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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA export rule stayed: Agency will delay implementation of the final rule on export notification and recordkeeping requirements until June 19, according to a 1May 14 Federal Register notice. Issued in December 2001, the rule was scheduled to take effect in March (2"The Gray Sheet" Dec. 24, 2001, p 4). Three petitions and one letter stating that "certain parties would be unable to comply by the original March 19 effective date and that some parties were confused as to the final rule's applicability to certain products," prompted the agency's decision to stay the rule. The rule implements provisions of FDA's Export Reform & Enhancement Act of 1996...

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