The term “health care provider” means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered.
(2)
The term “legal representative” means a parent or an individual who qualifies as a legal guardian under State law.
(3)
section 300aa–28 of this title The term “manufacturer” means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any vaccine set forth in the Vaccine Injury Table, except that, for purposes of , such term shall include the manufacturer of any other vaccine covered by that section. The term “manufacture” means to manufacture, import, process, or distribute a vaccine.
(4)
The term “significant aggravation” means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health.
(5)
The term “vaccine-related injury or death” means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine.
(6)(A)
section 300aa–19 of this title The term “Advisory Commission on Childhood Vaccines” means the Commission established under .
Pub. L. 108–7Pub. L. 107–2962003—Pars. (3), (5), (7). repealed , §§ 1714–1717, and provided that this chapter shall be applied as if the sections repealed had never been enacted. See 2002 Amendment notes below.
Pub. L. 107–296, § 1714Pub. L. 108–72002—Par. (3). , which directed amendment of first sentence by substituting “any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine” for “under its label any vaccine set forth in the Vaccine Injury Table” and of second sentence by inserting “including any component or ingredient of any such vaccine” before period at end, was repealed by .
Pub. L. 107–296, § 1715Pub. L. 108–7Par. (5). , which directed insertion of “For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine’s product license application or product label.” at end, was repealed by .
Pub. L. 107–296, § 1716Pub. L. 108–7, § 102(a)Par. (7). , which directed addition of par. (7), was repealed by . Par. (7) read as follows: “The term ‘vaccine’ means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body’s immune response to a disease or diseases and includes all components and ingredients listed in the vaccines’s product license application and product label.”
Statutory Notes and Related Subsidiaries
Effective Date of 2002 Amendment
Pub. L. 107–296, title XVII, § 1717116 Stat. 2321 Pub. L. 108–7, div. L, § 102(a)117 Stat. 528 , , , which provided that the amendments made by sections 1714, 1715, and 1716 (amending this section) shall apply to all actions or proceedings pending on or after , unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding, was repealed by , , .
42 U.S.C. 201Pub. L. 107–296The Public Health Service Act ( et seq.) shall be applied and administered as if the sections repealed by subsection (a) [repealing sections 1714 to 1717 of , which amended this section and enacted provisions set out as a note under this section] had never been enacted.
“(c)
Rule of Construction .—
Public Law 107–296Pub. L. 107–296Public Law 107–296No inference shall be drawn from the enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (), or from this repeal [repealing sections 1714 to 1717 of ], regarding the law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 () []. Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or that Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02–392V (), was incorrectly decided.”