F
National Vaccine Program Legislation

TITLE XXI-VACCINES SUBTITLE 1-NATIONAL VACCINE PROGRAM

Establishment

Sec. 2101. [300aa-1] The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary.

Program Responsibilities

Sec. 2102. [300aa-2] (a) The Director of the Program shall have the following responsibilities:

(1) Vaccine Research. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide directon for research 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 on means to induce human immunity against



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The Children's Vaccine Initiative: Achieving the Vision F National Vaccine Program Legislation TITLE XXI-VACCINES SUBTITLE 1-NATIONAL VACCINE PROGRAM Establishment Sec. 2101. [300aa-1] The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary. Program Responsibilities Sec. 2102. [300aa-2] (a) The Director of the Program shall have the following responsibilities: (1) Vaccine Research. —The Director of the Program shall, through the plan issued under section 2103, coordinate and provide directon for research 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 on means to induce human immunity against

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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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The Children's Vaccine Initiative: Achieving the Vision immunization activities (8) Coordinating Governmental and Non-Governmental Activities.—The Director of the Program shall, through the plan issued under section 2103, provide for the exchange of information between Federal agencies involved in the implementation of the Program and nongovernmental entities engaged in the development and production of vaccines and in vaccine research and encourage the investment of nongovernmental resources complementary to the governmental activities under the Program. (9) Funding of Federal Agencies. —The Director of the Program shall make available to Federal agencies involved in the implementation of the plan issued under section 2103 funds appropriated under section 2106 to supplement the funds otherwise available to such agencies for activities under the plan. (b) In carrying out subsection (a) and in preparing the plan under section 2103, the Director shall consult with all Federal agencies involved in research on and development, testing licensing, production, procurement, distribution, and use of vaccines. Plan Sec. 2103. [300aa-3] The Director of the Program shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 2102. The plan shall establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination with the Program and in conformity with such priorities. The first plan under this section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each succeeding year. Report Sec. 2104. [300aa-4] The Director shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate not later than January 1, 1988, and annually thereafter on the implementation of the Program and the plan prepared under section 2103.

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The Children's Vaccine Initiative: Achieving the Vision National Vaccine Advisory Committee Sec. 2105. [300aa-5] There is established the National Vaccine Advisory Committee. The members of the Committee shall be appointed by the Director of the Program, in consultation with the National Academy of Sciences, from among individuals who are engaged in vaccine research or the manufacture of vaccines or who are physicians, members of parent organizations concerned with immunizations, or representatives of State or local health agencies or public health organizations. (b) The Committee shall— (1) study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States, (2) recommend research priorities and other measures the Director of the Program should take to enhance safety and efficacy of vaccines, (3) advise the Director of the Program in the implementation of sections 2102, 2103, and 2104, and 4 identify annually for the Director of the Program the most important areas of government and nongovernment cooperation that should be considered in implementing sections 2102, 2103, and 2104. Authorizations Sec. 2106. [300aa-6] (a) To carry out this subtitle other than section 2102(9) there are authorized to be appropriated $4,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. (b) To carry out section 2102(9) there are authorized to be appropriated $30,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995.