Page:United States Statutes at Large Volume 106 Part 1.djvu/193

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 161 "(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtsuned, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and "(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of abihty to produce the drug for which the apphcation was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce. "(b) PROCEDURE. — The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. "(c) APPLICABILITY.— Subsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred. "(d) JUDICIAL REVIEW. —Any person that is the subject of an adverse decision under subsection (a) 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.". SEC. 5. INFORMATION. Section 505(j) (21 U.S.C. 355(j)) is amended by adding at the end the following: "(8) The Secretary shall, with respect to each apphcation submit- Records, ted under this subsection, msdntain a record of— "(A) the name of the apphcant, "(B) the name of the drug covered by the apphcation, "(C) the name of each person to whom the review of the chemistiy of the apphcation W2is assigned and the date of such assignment, and "(D) the name of each person to whom the bioequivalence review for such apphcation was assigned and the date of such assignment. The information the Secretary is required to maintain under this paragraph with respect to an application submitted under this subsection shall be made available to the public after the approval of such application.". SEC. 6. DEFINITIONS. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: "(bb) The term 'abbreviated drug application' means an apphcation submitted under section 505i(j) or 507 for the approval of a drug that relies on the approved apphcation of another drug with the same active ingredient to estabhsh safety and efficacy, and— S9-194 O—93 7:QL3(Pt1)

�