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GAO-02-933R 1 (2002-08-01)

handle is hein.gao/gaobaamaz0001 and id is 1 raw text is: £ Accountability * Integrity * Reliability United States General Accounting Office Washington, DC 20548 August 1, 2002 The Honorable Tommy Thompson Secretary Department of Health and Human Services Subject: Food and Drug Administration's Compliance With the Inflation Adjustment Act Dear Secretary Thompson: Earlier this year, we initiated a governmentwide review of the implementation of the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended (Inflation Adjustment Act).' The Inflation Adjustment Act required each federal agency to issue a regulation adjusting its covered maximum civil monetary penalties for inflation by October 23, 1996, and requires them to make necessary adjustments at least once every 4 years thereafter. During our review, the Food and Drug Administration's (FDA) Office of the Chief Counsel indicated that at least 14 of the agency's civil penalties are covered by the act but the agency had not adjusted any of them for inflation. This report is intended to bring this matter to your attention and to recommend corrective action. FDA Identified At Least 14 Civil Penalties That Are Covered by the Inflation Adjustment Act Section 3 of the Inflation Adjustment Act defines a covered civil penalty as any penalty, fine, or other sanction that ... is for a specific monetary amount as provided by Federal law or has a maximum amount provided for by Federal law, and is assessed or enforced by an agency pursuant to Federal law and is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts. FDA's Office of the Chief Counsel provided us with a list of civil penalties that it considered covered by the Inflation Adjustment Act. Table 1 lists those penalties as well as their maximum penalty amounts, assessment methods, and the dates that the penalties were last set or adjusted. 'The Inflation Adjustment Act is codified at 28 U.S.C. 2461 note. The 1990 act was amended in 1996 by the Debt Collection Improvement Act, which added the requirement for agencies to adjust their civil penalties by regulation (Pub. Law 104-134, Sec. 31001, 110 Stat. 1321-373). GAO-02-933R FDA Penalty Adjustments

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