83 FR 12143 - Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 54 (March 20, 2018)

Page Range		12143-12144
FR Document		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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the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 The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the ``small business'' definition.

Federal Register, Volume 83 Issue 54 (Tuesday, March 20, 2018)

[Federal Register Volume 83, Number 54 (Tuesday, March 20, 2018)]
[Proposed Rules]
[Pages 12143-12144]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05705]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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Business'' Definition in Parts 117 and 507: Draft Guidance for 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announcing the availability of a draft guidance for industry describing 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.thefederalregister.org/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

12144 Federal Register / Vol. 83, No. 54 / Tuesday, March 20, 2018 / Proposed Rules

Pl., Rockville, MD 20855, 240–402– DEPARTMENT OF HOMELAND II. Background, Purpose, and Legal
6246. SECURITY Basis
SUPPLEMENTARY INFORMATION:
Under the authority provided in 14
Coast Guard
U.S.C. 85, 43 U.S.C. 1333, and
I. Background Department of Homeland Security
33 CFR Part 147
Delegation No. 0170.1(90), Title 33, CFR
We are announcing the availability of 147.1, 147.5, and 147.10 permit the
a draft guidance for industry entitled [Docket Number USCG–2017–0446] establishment of safety zones for
‘‘Determining the Number of Employees facilities located on the Outer
for Purposes of the ‘Small Business’ RIN 1625–AA00 Continental Shelf (OCS) for the purpose
Definition in Parts 117 and 507: of protecting life and property on the
Guidance for Industry.’’ We are issuing Safety Zone; Appomattox FPS, facilities, their appurtenances and
the draft guidance consistent with our Mississippi Canyon 437, Outer attending vessels, and on the adjacent
good guidance practices regulation (21 Continental Shelf on the Gulf of Mexico waters within the safety zones.
CFR 10.115). The draft guidance, when AGENCY: Coast Guard, DHS. The safety zone proposed by this
finalized, will represent the current rulemaking is on the OCS in the
ACTION: Notice of proposed rulemaking.
thinking of FDA on this topic. It does deepwater area of the Gulf of Mexico at
not establish any rights for any person SUMMARY: The Coast Guard proposes to Mississippi Canyon Block 437. The area
and is not binding on FDA or the public. establish a safety zone around the for the safety zone would be 500 meters
You can use an alternate approach if it Appomattox Floating Production (1640.4 feet) from each point on the
satisfies the requirements of the System (FPS) facility located in facility, which is located at 28°34′25.47″
applicable statutes and regulations. This Mississippi Canyon Block 437 on the N, 87°56′03.11″ W. The deepwater area
guidance is not subject to Executive Outer Continental Shelf (OCS) in the would be considered to be waters of
Order 12866. Gulf of Mexico. The purpose of the 304.8 meters (1,000 feet) or greater
safety zone is to protect the facility from depth extending to the limits of the
This draft guidance concerns two Exclusive Economic Zone (EEZ)
regulations that we have established in all vessels operating outside the normal
shipping channels and fairways that are contiguous to the territorial sea of the
Title 21 of the Code of Federal United States and extending to a
Regulations (21 CFR) as part of our not providing services to or working
with the facility. Placing a safety zone distance up to 200 nautical miles from
implementation of the FDA Food Safety the baseline from which the breadth of
around the facility will significantly
Modernization Act (Pub. L. 111–353). the sea is measured. The deepwater area
reduce the threat of allisions, collisions,
These two regulations are 21 CFR part would also include an extensive system
oil spills, and releases of natural gas,
117 (part 117) (published in the Federal of fairways. Navigation in the vicinity of
and thereby protect the safety of life,
Register on September 17, 2015, 80 FR property, and the environment. We the safety zone consists of large
55907) and 21 CFR part 507 (part 507) invite your comments on this proposed commercial shipping vessels, fishing
(published in the Federal Register on rulemaking. vessels, cruise ships, tugs with tows and
September 17, 2015, 80 FR 56170). the occasional recreational vessels. The
DATES: Comments and related material
Under parts 117 and 507, whether a establishment of this safety zone will
must be received by the Coast Guard on
business is a ‘‘small business’’ has two not interfere with these vessels’
or before April 19, 2018.
main implications. First, certain small navigation in the area.
businesses are exempt from the human ADDRESSES: You may submit comments
identified by docket number USCG– III. Discussion of Proposed Rule
food preventive controls requirements
and the animal food preventive controls 2017–0446 using the Federal Shell Exploration and Production Co.
requirements if they are engaged only in eRulemaking Portal at http:// requested that an OCS safety zone
www.regulations.gov. See the ‘‘Public extending 500 meters from each point
specified low-risk activity/food
Participation and Request for on the Appomattox Floating Production
combinations. Second, small businesses
Comments’’ portion of the System (FPS) facility structure’s
have later compliance dates for parts
SUPPLEMENTARY INFORMATION section for outermost edge be established. There are
117 and 507 than larger businesses. This further instructions on submitting
guidance will provide additional safety concerns for both the personnel
comments. aboard the facility and the environment.
information to assist businesses in
determining their status as a ‘‘small FOR FURTHER INFORMATION CONTACT: If The District Commander has
you have questions about this proposed determined that it was highly likely that
business.’’
rulemaking, call or email Ms. Laura any allision with the facility would
II. Electronic Access Knoll, U.S. Coast Guard, District Eight result in a catastrophic event. Placing a
Waterways Management Branch; safety zone around the facility will
Persons with access to the internet telephone 504–671–2139, significantly reduce the threat of
may obtain the draft guidance at either laura.b.knoll@uscg.mil. allisions, oil spills, and releases of
https://www.fda.gov/FoodGuidances or natural gas, and thereby protect the
SUPPLEMENTARY INFORMATION:
https://www.regulations.gov. Use the safety of life, property, and the living
FDA website listed in the previous I. Table of Abbreviations marine resources.
daltland on DSKBBV9HB2PROD with PROPOSALS

sentence to find the most current In evaluating this request, the Coast
version of the guidance. CFR Code of Federal Regulations Guard explored relevant safety factors
DHS Department of Homeland Security and considered several criteria,
Dated: March 15, 2018. FPS Floating production system
FR Federal Register
including but not limited to (1) the level
Leslie Kux,
NPRM Notice of proposed rulemaking of the existing and foreseeable shipping
Associate Commissioner for Policy. activity, the presence of unusually
OCS Outer Continental Shelf
[FR Doc. 2018–05705 Filed 3–19–18; 8:45 am] § Section harmful or hazardous substances and
BILLING CODE 4164–01–P U.S.C. United States Code obstructions within 500 meters of the

VerDate Sep<11>2014 17:36 Mar 19, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\20MRP1.SGM 20MRP1

Document Created: 2018-03-20 01:10:26
Document Modified: 2018-03-20 01:10:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of availability.
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.
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.
FR Citation		83 FR 12143
CFR Citation		21 CFR 117 21 CFR 507

83 FR 12143 - Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 54 (March 20, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration