Notice2026-03772
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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Published
February 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for manufacturers of medicated animal feeds.
Full Text
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<title>Federal Register, Volume 91 Issue 37 (Wednesday, February 25, 2026)</title>
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[Federal Register Volume 91, Number 37 (Wednesday, February 25, 2026)]
[Notices]
[Pages 9285-9287]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03772]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0496]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Medicated Feeds
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the recordkeeping requirements for manufacturers
of medicated animal feeds.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 27, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 27, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2026-N-0496 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice Regulations For Medicated Feeds.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations,
Food and Drug Administration, 5001 Campus Drive, College Park, MD
20740, 240-402-5661, <a href="/cdn-cgi/l/email-protection#efbfbdaebc9b8e8989af898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this
[[Page 9286]]
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practice Regulations For Medicated Feeds--21
CFR parts 225 & 226
OMB Control Number 0910-0152 and 0910-0154--Revision
This information collection supports implementation of section 501
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
351), which governs current good manufacturing practice (CGMP) for
drugs, including medicated feeds and Type A medicated articles.
Medicated feeds are administered to animals for the prevention, cure,
mitigation, or treatment of disease or for growth promotion and feed
efficiency. A Type A medicated article is an animal feed product
containing a concentrated drug diluted with a feed carrier substance. A
Type A medicated article is intended solely for use in the manufacture
of another Type A medicated article or a Type B or Type C medicated
feed.
Under part 225, a manufacturer is required to establish, maintain,
and retain records for a medicated feed, including records to document
procedures required during the manufacturing process to assure that
proper quality control is maintained. Such records would, for example,
contain information concerning receipt and inventory of drug
components, batch production, laboratory assay results (i.e., batch and
stability testing), labels, and product distribution.
Manufacturers are required to establish, maintain, and retain
records for Type A medicated articles including records to document
procedures required under the manufacturing process to assure that
proper quality control is maintained under part 226. Type A medicated
articles which are not manufactured in accordance with these
regulations are considered adulterated under section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)).
This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
CGMP criteria in part 225 to determine whether the systems and
procedures used by manufacturers of medicated feeds are adequate to
ensure that their feeds meet the requirements of the FD&C Act as to
safety, and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required, and the recordkeeping requirements are less demanding,
for those medicated feeds for which FDA has determined that the drugs
used in their manufacture need less control.
The information collection provisions approved under OMB control
number 0910-0152 and 0910-0154 are similar in that they support FDA's
CGMP regulations for medicated feeds. Thus, with this notice, FDA
proposes to consolidate these collections of information into one OMB
control number for all reporting associated with CGMPs for medicated
feeds. FDA further proposes to consolidate all the regulations into a
summary. FDA has combined the commercial feed mills and the mixer
feeders, as the requirements for licensed medicated feedmills are the
same for commercial feed mills and mixer feeders. FDA will continue to
separate the licensed feed mills vs. the non-licensed feed mills, as
the recordkeeping requirements for non-licensed feedmills require less
burden than licensed feedmills. As with the licensed facilities, we
will combine the commercial feedmills with the mixer/feeders as the
requirements and burdens remain the same. The number of non-licensed
feedmills were updated with our current inventory data utilizing
production code for manufacturers of medicated feeds.
Because we are proposing to combine all reporting associated with
CGMPs for medicated feeds into one collection, we are consolidating the
burden under OMB control number 0910-0152 and discontinuing OMB control
number 0910-0154.
Description of Respondents: Respondents to this collection of
information are manufacturers of medicated feeds, commercial feed
mills, and licensed mixer/feeders.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)
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Noumber of
21 CFR section, activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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225.42, 225.58, 225.80, 225.102, 225.110, and 768 2919 2,241,792 .305 (18.3 minutes)....................... 683,747
225.115; Recordkeeping and maintenance of
records for components used in the manufacture
of the medicated feeds and premixes,
laboratory controls, packaging and labeling,
master formula and batch-production,
distribution records and complaint files.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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Table 2--Estimated Annual Recordkeeping Burden (Nonregistered Non-licensed Commercial Feed Mills)
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Number of
21 CFR section, activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.142, 225.158, 225.180, and 225.202; 1658 91 150,878 1.44...................................... 217,265
Recordkeeping and maintenance of records for
components used in the manufacture of the
medicated feeds and premixes, laboratory
controls, packaging and labeling, production
and distribution records.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Recordkeeping Burden (Nonregistered Non-licensed Mixer/Feeders)
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Number of
21 CFR section, activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.142, 225.158, 225.180, and 225.202; 3,400 91 309,400 1.36...................................... 420,784
Recordkeeping and maintenance of records for
components used in the manufacture of the
medicated feeds and premixes, laboratory
controls, packaging and labeling, production
and distribution records.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual Recordkeeping Burden (Manufacturers of Type A Medicated Feeds)
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Number of
21 CFR section, activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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226.42, 226.58, 226.80, 226.102, 226.110, and 65 1,370 89,050 ~ 1 hour.................................. 89,050
226.115; Recordkeeping and maintenance of
records for components used in the manufacture
of the medicated premixes, laboratory
controls, packaging and labeling, master
formula and batch-production, distribution
records and complaint files.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
After review of the information collection, we have adjusted our
estimated burden of the number of CGMP for medicated feeds
recordkeepers by 2,722. The reduction accurately reflects the current
number of firms that hold a medicated feed mill license and the number
of firms that are listed in the FDA database as manufacturing with
medicated feeds and meet the definition of a commercial feed
manufacturing facility. With this update, we note a corresponding
decrease of 13,731,017 records and a decrease of 913,153 hours.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03772 Filed 2-24-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 25, 2026.
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