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This article was originally published in The Gray Sheet

Executive Summary

Effective date of FDA's direct-to-final rule eliminating reporting requirements for distributors is delayed until Feb. 22, 1999. Originally scheduled to take effect Dec. 21, implementation of the reg is being postponed because FDA "has not yet received approval under the Paperwork Reduction Act" from the Office of Management and Budget for the reg's information collection requirements, FDA explains in the Nov. 18 Federal Register. FDA first published the rule, which the agency says received no significant adverse comment, in August ("The Gray Sheet" Aug. 10, In Brief)
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