[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consent..............................  Pregnant Women/Mothers    Members of NCS target             1,260               1            0.08             105
                                        of children ages 0-5.     population (not NCS
                                                                  participants).
                                                                                         ---------------------------------------------------------------
Cognitive Interview..................  Mothers of children ages  Members of NCS target                60               1            1.33              80
                                        0-5.                      population (not NCS
                                                                  participants).
                                                                                         ---------------------------------------------------------------
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.
                                                                                         ---------------------------------------------------------------
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.......
                                      ------------------------------------------------------------------------------------------------------------------
    Total............................  ........................  .......................           1,780  ..............  ..............           2,460
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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