Page:United States Statutes at Large Volume 117.djvu/658

 PUBLIC LAW 108–20—APR. 30, 2003

117 STAT. 639

determined, pursuant to the procedures established under section 262, to have been sustained by an individual as the direct result of— ‘‘(A) administration to the individual of a covered countermeasure during the effective period of the Declaration; or ‘‘(B) accidental vaccinia inoculation of the individual in circumstances in which— ‘‘(i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after the end of such period; ‘‘(ii) smallpox vaccine has not been administered to the individual; and ‘‘(iii) the individual has been in contact with an individual who is (or who was accidentally inoculated by) a covered individual. ‘‘(4) DECLARATION.—The term ‘Declaration’ means the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003. ‘‘(5) EFFECTIVE PERIOD OF THE DECLARATION.—The term ‘effective period of the Declaration’ means the effective period specified in the Declaration, unless extended by the Secretary. ‘‘(6) ELIGIBLE INDIVIDUAL.—The term ‘eligible individual’ means an individual who is (as determined in accordance with section 262)— ‘‘(A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or ‘‘(B) an individual who sustains a covered injury in the manner described in paragraph (3)(B). ‘‘(7) SMALLPOX EMERGENCY RESPONSE PLAN.—The term ‘smallpox emergency response plan’ or ‘plan’ means a response plan detailing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an active case of smallpox either within or outside the United States. ‘‘(b) VOLUNTARY PROGRAM.—The Secretary shall ensure that a State, local, or Department of Health and Human Services plan to vaccinate individuals that is approved by the Secretary establishes procedures to ensure, consistent with the Declaration and any applicable guidelines of the Centers for Disease Control and Prevention, that— ‘‘(1) potential participants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part; ‘‘(2) there is voluntary screening provided to potential participants that can identify health conditions relevant to contraindications; and ‘‘(3) there is appropriate post-inoculation medical surveillance that includes an evaluation of adverse health effects that may reasonably appear to be due to such vaccine and prompt referral of, or the provision of appropriate information to, any individual requiring health care as a result of such adverse health event.

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