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GAO-04-193R 1 (2003-10-23)

handle is hein.gao/gaobadwjl0001 and id is 1 raw text is: im Accountability * Integrity * Reliability United States General Accounting Office Washington, DC 20548 B-293038 October 23, 2003 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 W.J. Billy Tauzin 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: Registration of Food Facilities 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 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (RIN: 0910-AC40). We received the rule on October 10, 2003. It was published in the Federal Register as an interim final rule on October 10, 2003. 68 Fed. Reg. 58894. The interim final rule requires domestic and foreign facilities that manufacture/ process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003. The interim final rule implements the Public Health Security and Bioterrorism Preparedness Act of 2002. 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 the FDA complied with the applicable requirements. If you have any questions about this report, please contact James W. Vickers, Assistant General Counsel, at (202) 512-8210. The official responsible for GAO evaluation work relating to the subject matter of the rule is Robert Robinson, GAO-04-193R

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