfeeding. It is important to ask the same question of mothers in 
the IFPS II.
    (Comment 20) One comment states that new mothers are notoriously 
poor at remembering where advertising has been seen. It suggests that 
responses be collapsed into a single response on the question which 
asks where mothers where they have seen advertisements about 
breastfeeding and about infant formula.
    (Response) The agency disagrees that these response categories 
should be collapsed. This information was asked for breastfeeding on 
the population survey to assess precampaign attitudes toward 
breastfeeding. As noted previously, it is important to ask the same 
question of mothers in the IFPS II. It would be confusing to ask 
mothers one set of sources for breastfeeding and a different one for 
infant formula.
    (Comment 21) Both comments from industry suggest that the agency 
differentiate between emotional commitment and understanding of 
scientific relationships in the following question: ``How strongly do 
you agree or disagree with the following statement? Infant formula is 
as good as breast milk'' and other statements. Both comments from 
industry assert that the question does not specify the meaning of 
``good'' or of ``less'' likely.
    (Response) This question is one asked on the population survey 
conducted before the National Breastfeeding Awareness Campaign 
launched. Each statement asks about a specific information element of 
the campaign. These are essential and direct measures of agreement with 
the campaign messages. The agency is not persuaded that the question 
should be changed.
    (Comment 22) One comment asks that the following question be 
deleted because such adjective checklists of this type are typically 
administered immediately after exposure to an ad, not when respondents 
must recall their feelings about an ad they saw in the past. ``Thinking 
about the advertisement for breastfeeding, please mark whether

[[Page 58921]]

you agree or disagree with each of the following statements. It's 
entertaining,'' and other statements.
    (Response) The agency agrees that this question should be deleted 
throughout the questionnaires.
    (Comment 23) Both comments from industry recommend adding a 
question about formula feeding similar to the following question to 
reduce potential bias caused by a concentration on breastfeeding. 
``About how many of your friends and relatives have breastfed their 
baby?'' It also recommends adding ``if any'' after ``about how many,'' 
to ensure that the response ``none'' is not underreported.
    (Response) The agency agrees that it would enhance the study to 
include a similar question to determine whether the respondent has 
friends or relatives who have used formula. Because most infants 
receive formula some time during the first year even if they are 
breastfed, the more meaningful question would be how many friends and 
relatives used only formula from their baby's birth. We are not 
persuaded that the additional phrase ``if any'' is needed. The question 
is one from the original study, in which 3 percent of respondents chose 
the option ``none have breastfed.'' In addition, 1 percent said that 
none of their friends or relatives have children, and 8 percent 
responded ``don't know.'' In all, 12 percent chose an answer other than 
a number. While a frequency distribution cannot assure that a response 
was not underreported, it does at least indicate that a sizeable number 
of respondents noticed the response options other than numbers.
    (Comment 24) One comment notes that ``never'' was added to the 
response options and recommends that ``never'' be replaced with ``don't 
know'' in the following question: ``How old do you think your baby will 
be when you first feed him or her formula or any other food besides 
breast milk?''
    (Response) The agency is persuaded that ``never'' should be deleted 
from these response options. In order to keep the response options the 
same as in the original question, ``don't know'' will not be added.
    (Comment 25) One comment asks that the agency delete these 
questions: ``How old do you think your baby will be when you completely 
stop breastfeeding?'' and ``Using 1 to mean `not at all confident' and 
5 to mean `very confident,' how confident are you that you will be able 
to breastfeed until the baby is the age you marked in the previous 
question?'' The comment states that the questions are a repeated 
measure and that they invite mothers to speculate on when they will 
stop breastfeeding and their ability to do what they say (via a 
``confidence'' scale). Sensitizing mothers to this issue prenatally can 
bias their behavior postnatally. Similarly, repeatedly asking it 
postnatally could also bias continued behavior.
    (Response) The agency is not persuaded that the study would be 
improved by deleting these questions. Intended duration of 
breastfeeding was asked in the original study and is an important 
variable for explaining actual duration. The addition of how confident 
the mother is that she will breastfeed for that duration is a question 
suggested by the Health Belief Model of behavioral change. As noted 
previously, the agency is concerned about the possibility that asking 
questions about breastfeeding might affect subsequent behavior. As 
mentioned in the response to the first item commenting about the 
prenatal questionnaire, pregnant women are exposed to information about 
breastfeeding in multiple ways and from authoritative sources such as 
child birth educators, nurses, physicians, and important family 
members. It is unlikely that additional exposure through a 
questionnaire will have substantial additional effect.

VI. Birth Screener

    (Comment 26) One comment recommends that the agency clarify this 
question: ``Did the mother/you have any medical problems that prevented 
(her/you) from feeding the baby for more than a week?'' The comment 
states that it is not clear whether the question pertains only to 
breastfeeding.
    (Response) The agency is not persuaded that changing this question 
will improve the usefulness of the data because it was used in the 
previous study to screen out mothers with serious medical problems. 
However, we will add an interviewer instruction to clarify if needed to 
the respondent that we mean any type of feeding, not just 
breastfeeding. To mix the concepts of how the mother intended to feed 
the infant and her health in one question would change the selection 
criteria for the sample. Similarly, to change the question to a series 
of questions on mothers' health would eliminate comparability with the 
previous sample.

VII. Specific Comments on the Neonatal Questionnaire

    (Comment 27) One comment states that unnecessary complexity to the 
point that it interferes with comprehension has been added to this 
question modified from the 1993 study: ``In your opinion, which 
statement best describes your doctor or health professional's attitude 
about feeding your baby, and the attitude of the staff in the hospital, 
clinic, or birth center where you delivered?'' The comment suggests 
that influences be simplified to obstetrician/gynecologist (OB/GYN), 
pediatrician, doctor on staff at hospital, and other staff at hospital. 
It suggests that responses be simplified to breastfeed only, formula 
feed only, breastfeed and formula feed, or no opinion/did not discuss. 
The comment also recommends a simpler alternative, asking whether any 
medical professionals or staff at the hospital gave advice or opinions 
on how to feed your baby in the hospital. Those who responded yes would 
be asked to check all the ways they were advised to feed their baby 
with the responses listed above (breastfeed only, etc.).
    (Response) The agency notes that the 1993 question asked only about 
hospital staff and a different question asked about the recommendation 
of a doctor or other health professional. The new question asks about 
the two health professional categories in the same format while 
differentiating between the mother's and baby's doctors, and it asks 
about perception of attitude rather than recommendation.
    The agency is persuaded that some of the changes recommended in the 
comment will improve the usefulness of the data but that other 
recommended changes will not. In a paper published from the previous 
questions on this topic, we found that many women did not report 
receiving positive breastfeeding messages from doctors and hospital 
staff and that mothers who perceived that the hospital staff expressed 
no preference on feeding method were significantly less likely to 
breastfeed beyond 6 weeks. Cognitive interviews have suggested that 
mothers differentiate the attitudes of their physician or obstetrician 
and those of the baby's doctor. Therefore, in the proposed study, it is 
important to ask the mother to provide an answer for each type of 
physician and for hospital staff and to include ``had no preference for 
method of feeding'' as a response option. In cognitive interviews, the 
question was tested with the last two response options (had no 
preference and had no discussion of feeding) combined, and one of the 
mothers expressed a need for the latter category.
    The response options in the question, strongly favored 
breastfeeding to strongly favored bottle feeding, were tested in 
cognitive interviews to determine whether mothers differentiated 
strength of attitude. It was found that they did not. Therefore, the

[[Page 58922]]

agency has used the response option change recommended in the comment 
(breastfeed only, formula feed only, etc.), along with the no 
preference and no discussion response options.
    (Comment 28) One comment asks that the agency reword the question 
on what the mother thinks is the recommended number of months to 
exclusively breastfeed a baby to ask whether the mother received a 
recommendation about how long to exclusively breastfeed. The comment 
expresses concern that the current question will lead mothers to assume 
that there are a recommended number of months and invites them to guess 
what it is.
    (Response) The agency is not persuaded that this question should be 
changed as suggested. Because there is a recommendation from the 
American Academy of Pediatrics Work Group on Breastfeeding and from the 
American Dietetic Association to exclusively breastfeed for 6 months 
and from the American Academy of Pediatrics Committee on Nutrition to 
breastfeed exclusively for 4 to 6 months, and because the National 
Breastfeeding Awareness Campaign will include exclusive breastfeeding 
for 6 months as a message, the IFPS II needs to collect data on what 
mothers think the recommendation is, regardless of whether a health 
professional has made a specific recommendation to the mother. The 
agency added a response option, ``Don't know,'' so that mothers will 
not be encouraged to guess.
    (Comment 29) Both industry comments state that some response 
options are missing from this question: ``What were the reasons you 
decided not to breastfeed your baby?'' Both comments are concerned that 
personal preference and the inconvenience of breastfeeding are not 
included. Both comments also suggest rewording one of the response 
options from ``had to go back to work/school'' to ``planned to go back 
to work/school.'' Both recommend that the question obtain a measure of 
importance for the reasons. One comment recommended including responses 
to identify infant formula advertising and breastfeeding promotion as 
reasons for the feeding choice. The comment also recommended including 
economic reasons because of the claimed health benefits of continued 
breastfeeding and associated medical care cost reductions.
    (Response) The agency is persuaded that obtaining a measure of 
importance will improve the question because it will make it comparable 
to other similar questions. We note that ``breastfeeding was too 
inconvenient'' was a response option for a similar question on reasons 
for stopping breastfeeding, and we have changed this neonatal question 
to have the same response options, to the extent possible, as the 
question on stopping breastfeeding. It now includes the option, ``I 
thought that breastfeeding would be too inconvenient.'' The agency does 
not agree that ``personal preference'' will be a helpful response 
option because it is too vague. We also do not agree that adding a 
response option on economics will be useful for this question because 
the economic benefits are associated with breastfeeding, not with 
formula feeding.
    As discussed earlier, we do not believe that mothers will be aware 
of or be able to adequately report the influence of formula labeling 
and advertisement. That option has not been added.
    (Comment 30) One comment states that this question is vague and 
should be deleted ``How long was it until you became emotionally 
comfortable nursing your baby?''
    (Response) The agency is not persuaded that this question should be 
deleted. One reason is that it is repeated from the original study. 
Another reason is that initial cognitive testing has shown that mothers 
for whom breastfeeding has gone well have chosen shorter times than 
mothers who have had more difficulty with breastfeeding.
    (Comment 31) One comment recommends that this question be returned 
to the wording in the 1993 questionnaire: ``Did you get any help with 
these problems from a doctor or other health professional, a lactation 
consultant, or a breastfeeding support group?'' It notes that the 
original questions said ``did you ask for help.''
    (Response) The agency notes that these two questions address very 
different phenomena. The original question will reveal whether mothers 
recognize the need for help and ask for help in the early days of 
breastfeeding, whereas the revised question addresses the actual 
provision of assistance to mothers regardless of whether they asked for 
help. The agency is persuaded that the 1993 question should be 
retained; however, the revised question will be included as well to 
differentiate these two experiences. Because mothers may receive help 
whether they ask for it or not, one question is not contingent on the 
other.
    (Comment 32) One comment recommends changing the question on pain 
with breastfeeding. The comment states that the 10-point scale (from no 
pain at all to the worst pain you have ever felt) is not applicable to 
breastfeeding and risks trivializing the issue. It also states that it 
is debatable whether mothers can accurately recall and differentiate 
the pain level over four short and successive periods of time. It 
suggests that the question be divided into two questions. The first 
question would ask the mother to rate the pain the first time she 
breastfed on a 4-point scale from very severe to no pain. The second 
question would ask whether the pain became less severe over time.
    (Response) The agency disagrees that changing this question will 
improve the data. Cognitive interviews have shown that breastfeeding 
pain usually begins later than the first breastfeeding and that after 
pain develops, it diminishes rapidly for some mothers but slowly for 
others. Therefore, a question will not characterize the pain if it only 
asks about pain at the first breastfeeding and then evolution of this 
pain for a time. In addition, a 10-point scale for pain with anchors 
similar to those used in the question is a standard pain self-
assessment. We have changed the anchor to read ``worst possible pain'' 
to reflect the exact wording of the published anchors for this scale. 
Our use of this scale for different time periods will enable 
respondents to describe the level of pain over time, not only whether 
it got better. The mothers will be about 3 weeks postpartum when they 
answer this question, and it is unlikely that the time periods will 
have already blurred for them.
    (Comment 33) One comment states that the questions about gift packs 
should be modified to reflect the possibility of multiple gift packs or 
multiple samples in the mail.
    (Response) The agency acknowledges that mothers receive multiple 
gift packs and may also receive multiple samples of infant formula 
through the mail. A question was added that asks about receiving gift 
packs from places other than the hospital, and the question about 
receiving a gift pack from the hospital has been clarified. The issue 
of distinguishing formula brands from the various sources of gift packs 
is no longer relevant because we do not ask about formula brand.
    (Comment 34) One comment states that an added response option to 
this question is vague and could apply to almost any brand: ``When you 
first began buying formula, how did you decide which brand of formula 
to buy for your baby?'' The option of concern is: ``Chose a brand 
advertised as better for my baby's development.'' The comment notes 
that the statement is leading because consumers are not likely to 
distinguish between ``advertising'' and other forms of information 
about brand benefits.

[[Page 58923]]

    (Response) The agency is persuaded that the option should be 
changed rather than deleted, and we have reworded it as follows: ``I 
heard that the brand is better for my baby.'' The question is asking 
for the mothers' reasons for choosing a formula brand, and most of the 
response options could apply to any formula brand. We agree that 
mothers are not likely to distinguish advisements from brochures or 
other information about formula, and we are not interested in a narrow 
definition of advertisement. The new wording does not ask the mother to 
distinguish advertising from other information.
    (Comment 35) One comment states that the reference formula in this 
question is unclear: ``Did you discuss your choice of formula brand 
with the baby's doctor.''
    (Response) The agency agrees that the reference formula is unclear 
and has revised the question to clarify it.
    (Comment 36) One comment recommends that ``brand of formula'' 
replace ``choice of formula'' so that it is not confused with form of 
formula in two questions: ``Did you discuss your choice of formula 
brand with the baby's doctor,'' and ``During the past two weeks, have 
you switched the formula you feed your baby?''
    (Response) The agency notes that formula brand is already in the 
first question. The second one has been changed to incorporate the 
recommended change.
    (Comment 37) One comment states that too many response options have 
been added to this question: ``What kind of problem(s) have you had 
(breastfeeding since the first week)?'' The comment states that the 
added response options complicate the question and contribute to 
driving the questionnaire to an unacceptable length.
    (Response) The agency is not persuaded that adding relevant 
response options complicates a question. Rather, it gives respondents a 
way to indicate an answer that best fits them. In cognitive interviews, 
respondents offer additional responses to questions if they find that 
none of the responses fit them or if they have additional salient 
responses that they want to give. The agency is not persuaded that the 
neonatal questionnaire is an unacceptable length. The new questionnaire 
is about the same length as the neonatal questionnaire in the 1993 
study, which had a very high response rate.
    (Comment 38) One comment repeats comment 25 of this document on the 
prenatal questionnaire, concerning the repeated question regarding 
intended duration of breastfeeding and confidence in achieving the 
intended duration.
    (Response) See response under comment 25 of this document for the 
prenatal questionnaire.
    (Comment 39) One comment suggests that the agency change this 
question to ask about concerns rather than feelings: ``How often do you 
have the feelings described in the following statements?''
    (Response) The agency is not persuaded that the change would 
improve the data. The purpose of the question is to measure the 
mother's confidence in breastfeeding. The concepts included are those 
that occur in several lengthy measures of breastfeeding confidence, 
none of which as a whole were determined to be appropriate for the IFPS 
II. It is possible for a person to be very concerned about something, 
and therefore more vigilant and successful, or very concerned because 
they are not successful. Changing the question as recommended would 
provide an indication of concerns without information on how the 
mothers coped with the concerns. In cognitive interviews, mothers have 
indicated that they are concerned about some statements to which they 
respond very positively. For example, a mother said that she is always 
concerned whether her infant gets enough milk at a feeding, so she 
observes the baby to see that he appears satisfied. She marked 
``always'' for ``I feel that my baby gets enough breast milk at each 
feeding.'' It is the latter information that will be useful in the 
study.

VIII. Specific Comments on Module A

    (Comment 40) One comment states that this question attempts to 
combine two issues that should be kept separate to minimize the risk of 
overstating the situation: ``During the past two weeks, how often has 
your baby been put to bed with a bottle of formula, juice, juice drink, 
or milk of any kind?'' The two issues are how often and on what 
occasions babies are put to sleep with a bottle.
    (Response) The agency is not persuaded that the recommended change 
would improve the validity of the data and believes that it would be 
much more burdensome to respondents. This question is easy for mothers 
to answer and it repeats a question from the previous study. The 
purpose of the question is to find out how regularly the infant goes to 
sleep with a bottle of anything besides water. The naps and bedtimes 
were divided in the response options because mothers in the cognitive 
testing for the first study indicated that behavior sometimes differs 
by these sleep times.
    (Comment 41) One comment states that certain medical conditions 
need to be defined in the check list for this question: ``Did your baby 
have any of the following illnesses or problems during the past two 
weeks?'' In particular, the comment recommends that these terms be 
defined as the following: food allergy, eczema, and other skin rashes.
    (Response) The agency agrees that the term ``other skin rash'' is 
vague and has deleted it from the list of illnesses. As we stated in 
the response to the comment on the prenatal questionnaire item that 
asks the mother to report family history of medical conditions, it is 
likely that those mothers whose infants have a food allergy or eczema 
will know what the terms mean, and the others will not be concerned 
that they cannot define some of the terms. We do not agree that these 
terms need to be defined.

IX. Specific Comments on Module B

    (Comment 42) One comment states that the response grid has been 
lengthened substantially for this question: ``How important was each of 
the following reasons for your decision to stop breastfeeding your 
baby?'' The comment states that responses located at the end of the 
response grid will probably be understated. It recommends that similar 
responses be consolidated. Another comment recommends that additional 
response options be added to elicit information on the influence of 
formula advertisements and labels as reasons the mother stopped 
breastfeeding.
    (Response) The agency shares the comment's concern about lengthy 
lists of response options. The issue has been addressed in cognitive 
interviews, but a larger number of respondents is needed to evaluate 
the issue. In the previous IFPS, items at the end of the list had 
sizeable positive responses. For example, 20 percent of respondents to 
Module B at infant age 3 months marked the next-to-last item, ``I 
wanted my body back to myself'' as greater in importance than ``not at 
all important.'' (This response option was inadvertently omitted from 
the question and has been added.) It may be that when respondents are 
asked to rate each item, they are less likely to stop reading before 
the end of the list.
    The agency will conduct tests of the effects of long lists on 
responses after OMB approval of the study, when the questionnaires can 
be administered to additional respondents. The agency has combined as 
many responses as it deems sufficiently similar in this and other long 
response option lists to

[[Page 58924]]

reduce the number of items, and further items will be combined if 
possible after additional tests. As noted earlier, the agency does not 
agree that information about the influence of formula advertisements 
and labels can be obtained from this survey, and we have not added 
items regarding formula labels.
    (Comment 43) One comment recommends that this question should be 
revised and should be preceded by a question asking whether anyone said 
that the mother should stop breastfeeding: ``Did any of the following 
people want you to stop breastfeeding?'' It notes that this will enable 
asking a question that was on the 1993 questionnaire. It also suggests 
that respondent may feel uncomfortable singling out their employer or 
supervisor.
    (Response) The agency is not persuaded that two questions should be 
asked. It is not persuaded that the question should be asked as in the 
1993 questionnaire because ``said you should stop'' is only one form of 
communication; ``want you to stop'' allows for communications that are 
not direct statements. By asking the mother to consider whether each of 
the people listed wanted her to stop breastfeeding, we do not require 
the mothers to think through everyone they have contact with to answer 
a first broad question. By listing specifically those people of 
interest, we help the mothers remember all people of interest to us. 
The category, ``employer or supervisor,'' has been tested through 
cognitive interviewing and was not problematic. This is probably 
because mothers understand that their employers and supervisors do not 
have access to their responses on this survey. In all data files, 
mothers will be anonymous so that the possibility of anyone tracking 
down their employer or giving employers the information is even more 
remote.
    (Comment 44) One comment is concerned that the following question 
is too speculative: ``How likely is it that you would breastfeed again 
if you had another child * * * .'' It recommends that the question be 
changed to ask mothers how interested they would be in breastfeeding 
their next baby.
    (Response) The agency is not persuaded that the recommendation 
would improve the data. The question is repeated from the 1993 survey, 
so that change would destroy the possibility of comparison across time. 
In addition, intentionality and confidence in the decision to 
breastfeed have been found to be a strong predictor of actual 
subsequent breastfeeding behavior, whereas ``interest'' is a diffuse 
concept to operationalize.

X. Specific Comments on Module C

    (Comment 45) One comment relates to this question: ``What brand of 
formula did your baby have the problem with or react to?'' The comment 
is concerned that the question perpetuates a misconception that formula 
causes intolerance symptoms and states that if formula intolerance 
occurs, it would be more likely to be related to the type (e.g., milk 
or soy-based) than brand. It recommends that if the question is kept, 
the 1993 version be used because it does not ask mothers to attribute 
causality to formula used at the time. It also notes that it has asked 
that all questions that ask respondents to identify brands of formula 
be deleted.
    (Response) The agency agrees that formula brand is not needed for 
this question. We will ask the mother to choose a formula brand from 
grouped categories as described in the response to the first comment on 
the third topic for which we requested comments. In addition, the 
questions has been changed to that asked in the 1993 study.
    (Comment 46) One comment concerns this question: Is there an infant 
formula your baby was given and did not have a reaction to? The comment 
notes that it has asked that all questions that ask respondents to 
identify brands of formula be deleted. These alternative questions are 
recommended: ``What other types of infant formula have you used,'' or 
``What form of formula were you using when the baby did not experience 
any symptoms of allergy or intolerance?''
    (Response) The agency agrees that brand is not needed and has 
changed the question.
    (Comment 47) One comment concerns questions about age at first 
problem that mother thought was food allergy to formula and to any 
other food and symptoms of food allergy to formula and to food. The 
comment does not want specific brand to be indicated.
    (Response) The agency agrees that specific formula brands are not 
needed for this question. The questions have been reworded.
    (Comment 48) One comment concerns this question: ``Were the 
symptoms diagnosed as a food allergy by a doctor or other health 
professional?'' The comment is concerned that the question leads the 
respondents, and that they will interpret whatever the doctor said as 
indicating a food allergy. It recommends a rewording to include whether 
the problem was diagnosed as a food allergy or as an intolerance and 
offers several other options.
    (Response) The agency is not persuaded that the question leads the 
respondents. In the previous study, about half of respondents who had 
consulted a doctor for the baby's symptoms said that the baby had been 
diagnosed as having a food allergy. Without independent assessment, it 
is not possible to know whether the respondents properly classified 
themselves, but it is certainly the case that not all respondents who 
had seen a doctor reported that the baby had a food allergy. We note 
that additional information in the questionnaire is available regarding 
the probable accuracy of the mother's report, including method of 
diagnosis and symptoms.
    (Comment 49) One comment recommends that ``allergy'' be used in the 
following question and the instruction before it instead of ``food 
allergy.'' ``What method did the doctor use to diagnose the food 
allergy?'' The comment is concerned that the doctor may have only said 
``allergy'' and not ``food allergy'' so that the question will lead to 
underreporting.
    (Response) The agency is not persuaded that the wording of 
questions in this section should delete the term ``food'' to modify 
``allergy.'' The section screens people in only if they state that the 
baby has had an allergic reaction or intolerance to food. Therefore, 
only people who believe that their baby has some sort of reaction to 
food will be answering these questions. In question 6, which asks what 
symptoms of food allergy or intolerance the baby had, the question may 
be confusing to people whose infants have had reactions to substances 
other than food if we only ask about ``allergy.'' The agency will test 
these questions for clarity before the questionnaires are finalized.

XI. Specific Comments on Module D

    (Comment 50) One comment repeats comment 25 of this document on the 
prenatal questionnaire, concerning the repeated question regarding 
intended duration of breastfeeding and confidence in achieving the 
intended duration.
    (Response) See response under comment 25 of this document for the 
prenatal questionnaire.
    (Comment 51) One comment concerns this question: ``Where have you 
obtained information about breastfeeding and where have you obtained 
information about breast pumps for this baby or other babies?'' The 
comment states that recollection on sources of information for specific 
topics with previous children is likely to be poor. In addition, the 
list is too

[[Page 58925]]

long, risking understatement of items at the end.
    (Response) The agency is persuaded that the question should be 
changed. As with other questions about sources of information, sources 
for this baby and previous babies are combined so that the mother does 
not have to distinguish them. More important, the question has been 
revised to ask about breast pumps only and has been moved to the 
section on breast pumps.
    Rather than asking about sources of information about 
breastfeeding, we ask about sources of information about infant 
feeding, and this question will be asked in module F only. The times of 
administration of module F have been revised to obtain the information 
earlier.
    We kept the idea of including sources of information for previous 
babies because cognitive testing revealed that respondents with older 
children were concerned that they were not able to mark any sources of 
information, or very few, for the current baby, despite having obtained 
information prior to this child. They pointed out that they had already 
read the books, discussed issues with health professionals, etc., and 
didn't need to do it again. The agency is concerned about the lengthy 
list of sources and has shortened it.
    (Comment 52) One comment notes that answer grids are inconsistent 
between similar questions. For example, ``How important were each of 
the following reasons for feeding your baby formula?'' and other 
questions on reasons for not breastfeeding and questions about reasons 
for stopping breastfeeding have similar items as reasons, but some ask 
the respondent to complete a four-point rating scale of importance 
whereas others ask the respondent to mark which reasons were important. 
Both industry comments suggest that the response list include 
advertisements for infant formula including other media such as direct 
mail, Internet physician brochures, as well as infant formula labels as 
a possible reason the mother feeds her baby formula.
    (Response) The agency is persuaded that the data will be more 
useful if all of these types of questions have the same answer grids 
and have response options as similar as possible. The specific reasons 
have been revised to accommodate concerns about redundancy and lengthy 
lists to the extent possible to maintain comparability with the 1993 
questions and to provide the detail needed for some classes of reasons. 
As noted previously, the agency does not agree that information about 
the influence of infant formula advertising and labels can validly be 
obtained from this survey.
    (Comment 53) One comment offers a suggestion for changing the 
questions about cleaning the bottle nipples used to feed the baby 
expressed breast milk and about sterilizing the pump collection kit, 
the container used to collect the milk, and the bottle used to feed the 
baby the expressed milk. The suggestion is to ask two questions: ``What 
are all the ways you cleaned the bottle nipples in the last seven 
days,'' and ``Which one way did you clean the most often?''
    (Response) The agency is not persuaded that the suggestion is an 
improvement. Asking two questions would increase the length of the 
questionnaire. Asking which of several possible cleaning methods was 
used most often would increase respondent burden without adding 
important information because the main interest is in the less safe 
methods, which will rarely be used ``most often.'' Results from 
cognitive interviews and reviews by experts have led to changes in the 
question about sterilizing the pump collection kit, etc. The question 
now asks how often the items are sterilized rather than whether or not 
they are sterilized before being used again.
    (Comment 54) One comment states that the term ``hurt'' is vague in 
this question: ``Have you been hurt by any breast pump that you used or 
tried to use to express milk since this baby was born?''
    (Response) The agency is not persuaded that the term ``hurt'' is 
vague. Cognitive interviews were conducted using the term ``injured,'' 
which might be seen as more specific, in the above question. 
Respondents were alarmed and disturbed about the possibility of being 
injured by a breast pump. In subsequent interviews, the term ``hurt'' 
was used, and respondents answered the question without expressing 
alarm. The term ``hurt'' will enable respondents who have been injured 
to provide the information without alarming other mothers who have not 
been injured.

XII. Specific Comments on Module E

    (Comment 55) One comment states that the question asking 
respondents to evaluate certain characteristics of formula labels is 
complicated and will invite confusion and inconsistency. It recommends 
that respondents be asked if they have looked at certain information 
before they are asked to evaluate it. The comment also recommends 
specific questions to replace this one for the current brand of 
formula. The recommended questions are as follows: (1) Is there 
anything on the label that is hard to understand? (2) Is there any 
information you wanted that was missing? and (3) Is there any part of 
the label that you tried to look at but had difficulty finding or 
reading because the print size was too small? In addition, the comment 
asks that the agency include a question regarding the mother's 
perception or understanding of how important it is to follow the label 
directions regarding the prepared formula.
    (Response) The agency agrees that respondents need to be asked 
whether they have looked at the various types of information on formula 
labels before this question asking for their evaluation. It also agrees 
that this question needs to be simplified and has done so. However, the 
changes recommended in the comment are not adequate for our information 
needs. One reason is that the agency wants respondents to think about 
the specific types of information mentioned and not other information, 
such as the ingredient list, which might have different reading 
characteristics. The agency also does not want to rely on ``top-of-the-
mind'' responses from open-ended ``specify'' instructions, which may be 
too vague to interpret. The agency agrees that it would be useful to 
add a question about how important the mother believes it is to follow 
certain label directions.
    (Comment 56) Regarding the question asking the respondent to 
evaluate the pictorial directions for preparing formula, one comment 
asks that a question be added to establish whether the mother has 
looked at this part of the label.
    (Response) The agency agrees that a question should be added to 
establish whether the mother has looked at the pictorial directions 
before evaluating this part of the label.
    (Comment 57) One comment states that respondents will not be able 
to recall what ingredient they were looking for when they looked at the 
ingredient list of the label. It suggests that we ask what ingredient 
they were most concerned about when they decided to look at the label, 
with a response option, ``no particular ingredient.''
    (Response) The agency agrees that use of the phrase ``concerned 
about'' rather than ``looking for'' will make the question closer to 
the 1993 question, and the change will be made. The agency believes 
that respondents who were not looking for a specific ingredient are 
accommodated already by the preceding question that asks whether they 
used the list to look for any specific ingredient. Those who were not 
looking for a particular ingredient can mark ``no'' in this question 
and skip

[[Page 58926]]

the question about what ingredient they were looking for. In addition 
to these changes, the questions have been revised to allow for looking 
anywhere on the label for any particular ingredient or characteristics 
because the presence or absence of certain ingredients is often 
indicated somewhere else in addition to the ingredient list.
    (Comment 58) One comment recommends that questions be added to 
determine whether mothers find the nutrition content and information on 
special attributes on infant formula labels useful and desirable. The 
comment states that it would be valuable to know if mothers understand 
health claims and labels claims on formula in the proper context of one 
formula compared to other formulas, or if the statements require 
rewording to avoid inappropriate comparison of formula to 
breastfeeding, or unintended comparisons to other foods like cow milk 
or juice.
    (Response) The agency disagrees that the IFPS II is an appropriate 
mechanism to examine detailed understanding of label claims and the 
effect of specific label wording. These types of issues are better 
addressed in experimental studies where researchers know exactly what 
subjects are viewing when they answer specific questions. The label 
questions in the IFPS apply to all formula containers, whereas health 
and label claims differ by brand and other formula characteristics.
    (Comment 59) One comment recommends that a question be added to 
assess mother's perception of how safe infant formula powder is from a 
microbiological standpoint and whether infant formula powder is 
sterile.
    (Response) The agency agrees that this additional information will 
be useful and has added a question.
    (Comment 60) One comment recommends a simplification of the 
question about cleaning bottle nipples used to feed formula. It 
suggests this question, ``In the past seven days, how did you usually 
clean the bottle nipples (select one response from list)?''
    (Response) The agency is not persuaded that the suggestion is an 
improvement. This question needs to be parallel to the question about 
cleaning the nipples used to feed expressed milk (see comment 53 of 
this document under module D). As noted in the response to that 
comment, the main interest is in the less safe methods, which will 
probably be used only some of the time, so that asking about usual 
cleaning methods will not provide the information required.
    (Comment 61) One comment recommends a lead-in to help mothers feel 
more comfortable as they answer the question about handwashing before 
preparing formula.
    (Response) The agency agrees that a lead-in such as that 
recommended will improve the data and has added it.
    (Comment 62) One comment points out that respondents who have 
switched brands of formula more than 2 weeks earlier answer a question 
that includes no responses related to digestibility or tolerance, in 
contrast to those who switched in the past 2 weeks. They recommend that 
either the response list for the two questions be made comparable or 
that the time period for formula brand switching be lengthened to any 
period of time.
    (Response) The agency rejects the suggestion that the time period 
for formula brand switching be lengthened to any period of time. A 
longer time period for brand switching would lead to less precise 
answers and more misclassification because mothers would not be able to 
rely on their recent memory, particularly if the reasons for switching 
were not salient to them. Therefore, the time period has not been 
changed.
    We examined the possibility of making the two lists comparable. 
However, one question asks for reasons for leaving a brand and the 
other asks for reasons for using a brand, and the comparable reasons do 
not work for the two opposite questions. We added a response on the 
list for reasons for choosing a brand that relates to intolerance of 
the previous brand: ``My previous formula brand did not agree with my 
baby and this brand is better for the problem.''

XIII. Specific Comments on Module F

    (Comment 63) One comment recommends a different placement for the 
question on sources of information about herbal preparations and also 
states that the response list is unnecessarily detailed and too long. 
It also recommends that the questionnaire first establish whether the 
respondent has ever sought information about herbs, botanicals, or 
other dietary supplements.
    (Response) The agency calls attention to the note at the beginning 
of module F, which states that these questions will not be asked as a 
separate module, but will be inserted in appropriate places within 
other modules. This question about information sources for dietary 
supplements will follow questions about intake of these substances, but 
only in months 4 and 10.5.
    The agency has considered response lists for all questions about 
sources of information together, has make them consistent to the extent 
possible given the information needs, and has combined some of the 
detailed but similar categories. Regarding asking first whether the 
mother has sought information, we note that information is often 
unsolicited, whether or not the respondent chooses to use the 
substances.
    (Comment 64) One comment recommends that the agency not ask about 
sources of information for previous infants and that the response list 
for sources of information be consolidated and shortened. They refer to 
comment 53 of this document in module D.
    (Response) See comment 53 of this document in module D.

XIV. Specific Comments on Module G

    (Comment 65) One comment states that the questions in module G 
repeat questions in the prenatal and other questionnaires about the 
National Breastfeeding Awareness Campaign. It expresses concern that no 
questions determine whether the respondent has seen any of the campaign 
advertisements or that the campaign is responsible for any of the 
attitudes that are measured.
    (Response) The agency does not agree that awareness of campaign 
advertisements is not measured. These questions appear in the prenatal 
questionnaire, the neonatal questionnaire, and in module L, which will 
be sent at each administration of the postnatal questionnaires. The 
questions state that ``a description of a campaign advertisement will 
be provided,'' although one example is given. The specific 
advertisements asked about will rotate among the various ads from the 
campaign.
    It is the case that specific questions about the campaign are asked 
in the prenatal questionnaire and are repeated at infant ages 3 and 7 
months. While the research design will not be able to prove that 
breastfeeding attitudes are affected by the campaign, the design will 
be able to provide evidence of the effect of the campaign. The analysis 
of breastfeeding attitudes and knowledge in geographical areas with 
different extents of exposure to the campaign advertisements and 
between individuals who have and who have not seen the advertisements 
will provide this evidence.
    (Comment 66) One comment asks the agency to consider the comments 
stated in comment 20 of this document for the prenatal questionnaire 
regarding recall of where advertisements or other information was seen.
    (Response) The agency refers to the response under that comment.

[[Page 58927]]

    (Comment 67) One comment states that the lack of an infant age in 
the question asking what is the best way to feed a baby is a greater 
limitation in the ability to interpret the response when this question 
is asked of older infants.
    (Response) The agency is persuaded that the same question asked in 
the prenatal questionnaire cannot be repeated for older infants. We 
have added infant age in the month 3 question and dropped the question 
for month 7.
    (Comment 68) One comment states that comment 21 of this document 
for the prenatal questionnaire applies to this repeated question also. 
That comment concerned the question asking about agreement with 
campaign messages.
    (Response) The agency refers to the response under that comment.

XV. Specific Comments on Module H

    (Comment 69) One comment refers back to comment 18 of this document 
of the prenatal questionnaire for a repeated question regarding 
workplace supportiveness for breastfeeding.
    (Response) The agency refers to the response under that comment.
    (Comment 70) One comment suggests that a question on workplace 
policies regarding breastfeeding will require the respondent to 
speculate when they answer whether all mothers are covered by the 
policies. It recommends changing the question to a yes-no response 
format.
    (Response) The agency agrees that respondents may not know what the 
workplace policy is for other mothers. The question has been changed.
    (Comment 71) One comment states that the question about 
breastfeeding obstacles at work covers very sensitive material that may 
have legal implications to the extent that respondents are invited to 
record real or imagined improper actions by people at work.
    (Response) The agency disagrees that the question is sensitive or 
has legal implications. The question asks the mother whether she has 
had certain experiences at work, but the responses will be the mothers' 
perceptions. Details are not asked that would be needed to determine 
whether illegal behavior has occurred. Furthermore, none of the 
experiences asked about is illegal in the general way described. None 
of the respondents in cognitive interviews have thought the questions 
sensitive.
    FDA estimates the burden of this information collection as follows:

                                                  Table 1.--Estimated Annual Reporting Burden Year 1\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual
                 Questionnaire                      No. of       Frequency per   Total Annual        Hours per Response              Total Hours
                                                  Respondents      Response        Responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prenatal                                                 3,500               1           3,500                .25                       875
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prenatal Diet History Questionnaire                      1,400               1           1,400               1.00                     1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Questionnaire                     1,400               1           1,400               1.00                     1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 2 Questionnaire                                    2,250               1           2,250                .42                       945
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 3 Questionnaire                                    2,250               1           2,250                .42                       945
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 4 Questionnaire                                    2,250               1           2,250                .25                       562.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 5 Questionnaire                                    1,875               1           1,875                .42                       787.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 6 Questionnaire                                    1,500               1           1,500                .42                       630
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 7 Questionnaire                                    1,125               1           1,125                .42                       472.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Month 9 Questionnaire                                      375               1             375                .25                        94
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                           ..............  ..............          23,331  ...........................           8,953
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with the collection of information.


                              Table 2.--Estimated Annual Reporting Burden Year 2\1\
----------------------------------------------------------------------------------------------------------------
                                                Annual
       Questionnaire            No. of       Frequency per   Total Annual       Hours per         Total Hours
                              Respondents      Response        Responses         Response
----------------------------------------------------------------------------------------------------------------
Month 5 Questionnaire                  375               1             375                .42             157.5
----------------------------------------------------------------------------------------------------------------
Month 6 Questionnaire                  750               1             750                .42             315
----------------------------------------------------------------------------------------------------------------
Month 7 Questionnaire                1,125               1           1,125                .42             472.5
----------------------------------------------------------------------------------------------------------------

[[Page 58928]]


Month 9 Questionnaire                1,875               1           1,875                .25             469
----------------------------------------------------------------------------------------------------------------
Month 10 Questionnaire               2,250               1           2,250                .42             945
----------------------------------------------------------------------------------------------------------------
Month 12 Questionnaire               2,250               1           2,250                .42             945
----------------------------------------------------------------------------------------------------------------
Total                       ..............  ..............           8,625  .................           3,304
----------------------------------------------------------------------------------------------------------------
\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: September 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22052 Filed 9-30-04; 8:45 am]

BILLING CODE 4160-01-S