Notice2025-18615
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46217-46218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0354]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Prohibited
From Use in Animal Food or Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 27, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0339. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#603032213314010606200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="f2a2a0b3a186939494b2949693dc9a9a81dc959d84">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Substances Prohibited From Use in Animal Food or Feed
OMB Control Number 0910-0339--Revision
This information collection supports implementation of statutory
and regulatory requirements. Epidemiological evidence gathered in the
United Kingdom has suggested that bovine spongiform encephalopathy
(BSE), a progressively degenerative central nervous system disease, is
spread to ruminant animals by feeding protein derived from ruminants
infected with BSE. Agency regulation at Sec. 589.2000 (21 CFR
589.2000), authorized by section 701(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)), provides that animal
protein derived from mammalian tissue (with some exclusions) is not
generally recognized as safe (GRAS) for use in ruminant feed and is a
food additive subject to certain provisions of the FD&C Act (62 FR
30936, June 5, 1997). The regulation places general requirements on
persons that manufacture, blend, process, and distribute products that
contain, or may contain, protein derived from mammalian tissue, and
feeds made from such products.
Specifically, Sec. 589.2000(e)(1)(iv) requires renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution to maintain written procedures
specifying the cleanout procedures or other means and specifying the
procedures for separating products that contain or may contain protein
derived from mammalian tissue from all other protein products from the
time of receipt until the time of shipment. These written procedures
are intended to help the firm formalize consistent processes, and then
to help inspection personnel confirm that the firm is conducting these
processes in compliance with the regulation. Inspection personnel will
evaluate the written procedure and confirm it is being followed when
they are conducting an inspection. These written procedures must be
maintained if the facility is operating in a manner that necessitates
the record, and if the facility makes changes to an applicable
procedure or process, the record must be updated. Consistent with Sec.
589.2000(h), written procedures shall be made available for inspection
and copying by FDA, and records made available for inspection and
copying by FDA must be retained for 1 year.
Description of Respondents: Respondents include renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution.
In the Federal Register of September 2, 2025, 90 FR 27630, we
published a 60-day notice soliciting public comment on the proposed
collection of information. Two comments were received but did not
respond to the information collection topics solicited under 5 CFR
1320.8(d)(2). We also note an inadvertent calculation error which we
have corrected.
[[Page 46218]]
At the same time, on our own initiative and for efficiency of
Agency operations, we are revising the information collection to
include related activity currently approved and accounted for in OMB
control no. 0910-0627. Specifically, our regulation at 21 CFR 589.2001
is designed to safeguard against the establishment and amplification of
BSE in the United States through animal feed. The regulation prohibits
the use of certain cattle origin materials in the food or feed of all
animals. These materials are referred to as ``cattle materials
prohibited in animal feed'' or CMPAF. Under Sec. 589.2001, no animal
feed or feed ingredient can contain CMPAF. As a result, we impose
requirements to maintain adequate written procedures and recordkeeping
on renderers that receive, manufacture, process, blend, or distribute
raw material from cattle and to make these records available for
inspection and copying by FDA to demonstrate they are taking measures
to ensure that CMPAF is not introduced into animal feed.
Additionally, under Sec. 589.2001(f), we may designate a country
from which cattle materials are not considered CMPAF. A country seeking
to be so designated must send a written request to the Director of the
Center for Veterinary Medicine, including certain required information.
We use the information provided to determine whether to grant a request
for designation and to impose conditions if a request is granted.
Designated countries will be subject to our future review to determine
whether their designations remain appropriate. As part of this process,
we may ask designated countries at any time to confirm that their BSE
situation and the information submitted by them in support of their
original application remains unchanged. We may revoke a country's
designation if we determine that it is no longer appropriate.
Therefore, designated countries may respond to our periodic requests by
submitting information to confirm their designations remain
appropriate.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
21 CFR 589--Substances Prohibited From Number of records per annual per Total
Use in Animal Food or Feed recordkeepers recordkeeper records recordkeeping hours
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Written procedures (prohibited animal 150 1 150 12 1,800
proteins); 589.2000(e)(1)(iv)...........
Exemption designation requests & response 1 2 2 33 66
to FDA; 589.2001(f).....................
Written procedures (prohibited materials 145 1 145 45 6,525
to prevent BSE) & maintenance of records
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Total................................ ............... .............. 297 .............. 8,391
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We characterize all collection activity as recordkeeping noting
that a recordkeeping requirement, as defined by 5 CFR 1320.3(m),
includes the requirement to retain, disclose, and report the
information, including reporting the information to the Federal
government.
We base our estimate of the number of recordkeepers on inspectional
data. Upon evaluation, we have adjusted our burden estimate to reflect
a decrease of 1,350 hours annually to the currently approved burden
applicable to prohibited animal protein records required by 21 CFR
589.2000. Review of our inspection data suggests that the number of
facilities that need to conduct these separation practices is gradually
decreasing. These facilities are well aware of the requirements
established in the BSE rule (<a href="https://www.fda.gov/food/hfp-constituent-updates/fda-announces-final-rule-bovine-spongiform-encephalopathy">https://www.fda.gov/food/hfp-constituent-updates/fda-announces-final-rule-bovine-spongiform-encephalopathy</a>).
Compliance with the rule's requirements also helps facilitate
compliance with the requirements of the Food Safety Modernization Act
Preventive Controls in Animal Food rule (<a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food</a>) requiring every firm to have a written food safety plan.
The written procedure required by the BSE rule could be used as part of
a facility's food safety plan. Regardless, the number of facilities
subject to this portion of the BSE rule is decreasing and therefore, we
have decreased the number of facilities who must comply, as well as the
total number of hours needed to comply with this burden.
We have retained the annual burden estimate that we attribute to
activities under 21 CFR 589.2001 (147 responses, 6,591 hours) and
currently approved in OMB control no. 0910-0627. We intend to
discontinue the later control no. from our inventory upon OMB review
and approval.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18615 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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