Page:United States Statutes at Large Volume 106 Part 1.djvu/191

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 159 SEC. 3. CIVIL PENALTIES. Chapter III, as amended by section 2, is amended by adding after section 306 the following: "CIVIL PENALTIES "SEC. 307. (a) IN GENERAL. —Any person that the Secretary 21 USC 335b. finds— "(1) knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services, a false statement or misrepresentation of a material fact in connection with an abbreviated drug application, "(2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application, "(3) destroyed, altered, removed, or secreted, or procxu-ed the destruction, alteration, removzd, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department of Health and Human Services for the purpose of interfering with that Dep£utment's discharge of its responsibilities in connection with an abbreviated drug application, "(4) knowingly failed to disclose, to an officer or employee of the Department of Health and Hmnan Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug application, "(5) knowingly obstructed an investigation of the Department of Health and Human Services into any drug subject to an abbreviated drug application, "(6) is a person that has an approved or pending drug product application and has knowingly— "(A) employed or retained as a consultant or contractor, or "(B) otherwise used in any capacity the services of, a person who was debarred under section 306, or "(7) is an individual debarred under section 306 and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application, shall be liable to the United States for a civil penalty for each such violation in an simount not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person. " (b) PROCEDURE.— "(1) IN GENERAL.— "(A) ACTION BY THE SECRETARY.^A civil penalty under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an opportmiity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investigation or hearing under this subparagraph, 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. "(B) ACTION BY THE ATTORNEY GENERAL.—In lieu of a proceeding under subparagraph (A), the Attorney General

�