Page:United States Statutes at Large Volume 106 Part 1.djvu/186

 106 STAT. 154 PUBLIC LAW 102-282—MAY 13, 1992 involved and provide reasonable assurances that the offense will not occur in the future, and "(II) sufficient audits, conducted by the Food and Drug Administration or by independent experts acceptable to the Food and Drug Administration, demonstrate that pending applications and the development of drugs being tested before the submission of an appHcation are free of fraud or material false statements. In the case of persons debarred under subsection (a)(1), such termination shall take effect no earlier than the expiration of one year from the date of the debarment. "(B) INDIVIDUALS. — "(i) CONVICTION REVERSAL. — If the conviction which served as the basis for the debarment of an individual under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) 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 an individual who has been debarred under subsection (b)(2)(B) if such termination serves the interests of justice and adequately protects the integrity of the drug approval process. " (4) SPECIAL TERMINATION. — "(A) APPLICATION.— Any person that is debsured under subsection (a)(1) (other than a person permanently debarred under subsection (c)(2)(A)(i)) or any individual who is debarred under subsection (a)(2) may apply to the Secretary for special termination of debarment under this subsection. Any information submitted to the Secretary under this subparagraph does not constitute an amendment or supplement to pending or approved abbreviated drug applications. "(B) CORPORATIONS.— Upon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that— "(i) the person msiking the application under subparagraph (A) has demonstrated that the felony conviction which was the basis for such person's debarment involved the conunission of an offense which was not authorized, requested, commanded, performed, or recklessly tolerated by the board of directors or by a high managerial agent acting on behalf of the person within the scope of the board's or agent's office or employment, "(ii) all individuals who were involved in the conmiis-, sion of the offense or who knew or should have known of the offense have been removed from employment involving the development or approval of any drug subject to sections 505 or 507, "(iii) the person fully cooperated with all investigations and promptly (Usclosed all wrongdoing to the appropriate authorities, and (iv) the person acted to mitigate any impact on the public of any offense involved, including the recall, ' or the discontinuation of the distribution, of any drug

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