Page:United States Statutes at Large Volume 90 Part 1.djvu/1163

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PUBLIC LAW 94-000—MMMM. DD, 1976

PUBLIC LAW 94-380—AUG. 12, 1976

90 STAT. 1113

Public Law 94-380 94th Congress An Act To amend the Public Health Service Act to authorize the establishment and implementation of an emergency national swine flu immunization program and to provide an exclusive remedy for personal injury or death arising out of the manufacture, distribution, or administration of the swine flu vaccine under such program.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "National Swine Flu Immunization Program of 1976". SEC. 2. Section 317 of the Public Health Service Act (42 U.S.C. 247b) is amended by inserting after subsection (i) the following new subsections: " (j)(l) The Secretary is authorized to establish, conduct, and support (by grant or contract) needed activities to carry out a national swine flu immunization program until August 1, 1977 (hereinafter in this section referred to as the 'swine flu program'). The swine flu program shall be limited to the following: " (A) The development of a safe and effective swine flu vaccine. "(B) The preparation and procurement of such vaccine in sufficient quantities for the immunization of the population of the States. "(C) The making of grants to State health authorities to assist in meeting their costs in conducting or supporting, or both, programs to administer such vaccine to their populations, and the furnishing to State health authorities of sufficient quantities of such swine flu vaccine for such programs. "(D) The furnishing to Federal health authorities of appropriate quantities of such vaccine. " (E) The conduct and support of training of personnel for immunization activities described in subparagraphs (C) and (D) of this paragraph and the conduct and support of research on the nature, cause, and effect of the influenza against which the swine flu vaccine is designed to immunize, the nature and effect of such vaccine, immunization against and treatment of such influenza, and the cost and effectiveness of immunization programs against such influenza. " (F) The development, in consultation with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and implementation of a written informed consent form and procedures for assuring that the risks and benefits from the swine flu vaccine are fully explained to each individual to whom such vaccine is to be administered. Such consultation shall be completed within two weeks after enactment of this Act, or by September 1, 1976, whichever is sooner. Such procedures shall include the information necessary to advice individuals with respect to their rights and remedies arising out of the administration of such vaccine. "(G) Such other activities as are necessary to implement the swine flu program.

Aug. 12, 1976 [S. 3735]

National Swine Flu Immunization Program of 1976. 42 USC 201 note.

Grants.

Informed consent form and procedures.