Page:United States Statutes at Large Volume 106 Part 1.djvu/187

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 155 with respect to which the Secretary requested a recall or discontinuation of distribution due to concerns about the safety or efficacy of the drug. "(C) INDIVIDUALS. — 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 titiat such individual has provided substantial assistance in the investigations or prosecutions of offenses which are described in subsection (a) or (b) or which relate to any matter under the jurisdiction of the Food and Drug Administration. "(D) SECRETARIAL ACTION. —The action referred to in subparagraphs (B) and (C) is— "(i) in the case of a person other than an individual— "(I) terminating the debarment inmiediately, or "(II) limiting the period of debarment to less than one year, and "(ii) in the case of an individual, limiting the period of debarment to less than permanent but to no less than 1 year, whichever best serves the interest of justice and protects the integrity of the drug approval process. "(e) PUBLICATION AND LIST OF DEBARRED PERSONS.— The Secretary shall publish in the Federal Register the name of any person debarred under subsection (a) or (b), the effective date of the debarment, and the period of the debarment. The Secretary shall also maintain and make available to the public a Ust, updated no less often them quarterly, of such persons, of the effective dates and minimum periods of such debarments, and of the termination of debarments. " (f) TEMPORARY DENIAL OF APPROVAL.— "(1) IN GENERAL.— The Secretary, on the Secretary's own initiative or in response to a petition, may, in accordance with paragraph (3), refiise by order, for the period prescribed by paragraph (2), to approve any abbreviated drug application submitted by any person— "(A) if such person is under an active Federal criminal investigation in connection with an action described in subparagraph (B), "(B) if the Secretary finds that such person— "(i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity, or has induced or attempted to induce another person to bribe or pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services or to any other Federal, State, or local official in connection with any abbreviated drug application, or has conspired to commit, or aided or abetted, such actions, or "(ii) has knowingly made or caused to be made a pattern or practice of false statements or misrepresentations with respect to material facts relating to any abbreviated drug application, or the production of any drug subject to an abbreviated drug application, to any officer, employee, or agent of the Department of Health and Human Services, or has conspired to commit, or aided or abetted, such actions, and Federal Register, publication. Public information.

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