Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability, 598-600 [2018-00050]
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Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations
3. Will not affect intrastate aviation in
Alaska; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
center fuselage, which could result in
reduced structural integrity of the airplane.
List of Subjects in 14 CFR Part 39
(g) Required Action(s)
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
2018–01–05 Fokker Services B.V.:
Amendment 39–19146; Docket No.
FAA–2017–1182; Product Identifier
2013–NM–093–AD.
(a) Effective Date
This AD becomes effective January 22,
2018.
(b) Affected ADs
None.
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(c) Applicability
This AD applies to Fokker Services B.V.
Model F28 Mark 0070 and 0100 airplanes,
certificated in any category, having serial
numbers 11268 through 11283 inclusive,
11286, 11289, 11291, 11293, 11295, 11300,
11303, 11306, 11308, 11310, 11312 through
11314 inclusive, 11316, 11318, 11321, 11323
through 11335 inclusive, 11337, 11338,
11340, 11345, 11349, 11352 through 11361
inclusive, 11365 through 11367 inclusive,
11369, 11370, 11372, 11373, 11376 through
11380 inclusive, 11387, 11388, 11391, 11395,
11397, 11399, 11404, 11405, 11407, 11411
through 11419 inclusive, 11425 through
11428 inclusive, 11432, 11435 through 11439
inclusive, 11444 through 11450 inclusive,
11456 through 11460 inclusive, 11464
through 11469 inclusive. and 11475 through
11585 inclusive.
(d) Subject
Air Transport Association (ATA) of
America Code 53, Fuselage.
16:04 Jan 04, 2018
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Within 30 days after the effective date of
this AD, request instructions from the
Manager, International Section, Transport
Standards Branch, FAA, to address the
unsafe condition specified in paragraph (e) of
this AD; and accomplish the actions at the
times specified in, and in accordance with,
those instructions. Guidance can be found in
Mandatory Continuing Airworthiness
Information (MCAI) European Aviation
Safety Agency (EASA) AD 2013–0102, dated
May 2, 2013.
The Manager, International Section,
Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the International Section, send it to the
attention of the person identified in
paragraph (i)(2) of this AD. Information may
be emailed to: 9-ANM-116-AMOCREQUESTS@faa.gov. Before using any
approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office.
(i) Related Information
(1) Refer to MCAI EASA AD 2013–0102,
dated May 2, 2013, for related information.
You may examine the MCAI on the internet
at https://www.regulations.gov by searching
for and locating Docket No. FAA–2017–1182.
(2) For more information about this AD,
contact Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards
Branch, FAA, 1601 Lind Avenue SW,
Renton, WA 98057–3356; telephone: 425–
227–1137; fax: 425–227–1149.
(j) Material Incorporated by Reference
None.
Issued in Renton, Washington, on
December 26, 2017.
John P. Piccola, Jr.,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2017–28487 Filed 1–4–18; 8:45 am]
(e) Reason
This AD was prompted by an evaluation by
the design approval holder (DAH) indicating
that the fuselage frames are subject to
widespread fatigue damage (WFD). We are
issuing this AD to prevent cracking of the
VerDate Sep<11>2014
Comply with this AD within the
compliance times specified, unless already
done.
(h) Alternative Methods of Compliance
(AMOCs)
■
§ 39.13
(f) Compliance
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 11, 16, 106, 110, 111,
112, 114, 117, 120, 123, 129, 179, 211,
and 507
[Docket No. FDA–2017–N–6908]
Policy Regarding Certain Entities
Subject to the Current Good
Manufacturing Practice and Preventive
Controls, Produce Safety, and/or
Foreign Supplier Verification
Programs; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled ‘‘Policy
Regarding Certain Entities Subject to the
Current Good Manufacturing Practice
and Preventive Controls, Produce
Safety, and/or Foreign Supplier
Verification Programs.’’ This guidance
states agency compliance policy
regarding certain entities and/or
activities related to the ‘‘farm’’
definition, written assurances, food
contact substances, and human food byproducts for use as animal food.
DATES: The announcement of the
guidance is published in the Federal
Register on January 5, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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.
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• 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–N–6908 for ‘‘Enforcement Policy
for Certain Entities Subject to
Requirements in the CGMP and
Preventive Controls Regulations, the
Produce Safety Regulation, and the
Foreign Supplier Verification Programs
Regulation.’’ 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
VerDate Sep<11>2014
16:04 Jan 04, 2018
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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/201523389.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 Office of Food
Safety, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration (HFS–300), 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.
For questions relating to Foreign
Supplier Verification Programs for
Importers of Food for Humans and
Animals: Rebecca Buckner, Office of
Foods and Veterinary Medicine, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–4576.
For questions relating to Standards
for the Growing, Harvesting, Packing,
and Holding of Produce for Human
Consumption: Samir Assar, Center for
Food Safety and Applied Nutrition
(HFS–317), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘Policy
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599
Regarding Certain Entities Subject to the
Current Good Manufacturing Practice
and Preventive Controls, Produce
Safety, and/or Foreign Supplier
Verification Programs: Guidance for
Industry.’’ We are issuing the guidance
consistent with our good guidance
practices regulation (21 CFR 10.115). In
accordance with § 10.115(g)(2), we are
implementing the guidance immediately
because we have determined that prior
public participation is not feasible or
appropriate. Although the guidance
document is immediately in effect, FDA
will accept comments at any time. The
guidance is not subject to Executive
Order 12866.
This guidance document concerns
four of the seven foundational rules 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 (FSMA;
Pub. L. 111–353). The four final rules
are entitled ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food’’ (published
in the Federal Register of September 17,
2015, 80 FR 55908) (https://
www.fda.gov/food/guidanceregulation/
fsma/ucm334115.htm) (part 117);
‘‘Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals’’ (published in the Federal
Register of September 17, 2015, 80 FR
51670) (https://www.fda.gov/food/
guidanceregulation/fsma/
ucm366510.htm) (part 507); ‘‘Foreign
Supplier Verification Programs for
Importers of Food for Humans and
Animals’’ (published in the Federal
Register of November 27, 2015, 80 FR
74226) (https://www.fda.gov/food/
guidanceregulation/fsma/
ucm361902.htm) (FSVP regulation); and
‘‘Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption’’ (published in the
Federal Register of November 27, 2015,
80 FR 74354) (https://www.fda.gov/
food/guidanceregulation/fsma/
ucm334114.htm) (produce safety
regulation or part 112).
In the guidance, we state compliance
policy for certain entities and/or
activities under these four rules:
• Specific facilities subject to part 117
and/or part 507:
Æ Certain facilities that would qualify
as secondary activities farms except for
the ownership of the facility (e.g.,
certain produce packinghouses and
warehouses, egg packinghouses, grain
elevators, cotton ginners);
Æ Facilities that would qualify as
farms if they did not color RACs;
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Æ Facilities that would qualify as
secondary activities farms except that
they pack, package, label, and/or hold
processed food that consists only of
RACs that have been dried/dehydrated
to create a distinct commodity (e.g.,
dried beans);
Æ Farm mixed-type facilities making
silage food for animals;
• Written assurances under the
‘‘customer provisions’’ in part 117 and
related rules;
• Importation of food contact
substances under the FSVP regulation;
and
• Certain human food by-products for
use as animal food, with regard to
certain requirements under part 507.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 117 have been approved under
OMB control number 0910–0751. The
collections of information in part 507
have been approved under OMB control
number 0910–0789. The collections of
information in 21 CFR part 1, subpart L
have been approved under OMB control
number 0910–0752. The collections of
information in part 112 have been
approved under OMB control number
0910–0816.
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: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00050 Filed 1–4–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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21 CFR Part 892
[Docket No. FDA–2017–N–6539]
Medical Devices; Radiology Devices;
Classification of the Absorbable
Perirectal Spacer
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the absorbable perirectal
spacer into class II (special controls).
The special controls that apply to the
device type are identified in this order
and will be part of the codified language
for the absorbable perirectal spacer’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective January 5,
2018. The classification was applicable
on April 1, 2015.
FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
absorbable perirectal spacer as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness. In
addition, we believe this action will
enhance patients’ access to beneficial
innovation, in part by reducing
regulatory burdens by placing the
device into a lower device class than the
automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
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does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically placed within class III,
the De Novo classification is considered
to be the initial classification of the
device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application in order to market
a substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
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]]>Agencies
[Federal Register Volume 83, Number 4 (Friday, January 5, 2018)]
[Rules and Regulations]
[Pages 598-600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00050]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123,
129, 179, 211, and 507
[Docket No. FDA-2017-N-6908]
Policy Regarding Certain Entities Subject to the Current Good
Manufacturing Practice and Preventive Controls, Produce Safety, and/or
Foreign Supplier Verification Programs; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Policy Regarding
Certain Entities Subject to the Current Good Manufacturing Practice and
Preventive Controls, Produce Safety, and/or Foreign Supplier
Verification Programs.'' This guidance states agency compliance policy
regarding certain entities and/or activities related to the ``farm''
definition, written assurances, food contact substances, and human food
by-products for use as animal food.
DATES: The announcement of the guidance is published in the Federal
Register on January 5, 2018.
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.
[[Page 599]]
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-N-6908 for ``Enforcement Policy for Certain Entities Subject
to Requirements in the CGMP and Preventive Controls Regulations, the
Produce Safety Regulation, and the Foreign Supplier Verification
Programs Regulation.'' 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 Office
of Food Safety, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-300), 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.
For questions relating to Foreign Supplier Verification Programs
for Importers of Food for Humans and Animals: Rebecca Buckner, Office
of Foods and Veterinary Medicine, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.
For questions relating to Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption: Samir Assar,
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Policy Regarding Certain Entities Subject to the Current
Good Manufacturing Practice and Preventive Controls, Produce Safety,
and/or Foreign Supplier Verification Programs: Guidance for Industry.''
We are issuing the guidance consistent with our good guidance practices
regulation (21 CFR 10.115). In accordance with Sec. 10.115(g)(2), we
are implementing the guidance immediately because we have determined
that prior public participation is not feasible or appropriate.
Although the guidance document is immediately in effect, FDA will
accept comments at any time. The guidance is not subject to Executive
Order 12866.
This guidance document concerns four of the seven foundational
rules 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 (FSMA; Pub. L. 111-353). The four final rules
are entitled ``Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Human Food'' (published in the
Federal Register of September 17, 2015, 80 FR 55908) (https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm) (part 117);
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals'' (published in the Federal
Register of September 17, 2015, 80 FR 51670) (https://www.fda.gov/food/guidanceregulation/fsma/ucm366510.htm) (part 507); ``Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals''
(published in the Federal Register of November 27, 2015, 80 FR 74226)
(https://www.fda.gov/food/guidanceregulation/fsma/ucm361902.htm) (FSVP
regulation); and ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption'' (published in the Federal
Register of November 27, 2015, 80 FR 74354) (https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm) (produce safety regulation or
part 112).
In the guidance, we state compliance policy for certain entities
and/or activities under these four rules:
Specific facilities subject to part 117 and/or part 507:
[cir] Certain facilities that would qualify as secondary activities
farms except for the ownership of the facility (e.g., certain produce
packinghouses and warehouses, egg packinghouses, grain elevators,
cotton ginners);
[cir] Facilities that would qualify as farms if they did not color
RACs;
[[Page 600]]
[cir] Facilities that would qualify as secondary activities farms
except that they pack, package, label, and/or hold processed food that
consists only of RACs that have been dried/dehydrated to create a
distinct commodity (e.g., dried beans);
[cir] Farm mixed-type facilities making silage food for animals;
Written assurances under the ``customer provisions'' in
part 117 and related rules;
Importation of food contact substances under the FSVP
regulation; and
Certain human food by-products for use as animal food,
with regard to certain requirements under part 507.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 117 have been approved under OMB
control number 0910-0751. The collections of information in part 507
have been approved under OMB control number 0910-0789. The collections
of information in 21 CFR part 1, subpart L have been approved under OMB
control number 0910-0752. The collections of information in part 112
have been approved under OMB control number 0910-0816.
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: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00050 Filed 1-4-18; 8:45 am]
BILLING CODE 4164-01-P
