Fed Regist. 1998 Sep 22;63(183):50660-704.
The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.
美国食品药品监督管理局（FDA）正在发布一份经修订的经济分析声明，该声明与一项最终规则相关，该规则于1997年9月30日发布在《联邦公报》（62 FR 51021）上，要求在医疗器械上标注有关天然橡胶乳胶存在的声明。该规则是针对大量与含有天然橡胶的各类医疗器械相关的严重过敏反应和死亡报告而发布的。最终规则于1998年9月30日生效。为了允许对1997年9月30日最终规则的经济影响进行进一步评论，FDA于1998年6月1日在《联邦公报》上发布了一份经修订的经济影响声明，包括一份经修订的初始监管灵活性分析（IRFA），该分析是根据经《小企业监管执法与公平法案》（SBREFA）修订的《监管灵活性法案》（RFA）编制的。在考虑了针对1998年6月1日经修订的经济分析声明提交的评论后，FDA正在发布经修订的最终经济影响声明，包括经修订的最终监管灵活性分析。
