Source: https://www.federalregister.gov/documents/2019/06/21/2019-13223/determining-the-number-of-employees-for-purposes-of-the-small-business-definition-current-good
Timestamp: 2019-08-20 19:22:18
Document Index: 236978478

Matched Legal Cases: ['arts 117', 'arts 117', 'art 117', 'art 117', 'art 507', 'art 507', 'arts 117', 'arts 117', 'arts 117']

Federal Register :: 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
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
A Rule by the Food and Drug Administration on 06/21/2019
The announcement of the guidance is published in the Federal Register on June 21, 2019.
84 FR 29054
29054-29055 (2 pages)
Docket No. FDA-2018-D-0671
2019-13223
https://www.federalregister.gov/d/2019-13223 https://www.federalregister.gov/d/2019-13223
Start Preamble Start Printed Page 29054
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.
Instructions: All submissions received must include the Docket No. FDA-2018-D-0671 for “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 Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Submit written requests for single copies of the guidance to the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.
For questions relating to CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
We are announcing the availability of a guidance for industry entitled “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 Industry.” We are issuing the guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA 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. This guidance is not subject to Executive Order 12866.
This guidance concerns two regulations that we have established in Start Printed Page 29055Title 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 (21 CFR part 117) (September 17, 2015, 80 FR 55907) and part 507 (21 CFR part 507) (September 17, 2015, 80 FR 51670). Under parts 117 and 507, whether a business is a “small business” has two main implications. First, certain small businesses are exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Second, small businesses have later compliance dates for parts 117 and 507 than larger businesses. This guidance provides additional information to assist businesses in determining their status as a “small business.”
In the Federal Register of March 20, 2018 (83 FR 12143), we made available a draft guidance for industry entitled “Determining the Number of Employees for Purposes of the `Small Business' Definition in Parts 117 and 507: Guidance for Industry” and gave interested parties an opportunity to submit comments by May 21, 2018, for us to consider before beginning work on the final version of the guidance. We received no substantive comments on the draft guidance and are issuing the guidance with editorial changes to improve clarity and revision of one example to improve usefulness. The guidance announced in this notice finalizes the draft guidance dated March 2018.
[FR Doc. 2019-13223 Filed 6-20-19; 8:45 am]