Page:United States Statutes at Large Volume 106 Part 1.djvu/182

 106 STAT. 150 PUBLIC LAW 102-282—MAY 13, 1992 "(c) Applicability. "(d) Judicial review.". Sec. 5. Information. Sec. 6. Definitions. Sec. 7. Effect on other laws. SEC. 2. DEBARMENT AND OTHER RESTRICTIONS. Sections 306 and 307 (21 U.S.C. 336, 337) are redesignated as sections 309 and 310, respectively, and the following is inserted after section 305: "DE B AR MENT, TEMPORARY DENIAL OF APPROVAL, AND SUSPENSION 21 USC 335a. «SEC. 306. (a) MANDATORY DEBARMENT.— "(1) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS.— I f the Secretary finds that a person other than an individual has been convicted, after the date of the enactment of this section, of a felony under Federed law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application, the Secretary shall debar such person from submitting, or assisting in the submission of, any such application. "(2) INDIVIDUALS.— If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct— "(A) relating to the development or approval, including the process for development or approval, of any drug product, or "(B) otherwise relating to the regulation of any drug product under this Act, the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application. "(b) PERMISSIVE DEBARMENT.— "(1) IN GENERAL.— The Secretary, on the Secretary own initiative or in response to a petition, may, in accordance with paragraph (2), debar— "(A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application, or "(B) an individual from providing services in any capacity to a person that has an approved or pending drug product ^ application. "(2) PERSONS SUBJECT TO PERMISSIVE DEBARMENT.— The following persons are subject to debarment under paragraph (1): "(A) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS. — Any person other than an individual that the Secretary finds has been convicted— "(i) for conduct that— "(I) relates to the development or approval, including the process for the development or approval, of any abbreviated drug application; and "(II) is a felony under Federal Taw (if the person e was convicted before the date of the enactment of this section), a misdemeanor under Federal law, or a felony under State law, or "(ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in clause (i) or a felony described in subsection (a)(D,

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