Page:United States Statutes at Large Volume 106 Part 1.djvu/194

 106 STAT. 162 PUBLIC LAW 102-282—MAY 13, 1992 "(1) in the case of section 306, includes a supplement to ^ such an application for a different or additional use of the drug but does not include a supplement to such an apphcation for other than a different or additional use of the drug, and "(2) in the case of sections 307 and 308, includes any supplement to such an application, "(cc) The term Tcnowingly* or 'knew' means that a person, with respect to information— "(1) has actual knowledge of the information, or "(2) acts in deliberate ignorance or reckless disregsird of the truth or falsity of the information, "(dd) For purposes of section 306, the term *high managerial agent'— "(1) meeuis— "(A) an officer or (hrector of a corporation or an sissociation, "(B) a partner of a pgirtnership, or "(C) any employee or other agent of a corporation, association, or partnership, having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and "(2) includes persons having management responsibility for— "(A) submissions to the Food and Drug Administration regarding the development or approval of any drug product, "(B) production, quality assurance, or quedity control of any drug product, or "(C) research and development of any drug product, "(ee) For purposes of sections 306 and 307, the term 'drug product' means a drug subject to regulation under section 505, 507, 512, or 802 of this Act or under section 351 of the Public Health Service Act.". 21 USC 335a SEC. 7. EFFECT ON OTHER LAWS. "°• No amendment made by this Act shall preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by this Act. Approved May 13, 1992. LEGISLATIVE HISTORY—H.R. 2454: HOUSE REPORTS: No. 102-272 (Comm. on Energy and Commerce). CONGRESSIONAL RECORD: Vol. 137 (1991): Oct. 28, 31, considered and passed House. Vol. 138 (1992): Apr. 10, considered and passed Senate, amended. Apr. 28, House concurred in Senate amendments.

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