Notice2024-06438
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cattle Materials 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
March 27, 2024
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 89 Issue 60 (Wednesday, March 27, 2024)</title>
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[Federal Register Volume 89, Number 60 (Wednesday, March 27, 2024)]
[Notices]
[Pages 21257-21259]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4181]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Cattle Materials
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 April 26, 2024.
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 0910-0627. The title of this information
collection is ``Cattle Materials Prohibited From Use in Animal Food or
Feed.'' Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#623230233116030404220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="aefefceffddacfc8c8eec8cacf80c6c6dd80c9c1d8">[email protected]</span></a>.
[[Page 21258]]
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.
Cattle Materials Prohibited From Use in Animal Food or Feed
OMB Control Number 0910-0627--Extension
This information collection helps to support implementation of
section 402 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
342(a)(5)), which governs substances prohibited from use in animal food
or feed. Bovine spongiform encephalopathy (BSE) is a progressive and
fatal neurological disorder of cattle that results from an
unconventional transmissible agent. Our regulation at Sec. 589.2001
(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.
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.
Additionally, 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.
The reporting and recordkeeping requirements are necessary because
once materials are separated from an animal it may not be possible,
without records, to know whether the cattle material meets the
requirements of our regulation.
Description of Respondents: Respondents to this information
collection are foreign governments seeking designation under Sec.
589.2001(f) and private sector rendering facilities that process cattle
materials under Sec. 589.2001(c).
In the Federal Register of October 12, 2023 (88 FR 70676), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, the
comments were not responsive to the four collection of information
topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
21 CFR part; activity Number of responses per annual burden per Total
respondents respondent responses response hours
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589.2001(f); Request for designation by 1 2 2 33 66
FDA for exemption from requirements of
this regulation and response to request
for review by FDA........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since the last renewal, we reduced the request for designation
average burden per response by 40 hours (from 80 hours to 40 hours). We
take this reduction because foreign governments are required to provide
this information to other entities in order to comply with
international standards and therefore will have already compiled the
necessary information. The average burden per response to a request for
review by FDA remains the same (26 hours). The burden we attribute to
reporting activities is assumed to be distributed among the individual
elements of the information collection activities.
Since the effective date of the regulations in 2009, only two
requests for designation have been received; however, we retain our
current estimate of one respondent to permit such requests for
designation by respondents and also to permit related responses to FDA.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
21 CFR part; activity Number of records per annual per Total
recordkeepers recordkeeper records recordkeeping hours
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589.2001(c)(2)(ii), 145 1 145 45 6,525
589.2001(c)(2)(vi), and (c)(3)(i),
and 589.2001(c)(3)(i)(A) and (B);
Rendering facilities maintain written
procedures and records, and
certification or documentation from
the supplier.........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2 reflects an adjustment decrease in our recordkeeping burden
estimate, based primarily on consolidation within the industry and the
related decrease in the estimated number of respondents subject to
recordkeeping requirements. The burden we attribute to recordkeeping
activities is assumed to be distributed among the individual elements
and averaged among respondents. The total number of recordkeepers
contains a
[[Page 21259]]
subset of 50 recordkeepers who maintain written procedures and records
specifically required by Sec. 589.2001(c).
Based on our review since the last OMB approval, there is an
overall adjustment decrease of 2,565 burden hours. The adjustment is
attributable to decreases in the average reporting burden time and in
respondents subject to recordkeeping requirements.
Dated: March 21, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06438 Filed 3-26-24; 8:45 am]
BILLING CODE 4164-01-P
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