Fed Regist. 1999 May 17;64(94):26657.
The Food and Drug Administration (FDA) published in the Federal Register of January 5, 1999 (64 FR 396), a direct final rule. The direct final rule amended FDA's regulations by removing references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. The direct final rule also removed references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. This document confirms the effective date of the direct final rule.
美国食品药品监督管理局(FDA)于1999年1月5日在《联邦公报》(第64卷,第396页)上发布了一项直接最终规则。该直接最终规则修订了FDA的法规,删除了对已废除的《联邦食品、药品和化妆品法案》(该法案)中机构认证抗生素药物的法定条款的引用。该直接最终规则还删除了对已废除的抗生素专论法规以及处理抗生素申请的法规的引用。本文确认了该直接最终规则的生效日期。