Other Branch Activities National Children's Study
Best Pharmaceuticals for Children Act (BPCA)
DHHS Interagency Coordinating Council on LBW and Preterm Birth
      and Disparities Subcommittee
Web Site: Committee Expertise in Obstetrics and Gynecology

National Children's Study

The National Children's Study is a large, long-term study of environmental influences on children's health and development. For this effort, environment is broadly defined to include chemical, physical, social, and behavioral influences on children that will help researchers better understand the roles of these factors on health and disease. The study grew out of the President's Task Force on Environmental Health Risks and Safety Risks to Children and was authorized in the Children's Health Act of 2000, which directed the NICHD to conduct the study with a consortium of federal agencies, including the Environmental Protection Agency, the CDC, and the National Institute of Environmental Health Sciences.

Researchers will follow about 100,000 U.S. children from conception, through birth and childhood, into adulthood. By examining participants over a span of 21 years, the study will allow the evaluation of exposure and outcome links in the context of life stages of development. Planning and organization of the study are well under way; working groups for the study are considering issues, such as hypotheses and study design, ethics, development and behavior, chemical and physical exposures, injuries, emerging technologies to measure exposures and outcomes, privacy, and community outreach/participation.

The PPB is active in this planning process. For example, Drs. Marian Willinger and Cathy Spong are the federal co-chairs of the Pregnancy and the Infant Working Group, which was charged to focus on events, outcomes and measurements of pregnancy and infancy and to develop findings on information to be collected about pregnant women, fetuses, and infants in the context of this large, long-term study. The Working Group will also develop findings regarding potential core study hypotheses in those areas relevant to its expertise. Drs. Willinger and Spong have sponsored a number of workshops to help define issues relevant to the Working Group and have led in the development of overarching study hypotheses and pilot studies.

Best Pharmaceuticals for Children Act (BPCA)

The congressional mandates of the BPCA provide an opportunity to address the challenges of clinical trials of drugs in children, for the purpose of labeling drugs for use in pediatric populations. Branch staff, especially Drs. Tonse Raju and Rosemary Higgins, are actively involved in this important initiative, in collaboration with other NICHD and NIH staff. Drs. Raju and Higgins have also helped to organize an NICHD/FDA Newborn Drug Development Initiative to foster the development of safe and effective drug therapies for term and preterm infants.

DHHS Interagency Coordinating Council on LBW and Preterm Birth and Disparities Subcommittee

The purpose of this Interagency Coordinating Council is to galvanize multidisciplinary research, scientific exchange, policy initiatives, and collaboration among DHHS agencies, including the NIH, and to assist the Department in focusing efforts to achieve the greatest advances toward the national goal of reducing infant mortality. The challenges faced by the Council include assuring adequacy of data, uncovering new knowledge through research, and promoting the best possible delivery and financing of relevant health care. In particular, the DHHS Secretary asked the council to develop a Department-wide research agenda on combating LBW and its associated outcomes.

On August 4, 2003, the Deputy Secretary of DHHS charged a subgroup of the council with developing an agenda focused on the disparity that exists in the rates of infant mortality among African American and American Indian/Alaska Native populations. Specifically, the Deputy Secretary asked the subcommittee to identify appropriate best practices from research outcomes and to develop a set of recommendations for DHHS on research, interventions, and policy actions that will help reduce infant mortality (especially LBW and SIDS) among African American and American Indian/Alaska Native infants. Dr. Higgins, Dr. Willinger, and other PPB staff are actively involved in the Council and the subcommittee.

Web Site: Committee Expertise in Obstetrics and Gynecology

To better provide study section and advisory groups with needed expertise, the PPB developed an internal, password-protected, NIH Web resource, http://extranet.nichd.nih.gov\comm\. The site provides a database of obstetric and gynecological expertise from scientists and physicians; those involved in the review process can use this expertise to inform their decisions about incoming applications. The database also increases the number of obstetrician/gynecologists involved in the review process. The Web site provides the experts' contact information, curricula vitae, and keywords. Dr. Uma Reddy is actively working on and supporting this project. Additional experts' names can be submitted electronically at NICHDObGynExpertise@exchange.nih.gov.

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