Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability
other · Food and Drug Administration · Rule · Published 2019-06-21 · 84 FR 29054
Document
Document number
2019-13223
Federal Register citation
84 FR 29054
CFR reference
21 CFR 117
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2019-06-21
HHS docket
Docket No. FDA-2018-D-0671
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the "small business" definition in the current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the "small business" definition.