Page:United States Statutes at Large Volume 106 Part 1.djvu/185

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 153 retary that the person acquiesces to debarment and such person's debarment shall commence upon such notification. "(3) CONSIDERATIONS.— In determining the appropriateness and the period of a debarment of a person under subsection (b) and any period of debarment beyond the minimum specified in subparagraph (A)(i) of paragraph (2), the Secretary shall consider where applicable— "(A) the nature and seriousness of any offense involved, "(B) the nature and extent of management participation in any offense involved, whether corporate poUcies and practices encouraged the offense, including whether inadequate institutional controls contributed to the offense, "(C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including the recall or the discontinuation of the distribution of suspect drugs, full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing), the relinquishing of profits on drug approvals fraudulently obtained, and any other actions taken to substantially limit potential or actual adverse effects on the public health, "(D) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future, "(E) whether the person to be debarred is able to present adequate evidence that current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements, and "(F) prior convictions under this Act or under other Acts involving matters within the jurisdiction of the Food and Drug Administration. '(d) TERMINATION OF DEBARMENT.— "(1) APPLICATION. — Any person that is debarred under subsection (a) (other than a person permanently debarred) or any person that is debarred under subsection (b) may apply to the Secretary for termination of the debarment under this subsection. Any information submitted to the Secretary under this paragraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications. "(2) DEADLINE. —The Secretary shall grant or deny any application respecting a debarment which is submitted under paragraph (1) within 180 days of the date the application is submitted. " (3) ACTION BY THE SECRETARY. — " (A) CORPORATIONS.— "(i) CONVICTION REVERSAL. — If the conviction which served as the basis for the debarment of a person under subsection (a)(1) or (b)(2)(A) is reversed, the Secretary shall withdraw the order of debarment. "(ii) APPLICATION. —Upon application submitted under paragraph (1), the Secretary shall terminate the debarment of a person if the Secretary finds that— "(I) changes in ownership, management, or operations have fully corrected the causes of the offense

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