[Federal Register Volume 83, Number 54 (Tuesday, March 20, 2018)]
[Proposed Rules]
[Pages 12143-12144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05705]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 83, No. 54 / Tuesday, March 20, 2018 / 
Proposed Rules  

[[Page 12143]]



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Business'' Definition in Parts 117 and 507: Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

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announcing the availability of a draft guidance for industry describing 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 The draft 
guidance, when finalized, will help industry subject to those rules 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.

DATES: Submit either electronic or written comments on the draft 
guidance by May 21, 2018 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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.

ADDRESSES: You may submit comments on any guidance 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: 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 draft 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 draft 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

[[Page 12144]]

Pl., Rockville, MD 20855, 240-402-6246.

SUPPLEMENTARY INFORMATION: 

I. Background

    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.''

II. Electronic Access

    Persons with access to the internet may obtain the draft 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: March 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05705 Filed 3-19-18; 8:45 am]
 BILLING CODE 4164-01-P