Federal Register Direct final rule/proposed rule: FDA is amending its regulations to require that the holder of an NDA submit certain information on authorized generic drugs in an annual report. Section 920 of FDAAA adds new section 505(t) to FDCA and requires that FDA publish on its Web site a complete list of all authorized generic drugs included in an annual report submitted to the agency after 1/1/99, consisting of the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market. It also requires FDA to update the list quarterly and to notify relevant federal agencies, including the Centers for Medicare and Medicaid Services and the Federal Trade Commission, that the list has been published and will be updated quarterly. The agency is using direct final rulemaking for this action because it expects that there will be no significant adverse comment on the rule. To view this direct final rule, click here.