Department of Health and Human Services. Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients Letter and Attachment From Robert P. Murphy, General Counsel, United States General Accounting Office to Sen. James M. Jeffords and Sen. Edward M. Kennedy and Rep. Thomas J. Bliley, Jr. and Rep. John D. Dingell