Fed Regist. 2008 Sep 29;73(189):56487-91.
The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.
美国食品药品监督管理局（FDA）正在修订其法规，要求新药申请（NDA）持有人在年度报告中提交有关获批仿制药的某些信息。我们采取这一行动是作为实施《2007年食品药品监督管理局修正案法案》（FDAAA）的一部分。FDAAA要求FDA公布自1999年以来年度报告中包含的所有获批仿制药清单，并且该机构要每季度更新该清单。我们对此行动采用直接最终规则制定程序，因为该机构预计对该规则不会有重大负面评论。在本期《联邦公报》的拟议规则部分，我们同时提议并征求对此规则的意见。如果收到重大负面评论，我们将撤回此最终规则，并在后续最终规则中处理这些评论。FDA不会提供额外的评论机会。
