covered countermeasure against smallpox
(7) Definitions As used in this subsection, terms have the following meanings: (A) Covered countermeasure The term “covered countermeasure” or “covered countermeasure against smallpox”, means a substance that is— (i) (I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or (II) used to control or treat the adverse effects of vaccinia inoculation or of administration of another covered countermeasure; and (ii) specified in a declaration under paragraph (2). (B) Covered person The term “covered person”, when used with respect to the administration of a covered countermeasure, means a person who is— (i) a manufacturer or distributor of such countermeasure; (ii) a health care entity under whose auspices— (I) such countermeasure was administered; (II) a determination was made as to whether, or under what circumstances, an individual should receive a covered countermeasure; (III) the immediate site of administration on the body of a covered countermeasure was monitored, managed, or cared for; or (IV) an evaluation was made of whether the administration of a countermeasure was effective; (iii) a qualified person who administered such countermeasure; (iv) a State, a political subdivision of a State, or an agency or official of a State or of such a political subdivision, if such State, subdivision, agency, or official has established requirements, provided policy guidance, supplied technical or scientific advice or assistance, or otherwise supervised or administered a program with respect to administration of such countermeasures; (v) in the case of a claim arising out of alleged transmission of vaccinia from an individual— (I) the individual who allegedly transmitted the vaccinia, if vaccinia vaccine was administered to such individual as provided by paragraph (2)(B) and such individual was within a category of individuals covered by a declaration under paragraph (2)(A)(i); or (II) an entity that employs an individual described by clause (I) or where such individual has privileges or is otherwise authorized to provide health care; (vi) an official, agent, or employee of a person described in clause (i), (ii), (iii), or (iv); (vii) a contractor of, or a volunteer working for, a person described in clause (i), (ii), or (iv), if the contractor or volunteer performs a function for which a person described in clause (i), (ii), or (iv) is a covered person; or (viii) an individual who has privileges or is otherwise authorized to provide health care under the auspices of an entity described in clause (ii) or (v)(II). (C) Qualified person The term “qualified person”, when used with respect to the administration of a covered countermeasure, means a licensed health professional or other individual who— (i) is authorized to administer such countermeasure under the law of the State in which the countermeasure was administered; or (ii) is otherwise authorized by the Secretary to administer such countermeasure. (D) Arising out of administration of a covered countermeasure The term “arising out of administration of a covered countermeasure”, when used with respect to a claim or liability, includes a claim or liability arising out of— (i) determining whether, or under what conditions, an individual should receive a covered countermeasure; (ii) obtaining informed consent of an individual to the administration of a covered countermeasure; (iii) monitoring, management, or care of an immediate site of administration on the body of a covered countermeasure, or evaluation of whether the administration of the countermeasure has been effective; or (iv) transmission of vaccinia virus by an individual to whom vaccinia vaccine was administered as provided by paragraph (2)(B).