Page:United States Statutes at Large Volume 106 Part 1.djvu/188

 106 STAT. 156 PUBLIC LAW 102-282—MAY 13, 1992 ., "(C) if a significant question has been raised regarding— "(i) the integrity of the approv£d process with respect to such abbreviated drug apphcation, or "(ii) the rehability of data in or concerning such person's abbreviated drug apphcation. Such an order may be modified or terminated at any time. "(2) APPLICABLE PERIOD.— "(A) IN GENERAL. —Except as provided in subparagraph (B), a denial of approval of an sypplication of a person under paragraph (1) shall be in effect for a period determined by the Secretary but not to exceed 18 months beginning on the date the Secretary finds that the conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary shall terminate such denial— "(i) if the investigation with respect to which the finding was made does not result in a criminal charge against such person, if criminal charges have been brought and the charges have been dismissed, or if a judgment of acquittal has been entered, or "(ii) if the Secretary determines that such finding was in error. ^ "(B) EXTENSION. —If, at the end of the period described in subparagraph (A), the Secretary determines that a person has been criminally charged for an action described in subparagraph (B) of paragraph (1), the Secretary may extend the period of denial of approval of an application for a period not to exceed 18 months. The Secretary shall terminate such extension if the charges have been dismissed, if a judgment of acquittal has been entered, or if the Secretary determines that the finding described in subparagraph (A) was in error. "(3) INFORMAL HEARING.—Within 10 days of the date an order is issued under paragraph (1), the Secretary shall provide such person with an opportunity for an informal hearing, to be held within such 10 days, on the decision of the Secretary i* to refuse approval of an abbreviated drug apphcation. Within 60 days of the date on which such hearing is held, the Secretary shall notify the person given such hearing whether the Secretary's refusal of approval will be continued, terminated, or otherwise modified. Such notification shall be final agency action. ^ " (g) SUSPENSION AUTHORITY.— "(1) IN GENERAL. —I f— "(A) the Secretary finds— "(i) that a person has engaged in conduct described in subparagraph (B) of subsection (f)(1) in connection with 2 or more drugs under abbreviated drug apphcations, or "(ii) that a person has engaged in flagrant and repeated, material violations of good mgrnufacturing practice or good laboratory practice in connection with the development, manufacturing, or distribution of one or more drugs approved under an abbreviated drug application during a 2-year period, and— "(I) such violations may undermine the safety and efficacy of such drugs, and

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