[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24964-24967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10113]
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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
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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.
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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
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Screening Activities
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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)
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Continuous Activities
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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).
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Pregnancy Activities
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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
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Birth-Related Activities
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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).
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Postnatal Activities
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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
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Total, Formative Research............. ............................ .............. .............. .............. 4,847 48,473
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Grand Total....................... ............................ 31,082 .............. .............. 22,791 229,804
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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 [email protected], 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 [email protected].
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