Fed Regist. 1998 Jun 1;63(104):29552-90.
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 is publishing an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it has prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). FDA will respond to comments to this amended economic analysis statement, and publish in the Federal Register an amended final economic impact statement prior to the effective date of the September 30, 1997 rule.
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，该最终规则于1997年9月30日刊登在《联邦公报》（62 FR 51021）上，要求在医疗器械标签上声明是否含有天然橡胶乳胶。该规则是针对大量有关含有天然橡胶的各类医疗器械引发严重过敏反应和死亡的报告而发布的。该最终规则于1998年9月30日生效。为了让各方能就1997年9月30日最终规则的经济影响发表更多意见，FDA正在发布一份经修订的经济影响声明，其中包括一份经修订的初始监管灵活性分析（IRFA），这是FDA根据经《小企业监管执法公平法》（SBREFA）修订的《监管灵活性法》（RFA）编制的。FDA将对这份经修订的经济分析声明的意见作出回应，并在1997年9月30日规则生效日期之前在《联邦公报》上发布一份经修订的最终经济影响声明。
