82 FR 48828 - Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 202 (October 20, 2017)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 507; Draft Guidance for Industry.'' The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are ``solely engaged'' in certain activities. Establishments and facilities ``solely engaged'' in certain activities are exempt from some or all requirements of the regulations.

[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48828-48830]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 [Docket No. FDA-2017-D-6133]


Application of the ``Solely Engaged'' Exemptions in Parts 117 and 
507; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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[[Page 48829]]

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 
507; Draft Guidance for Industry.'' The draft guidance, when finalized, 
will help establishments and facilities subject to certain FDA 
regulations determine whether they are ``solely engaged'' in certain 
activities. Establishments and facilities ``solely engaged'' in certain 
activities are exempt from some or all requirements of the regulations.

DATES: Submit either electronic or written comments on the draft 
guidance by April 18, 2018, to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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-2017-D-6133 for ``Application of the ``Solely Engaged'' Exemptions 
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 office 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 Office of Food Safety (HFS-300), 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 the guidance 
as it applies to human food: Jenny Scott, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2166. For questions relating to the 
guidance as it applies to animal food: Jeanette Murphy, Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6246.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 
117 and 507.'' 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 the 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 guidance concerns two regulations that we have established in 
Title 21 of the Code of Federal Regulations as part of our 
implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 
111-353). These two regulations are part 117 (published in the Federal 
Register on September 17, 2015, 80 FR 55908 and part 507 (published in 
the Federal Register on September 17, 2015, 80 FR 56170). This guidance 
is intended to help establishments and facilities subject to part 117 
or part 507 determine whether they are ``solely engaged'' in certain 
activities. Establishments and facilities ``solely engaged'' in certain 
activities are exempt from some or all requirements in parts 117 or 
507.
    Parts 117 and 507 contain exemptions specific to establishments and 
facilities ``solely engaged'' in certain activities. The relevant 
exemptions can be categorized as follows: (1) Exemption from human food 
current good manufacturing practice (CGMP) requirements, (2) exemption 
from human food preventive controls

[[Page 48830]]

requirements, (3) exemption from animal food CGMP requirements, and (4) 
exemption from animal food preventive controls requirements.
    This draft guidance, when finalized, will clarify that if all of 
the activities performed by an establishment are exempt under one or 
more CGMP exemptions, then the establishment is not subject to the part 
117 and/or part 507 CGMPs, as applicable. If all the activities 
performed by a facility are exempt under one or more preventive 
controls exemptions, then the facility is not subject to the part 117 
and/or part 507 preventive controls requirements, as applicable. If all 
the activities performed by a facility are exempt under one or more 
CGMP exemptions and one or more preventive controls exemptions, then 
the facility is not subject to the CGMP or preventive controls 
requirements in part 117 and/or part 507, as applicable.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm (whichever is applicable) or https://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: October 16, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22731 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P