Page:United States Statutes at Large Volume 100 Part 5.djvu/304

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3778 Fraud.

"(b) SANCTION.—Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall— "(1) be subject to a civil penalty of up to $100,000 per occurrence, or "(2) be fined $50,000 or imprisoned for not more than 1 year, or both. Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence. "PART D—GENERAL PROVISIONS " C I T I Z E N ' S ACTIONS

42 USC

300aa-31.

Courts, U.S.

"SEC. 2131. (a) GENERAL RULE.—Except as provided in subsection

(b), any person may commence in a district court of the United States a civil action on such person's own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under this subtitle. "(b) NOTICE.—No action may be commenced under subsection (a) before the date which is 60 days after the person bringing the action has given written notice of intent to commence such action to the Secretary. "(c) COSTS OF LITIGATION.—The court, in issuing any final order in any action under this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any party, whenever the court determines such award is appropriate.

Regulations.

42 USC

300aa-32.

JUDICIAL R E VI E W

"SEC. 2132. A petition for review of a regulation under this subtitle may be filed in a court of appeals of the United States within 60 days from the date of the promulgation of the regulation or after such date if such petition is based solely on grounds arising after such 60th day. "DEFINITIONS

42 USC 300aa-33.

"SEC. 2133. For purposes of this subtitle: "(1) 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) The term 'manufacturer' means any corporation, organization, or institution, whether public or private (includTi ing 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 section 2128, such term shall include the manufacturer of any other vaccine cov-

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