[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15780-15782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request: Child Health
Disparities Measurement for the National Children's 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
[[Page 15781]]
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: Child Health Disparities Substudy for
the National Children's Study (NCS). Type of Information Collection
Request: NEW. Need and Use of Information Collection: The Children's
Health Act of 2000 (Pub. L. 106-310) states:
(a) PURPOSE.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
physical, chemical, biological, and psychosocial) on children's
health and development.
(b) IN GENERAL.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) Plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
(2) Investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence
health and developmental processes.
(c) REQUIREMENT.--The study under subsection (b) shall--
(1) Incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of the
physical, chemical, biological, and psychosocial environmental
influences on children's well-being;
(2) Gather data on environmental influences and outcomes on
diverse populations of children, which may include the consideration
of prenatal exposures; and
(3) Consider health disparities among children, which may
include the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the Child
Health Disparities Substudy will validate measures needed for studying
health disparities and selected biomarkers. Utilizing cognitive
interview techniques and components of standardized questionnaires,
responses will be used to assess and validate measures of health
literacy, discrimination, parenting self-efficacy, and health care
accessibility.
Acceptability and feasibility of saliva collection from a subsample
of women and young children will also be evaluated. The incorporation
of saliva measurements will increase understanding of biological
responses to environmental factors and how these may be correlated with
health disparities within this population.
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. By studying children through their different phases of growth
and development, researchers will be better able to understand the role
these factors have on health and disease. 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
is led by a consortium of federal partners: the U.S. Department of
Health and Human Services (including the Eunice Kennedy Shriver
National Institute of Child Health and Human Development and the
National Institute of Environmental Health Sciences of the National
Institutes of Health and the Centers for Disease Control and
Prevention), and the U.S. Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS was designed to include a preliminary pilot
study known as the Vanguard Study. The purpose of the Vanguard Study is
to assess the feasibility, acceptability, and cost of the recruitment
strategy, study procedures, and outcome assessments that are to be used
in the NCS Main Study. The Vanguard Study begins prior to the NCS Main
Study and will run in parallel with the Main Study. At every phase of
the NCS, the multiple methodological studies conducted during the
Vanguard phase will inform the implementation and analysis plan for the
Main Study.
In this information collection request, the NCS requests approval
from OMB to perform a multi-center substudy called the Child Health
Disparity Substudy. This substudy aims to validate measures needed for
studying health disparities and selected biomarkers. Developing optimum
measures for studying health disparities is of particular interest to
the NCS because studies have shown that health literacy,
discrimination, parenting self-efficacy, health care (access,
utilization, and quality) contribute to health disparities.
Additionally, aspects of the social environment such as social
isolation, lack of control and contingency and social support,
violence, discrimination, challenging and changing social
relationships, and restricted access to health care are thought to
interact with biological processes. Variation in these processes has
been associated with negative emotional states, cognitive deficits,
problem behavior, and a variety of metabolic and immune-related
processes. Alone, or particularly in combination with other commonly
collected measures of social forces and family relationships, salivary
analytes have the potential to advance our understanding of maternal
and child health and development. This project will make its
contribution to the NCS Main Study and to the health disparities field
as a whole by constructing a validated set of questionnaire measures
and biomarker analyses that can be used among pregnant women and
mothers of young children for the purpose of investigating disparities.
Frequency of Response: One-time data collection conducted in
multiple phases.
Affected Public: Pregnant women, mothers with young children, and
their children.
Type of Respondents: Pregnant women, mothers with young children,
and their children who are not geographically eligible to enroll in the
NCS Vanguard Study.
Annual Reporting Burden: See Table 1. The annualized cost to
respondents is estimated at $24,600 (based on $10 per hour). There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
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Table 1--Estimated Annual Reporting Burden Summary, Child Health Disparities Substudy
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Estimated
Estimated number of Average burden Estimated
Data collection activity Type of respondent number of responses per hours per total annual
respondents respondent response burden hours
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Consent.............................. Pregnant Women/Mothers Members of NCS target 1,260 1 0.08 105
of children ages 0-5. population (not NCS
participants).
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Cognitive Interview.................. Mothers of children ages Members of NCS target 60 1 1.33 80
0-5. population (not NCS
participants).
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Primary Data Collection.............. Pregnant Women/Mothers Members of NCS target 600 2 1.08 1,300
of children ages 0-5. population (not NCS 600 1 1.08 650
Mothers of children ages participants).
0-5.
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Saliva Collection.................... Pregnant Women/Mothers Members of NCS target 260 2 0.25 130
of children ages 0-5. population (not NCS 260 1 0.25 65
Additional mothers of participants). 520 1 0.25 130
children ages 0-5.
Children ages 0-5.......
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Total............................ ........................ ....................... 1,780 .............. .............. 2,460
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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 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 Dr. Sarah L. Glavin, Deputy Director, 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 [email protected].
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: March 12, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2012-6354 Filed 3-15-12; 8:45 am]
BILLING CODE 4140-01-P