Page:United States Statutes at Large Volume 106 Part 1.djvu/189

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 157 "(II) the causes of such violations have not been corrected within a reasonable period of time following notice of such violations by the Secretary, and "(B) such person is under an active investigation by a Federal authority in connection with a civil or criminal action involving conduct described in subparagraph (A), the Secretary shall issue an order suspending the distribution of all drugs the development or approval of which was related to such conduct described in subparagraph (A) or suspending the distribution of all drugs approved under abbreviated drug applications of such person if the Secretary finds that such conduct may have affected the development or approval of a significEUit number of drugs which the Secretary is unable to identify. The Secretary shall exclude a drug from such order if the Secretary determines that such conduct was not likely to have influenced the safety or efficacy of such drug. "(2) PUBLIC HEALTH WAIVER.—The Secretary shall, on the Secretary own initiative or in response to a petition, waive the suspension under paragraph (1) (involving an action described in paragraph (l)(A)(i)) with respect to any drug if. the Secretary finds that such waiver is necessary to protect the public health because sufficient quantities of the drug would not otherwise be available. The Secretary shall act on any petition seeking action under this paragraph within 180 days of the date the petition is submitted to the Secretary. "(h) TERMINATION OF SUSPENSION. —The Secretary shall withdraw an order of suspension of the distribution of a drug under subsection (g) if the person with respect to whom the order was issued demonstrates in a petition to the Secretary— "(1)(A) on the basis of an audit by the Food and Drug Administration or by experts acceptable to the Food and Drug Administration, or on the basis of other information, that the development, approval, manufacturing, and distribution of such drug is in substantial compliance with the applicable requirements of this Act, and "(B) changes in ownership, management, or operations— "(i) fully remedy the patterns or practices with respect to which the order was issued, and "(ii) provide reasonable assurances that such actions will not occur in the future, or "(2) the initial determination was in error. The Secretary shall act on a submission of a petition under this subsection within 180 days of the date of its submission and the Secretary may consider the petition concurrently with the suspension proceeding. Any information submitted to the Secretary under this subsection does not constitute an amendment or supplement to a pending or approved abbreviated drug application. "(i) PROCEDURE.— The Secretary may not take any action under subsection (a), (b), (c), (d)(3), (g), or (h) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the

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