Source: https://www.federalregister.gov/documents/2018/03/20/2018-05705/determining-the-number-of-employees-for-purposes-of-the-small-business-definition-in-parts-117-and
Timestamp: 2018-04-22 18:49:54
Document Index: 483806380

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

Federal Register :: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability
Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability
A Proposed Rule by the Food and Drug Administration on 03/20/2018
This document has a comment period that ends in 29 days. (05/21/2018) Submit a formal comment
Submit either electronic or written comments on the draft guidance by May 21, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
12143-12144 (2 pages)
https://www.federalregister.gov/d/2018-05705 https://www.federalregister.gov/d/2018-05705
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the “small business” definition in the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 The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the “small business” definition.
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: 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 between9 a.m. and 4 p.m., Monday through Friday.
For questions relating to CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Start Printed Page 12144Pl., Rockville, MD 20855, 240-402-6246.
We are announcing the availability of a draft guidance for industry entitled “Determining the Number of Employees for Purposes of the `Small Business' Definition in Parts 117 and 507: Guidance for Industry.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft 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 (Pub. L. 111-353). These two regulations are 21 CFR part 117 (part 117) (published in the Federal Register on September 17, 2015, 80 FR 55907) and 21 CFR part 507 (part 507) (published in the Federal Register on September 17, 2015, 80 FR 56170). 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 will provide additional information to assist businesses in determining their status as a “small business.”
[FR Doc. 2018-05705 Filed 3-19-18; 8:45 am]