美国FDA 指导原则 新冠肺炎突发公共卫生事件中有条件豁免《人类消费产品种植、收获、包装、持有标准》的暂行政策工业指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Guidance for Industry May 2020 This guidance is intended to remain in effect until November 7, 2023. For further information, refer to 88 FR 15417, March 13, 2023. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition Contains Nonbinding Recommendations Preface Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or the Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with statutory requirement and the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the docket number FDA-2020-D-1386 and complete title of the guidance in the request. Additional Copies Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance Docum