FDA Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
标准简介
Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507[附网盘链接]](/img/202109141037130toit.jpg)
标准文档说明
标准文档类型为Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food): Guidance for 1
Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction The purpose of this guidance is to help industry subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine the number of employees for purposes of the “small business” definition under parts 117 and 507. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background This guidance concerns two regulations that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111–353). These two regulations are part 117 (published in 1
This guidance has been jointly prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of Food Policy and Response at the U.S. Food and Drug Administration. 3
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