[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41339-41340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute for Child Health and Human Development; 
National Children's Study 2007 Research Plan

ACTION: Notice; opportunity for review and comment.

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SUMMARY: Attached is the proposed Research Plan for the National

[[Page 41340]]

Children's Study (NCS). The purpose of this notice is to inform 
scientific reviewers, professional colleagues, contributors, and all 
who are interested in this ground-breaking initiative, of the 
opportunity for review and comment. The Research Plan describes the 
Study's background, design, measures, and the rationale for their 
selections in sufficient detail so that readers can understand the 
basis of the Study and how it will be carried out. This plan was 
developed with input from scientists and other professionals across the 
country and from multiple federal agencies, especially the National 
Institute of Child Health and Human Development (NICHD) and the 
National Institute of Environmental Health Sciences (NIEHS) at the 
National Institutes of Health (NIH), the Centers for Disease Control 
and Prevention, and the U.S. Environmental Protection Agency (EPA). We 
welcome constructive comments and proposals for how the National 
Children's Study might address the pressing health concerns of our 
nation's children even more effectively. Procedures for commenting and 
communicating about the Research Plan are found on the NCS Web site at: 
http://www.nationalchildrensstudy.gov/research/research_plan/index.cfm.

DATES: Submit responses to the National Children's Study (see below) on 
or before September 25, 2007.

FOR FURTHER INFORMATION CONTACT: The National Children's Study, NICHD, 
NIH, 6100 Executive Blvd., Room 5C01, Bethesda, MD 20892. Telephone: 
301-594-9147, Fax: 301-480-1222, e-mail: [email protected], Internet 
at: http://www.nationalchildrensstudy.gov.

SUPPLEMENTARY INFORMATION: The National Children's Study is a long-term 
study of child health conducted in the United States. By following 
100,000 children from before birth to age 21, Study researchers hope to 
better understand how children's genes and their environments interact 
to affect their health and development. In the Study, ``environment'' 
includes factors such as: Air, water, and house dust; what children 
eat; how they are cared for; the safety of their neighborhoods; and how 
often they see a doctor.
    The goal of the National Children's Study is to provide information 
that will ultimately lead to improvements in the health, development, 
and well-being of children. The primary aim of the Study is to 
investigate the separate and combined effects of environmental 
exposures (chemical, biological, physical, psychosocial) as well as 
gene-environment interactions on pregnancy outcomes, child health and 
development, and precursors of adult disease.
    The Study will examine important health issues, including: birth 
defects and pregnancy-related problems, injuries, asthma, obesity and 
diabetes, and behavior, learning, and mental health disorders. By 
establishing links between children's environments and their health, 
and charting their development through infancy, childhood, and early 
adulthood, the Study hopes to determine the root causes of many 
childhood and adult diseases. Findings from the Study will benefit all 
Americans by providing researchers, health care providers, and public 
health officials with information from which to develop prevention 
strategies, health and safety guidelines, and possibly new treatments 
and cures for disease.
    The Study will employ a national probability sampling approach to 
select locations for conduct of the study. The sampling design utilizes 
a multistage clustered approach. In the first stage, 105 locations 
(generally corresponding to single counties) were randomly selected 
from all U.S. counties. Seven of the locations will serve as the 
Vanguard Locations and will participate in the pilot phase of the 
Study. Because the focus of the study includes assessment of the impact 
of exposures that occur early in pregnancy, both pregnant women and 
their partners, and women of childbearing age, comprise the initial 
target population for enrollment in each of the Study Locations. At the 
time of enrollment, participants will be asked to provide written 
informed consent for participation in the study. Three distinct groups 
will be enrolled and followed: Pregnant women and their partners, 
couples planning pregnancy, and women not currently planning pregnancy 
but with some probability of becoming pregnant during the four year 
enrollment timeframe.
    The National Children's Study is in a unique position to answer 
many questions regarding the effects of environmental exposures on the 
long-term health of children. The focus on exposures prior to and early 
in pregnancy is a unique feature of this study, as is the breadth of 
planned exposure and outcome measurements. As technology continues to 
evolve, stored data specimens (biologic and environmental) will provide 
a valuable resource to answer important questions for future 
generations.
    The prospective longitudinal design of the study will permit an in-
depth examination of the effects of environmental exposures as they 
unfold over the course of development. This will include an 
unprecedented, process-oriented understanding of how exposures at 
particular points in development lead to both immediate and long-term 
consequences for children, and what circumstances, characteristics, or 
genetic predispositions mediate or moderate the relation between 
exposure and outcome. The size and representative nature of the sample 
will permit both valid inferences about the U.S. population as a whole, 
and exploration of subgroup-specific patterns of adaptation and 
maladapation.
    Additionally, the data collected for the Study will provide a 
platform for future research. Data, biological samples, and 
environmental samples will be available for future studies as science 
evolves and new questions arise. The Study will serve as an exceptional 
resource both for science and for society.

Duane Alexander,
Director, National Institutes of Child Health and Human Development, 
National Institutes of Health.
 [FR Doc. E7-14514 Filed 7-26-07; 8:45 am]
BILLING CODE 4140-01-P