Health and Human Services Department Docket FDA-2018-D-0671 Proposed Rule

2018-05705: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the "small business" definition in the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, Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the "small business" definition.

The agency’s own summary, as published.

What this changes

Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

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