August
12,
2005
Population­
based
Pilot
Study
of
Children's
Environmental
Health
in
Support
of
the
National
Children's
Study
Supporting
Statement
Docket
#:
ORD­
2005­
0010
ICR
#
2187.01
Contact
Information
Pauline
Mendola
US
EPA/
NHEERL
Human
Studies
Division
MD
58A
Research
Triangle
Park
NC
27711
919­
966­
6953
Mendola.
Pauline@
epa.
gov
i
TABLE
OF
CONTENTS
FOR
ICR
SUPPORTING
STATEMENT
Part
A
of
the
ICR
Supporting
Statement.................................................................................
4
1.
Identification
of
the
Information
Collection.................................................................
4
1(
a)
Title
of
the
Information
Collection...........................................................................
4
1(
b)
Short
Characterization/
Abstract
...............................................................................
4
2.
Need
for
and
Use
of
the
Collection................................................................................
4
2(
a)
Need/
Authority
for
the
Collection............................................................................
4
2(
b)
Practical
Utility/
Users
of
the
Data............................................................................
5
3.
Non­
duplication,
Consultations,
and
Other
Collection
Criteria..................................
7
3(
a)
Non­
duplication.......................................................................................................
7
3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
.......................................
7
3(
c)
Consultations...........................................................................................................
7
3(
d)
Effects
of
Less
Frequent
Collection
.........................................................................
9
3(
e)
General
Guidelines
..................................................................................................
9
3(
f)
Confidentiality.........................................................................................................
9
3(
g)
Sensitive
Questions................................................................................................
10
4.
The
Respondents
and
the
Information
Requested........................................................
11
4(
a)
Respondents/
SIC
Codes.........................................................................................
11
4(
b)
Information
Requested...........................................................................................
12
5.
The
Information
Collected
 
Agency
Activities,
Collection
Methodology,
and
Information
Management...................................................................................................
31
5(
a)
Agency
Activities
..................................................................................................
31
5(
b)
Collection
Methodology
and
Management.............................................................
31
5(
c)
Small
Entity
Flexibility..........................................................................................
32
5(
d)
Collection
Schedule
...............................................................................................
32
6.
Estimating
the
Burden
and
Cost
of
the
Collection.....................................................
34
6(
a)
Estimating
Respondent
Burden..............................................................................
34
6(
b)
Respondent
Costs
..................................................................................................
39
6(
c)
Estimating
Agency
Burden
and
Cost......................................................................
40
6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs..........................
41
6(
e)
Bottom
Line
Burden
Hours
and
Costs
Tables.........................................................
44
6(
f)
Reasons
for
Change
in
Burden...............................................................................
45
6(
g)
Burden
Statement..................................................................................................
45
Part
B.
Required
Items
for
Information
Collections
Involving
Statistical
Sampling
...
47
1.
Survey
Objectives,
Key
Variables,
and
Other
Preliminaries.....................................
47
1(
a)
Survey
Objectives..................................................................................................
47
1(
b)
Key
Variables
........................................................................................................
48
1(
c)
Statistical
Approach...............................................................................................
48
1(
d)
Feasibility..............................................................................................................
49
2.
Survey
Design
..............................................................................................................
49
2(
a)
Target
Population
and
Coverage
............................................................................
49
2(
b)
Sample
Design.......................................................................................................
52
2(
c)
Precision
Requirements
.........................................................................................
54
3.
Pretests
and
Pilot
Tests
...............................................................................................
59
4.
Collection
Methods
and
Follow­
Up
........................................................................
59
ii
4(
a)
Collection
Methods................................................................................................
59
4(
b)
Survey
Response
and
Follow­
Up
...........................................................................
61
5.
Analyzing
and
Reporting
Survey
Results
...............................................................
61
5(
a)
Data
Preparation
....................................................................................................
61
5(
b)
Analysis.................................................................................................................
62
5(
c)
Reporting
Results
..................................................................................................
62
Appendix
A:
Copy
of
60­
Day
Federal
Register
Notice
(
FR)
and
Supporting
Documentation
.................................................................................................................................................
63
1.
Copy
of
the
FRN
Used
To
Solicit
Public
Comments..................................................
63
2.
Draft
of
the
30­
Day
FRN.............................................................................................
78
References
...............................................................................................................................
83
Appendix
B:
Final
Visit
Schedule
and
Burden
Estimates
.....................................................
84
Appendix
C:
Questionnaire
Instrument
Table
......................................................................
94
iii
Table
of
Exhibits
Exhibit
1.
Non­
EPA
Individuals
Consulted
on
the
Pilot
Study
8
Exhibit
2.
NCS
Interagency
Coordinating
Committee
8
Exhibit
3
Domains
for
maternal
and
partner
interview/
questionnaires
13
Exhibit
4.
Schedule
of
Preconception
Visits
33
Exhibit
5.
Schedule
of
Post­
conception
Visits
33
Exhibit
6.
Number
of
Eligible
Women
Screened
and
Enrolled,
and
Number
of
Births
Expected
by
Group
35
Exhibit
7.
Burden
Estimates
for
Screening
and
Preconception
Visits
36
Exhibit
8.
Burden
Estimates
for
Pregnancy
and
Birth/
Childhood
Visits
37
Exhibit
9.
Estimated
Respondent
Burden
in
Hours
38
Exhibit
10.
Total
Estimated
Burden
and
Costs:
Screening,
Preconception,
Pregnancy,

Birth,
and
Childhood
Visits
40
Exhibit
11.
Agency
Cost
Annual
Burden
41
Exhibit
12.
Respondent
Universe
Estimates
for
Screening
and
Preconception
Visits
43
Exhibit
13.
Respondent
Universe
Estimates
for
Pregnancy
and
Birth/
Childhood
Visits
44
Exhibit
14.
Annual
Burden
by
Respondent
Type
46
Exhibit
15.
Births
in
2003
by
Mother's
County
of
Residence
51
Exhibit
16.
Estimated
Power
to
Compare
Screening
Response
Rates
between
Two
Equal
Subgroups
of
Housing
Units
56
Exhibit
17.
Estimated
Power
to
Compare
Enrollment
Rates
between
Two
Equal
Subgroups
of
Women
57
Exhibit
18.
Estimated
Power
to
Compare
Newborn
Enrollment
Rates
between
Two
Equal
Subgroups
of
Women
Giving
Birth
During
the
Study
58
4
Part
A
of
the
ICR
Supporting
Statement
1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection
The
title
of
the
information
collection
is:
"
Population­
based
pilot
study
of
children's
environmental
health
in
support
of
the
National
Children's
Study."
This
study
will
be
referred
to
as
the
"
Pilot
Study"
within
this
Supporting
Statement.

**
This
ICR
requires
a
"
Privacy
Impact
Assessment
(
P.
I.
A.)"
It
is
currently
being
conducted
and
will
be
submitted
to
OMB
at
its
completion.

1(
b)
Short
Characterization/
Abstract
The
U.
S.
Environmental
Protection
Agency
(
EPA)
is
conducting
this
information
collection
activity
in
partnership
with
the
National
Children's
Study
(
NCS)
Program
Office
at
the
National
Institute
of
Child
Health
and
Human
Development
(
NICHD)
of
the
National
Institutes
of
Health
(
NIH)
as
well
as
the
other
NCS
lead
agencies:
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
and
the
National
Institute
of
Environmental
Health
Sciences
(
NIEHS)
at
NIH.
The
information
will
be
used
by
federal
and
non­
federal
entities
planning
the
implementation
and
operations
for
the
NCS.

The
purpose
of
this
Pilot
Study
is
to
test
logistics,
protocols
and
procedures
considered
for
implementation
in
the
NCS,
a
long
term
study
of
the
influence
of
environmental
factors
on
child
health
and
development.
The
goal
is
to
improve
the
efficiency
and
enhance
the
likelihood
of
successfully
recruiting
and
retaining
the
study
subjects
in
the
NCS
by
testing
procedures
for
population­
based
sampling
and
subject
recruitment,
proposed
study
logistics
and
estimates
of
subject
burden,
and
evaluating
data
collection
strategies
including
interviews
and
acquisition
of
biologic
and
environmental
samples.
Further
details
on
the
NCS,
including
the
NCS
Study
Plan,

can
be
found
at
www.
nationalchildrensstudy.
gov.

2.
Need
for
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection
The
goal
of
the
proposed
information
collection
is
to
test
the
methods
of
populationbased
recruitment
and
implementation
protocols
for
the
NCS.
The
Pilot
Study
will
provide
relevant
data
on
the
response
rate,
completion
rate
and
acceptability
of
data
collection
procedures,
and
burden
for
various
survey
methods
proposed
for
the
NCS.
This
collection
5
supports
activities
outlined
in
the
Children's
Health
Act
of
2000
(
PL
106­
310).
This
law
specifically
authorizes
the
conduct
of
a
national
longitudinal
study
of
environmental
influences
on
children's
health
and
development
and
directs
the
participation
of
EPA,
in
collaboration
with
its
federal
partners,
in
this
effort.
The
full
NCS
meets
several
scientific
needs,
including:

 
Conducting
a
national,
longitudinal
cohort
study.
To
make
valid
conclusions
about
relationships
between
exposures
and
health
outcomes
in
children
that
can
be
generalized
to
the
U.
S.
population,
the
NCS
requires
a
national
probability­
based
sampling
design
that
includes
children
and
families
from
different
areas
of
the
U.
S.
with
diverse
backgrounds.
The
NCS
will
use
a
long­
term
prospective
cohort
study
design,
beginning
before
birth
until
children
are
21
years
old,
giving
researchers
an
unmatched
data
source
from
which
to
study
children's
health.

 
Investigating
exposure
from
a
broader
perspective.
The
NCS
will
examine
exposure
from
various
perspectives,
including
biological,
physical,
genetic,
social,
cultural,
and
chemical
factors
that
may
affect
a
child's
health
and
development.

 
Examining
many
complex
hypotheses
on
children's
health
and
the
environment.
The
NCS
will
address
research
questions
of
public
health
importance
for
children's
wellbeing.
Results
from
the
NCS
will
help
identify
environmental
factors
that
are
harmful
as
well
as
those
factors
that
are
helpful
or
harmless.

The
NCS
held
an
expert
panel
Sampling
Design
Workshop
on
March
21­
22,
2004,
that
recommended
pursuing
a
population­
based
sampling
strategy,
but
noted
that
"
The
lack
of
precedent
for
a
study
of
this
size
and
complexity
at
least
in
the
United
States
dictate
the
need
for
pilot
efforts
to
assess
the
feasibility
of
this
approach.
The
pilot
study
needs
to
be
carefully
planned
and
implemented
so
that
the
most
effective
methods
of
recruitment
and
data
collection
are
identified."
The
report
can
be
found
on
the
NCS
web­
site
at
http://
www.
nationalchildrensstudy.
gov/
events/
workshops/
samplingdesign032004.
cfm.
This
Pilot
Study
is
designed
to
provide
that
information.

2(
b)
Practical
Utility/
Users
of
the
Data
The
NCS
Study
Plan
outlines
a
very
complex
design
for
sampling
and
data
collection.

EPA
anticipates
that
the
data
collected
in
this
Pilot
Study
will
be
very
useful
to
the
NCS
planners,
including
federal
partners
at
NIH
and
CDC
as
well
as
to
the
non­
federal
contractors
that
will
manage
the
NCS
Coordinating
Center
and
Vanguard
Study
Centers.
Study
data,

including
information
on
logistics,
subject
burden
and
acceptance
of
procedures,
will
be
provided
to
the
study
planners,
including
the
NCS
Program
Office,
NCS
Interagency
Coordinating
Committee
(
ICC)
and
NCS
Steering
Committee,
on
a
regular
basis
to
guide
and
improve
the
efficiency
and
effectiveness
of
plans
for
full
NCS
implementation.
6
7
3.
Non­
duplication,
Consultations,
and
Other
Collection
Criteria
3(
a)
Non­
duplication
The
Pilot
Study
is
designed
specifically
to
support
the
National
Children's
Study,
a
large
prospective
cohort
study
of
the
influence
of
the
environment
on
child
health
and
development.

Early
in
the
planning
phase,
a
review
of
existing
studies
and
data
available
from
previous
federal
surveys
was
conducted
by
the
President's
Task
Force
on
Environmental
Health
Risks
and
Safety
Risks
to
Children.
This
panel
of
experts
determined
that
a
new
effort
was
needed
to
comprehensively
address
children's
environmental
health.
This
Pilot
Study
can
provide
information
about
how
well
the
proposed
NCS
methods
work
in
field
settings.
We
know
of
no
other
effort
at
this
time
that
will
provide
the
important
data
required
for
this
major
interagency
effort
to
study
children's
environmental
health.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
The
initial
60­
day
Federal
Register
Notice
(
FR)
for
this
proposed
data
collection
was
published
on
April
12,
2005.
A
copy
of
the
60­
day
FR
is
included
in
Part
B
Section
6
and
is
also
available
on
the
E­
docket
ORD­
2005­
0010,
located
at:

http://
docket.
epa.
gov/
edkpub/
do/
EDKStaffCollectionDetailViewByID?
collectionId=
ORD­
2005­

0010.

During
the
60­
day
FR
period,
one
comment
was
received
and
addressed
by
EPA.
The
comment
is
included
in
Appendix
A,
along
with
a
copy
of
the
response.
More
details
on
the
comment
can
also
be
found
in
Section
3(
c)
Consultations.

3(
c)
Consultations
The
following
non­
EPA
individuals,
listed
in
Exhibit
1,
were
consulted
to
provide
advice
and
guidance
on
all
aspects
of
the
design
and
conduct
of
the
study.
8
Exhibit
1.
Non­
EPA
Individuals
Consulted
on
the
Pilot
Study
Name
Phone
Number
Affiliation
Amoke
Alakoye,
MHS
301­
230­
4656
RTI
International
Ruth
Brenner,
MD,
MPH
301­
496­
5581
NICHD,
NIH,
DHHS
Margie
Byron,
MS
919­
541­
6086
RTI
International
Linda
Dimitropoulos,
PhD
312­
456­
5246
RTI
International
Warren
Galke,
PhD
301­
594­
1336
NICHD,
NIH,
DHHS
Richard
Kwok,
PhD
919­
316­
3336
RTI
International
Sharon
Myers,
MPH
919­
541­
7316
RTI
International
Roy
Whitmore,
PhD
919­
541­
5809
RTI
International
The
ICC,
which
is
responsible
for
planning
the
NCS,
has
provided
extensive
feedback
on
the
planning
for
this
Pilot
Study.
ICC
members
are
listed
in
Exhibit
2.
Concept
clearance
was
also
sought
from
the
NCS
chartered
federal
advisory
committee.
A
subcommittee
reviewed
and
approved
the
Pilot
Study
concept.
The
Pilot
Study
was
presented
to
the
full
NCS
Advisory
Committee
at
their
public
meeting
in
April
2005
with
opportunity
for
discussion
among
committee
members
as
well
as
comment
from
the
public
audience.

Exhibit
2.
NCS
Interagency
Coordinating
Committee
Name
Phone
Number
Affiliation
Elizabeth
H.
Blackburn,
BSN
202­
564­
2192
Office
of
Children's
Health
Protection,
EPA
Amy
Branum,
MSPH
301­
458­
4731
National
Center
for
Health
Statistics
(
NCHS),
CDC,
DHHS
Adolfo
Correa,
MD,
PhD
404­
498­
3811
National
Center
for
Birth
Defects
and
Developmental
Disabilities
(
NCBDDD),
CDC,
DHHS
Sarah
Keim,
MA
301­
435­
6923
NICHD,
NIH,
DHHS
Woodie
Kessel,
MD,
MPH
240­
453­
8256
Office
of
the
Secretary,
DHHS
Mark
Klebanoff,
MD,
MPH
301­
496­
5267
NICHD,
NIH,
DHHS
Pauline
Mendola,
PhD
919­
966­
6953
National
Health
and
Environmental
Effects
Research
Laboratory
(
NHEERL),
EPA
Sheila
A.
Newton,
MS,
PhD
919­
541­
4343
NIEHS,
NIH,
DHHS
James
J.
Quackenboss,
MS
702­
798­
2642
National
Exposure
Research
Laboratory
(
NERL),
EPA
Peter
C.
Scheidt,
MD,
MPH
301­
496­
6287
NICHD,
NIH,
DHHS
Kenneth
Schoendorf,
MD,
MPH
301­
458­
4486
NCHS,
CDC,
DHHS
Sherry
G.
Selevan,
PhD
202­
564­
3312
National
Center
for
Environmental
Assessment
(
NCEA),
EPA
Marshalyn
Yeargin­
Allsopp,
MD
404­
498­
3842
NCBDDD,
CDC,
DHHS
9
3(
d)
Effects
of
Less
Frequent
Collection
The
study
design
and
visit
schedule
of
the
Pilot
Study
is
based
on
the
proposed
design
and
visit
schedule
in
the
NCS
Study
Plan.
The
study
planners
for
the
NCS
have
optimized
the
number
of
data
collection
time
points
to
gather
comprehensive,
relevant
information
while
minimizing
burden
on
participants
and
study
staff
alike.
Given
that
exposures
can
change
over
time
and
the
impact
of
exposure
on
health
and
development
can
be
different
at
various
developmental
stages
during
pregnancy
and
childhood,
it
is
important
to
collect
data
frequently
enough
to
assess
the
environmental
impact
on
child
health.
In
order
to
maximize
the
utility
of
the
Pilot
Study
for
the
NCS,
the
same
frequency
of
subject
contact
is
proposed.

3(
e)
General
Guidelines
The
Pilot
Study
will
conform
to
all
OMB
general
guidelines
for
information
collections.

Women
who
are
potential
participants
in
the
study
areas
will
be
contacted
for
a
household
screening
by
field
interviewers
and
provided
with
basic
information
about
the
study
to
determine
if
they
are
eligible
to
participate.
Potential
participants
will
be
screened
to
determine
their
likelihood
of
pregnancy
status
and
confirm
their
age
eligibility.
Potential
participants
may
also
be
contacted
via
telephone,
if
necessary.
Respondents
interested
in
participating
will
be
invited
to
complete
a
schedule
of
telephone
and
home
visits
similar
to
those
proposed
for
the
NCS.

3(
f)
Confidentiality
Because
this
study
will
collect
sensitive
and
personal
information,
data
must
be
protected
to
maintain
confidentiality.
We
will
adhere
to
several
procedures
and
processes
for
maintaining
confidentiality,
including:

 
assigning
unique
case
identification
numbers
to
identify
study
participants;

 
de­
identifying
data
to
strip
any
identifying
information
from
the
data,
i.
e.,
keeping
the
identifiable
information
in
separate
files
for
which
a
restricted
number
of
people
will
have
access;

 
obtaining
a
certificate
of
confidentiality
for
the
study
to
provide
assurance
to
study
participants;

 
obtaining
signed
Assurances
of
Confidentiality
from
all
project
staff
pledging
their
commitment
to
protecting
the
study
data;

 
conducting
annual
and
refresher
training
according
to
the
Office
of
Human
Research
Protections
(
OHRP)
guidelines;
and
10
 
training
study
staff
in
the
application
of
Health
Insurance
Portability
and
Accountability
Act
(
HIPAA)
regulations
regarding
obtaining
protected
health
information
from
health
providers
or
insurance
companies
(
i.
e.,
covered
entities).

Study
procedures
will
be
developed
to
ensure
the
physical
security
of
hardcopy
data
forms
and
the
electronic
security
of
computerized
data.
We
will
create
unique
study
identifiers
to
protect
the
confidentiality
of
study
participants.
All
completed
hardcopy
questionnaires
will
be
stored
in
locked
files
in
secure
facilities.
EPA
will
regularly
monitor
contractor
compliance
with
confidentiality
requirements.
Any
electronic
copies
of
data
containing
personal
information
will
be
kept
in
password
protected
computers
or
CDs
in
a
locked
filing
cabinet
in
a
secure
facility.

No
reports
will
contain
any
uniquely
identifying
information
about
the
participants.

3(
g)
Sensitive
Questions
This
Pilot
Study
will
collect
longitudinal
data
from
pregnant
women
and
women
attempting
pregnancy
and
their
husbands
or
partners.
The
study
will
ask
sensitive
questions
in
several
questionnaire
domains
including:

 
alcohol
 
demographics
(
e.
g.,
marital
status,
income)

 
tobacco
(
self)

 
family
history
 
financial
security
 
medical
history
 
mental
health
 
reproductive
health
(
i.
e.,
current
contraceptive
method,
pregnancy
status,
reproductive
history)

 
paternity
The
NCS
Study
Plan
(
http://
www.
eps.
gov/
spg/
HHS/
NIH/
NICHD/
RFP­
NICHD­
2004­

07/
Attachments.
html)
proposes
the
need
for
information
on
a
variety
of
potentially
sensitive
topics
both
to
determine
eligibility
(
such
as
factors
related
to
likelihood
of
pregnancy:

contraceptive
use,
etc.)
and
to
examine
multiple
exposures,
including
physical
and
social
factors
that
may
be
important
for
child
health
outcomes.
This
Pilot
Study
addresses
similar
domains
in
order
to
field
test
the
methods
and
acceptability
of
these
questions
including
a
test
of
processes,

procedures,
question
content,
question
layout,
questionnaire
design,
and
questionnaire
modality.
11
The
informed
consent
process
will
alert
respondents
to
the
broad
range
of
sensitive
questions.
Respondents
can
refuse
to
answer
any
question
and
still
participate
in
the
study.

The
sensitive
portions
of
the
interview
will
be
self­
administered
via
Audio
Computer­

Assisted
Self
Interviewing
(
ACASI)
so
that
the
interviewers
will
not
know
respondents'
answers.

ACASI
enables
respondents
to
complete
the
questions
privately
by
either
listening
to
them
using
an
audio
headset
or
reading
them
on
the
computer
screen,
and
then
entering
their
own
responses
directly
into
the
computer.
This
method
maximizes
respondent
privacy
and
confidentiality.

4.
The
Respondents
and
the
Information
Requested
4(
a)
Respondents/
SIC
Codes
Respondents
for
this
information
collection
will
be
recruited
among
women
residing
in
selected
areas
of
Forsyth
and
Davidson
Counties
of
North
Carolina
across
three
major
categories:
(
1)
pregnant
women
aged
18
and
older,
(
2)
non­
pregnant
women
aged
18
to
40,
and
(
3)
women
enrolled
at
the
hospital
after
giving
birth.
Non­
pregnant
women
will
be
further
stratified
as
proposed
in
the
NCS
Study
Plan:

 
High
likelihood
for
pregnancy
 
women
who
are
not
using
any
method
of
birth
control
and
are
attempting
to
become
pregnant.

 
Moderate
likelihood
for
pregnancy
 
women
who
are
using
a
birth
control
method
with
less
than
90
percent
effectiveness
and
are
sexually
active.

 
Low
likelihood
for
pregnancy
 
women
who
are
not
sexually
active
or
are
using
a
birth
control
method
with
greater
than
90%
effectiveness.

Respondents
for
this
study
will
also
include
partners
(
e.
g.,
husbands
or
domestic
partners)

and
children
of
the
participating
women.

Because
the
Pilot
Study
will
also
collect
information
from
hospitals
and
clinics,
Standard
Industrial
Codes
(
SIC)
will
define
these
sources
of
information.
SIC
codes
chosen
for
this
study
can
be
referenced
from
OSHA
"
Division
I:
Services,
Major
Group
80:
Health
Services"
and
include:

 
SIC
Code
8011
 
Offices
and
Clinics
of
Doctors
of
Medicine.
This
code
is
included
because
we
anticipate
collecting
biologic
specimens
at
private
clinics
from
study
participants.

 
SIC
Code
8062
­
General
Medical
and
Surgical
Hospitals.
This
code
is
included
because
we
will
be
working
with
hospitals
and
study
participants
to
collect
biologic
specimens
at
birth
(
e.
g.,
cord
blood,
infant
blood
spot,
placental
weight,
etc.).
12
4(
b)
Information
Requested
(
i)
Data
items,
including
recordkeeping
requirements
In
order
to
determine
an
individual's
eligibility
for
the
study,
it
will
first
be
necessary
to
determine
whether
any
eligible
participants
reside
in
the
identified
geographic
areas
through
a
process
known
as
"
rostering."
Trained
field
staff
will
visit
every
dwelling
unit
within
an
identified
geographic
area
in
order
to
roster
each
household
(
Instrument
#
1
in
Appendix
B)
to
determine
whether
any
potentially
eligible
participants
are
available.
Rostering
is
expected
to
take
10
minutes
per
household.
Should
any
potentially
eligible
participants
be
identified,
these
individuals
will
be
screened
(
Instrument
#
2
in
Appendix
B)
in
order
to
determine
whether
or
not
they
are
truly
eligible
and
interested
in
participating
in
the
study.
Screening
is
expected
to
take
10
minutes
per
respondent.
Once
a
participant
volunteers
and
is
enrolled
into
the
study,
a
variety
of
information
will
be
collected
using
a
series
of
questionnaires
at
different
points
in
time
during
the
study
as
noted
below.
13
Exhibit
3
Domains
for
maternal
and
partner
interview/
questionnaires
Preconception
(
16
Mths)
Pregnancy
visits
(
9
months)
Childhood
visits
(
18
months)

Roster
Screen
Initial
#
2
#
3
#
4
Phone
FU
First
home*
#
1
OGT
T
#
2
#
3
First
home*
Birth
1
month
6
month
12
month
18
month
Instrument
#
1
2
3,
4,
5
6,
7
8
9
10
13,
14
11,
12
15,

16
17,

18,
19
20,
21
22
23,
24,

25,
26
27
28
Acceptability
y
(
w&
p)
y
y
y
y
(
w&
p)
y
(
w&
p)
y
y
y
(
w&
p)
y
y
y
y
Activity­
maternal
f
f+
f
(
w&
p)
u
f
Alcohol
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u
(
w&
p)
u
Chemical
exposures
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u
u
(
w&
p)
u
u
Child
development
y
y
y+
y+
y+

Demographics
Name
y
Age/
DOB
y
y
y
(
p)
y
(
p)
y
(
p)

Gender
y
Race/
ethn
y
y
(
p)
y
(
p)
y
(
p)

Nativity
y
y
(
p)
y
(
p)
y
(
p)

Hispanic
y
y
(
p)
y
(
p)
y
(
p)

Education
y
y
(
p)
y
(
p)
y
(
p)

Home
Address
y
y
u
u
u
y
u
u
u
u
u
(
w&
p)
u
Telephone
number
y
u
u
u
u
u
u
u
u
(
w&
p)
u
Plans
to
move
y
y
u
u
u
y
u
u
Income
f
(
w&
p)
f
(
w&
p)
f
(
w&
p)
u
Language
y
14
Roster
Screen
Initial
#
2
#
3
#
4
Phone
FU
first
home*
#
1
OGTT
#
2
#
3
first
home*
Birth
1
month
6
month
12
month
18
month
Dental
health
f
f
u
f
Diet
­
Child
Breastfeeding/

Formula
feeding
intent
f
f
u
u
u
Solid
foods
f
u+
u+

Other
food
f
u+
u+

Diet­
maternal
(
SAQ)
t
t
Diet­
maternal
f
f
f
Feelings
about
pregnancy
y
(
w&
p)
y
(
w&
p)
y
(
w&
p)

Health
Care
Access
to
care
f
f
u+
f
Insurance
f
f
u
f
Prenatal
care
b
b
f
Home
Environment
/
Cond.*
f
f
f
Heat
and
Air
Conditioning
f
f
f
Cooking
f
f
f
Pesticides
and
Lawn
Care
f
f
f
u
u
Renovations
and
Paint
f
f
f
u
u
Water
Damage/
Mold
f
f
f
u
u
Household
composition
f
f
f
Infant
safety
f
f
15
Roster
Screen
Initial
#
2
#
3
#
4
Phone
FU
first
home*
#
1
OGT
T
#
2
#
3
first
home*
Birth
1
month
6
month
12
month
18
month
Medical
(
pers
and
family
hx)
Allergies
(
detailed)
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u
u
(
w&
p)
u
u
Asthma
(
detailed)
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u
u
(
w&
p)
u
u
Other
chronic
cond
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u
u
(
w&
p)
u
u
Family
hx
f
(
w&
p)
f
(
w&
p)
f
(
w&
p)

Pregnancyrelated
cond
f
f
u
u
f
Medical
Hx
­
Child
f
f
u+
u+
u+

Well
baby
care
f
u
u
Medications
­
Rx
and
OTC
f
u
u
u
f
u
u
u
f
u
u
Mental
health
(
SAQ)
MOS
Social
Support
t
(
w&
p)
t
(
w&
p
)
t
(
w&
p)

CES­
Depression
t
(
w&
p)
t
(
w&
p
)
t
(
w&
p)

Life
events
t
(
w&
p)
t
(
w&
p
)
t
(
w&
p)

Cohen
perceived
stress
t
(
w&
p)
t
(
w&
p
)
t
(
w&
p)

Financial
security
t
(
w&
p)
t
(
w&
p
)
t
(
w&
p)

Pregnancy
related
anxiety
t
Neighborhood*
f
f
u
f
u
u
Occupation
f
(
w&
p)
u
u
u
f+

(
w&
p)
u
(
w&
p)
u
u+
f+
(
w&
p)
u
u
(
w&
p)
u
u
16
Roster
Screen
Initial
#
2
#
3
#
4
Phone
FU
first
home*
#
1
OGT
T
#
2
#
3
first
home**
Birth
1
month
6
month
12
month
18
month
Partner
name/
address
y
u
u
u
u
u
u
u
u
Pets
and
pests
f
f
u
f
u
u
Post­
partum
depression
f
f
Pregnancy
Status/
Risk
Recognition
of
Preg
y
u
u
u
u
u
u
u
u
Current
contraception
y
u
u
u
u
u
u
u
Desire
to
become
preg.
y
u
u
u
u
u
u
u
Sexual
Activity
y
u
u
OB/
GYN
y
y
y
y
y
y
u
u
Hospital/
Facility
for
Delivery
y
y
y
y
y
y
u
u
u
u
Last
Menstrual
Period
/
Due
Date
y
f
u
u
u
u
u
u
u
u
Reproductive
health
Menstrual
History
f
f
f
Pregnancy
History
f
f
f
Sleep
y
y
y
y
y
Supplements,

Vitamins
f
u
u
u
f
u
u
u
f
u
u
Tobacco
­
self
and
ets
f
(
w&
p)
u
u
u
f
(
w&
p)
u
(
w&
p)
u
u
f
(
w&
p)
u+

(
w&
p)
u+
u+

f
=
full;
f+
=
full,
revised;
u
=
update;
u+
=
update
+
new
questions;
b
=
basic;
y
=
yes;
(
w&
p)
=
woman
and
partner;
t
=
take
home
*
enrolled
at
1st
trimester
pregnancy
**
enrolled
at
2nd
or
3rd
trimester
pregnancy
or
delivery
*
Will
collect
full
instrument
(#
29)
any
time
the
participant
has
moved
to
a
new
address
17
QUESTIONNAIRE
DESIGN
The
questionnaires
have
been
designed
to
collect
information
as
part
of
a
longitudinal
cohort
study
of
children's
health.
A
careful
review
of
questionnaires
and
domains
employed
in
other
studies
of
children's
health,
notably
the
Pregnancy,
Infection
and
Nutrition
study
(
PIN),
the
Pregnancy
Risk
Assessment
Monitoring
System
(
PRAMS)
and
the
Avon
Longitudinal
Study
of
Parents
and
Children
(
ALSPAC),
was
conducted
to
maximize
the
utility
of
the
study
design
and
question
elements.
Data
collection
will
begin
during
the
preconception
period
and
continue
until
the
child
is
18
months
of
age.
A
maximum
of
19
questionnaires
will
be
administered
to
each
participant;
5
take
home
questionnaires
and
14
in
person
interviews
that
will
contain
questions
administered
to
any
participant
via
Computer
Assisted
Personal
Interviewing
(
CAPI).
Women
enrolled
during
pregnancy
will
receive
fewer
questionnaires
and
study
visits
than
women
enrolled
during
their
preconception
period.
Similarly,
partners
of
women
enrolled
during
pregnancy
will
receive
fewer
questionnaires
than
those
enrolled
during
preconception.
Women
will
also
be
asked
to
complete
five
self­
administered
questionnaires
on
paper
and
return
them
by
mail.
Partners
of
the
female
participants
who
choose
to
participate
in
the
study
will
receive
a
maximum
of
six
questionnaires
(
three
in­
person
interviews
and
three
self­
administered
questionnaires).

The
questionnaires
are
divided
into
sections
(
domains)
of
related
questions.
Questions
for
most
domains
are
asked
initially
during
the
first
visit
after
enrollment
and
updated
during
each
of
the
following
visits
(
up
to
14
times
during
the
study
follow­
up
period).
Responses
that
are
expected
to
remain
relatively
constant
are
queried
less
frequently.
Certain
questions
pertain
only
to
specific
stages
in
preconception,
pregnancy
or
childhood.
Personal
identifying
information
included
on
the
questionnaires
will
not
become
part
of
the
statistical
database.
Exhibit
3
illustrates
which
domains
are
queried
at
each
visit,
who
responds
(
the
women
alone
or
both
women
and
their
partners)
and
if
the
questionnaire
is
a
take­
home
or
in
person
interview.

Data
on
household
composition
(
4
questions
minimum,
7
questions
maximum)
are
required
to
enumerate
household
members
of
specific
ages
(>
18
years,
5­
17
years,
<
5
years)
and
determine
whether
the
female
participant
acts
as
a
caregiver
to
any
household
member.
This
information
is
18
needed
to
define
the
social
and
family
context
that
may
influence
the
health
of
the
mother
and
the
child.
This
section
is
included
in
any
first
home
visit.

During
screening,
the
female
participant
is
asked
to
provide
information
about
her
husband
/

partner
(
2
question
minimum,
6
questions
maximum)
in
order
capture
information
on
marital
status
and
identifying
information
for
her
partner
(
name,
telephone
number,
address)
so
that
he
or
she
can
be
contacted
and
invited
to
participate
in
the
study.
Partner
update
information
(
1
question
minimum,
5
questions
maximum)
is
collected
in
the
initial
interview
and
all
preconception
interviews,
the
first
trimester
pregnancy
visit
and
the
one­
month
child
visit.

The
section
on
pregnancy
status
(
2
question
minimum,
6
questions
maximum)
is
included
to
determine
if
women
followed
during
preconception
have
become
pregnant
and
if
a
new
participant
is
currently
pregnant.
If
a
participant
is
pregnant,
her
due
date,
the
name
and
address
of
her
doctor
and
hospital
for
delivery
are
obtained
so
that
she
can
be
located
and
followed
during
her
delivery.
For
women
who
are
not
currently
pregnant,
information
regarding
desire
to
become
pregnant
and
method
of
birth
control
is
captured
so
that
her
likelihood
of
becoming
pregnant
can
be
established.
Likelihood
of
pregnancy
is
an
important
parameter
in
the
study
to
determine
the
woman's
data
collection
schedule.
This
section
is
included
at
screening.

Pregnancy
status
information
(
4
questions
minimum
and
maximum)
is
updated
during
all
preconception
interviews,
as
well
as
the
6­
month,
12­
month
,
and
18­
month
childhood
visits.

The
occupation
section
(
9
question
minimum,
31
question
maximum)
captures
information
on
student
and
employment
status.
For
the
women
who
work,
their
occupation,
industry,
hours
per
week,
whether
they
do
shift
work
or
hold
additional
jobs
are
also
collected.
These
data
are
needed
because
work
related
exposure
may
be
important
risk
factors
for
the
birth
outcomes
of
interest
and
factors
related
to
child
development.
After
the
child
is
born,
we
ask
about
early
childhood
education
or
other
child
care
arrangements,
including
those
associated
with
employment
and
those
outside
the
employment
setting,
because
the
amount
of
time
children
spend
in
these
settings
has
been
shown
to
have
an
impact
on
child
development.
The
full
complement
of
questions
is
administered
at
the
initial
home
visit.
We
update
occupational
information
(
2
question
minimum,
23
question
maximum)
at
all
preconception
interviews
19
(
except
telephone
follow­
up),
any
first
home
visit,
pregnancy
visits
except
for
OGTT,
and
at
all
childhood
visits
except
birth.

Chemical
exposures
are
of
interest
for
this
study
(
1
question
minimum,
48
question
maximum).

Twelve
exposures
that
are
known
or
suspected
to
affect
birth
outcomes
and
child
development
are
included
in
this
section
(
e.
g.,
solvents,
paint,
lead,
anesthetic
gases,
x­
rays,
dental
amalgam,

pesticides,
beauty
products,
cleaning
products,
coal
tar,
carbon
black,
metal
fumes).
The
question
format
will
allow
the
frequency
and
duration
of
exposure
at
work,
home
or
for
hobbies
to
be
estimated.
Since
the
timing
of
exposure
is
of
interest
with
birth
outcomes,
questions
updating
chemical
exposures
information
are
asked
during
each
follow­
up
interview.
The
chemical
exposures
section
is
included
for
all
preconception
visits
except
telephone
follow­
up;

any
first
home
visit;
pregnancy
visits
1,
2,
and
3;
and
1­
month,
6­
month,
12­
month,
and
18­

month
childhood
visits.

Home
environment
and
conditions
are
measured
as
an
exposure
of
interest
for
this
study
(
21
question
minimum,
36
question
maximum).
Environmental
characteristics
and
conditions
that
may
influence
human
health
and
birth
outcomes
through
their
effect
on
indoor
air
quality
and
home
contamination
are
queried
in
this
section.
These
characteristics
and
conditions
include
home
water
sources,
cooking
practices,
pesticide
use
and
lawn
care,
renovations
and
paint,
water
damage
and
mold.
This
full
section
is
included
in
the
questionnaire
during
any
first
home
interview
and
the
first
home
visit
after
a
participant
moves.
However,
should
an
eligible
study
participant
move
to
a
new
location
(
and
remains
eligible),
they
will
be
asked
to
fill
out
the
full
module
(
Instrument
#
29)
to
determine
the
characteristics
of
their
new
home
environment
at
the
next
regularly
scheduled
home
visit.
An
update
of
these
questions
(
7
questions
minimum,
16
questions
maximum)
is
collected
in
the
six
month
and
18
month
visits
to
capture
changes
that
occur
in
the
household
over
time.

Pets
and
pests
are
potential
sources
of
exposure
that
may
affect
birth
outcome
and
children's
health
(
3
question
minimum,
7
question
maximum).
Questions
in
this
section
capture
specific
information
on
the
number
of
domestic
and
outdoor
pets,
flea
and
tick
control
methods
and
the
presence
of
rodents
and
roaches
inside
the
home.
This
section
is
included
in
the
initial
interview
20
and
all
subsequent
follow­
up
interviews
as
the
timing
of
exposure
is
an
important
factor
in
assessing
the
impact
of
exposures
on
birth
outcomes
and
children's
health
such
as
the
development
of
asthma
and
allergy.
This
section
is
included
in
the
initial
visit,
any
first
home
visit,
the
first
trimester
pregnancy
visit,
and
1­
month
and
12­
month
childhood
visits.

A
full
assessment
of
personal
and
family
medical
history
(
8
question
minimum,
13
question
maximum)
is
included
in
the
questionnaire
because
the
mother's
health
as
well
as
her
medical
history
may
influence
the
health
of
her
baby
or
confound
or
modify
the
association
of
other
exposures
with
the
birth
or
the
child's
health
outcomes.
Specific
questions
on
allergies,
asthma,

hypertension,
diabetes,
hyper­
cholesterol,
anemia,
heart
problems
and
family
history
of
hypertension,
diabetes,
hyper­
cholesterol
and
heart
problems
are
included.
The
full
complement
of
questions
in
this
section
is
asked
during
the
initial
visit.
Personal
and
family
medical
history
is
updated
at
all
preconception
visits
except
for
telephone
follow­
up,
any
first
home
visit,
all
pregnancy
visits
except
for
OGTT,
and
at
all
childhood
visits
except
for
birth.
An
event
form
(
Instrument
#
30)
is
provided
for
the
woman
to
report
any
illnesses,
non­
routine
doctor
visits,

emergency
room
visits,
or
hospital
admissions
for
herself
or
her
child
during
the
course
of
the
study.
This
form
is
to
be
used
as
needed
and
is
intended
to
collect
adverse
health
outcomes
that
may
arise
during
the
study.

Both
prescription
and
over­
the­
counter
medications
(
2
question
minimum,
14
question
maximum)
taken
by
the
mother
may
influence
birth
outcome
or
children's
health.
The
specific
medications
included
in
this
section
of
the
questionnaire
are
antibiotics,
decongestants,
pain
killers,
anti­
depressant
medication,
acetaminophen,
ibuprofen,
cough
medicine,
cold
medicine,

aspirin
and
other
medicines
and
are
collected
at
the
initial
interview.
Since
timing
of
medication
use
during
preconception,
pregnancy,
and
breastfeeding
is
needed
to
determine
the
effect
of
these
substances
on
children's
health,
prescription
and
over­
the­
counter­
medications
are
updated
(
2
question
minimum,
16
question
maximum)
during
all
preconception
visits
except
telephone
follow­
up,
any
first
home
visit,
all
pregnancy
visits
except
for
OGTT,
and
1­
month
and
12­

month
childhood
visits.

Maternal
use
of
supplements
and
vitamins
(
2
question
minimum,
7
question
maximum)
may
have
an
influence
on
both
birth
outcome
and
maternal
health.
Maternal
use
of
commonly
used
supplements
is
queried
by
showing
the
woman
a
list
including,
fiber
supplements,
multivitamins,
21
herbal
supplements,
beta
carotene,
Vitamin
A,
Vitamin
C,
Vitamin
E,
Calcium,
Vitamin
D,
B­
6,

B­
Complex,
Brewer's
yeast,
cod
liver
oil,
Coenzyme
Q,
fish
oil,
folic
acid,
glucosamine,

hydroxytryptophen,
iron,
niacin,
selenium,
zinc,
aloe
vera,
bilberry,
cayenne,
Dong
Kuai,

Echinacea,
evening
primrose
oil,
feverfew,
garlic,
ginger,
ginkgo
biloba,
ginseng,
golden
seal,

grapeseed
extract,
kava,
milk
thistle,
Siberian
ginseng,
St.
John's
Wart,
Valerian
root
during
the
initial
visit.
Vitamin
and
supplement
use
is
updated
at
the
all
preconception
visits
except
the
telephone
follow­
up,
any
first
home
visit,
all
pregnancy
visits
except
OGTT,
and
at
6­
month,
12­

month
childhood
visits.

Health
care
access
and
insurance
(
3
question
minimum,
4
question
maximum)
are
part
of
the
social
and
economic
context
that
may
influence
birth
outcomes
and
children's
health
directly
or
confound
or
modify
the
association
of
other
exposures
and
outcomes
of
interest.
This
section
is
included
during
the
initial
interview.
Health
care
access
and
insurance,
with
special
attention
to
prenatal
care,
is
updated
(
4
question
minimum,
6
question
maximum)
during
the
first
and
third
trimester
visits.

Elements
on
a
woman's
reproductive
history
including
menstrual
and
pregnancy
history
may
influence
subsequent
birth
outcomes
(
4
question
minimum,
8
question
maximum).
Since
reproductive
history
will
not
change
over
time,
questions
in
this
section
are
included
only
on
the
questionnaire
administered
during
any
first
home
visit.

Maternal
demographic
information
on
age,
race
or
ethnicity,
marital
status,
nativity
and
educational
attainment
is
collected
(
9
question
minimum,
12
question
maximum)
during
screening.
These
variables
may
be
determinants
in
birth
outcome
and
children's
health
as
well
as
potential
confounders
of
associations
of
interest.
Home
address
and
plans
to
move
are
also
collected
as
this
information
is
needed
to
facilitate
follow­
up
and
determine
eligibility;
this
information
is
updated
(
2
question
minimum,
3
question
maximum)
during
the
telephone
follow
up,
preconception
visits
two,
three,
and
four,
the
first
trimester
pregnancy
visit,
and
the
1,
6,
and
12
month
childhood
visits.
The
section
on
income
includes
four
questions
on
income
level,

source
of
income,
and
number
of
people
(
adults
and
children)
dependent
on
the
income.
Income
22
questions
are
not
asked
at
screening
but
during
the
initial
home
interview
and
updated
at
the
18
month
childhood
visit.

Maternal
consumption
of
alcohol
during
pregnancy
(
1
question
minimum,
5
question
maximum)

is
well
known
to
affect
fetal
development
and
alcohol
is
found
in
breast
milk
of
women
who
consume
alcohol.
Alcohol
consumption
may
be
a
confounder
or
modifier
of
associations
of
interest
in
this
study.
The
question
format
allows
calculation
of
average
alcohol
consumption
during
the
past
2
years,
consumption
during
the
past
3
months,
frequency
during
an
average
week,
frequency
of
consumption
of
5
or
more
alcoholic
beverages
and
type
of
alcoholic
beverage
to
be
estimated.
Alcohol
consumption
is
reported
during
the
initial
home
interview,

and
is
updated
(
1
question
minimum,
3
questions
maximum)
in
all
preconception
visits
except
telephone
follow­
up,
any
first
home
visit,
all
pregnancy
visits
except
OGTT,
and
6­
month
and
18­
month
childhood
visits
Maternal
tobacco
use
and
exposure
to
second
hand
smoke
are
also
a
well­
known
factors
that
affect
health
outcomes
of
the
fetus
and
child
(
7
question
minimum,
11
question
maximum).

Specific
questions
relating
to
the
type
of
tobacco
smoke,
smoking
in
the
last
30
days,
2
years,

and
current
smoking
are
included.
Questions
on
tobacco
smoke
exposure
are
included
during
the
initial
home
interview
and
updated
(
6
question
minimum,
10
question
maximum)
in
all
preconception
visits
except
telephone
follow­
up;
any
first
home
visit;
all
pregnancy
visits
except
OGTT;
and
6­
month,
12­
month,
and
18­
month
childhood
visits.

Acceptability
of
the
study
to
the
participants
is
an
important
parameter
in
order
to
maximize
the
utility
of
the
Pilot
Study
for
the
NCS
(
5
question
minimum,
10
question
maximum).
Factors
that
increase
participant
satisfaction
can
be
incorporated
into
the
larger
study
and
difficulties
may
be
avoided.
Open­
ended
questions
are
included
to
more
completely
explore
the
participants'

thoughts
about
the
positive
and
negative
aspects
of
the
study,
this
information
should
greatly
benefit
the
development
of
the
NCS.
This
section
also
contains
questions
on
the
convenience
of
the
interview
and
obstacles
to
participation.
This
section
is
included
in
all
visits
except
for
rostering,
screening,
the
preconception
telephone
follow­
up,
the
OGTT
visit
and
birth.
23
Poor
maternal
dental
health
is
directly
associated
with
preterm
birth
and
low
birth
weight,
and
may
also
be
an
indicator
of
general
maternal
health
status
that
can
impact
child
development
(
9
question
minimum,
10
question
maximum).
This
section
contains
questions
on
routine
cleaning
and
dental
problems
including
plaque,
bleeding
gums,
tooth
ache,
dentist
diagnosed
gingivitis
or
periodontitis.
This
section
is
included
at
the
second
preconception
visit,
any
first
home
visit
for
women
enrolled
during
pregnancy
or
at
delivery,
and
is
updated
at
the
first
trimester
pregnancy
visit.

Neighborhood
questions
(
17
question
minimum,
18
question
maximum)
are
included
in
the
interviews
to
measure
the
level
of
community
cohesiveness
and
support,
perceived
safety
and
potential
for
violence.
These
variables
are
stressors
or
sources
of
support
from
preconception
through
childhood
that
may
affect
the
well
being
of
the
mother
and
child.
Neighborhood
questions
are
asked
during
the
second
preconception
interview
or
during
any
first
home
visit,

during
the
first
trimester
pregnancy
visit,
at
the
6
month
and
18
month
childhood
visits.

Additionally,
neighborhood
questions
are
asked
at
the
first
home
visit
after
a
woman
moves.

Maternal
nutrition
is
an
important
factor
for
a
healthy
pregnancy,
and
an
important
predictor
for
childhood
eating
patterns.
Diet
questions
(
maternal:
19
question
minimum,
23
question
maximum)
are
asked
three
times
over
the
course
of
the
study
(
the
second
preconception
interview,
the
second
pregnancy
interview,
and
when
the
child
is
six
months
old).
A
separate
self­
administered
questionnaire
(
133
questions)
distributed
during
the
second
preconception
interview
and
again
during
the
second
trimester
pregnancy
visit.

Activity
questions
(
10
question
minimum,
28
question
maximum)
are
asked
in
order
to
assess
both
potential
reproductive
risk
factors
associated
with
exertion
and
healthy
lifestyle
habits
such
as
routine
physical
activity.
This
section
is
included
during
the
second
preconception
visit,
the
second
pregnancy
visit,
the
6
month,
12
month
and
18
month
childhood
visits
Mental
health
and
financial
security
of
the
woman
and
her
partner
will
have
a
significant
impact
on
both
maternal
and
household
stress
level
(
101
questions
preconception
visit;
111
questions
third
trimester
pregnancy
visit
woman;
101
questions
third
trimester
pregnancy
visit
partner;
112
24
questions
6
month
childhood
visit
woman;
103
questions
6
month
childhood
visit
partner).

Stress
can
increase
risk
for
poor
health
outcomes
and
may
also
be
related
to
unhealthy
behaviors,

such
as
smoking.
A
mental
health
questionnaire
is
distributed
during
the
initial
home
interview,

third
trimester
pregnancy
visit
and
the
6
month
visit
for
the
mother
and
her
partner
to
complete
in
privacy
and
mail
back.
This
questionnaire
is
composed
of
five
subsections
using
standard
instruments
to
measure
social
support,
depression,
stressful
life
events,
perceived
stress
and
financial
security;
for
the
6
month
childhood
visit
there
is
also
a
subsection
on
child­
rearing
support.
Mental
health
and
financial
security
questions
are
asked
at
the
initial
preconception
visit,
the
third
trimester
pregnancy
visit,
and
the
6­
month
childhood
visit.

The
child
development
section
(
18
questions
for
one­
month
olds,
36
questions
for
six
month
olds,
43
questions
for
12
month
olds
and
48
questions
for
18
month
olds)
captures
information
about
the
activities
and
development
of
the
child
to
determine
whether
or
not
they
are
developing
normally
for
their
age.
These
questions
encompass
age­
appropriate
communication,
gross
motor,
fine
motor,
problem
solving,
and
personal/
social
parameters.
Additionally,
questions
about
parent­
child
activities
and
the
mother's
perception
of
her
baby's
personality
are
included.

This
section
is
included
in
all
post­
birth
interviews.

The
sleep
characteristics
of
the
child
(
four
questions)
are
included
in
the
questionnaire
to
determine
the
presence
of
specific
sleep­
related
practices
that
may
put
children
at
increased
risk
for
potentially
adverse
health
outcomes,
including
Sudden
Infant
Death
Syndrome
(
SIDS).
These
questions
may
also
offer
an
indicator
of
infant
or
child
temperament.
This
section
is
included
as
part
of
the
child
development
section
and
is
included
in
all
post­
birth
interviews.

The
child's
diet
section
(
28
question
minimum,
33
question
maximum
for
one­
month
olds;
28
question
minimum,
43
question
maximum
for
six
month
olds;
33
question
minimum,
44
question
maximum
for
12
and
18
month
olds)
section
is
included
to
determine
potential
confounders
and
risk
factors
associated
with
nutritional
intake
and
healthy
lifestyle
habits.
Additionally,
the
mother's
intent
to
breastfeed
her
child
(
2
questions
minimum,
3
questions
maximum)
is
asked
to
determine
the
sources
of
nutritional
intake
the
child
will
have.
The
intent
section
is
included
in
25
the
third
trimester
visit
while
child
diet
is
measured
in
the
one,
six,
twelve,
and
eighteen
month
visits.

The
medical
history
of
the
child
(
12
questions
minimum,
16
questions
maximum
for
one
month
olds;
5
question
minimum,
8
questions
maximum
for
six
month
olds;
7
question
minimum,
17
questions
maximum
for
12
and
18
month
olds)
section
is
asked
in
order
to
capture
any
health
conditions
that
the
child
may
have.
These
health
outcomes
are
an
important
indicator
of
potentially
adverse
effects
of
the
environmental
exposures
the
study
is
measuring.
This
section
is
included
in
all
post­
birth
interviews.

The
infant
safety
(
3
questions
minimum,
6
questions
maximum)
section
is
asked
to
determine
physical
and
behavioral
risk
factors
experienced
by
the
child.
Car
seat
use,
firearms,
and
smoke
alarms
use
are
of
particular
interest
due
to
the
risks
posed
to
the
health
of
the
child
and
the
mother.
This
series
of
questions
is
asked
only
during
the
1
month
visit.

The
post­
partum
depression
(
6
questions
minimum,
12
questions
maximum)
section
is
asked
in
order
to
determine
the
mental
health
of
the
mother
following
delivery
and
whether
or
not
the
woman
has
sought
help
from
medical
professionals
for
depression
related
to
her
pregnancy
or
child­
birth.
This
series
of
questions
is
only
asked
during
the
one
month
visit.

Where
appropriate
if
the
participant's
answers
to
questions
that
indicate
they
are
engaging
in
behavior
that
is
counter
to
the
current
public
health
understanding,
the
interviewer
will
be
notified
by
the
computer
program
to
provide
the
participant
with
public
health
brochures
dealing
with
topics
such
as
infant
safety
(
car
seat
use),
the
importance
of
prenatal
care,
and
infant
sleeping
positions.
These
public
health
materials
are
freely
available
from
local
health
departments
and
will
be
given
to
the
participant
should
their
answers
indicate
that
their
behavior
does
not
correspond
to
recommended
practice.
No
other
interventions
are
planned.

Style
of
Questions
Most
questions
have
a
forced
choice
between
multiple
responses
or
two
choices
(
Yes,
No).
The
number
of
free
form
questions
is
limited
to
items
where
the
respondent's
verbatim
response
is
anticipated
to
be
particularly
useful
for
the
study.
26
Purpose
of
Questions
The
purpose
of
these
questions
is
to
evaluate
the
feasibility
and
acceptability
of
the
proposed
NCS
schedule
of
visits
by
assessing
the
subject
burden
associated
with
questionnaires
administered
at
home
visits
as
well
as
participant
compliance
with
mail­
back
survey
instruments.

All
of
the
questionnaire
domains
are
expected
to
be
included
in
the
National
Children's
Study
(
NCS).
This
Pilot
Study
provides
an
additional
benefit
of
field
testing
questionnaire
elements
that
may
be
used
in
the
NCS.
The
NCS
will
examine
many
aspects
of
children's
lives
via
home
interviews
and
questionnaires,
from
the
physical
environment
of
neighborhoods
and
schools;
to
chemical
exposures
linked
to
the
atmosphere,
food,
or
water
supplies;
to
the
social
and
behavioral
environment
in
which
the
children
grow
and
develop.
Domains
were
also
chosen
for
this
Pilot
Study
to
address
exposures
and
outcomes
that
are
common
enough
to
provide
information
to
Pilot
Study
subjects
that
would
relate
to
their
own
child's
general
growth
and
development.

(
ii)
Respondent
Activities
Potential
respondents
will
be
contacted
via
an
introductory
letter
and
informational
brochure
about
the
study
about
two
weeks
prior
to
either
receiving
a
call
or
being
visited
by
study
staff.
The
interviewer
will
elicit
verbal
informed
consent
during
this
introductory
screening
meeting
(
Instruments
#
1
and
#
2;
10
minutes
each).
The
respondent
need
only
reply
to
the
questions
asked
during
the
screening
meeting.
The
risks
associated
with
this
activity
do
not
extend
beyond
those
of
daily
living.
Subsequent
contact
will
include
both
in­
home
and
clinic
visits
with
participants.
The
proposed
data
collection
is
planned
to
begin
in
the
first
quarter
of
2006.
The
household
screening
phase
of
the
study
is
expected
to
take
approximately
4
months
to
complete.
Recruitment
and
enrollment
of
eligible
women
into
the
study
will
begin
concurrently
with
the
household
screening
phase,
and
will
take
approximately
18
months
to
complete.
There
are
three
basic
data
collection
schedules:
preconception,
pregnancy,
and
post­
pregnancy.
27
PRECONCEPTION
VISIT
SCHEDULE
Eligible
women
enrolled
prior
to
conception
who
are
planning
to
become
pregnant
(
high
likelihood
group)
will
be
invited
to
participate
in
a
home
visit
approximately
two
weeks
after
screening.
This
first
visit
will
take
about
2.5
hours
(
75
minutes
for
in­
person
interview
for
the
woman
(
Instrument
#
3),
15
minutes
for
mail
back
questionnaire
(
Instrument
#
5),
and
60
minutes
for
biologic
and
environmental
sample
collection
and
instructions,
etc.).
Note
that
the
burden
for
environmental
sample
collection
is
calculated
only
when
the
woman's
participation
is
necessary.

Otherwise,
technicians
would
be
performing
data
collection
concurrently
while
the
woman
is
being
interviewed.
Women
and
their
husbands/
partners
(
if
they
choose
to
participate)
will
be
interviewed
and
asked
to
provide
biologic
samples
(
40
minutes
for
in
person
interview
with
the
husband/
partner
concurrent
with
the
woman
(
Instrument
#
4),
and
35
minutes
for
sample
collection
in
the
first
visit).
Study
staff
will
collect
environmental
samples
from
the
home.

Women
in
this
group
will
receive
pregnancy
test
kits
and
fertility
monitors
for
their
use.

Home
visits
that
last
approximately
1.5
hours
will
be
conducted
every
two
months
(
45
minutes
for
in­
person
interview
with
the
woman
(
Instrument
#
6),
30
minutes
for
mail
back
questionnaire
(
Instrument
#
7)
after
the
second
preconception
visit
only,
and
15
minutes
for
environmental
sample
collection
and
instructions,
etc.),
with
a
5
minute
telephone
call
(
Instrument
#
10)
during
the
intervening
month
to
update
pregnancy
status.
Follow­
up
in
this
group
continues
for
a
maximum
of
three
visits
or
until
a
woman
becomes
pregnant
(
transfers
to
pregnancy
schedule).
If
the
woman
is
not
pregnant
in
six
months,
she
joins
the
moderate
likelihood
group
and
will
be
followed
by
telephone
call
only.
Subsequent
follow­
up
home
visits
at
4
and
6
months
(
visit
#
3
and
4)
last
only
45
minutes
(
30
minutes
for
an
in­
person
interview
(
Instruments
#
8,
9)
and
15
minutes
for
biologic
and
environmental
sample
collection
and
instructions,
etc.).

Eligible
women
enrolled
prior
to
conception
who
have
a
moderate
likelihood
of
pregnancy
based
on
the
screening
questions
are
invited
to
participate
in
a
home
visit
approximately
two
weeks
after
screening.
The
first
preconception
visit
is
identical
to
the
one
women
in
the
high
likelihood
group
receive.
Women
in
this
group
will
receive
a
5
minute
telephone
follow­
up
(
Instrument
#
10)
once
every
three
months
for
a
maximum
of
one
year.
If
their
plans
change
and
they
want
to
try
to
become
pregnant,
they
will
be
invited
to
participate
in
the
high
likelihood
group.
If
they
become
pregnant,
they
will
be
invited
to
participate
in
the
pregnancy
schedule
of
visits.
28
Women
who
are
otherwise
eligible,
but
not
likely
to
become
pregnant
based
on
the
screening
(
low
likelihood)
will
receive
a
5
minute
telephone
follow­
up
(
Instrument
#
10)
one
year
after
the
screening
visit.
If
their
pregnancy
status
or
intention
changes,
they
can
move
to
one
of
the
other
follow­
up
groups.

PREGNANCY
VISIT
SCHEDULE
Women
may
be
enrolled
at
any
point
during
pregnancy.
Women
who
join
this
group
after
participating
in
preconception
visits
will
have
a
1.5
hour
home
visit
during
the
first
trimester
(
45
minutes
for
in
person
interview
for
the
woman
(
Instrument
#
11),
and
45
minutes
for
biologic
and
environmental
sample
collection
and
instructions,
etc.).
Women
and
their
husbands/
partners
(
if
they
choose
to
participate)
will
be
interviewed
and
asked
to
provide
biologic
samples
(
30
minutes
for
in
person
interview
with
the
husband/
partner
concurrent
with
the
woman
(
Instrument
#
12)
in
the
first
visit).
Study
staff
will
collect
environmental
samples
from
the
home.
In
the
first
trimester,
women
may
be
invited
to
have
an
oral
glucose
tolerance
test
(
2.5
hour
in
subject
time,
no
questionnaires;
approximately
ten
percent
are
expected
to
participate).
Second
and
third
trimester
clinic
visits
will
have
clinical
assessments,
such
as
ultrasound
exams,
collection
of
biologic
specimens
and
personal
interview
with
a
take­
home
mail
back
questionnaire
(
each
visit
is
3
hours:
45
minutes
for
interview
(
Instruments
#
15,
17),

30
and
15
minutes
for
mail
in
survey
(
Instruments
#
16,
18
respectively),
and
2
hours
for
biologic
collection
and
instructions,
etc.).
Partners
will
also
be
asked
to
fill
out
a
mail­
in
survey
15
minutes
(
Instrument
#
19).

Women
who
come
into
the
study
already
pregnant
will
pick
up
with
the
visit
schedule
appropriate
for
the
baby's
gestational
age.
If
women
are
enrolled
in
the
first
trimester,
they
will
participate
in
a
home
visit
lasting
1.75
hours
(
60
minute
in­
person
interview
(
Instrument
#
13),
45
minute
for
biologic
and
environmental
sample
collection
and
instructions,
etc.).
Partners
of
women
in
their
first
trimester,
should
they
choose
to,
will
participate
in
a
30
minute
interview
(
Instrument
#
14).
This
home
visit
includes
the
domains
for
"
any
first
home
basic"
visit
plus
the
first
trimester
home
visit.
Visits
for
the
second
and
third
trimester
are
the
same
as
the
preconception
group.
A
few
women
may
join
early
enough
in
the
first
trimester
to
also
participate
in
the
oral
glucose
tolerance
test,
but
we
do
not
anticipate
that
will
be
common.

Women
enrolled
in
the
second
or
third
trimester
will
participate
in
those
clinic
visits
but
will
not
be
visited
in
their
homes
until
their
baby
is
one
month
old.

For
women
who
deliver
at
participating
hospitals,
we
hope
to
collect
biologic
specimens
and
a
limited
amount
of
clinical
information
(
total
time
26
hours
for
all
hospital
staff
who
may
29
not
be
subcontractors,
etc.)
In
addition
to
the
women
previously
enrolled,
we
anticipate
enrolling
a
few
women
during
their
hospital
stay
after
delivering
their
babies.

POST
PREGNANCY
VISIT
SCHEDULE
Following
the
birth
visit,
there
will
be
4
home
visits
for
data
collection.
The
visits
will
take
place
when
the
child
is
1,
6,
12,
and
18
months
of
age.
No
children
will
be
enrolled
after
the
hospital
delivery
stay.
All
parents
and
children
participating
in
these
visits
were
enrolled
during
the
preconception
or
pregnancy
visit
schedules,
or
at
the
time
of
delivery.

1­
Month
Visit
The
first
post­
pregnancy
visit
will
take
place
in
the
home
when
the
child
is
one
month
of
age.
The
visit
is
estimated
to
take
about
1
hour
(
45
minutes
for
in­
person
interview
(
Instrument
#
22),
15
minutes
for
biologic
and
environmental
sample
collection
and
instructions,
etc.).

For
women
enrolled
after
the
first
trimester
of
pregnancy
or
at
delivery,
this
visit
will
also
include
the
`
any
first
home
visit"
domains,
and
is
expected
to
take
about
1.25
hours
(
60
minutes
for
in­
person
interview
(
Instrument
#
20),
15
minutes
for
sample
collection),
and
30
minutes
for
partner
interview
(
Instrument
#
21).

6­
Month
Visit
The
second
visit
will
take
place
in
the
home
when
the
child
is
six
months
of
age.
The
information
collection
associated
with
this
visit
is
estimated
to
take
2
hours
(
60
minutes
for
inperson
interview
(
Instrument
#
23),
15
minutes
for
mail­
in
survey
to
be
completed
after
the
visit
(
Instrument
#
25),
45
minutes
biologic
and
environmental
sample
collection
and
instructions).

The
data
will
be
collected
from
the
mother,
father/
partner,
and
child.
The
partner
in­
person
questionnaire
is
estimated
to
take
20
minutes
(
Instrument
#
24)
and
the
mail­
in
survey
to
take
15
minutes
(
Instrument
#
26).

12­
Month
Visit
The
third
post­
pregnancy
visit
will
take
place
in
the
home
when
the
child
is
twelve
months
of
age.
The
visit
is
estimated
to
take
1.5
hours
(
60
minutes
for
an
in­
person
interview
30
(
instrument
#
27),
and
30
minutes
for
biologic
and
environmental
sample
collection).
The
data
will
be
collected
from
the
mother
and
child.

18­
Month
Visit
The
final
visit
planned
for
the
Pilot
Study
will
take
place
when
the
child
is
18
months
of
age.
Questionnaire
domains
to
be
updated
will
be
the
same
as
those
at
the
6­
month
visit.
The
non­
interview
domains
will
also
be
similar,
including
biologic
samples
of
the
child's
nails,

saliva,
and
urine.
The
child
exam
will
focus
on
physical
and
developmental
milestones
appropriate
for
the
age
group.
The
visit
is
estimated
to
take
two
hours
(
60
minutes
for
an
inperson
interview
(
instrument
#
28),
and
60
minutes
for
biologic
and
environmental
sample
collection).

Relocation
Interview
and
Event
Form
Should
participants
relocate
during
the
course
of
the
study
and
remain
eligible
(
moving
within
segment
boundaries
before
birth
of
child),
they
will
be
administered
a
questionnaire
consisting
of
the
Home
Environment
and
Neighborhood
domains
(
Instrument
#
29)
this
is
expected
to
take
5
minutes.

A
one
page
Event
Form
(
Instrument
#
30)
will
be
given
to
the
participants
to
be
completed
whenever
a
woman
or
her
child
has
a
non­
routine
doctor
visit,
an
emergency
room
visit,
a
hospital
admission,
a
significant
illness
that
did
not
result
in
medical
attention,
or
other
medical
events.
Completion
of
this
form
is
anticipated
to
take
5
minutes.

Incentives
The
results
of
focus
groups
conducted
across
the
country
in
populations
similar
to
the
ones
here
indicate
that
a
range
of
incentives
should
be
considered
but
should
also
include
some
cash
or
cash
equivalent
(
gift
cards
for
department
stores
such
as
Target
or
Walmart,
local
grocery
stores,

or
local
child­
focused
stores
such
as
Babies­
R­
Us)
as
a
token
of
appreciation,
particularly
after
collection
of
biologic
specimens.
Currently,
a
number
of
incentives
are
under
consideration
including
cash
or
cash
equivalent
incentives
associated
with
each
sample
provided,
for
example:

$
25
for
blood,
$
5
for
urine,
$
5
for
saliva,
$
20
for
semen,
and
$
20
for
vaginal
swab.
31
5.
The
Information
Collected
 
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
The
Agency
has
a
support
contract
in
place
with
a
private
research
organization
whose
scope
of
work
includes
the
ability
to
conduct
all
aspects
of
this
Pilot
Study.
The
contractor's
workplan
will
include
development
of
the
study
materials
and
operational
manuals,
household
enumeration
and
recruitment,
conduct
of
telephone,
home
and
clinic
study
visits,
and
to
assist
with
the
analysis.
The
Agency
will
administer
the
contract
and,
with
support
from
the
previously
identified
federal
partners,
oversee
the
design
and
conduct
of
the
research
and
perform
quality
assurance
procedures
throughout
the
data
collection.

5(
b)
Collection
Methodology
and
Management
Following
the
initial
screening
visit,
all
women
enrolled
into
the
study
will
be
scheduled
a
visit
with
a
trained
interviewer
to
answer
questions
about
her
health,
relevant
background
information,
and
information
on
other
potential
risk
factors.
The
appointment
for
these
women
will
be
scheduled
either
during
the
screening
visit
or
through
a
recruitment
phone
call.
After
obtaining
informed
consent,
questionnaires
will
be
administered
in
the
woman's
home
using
computer­
assisted
interviewing
(
CAI)
techniques,
including
both
computer­
assisted
personal
interviewing
(
CAPI)
and
audio
computer­
assisted
self­
interviewing
(
ACASI).

Once
a
woman
is
enrolled
in
the
study,
the
schedule
of
follow­
up
depends
on
her
pregnancy
status
(
with
non­
pregnant
women
stratified
into
three
groups
according
to
the
NCS
Study
Plan).
The
schedule
for
follow­
up
after
delivery
depends
on
the
age
of
the
child.
A
central
scheduling
and
tracking
system,
with
appropriate
access
limits
in
place
to
preserve
confidentiality,
will
be
maintained
by
the
contractor.

Every
effort
will
be
made
to
minimize
the
burden
placed
on
the
participant
by
utilizing
time­
efficient
questionnaires
and
grouping
different
data
collection
metrics
together.
For
instance,
interview
data
collection
may
be
scheduled
in
conjunction
with
environmental
exposure
assessment
to
minimize
the
overall
impact
on
the
participant.
Furthermore,
clinic
and
other
healthcare
visits
will
be
coordinated
so
biologic,
any
necessary
environmental
samples,
and
questionnaire
information
will
be
collected
in
a
single
visit
with
minimal
burden
on
the
participant.

If
at
any
point
in
time
the
participant
has
any
questions,
the
participant
can
contact
a
tollfree
number
or
ask
the
interviewer
to
respond
to
them.
If
the
participant
does
not
wish
to
continue
with
the
interview
at
any
point
in
time,
the
interviewer
will
end
the
interview.
Because
32
the
purpose
of
the
Pilot
Study
is
to
understand
concerns
of
potential
participants,
we
will
ask
the
participant
if
they
are
willing
to
indicate
why
they
want
to
terminate
the
interview.

The
contractor
will
assemble
the
data
into
a
SAS
dataset,
using
only
an
identifying
code
to
link
with
the
dataset
already
assembled
from
the
study's
previous
data
collection
activities.

The
electronic
questionnaires,
with
unique
identifiers,
will
be
turned
over
to
the
EPA
and
kept
on
CD
in
the
principal
investigator's
office
in
a
locked
cabinet.
Quality
assurance
measures
will
be
taken;
the
principal
investigator
may
call
a
sample
of
participants
to
ask
them
about
the
quality
of
the
interview
experience.

5(
c)
Small
Entity
Flexibility
This
section
does
not
apply
because
this
collection
does
not
support
regulatory
requirements,
and
small
businesses
will
not
be
respondents.

5(
d)
Collection
Schedule
The
proposed
data
collection
is
planned
to
begin
in
the
first
quarter
of
2006.
The
household
screening
phase
of
the
study
is
expected
to
take
approximately
4
months
to
complete.

Recruitment,
enrollment,
and
follow­
up
of
eligible
women
into
the
study
will
begin
concurrently
with
the
household
screening
phase,
and
will
take
approximately
3
years
to
complete.
Exhibit
4
outlines
the
data
collection
schedule
for
women
who
are
not
pregnant
at
enrollment;
Exhibit
5
provides
the
schedule
for
women
enrolled
at
pregnancy
or
who
become
pregnant
at
some
point
during
the
preconception
follow­
up.
33
Exhibit
4.
Schedule
of
Preconception
Visits
TYPE
OF
CONTACT2
Month
of
Enrollment
Period
Time1
High
Likelihood
Moderate
Likelihood
Low
Likelihood
1­
5
Time
plus
2
weeks
(
Preconception
#
1)
H
H
No
home
visits
2­
6
Time
+
1
month
T
3­
7
Time
+
2
months
(
Preconception
#
2)
H
4­
8
Time
+
3
months
T
T
5­
9
Time
+
4
months
(
Preconception
#
3)
H
6­
10
Time
+
5
months
T
7­
11
Time
+
6
months
(
Preconception
#
4)
H
T
8­
12
Time
+
7
months
9­
13
Time
+
8
months
10­
14
Time
+
9
months
T
T
11­
15
Time
+
10
months
12­
16
Time
+
11
months
13­
17
Time
+
12
months
T
T
T
14­
18
Time
+
13
months
15­
18
Time
+
14
months
16­
18
Time
+
15
months
T
T
17­
18
Time
+
16
months
1
Time
is
defined
as
the
time
of
enrollment
2
H=
home
visit;
T=
telephone
Exhibit
5.
Schedule
of
Post­
conception
Visits
Visit
time
Type/
Location
of
Contact1
First
trimester
(
Pregnancy
#
1)
H
OGTT
C
Second
trimester
(
Pregnancy
#
2)
C
Third
trimester
(
Pregnancy
#
3)
C
Birth
C
1
month
H
6
months
H
12
months
H
18
months
H
1
H=
Home;
C=
Clinical
Facility/
Hospital
34
6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a)
Estimating
Respondent
Burden
Respondent
burden
can
be
organized
by
information
collection
activity
(
i.
e.,
visit
or
contact)
and
respondent
type.
The
respondent
types
include
women
(
according
to
their
status
at
enrollment),
their
husbands
or
partners,
and
children
born
to
them.
Burden
for
these
study
groups
is
totaled
to
estimate
the
entire
participant
burden
for
the
Pilot
Study.

The
schedule
for
preconception
visits
will
depend
on
the
woman's
likelihood
of
pregnancy,
classified
by
the
NCS
Study
Plan
as
high,
moderate,
and
low
likelihood
for
pregnancy.
Women
with
a
high
or
moderate
likelihood
of
pregnancy
will
be
visited
in
their
homes
within
2
weeks
of
their
enrollment
to
collect
interview
data,
biologic
and
environmental
samples,
and
anthropometric
measurements.
After
this
initial
home
visit,
the
schedule
for
high
and
moderate
likelihood
groups
will
include
a
combination
of
home
visits
and
telephone
calls
at
varying
intervals.
It
is
estimated
that
70
to
90
percent
of
the
women
in
the
high
likelihood
group
will
get
pregnant
within
6
months
of
enrollment;
therefore,
follow­
up
for
this
group
is
most
intense.
The
low
likelihood
group
will
not
receive
home
visits;
rather,
women
in
this
group
will
be
asked
to
contact
the
study
staff
in
the
event
that
their
pregnancy
plans
change.
The
only
follow­
up
with
this
group
will
be
by
telephone
at
12
months
after
enrollment.

Once
enrolled
women
become
pregnant,
the
visit
schedule
will
follow
that
defined
in
the
NCS
Study
Plan.
The
Pilot
Study
will
enroll
more
women
late
in
pregnancy
compared
to
the
NCS
Study
Plan,
which
focuses
on
preconception
and
first
trimester
enrollment.
These
women
will
be
folded
into
the
NCS
Visit
Schedule
at
the
appropriate
time
point.

Approximately
10,000
occupied
households
will
be
visited
and
we
assume
that
approximately
85%
(
n=
8,770)
will
be
rostered
to
identify
age­
eligible
women
based
on
our
preliminary
sampling
estimates.
As
a
result,
we
expect
that
approximately
4,426
women
will
be
screened
and
of
those,
2,657
will
be
enrolled
in
the
study
based
on
Census
data
for
the
number
of
age­
eligible
women
in
the
population.
We
also
assume
that
35
women
will
be
enrolled
at
delivery
and
another
48
women
who
express
interest
in
the
study
(
i.
e.,
volunteers)
will
be
screened
and
enrolled,
for
a
total
of
2,740
women.
These
2,740
enrolled
women
are
estimated
to
contribute
406
births
over
the
study
enrollment
period,
as
shown
in
Exhibit
6
below.
Estimates
of
enrollment
rates
and
birth
rates
were
adapted
from
the
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
located
on
the
NCS
website
at
http://
www.
nationalchildrensstudy.
gov/
research/
analytic_
reports/
loader.
cfm?
url=/
commonspot/
s
ecurity/
getfile.
cfm&
PageID=
9099
(
Pivetz,
Iroz­
Elardo,
Strauss,
Rust,
and
Menkedick,
2004).
35
Exhibit
6.
Number
of
Eligible
Women
Screened
and
Enrolled,
and
Number
of
Births
Expected
by
Group
Enrolled
Births
Group
Number
Screened
N
%
N
%

Pregnant
at
enrollment
186
121
65
108
89
High
likelihood
of
pregnancy
256
167
65
57
34
Moderate
likelihood
of
pregnancy
962
572
59
50
9
Low
likelihood
of
pregnancy
3,022
1,797
59
115
6
Subtotal
of
women
from
household
recruiting
4,426
2,657
60
330
12
Women
at
delivery
N/
A
35
 
35
100
Volunteers
64
48
75
41
85
Total
4,490
2,740
 
406
15
Exhibit
7
provides
estimates
of
the
burden
per
respondent
type
by
visit/
contact
for
screening
and
preconception
visits.
The
estimated
total
burden
by
respondent
and
visit
type
is
calculated
by
multiplying
the
burden
estimate
for
each
visit
by
the
total
number
of
participants.

The
total
burden
by
participant
type
is
then
obtained
by
summing
over
all
visits.
Detailed
estimates
provided
in
the
Final
Visit
Schedule
and
Burden
Estimates:
Population­
based
pilot
study
of
children's
environmental
health
in
support
of
the
National
Children's
Study
report,

available
in
EPA
E­
Docket
number
ORD­
2005­
0010,
were
used
to
calculate
annualized
burden
estimates.
Several
assumptions
were
made
in
estimating
the
number
of
respondents;
these
are
described
in
see
Section
6(
d)
below.

The
burden
estimates
for
post­
conception
visits,
from
the
first
trimester
to
18
months
of
age,
are
detailed
in
Exhibit
8.
The
pregnancies
resulting
from
the
preconception
group
will
all
begin
with
the
first
trimester
visit.
Exhibit
8
also
includes
estimated
burden
for
medical
staff
who
will
be
asked
to
assist
in
biologic
sample
collection
and
clinical
measurements
at
each
of
the
clinic
visits
(
OGTT,
2nd
trimester,
3rd
trimester,
and
delivery).

To
obtain
the
total
participant
burden,
the
burdens
by
participant
type
for
preconception
visits
(
Exhibit
7)
and
post­
conception
visits
(
Exhibit
8)
are
combined
with
the
burden
for
the
household
unit
rostering
visit
and
the
burden
for
women
who
complete
the
screening
but
are
not
enrolled
in
the
Study
(
n=
1,750).
The
rostering
visit,
to
identify
eligible
women
to
be
screened
for
the
Study,
can
be
completed
by
any
adult
member
of
the
household.
Therefore,
the
respondent
type
has
been
specified
as
"
Household
Unit"
in
the
table
below.
The
total
burden
for
each
information
collection
activity
is
shown
in
Exhibit
9.
36
Exhibit
7.
Burden
Estimates
for
Screening
and
Preconception
Visits
Total
Burden
per
Information
Collection
Activity
(
Hours)

Enrolled
Women
Information
Collection
Activity
High
Moderate
Low
Pregnant,
1st
Trimester
Pregnant,
2nd
Trimester
Pregnant,
3rd
Trimester
Enrolled
at
Delivery
Part­
ners
Children
Screening
(
Home)
*
56
191
599
19
19
19
0
0
0
Preconception
#
1
(
Home)
418
1,430
0
0
0
0
0
646
0
Telephone
Follow­
Up
#
1
28
91
249
0
0
0
0
0
0
Preconception
#
2
(
Home)
227
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
2
22
85
0
0
0
0
0
0
0
Preconception
#
3
(
Home)
95
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
3
20
82
0
0
0
0
0
0
0
Preconception
#
4
(
Home)
88
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
4
18
78
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
5
17
75
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
6
16
0
0
0
0
0
0
0
0
Pregnancy
Tests
**
(
number
per
test)
121
48
0
0
0
0
0
0
0
Event
Form
8
38
104
0
0
0
0
0
0
Moving
Questions
5
16
0
0
0
0
0
0
0
Estimated
Total
Burden
Hours
1139
2134
952
19
19
19
0
646
0
*
Although
technically
not
part
of
the
preconception
visits,
burden
for
screening
women
is
included
in
this
table.
Burden
estimates
for
women
who
are
pregnant
when
screened
is
therefore
included
here.
**
Assume
one
test
per
month
for
high
likelihood
group,
and
one
test
total
for
the
moderate
likelihood
group.
***
Assume
one
event
per
year
****
Assume
one­
third
of
women
move
37
Exhibit
8.
Burden
Estimates
for
Pregnancy
and
Birth/
Childhood
Visits
*
Oral
glucose
tolerance
test;
assume
10%
of
women
in
pre­
pregnancy
and
first
trimester
groups
will
participate.
**
Assumes
4
events
per
year
per
child
and
1
event
per
year
for
the
woman.
***
Assume
one­
third
of
women
move
during
pregnancy
visit
and
one­
third
move
during
childhood
visits.
Total
Burden
per
Information
Collection
Activity
(
Hours)

Enrolled
Women
Information
Collection
Activity
High
Moderate
Low
Pregnant,
1st
Trimester
Pregnant,
2nd
Trimester
Pregnant,
3rd
Trimester
Enrolled
at
Delivery
Medical
staff
Partners
Children
Any
first
visit:
basic
(
Home)
0
0
33
14
14
14
14
0
264
0
Pregnancy
visit
#
1
(
Home)
99
89
200
84
0
0
0
0
44
0
OGTT*
(
Clinic)
18
15
33
15
0
0
0
8
0
0
Pregnancy
visit
#
2
(
Clinic)
189
168
381
159
168
0
0
178
0
0
Pregnancy
visit
#
3
(
Clinic)
180
159
363
150
159
159
0
195
0
0
Birth
(
Clinic)
10
8
19
8
8
9
12
518
0
68
1
Month
(
Home)
54
48
109
45
48
49
33
0
0
129
6
Months
(
Home)
102
92
208
86
90
94
62
0
171
122
12
Months
(
Home)
72
66
149
62
65
66
44
0
0
174
18
Months
(
Home)
92
84
188
80
80
82
56
0
0
110
Event
Form**
21
19
43
18
19
19
13
0
0
0
Moving
Questions***
3
3
7
3
1
1
1
0
0
0
Estimated
Total
Burden
Hours
840
751
1,733
724
652
493
235
899
479
603
38
Exhibit
9.
Estimated
Respondent
Burden
in
Hours
Burden
(
Hours)
by
Respondent
Type
Information
Collection
Activity
Household
Unit
Women
Partners
Children
Medical
staff
Total
Respondent
Burden
(
Hours)
Annual
Respondent
Burden
(
Hours)
Household
Rostering
833
0
0
0
0
833
278
Screening
(
Home)
0
1,486*
0
0
0
1,486
495
Preconception
#
1
(
Home)
0
1,848
646
0
0
2,494
831
Telephone
Follow­
Up
#
1
0
368
0
0
0
368
123
Preconception
#
2
(
Home)
0
227
0
0
0
227
76
Telephone
Follow­
Up
#
2
0
107
0
0
0
107
36
Preconception
#
3
(
Home)
0
95
0
0
0
95
32
Telephone
Follow­
Up
#
3
0
102
0
0
0
102
34
Preconception
#
4
(
Home)
0
88
0
0
0
88
29
Telephone
Follow­
Up
#
4
0
96
0
0
0
96
32
Telephone
Follow­
Up
#
5
0
92
0
0
0
92
31
Telephone
Follow­
Up
#
6
0
16
0
0
0
16
5
Pregnancy
Tests
0
169
0
0
0
169
56
Any
first
visit:
basic
(
Home)
0
89
264
0
0
353
118
Pregnancy
visit
#
1
(
Home)
0
472
44
0
0
516
172
OGTT
(
Clinic)
0
81
0
0
8
89
30
Pregnancy
visit
#
2
(
Clinic)
0
1,065
0
0
178
1,243
414
Pregnancy
visit
#
3
(
Clinic)
0
1,170
0
0
195
1,365
455
Birth
(
Clinic)
0
74
0
68
518
660
220
1
Month
(
Home)
0
386
0
129
0
515
172
6
Months
(
Home)
0
734
171
122
0
1,027
342
12
Months
(
Home)
0
524
0
174
0
698
233
18
Months
(
Home)
0
662
0
110
0
772
257
Event
Form**
0
302
0
0
0
302
101
Moving
Questions***
0
40
0
0
0
40
13
Total
833
10,293
1,125
603
899
13,753
4,585
*
Includes
burden
for
women
who
complete
the
screening
but
are
not
enrolled
in
the
Study
(
1,750
women
x
20
minutes
per
response
=
583
total
hours).
**
Assumes
4
events
per
year
per
child
and
1
event
per
year
for
the
woman.
***
Assume
one­
third
of
women
move
during
pregnancy
visit
and
one­
third
move
during
childhood
visits.

Annual
Respondent
Burden:
4,585
hours
Annual
Record
Keeping
Burden:
None
39
6(
b)
Respondent
Costs
Respondent
costs
have
been
calculated
using
the
average
hourly
wage
for
adults
determined
from
the
Greensboro­
Winston­
Salem­
High
Point
May
2004
Metropolitan
Area
Occupational
Employment
and
Wage
Estimates
from
the
Bureau
of
Labor
Statistics1.
The
rate
for
adults
($
16.33)
is
the
mean
hourly
rate
for
all
occupations
in
this
area.
For
children,
the
hourly
wage
is
estimated
at
$
5.15,
the
minimum
wage
for
North
Carolina.
For
medical
staff,
an
hourly
wage
of
$
50.00
was
used
to
estimate
costs,
assuming
that
the
overall
burden
for
medical
staff
would
be
apportioned
between
obstetricians/
gynecologists
(
with
a
mean
hourly
wage
of
$
94.38)
and
registered
nurses
(
with
a
mean
hourly
wage
of
$
23.40).
The
annual
cost
to
respondents
is
calculated
as
shown
in
Exhibit
10.

1
Source:
Bureau
of
Labor
Statistics.
(
May
2004).
Occupational
Employment
Statistics
(
http://
www.
bls.
gov/
oes/
current/
oes_
3120.
htm#
b00­
0000).
40
Exhibit
10.
Total
Estimated
Burden
and
Costs:
Screening,
Preconception,
Pregnancy,
Birth,
and
Childhood
Visits
Information
Collection
Activity
Total
Respondent
Burden
(
Hours)
Annual
Respondent
Burden
(
Hours)
Estimated
Annual
Cost
Household
Rostering
833
278
$
4,540
Screening
(
Home)
1,486
495
$
8,083
Preconception
#
1
(
Home)
2,494
831
$
13,570
Telephone
Follow­
Up
#
1
368
123
$
2,009
Preconception
#
2
(
Home)
227
76
$
1,241
Telephone
Follow­
Up
#
2
107
36
$
588
Preconception
#
3
(
Home)
95
32
$
523
Telephone
Follow­
Up
#
3
102
34
$
555
Preconception
#
4
(
Home)
88
29
$
474
Telephone
Follow­
Up
#
4
96
32
$
523
Telephone
Follow­
Up
#
5
92
31
$
506
Telephone
Follow­
Up
#
6
16
5
$
82
Pregnancy
Tests
(
number
per
test)
169
56
$
914
Any
first
visit:
basic
(
Home)
353
118
$
1,927
Pregnancy
visit
#
1
(
Home)
515
172
$
2,809
OGTT
(
Clinic)
89
30
$
574
Pregnancy
visit
#
2
(
Clinic)
1,243
414
$
8,766
Pregnancy
visit
#
3
(
Clinic)
1,365
455
$
9,621
Birth
(
Clinic)
660
220
$
9,155
1
Month
(
Home)
515
172
$
2,325
6
Months
(
Home)
1,027
342
$
5,138
12
Months
(
Home)
698
233
$
3,151
18
Months
(
Home)
772
257
$
3,792
Event
Form
302
101
$
1,644
Moving
Questions
40
13
$
218
Total
13,752
4,585
$
82,728
Annual
Respondent
Cost:
$
82,728
Capital/
Start­
Up
Cost:
None
Operating
and
Maintenance
(
O&
M)
Cost:
None
6(
c)
Estimating
Agency
Burden
and
Cost
The
Agency
already
has
a
contract
in
place
with
a
private
research
organization
whose
scope
of
work
includes
the
ability
to
conduct
all
aspects
of
the
Pilot
Study.
These
costs
are
included
in
Exhibit
12,
along
with
hours
and
costs
associated
with
the
Agency
activities
and
those
of
an
Information
Technology
(
IT)
contractor.
Based
on
the
2005
GS
pay
schedule,
EPA
estimates
an
average
hourly
rate
of
$
54.00
for
Agency
staff.
To
derive
hourly
estimates,
EPA
divided
the
annual
compensation
for
a
GS­
13,
Step
1
by
2,080
which
is
the
number
of
hours
in
the
Federal
work
year.
EPA
then
multiplied
the
hourly
rate
by
the
standard
government
benefits
multiplication
factor
of
1.6.
41
Exhibit
11.
Agency
Cost
Annual
Burden
Annual
Burden
Hours
Costs
($)
Agency
Activities
Contractor
IT
Contractor
EPA
Freq
Total
Hours
Contractor
$
100/
hour
IT
Contractor
$
125/
hour
EPA
$
54.00/
hour
Planning
2,790
1,000
1,500
1
5,290
$
279,000
$
125,000
$
81,000
Field
Preparations
1,860
200
372
1
2,432
$
186,000
$
25,000
$
20,088
Data
Collection
11,160
0
416
1
11,576
$
1,116,000
$
0
$
22,464
Data
Editing
and
Statistical
Analysis
2,790
0
480
1
3,270
$
279,000
$
0
$
25,920
TOTAL
18,600
1,200
2,768
1
22,568
$
1,860,000
$
150,000
$
149,472
Agency
Total
Annual
Burden:
22,568
Agency
Total
Annual
Cost:
$
2,159,472
6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
Because
the
data
collection
period
for
this
study
is
expected
to
occur
over
a
period
of
3
years,
we
anticipate
some
respondent
attrition
throughout
the
follow­
up.
Women
who
are
enrolled
during
pregnancy
or
at
delivery
will
have
a
different
total
burden
depending
on
where
in
the
visit
schedule
they
begin.
In
addition,

women
enrolled
during
preconception
will
have
a
different
burden
depending
on
if
and
when
they
become
pregnant.
A
number
of
assumptions
have
been
made
in
estimating
the
total
respondent
burden
and
cost
described
in
Sections
6(
a)
and
6(
b):

Preconception
visits
 
The
total
number
pregnant
women
in
each
pregnancy
likelihood
group
is
estimated
from
a
document
prepared
by
Battelle
for
the
NCS,
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
located
on
the
NCS
website
at
http://
www.
nationalchildrensstudy.
gov/
research/
analytic_
reports/
loader.
cfm?
url=/
commonspot/
secur
ity/
getfile.
cfm&
PageID=
9099
(
Pivetz,
Iroz­
Elardo,
Strauss,
Rust,
and
Menkedick,
2004).

 
The
distribution
of
time­
to­
pregnancy
for
the
high
likelihood
group
has
been
adapted
from
information
received
from
NICHD
as
a
result
of
a
literature
review
performed
for
a
study
of
women
seeking
to
become
pregnant.

 
The
distribution
of
time­
to­
pregnancy
for
the
moderate
likelihood
group
uses
somewhat
similar
rates
as
the
high
likelihood
group,
but
delayed
by
1
month.
For
the
low
likelihood
group,
the
number
of
total
pregnancies
was
almost
equally
divided
by
time.
42
 
Women
may
move
between
likelihood
groups
throughout
the
enrollment
period,
but
we
have
not
made
any
estimates
of
these
rates
or
the
direction
of
movement.
The
assumption
is
that
movement
in
and
out
of
groups
will
result
in
similar
numbers
of
women
with
infants
for
follow­
up.

 
The
Battelle
report
previously
referenced
assumed
a
0.003%
attrition
rate
per
month;
we
have
used
a
more
conservative
estimate
of
1%
per
month
for
the
preconception
visits.

 
The
number
of
husband/
partner
respondents
has
been
estimated
at
70%
of
the
number
of
women
for
each
applicable
visit.

Post­
conception
visits
 
For
women
enrolled
during
pregnancy,
we
have
assumed
that
there
will
be
a
5%
attrition
rate
between
each
visit.

 
For
the
121
women
pregnant
at
enrollment
and
the
48
volunteers,
we
are
assuming
that
1/
3
of
the
women
will
enter
at
each
of
the
three
trimester
visits.

 
After
the
birth
visit,
we
estimate
a
5%
attrition
rate
per
visit.

 
Finally,
the
women
who
are
enrolled
at
delivery
will
begin
with
the
birth
visit,
and
it
is
estimated
that
there
will
be
a
5%
attrition
rate
for
each
subsequent
visit.

 
The
number
of
husband/
partner
respondents
has
been
estimated
at
70%
of
the
number
of
women
for
each
applicable
visit.

 
For
purposes
of
estimating
burden,
we
have
assumed
that
half
of
the
biologic
samples
in
the
OGTT
and
second
and
third
trimester
visits
will
be
collected
by
clinic
staff
and
the
remaining
samples
will
be
collected
by
study
staff.

 
For
the
biologic
samples
collected
at
birth,
we
are
assuming
that
85%
of
the
samples
will
by
collected
by
hospital
staff.
Samples
will
be
collected
by
contractor
staff
in
those
instances
that
hospitals
or
clinics
choose
not
to
participate
in
the
study.

The
respondent
universe
for
each
information
collection
activity
and
respondent
type
is
provided
in
Exhibits
12
and
13.
43
Exhibit
12.
Respondent
Universe
Estimates
for
Screening
and
Preconception
Visits
Number
of
Respondents
per
Information
Collection
Activity
Women
Information
Collection
Activity
High
Moderate
Low
Pregnant,
1st
Trimester
Pregnant,
2nd
Trimester
Pregnant,
3rd
Trimester
Enrolled
at
Delivery
Partners
Children
Screening
(
Home)
167
572
1,797
56
56
57
0
0
0
Preconception
#
1
(
Home)
167
572
0
0
0
0
0
517
0
Telephone
Follow­
Up
#
1
167
547
1,491
0
0
0
0
0
0
Preconception
#
2
(
Home)
151
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
2
132
508
0
0
0
0
0
0
0
Preconception
#
3
(
Home)
126
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
3
120
489
0
0
0
0
0
0
0
Preconception
#
4
(
Home)
117
0
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
4
110
469
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
5
101
450
0
0
0
0
0
0
0
Telephone
Follow­
Up
#
6
95
0
0
0
0
0
0
0
0
Pregnancy
Tests*
(
number
per
test)
1,453
572
0
0
0
0
0
0
0
Event
Form**
95
450
1250
0
0
0
0
0
0
Moving
Questions***
55
189
0
0
0
0
0
0
0
*
Assume
one
test
per
month
for
high
likelihood
group,
and
one
test
total
for
moderate
likelihood
group.
**
Assumes
4
events
per
year
per
child
and
1
event
per
year
for
the
woman.
***
Assume
one­
third
of
women
move
during
pregnancy
visit
and
one­
third
move
during
childhood
visits.
44
Exhibit
13.
Respondent
Universe
Estimates
for
Pregnancy
and
Birth/
Childhood
Visits
Number
of
Respondents
per
Information
Collection
Activity
Women
Information
Collection
Activity
High
Moderate
Low
Pregnant,
1st
Trimester
Pregnant,
2nd
Trimester
Pregnant,
3rd
Trimester
Enrolled
at
Delivery
Medical
staff
*
Partners
Children
Any
first
visit:
basic
(
Home)
0
0
133
56
56
57
33
0
211
0
Pregnancy
visit
#
1
(
Home)
66
59
133
56
0
0
0
0
88
0
OGTT**
(
Clinic)
7
6
13
6
0
0
0
16
0
0
Pregnancy
visit
#
2
(
Clinic)
63
56
127
53
56
0
0
178
0
0
Pregnancy
visit
#
3
(
Clinic)
60
53
121
50
53
53
0
195
0
0
Birth
(
Clinic)
57
50
115
48
50
51
35
345
0
406
1
Month
(
Home)
54
48
109
45
48
49
33
0
0
386
6
Months
(
Home)
51
46
104
43
45
47
31
0
257
367
12
Months
(
Home)
48
44
99
41
43
44
29
0
0
348
18
Months
(
Home)
46
42
94
40
40
41
28
0
0
331
Event
Form***
256
230
521
217
226
232
156
0
0
0
Moving
Questions****
40
35
80
33
16
16
11
0
0
0
*
Medical
staff
respondent
universe
includes
the
total
number
of
staff
persons
required
to
carry
out
required
tasks
on
an
annual
basis.
Estimates
are
for
both
Davidson
and
Forsyth
Counties
and
include
both
clinic
and
hospital
settings.
**
Oral
glucose
tolerance
test;
assume
ten
percent
of
women
in
pre­
pregnancy
and
first
trimester
groups
will
be
asked
to
participate.
***
Assumes
4
events
per
year
per
child
and
1
event
per
year
for
the
woman.
****
Assumes
one­
third
of
women
move
during
pregnancy
visit
and
one­
third
move
during
childhood
visits.

6(
e)
Bottom
Line
Burden
Hours
and
Costs
Tables
(
i)
Respondent
Tally:
The
annual
respondent
burden
(
for
all
respondents
and
all
visits)
is
4,585
hours
at
an
estimated
annual
cost
of
$
82,728.

(
ii)
Agency
Tally:
The
annual
agency
burden
is
22,568
hours
at
a
cost
of
$
2,159,472.

(
iii)
Variations
in
the
Annual
Bottom
Line:
We
do
not
anticipate
a
significant
variation
(>
25%)
in
the
annual
respondent
reporting/
recordkeeping
burden
or
cost
over
the
3­
year
OMB
approval
period.
45
6(
f)
Reasons
for
Change
in
Burden
There
is
no
change
in
the
burden
because
this
is
a
new
request.

6(
g)
Burden
Statement
The
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
varies
depending
on
the
eligibility
and
pregnancy
status
of
women
at
the
time
of
enrollment.
Exhibit
15
provides
a
summary
of
annual
burden,
in
time
and
cost,
by
respondent
type.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
the
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
ORD­
2005­
0010,
which
is
available
for
which
is
available
for
public
viewing
at
the
Office
of
Research
and
Development
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Office
of
Research
and
Development
Docket
is
(
202)
566­
1752.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
obtain
a
copy
of
the
draft
collection
of
information,
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,

Office
of
Management
and
Budget,
725
17th
Street
NW,
Washington,
DC
20503,
Attention:

Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
number
(
ORD­
2005­
0010)
and
OMB
control
number
(
TBD)
in
any
correspondence.
46
Exhibit
14.
Annual
Burden
by
Respondent
Type
Type
of
Respondent
Estimated
Number
of
Respondents
Annual
Burden
(
Hours)
Annual
Burden
(
Cost)*

Household
Unit
10,000
278
$
4,540
Women
Screened,
Not
Enrolled
1,750
194
$
3,168
Women
Screened
and
Enrolled
High
likelihood
of
pregnancy
167
660
$
10,778
Moderate
likelihood
of
pregnancy
572
962
$
15,710
Low
likelihood
of
pregnancy
1,797
895
$
14,615
Pregnant
at
enrollment
169
642
$
10,484
Enrolled
at
delivery
35
78
$
1,274
Partners
728
375
$
6,124
Children
406
201
$
1,035
Medical
Staff
53
300
$
15,000
TOTAL
15,677
4,585
$
82,728
*
Burden
hours
are
multiplied
by
the
following
rates:
$
16.33
for
women
and
their
partners,
$
5.15
for
children,
and
$
50.00
for
medical
staff.
Source:
Greensboro­
Winston­
Salem­
High
Point
May
2004
Metropolitan
Area
Occupational
Employment
and
Wage
Estimates
from
the
Bureau
of
Labor
Statistics
(
http://
www.
bls.
gov/
oes/
current/
oes_
3120.
htm#
b00­
0000).
47
Part
B.
Required
Items
for
Information
Collections
Involving
Statistical
Sampling
1.
Survey
Objectives,
Key
Variables,
and
Other
Preliminaries
1(
a)
Survey
Objectives
The
goal
of
the
NCS
is
to
improve
the
health
and
well­
being
of
children
through
the
examination
of
the
effects
of
environmental
influences
on
the
health
and
development
of
more
than
100,000
children
across
the
United
States,
following
them
from
before
birth
until
age
21.
To
successfully
achieve
this
ambitious
goal,
careful
planning
must
be
performed
to
ensure
that
the
proposed
protocols
and
measurements
collected
will
be
amenable
to
the
study
participants
and
collaborators,
while
maintaining
scientific
validity.
The
Pilot
Study
will
provide
an
opportunity
to
field
test
these
protocols
and
measures
including
sampling
strategies,
recruitment
and
retention,
and
specific
measurement
methods
and
procedures
that
are
proposed
for
the
NCS.
The
Pilot
Study
will
serve
as
a
platform
for
validation
studies
to
compare
the
performance
of
alternative
sampling,
recruitment,
and
data
collection
methodologies
and
to
estimate
response
rates
and
study
costs,
as
well
as
to
estimate
and
ideally
lower,
the
burden
on
future
NCS
participants.
The
Pilot
Study
also
will
provide
the
platform
for
testing
additional
NCS
protocols
that
will
be
developed
over
the
anticipated
21­
year
course
of
the
NCS
(
e.
g.,
protocols
for
collection
of
data
at
the
5­
year
follow­
up
or
for
collection
of
supplemental
data
for
a
case­
cohort
substudy
of
asthmatic
and
non­
asthmatic
children).

Some
of
the
questions
to
be
answered
by
the
Pilot
Study
are
the
following:

1.
Is
a
household
survey
a
feasible
method
(
considering
operational
feasibility,
study
costs,
and
response
rates)
for
recruiting
women
and
infants
for
a
complex
longitudinal
study?

2.
Do
commercially­
available
postal
mailing
lists
provide
a
more
efficient
method
with
sufficient
coverage
for
preparing
a
sampling
frame
of
housing
units
in
a
specified
area
compared
to
the
standard
method
of
counting
and
listing?

3.
What
ranges
of
response
rates
can
be
expected
for
the
various
stages
of
data
collection
planned
for
the
NCS?

4.
What
field
interviewing
techniques
will
be
most
effective
and
efficient
for
gaining
cooperation
from
women
who
are
eligible
to
participate
in
the
study
(
e.
g.,
how
many
attempts
should
be
made
to
contact
sample
housing
units
and
should
advance
letters
be
sent
to
sample
housing
units)?
48
5.
Will
racial/
ethnic,
socioeconomic
or
urban/
rural
characteristics
of
the
study
areas
pose
unique
challenges
for
recruiting
and
retaining
participants?

6.
Will
the
types
of
local
medical
systems
pose
different
challenges
for
gaining
their
cooperation
in
the
study?

7.
Will
the
use
of
Census
areas
or
school
catchment
areas
to
define
the
study
areas
have
an
effect
on
community
engagement
activities
and
participant
retention?

8.
To
what
extent
is
data
analysis
compromised
by
environmental
samples
collected
by
less
highly
trained
individuals?

1(
b)
Key
Variables
Since
the
primary
goals
of
the
Pilot
Study
are
to
test
various
data
collection
methods,
the
key
variables
to
be
analyzed
upon
the
completion
of
the
study
are
acceptability
of
the
study
protocol,
response
rates
and
other
measures
of
data
quality.
Calculating
unit
response
rates
for
various
subgroups
within
and
across
the
study
areas
will
require
tracking
of
each
housing
unit
listed
in
the
sampling
frames
and
each
eligible
woman
identified
in
the
household
rosters
of
responding
households.
Status
codes
will
be
assigned
to
each
case
(
housing
unit
or
woman)

during
the
field
data
collection
stages
to
track
whether
the
case
is
eligible,
participating,
or
in
progress.
Upon
completion
of
the
data
collection
activities,
the
status
codes
will
be
finalized
and
can
then
be
used
to
calculate
the
appropriate
response
rates.
In
addition,
item
response
rates
and
data
quality
flags
will
be
analyzed
to
determine
the
success
of
the
protocols
for
collection
of
usable
data.

1(
c)
Statistical
Approach
The
current
study
plan
for
the
NCS
calls
for
a
probability­
based
selection
of
households
to
recruit
women
to
participate
in
the
study.
In
order
to
provide
useful
information
for
the
implementation
of
the
NCS,
the
Pilot
Study
needs
to
emulate
certain
aspects
of
the
NCS
study
design.
Since
the
goals
of
the
Pilot
Study
do
not
involve
the
analysis
of
outcomes
to
make
inferences
about
a
specific
target
population,
but
rather
emphasizes
the
testing
of
various
data
collection
methods,
it
was
not
deemed
necessary
to
emulate
the
statistical
methods
planned
for
the
selection
of
study
locations
and
study
areas
(
in
which
counties
are
area
segments).
However,

to
make
informative
conclusions
regarding
the
anticipated
success
of
the
recruitment
and
retention
procedures
planned
for
the
NCS,
a
range
of
study
areas
were
selected
(
urban,
rural,

etc.).
Women
and
children
will
be
recruited
from
these
study
areas
using
the
household
interviewing
procedures
that
are
planned
for
the
NCS.
Some
additional
recruitment
through
hospitals
and
medical
providers
also
is
planned
to
supplement
the
household
sample
and
to
test
the
feasibility
of
these
alternative
recruitment
procedures.
Women
will
be
eligible
for
49
recruitment
only
if
they
reside
in
the
sampled
study
areas
at
the
time
of
delivery.
Household
recruitment
will
be
performed
for
a
census
of
all
households
in
the
selected
areas.

1(
d)
Feasibility
The
Pilot
Study
is
a
feasibility
study
of
potential
data
collection
methods
for
the
NCS.

Under
the
current
schedule,
the
Vanguard
centers
of
the
NCS
are
due
to
start
data
collection
in
June,
2007.
Provided
the
Pilot
Study
starts
the
initial
recruitment
phase
of
data
collection
in
early
2006,
the
rostering
of
households
and
screening
and
enrollment
of
eligible
women
for
the
Pilot
Study
will
be
completed
in
sufficient
time
to
allow
for
modifications
to
the
NCS
study
plan
and
protocols
prior
to
the
start
of
data
collection
for
the
Vanguard
centers.
As
subsequent
stages
of
the
Pilot
Study
data
collection
are
completed,
the
results
of
the
data
collection
activities
will
inform
the
ICC
of
any
necessary
modifications
to
the
corresponding
NCS
study
protocols
prior
to
the
implementation
of
those
protocols
in
the
field.

2.
Survey
Design
2(
a)
Target
Population
and
Coverage
The
goals
of
the
Pilot
Study
are
to
test
various
data
collection
methodologies
in
preparation
for
the
NCS
rather
than
to
make
analytical
inferences
about
a
particular
population.

To
meet
the
goals
of
the
study,
study
locations
and
study
areas
have
been
purposively
chosen
to
test
the
methodologies
on
areas
with
different
population
characteristics.

In
an
effort
to
control
costs,
the
two
study
locations
for
the
Pilot
Study
needed
to
be
in
close
proximity
to
Research
Triangle
Park,
NC,
to
enable
the
project
staff
to
make
occasional
trips
to
the
study
locations
to
observe
study
activities.
Data
collection
activities
in
urban
areas
may
pose
different
challenges
than
in
rural
areas,
so
the
two
study
locations
needed
to
have
urban
or
rural
areas
in
which
the
study
could
be
concentrated.
Another
important
consideration
was
to
choose
study
locations
that
would
not
have
a
lot
of
overlap
with
any
of
the
seven
NC
counties
which
have
been
selected
to
participate
in
the
NCS
in
order
to
avoid
confusion
among
community
members
and
medical
staff
between
the
Pilot
Study
and
the
NCS.
The
seven
counties
selected
for
the
NCS
are:

 
Buncombe
County
 
Burke
County
 
Cumberland
County
 
Duplin
County
 
Durham
County
 
Gaston
County
50
 
Rockingham
County.

After
considering
the
characteristics
and
locations
of
all
counties
within
approximately
a
100­
mile
radius
of
Research
Triangle
Park,
NC,
Davidson
and
Forsyth
counties
were
chosen
as
the
most
optimal
study
locations
for
the
Pilot
Study.
Davidson
County
is
a
predominantly
rural
area,
while
Forsyth
County
contains
the
city
of
Winston­
Salem,
one
of
the
larger
cities
in
NC.

The
two
counties
are
adjacent
to
one
another.

The
NCS
study
locations
in
closest
proximity
to
Forsyth
and
Davidson
counties
are
Durham
and
Rockingham
counties.
Exhibit
15
shows
the
birth
locations
for
births
that
occurred
in
2003
by
the
mother=
s
county
of
residence
for
Davidson,
Forsyth,
counties.
The
small
number
of
births
that
may
occur
in
NCS
counties
to
mothers
who
live
in
Pilot
Study
counties
and
vice
versa,
combined
with
a
2­
year
lag
between
the
start
of
the
Pilot
Study
data
collection
and
NCS
data
collection,
will
result
in
very
few,
if
any,
births
that
overlap
between
the
two
studies
in
the
same
time
frame.

While
trying
to
avoid
as
much
overlap
in
births
as
possible
between
the
NCS
and
Pilot
Study
locations,
it
is
advantageous
to
choose
two
study
locations
for
the
Pilot
Study
that
would
have
a
significant
overlap
in
births
across
the
study
locations
so
that
fewer
medical
facilities
would
need
to
be
recruited
in
order
to
cover
the
facilities
where
the
majority
of
the
births
occur
for
residents
of
the
study
locations.
Less
than
one
percent
of
the
births
in
2003
to
mothers
who
lived
in
Forsyth
County
occurred
in
Davidson
County,
however
more
than
17%
of
the
births
to
mothers
who
lived
in
Davidson
County
occurred
in
Forsyth
County.
51
Exhibit
15.
Births
in
2003
by
Mother's
County
of
Residence
County
of
Birth
Location
Number
of
Births
Percent
of
Births
Mothers
Residing
in
Pilot
Study
Locations
County
of
Residence:
Davidson
Davidson
1,121
57.8%

Guilford
400
20.6%

Forsyth
342
17.6%

Rowan
36
1.9%

Randolph
11
0.6%

Cabarrus
7
0.4%

Mecklenberg
5
0.3%

Stanly
4
0.2%

Wake
3
0.2%

Durham
2
0.1%

Out
of
State
2
0.1%

Columbus
1
0.1%

Gaston
1
0.1%

Iredell
1
0.1%

Moore
1
0.1%

Orange
1
0.1%

Rockingham
1
0.1%

Scotland
1
0.1%

County
of
Residence:
Forsyth
Forsyth
4,300
92.9%

Guilford
269
5.8%

Davidson
18
0.4%

Out
of
State
11
0.2%

Surry
6
0.1%

Iredell
5
0.1%

Mecklenberg
5
0.1%

Orange
5
0.1%

Durham
2
0.0%

Wake
2
0.0%

Alamance
1
0.0%

Buncombe
1
0.0%

Carteret
1
0.0%

Catawba
1
0.0%

Rowan
1
0.0%
52
In
order
to
control
field
data
collection
costs
associated
with
conducting
a
household
survey,
two
well­
defined
areas
were
chosen
within
each
study
location.
One
of
the
goals
of
the
Pilot
Study
is
to
test
the
effects
of
choosing
study
areas
defined
by
school
catchment
areas
as
contrasted
with
the
traditional
use
of
Census
areas.
To
evaluate
the
effects
of
the
different
boundary
definitions,
one
Census
area
and
one
school
catchment
area
were
chosen
within
each
study
location.
In
Davidson
County,
the
Census
area
was
chosen
to
be
in
the
city
of
Lexington
and
the
school
area
was
chosen
in
a
very
rural
area
in
northwest
Davidson
County.
With
a
population
of
less
than
20,000
people,
Lexington
is
representative
of
a
small
town.
The
rural
elementary
school
catchment
area
has
similar
characteristics
as
many
rural
areas
in
the
mid­
west
United
States.
In
Forsyth
County,
both
the
Census
and
school
catchment
areas
were
chosen
in
the
central
part
of
Winston­
Salem.
Both
areas
are
similar
to
urban
areas
in
U.
S.
cities
and
have
been
chosen
with
similar
demographic
and
socioeconomic
characteristics
to
facilitate
comparisons
between
the
Census
and
school
catchment
areas.

As
a
result
of
the
purposive
selection
of
the
study
locations
and
their
associated
study
areas,
the
target
population
for
the
Pilot
Study
will
be
all
women
who
reside
in
the
study
areas
who
are
eligible
for
participation
in
the
study.
The
coverage
will
be
the
same
as
the
target
population.
The
eligibility
criteria
for
women
to
participate
in
the
Pilot
Study
are
as
follows:

 
Woman
who
are
at
least
18
years
of
age.

 
Women
who
reside
in
a
study
area.

 
Women
with
no
plans
to
move
out
of
the
study
area
before
delivery
(
if
pregnant
at
the
time
of
enrollment).

 
Women
and
their
partners
are
not
surgically
sterile.

2(
b)
Sample
Design
i)
Sampling
Frame
The
sampling
frame
for
the
Pilot
Study
will
be
a
list
of
all
housing
units
in
the
designated
study
areas
in
Davidson
and
Forsyth
Counties,
NC.
The
sampling
frames
for
each
study
area
will
be
compiled
using
two
methods:

 
Counting
and
listing
 
Residential
postal
address
mailing
lists.

To
evaluate
the
costs
and
coverage
of
each
of
the
household
sampling
frame
construction
methods,
we
expect
to
construct
the
sampling
frame
for
half
of
each
study
area
using
counting
53
and
listing
methods
and
the
other
half
of
each
study
area
using
commercially
available
residential
postal
address
mailing
lists.
Quality
assurance
checks
will
be
incorporated
into
the
sampling
frame
construction
procedures
in
order
to
identify
housing
units
missing
from
either
source.

ii)
Sample
Size
For
the
Pilot
Study,
a
census
of
all
eligible
women
in
the
designated
study
areas
will
be
implemented.
This
strategy
will
provide
NCS
planners
information
about
feasibility
issues
in
undertaking
a
census
approach.
Each
of
the
chosen
study
areas
is
estimated
to
contain
between
2,000
and
3,000
occupied
housing
units,
for
a
total
of
approximately
10,000
occupied
housing
units
in
which
rostering
and
screening
activities
will
be
attempted.
Data
from
the
2000
Census
and
2000
Public
Use
Microdata
Sample
(
PUMS)
indicate
that
approximately
50%
of
households
will
contain
a
woman
of
child
bearing
age
(
18
to
44
years
old).
Based
on
assumed
response
rates
and
tables
of
estimated
pregnancy
rates
by
age
groups
and
likelihood
of
pregnancy
in
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
located
on
the
NCS
website
at
http://
www.
nationalchildrensstudy.
gov/
research/
analytic_
reports/
loader.
cfm?
url=/
commonspot/
s
ecurity/
getfile.
cfm&
PageID=
9099
(
Pivetz,
Iroz­
Elardo,
Strauss,
Rust,
and
Menkedick,
2004)

prepared
for
the
NCS,
we
estimate
that
approximately
2,740
women
will
enroll
in
the
study.

From
the
women
who
enroll
in
the
study,
we
estimate
that
approximately
406
children
will
be
born
within
the
monitored
time
frame
and
enrolled
in
the
study
with
their
mothers.

iii)
Stratification
Variables
No
stratification
variables
will
be
used
in
the
rostering
of
all
households
in
the
study
areas
or
in
the
screening
of
eligible
women
within
the
rostered
households.
After
completing
the
screening
questionnaire,
each
woman
participating
in
the
Pilot
Study
will
be
enrolled
into
one
of
the
following
four
strata,
as
defined
in
the
study
plan
for
the
NCS:

 
Currently
pregnant
 
High
likelihood
of
pregnancy
 
Moderate
likelihood
of
pregnancy
 
Low
likelihood
of
pregnancy.

Women
who
indicate
at
the
time
of
completing
the
screening
questionnaire
that
they
are
pregnant
will
be
assigned
to
the
"
currently
pregnant"
group.
Women
who
report
in
the
screening
questionnaire
that
they
are
planning
on
becoming
pregnant
will
be
assigned
to
the
high
likelihood
group.
Women
of
child­
bearing
age
(
18
to
44
years
old)
who
report
in
the
screening
54
questionnaire
that
they
are
sexually
active,
are
not
planning
on
becoming
pregnant
and
are
using
either
no
contraception
or
using
a
contraceptive
method
with
at
least
a
10%
known
failure
rate
will
be
assigned
to
the
moderate
likelihood
group.
Women
of
child­
bearing
age
who
report
in
the
screening
questionnaire
that
they
currently
are
not
sexually
active
or
are
sexually
active
and
using
a
contraceptive
method
with
a
less
than
10%
known
failure
rate
will
be
assigned
to
the
low
likelihood
group.
As
described
in
Part
A
(
4a),
the
stratum
assignments
of
women
enrolled
in
the
study
by
likelihood
of
pregnancy
will
determine
the
type
and
frequency
of
subsequent
data
collection
activities.

iv)
Sampling
Method
Since
the
Pilot
Study
sample
design
involves
a
census
of
all
households
and
all
eligible
women
in
the
designated
study
areas,
no
sampling
methods
will
be
used
in
the
implementation
of
the
study.

v)
Multi­
Stage
Sampling
Even
though
no
samples
will
be
selected
in
the
implementation
of
the
study,
two
stages
of
activities
will
be
performed
to
obtain
a
census
of
all
eligible
women
in
the
designated
study
areas.
The
first
stage
consists
of
attempting
to
roster
every
household
in
the
study
areas.
Once
a
household
is
rostered,
each
woman
meeting
the
preliminary
eligibility
criteria
listed
in
Section
Part
B
will
be
screened
for
enrollment
in
the
study
and
assigned
to
her
corresponding
likelihoodof
pregnancy
group.

2(
c)
Precision
Requirements
i)
Precision
Targets
Since
the
goals
of
the
Pilot
Study
primarily
focus
on
the
testing
of
various
data
collection
methods,
precision
targets
are
displayed
with
respect
to
detectable
differences
in
response
rates
calculated
for
various
subgroups
within
and
across
the
designated
study
areas.
Exhibit
16
through
Exhibit
18
presents
estimated
power
to
detect
differences
in
response
rates
between
two
subgroups.

Exhibit
16
presents
power
estimates
for
comparing
screening
response
rates
between
two
subgroups
of
occupied
housing
units.
Since
the
total
estimated
number
of
occupied
housing
units
in
the
study
is
approximately
10,000,
Exhibit
18
shows
equal
sample
sizes
that
total
5,000
and
10,000
housing
units.
The
total
sample
size
of
10,000
housing
units
would
be
equivalent
to
comparing
response
rates
between
Davidson
and
Forsyth
counties,
while
the
total
sample
size
of
5,000
housing
units
would
be
equivalent
to
comparing
response
rates
between
the
two
study
55
areas
within
Forsyth
County.
For
example,
if
we
wanted
to
compare
response
rates
between
the
two
study
areas
in
Forsyth
county,
we
would
want
to
look
at
the
scenario
in
Exhibit
16
that
shows
sample
sizes
for
group
1
and
group
2
of
2,500
each,
producing
a
total
sample
size
of
5,000
housing
units
(
the
estimated
number
of
housing
units
in
the
Forsyth
county
study
areas.
If
the
response
rate
of
the
school
catchment
study
area
(
group
1)
is
50%,
we
will
have
sufficient
power
in
the
study
to
detect
at
least
a
5%
difference
in
a
comparison
of
response
rates
between
the
school
catchment
study
area
and
the
Census
study
area.

Exhibit
17
presents
power
estimates
for
comparing
enrollment
rates
between
two
subgroups
of
women
who
are
identified
as
eligible
for
the
study.
Since
the
total
estimated
number
of
eligible
women
in
the
study
is
approximately
4,400,
Exhibit
17
shows
equal
samples
sizes
that
total
2,200
and
4,400
women.

Exhibit
18
presents
power
estimates
for
comparing
enrollment
rates
between
two
subgroups
of
women
who
are
enrolled
in
the
study
and
give
birth
to
a
live
infant
during
the
enrollment
period.
Since
the
total
estimated
number
of
eligible
women
in
the
study
is
approximately
415,

Exhibit
18
shows
equal
samples
sizes
that
total
208
and
416
women.
In
the
sample
size
scenarios
provided,
there
will
be
sufficient
power
to
detect
at
least
10%
differences
between
response
rates
of
chosen
subgroups
of
occupied
housing
units
or
eligible
women
in
the
Pilot
Study
and
sufficient
power
to
detect
at
least
20%
differences
between
response
rates
of
women
who
give
birth
to
eligible
newborns.
56
Exhibit
16.
Estimated
Power
to
Compare
Screening
Response
Rates
between
Two
Equal
Subgroups
of
Housing
Units
Sample
Size
Group
1
Sample
Size
Group
2
Response
Rate
Group
1
Response
Rate
Group
2
Difference
of
Response
Rates
Power
2,500
2,500
0.40
0.45
0.05
94.9%

2,500
2,500
0.40
0.50
0.10
100.0%

2,500
2,500
0.40
0.60
0.20
100.0%

2,500
2,500
0.50
0.55
0.05
94.3%

2,500
2,500
0.50
0.60
0.10
100.0%

2,500
2,500
0.50
0.70
0.20
100.0%

2,500
2,500
0.60
0.65
0.05
95.3%

2,500
2,500
0.60
0.70
0.10
100.0%

2,500
2,500
0.60
0.80
0.20
100.0%

2,500
2,500
0.70
0.75
0.05
97.4%

2,500
2,500
0.70
0.80
0.10
100.0%

2,500
2,500
0.70
0.90
0.20
100.0%

2,500
2,500
0.80
0.85
0.05
99.5%

2,500
2,500
0.80
0.90
0.10
100.0%

2,500
2,500
0.80
1.00
0.20
100.0%

2,500
2,500
0.40
0.45
0.05
94.9%

5,000
5,000
0.40
0.45
0.05
99.9%

5,000
5,000
0.40
0.50
0.10
100.0%

5,000
5,000
0.40
0.60
0.20
100.0%

5,000
5,000
0.50
0.55
0.05
99.9%

5,000
5,000
0.50
0.60
0.10
100.0%

5,000
5,000
0.50
0.70
0.20
100.0%

5,000
5,000
0.60
0.65
0.05
99.9%

5,000
5,000
0.60
0.70
0.10
100.0%

5,000
5,000
0.60
0.80
0.20
100.0%

5,000
5,000
0.70
0.75
0.05
100.0%

5,000
5,000
0.70
0.80
0.10
100.0%

5,000
5,000
0.70
0.90
0.20
100.0%

5,000
5,000
0.80
0.85
0.05
100.0%

5,000
5,000
0.80
0.90
0.10
100.0%

5,000
5,000
0.80
1.00
0.20
100.0%
57
Exhibit
17.
Estimated
Power
to
Compare
Enrollment
Rates
between
Two
Equal
Subgroups
of
Women
Sample
Size
Group
1
Sample
Size
Group
2
Response
Rate
Group
1
Response
Rate
Group
2
Difference
of
Response
Rates
Power
1,100
1,100
0.40
0.45
0.05
66.7%

1,100
1,100
0.40
0.50
0.10
99.7%

1,100
1,100
0.40
0.60
0.20
100.0%

1,100
1,100
0.50
0.55
0.05
65.0%

1,100
1,100
0.50
0.60
0.10
99.7%

1,100
1,100
0.50
0.70
0.20
100.0%

1,100
1,100
0.60
0.65
0.05
67.0%

1,100
1,100
0.60
0.70
0.10
99.8%

1,100
1,100
0.60
0.80
0.20
100.0%

1,100
1,100
0.70
0.75
0.05
73.1%

1,100
1,100
0.70
0.80
0.10
100.0%

1,100
1,100
0.70
0.90
0.20
100.0%

1,100
1,100
0.80
0.85
0.05
84.7%

1,100
1,100
0.80
0.90
0.10
100.0%

2,200
2,200
0.40
0.45
0.05
92.1%

2,200
2,200
0.40
0.50
0.10
100.0%

2,200
2,200
0.40
0.60
0.20
100.0%

2,200
2,200
0.50
0.55
0.05
91.3%

2,200
2,200
0.50
0.60
0.10
100.0%

2,200
2,200
0.50
0.70
0.20
100.0%

2,200
2,200
0.60
0.65
0.05
92.6%

2,200
2,200
0.60
0.70
0.10
100.0%

2,200
2,200
0.60
0.80
0.20
100.0%

2,200
2,200
0.70
0.75
0.05
95.6%

2,200
2,200
0.70
0.80
0.10
100.0%

2,200
2,200
0.70
0.90
0.20
100.0%

2,200
2,200
0.80
0.85
0.05
98.9%

2,200
2,200
0.80
0.90
0.10
100.0%

2,200
2,200
0.80
1.00
0.20
100.0%
58
Exhibit
18.
Estimated
Power
to
Compare
Newborn
Enrollment
Rates
between
Two
Equal
Subgroups
of
Women
Giving
Birth
During
the
Study
Sample
Size
Group
1
Sample
Size
Group
2
Response
Rate
Group
1
Response
Rate
Group
2
Difference
of
Response
Rates
Power
104
104
0.40
0.45
0.05
11.6%

104
104
0.40
0.50
0.10
31.4%

104
104
0.40
0.60
0.20
83.6%

104
104
0.50
0.55
0.05
11.0%

104
104
0.50
0.60
0.10
30.0%

104
104
0.50
0.70
0.20
83.1%

104
104
0.60
0.65
0.05
11.0%

104
104
0.60
0.70
0.10
30.6%

208
208
0.40
0.45
0.05
18.2%

208
208
0.40
0.50
0.10
54.7%

208
208
0.40
0.60
0.20
98.6%

208
208
0.50
0.55
0.05
17.4%

208
208
0.50
0.60
0.10
53.1%

208
208
0.50
0.70
0.20
98.6%

208
208
0.60
0.65
0.05
17.7%

208
208
0.60
0.70
0.10
54.9%

208
208
0.60
0.80
0.20
99.2%

208
208
0.70
0.75
0.05
19.2%

208
208
0.70
0.80
0.10
61.0%

208
208
0.70
0.90
0.20
99.8%

208
208
0.80
0.85
0.05
23.5%

208
208
0.80
0.90
0.10
74.7%

208
208
0.80
1.00
0.20
100.0%

ii)
Nonsampling
Error
One
of
the
goals
of
the
Pilot
Study
is
to
evaluate
the
potential
for
nonresponse
bias
in
the
NCS.
First,
the
coverage
of
two
alternative
sources
of
household
sampling
frames
 
commercially­
available
postal
address
lists
versus
standard
field
counting
and
listing
procedures
 
will
be
evaluated
regarding
their
coverage
of
all
occupied
housing
units
in
study
areas.
Second,

alternative
household
contacting
and
recruitment
protocols
will
be
evaluated
regarding
cost
59
effectiveness
for
controlling
nonresponse
bias.
Finally,
the
extent
to
which
data
analysis
is
compromised
by
environmental
samples
collected
by
less
highly
trained
individuals
will
be
evaluated.

3.
Pretests
and
Pilot
Tests
Prior
to
the
Pilot
Study,
the
questionnaires
will
be
pretested
for
consistency,
timing,

content
and
translation
of
the
materials
using
no
more
than
9
individuals
per
questionnaire
by
an
EPA
contractor
with
expertise
in
this
area.

4.
Collection
Methods
and
Follow­
Up
4(
a)
Collection
Methods
Advance
Mailing:
An
advance
mailing
will
be
sent
to
all
households
in
the
study
area
to
inform
the
households
that
they
will
be
contacted
about
the
study.
The
advance
letter
will
include
information
about
the
Pilot
Study,
community
organizations
that
are
supporting
the
study
and
the
toll­
free
number
to
call
to
volunteer
for
the
study.
Also
enclosed
with
the
advance
letter
will
be
a
token
incentive
(
refrigerator
magnet
or
hangtag
with
the
study
name
and
toll­
free
number).
Letters
sent
to
sample
households
in
advance
of
an
interviewer's
visit
has
shown
to
generally
increase
the
willingness
of
the
household
to
participate
and
to
increase
the
confidence
of
the
interviewers
who
are
trying
to
gain
the
household's
cooperation
(
Groves
and
Couper,

1998).
Advance
letters
are
sent
in
order
to
alert
sample
households
that
an
interviewer
will
be
coming
to
their
homes
and
the
letters
seek
to
convey
the
sponsorship,
purpose,
and
legitimacy
of
the
study.
Sometimes
the
advance
letters
include
a
prepaid
monetary
incentive
or
small
gift
which
has
shown
to
be
effective
in
increasing
cooperation
rates.
Groves
and
Couper
discuss
the
idea
of
reciprocation
as
it
relates
to
prepaid
incentives
where
by
offering
someone
a
"
gift"
in
advance,
the
householder
will
feel
some
obligation
to
return
the
favor
(
i.
e.,
participate
in
the
survey).

Household
Rostering
and
Screening:
Approximately
1
to
2
weeks
after
the
advance
mailing,
field
interviewers
will
begin
rostering
and
screening
the
study
areas
for
eligible
participants.
Each
field
interviewer
(
FI)
will
be
provided
with
a
list
of
all
eligible
residential
housing
units
within
their
assigned
portion
of
the
selected
area.
Staff
will
visit
each
listed
household
to
complete
a
roster
of
all
people
who
currently
reside
in
the
household.
The
FI
will
follow
prescribed
scripts
for
the
rostering
visits.
The
roster
will
include
name,
gender,
and
age
as
of
the
start
of
recruitment
of
any
females
living
in
the
household.
After
the
FI
completes
the
household
roster,
any
age­
eligible
females
will
be
flagged
for
screening.
If
an
age­
eligible
60
woman
is
at
home,
the
FI
may
conduct
the
screening
interview.
The
screening
interview
will
include
data
on
basic
demographic
characteristics
and
current
pregnancy
status.
Non­
pregnant
age­
eligible
women
will
be
asked
a
series
of
questions
to
determine
their
likelihood
of
pregnancy
status.
If
the
woman
is
eligible
for
the
study,
then
the
FI
will
make
an
appointment
for
the
enrollment
interview
and
consent
process.
The
FI
will
leave
an
interview
appointment
card,

reminding
the
respondent
of
the
agreed­
upon
interview
time
and
providing
a
phone
number
for
any
rescheduling
needs.
The
respondents
will
also
be
reminded
to
gather
any
necessary
information
(
such
as
prescription
medicines,
etc.)
prior
to
the
interview
to
save
time
during
the
interview.

If
an
age­
eligible
woman
refuses
to
be
screened,
the
FI
will
be
trained
to
accept
the
refusal
in
a
positive
manner
to
avoid
creating
an
adversarial
relationship
and
precluding
future
opportunities
for
conversion.

If
any
age­
eligible
person
is
not
at
home,
the
FI
will
ask
for
the
best
time
to
contact
the
person
and
will
ask
for
a
telephone
number.
The
FI
will
also
leave
study
material
and
the
tollfree
number
for
any
age­
eligible
sample
member
to
call
to
schedule
a
screening
appointment.

Data
Collection
Activities.
Women
and
their
partners
in
the
sample
households
who
agree
to
complete
the
screener
questionnaire
will
be
assigned
to
one
of
the
following
categories:

 
Currently
pregnant
 
At
high
likelihood
of
pregnancy
 
At
moderate
likelihood
of
pregnancy
 
At
low
likelihood
of
pregnancy.

Even
though
it
is
unlikely
that
many
women
in
the
moderate
and
low
likelihood­

ofpregnancy
groups
will
have
a
child
enrolled
in
the
study
within
an
18­
month
period,
we
will
recruit
these
women
for
the
study
to
test
the
recruitment
rates
and
follow­
up
procedures
for
the
NCS.
More
frequent
follow­
ups
than
once
a
year
may
be
needed
to
enroll
the
women
from
the
low
likelihood­
of­
pregnancy
groups
because
the
NCS
needs
to
recruit
them
during
their
first
trimester,
if
they
become
pregnant.

The
questionnaire
and
interview
methods
are
designed
to
retain
respondents'
interest,

ensure
confidentiality,
and
maximize
the
validity
of
responses.
The
sensitive
portions
of
the
interview
will
be
self­
administered
via
ACASI
so
that
the
interviewers
will
not
know
respondents'
answers.
ACASI
enables
respondents
to
complete
the
questions
privately
by
either
61
listening
to
them
using
an
audio
headset
or
reading
them
on
the
computer
screen,
and
then
entering
their
own
responses
directly
into
the
computer.
This
method
maximizes
respondent
privacy
and
confidentiality.

The
bulk
of
the
information
gathered
will
be
from
questionnaires.
However,

environmental
exposure
information
will
also
be
collected
via
environmental
samples
in
and
around
the
participants'
household.
At
various
points
in
time,
air,
dust,
water
and
soil
samples
will
be
collected
using
standardized
protocols.
Additionally,
biospecimens
will
be
collected
at
regularly
scheduled
visits.
Information
will
also
be
collected
from
the
father/
partner
(
if
available
and
agreed
to
participate)
and
also
from
the
infant.

4(
b)
Survey
Response
and
Follow­
Up
Our
ability
to
gain
the
cooperation
of
potential
respondents
is
key
to
the
success
of
this
endeavor.
Based
on
information
obtained
from
focus
groups
and
external
reports
(
Pivetz
et.
al.,

2004),
it
is
anticipated
that
the
response
rate
for
women
willing
to
participate
in
the
study
will
be
around
65%.
These
estimates
are
also
reflected
in
the
response
rate
estimates
of
the
statistical
power
calculations
presented
in
Exhibits
17­
19.

The
study
design
and
enrollment
procedures
were
created
in
order
to
make
participation
as
easy
and
non­
burdensome
for
sample
members
as
possible.
Our
FIs
will
have
flexible
schedules
so
as
to
be
able
to
set
up
appointments
at
dates
and
times
that
are
most
convenient
for
the
sample
household
member.
Most
interviews
will
be
conducted
in
the
sample
member's
home.
To
reduce
respondent
burden
associated
with
collecting
biospecimen
samples,
we
will
make
every
effort
to
conduct
clinic
visits
in
conjunction
with
the
respondents'
regularly
scheduled
doctor
appointments.
Our
FIs
are
trained
to
stress
the
importance
of
the
project
and
the
commitment
EPA
has
to
respondent
confidentiality.
The
proposed
per
sample
incentive
structure
using
token
amounts
of
cash
or
cash­
equivalents
(
gift
cards
to
grocery
stores,
etc.)
will
be
offered
to
compensate
participants
for
their
time
and
effort.
Nonmonetary
incentives
(
e.
g.,

refrigerator
magnets,
calendars,
public
health
education
materials)
will
also
be
offered
to
participants.
As
an
additional
benefit,
participants
will
be
provided
with
results
from
their
clinical
and
environmental
measurements.

5.
Analyzing
and
Reporting
Survey
Results
5(
a)
Data
Preparation
Due
to
the
extensive
use
of
CAI
techniques
on
all
questionnaire
elements,
data
entry
will
be
minimal.
Information
collected
from
the
clinics,
environmental
sampling
measures,
and
62
respondent
self­
administered
PAPI
questionnaires
will
be
captured
via
machine­
scanned
forms,

or
double
data
entered
(
if
non­
scannable
hardcopy
forms
are
used
for
some
materials).
Specially
designed
software
will
be
used
to
ensure
that
out­
of­
range
and
implausible
values
are
flagged.

Inconsistencies
also
will
be
investigated
and
resolved
to
the
extent
feasible.

5(
b)
Analysis
Since
the
primary
goals
of
the
Pilot
Study
focus
on
the
testing
of
various
data
collection
methods,
the
analysis
of
the
Pilot
Study
data
will
center
on
the
calculation
of
response
rates
for
subgroups
within
and
across
the
designated
study
areas.
Comparisons
of
response
rates
by
subgroups
will
be
calculated
using
difference
of
proportions
tests
for
two
populations
with
large
sample
sizes
(
i.
e.,
sample
size
of
each
subgroup
at
least
30)
and
assessed
for
statistical
significance
in
comparing
the
test
statistic
to
a
standard
normal
distribution.
If
the
comparisons
of
response
rates
for
two
different
subgroups
involve
sample
sizes
for
each
group
that
are
less
than
30,
the
test
statistic
for
the
difference
of
the
response
rates
will
be
compared
to
a
Student's
t
distribution
with
appropriate
degrees
of
freedom.

5(
c)
Reporting
Results
Databases
without
individually­
identifiable
information
will
be
available
to
EPA
study
personnel.
Because
the
purpose
of
the
pilot
study
is
to
provide
both
quantitative
and
qualitative
results
to
inform
the
NCS,
databases
will
include
questionnaire
data,
measures
from
environmental
and
biologic
samples,
and
variables
intended
to
qualitatively
measure
successful
or
unsuccessful
data
collection
attempts.
A
report
analyzing
the
findings
and
the
results
of
the
Pilot
Study
will
be
developed,
reported
to
EPA,
and
made
available
to
the
NCS
Program
Office
and
the
NCS
Steering
Committee
through
a
presentation
at
a
public
meeting.
Upon
approval
by
EPA
and
NCS
planners,
it
is
anticipated
that
reports
will
be
posted
on
the
NCS
web­
site.

Reports
will
provide
only
aggregate
data,
and
no
individual
identifiers
will
be
included.
We
anticipate
one
or
more
papers
related
to
the
Pilot
Study
and
its
implications
to
the
NCS
will
be
prepared
and
submitted
to
peer­
reviewed,
relevant
scientific
journals.
63
Appendix
A:
Copy
of
60­
Day
Federal
Register
Notice
(
FR)
and
Supporting
Documentation
1.
Copy
of
the
FR
Used
To
Solicit
Public
Comments
(
a)
Copy
of
60­
day
FR
64
65
66
67
68
69
70
71
72
73
74
75
(
b)
Summary
of
Comments
and
Actions
Taken
in
Response
to
the
Comments
76
77
78
2.
Draft
of
the
30­
Day
FRN
ENVIRONMENTAL
PROTECTION
AGENCY
(
EPA)
ORD­
2005­
0010,
FRL­
Agency
Information
Collection
Activities:
Proposed
Collection;
Comment
Request;

Population­
based
pilot
study
of
children's
environmental
health
in
support
of
the
National
Children's
Study,
EPA
ICR
Number
2187.01.
AGENCY:
Environmental
Protection
Agency
ACTION:
Notice.

SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.),
this
document
announces
that
an
Information
Collection
Request
(
ICR)
has
been
forwarded
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
and
approval.
This
is
a
request
for
a
new
collection.
This
ICR
describes
the
nature
of
the
information
collection
and
its
estimated
burden
and
cost.

DATES:
Comments
must
be
submitted
on
or
before
[
INSERT
DATE
30
DAYS
AFTER
PUBLICATION
IN
THE
FEDERAL
REGISTER].
ADDRESSES:
Submit
your
comments,
referencing
docket
ID
number
ORD­
2005­
0010,
to
EPA
online
using
EDOCKET
(
our
preferred
method),
by
email
to
oei.
docket@
epa.
gov,
or
by
mail
to:
EPA
Docket
Center,
Environmental
Protection
Agency,
Office
of
Environmental
Information
Docket,
Mail
Code
28221T,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460.

FOR
FURTHER
INFORMATION
CONTACT:
Susan
Auby,
Environmental
Protection
Agency,
Office
of
Information
Collection,
Office
of
Environmental
Information,
1200
Pennsylvania
Ave.,
NW,
Mail
Code
28221T,
Washington,
DC
20460;
telephone
number:
(
202)

566­
1672;
fax
number:
(
202)
566­
1753;
email
address:
auby.
susan@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
EPA
has
submitted
the
following
ICR
to
OMB
for
review
and
approval
according
to
procedures
prescribed
in
5
CFR
1320.12.
On
April
12,
2005
(
70
FR
19076),
EPA
sought
comments
on
this
ICR
pursuant
to
5
CFR
1320.8(
d).
EPA
received
one
comment
and
has
addressed
the
comment
received.

EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
number
ORD­
2005­
0010,
which
is
available
for
public
viewing
at
the
Office
of
Research
and
Development
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,

Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Office
of
Research
and
Development
Docket
is
(
202)
566­
1752.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
obtain
a
copy
of
the
79
draft
collection
of
information,
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.

Any
comments
related
to
this
ICR
should
be
submitted
to
EPA
within
30
days
of
this
notice.

EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EDOCKET
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
Confidential
Business
Information
(
CBI),
or
other
information
whose
public
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EDOCKET.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Although
identified
as
an
item
in
the
official
docket,
information
claimed
as
CBI,
or
whose
disclosure
is
otherwise
restricted
by
statute,
is
not
included
in
the
official
public
docket,
and
will
not
be
available
for
public
viewing
in
EDOCKET.
For
further
information
about
the
electronic
docket,
see
EPA's
Federal
Register
notice
describing
the
electronic
docket
at
67
FR
38102
(
May
31,
2002),
or
go
to
www.
epa.
gov/
edocket.

Title:
Population­
based
pilot
study
of
children's
environmental
health
in
support
of
the
National
Children's
Study.

Abstract:
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
in
40
CFR
are
listed
in
40
CFR
part
9.
The
proposed
study
will
be
conducted
by
the
Epidemiology
and
Biomarkers
Branch,
Human
Studies
Division,
National
Health
and
Environmental
Effects
Research
Laboratory,
Office
of
Research
and
Development,
US
EPA.
The
US
EPA
will
conduct
this
research
in
partnership
with
the
National
Children's
Study
(
NCS)
Program
Office
at
the
National
Institute
of
Child
Health
and
Human
Development
(
NICHD)
as
well
as
the
other
lead
agencies
of
the
NCS:
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
and
the
National
Institute
of
Environmental
Health
Sciences
(
NIEHS).

This
proposed
data
collection
will
pilot
test
logistics,
protocols
and
procedures
for
the
NCS,
a
long
term
study
of
the
influence
of
environmental
factors
on
child
health
and
development.
The
goal
is
to
improve
the
efficiency
of
the
implementation
of
NCS
by
testing
procedures
for
population­
based
sampling
and
subject
recruitment,
proposed
study
logistics
and
estimates
of
80
subject
burden,
and
evaluating
data
collection
strategies
including
interviews
and
acquisition
of
biologic
and
environmental
samples.
Further
details
on
the
NCS,
including
the
Study
Plan,
can
be
found
at
www.
nationalchildrensstudy.
gov.

Approximately
10,000
households
will
be
screened
and
2,740
women
will
be
enrolled
who
meet
eligibility
criteria,
primarily
defined
by
age
and
likelihood
of
pregnancy.
The
schedule
of
visits
follows
the
proposed
NCS
Study
Plan.
Briefly,
women
who
are
planning
pregnancy
will
be
visited
bimonthly,
women
with
lower
likelihood
of
pregnancy
will
be
visited
once;
pregnant
women
will
have
a
home
visit
in
the
first
trimester
and
a
clinic
visit
in
the
second
and
third
trimester.
A
hospital
visit
at
birth
is
planned
as
well
as
home
visits
to
follow­
up
with
the
mother
and
infant
at
1,
6,
12,
and
18
months
of
age.
Data
from
interviews
as
well
as
biologic
and
environmental
samples
will
address
the
relationship
between
common
environmental
factors
and
the
physical
and
developmental
growth
of
children.
Qualitative
assessments
of
the
participants'

perceptions
about
the
study
will
be
gathered
at
each
visit
to
enhance
the
lessons
that
can
be
learned
to
aid
the
successful
implementation
of
the
NCS.

Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
varies
depending
on
the
eligibility
and
pregnancy
status
of
women
at
the
time
of
enrollment.
Detailed
estimates
regarding
the
number
of
potential
respondents
and
burden
associated
with
each
visit
are
provided
in
the
EDOCKET.
Table
1
provides
the
annual
burden
hours
and
cost
by
respondent
type.

Approximately
10
minutes
per
household
is
required
to
determine
potentially
eligible
occupants.

Potentially
eligible
women
are
asked
to
complete
a
10­
minute
screening
interview.
The
estimated
total
burden
for
a
fully
participating
woman
ranges
from
8
hours
(
for
a
woman
enrolled
at
delivery)
to
21
hours
(
for
a
"
high
likelihood"
woman
who
receives
all
contacts
in
the
preconception
period)
over
a
three
year
period.
The
burden
for
husbands/
partners
is
somewhat
more
consistent
because
they
only
receive
one
visit
in
each
of
the
preconception,
pregnancy,
and
childhood
visit
periods;
each
visit
is
approximately
1
hour.
The
burden
for
children
ranges
from
10
minutes
at
the
birth
visit
to
approximately
2
hours
for
full
participation
up
to
18
months
of
age.

Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,

maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
81
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

Respondents/
Affected
Entities:
Entities
potentially
affected
by
this
action
are
women
aged
18­

40
years,
pregnant
women,
their
husbands
or
partners,
and
their
children
who
live
in
selected
areas
of
North
Carolina.

Estimated
Number
of
Respondents:
10,000
Frequency
of
Response:
On
occasion
Estimated
Total
Annual
Hour
Burden:
4,585
Estimated
Total
Annual
Cost
to
Respondents:
$
82,728.
There
are
no
annualized
capital
costs
or
O&
M
costs.

Changes
in
the
Estimates:
Not
applicable;
this
is
a
new
information
collection.

Dated:
________________

______________________

Rebecca
L.
Calderon,
Director,
Human
Studies
Division
82
Table
1.
Annual
Burden
and
Cost
by
Respondent
Types
Type
of
Respondent
Estimated
Number
of
Respondents
Annual
Burden
(
Hours)
Annual
Burden
(
Cost)
2
Household
Unit
10,000
278
$
4,540
Women
Screened,
Not
Enrolled
1,750
194
$
3,168
Women
Screened
and
Enrolled
High
likelihood
of
pregnancy
167
660
$
10,778
Moderate
likelihood
of
pregnancy
572
962
$
15,710
Low
likelihood
of
pregnancy
1,797
895
$
14,615
Pregnant
at
enrollment
1
169
642
$
10,484
Enrolled
at
delivery
35
78
$
1,274
Partners
728
375
$
6,124
Children
406
201
$
1,035
Medical
Staff
53
300
$
15,000
Total
15,677
4,585
$
82,728
1
Includes
48
volunteers
assumed
to
be
pregnant
at
enrollment
2
Burden
hours
are
multiplied
by
the
following
rates:
$
16.33
for
women
and
their
partners,
$
5.15
for
children,
and
$
50.00
for
medical
staff.
Source:
Greensboro­
Winston­
Salem­
High
Point
May
2004
Metropolitan
Area
Occupational
Employment
and
Wage
Estimates
from
the
Bureau
of
Labor
Statistics
(
http://
www.
bls.
gov/
oes/
current/
oes_
3120.
htm#
b00­
0000).
83
References
Final
Report
for
Task
2,
Develop
a
Preliminary
Study
Plan
for
Recruitment
and
Retention
with
Options
for
Specific
Measures.
Prepared
by
RTI
for
EPA
Work
Assignment
03­
04,
Pilot
Cohort
Planning
and
Support.

Pivetz,
T.,
Iroz­
Elardo,
N.,
Strauss,
W.,
Rust,
S.,
Menkedick,
J.
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
(
Revised
June
15,
2004).
Available
at
http://
www.
nationalchildrensstudy.
gov/
research/
analytic_
reports/

Groves,
R.
M.,
and
Couper,
M.
P.
(
1998).
Nonresponse
in
Household
Interview
Surveys.
New
York:
John
Wiley
&
Sons,
Inc.
84
Appendix
B:
Final
Visit
Schedule
and
Burden
Estimates
Contract
No.
68­
D­
02­
069
August
9,
2005
Final
Visit
Schedule
and
Burden
Estimates
Population­
based
pilot
study
of
children's
environmental
health
in
support
of
the
National
Children's
Study:
Pilot
Cohort
Planning
and
Support
Work
Assignment
Number:
03­
04
RTI
Project
No.
08601.002.004
Prepared
for:
EPA
Work
Assignment
Manager:
Pauline
Mendola,
Ph.
D.

Attn:
Ms.
Frances
Legg
U.
S.
Environmental
Protection
Agency
RTP­
Procurement
Operations
Division
(
D143­
01)
4930
Old
Page
Road
Durham,
NC
27709
Prepared
by:
RTI
Work
Assignment
Leader:
Sharon
Myers,
M.
P.
H.
RTI
Principal
Investigator:
Richard
Kwok,
Ph.
D.
RTI
International
3040
Cornwallis
Road
Research
Triangle
Park,
NC
27709
Telephone:
(
919)
541­
7316
Fax:
(
919)
541­
7250
E­
mail:
sharonm@
rti.
org
RTI
Contracting
Officer:
Kelly
Koeller­
Anna
Office
of
Research
Contracts
RTI
International
P.
O.
Box
12194
Research
Triangle
Park,
NC
27709­
2194
Telephone:
(
919)
316­
3746
Fax:
(
919)
541­
6624
E­
mail:
kellyk@
rti.
org
85
This
report
provides
final
estimates
for
respondent
burden
levels
for
each
study
visit/
contact
with
women
enrolled
in
the
NCS
Pilot
Cohort,
their
male
partners,
and
the
children
born
to
them.
The
schedule
for
pre­
conception
visits
will
depend
on
the
woman's
likelihood
of
pregnancy,
classified
by
the
NCS
Study
Plan
as
high,
moderate,
and
low
"
risk."
Women
with
a
high
or
moderate
likelihood
of
pregnancy
will
be
visited
in
their
homes
within
2
weeks
of
their
enrollment
to
collect
interview
data,
biologic
and
environmental
samples,
and
anthropometric
measurements.
After
this
initial
home
visit,
the
schedule
for
high
and
moderate
likelihood
groups
will
vary,
with
a
combination
of
home
visits
and
telephone
calls
at
varying
intervals.
It
is
estimated
that
70
to
90
percent
of
the
women
in
the
high
likelihood
group
will
get
pregnant
within
6
months
of
enrollment;
therefore,
follow­
up
for
this
group
is
most
intense.
The
low
likelihood
group
will
not
receive
home
visits,
rather,
women
in
this
group
will
be
asked
to
contact
RTI
in
the
event
that
their
pregnancy
plans
change.
The
only
follow­
up
with
this
group
will
be
by
telephone
at
12
months
after
enrollment.

Once
enrolled
women
become
pregnant,
the
visit
schedule
will
follow
that
defined
in
the
NCS
Study
Plan.
For
the
NCS
Pilot
Cohort,
however,
we
also
plan
to
enroll
women
after
their
first
trimester
and
at
delivery.
These
women
will
be
folded
into
the
NCS
Visit
Schedule
at
the
appropriate
time
point.

Preliminary
sampling
estimates
from
the
Final
Task
2
Report,
Develop
a
Preliminary
Study
Plan
for
Recruitment
and
Retention
with
Options
for
Specific
Measures,
are
that
approximately
10,000
occupied
households
will
be
visited
and
that
approximately
85%

(
n=
8,770)
will
be
rostered
to
identify
age­
eligible
women.
As
a
result,
we
assume
that
approximately
4,426
women
will
be
screened
and
of
those,
2,657
will
be
enrolled
in
the
study.

We
also
assume
that
35
women
will
be
enrolled
at
delivery
and
another
48
women
who
express
interest
in
the
study
(
i.
e.,
volunteers)
will
be
screened
and
enrolled,
for
a
total
of
2,740
women.

These
2,740
enrolled
women
are
estimated
to
yield
406
births
over
the
study
enrollment
period,

as
shown
in
Table
1
below.
Estimates
of
enrollment
rates
and
birth
rates
were
adapted
from
the
Battelle
document,
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
(
Pivetz,
Iroz­
Elardo,
Strauss,
Rust,
and
Menkedick,
2004).
86
Table
1
Number
of
eligible
women
screened
and
enrolled,
and
number
of
births
expected
by
group
Enrolled
Births
Group
Number
Screened
N
%
N
%

Pregnant
at
enrollment
186
121
65
108
89
High
likelihood
of
pregnancy
256
167
65
57
34
Moderate
likelihood
of
pregnancy
962
572
59
50
9
Low
likelihood
of
pregnancy
3,022
1,797
59
115
6
Subtotal
of
women
from
household
recruiting
4,426
2,657
60
330
12
Women
at
delivery
N/
A
35
­­
35
100
Volunteers
64
48
75
41
85
Total
4,490
2,740
­­
406
15
The
burden
for
household
rostering
is
expected
to
take
up
to
5
minutes
per
household,
and
any
adult
household
member
can
provide
the
necessary
information.
Although
we
do
not
expect
100%

response,
the
maximum
burden
to
roster
10,000
households
is
833
hours.
Realistically,
closer
to
85%
of
these
households
will
agree
to
the
rostering,
for
a
total
of
731
burden
hours.

For
purposes
of
calculating
the
respondent
burden
levels,
Table
2
provides
estimates
of
the
burden
per
respondent
by
visit/
contact,
the
estimated
number
of
respondents
for
each
visit,
and
the
total
burden
for
all
respondents
at
each
visit.
A
number
of
assumptions
have
been
made
in
estimating
the
number
of
respondents
for
each
visit:


The
total
number
pregnant
in
each
likelihood
group
is
estimated
as
described
above.


The
distribution
of
time­
to­
pregnancy
for
the
high
likelihood
group
has
been
adapted
from
information
received
from
NICHD
as
a
result
of
a
literature
review
performed
for
a
study
of
women
seeking
to
become
pregnant.


The
distribution
of
time­
to­
pregnancy
for
the
moderate
likelihood
group
uses
somewhat
similar
rates
as
the
high
likelihood
group,
but
delayed
by
1
month.
For
the
low
likelihood
group,
the
number
of
total
pregnancies
was
almost
equally
divided
by
time.
These
are
general
assumptions
made
due
to
lack
of
better
information
to
estimate
these
rates.


Women
will
move
between
likelihood
groups
throughout
the
enrollment
period,
but
we
have
not
made
any
estimates
of
these
rates
or
the
direction
of
movement.


The
Battelle
report
previously
referenced
assumed
a
0.003%
attrition
rate
per
month;
we
have
used
a
more
conservative
estimate
of
1%
per
month
for
the
pre­
conception
visits.


The
number
of
partner
respondents
at
each
applicable
visits
has
been
estimated
at
70%
of
the
number
of
women.

The
burden
estimates
for
post­
conception
visits,
from
the
first
trimester
to
18
months
of
age,
are
detailed
in
Table
3.
The
pregnancies
resulting
from
the
prepregnancy
group
will
all
begin
with
the
first
trimester
visit.
For
this
group,
we
have
assumed
that
there
will
be
a
5%
attrition
rate
between
each
visit.

For
the
121
women
pregnant
at
enrollment
and
the
48
volunteers,
we
are
assuming
that
1/
3
of
the
women
87
will
enter
at
each
of
the
three
trimester
visits.
After
the
birth
visit,
we
estimate
a
5%
attrition
rate
per
visit.

Finally,
the
women
who
are
enrolled
at
delivery
will
begin
with
the
birth
visit,
and
it
is
estimated
that
there
will
be
a
5%
attrition
rate
for
each
subsequent
visit.

Table
3
also
includes
burden
estimates
for
medical
facility
staff
who
will
be
asked
to
assist
in
biologic
sample
collection
and
clinical
measurements
at
each
of
the
clinic
visits
(
OGTT,
2nd
trimester,

3rd
trimester,
and
delivery).
For
purposes
of
estimating
burden,
we
have
assumed
that
half
of
the
biologic
samples
in
the
OGTT
and
second
and
third
trimester
visits
will
be
collected
by
clinic
staff.
For
the
biologic
samples
collected
at
birth,
we
are
assuming
that
85%
of
the
samples
will
by
collected
by
hospital
staff.
Samples
will
be
collected
by
contractor
staff
in
those
instances
that
hospitals
or
clinics
choose
not
to
participate
in
the
study.
Furthermore,
the
burden
on
the
medical
staff
for
the
clinic
visits
has
been
calculated
using
the
burden
for
the
visit
multiplied
by
the
number
of
women
at
each
clinic
visit,
rather
than
by
the
number
of
medical
staff.
The
overall
burden
on
medical
staff
for
collection
of
samples
will
be
shared
across
a
team
of
staff
members,
and
the
overall
size
of
that
team
is
reflected
in
the
"
Number
of
respondents
per
visit"
column.
For
example,
a
team
of
several
physician's
office
staff
would
be
responsible
for
collecting
the
biologic
samples
for
the
women
who
receive
care
at
a
specific
practice.

The
figures
in
these
tables
illustrate
the
wide
range
of
burden
level
and
frequency
of
responses
depending
on
the
pregnancy
plans
or
stage
of
pregnancy
of
enrolled
women.
Women
in
the
"
high
likelihood
of
pregnancy"
group
who
do
not
become
pregnant
until
the
end
of
the
pre­
conception
visit
schedule
will
have
the
highest
burden,
since
they
will
receive
all
pre­
conception
visits
as
well
as
the
pregnancy
and
childhood
visits.
Women
who
remain
in
the
"
low
likelihood
of
pregnancy"
group
throughout
the
pre­
conception
period
and
who
do
not
become
pregnant
have
the
lowest
burden,
as
they
will
receive
only
three
10­
minute
telephone
contacts.
Tables
4
through
6
below
provide
the
minimum
and
maximum
for
the
range
in
response
frequency
and
burden
hours,
by
respondent
type.
Table
4
provides
statistics
on
the
Pre­
conception
contacts,
i.
e.
contacts
from
household
screening
to
conception.
Table
5
gives
similar
statistics
for
Pregnancy
visits,
and
Table
6,
for
all
visits
from
delivery
to
18
months.
88
Table
2
Burden
estimates
for
pre­
conception
visits
Screening
(
H)
1
Initial
(
H)
#
1
(
T)
#
2
(
H)
#
2
(
T)
#
3
(
H)
#
3
(
H)
#
4
(
H)
#
4
(
T)
#
5
(
T)
#
6
(
T)
Pregnancy
tests
Event
Form
Moving
Quest.

Burden
(
minutes)
per
respondent
Women
High
likelihood
of
pregnancy
20
150
10
90
10
45
10
45
10
10
10
5
5
5
Moderate
likelihood
of
pregnancy
20
150
10
­­
10
­­
10
­­
10
10
­­
5
5
5
Low
likelihood
of
pregnancy
20
­­
10
­­
­­
­­
­­
­­
­­
­­
­­
­­
5
­­

Pregnant
at
enrollment
20
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­

Partners
­­
75
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­

Children
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­
­­

Number
of
respondents
per
visit
Women
High
likelihood
of
pregnancy
167
167
167
151
132
126
120
117
110
101
95
1,453
2
953
554
Moderate
likelihood
of
pregnancy
572
572
547
0
508
0
489
0
469
450
0
572
2
4503
1894
Low
likelihood
of
pregnancy
1,797
0
1,491
0
0
0
0
0
0
0
0
0
12503
0
Pregnant,
1st
trimester
56
0
0
0
0
0
0
0
0
0
0
0
0
0
Pregnant,
2nd
trimester
56
0
0
0
0
0
0
0
0
0
0
0
0
0
Pregnant,
3rd
trimester
57
0
0
0
0
0
0
0
0
0
0
0
0
0
Enrolled
at
delivery
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Partners
0
517
0
0
0
0
0
0
0
0
0
0
0
0
Children
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Total
burden
(
hours)

Women
High
likelihood
of
pregnancy
56
418
28
227
22
95
20
88
18
17
16
121
8
5
Moderate
likelihood
of
pregnancy
191
1430
91
0
85
0
82
0
78
75
0
48
38
16
Low
likelihood
of
pregnancy
599
0
249
0
0
0
0
0
0
0
0
0
104
0
Pregnant,
1st
trimester
19
0
0
0
0
0
0
0
0
0
0
0
0
0
Pregnant,
2nd
trimester
19
0
0
0
0
0
0
0
0
0
0
0
0
0
Pregnant,
3rd
trimester
19
0
0
0
0
0
0
0
0
0
0
0
0
0
Enrolled
at
delivery
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Partners
0
646
0
0
0
0
0
0
0
0
0
0
0
0
Children
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
H=
home
visit;
T=
telephone
2
Assume
one
test
per
month
for
high
likelihood
group,
one
test
at
first
home
visit
for
moderate
likelihood
group.

3
Assume
one
event
per
year
4
Assume
one­
third
of
women
move
89
Table
3
Burden
estimates
for
pregnancy
and
birth/
childhood
visits
Pregnancy
Visits
Birth/
Childhood
Visits
Any
first
visit:
basic
(
H)
1
#
1
(
H)
OGTT
(
C)
2
#
2
(
C)
#
3
(
C)
Birth
(
C)
1
month
(
H)
6
months
(
H)
12
months
(
H)
18
months
(
H)
Event
Form4
Moving
Questions6
Burden
(
minutes)
per
respondent
Women
High
likelihood
of
pregnancy
­­
90
150
180
180
10
60
120
90
120
5
5
Moderate
likelihood
of
pregnancy
­­
90
150
180
180
10
60
120
90
120
5
5
Low
likelihood
of
pregnancy
155
90
150
180
180
10
60
120
90
120
5
5
Pregnant
at
enrollment
155
90
150
180
180
10
60
120
90
120
5
5
Enrolled
at
delivery
155
­­
­­
­­
­­
20
60
120
90
120
5
5
Partners
75
30
­­
­­
­­
­­
­­
40
­­
­­
­­
­­

Children
­­
­­
­­
­­
­­
10
20
20
30
20
­­
­­

Medical
staff
3
­­
­­
30
60
60
90
­­
­­
­­
­­
­­
­­

Number
of
respondents
per
visit
Women
High
likelihood
of
pregnancy
0
66
7
63
60
57
54
51
48
46
256
40
Moderate
likelihood
of
pregnancy
0
59
6
56
53
50
48
46
44
42
230
35
Low
likelihood
of
pregnancy
133
133
13
127
121
115
109
104
99
94
521
80
Pregnant,
1st
trimester
56
56
6
53
50
48
45
43
41
40
217
33
Pregnant,
2nd
trimester
56
0
0
56
53
50
48
45
43
40
226
16
Pregnant,
3rd
trimester
57
0
0
0
53
51
49
47
44
41
232
16
Enrolled
at
delivery
33
0
0
0
0
35
33
31
29
28
156
11
Partners
211
88
0
0
0
0
0
257
0
0
0
0
Children
0
0
0
0
0
406
386
367
348
331
0
0
Medical
staff
3
0
0
16
178
195
345
0
0
0
0
0
0
90
Table
3
Burden
estimates
for
pregnancy
and
birth/
childhood
visits
(
cont.)

Pregnancy
Visits
Birth/
Childhood
Visits
Any
first
visit:
basic
(
H)
1
#
1
(
H)
OGTT
(
C)
2
#
2
(
C)
#
3
(
C)
Birth
(
C)
1
month
(
H)
6
months
(
H)
12
months
(
H)
18
months
(
H)
Event
Form
Moving
Questions
Total
burden
(
hours)

Women
High
likelihood
of
pregnancy
0
99
18
189
180
10
54
102
72
92
21
3
Moderate
likelihood
of
pregnancy
0
89
15
168
159
8
48
92
66
84
19
3
Low
likelihood
of
pregnancy
33
200
33
381
363
19
109
208
149
188
43
7
Pregnant,
1st
trimester
14
84
15
159
150
8
45
86
62
80
18
3
Pregnant,
2nd
trimester
14
0
0
168
159
8
48
90
65
80
19
1
Pregnant,
3rd
trimester
14
0
0
0
159
9
49
94
66
82
19
1
Enrolled
at
delivery
14
0
0
0
0
12
33
62
44
56
13
1
Partners
264
44
0
0
0
0
0
171
0
0
0
0
Children
0
0
0
0
0
68
129
122
174
110
0
0
Medical
staff
3
0
0
8
178
195
518
0
0
0
0
0
0
1
H=
home
visit;
C=
Clinic/
Hospital
2
Oral
glucose
tolerance
test;
assume
10%
of
women
in
pre­
pregnancy
and
first
trimester
groups
will
participate.

3
The
burden
on
the
medical
staff
for
the
clinic
visits
has
been
calculated
using
the
burden
per
woman
multiplied
by
the
number
of
women
at
each
clinic
visit,
rather
than
by
the
number
of
medical
staff.
The
overall
burden
on
medical
staff
for
collection
of
samples
will
be
shared
across
a
team
of
staff
members,
and
the
overall
size
of
that
team
is
reflected
in
the
"
Number
of
respondents
per
visit"
column.

4
Assumes
4
events
per
year
per
child
and
1
event
per
year
for
the
woman.

5
The
burden
for
any
first
basic
visit
is
in
addition
to
the
burden
associated
with
the
visit
in
which
the
woman
first
enrolls.
For
example,
the
1­
month
visit
for
woman
enrolled
at
delivery
is
75
minutes:
60
minutes
for
the
1­
month
protocol
plus
15
min
for
additional
questions.

6
Assume
one­
third
of
women
move
during
pregnancy
visit
and
one­
third
move
during
childhood
visits.
91
Table
4
Estimated
burden
for
screening
and
pre­
conception
contacts
Type
of
Respondent
Estimated
Number
of
Respondents
Minimum
Number
of
Responses
Maximum
Number
of
Responses
Minimum
Burden
Hours
per
Response
Maximum
Burden
Hours
per
Response
Estimated
Total
Burden
Hours
Household
Unit
10,000
1
1
0.08
0.08
833
Women
Screened,
Not
Enrolled
1,750
1
1
0.33
0.33
578
Women
Screened
and
Enrolled
High
likelihood
of
pregnancy
167
2
10
0.17
2.50
1,124
Moderate
likelihood
of
pregnancy
572
2
7
0.17
2.50
2,079
Low
likelihood
of
pregnancy
1,797
1
2
0.17
0.33
848
Pregnant
at
enrollment
1,2
169
1
1
0.33
0.33
56
Enrolled
at
delivery
0
0
0
0.00
0.00
0
Partners
517
1
1
1.25
1.25
646
Children
0
0
0
0.00
0.00
0
1
Includes
48
volunteers
assumed
to
be
pregnant
at
enrollment
2
Only
includes
burden
for
the
screening
visit
Table
5
Estimated
burden
for
pregnancy
visits
Type
of
Respondent
Estimated
Number
of
Respondents
Minimum
Number
of
Responses
Maximum
Number
of
Responses
Minimum
Burden
Hours
per
Response
Maximum
Burden
Hours
per
Response
Estimated
Total
Burden
Hours
Women
Screened
and
Enrolled
High
likelihood
of
pregnancy
66
4
4
1.50
3.00
486
Moderate
likelihood
of
pregnancy
59
4
4
1.50
3.00
431
Low
likelihood
of
pregnancy
133
4
4
2.00
3.00
1,109
Pregnant
at
enrollment
1
169
1
4
2.00
3.00
1,063
Enrolled
at
delivery
0
0
0
0.00
0.00
0
Partners
299
1
1
0.33
1.00
308
Children
0
0
0
0.00
0.00
0
Medical
staff
2
33
1
10
0.50
1.00
381
1
Includes
48
volunteers
assumed
to
be
pregnant
at
enrollment
2
The
overall
burden
on
medical
staff
for
collection
of
samples
will
be
shared
across
a
team
of
staff
members,
and
the
overall
size
of
that
team
is
reflected
in
the
"
Estimated
Number
of
Respondents"
column.
92
Table
6
Estimated
burden
for
birth
and
childhood
visits
Type
of
Respondent
Estimated
Number
of
Respondents
Minimum
Number
of
Responses
Maximum
Number
of
Responses
Minimum
Burden
Hours
per
Response
Maximum
Burden
Hours
per
Response
Estimated
Total
Burden
Hours
Women
Screened
and
Enrolled
High
likelihood
of
pregnancy
57
5
5
0.33
2.00
330
Moderate
likelihood
of
pregnancy
50
5
5
0.33
2.00
298
Low
likelihood
of
pregnancy
115
5
5
0.33
2.00
673
Pregnant
at
enrollment
1
149
5
5
0.33
2.00
871
Enrolled
at
delivery
35
5
5
0.58
2.00
239
Partners
257
1
1
0.67
0.67
171
Children
406
5
5
0.17
0.50
603
Medical
Staff
2
20
1
1
1.50
1.50
518
1
Includes
41
volunteers
(
out
of
48)
who
give
birth
2
The
overall
burden
on
medical
staff
for
collection
of
samples
will
be
shared
across
a
team
of
staff
members,
and
the
overall
size
of
that
team
is
reflected
in
the
"
Estimated
Number
of
Respondents"
column.
93
References
Final
Report
for
Task
2,
Develop
a
Preliminary
Study
Plan
for
Recruitment
and
Retention
with
Options
for
Specific
Measures.
Prepared
by
RTI
for
EPA
Work
Assignment
03­
04,
Pilot
Cohort
Planning
and
Support.

Pivetz
T,
Iroz­
Elardo
N,
Strauss
W,
Rust
S,
Menkedick
J.
Brief
on
Estimated
Sample
Size
of
Women
Needed
to
Result
in
100,000
Live
Births
(
Revised
June
15,
2004).
Available
at:

http://
www.
nationalchildrensstudy.
gov/
research/
analytic_
reports/
94
Appendix
C:
Questionnaire
Instrument
Table
#
Instrument
Time
of
Visit
File
Name
1
Rostering
Script
T
Q1
NCS
Pilot
8.10.05.
doc
2
Screening
T
Q2
NCS
Pilot
8.10.05.
doc
3
Preconception
#
1,
Female
T
+
2
weeks
Q3
NCS
Pilot
8.10.05.
doc
4
Preconception
#
1,
Partner
T
+
2
weeks
Q4
NCS
Pilot
8.10.05.
doc
5
Preconception
Female
and
Partner
Mental
Health
Questionnaire
T
+
2
weeks
Q5
NCS
Pilot
8.10.05.
doc
6
Preconception
#
2,
Female
T
+
10
weeks
Q6
NCS
Pilot
8.10.05.
doc
7
Preconception
Female
Diet
Self
Administered
Questionnaire
T
+
10
weeks
Q7
NCS
Pilot
8.10.05.
doc
8
Preconception
#
3,
Female
T
+
18
weeks
Q8
NCS
Pilot
8.10.05.
doc
9
Preconception
#
4,
Female
T
+
26
weeks
Q9
NCS
Pilot
8.10.05.
doc
10
Preconception
Telephone
Followup
Between
preconception
visits
Q10
NCS
Pilot
8.10.05.
doc
11
Pregnancy
#
1,
Female
(
enrolled
during
preconception)
1st
Trimester
Q11
NCS
Pilot
8.10.05.
doc
12
Pregnancy
#
1,
Partner
(
enrolled
during
preconception)
1st
Trimester
Q12
NCS
Pilot
8.10.05.
doc
13
Pregnancy
#
1,
Female
(
enrolled
while
pregnant
(
1st
trimester),
first
home
visit)
1st
Trimester
Q13
NCS
Pilot
8.10.05.
doc
14
Pregnancy
#
1,
Partner
(
enrolled
while
pregnant
(
1st
trimester),
first
home
visit)
1st
Trimester
Q14
NCS
Pilot
8.10.05.
doc
15
Pregnancy
#
2,
Female
2nd
Trimester
Q15
NCS
Pilot
8.10.05.
doc
95
#
Instrument
Time
of
Visit
File
Name
16
Pregnancy
Female
Diet
Self
Administered
Questionnaire
2nd
Trimester
Q16
NCS
Pilot
8.10.05.
doc
17
Pregnancy
#
3,
Female
3rd
Trimester
Q17
NCS
Pilot
8.10.05.
doc
18
Pregnancy
Female
Mental
Health
Self
Administered
Questionnaire
3rd
Trimester
Q18
NCS
Pilot
8.10.05.
doc
19
Pregnancy
Partner
Mental
Health
Self
Administered
Questionnaire
3rd
Trimester
Q19
NCS
Pilot
8.10.05.
doc
20
Female
(
Enrolled
at
delivery,
2nd
or
3rd
trimester)
First
Home
Visit
Child
1
month
of
age
Q20
NCS
Pilot
8.10.05.
doc
21
Partner
(
Enrolled
at
delivery,
2nd
or
3rd
trimester)
First
Home
Visit
Child
1
month
of
age
Q21
NCS
Pilot
8.10.05.
doc
22
Post­
Pregnancy
1
Month
Home
Visit,
Female
Child
1
month
of
age
Q22
NCS
Pilot
8.10.05.
doc
23
Post­
Pregnancy
6
Month
Home
Visit,
Female
Child
6
months
of
age
Q23
NCS
Pilot
8.10.05.
doc
24
Post­
Pregnancy
6
Month
Home
Visit,
Partner
Child
6
months
of
age
Q24
NCS
Pilot
8.10.05.
doc
25
Post­
Pregnancy
Female
Mental
Health
Self
Administered
Questionnaire
Child
6
months
of
age
Q25
NCS
Pilot
8.10.05.
doc
26
Post­
Pregnancy
Partner
Mental
Health
Self
Administered
Questionnaire
Child
6
months
of
age
Q26
NCS
Pilot
8.10.05.
doc
27
Post­
Pregnancy
12
Month
Home
Visit,
Female
Child
12
months
of
age
Q27
NCS
Pilot
8.10.05.
doc
28
Post­
Pregnancy
18
Month
Home
Visit,
Female
Child
18
months
of
age
Q28
NCS
Pilot
8.10.05.
doc
29
New
Home
Address
Questionnaire
1st
home
visit
after
relocation
Q29
NCS
Pilot
8.10.05.
doc
30
Medical
Event
Form
Self­
administered,
reported
as
needed
Q30
NCS
Pilot
8.10.05.
doc
