Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability, 3163-3164 [2018-01126]
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<![CDATA[
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2343]
Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a draft
guidance for industry #245 entitled
‘‘Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals.’’ This draft guidance
document, when finalized, will help
animal food facilities comply with the
requirements for hazard analysis and
risk-based preventive controls under our
regulation ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals.’’
DATES: Submit either electronic or
written comments on the draft guidance
by July 23, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on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:
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:59 Jan 22, 2018
Jkt 244001
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–
2016–D–2343 for ‘‘Hazard Analysis and
Risk-Based Preventive Controls for Food
for Animals.’’ 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
3163
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 the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jenny Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6246,
jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public (human
and animal) health by helping to ensure
the safety and security of the food
supply. FSMA enables FDA to focus
more on preventing animal food safety
problems rather than relying primarily
on reacting to problems after they occur.
Section 103 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), by adding section 418 (21
U.S.C. 350g) with requirements for
hazard analysis and risk-based
preventive controls for establishments
that are required to register as food
facilities under our regulations in 21
CFR part 1, subpart H, in accordance
with section 415 of the FD&C Act (21
U.S.C. 350d). We have established
regulations to implement the hazard
analysis and risk-based preventive
controls requirements within part 507
(21 CFR part 507).
We are announcing the availability of
a draft guidance for industry #245
entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Food for
Animals.’’ This multi-chapter draft
guidance for industry is intended to
E:\FR\FM\23JAN1.SGM
23JAN1
3164
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
explain how to comply with the
requirements for hazard analysis and
risk-based preventive controls for food
for animals under part 507. The
chapters we are announcing in this
document are as follows:
• Introduction
• Chapter One—The Food Safety Plan
• Chapter Two—Conducting a Hazard
Analysis
• Chapter Three—Hazards Associated
with the Manufacturing, Processing,
Packing, and Holding of Animal Food
• Chapter Four—Preventive Controls
• Chapter Five—Overview of
Preventive Control Management
Components
We intend to announce the
availability for public comment of
additional chapters of the draft guidance
as we complete them.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on how to comply with
the hazard analysis and risk-based
preventive controls requirements for the
regulation ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals.’’ 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.
III. Paperwork Reduction Act of 1995
This draft 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 507 have been
approved under OMB control number
0910–0789.
sradovich on DSK3GMQ082PROD with NOTICES
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
17:59 Jan 22, 2018
[FR Doc. 2018–01126 Filed 1–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6702]
The Least Burdensome Provisions:
Concept and Principles; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that appeared in
the Federal Register of December 15,
2017. In the notice of availability, FDA
requested comments on the draft
guidance for industry and FDA staff
entitled ‘‘The Least Burdensome
Provisions: Concept and Principles.’’
The Agency is taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the document published
December 15, 2017 (82 FR 59623), by an
additional 30 days. Submit either
electronic or written comments on the
draft guidance by March 15, 2018, to
ensure that the Agency considers your
comment on this 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:
SUMMARY:
II. Significance of Guidance
VerDate Sep<11>2014
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Jkt 244001
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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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–6702 for ‘‘The Least
Burdensome Provisions: Concept and
Principles; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability.’’ 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
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3163-3164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01126]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2343]
Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry #245
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food
for Animals.'' This draft guidance document, when finalized, will help
animal food facilities comply with the requirements for hazard analysis
and risk-based preventive controls under our regulation ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals.''
DATES: Submit either electronic or written comments on the draft
guidance by July 23, 2018 to ensure that the Agency considers your
comment on this 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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Food for Animals.'' 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
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jenny Murphy, Center for Veterinary
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-6246, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public (human and animal) health by
helping to ensure the safety and security of the food supply. FSMA
enables FDA to focus more on preventing animal food safety problems
rather than relying primarily on reacting to problems after they occur.
Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with
requirements for hazard analysis and risk-based preventive controls for
establishments that are required to register as food facilities under
our regulations in 21 CFR part 1, subpart H, in accordance with section
415 of the FD&C Act (21 U.S.C. 350d). We have established regulations
to implement the hazard analysis and risk-based preventive controls
requirements within part 507 (21 CFR part 507).
We are announcing the availability of a draft guidance for industry
#245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for
Food for Animals.'' This multi-chapter draft guidance for industry is
intended to
[[Page 3164]]
explain how to comply with the requirements for hazard analysis and
risk-based preventive controls for food for animals under part 507. The
chapters we are announcing in this document are as follows:
Introduction
Chapter One--The Food Safety Plan
Chapter Two--Conducting a Hazard Analysis
Chapter Three--Hazards Associated with the Manufacturing,
Processing, Packing, and Holding of Animal Food
Chapter Four--Preventive Controls
Chapter Five--Overview of Preventive Control Management
Components
We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on how to
comply with the hazard analysis and risk-based preventive controls
requirements for the regulation ``Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Food for
Animals.'' 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.
III. Paperwork Reduction Act of 1995
This draft 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 507 have been approved under OMB
control number 0910-0789.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm 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 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01126 Filed 1-22-18; 8:45 am]
BILLING CODE 4164-01-P
