[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Rules and Regulations]
[Pages 29054-29055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13223]



[[Page 29054]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

[Docket No. FDA-2018-D-0671]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: 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.

DATES: The announcement of the guidance is published in the Federal 
Register on June 21, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 FURTHER INFORMATION CONTACT: 
    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.
    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 Pl., Rockville, MD 20855, 240-402-6246.

SUPPLEMENTARY INFORMATION:

I. Background

    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

[[Page 29055]]

Title 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.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13223 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P


