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August 12, 2004 

FDA Issues Updated Guidance for Industry on Questions and Answers Regarding Registration of Food Facilities

The U.S. Food and Drug Administration (FDA) has issued the fourth edition of the FDA's Web-based guidance for industry entitled "Questions and Answers Regarding Registration of Food Facilities." The fourth edition includes answers to new inquiries regarding the implementation of the FDA's Registration of Food Facilities Interim Final Rule (21 CFR Part 1, Subpart H) that was published on October 10, 2003. See 68 Fed. Reg. 58,894 (Oct. 10, 2003). The FDA's interim final regulation was issued to implement the Bioterrorism Act's requirement that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA by December 12, 2003. The updated guidance document can be found at the following Web site:



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