Food

Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507

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How to Comment

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance by May 21, 2018.

Submit electronic comments to http://www.regulations.gov to docket number FDA-2018-D-0671.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2018-D-0671.

Contains Nonbinding Recommendations

Draft-Not for Implementation

March 2018

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.

Questions?

For questions regarding this draft document as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2166.

For questions regarding this draft document as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” contact the Center for Veterinary Medicine (CVM) at 240-402-6246.

Download the Draft Guidance

Page Last Updated: 09/15/2018
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