Notice2023-01764
Practices To Prevent Unsafe Contamination of Animal Feed From Drug Carryover; Guidance for Industry; Availability
Primary source
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Published
January 30, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #272 entitled "Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover." We are issuing this final guidance to describe practices that medicated feed manufacturers can use to prevent unsafe contamination from drug carryover into a non-medicated animal feed or an animal feed containing a different approved new animal drug. Unsafe contamination of animal feed from drug carryover can pose a risk to human and animal health. This guidance replaces Compliance Policy Guides Sec. 680.500 and 680.600.
Full Text
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<title>Federal Register, Volume 88 Issue 19 (Monday, January 30, 2023)</title>
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[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5896-5897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01764]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0173]
Practices To Prevent Unsafe Contamination of Animal Feed From
Drug Carryover; 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, Agency, or we) is
announcing the availability of a final guidance for industry #272
entitled ``Practices to Prevent Unsafe Contamination of Animal Feed
from Drug Carryover.'' We are issuing this final guidance to describe
practices that medicated feed manufacturers can use to prevent unsafe
contamination from drug carryover into a non-medicated animal feed or
an animal feed containing a different approved new animal drug. Unsafe
contamination of animal feed from drug carryover can pose a risk to
human and animal health. This guidance replaces Compliance Policy
Guides Sec. 680.500 and 680.600.
DATES: The announcement of the guidance is published in the Federal
Register on January 30, 2023.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-0173 for ``Practices to Prevent Unsafe Contamination of
Animal Feed from Drug Carryover.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Kevin Klommhaus, Center for Veterinary
Medicine (HFV-236), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 515-378-8075, <a href="/cdn-cgi/l/email-protection#bff4dac9d6d191f4d3d0d2d2d7decaccffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="266d43504f48086d4a494b4b4e47535566404247084e4e5508414950">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 10, 2022 (87 FR 28018), FDA
published the notice of availability for draft guidance #272 entitled
``Practices to Prevent Unsafe Contamination of Animal Feed from Drug
Carryover,'' giving interested persons until August 8, 2022, to comment
on the draft guidance. FDA received two comment submissions on the
draft guidance and the comments within these submissions were
considered as the guidance was finalized. Several editorial changes
were made to improve clarity. The guidance announced in this notice
finalizes the draft guidance dated May 10, 2022.
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 ``Practices to Prevent Unsafe
Contamination of Animal Feed from Drug Carryover.'' 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
FDA concludes that this final guidance contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under
[[Page 5897]]
the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01764 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P
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