subpart d—general provisions

§300aa–31. Citizen's actions

(a) General rule

Except as provided in subsection (b) of this section, 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 part.

(b) Notice

No action may be commenced under subsection (a) of this section 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 plaintiff who substantially prevails on one or more significant issues in the action.

(July 1, 1944, ch. 373, title XXI, §2131, as added Pub. L. 99–660, title III, §311(a), Nov. 14, 1986, 100 Stat. 3778; amended Pub. L. 100–203, title IV, §4305, Dec. 22, 1987, 101 Stat. 1330–224.)

Amendments

1987—Subsec. (c). Pub. L. 100–203, which directed that subsec. (c) be amended by substituting "to any plaintiff who substantially prevails on one or more significant issues in the action" for "to any party, whenever the court determines that such award is appropriate", was executed by making the substitution for "to any party, whenever the court determines such award is appropriate", to reflect the probable intent of Congress.

Effective Date

Subpart effective Dec. 22, 1987, see section 323 of Pub. L. 99–660, set out as a note under section 300aa–1 of this title.

§300aa–32. Judicial review

A petition for review of a regulation under this part 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.

(July 1, 1944, ch. 373, title XXI, §2132, as added Pub. L. 99–660, title III, §311(a), Nov. 14, 1986, 100 Stat. 3778.)

§300aa–33. Definitions

For purposes of this part:

(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 (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 section 300aa–28 of this title, 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) The term "Advisory Commission on Childhood Vaccines" means the Commission established under section 300aa–19 of this title.

(B) The term "Vaccine Injury Table" means the table set out in section 300aa–14 of this title.

(July 1, 1944, ch. 373, title XXI, §2133, as added Pub. L. 99–660, title III, §311(a), Nov. 14, 1986, 100 Stat. 3778.)

§300aa–34. Termination of program

(a) Reviews

The Secretary shall review the number of awards of compensation made under the program to petitioners under section 300aa–11 of this title for vaccine-related injuries and deaths associated with the administration of vaccines on or after December 22, 1987, as follows:

(1) The Secretary shall review the number of such awards made in the 12-month period beginning on December 22, 1987.

(2) At the end of each 3-month period beginning after the expiration of the 12-month period referred to in paragraph (1) the Secretary shall review the number of such awards made in the 3-month period.

(b) Report

(1) If in conducting a review under subsection (a) of this section the Secretary determines that at the end of the period reviewed the total number of awards made by the end of that period and accepted under section 300aa–21(a) of this title exceeds the number of awards listed next to the period reviewed in the table in paragraph (2)—

(A) the Secretary shall notify the Congress of such determination, and

(B) beginning 180 days after the receipt by Congress of a notification under paragraph (1), no petition for a vaccine-related injury or death associated with the administration of a vaccine on or after December 22, 1987, may be filed under section 300aa–11 of this title.

Section 300aa–11(a) of this title and subpart B of this part shall not apply to civil actions for damages for a vaccine-related injury or death for which a petition may not be filed because of subparagraph (B).

(2) The table referred to in paragraph (1) is as follows:

        

(July 1, 1944, ch. 373, title XXI, §2134, as added Pub. L. 100–203, title IV, §4303(f), Dec. 22, 1987, 101 Stat. 1330–222.)

Codification

In subsecs. (a) and (b), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.