Page:United States Statutes at Large Volume 106 Part 1.djvu/190

 106 STAT. 158 PUBLIC LAW 102-282—MAY 13, 1992 production of evidence that relates to the matter under investigation, "(j) JUDICIAL REVIEW. — "(1) IN GENERAL.— Except as provided in paragraph (2), any person that is the subject of an adverse decision under subsection (a), (b), (c), (d), (f), (g), or (h) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside. "(2) EXCEPTION.— Any person that is the subject of an adverse decision under clause (iii) or (iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District Court for the District of Columbia or a district court of the United States for the district in which the person resides, by filing in such court (within 30 days following the date the person is notified of the Secretary's decision) a complaint requesting that the decision be modified or set aside. In such an action, the court shall determine the matter de novo, "(k) CERTIFICATION.— Any application for approval of a drug product shall include— "(1) a certification that the applicant did not and will not use in any capacity the services of any person debarred under subsection (a) or (b), in connection with such application, and "(2) if such application is an abbreviated drug application, a list of all convictions, described in subsections (a) and (b) which occurred within the previous 5 years, of the applicant and afiiliated persons responsible for the development or submission of such application. "(1) APPLICABILITY.— "(1) CONVICTION.—For purposes of this section, a person is considered to have been convicted of a crimingd offense— "(A) when a judgment of conviction has been entered against the person by a Federal or State coiui;, regardless of whether there is an appeal pending, "(B) when a plea of guilty or nolo contendere by the person has been accepted by a Federal or State court, •^i;,,,:,,• or , "(C) when the person has entered into participation in a first offender, deferred adjudication, or other similar arrangement or program where judgment of conviction has been withheld. "(2) EFFECTIVE DATES.— Subsection (a), subparagraph (A) of subsection (b)(2), and clauses (i) and (ii) of subsection (b)(2)(B) shall not apply to a conviction which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (a) or (b). Clauses (iii) and (iv) of subsection (b)(2)(B) and subsections (f) and (g) shall not apply to an act or action which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall not apply to an action which occurred before Jiuie 1, 1992. Subsection (k) shall not apply to applications submitted to the Secretary before June 1, 1992.**.

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