[Federal Register Volume 87, Number 130 (Friday, July 8, 2022)]
[Notices]
[Pages 40846-40847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14567]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-0388]
Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #245 entitled
``Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals.'' This final guidance document is intended to 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.'' The guidance announced in this notice
finalizes the draft guidance of the same title dated January 23, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on July 8, 2022.
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.
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-0388 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
[[Page 40847]]
a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 guidance document.
FOR FURTHER INFORMATION CONTACT: Jennifer Erickson, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-7382,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 23, 2018 (83 FR 3163) and a
correction in the Federal Register of February 5, 2018 (83 FR 5106),
FDA published the notice of availability for a draft guidance #245
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food
for Animals,'' giving interested persons until July 23, 2018, to
comment on the draft guidance. FDA received numerous comments on the
draft guidance and those comments were considered as the guidance was
finalized. We have made some changes and updates. First, we removed
Appendix E: ``Aid to Identifying Animal Food Hazards'' based on
comments questioning how it should be used and concerns about how to
distinguish whether a listed hazard is known or reasonably foreseeable
for a facility, specific ingredient, or type of animal food. Second, we
provided additional clarity, based on comments, that not all the known
or reasonably foreseeable hazard examples in the guidance are
applicable to all animal food. Third, we included additional examples
of certain hazards in animal food, preventive controls, and situations
that would require a reanalysis of a food safety plan. Fourth, we
updated some of the references used throughout the guidance. Lastly,
editorial and formatting changes were made to improve clarity and
consistency. The guidance announced in this notice finalizes the draft
guidance dated January 23, 2018.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 507 have been approved under OMB Control
No. 0910-0751.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14567 Filed 7-6-22; 8:45 am]
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