[Federal Register Volume 89, Number 60 (Wednesday, March 27, 2024)]
[Notices]
[Pages 21257-21259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

[[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
----------------------------------------------------------------------------------------------------------------
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