National Institute of Child Health and Human Development Submission for OMB Review; Comment Request; Provider-Based Sampling Feasibility Study for the Vanguard (Pilot) Study and Data Collection Updates for the National Children's Study (NICHD), 24964-24967 [2012-10113]
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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
Number of record
keepers
Recordkeeping
Hours per year
Total burden
hours
Recordkeeping
Non-alternative Facilities (124.510(a)) ......................................................................
Unrestricted Availability (124.510(b)) ........................................................................
33
30
50
50
1,650.00
1,500.00
Subtotal Recordkeeping Burden ........................................................................
..............................
..............................
3,150.00
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: April 20, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–10031 Filed 4–25–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development Submission for
OMB Review; Comment Request;
Provider-Based Sampling Feasibility
Study for the Vanguard (Pilot) Study
and Data Collection Updates for the
National Children’s Study (NICHD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 30,
2012, pages 4569–4571, and allowed 60
days for public comment. No written
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Proposed Collection
Title: Provider-Based Sampling
Feasibility Study for the Vanguard
(Pilot) Study and Data Collection
Updates for the National Children’s
Study (NICHD).
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17:51 Apr 25, 2012
Jkt 226001
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 about 100 of the about 3,000
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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 the summer of
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 ProviderBased 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
Federal 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. One goal is to test the
feasibility of Provider-Based Sampling
using three study locations. Another
goal is to systematically pilot additional
study visit measures and collections to
assess the scientific robustness, burden
to participants and study infrastructure,
and cost for use in the Vanguard (Pilot)
Study and to inform the design of the
Main Study.
Methods
Provider Based Sampling
We will compile a list of prenatal
providers serving women who reside
within the Primary Sampling Unit at
three study locations. Providers will be
asked to complete a brief questionnaire
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26APN1
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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
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 largely
follow the protocol and procedures
developed for the Provider-Based
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 pregnancy
status at the initial prenatal visit. In
some locations, medical records may be
pre-screened to identify participants
meeting these eligibility criteria.
Supplemental Information and
Biospecimen Collections
We will continue data collection with
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.
Core Questionnaire: We propose to
pilot 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 an age-specific
module alongside of the Core
Questionnaire with the 30-Month
Interview.
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: We
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, 12, and 24-Month infant
measures of child anthropometry and/or
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: We
seek 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
Estimated
number of
respondents
Type of
respondent
Data collection activity
Estimated
number of
responses per
respondent
and attitudes towards engaging with
mothers and children.
Additional Instrument at the 24Month Interview: The Modified
Checklist for Autism in toddlers (M–
CHAT TM) 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 12Month Visits: Additional collections are
needed to determine the feasibility,
acceptability and cost of collection.
Infant Blood and Saliva Collection at
the 12-Month Visit: Additional
collections are needed to determine the
feasibility, acceptability and cost of
collection.
Frequency of Response: See above
descriptions.
Affected Public: Healthcare providers,
pregnant women, fathers, and their
children. The additional annualized
cost to respondents over the three-year
data collection period is estimated at
annualized cost of $229,804. This is
calculated as estimating 31,082
respondent contacts at an estimated
average of 0.73 hours per contact, for a
total estimated annual respondent
burden as 22,791 hours. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
Estimated total
annual
respondent
cost
Screening Activities
Provider Based Sampling Eligibility
Screener (PBS)
Provider Based Sampling Frame
Questionnaire (PBS)
Pregnant Women
3,125
1
20/60
1,042
$10,417
50
1
25/60
21
2,104
480
1
5/60
40
400
1,268
1
5/60
106
$1,057
2,320
1
5/60
193
1,933
1,167
13
10/60
2,528
25,281
1
15/60
43
432
Healthcare Providers
Continuous Activities
Nonrespondent Questionnaire (PB,
EH, TT–HI, TT–LI, PBS)
tkelley on DSK3SPTVN1PROD with NOTICES
Validation Interview—up to 30
Months (PB, EH, TT–HI, TT–LI,
PBS).
Participant Verification (PB, EH, TT–
HI, TT–LI, PBS).
Tracing Interview (PB, EH, TT–HI,
TT–LI, PBS).
Pregnant Women,
Mothers or Fathers
Respondents .......
Pregnant Women,
Mothers or Fathers.
Respondents .......
Pregnancy Activities
Low-intensity Questionnaire (Found
Pregnant) (TT–LI).
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Pregnant Women
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173
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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
Estimated total
annual burden
hours
Estimated total
annual
respondent
cost
35/60
1,177
11,774
1
25/60
757
7,569
1,456
2
60/60
2,913
29,127
1,615
1
20/60
538
5,382
818
1
35/60
477
4,770
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Data collection activity
Type of
respondent
Pregnancy Visit 1 Interview (PB, EH,
TT–HI, PBS).
Pregnancy Visit 2 Interview (PB, EH,
TT–HI, PBS).
Biological and Environmental Sample
Collection—Prenatal (PB, EH, TT–
HI).
Pregnancy Health Care Log (PB, EH,
TT–HI, PBS).
Father Interview (PB, EH, TT–HI) .....
Pregnant Women
2,018
1
Pregnant Women
1,817
Pregnant Women
Pregnant Women
Average
burden per
response
(in hours)
Alternate Caregiver.
Birth-Related Activities
Birth Visit Interview (PB, EH, TT–HI,
PBS).
Low-intensity Questionnaire (Birthfocus) (TT–LI).
Mother/Baby ........
1,141
1
20/60
380
3,802
Mother/Baby ........
432
1
15/60
108
1,080
Postnatal Activities
Mother/Baby ........
1,106
1
20/60
369
3,688
Mother/Baby ........
761
4
22.5/60
1,141
11,411
Mother/Baby ........
1,518
1
20/60
506
5,061
Mother/Baby ........
1,066
1
30/60
533
5,331
Baby/Child ...........
701
3
20/60
701
7,014
Baby/Child ...........
675
2
10/60
225
2,250
Mother/Baby ........
1,428
1
10/60
238
2,381
Mother/Baby ........
1,003
1
50/60
836
8,360
Mother/Child ........
1,316
1
30/60
658
6,582
Mother/Child ........
1,251
1
35/60
729
7,295
Mother/Child ........
1,188
1
30/60
594
5,940
Mother/Child ........
1,188
1
55/60
1,089
10,890
Total, Vanguard (Pilot) Study .....
..............................
31,082
........................
........................
17,943
181,331
Total, Formative Research .........
..............................
........................
........................
........................
4,847
48,473
Grand Total .........................
tkelley on DSK3SPTVN1PROD with NOTICES
Infant Feeding Log (PB, EH, TT–HI,
PBS).
Biological Sample Collection—Mother/Baby (PB, EH, TT–HI).
3-Month Interview (PB, EH, TT–HI,
TT–LI, PBS).
6-Month Interview (PB, EH, TT–HI,
PBS).
Physical Measures—Child Anthropometry (6-,12-, 24-Month) (PB,
EH, TT–HI).
Physical Measures—Child Blood
Pressure (12-, 24-Month) (PB, EH,
TT–HI).
9-Month Interview (PB, EH, TT–HI,
TT–LI, PBS).
12-Month Interview (PB, EH, TT–HI,
PBS).
18-Month Interview (PB, EH, TT–HI,
TT–LI, PBS).
24-Month Interview (PB, EH, TT–HI,
TT–LI, PBS).
Core Questionnaire (PB, EH, TT–HI,
TT–LI, PBS).
30-Month Visit Interview (PB, EH,
TT–HI, TT–LI, PBS).
..............................
31,082
........................
........................
22,791
229,804
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 enhance
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
the quality, utility, and clarity of the
information collected; and (4) 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
time, should be directed to Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attn: NIH Desk Officer, by Email to
OIRA_submission@omb.eop.gov, or by
fax to (202) 395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Ms.
Jamelle E. Banks, Public Health Analyst,
Office of Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive, Room 2A18, Bethesda,
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26APN1
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
Maryland 20892, or call a 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 30 days of the date of
this publication.
Dated: April 16, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science
Policy, Analysis and Communications,
National Institute of Child Health and Human
Development.
[FR Doc. 2012–10113 Filed 4–25–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications.
Date: May 16, 2012.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Maja Maric, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
DHHS/NIH/NIAID, 6700B Rockledge Drive,
Room 3266, Bethesda, MD 20892–7616, 301–
451–2634, maja.maric@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
Dated: April 19, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–10089 Filed 4–25–12; 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
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: Center for Scientific
Review Special Emphasis Panel RFA–RM–
11–016 Regional Comprehensive
Metabolomics Resource Cores.
Date: May 15–16, 2012.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: James J Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5148, MSC 7849, Bethesda, MD
20892, 301–806–8065, lijames@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR12–010
Smoking and Tobacco Revision Applications:
Social Sciences and Population Studies.
Date: May 21–22, 2012.
Time: 8:30 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco Alexandria, 480 King
Street, Alexandria, VA 22314.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 3139, MSC 7770,
Bethesda, MD 20892, (301) 435–1712,
ryansj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Social
Sciences and Population Studies: Second
Panel.
Date: May 21–22, 2012.
Time: 8:30 a.m. to 12 p.m.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
24967
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco Alexandria, 480 King
Street, Alexandria, VA 22314.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Myocardial Metabolism, Ischemia
and Heart Failure.
Date: May 22, 2012.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 19, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–10088 Filed 4–25–12; 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 Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Risk, Prevention and Health
Behavior.
Date: May 9–10, 2012.
Time: 9 a.m. to 5 p.m.
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24964-24967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10113]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development
Submission for OMB Review; Comment Request; Provider-Based Sampling
Feasibility Study for the Vanguard (Pilot) Study and Data Collection
Updates for the National Children's Study (NICHD)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Child Health and Human
Development (NICHD), the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on January 30, 2012, pages 4569-4571, and allowed 60 days for
public comment. No written comments were received. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Institutes of Health may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
Proposed Collection
Title: Provider-Based Sampling Feasibility Study for the Vanguard
(Pilot) Study and Data Collection Updates for the National Children's
Study (NICHD).
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 about 100 of the about 3,000
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 the summer
of 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 Federal
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. One goal is to test the feasibility of Provider-Based
Sampling using three study locations. Another goal is to systematically
pilot additional study visit measures and collections to assess the
scientific robustness, burden to participants and study infrastructure,
and cost for use in the Vanguard (Pilot) Study and to inform the design
of the Main Study.
Methods
Provider Based Sampling
We will compile a list of prenatal providers serving women who
reside within the Primary Sampling Unit at three study locations.
Providers will be asked to complete a brief questionnaire
[[Page 24965]]
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
largely follow the protocol and procedures developed for the Provider-
Based 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 pregnancy status at
the initial prenatal visit. In some locations, medical records may be
pre-screened to identify participants meeting these eligibility
criteria.
Supplemental Information and Biospecimen Collections
We will continue data collection with 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.
Core Questionnaire: We propose to pilot 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 an age-
specific module alongside of the Core Questionnaire with the 30-Month
Interview.
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: We 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, 12, and 24-Month infant
measures of child anthropometry and/or 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: We seek 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.
Additional Instrument at the 24-Month Interview: The Modified
Checklist for Autism in toddlers (M-CHAT \TM\) 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-Month Visits: Additional
collections are needed to determine the feasibility, acceptability and
cost of collection.
Infant Blood and Saliva Collection at the 12-Month Visit:
Additional collections are needed to determine the feasibility,
acceptability and cost of collection.
Frequency of Response: See above descriptions.
Affected Public: Healthcare providers, pregnant women, fathers, and
their children. The additional annualized cost to respondents over the
three-year data collection period is estimated at annualized cost of
$229,804. This is calculated as estimating 31,082 respondent contacts
at an estimated average of 0.73 hours per contact, for a total
estimated annual respondent burden as 22,791 hours. There are no
Capital Costs to report. There are no Operating or Maintenance Costs to
report.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden Estimated total annual
Data collection activity Type of respondent number of responses per per response total annual respondent
respondents respondent (in hours) burden hours cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provider Based Sampling Eligibility Pregnant Women.............. 3,125 1 20/60 1,042 $10,417
Screener (PBS)
Provider Based Sampling Frame Healthcare Providers 50 1 25/60 21 2,104
Questionnaire (PBS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuous Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonrespondent Questionnaire (PB, EH, TT- Pregnant Women, Mothers or 480 1 5/60 40 400
HI, TT-LI, PBS) Fathers
Validation Interview--up to 30 Months (PB, Respondents................. 1,268 1 5/60 106 $1,057
EH, TT-HI, TT-LI, PBS).
Participant Verification (PB, EH, TT-HI, Pregnant Women, Mothers or 2,320 1 5/60 193 1,933
TT-LI, PBS). Fathers.
Tracing Interview (PB, EH, TT-HI, TT-LI, Respondents................. 1,167 13 10/60 2,528 25,281
PBS).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pregnancy Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low-intensity Questionnaire (Found Pregnant Women.............. 173 1 15/60 43 432
Pregnant) (TT-LI).
[[Page 24966]]
Pregnancy Visit 1 Interview (PB, EH, TT- Pregnant Women.............. 2,018 1 35/60 1,177 11,774
HI, PBS).
Pregnancy Visit 2 Interview (PB, EH, TT- Pregnant Women.............. 1,817 1 25/60 757 7,569
HI, PBS).
Biological and Environmental Sample Pregnant Women.............. 1,456 2 60/60 2,913 29,127
Collection--Prenatal (PB, EH, TT-HI).
Pregnancy Health Care Log (PB, EH, TT-HI, Pregnant Women.............. 1,615 1 20/60 538 5,382
PBS).
Father Interview (PB, EH, TT-HI).......... Alternate Caregiver......... 818 1 35/60 477 4,770
--------------------------------------------------------------------------------------------------------------------------------------------------------
Birth-Related Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Birth Visit Interview (PB, EH, TT-HI, PBS) Mother/Baby................. 1,141 1 20/60 380 3,802
Low-intensity Questionnaire (Birth-focus) Mother/Baby................. 432 1 15/60 108 1,080
(TT-LI).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postnatal Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant Feeding Log (PB, EH, TT-HI, PBS)... Mother/Baby................. 1,106 1 20/60 369 3,688
Biological Sample Collection--Mother/Baby Mother/Baby................. 761 4 22.5/60 1,141 11,411
(PB, EH, TT-HI).
3-Month Interview (PB, EH, TT-HI, TT-LI, Mother/Baby................. 1,518 1 20/60 506 5,061
PBS).
6-Month Interview (PB, EH, TT-HI, PBS).... Mother/Baby................. 1,066 1 30/60 533 5,331
Physical Measures--Child Anthropometry (6- Baby/Child.................. 701 3 20/60 701 7,014
,12-, 24-Month) (PB, EH, TT-HI).
Physical Measures--Child Blood Pressure Baby/Child.................. 675 2 10/60 225 2,250
(12-, 24-Month) (PB, EH, TT-HI).
9-Month Interview (PB, EH, TT-HI, TT-LI, Mother/Baby................. 1,428 1 10/60 238 2,381
PBS).
12-Month Interview (PB, EH, TT-HI, PBS)... Mother/Baby................. 1,003 1 50/60 836 8,360
18-Month Interview (PB, EH, TT-HI, TT-LI, Mother/Child................ 1,316 1 30/60 658 6,582
PBS).
24-Month Interview (PB, EH, TT-HI, TT-LI, Mother/Child................ 1,251 1 35/60 729 7,295
PBS).
Core Questionnaire (PB, EH, TT-HI, TT-LI, Mother/Child................ 1,188 1 30/60 594 5,940
PBS).
30-Month Visit Interview (PB, EH, TT-HI, Mother/Child................ 1,188 1 55/60 1,089 10,890
TT-LI, PBS).
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Total, Vanguard (Pilot) Study......... ............................ 31,082 .............. .............. 17,943 181,331
-------------------------------------------------------------------------------------------------------------
Total, Formative Research............. ............................ .............. .............. .............. 4,847 48,473
-------------------------------------------------------------------------------------------------------------
Grand Total....................... ............................ 31,082 .............. .............. 22,791 229,804
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 enhance the quality, utility, and
clarity of the information collected; and (4) 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to Office of Management and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk Officer, by Email to OIRA_submission@omb.eop.gov, or by fax to (202) 395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Ms. Jamelle E. Banks, Public
Health Analyst, Office of Science Policy, Analysis and Communication,
National Institute of Child Health and Human Development, 31 Center
Drive, Room 2A18, Bethesda,
[[Page 24967]]
Maryland 20892, or call a 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 30 days
of the date of this publication.
Dated: April 16, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development.
[FR Doc. 2012-10113 Filed 4-25-12; 8:45 am]
BILLING CODE 4140-01-P
