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The Children's Vaccine Initiative: Achieving the Vision (1993)
Institute of Medicine (IOM)

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. "Appendix F: National Vaccine Program Legislation." The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press, 1993.

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The Children's Vaccine Initiative: Achieving the Vision

naturally occurring infectious diseases and to prevent adverse reactions to vaccines.

(2) Vaccine Development. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for activities carried out in or through the National Institutes of Health, the Office of Biologics Research and Review of the Food and  Drug Administration, the Department of Defense, and the Agency for International Development to develop the techniques needed to produce safe effective vaccines.

(3) Safety and Efficacy Testing of Vaccines. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development.

(4) Licensing of Vaccine Manufacturers and Vaccines. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for the allocation of resources in the implementation of the licensing program under section 353.

(5) Production and Procurement of Vaccines. —The Director of the Program shall, through the plan issued under section 2103 ensure that the governmental and nongovernmental production and procurement of safe and effective vaccines by the Public Health Service, the Department of Defense, and the Agency for International Development meet the needs of the United States population and fulfill commitments of the United States to prevent human infectious diseases in other countries.

(6) Distribution and Use of Vaccines. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the Centers for Disease Control and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines.

(7) Evaluation of the Need for and the Effectiveness and Adverse Effects of Vaccines and Immunization Activities. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the National Institutes of Health, the Centers for Disease Control, the Office of Biologics Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technology Assessment, and the Health Care Financing Administration in monitoring the need for and the effectiveness and adverse effects of vaccines and

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