Fed Regist. 2005 Oct 3;70(190):57505-9.
The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.
美国食品药品监督管理局（FDA）正在发布一项最终法规，该法规确认了题为“根据2002年《公共卫生安全与生物恐怖主义防范与应对法案》对食品设施进行注册”的临时最终规则（2003年10月10日，68联邦法规58894号（临时最终规则），经一项技术修正（2004年5月24日，69联邦法规29428号）修正），并回应了针对临时最终规则中的征求意见请求所提交的评论。本最终规则确认了临时最终规则的要求，即在美国制造/加工、包装或储存供人类或动物食用的食品的国内外设施必须在2003年12月12日前向FDA注册。临时最终规则实施了2002年《公共卫生安全与生物恐怖主义防范与应对法案》（《生物恐怖主义法案》），该法案要求国内外设施在2003年12月12日前向FDA注册。本最终规则未对临时最终规则所确立的监管要求作出任何更改。
