Revision to Proposed Collection; Comment Request; National Institute of Child Health and Human Development; the National Children's Study, Vanguard (Pilot) Study, 4569-4571 [2012-1934]
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Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices
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BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Revision to Proposed Collection;
Comment Request; National Institute
of Child Health and Human
Development; the National Children’s
Study, Vanguard (Pilot) Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
emcdonald on DSK29S0YB1PROD with NOTICES
SUMMARY:
Proposed Collection
Title: The National Children’s Study,
Vanguard (Pilot) Study.
Type of Information Collection
Request: Revision.
Need and Use of Information
Collection: The purpose of the proposed
methodological study is to continue the
Vanguard phase of the National
Children’s Study with updated
instruments and additional biospecimen
collections and physical measures and
to evaluate the feasibility, acceptability,
and cost of a different sampling strategy
for enrollment of pregnant women. This
study is one component of a larger
group of studies being conducted during
the Vanguard Phase of the National
Children’s Study (NCS), a prospective,
national longitudinal study of child
health and development. In
combination, these studies will be used
to inform the design of the Main Study
of the National Children’s Study.
Background
The National Children’s Study is a
prospective, national longitudinal study
of the interaction between environment,
genetics on child health and
development. The Study defines
‘‘environment’’ broadly, taking a
VerDate Mar<15>2010
15:09 Jan 27, 2012
Jkt 226001
number of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account.
Findings from the Study will be made
available as the research progresses,
making potential benefits known to the
public as soon as possible.
The National Children’s Study (NCS)
has several components, including a
pilot or Vanguard Study, and a Main
Study to collect exposure and outcome
data. The sample frame for the NCS
Vanguard and Main Study was initially
based on a national probability sample
using geography as the basis and
selecting about100 of the about 3000
counties in the United States as the
basis for Primary Sampling Units.
Within the Primary Sampling Units,
smaller geographic segments were
selected as Secondary Sampling Units
in an attempt to normalize live birth
rates per area sampled. Women who
resided at the time of enrollment within
a designated Secondary Sampling Unit
and were either pregnant or between 18
and 49 were eligible for enrollment. The
initial recruitment technique within the
selected geographic areas was
household contact by field workers
going door to door.
The Vanguard Study was launched in
January 2009, and by summer 2009,
field experience suggested that the
household contact recruitment strategy
was not feasible with available
resources. Thus, in 2010 new
recruitment strategies were launched to
evaluate options. By late 2011, the NCS
had sufficient data to evaluate
operational aspects of various
recruitment strategies. Preliminary
analyses suggested that a provider based
recruitment strategy was the most
efficient, but due to constrictions of the
geographic sampling frame, the
potential of the strategy was limited.
Specifically, many women had to be
screened at a particular provider to
locate the relatively few who resided in
a designated segment. Anticipating this
limitation, the NCS Program Office
developed and discussed with the NCS
Advisory Committee a different
sampling frame, using provider location.
This new sampling strategy is termed
Provider Based Sampling (PBS).
Information from this data collection is
critical to determine the plausibility of
a provider based sampling frame as an
option for some parts of the NCS Main
Study.
Research Questions
Two research goals will be
accomplished by this information
collection. The first goal is to
systematically pilot additional study
visit measures and collections whose
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4569
scientific robustness, burden to
participants and study infrastructure,
and cost for use in the Vanguard (Pilot)
Study and to inform the Main Study.
The second goal is to test the feasibility,
acceptability, and cost of Provider Based
Sampling using three locations.
Methods
We will continue with the current
data collection schedule which include
pre-pregnancy, pregnancy, and birth
periods, as well as postnatal data
collection points at 3, 6, 9, 12, 18, and
24 months of age. We propose to add or
modify the selected measures below to
address analytic goals of assessing
feasibility, acceptability and cost of
specific study visit measures.
Supplemental Information and
Biospecimen Collections
Core Questionnaire: We propose to
pilot use of a core questionnaire
containing key variables and designed
to collect core data at every study visit
contact from the time that the enrolled
child is 6 months of age to the time the
child is 5 years of age.
30-Month Data Collection Module: We
propose piloting the approach of use of
a core instrument plus an age specific
module with the 30 month visit.
Validation Questions for 18, 24 and
30 month: We propose addition of brief,
telephone-based questions that would
be fielded to a random sample of each
interviewer’s cases after completion of
the 18-Month, 24-Month, and 30-Month
interviews to monitor interviewer
performance and identify occurrences of
data falsification.
Nonrespondent Questionnaire will
collect information on why a participant
chose to not enroll or withdraw from the
NCS. This information may be used to
revise our approaches to recruitment
and will help the Study frame other
systematic analyses of nonresponse bias.
Physical Measures: The addition of 6
month and 12 month infant measures of
child anthropometry and blood pressure
may provide critical pieces of
information for future research on the
causes of obesity, diabetes, premature
puberty and a host of other health
outcomes.
Revised Father Questionnaire: The
NCS seeks to incorporate behavioral,
emotional, educational and contextual
consequences to enable a complete
assessment of psychosocial influences
on children’s well-being. The Revised
Father Questionnaire now includes
measures addressing key social/personal
resources and fathers’ capacity, desire
and attitudes towards engaging with
mothers and children.
E:\FR\FM\30JAN1.SGM
30JAN1
4570
Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices
Revised 24 Month Interview: The
Modified Checklist for Autism in
toddlers (M–CHATTM) is a validated
brief screening measure for
identification of Autism and will be
added to the 24 month interview.
Breast Milk Collection 1 and 3
months: Additional collections are
needed to determine the feasibility,
acceptability and cost of collection.
Infant Urine Collection at 6 and 12
months: Additional collections are
needed to determine the feasibility,
acceptability and cost of collection.
Infant Blood and Saliva Collection at
12 months: Additional collections are
needed to determine the feasibility,
acceptability and cost of collection.
Provider Based Sampling
We will compile, at three Vanguard
Study locations, a list of prenatal
providers serving women who reside in
the Primary Sampling Unit. Providers
will be asked to complete a brief
questionnaire about their practice and
their patient demographics. For this
pilot, a woman will be eligible for
recruitment if she resides in the Primary
Sampling Unit and is seeing a provider
for her first prenatal visit.
Recruitment of participants at the
selected provider offices will follow the
protocol and procedures developed for
the Provider-Based Sample Recruitment
Substudy, as previously approved by
the Office of Information and Regulatory
Affairs within the Office of Management
and Budget. Potential participants will
be screened on age eligibility, residence
in the sampled Primary Sampling Unit,
and status of an initial prenatal visit. In
some locations, medical records may be
prescreened to identify participants
meeting these eligibility criteria.
Frequency of Response: See above
descriptions.
Affected Public: Healthcare Providers,
Age-eligible women, Pregnant women,
Fathers, and their children.
Annual Reporting Burden: See Table
1. The additional annualized cost to
respondents over the 3 year data
collection period is estimated at
annualized cost of $1,966,069 (based on
$10 per hour). This is calculated as
estimating 415,894 respondent contacts
at an estimated average of 0.47 hours
per contact, for a total estimated annual
respondent burden as 196,607 hours.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR RECRUITMENT SUBSTUDY RESPONDENTS, PRENATAL TO 30
MONTHS, PHASE 2
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Type of respondent
Pregnancy Screener (PB, EH, TT–HI) ...............
Provider Based Sampling Eligibility Screener
(PBS).
Healthcare Provider Questionnaire (PB) ............
Provider Based Sampling Frame Questionnaire
(PBS).
Household Enumeration Instrument (EH) ...........
Low-intensity Invitation to High-intensity Script
(TT–HI).
Pregnancy Screener (TT–LI, TT–HI) ..................
Low-Intensity Consent Script (TT–LI) .................
Nonrespondent Questionnaire (PB, EH, TT–HI,
TT–LI, PBS).
emcdonald on DSK29S0YB1PROD with NOTICES
Data collection activity
Age-Eligible Women .......
Age-Eligible Women .......
68,538
9,375
1
1
0.42
0.25
28,558
2,344
Healthcare Providers ......
Healthcare Providers ......
600
1,225
1
1
0.17
0.17
100
204
HH Reporters .................
Age-Eligible Women .......
120,000
15,840
1
1
0.33
0.25
40,000
3,960
Age-Eligible Women .......
Age-Eligible Women .......
Pregnant Women, NonPregnant Women,
Mothers or Fathers.
48,000
28,800
3,000
1
1
1
0.35
0.33
0.08
16,800
9,600
250
Age-Eligible Women .......
1,825
1
0.50
913
Age-Eligible Women .......
Age-Eligible Women .......
1,095
986
1
1
0.75
0.25
821
246
Age-Eligible Women .......
11,152
6
0.10
6,691
Age-Eligible Women .......
10,057
1
0.50
5,029
Age-Eligible Women .......
3,805
1
0.08
304
Pregnant Women ...........
12,967
1
0.50
6,484
Pregnant Women ...........
518
1
0.50
259
Pregnant Women ...........
6,310
1
1.00
6,310
Pregnant Women ...........
10,363
1
0.25
2,591
Pregnant Women ...........
6,190
1
0.75
4,643
Pregnant Women ...........
5,048
1
0.33
1,683
Alternate Caregiver ........
5,048
1
0.50
2,524
Alternate Caregiver ........
3,029
1
0.25
757
Preconception Activities:
Non-pregnant Women’s Informed Consent
(PB, EH, TT–HI).
Pre-Pregnancy Interview (PB, EH, TT–HI) ..
Biological and Environmental Sample Collection—Preconception (PB, EH, TT–HI).
Pregnancy Probability Group Follow Up
Script (PB, EH, TT–HI, TT–LI).
Low-intensity Questionnaire (Non-Pregnant)
(TT–LI).
Validation Script (PB, EH, TT–HI, TT–LI,
PBS).
Pregnancy Activities:
Pregnant Women’s Informed Consent Form
(PB, EH, TT–HI, PBS).
Low-intensity Questionnaire (Found Pregnant) (TT–LI).
Pregnancy Visit 1 Interview (PB, EH, TT–
HI, PBS).
Biological and Environmental Sample Collection—Pregnancy (PB, EH, TT–HI,
PBS).
Pregnancy Visit 2 Interview (PB, EH, TT–
HI, PBS).
Pregnancy Health Care Log (PB, EH, TT–
HI, PBS).
Father Informed Consent Form (PB, EH,
TT–HI, PBS).
Father Interview (PB, EH, TT–HI, PBS) ......
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Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR RECRUITMENT SUBSTUDY RESPONDENTS, PRENATAL TO 30
MONTHS, PHASE 2—Continued
Data collection activity
Estimated
number of
respondents
Type of respondent
Birth-Related Activities:
Birth Visit Interview (PB, EH, TT–HI, PBS)
Low-intensity Questionnaire (Birth-focus)
(TT–LI).
Postnatal Activities:
Infant Feeding Log (PB, EH, TT–HI, PBS)
Low-intensity Questionnaire (Child-focus)
(TT–LI).
Biological Sample Collection—Mother/Baby
(PB, EH, TT–HI, PBS).
3-Month Interview (PB, EH, TT–HI, PBS) ...
Core Questionnaire (PB, EH, TT–HI, TT–LI,
PBS).
6-Month Visit Interview (PB, EH, TT–HI,
PBS).
Physical Measures (6-Month, 12-Month,
24-Month).
9-Month Interview (PB, EH, TT–HI, PBS) ...
12-Month Visit Interview (PB, EH, TT–HI,
PBS).
18-Month Interview (PB, EH, TT–HI, PBS)
24-Month Interview (PB, EH, TT–HI, PBS)
30-Month Visit Interview (PB, EH, TT–HI,
TT–LI, PBS).
Formative Research:
Formative—Developmental .........................
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Mother/Baby ...................
Mother/Baby ...................
3,422
1,296
1
1
0.40
0.50
1,369
648
Mother/Baby ...................
Mother/Baby ...................
3,319
1,147
1
4
0.33
0.50
1,106
2,295
Mother/Baby ...................
11,635
1
1.50
17,452
Mother/Baby ...................
Mother/Child ...................
3,298
2,911
1
6
0.33
0.30
1,099
5,240
Mother/Baby ...................
3,199
1
0.50
1,599
Baby/Child ......................
2,677
3
0.50
4,016
Mother/Baby ...................
Mother/Baby ...................
3,103
3,010
1
1
0.17
0.50
517
1,505
Mother/Child ...................
Mother/Child ...................
Mother/Child ...................
2,859
2,716
2,580
1
1
1
0.50
0.75
0.92
1,430
2,037
2,365
.........................................
........................
........................
........................
14,542
.........................................
415,894
........................
........................
182,065
.........................................
........................
........................
........................
14,542
Grand Total ...........................................
emcdonald on DSK29S0YB1PROD with NOTICES
Grand Total, Alternate Recruitment
Substudy.
Total, Formative Research ...................
.........................................
415,894
........................
........................
196,607
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to minimize
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Jamelle E. Banks,
Project Clearance Liaison, Office of
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
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31 Center Drive Room 2A18, Bethesda,
Maryland, 20892, or call non-toll free
number (301) 496–1877 or Email your
request, including your address to
banksj@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: January 19, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science
Policy, Analysis and Communications,
National Institute of Child Health and Human
Development.
[FR Doc. 2012–1934 Filed 1–27–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Vascular and
Hematology Integrated Review Group,
Hemostasis and Thrombosis Study Section.
Date: February 22, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Bukhtiar H Shah, Ph.D.,
DVM, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4120,
MSC 7802, Bethesda, MD 20892, (301) 435–
1233, shahb@csr.nih.gov.
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]]>Agencies
[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4569-4571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1934]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Revision to Proposed Collection; Comment Request; National
Institute of Child Health and Human Development; the National
Children's Study, Vanguard (Pilot) Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: The National Children's Study, Vanguard (Pilot) Study.
Type of Information Collection Request: Revision.
Need and Use of Information Collection: The purpose of the proposed
methodological study is to continue the Vanguard phase of the National
Children's Study with updated instruments and additional biospecimen
collections and physical measures and to evaluate the feasibility,
acceptability, and cost of a different sampling strategy for enrollment
of pregnant women. This study is one component of a larger group of
studies being conducted during the Vanguard Phase of the National
Children's Study (NCS), a prospective, national longitudinal study of
child health and development. In combination, these studies will be
used to inform the design of the Main Study of the National Children's
Study.
Background
The National Children's Study is a prospective, national
longitudinal study of the interaction between environment, genetics on
child health and development. The Study defines ``environment''
broadly, taking a number of natural and man-made environmental,
biological, genetic, and psychosocial factors into account. Findings
from the Study will be made available as the research progresses,
making potential benefits known to the public as soon as possible.
The National Children's Study (NCS) has several components,
including a pilot or Vanguard Study, and a Main Study to collect
exposure and outcome data. The sample frame for the NCS Vanguard and
Main Study was initially based on a national probability sample using
geography as the basis and selecting about100 of the about 3000
counties in the United States as the basis for Primary Sampling Units.
Within the Primary Sampling Units, smaller geographic segments were
selected as Secondary Sampling Units in an attempt to normalize live
birth rates per area sampled. Women who resided at the time of
enrollment within a designated Secondary Sampling Unit and were either
pregnant or between 18 and 49 were eligible for enrollment. The initial
recruitment technique within the selected geographic areas was
household contact by field workers going door to door.
The Vanguard Study was launched in January 2009, and by summer
2009, field experience suggested that the household contact recruitment
strategy was not feasible with available resources. Thus, in 2010 new
recruitment strategies were launched to evaluate options. By late 2011,
the NCS had sufficient data to evaluate operational aspects of various
recruitment strategies. Preliminary analyses suggested that a provider
based recruitment strategy was the most efficient, but due to
constrictions of the geographic sampling frame, the potential of the
strategy was limited. Specifically, many women had to be screened at a
particular provider to locate the relatively few who resided in a
designated segment. Anticipating this limitation, the NCS Program
Office developed and discussed with the NCS Advisory Committee a
different sampling frame, using provider location. This new sampling
strategy is termed Provider Based Sampling (PBS). Information from this
data collection is critical to determine the plausibility of a provider
based sampling frame as an option for some parts of the NCS Main Study.
Research Questions
Two research goals will be accomplished by this information
collection. The first goal is to systematically pilot additional study
visit measures and collections whose scientific robustness, burden to
participants and study infrastructure, and cost for use in the Vanguard
(Pilot) Study and to inform the Main Study. The second goal is to test
the feasibility, acceptability, and cost of Provider Based Sampling
using three locations.
Methods
We will continue with the current data collection schedule which
include pre-pregnancy, pregnancy, and birth periods, as well as
postnatal data collection points at 3, 6, 9, 12, 18, and 24 months of
age. We propose to add or modify the selected measures below to address
analytic goals of assessing feasibility, acceptability and cost of
specific study visit measures.
Supplemental Information and Biospecimen Collections
Core Questionnaire: We propose to pilot use of a core questionnaire
containing key variables and designed to collect core data at every
study visit contact from the time that the enrolled child is 6 months
of age to the time the child is 5 years of age.
30-Month Data Collection Module: We propose piloting the approach
of use of a core instrument plus an age specific module with the 30
month visit.
Validation Questions for 18, 24 and 30 month: We propose addition
of brief, telephone-based questions that would be fielded to a random
sample of each interviewer's cases after completion of the 18-Month,
24-Month, and 30-Month interviews to monitor interviewer performance
and identify occurrences of data falsification.
Nonrespondent Questionnaire will collect information on why a
participant chose to not enroll or withdraw from the NCS. This
information may be used to revise our approaches to recruitment and
will help the Study frame other systematic analyses of nonresponse
bias.
Physical Measures: The addition of 6 month and 12 month infant
measures of child anthropometry and blood pressure may provide critical
pieces of information for future research on the causes of obesity,
diabetes, premature puberty and a host of other health outcomes.
Revised Father Questionnaire: The NCS seeks to incorporate
behavioral, emotional, educational and contextual consequences to
enable a complete assessment of psychosocial influences on children's
well-being. The Revised Father Questionnaire now includes measures
addressing key social/personal resources and fathers' capacity, desire
and attitudes towards engaging with mothers and children.
[[Page 4570]]
Revised 24 Month Interview: The Modified Checklist for Autism in
toddlers (M-CHATTM) is a validated brief screening measure
for identification of Autism and will be added to the 24 month
interview.
Breast Milk Collection 1 and 3 months: Additional collections are
needed to determine the feasibility, acceptability and cost of
collection.
Infant Urine Collection at 6 and 12 months: Additional collections
are needed to determine the feasibility, acceptability and cost of
collection.
Infant Blood and Saliva Collection at 12 months: Additional
collections are needed to determine the feasibility, acceptability and
cost of collection.
Provider Based Sampling
We will compile, at three Vanguard Study locations, a list of
prenatal providers serving women who reside in the Primary Sampling
Unit. Providers will be asked to complete a brief questionnaire about
their practice and their patient demographics. For this pilot, a woman
will be eligible for recruitment if she resides in the Primary Sampling
Unit and is seeing a provider for her first prenatal visit.
Recruitment of participants at the selected provider offices will
follow the protocol and procedures developed for the Provider-Based
Sample Recruitment Substudy, as previously approved by the Office of
Information and Regulatory Affairs within the Office of Management and
Budget. Potential participants will be screened on age eligibility,
residence in the sampled Primary Sampling Unit, and status of an
initial prenatal visit. In some locations, medical records may be
prescreened to identify participants meeting these eligibility
criteria.
Frequency of Response: See above descriptions.
Affected Public: Healthcare Providers, Age-eligible women, Pregnant
women, Fathers, and their children.
Annual Reporting Burden: See Table 1. The additional annualized
cost to respondents over the 3 year data collection period is estimated
at annualized cost of $1,966,069 (based on $10 per hour). This is
calculated as estimating 415,894 respondent contacts at an estimated
average of 0.47 hours per contact, for a total estimated annual
respondent burden as 196,607 hours. There are no Capital Costs to
report. There are no Operating or Maintenance Costs to report.
Table 1--Estimated Annual Reporting Burden for Recruitment Substudy Respondents, Prenatal to 30 Months, Phase 2
----------------------------------------------------------------------------------------------------------------
Estimated
Type of Estimated number of Average Estimated
Data collection activity respondent number of responses per burden hours total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Pregnancy Screener (PB, EH, TT- Age-Eligible 68,538 1 0.42 28,558
HI). Women.
Provider Based Sampling Age-Eligible 9,375 1 0.25 2,344
Eligibility Screener (PBS). Women.
Healthcare Provider Healthcare 600 1 0.17 100
Questionnaire (PB). Providers.
Provider Based Sampling Frame Healthcare 1,225 1 0.17 204
Questionnaire (PBS). Providers.
Household Enumeration HH Reporters.... 120,000 1 0.33 40,000
Instrument (EH).
Low-intensity Invitation to Age-Eligible 15,840 1 0.25 3,960
High-intensity Script (TT-HI). Women.
Pregnancy Screener (TT-LI, TT- Age-Eligible 48,000 1 0.35 16,800
HI). Women.
Low-Intensity Consent Script Age-Eligible 28,800 1 0.33 9,600
(TT-LI). Women.
Nonrespondent Questionnaire Pregnant Women, 3,000 1 0.08 250
(PB, EH, TT-HI, TT-LI, PBS). Non-Pregnant
Women, Mothers
or Fathers.
Preconception Activities:
Non-pregnant Women's Age-Eligible 1,825 1 0.50 913
Informed Consent (PB, EH, Women.
TT-HI).
Pre-Pregnancy Interview Age-Eligible 1,095 1 0.75 821
(PB, EH, TT-HI). Women.
Biological and Age-Eligible 986 1 0.25 246
Environmental Sample Women.
Collection--Preconception
(PB, EH, TT-HI).
Pregnancy Probability Age-Eligible 11,152 6 0.10 6,691
Group Follow Up Script Women.
(PB, EH, TT-HI, TT-LI).
Low-intensity Age-Eligible 10,057 1 0.50 5,029
Questionnaire (Non- Women.
Pregnant) (TT-LI).
Validation Script (PB, EH, Age-Eligible 3,805 1 0.08 304
TT-HI, TT-LI, PBS). Women.
Pregnancy Activities:
Pregnant Women's Informed Pregnant Women.. 12,967 1 0.50 6,484
Consent Form (PB, EH, TT-
HI, PBS).
Low-intensity Pregnant Women.. 518 1 0.50 259
Questionnaire (Found
Pregnant) (TT-LI).
Pregnancy Visit 1 Pregnant Women.. 6,310 1 1.00 6,310
Interview (PB, EH, TT-HI,
PBS).
Biological and Pregnant Women.. 10,363 1 0.25 2,591
Environmental Sample
Collection--Pregnancy
(PB, EH, TT-HI, PBS).
Pregnancy Visit 2 Pregnant Women.. 6,190 1 0.75 4,643
Interview (PB, EH, TT-HI,
PBS).
1Pregnancy Health Care Log Pregnant Women.. 5,048 1 0.33 1,683
(PB, EH, TT-HI, PBS).
Father Informed Consent Alternate 5,048 1 0.50 2,524
Form (PB, EH, TT-HI, PBS). Caregiver.
Father Interview (PB, EH, Alternate 3,029 1 0.25 757
TT-HI, PBS). Caregiver.
[[Page 4571]]
Birth-Related Activities:
Birth Visit Interview (PB, Mother/Baby..... 3,422 1 0.40 1,369
EH, TT-HI, PBS).
Low-intensity Mother/Baby..... 1,296 1 0.50 648
Questionnaire (Birth-
focus) (TT-LI).
Postnatal Activities:
Infant Feeding Log (PB, Mother/Baby..... 3,319 1 0.33 1,106
EH, TT-HI, PBS).
Low-intensity Mother/Baby..... 1,147 4 0.50 2,295
Questionnaire (Child-
focus) (TT-LI).
Biological Sample Mother/Baby..... 11,635 1 1.50 17,452
Collection--Mother/Baby
(PB, EH, TT-HI, PBS).
3-Month Interview (PB, EH, Mother/Baby..... 3,298 1 0.33 1,099
TT-HI, PBS).
Core Questionnaire (PB, Mother/Child.... 2,911 6 0.30 5,240
EH, TT-HI, TT-LI, PBS).
6-Month Visit Interview Mother/Baby..... 3,199 1 0.50 1,599
(PB, EH, TT-HI, PBS).
Physical Measures (6- Baby/Child...... 2,677 3 0.50 4,016
Month, 12-Month, 24-
Month).
9-Month Interview (PB, EH, Mother/Baby..... 3,103 1 0.17 517
TT-HI, PBS).
12-Month Visit Interview Mother/Baby..... 3,010 1 0.50 1,505
(PB, EH, TT-HI, PBS).
18-Month Interview (PB, Mother/Child.... 2,859 1 0.50 1,430
EH, TT-HI, PBS).
24-Month Interview (PB, Mother/Child.... 2,716 1 0.75 2,037
EH, TT-HI, PBS).
30-Month Visit Interview Mother/Child.... 2,580 1 0.92 2,365
(PB, EH, TT-HI, TT-LI,
PBS).
Formative Research:
Formative--Developmental.. ................ .............. .............. .............. 14,542
---------------------------------------------------------------------------------
Grand Total, Alternate ................ 415,894 .............. .............. 182,065
Recruitment Substudy.
Total, Formative ................ .............. .............. .............. 14,542
Research.
---------------------------------------------------------------------------------
Grand Total........... ................ 415,894 .............. .............. 196,607
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to minimize the burden of the collection
of information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Jamelle E. Banks, Project Clearance Liaison,
Office of Science Policy, Analysis and Communication, National
Institute of Child Health and Human Development, 31 Center Drive Room
2A18, Bethesda, Maryland, 20892, or call non-toll free number (301)
496-1877 or Email your request, including your address to
banksj@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: January 19, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development.
[FR Doc. 2012-1934 Filed 1-27-12; 8:45 am]
BILLING CODE 4140-01-P
