[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28018-28019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09939]


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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Drug Carryover; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry #272 
entitled ``Practices to Prevent Unsafe Contamination of Animal Feed 
from Drug Carryover.'' We are issuing this draft guidance to describe 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. When finalized, this guidance will replace 
Compliance Policy Guides (CPGs) Sec. 680.500 and 680.600.

DATES: Submit either electronic or written comments on the draft 
guidance by August 8, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <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 https://www.regulations.gov 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 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kevin Klommhaus, Center for

[[Page 28019]]

Veterinary Medicine (HFV-236), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 515-318-8075.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#272 entitled ``Practices to Prevent Unsafe Contamination of Animal 
Feed from Drug Carryover.'' This draft guidance contains much of the 
information found in the CPGs Sec. 680.500 ``Unsafe Contamination of 
Animal Feed from Drug Carryover'' and 680.600 ``Sequencing as a Means 
to Prevent Unsafe Drug Contamination in the Production, Storage, and 
Distribution of Feeds'' but includes updates and additional 
information. We intend to withdraw the CPGs after this guidance is 
finalized. Drug carryover generally occurs when a drug used in the 
manufacture of a batch of medicated feed, for which the drug is 
approved, gets inadvertently included in a subsequent batch of: (1) A 
non-medicated feed, (2) a different medicated feed for which the drug 
is not approved (e.g., medicated feed for another species), or (3) a 
medicated feed that contains the same drug that can result in a higher 
drug level than is stated on the labeling. This carryover can occur for 
multiple reasons, including the use of the same equipment to 
manufacture both medicated and non-medicated feed, inadequate cleanout 
practices for manufacturing and distribution equipment between 
sequential batches, or human error.
    We understand that an absolute avoidance of all batch-to-batch drug 
carryover may not be possible. However, measures can be implemented to 
avoid unsafe contamination of animal feed from drug carryover. In this 
draft guidance, unsafe contamination of an animal feed refers to a 
degree of contamination, by a drug approved for a medicated feed use, 
that poses an unacceptable risk to human or animal health. Human health 
may be at risk if humans consume a product derived from animals that 
have consumed animal feed contaminated from drug carryover and there is 
drug residue in the edible tissues of that animal (e.g., milk, meat, or 
eggs). Unsafe contamination from drug carryover in animal feed can 
impact animal health when an animal consumes the contaminated feed, 
e.g., horses consuming feed contaminated with the drug monensin. Horses 
are sensitive to ionophore drugs like monensin, and ingestion can 
result in severe illness or death.
    Our regulation ``Current Good Manufacturing Practice for Medicated 
Feeds,'' 21 CFR part 225, contains requirements for equipment cleanout 
procedures to avoid unsafe contamination of feeds with drugs (see 21 
CFR 225.65 and 225.165). In this guidance, we provide information on 
some ways to comply with these requirements to help prevent unsafe 
contamination of animal feed from drug carryover.
    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 some 
practices that can be used in feed mills manufacturing medicated feed 
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 tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft 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: May 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09939 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P