Page:United States Statutes at Large Volume 106 Part 1.djvu/184

 106 STAT. 152 PUBLIC LAW 102-282—MAY 13, 1992 or failed to take action for the purpose of avoiding such actual knowledge, "(III) knew that the actions described in subclause (I) were violative of law, and "(IV) did not report such actions, or did not cause such actions to be reported, to an ofQcer, employee, or agent of the Department or to an appropriate law enforcement oflScer, or failed to take other appropriate action that would have ensured that the process for the regulation of drugs was not undermined, within a reasonable time after such agent first knew of such actions, if the Secretary finds that the type of conduct which served as the basis for such other individual's conviction undermines the process for the regulation of drugs. Effective date. "(3) STAY OF CERTAIN ORDERS.—An order of the Secretfiuy under clause (iii) or (iv) of paragraph (2)(B) shall not take effect until 30 days after the order has been issued. "(c) DEBARMENT PERIOD AND CONSIDERATIONS. — "(1) EFFECT OF DEBARMENT.—The Secretary— "(A) shall not accept or review (other than in connection with an audit under this section) any abbreviated drug application submitted by or with the assistance of a person debarred under subsection (a)(1) or (b)(2)(A) during the period such person is debarred, "(B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B), debar an individual from providing services in any capacity to a person that has an approved or pending drug product application and shall not accept or review (other than in connection with an audit under this section) an abbreviated drug application from such individual, and "(C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of section 307(a), assess a civil penalty in accordance with section 307. "(2) DEBARMENT PERIODS. — "(A) IN GENERAL.—The Secretary shall debar a person under subsection (a) or (b) for the following periods: "(i) The period of debarment of a person (other than an individual) under subsection (a)(l) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under subsection (a) occurs within 10 years after such person has been debarred under subsection (a)(D, the period of debarment shall be permanent. "(ii) The debarment of an individual under subsection (a)(2) shall be permanent. "(iii) The period of debarment of any person under subsection (b)(2) shall not be more than 5 years. The Secretary may determine whether debarment periods shall run concurrently or consecutively in the case of a person debarred for multiple offenses. "(B) NOTIFICATION.—Upon a conviction for an offense described in subsection (a) or (b) or upon execution of an agreement with the United States to plead guilty to such an offense, the person involved may notify the Sec-

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