Page:United States Statutes at Large Volume 100 Part 5.djvu/274

From Wikisource
Jump to: navigation, search
This page needs to be proofread.
PUBLIC LAW 99-000—MMMM. DD, 1986

100 STAT. 3748 Safety.

..5- ,,

='

J;,, 3.

PUBLIC LAW 99-660—NOV. 14, 1986

"(B) the manufacture of a 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 subsection (b), then before taking action against the holder of an application for which a determination was made under subparagraph (A) or (B), 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. "(2) If the Secretary determines that the approval of a drug is not being actively pursued as required by subsection (b)(1)(A), the Secretary shall give the holder of the application authorizing the export of such drug 60 days to assure that actions are taken to actively pursue such approval. During the 60-day period the Secretary shall give the holder an opportunity for an informal hearing on the determination of the Secretary. If upon the expiration of such 60-day period the Secretary determines that approval of such drug is not being actively pursued, the Secretary shall prohibit the export of such drug. "(3)(A) 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 subsection (b) I is exporting a drug from the United States to an importer, "(ii) such importer is exporting the drug to a country which is s. not listed under subsection (b)(4), 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. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(4)(A) 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 subsection Ob) is exporting a drug to a country which is not listed under subsection (b)(4) 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. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(5) If the Secretary receives credible evidence that the holder of an application approved under subsection (b) is exporting a drug to a country which is not listed under subsection (b)(4), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an oppor-