Page:United States Statutes at Large Volume 100 Part 5.djvu/276

 100 STAT. 3750

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PUBLIC LAW 99-660—NOV. 14, 1986

"(B) the receipt of any information indicating any adverse reactions to such drug. . "(4)(A) If the Secretary determines that— "(i) a drug for which an appHcation is approved under paragraph (2) does not continue to meet the requirements of paragraph (1), "(ii) the holder of such application has not made the report required by paragraph (3), or "(iii) the manufacture of such drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under paragraph (2), then before taking action against the holder of an application for which a determination was made under clause (i), (ii), or (iii), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination. "(B) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that— "(i) the holder of an approved application under paragraph (2) is exporting a drug from the United States to an importer, "(ii) such importer is exporting the drug to a country for which the Secretary cannot make a finding under paragraph dXA),and "(iii) such export presents an imminent hazard to the public health in such country, the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(C) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (I)(A), and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(D) If the Secretary receives credible evidence that the holder of an application approved under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (I)(A), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary

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