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GAO-05-216R 1 (2004-12-22)

handle is hein.gao/gaobadwlx0001 and id is 1 raw text is: I Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 B-295520 December 22, 2004 The Honorable Judd Gregg Chairman The Honorable Edward M. Kennedy Ranking Minority Member Committee on Health, Education, Labor and Pensions United States Senate The Honorable Joe Barton Chairman The Honorable John D. Dingell Ranking Minority Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and DrugAdministration: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA), entitled Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (RIN: 0910-AC39). We received the rule on December 9, 2004. It was published in the Federal Register as a final rule on December 9, 2004. 69 Fed. Reg. 71562. The final rule requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. The rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to help address credible threats of serious adverse health consequences or death to humans and animals. Enclosed is our assessment of the FDA's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review indicates that FDA complied with the applicable requirements. GAO-05-216R

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