Page:United States Statutes at Large Volume 119.djvu/2847

 PUBLIC LAW 109–148—DEC. 30, 2005

119 STAT. 2829

device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is— ‘‘(A)(i) a product manufactured, used, designed, developed, modified, licensed, or procured— ‘‘(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or ‘‘(II) to limit the harm such pandemic or epidemic might otherwise cause; or ‘‘(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); and ‘‘(B)(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; ‘‘(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; or ‘‘(iii) authorized for emergency use in accordance with section 564 of the Federal Food, Drug, and Cosmetic Act. ‘‘(8) QUALIFIED PERSON.—The term ‘qualified person’, when used with respect to the administration or use of a covered countermeasure, means— ‘‘(A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or ‘‘(B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b). ‘‘(9) SECURITY COUNTERMEASURE.—The term ‘security countermeasure’ has the meaning given such term in section 319F–2(c)(1)(B). ‘‘(10) SERIOUS PHYSICAL INJURY.—The term ‘serious physical injury’ means an injury that— ‘‘(A) is life threatening; ‘‘(B) results in permanent impairment of a body function or permanent damage to a body structure; or ‘‘(C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.’’. SEC. 3. COVERED COUNTERMEASURE PROCESS.

Part B of title III of the Public Health Service Act is further amended by inserting after section 319F–3 (as added by section 2) the following new section: ‘‘SEC. 319F–4. COVERED COUNTERMEASURE PROCESS.

42 USC 247d–6e.

‘‘(a) ESTABLISHMENT OF FUND.—Upon the issuance by the Secretary of a declaration under section 319F–3(b), there is hereby established in the Treasury an emergency fund designated as the ‘Covered Countermeasure Process Fund’ for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration, which

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