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GAO-07-1057R 1 (2007-07-06)

handle is hein.gao/gaobadwrf0001 and id is 1 raw text is: I im T I M Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 B-309689 July 6, 2007 The Honorable Edward M. Kennedy Chairman The Honorable Michael B. Enzi Ranking Minority Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable John D. Dingell Chairman The Honorable Joe Barton Ranking Minority Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and DrugAdministration: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietaiy Supplements 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 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (RIN: 0910-AB88). We received the rule on June 22, 2007. It was published in the Federal Register as a final rule on June 25, 2007. 72 Fed. Reg. 34,752. The final rule establishes the minimum current good manufacturing practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplements. The final rule is effective on August 24, 2007, 60 days after it was published in the Federal Register The compliance date is June 25, 2008. However, for businesses employing fewer than 500, but 20 or more full-time equivalent employees, the compliance date is June 25, 2009, and for businesses that employ fewer than 20 full-time equivalent employees, the compliance date is June 25, 2010. FDA also issued an interim final rule, published in the Federal Register on June 25, 2007, that sets forth a procedure for requesting an exception to a CGMP requirement in the final rule. 72 Fed. Reg. 34,959. This interim final rule is not a major rule under section 804(2) of title 5, United States Code. GAO-07-1057R

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