Each year the 4 million infants born in the United States are screened shortly after birth to detect a variety of congenital conditions. These public health screening programs have become models for population-based screening. Newborn screening programs in this country began with the work of Dr Robert Guthrie in the 1960s with the development of a screening test for phenylketonuria (PKU). Today, all states screen for a wide range of conditions. However, the array of screening tests performed by each state varies and changes periodically. The variability reflects differences in community values, in state political and economic environments, and in technical capabilities.The Health Resources and Services Administration's (HRSA) Maternal and Child Health programs have supported the development of these programs from their inception. HRSA funded the early work of Dr Guthrie to develop the screening test for PKU, sponsored cost-effectiveness studies for the PKU screening test, and facilitated the expansion of newborn screening programs to include screening tests for sickle cell anemia. In recognition of this historical involvement with state newborn screening programs, HRSA requested the American Academy of Pediatrics (AAP) to convene The Task Force on Newborn Screening. Genuine concern for the health of infants and children demands a periodic assessment of health service programs such as newborn screening so that these programs can provide better service. The Task Force on Newborn Screening addresses this responsibility in a thoughtful and comprehensive manner. The charge to the Task Force was to review and evaluate the issues and challenges facing the nation's newborn screening programs and to make recommendations to strengthen these programs. This Task Force has appropriately involved many groups and individuals from within and outside the newborn screening, pediatrics, and genetics communities, representing a diversity of views and expertise.The Task Force recommendations were developed with recognition that the environmental context within which these programs were established has changed dramatically over the past 10 years. The growing impact of consumer advocacy has resulted in a congressional directive to federal agencies to expand and evaluate newborn screening programs. New technologies such as tandem mass spectrometry and DNA-based tests offer the possibility for screening for additional conditions. Changing demographics emphasize the importance of understanding the cultural uniqueness in approaches to health. The Human Genome Project provides the basis for understanding variations in risk among individuals for medically important and genetically complex human diseases. This project brings new understandings about race and ethnicity. The advances in basic and clinical science and technology resulting from the Human Genome Project will offer unparalleled promise to improve abilities to promote health and prevent, diagnose, and treat diseases in children. Not to be forgotten will be those essential ethical, legal, and social questions that must be addressed as well as the challenge in balancing the need to both protect a population's health and to respect individual rights. Further, with the advent of new technologies and new knowledge, it is critical that the newborn screening programs continue to operate under sound public health principles and are connected to medical homes to provide care that is accessible, family-centered, continuous, comprehensive, coordinated, compassionate, and culturally competent.The task of proposing changes to meet the challenges of the 21st century, while preserving the accomplishments of the past, has been undertaken with objectivity, sensitivity, and creativity by the newborn screening, pediatric, and genetics communities. One outcome of this process is the report published here. It will provide a basis for constructive dialogue and for setting a national agenda for progress.The HRSA wishes to thank the Task Force and members of the workgroups for their hard work and their commitment to this process. We also wish to recognize the leadership that the AAP brought to the success of this process. Finally, we would like to acknowledge Linda L. McCabe, PhD, for her skillful editing of this report.