[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70676-70678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4181]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 extension of an existing collection of 
information, and to allow 60 days for public comment in

[[Page 70677]]

response to the notice. This notice solicits comments on the reporting 
and recordkeeping requirements for cattle materials prohibited from use 
in animal food or feed.

DATES: Either electronic or written comments on the collection of 
information must be submitted by December 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 11, 2023. 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:
     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.
     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:
     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.
     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-2023-N-4181 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Cattle Materials Prohibited From 
Use in Animal Food or Feed.'' 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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.

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].

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 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.

Cattle Materials Prohibited From Use in Animal Food or Feed--21 CFR 
589.2001

OMB Control Number 0910-0627--Extension

    This information collection supports implementation of Agency 
statutory and regulatory requirements regarding 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

[[Page 70678]]

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 on 
renderers that process cattle materials, including reporting and 
recordkeeping requirements. 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.
    Under our regulations, 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. We use the information to ensure their 
designations remain appropriate.
    Renderers that receive, manufacture, process, blend, or distribute 
CMPAF, or products that contain or may contain CMPAF, must take 
measures to ensure that the materials are not introduced into animal 
feed, including maintaining adequate written procedures specifying how 
such processes are to be carried out.
    Description of Respondents: Respondents to this information 
collection are foreign governments seeking designation under Sec.  
589.2001(f) and rendering facilities that process cattle materials.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
      21 CFR part; activity          Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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589.2001(f); Process for                       1               1               1              40              40
 designating countries to
 request exemption from the
 requirements of this regulation
589.2001(f); response to request               1               1               1              26              26
 for review by FDA..............
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    Total.......................  ..............  ..............  ..............  ..............              66
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information the country is required to submit includes 
information about that country's BSE case history, risk factors, 
measures to prevent the introduction and transmission of BSE, and any 
other information relevant to determining whether the cattle materials 
from the requesting country do or do not meet the definitions set forth 
in Sec.  589.2001(b)(1).
    Since the last renewal, we have reduced the request for designation 
burden from 80 hours to 40 hours. This reduction is because respondents 
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.
    Our estimate of the reporting burden for designation under Sec.  
589.2001(f) is based on estimates found in our final rule. Since the 
rule's effective date in 2009, only two requests for designation have 
been received; however, we retain our current estimate of one to permit 
such requests for designation by respondents and to permit related 
responses to FDA.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                       21 CFR part; activity                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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589.2001(c)(2)(ii), 589.2001(c)(2)(vi) and (c)(3)(i), and                       145                1              145               45            6,525
 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.

    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 subset of 50 
recordkeepers who maintain written procedures and records specifically 
required by 21 CFR 589.2001(c).
    We have adjusted our recordkeeping burden estimate in Table 2, 
which results in a decrease of 2,525 hours. This is based primarily on 
consolidation within the industry and a decrease in the estimated 
number of respondents subject to recordkeeping requirements.
    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 
respondent subject to recordkeeping requirements.

    Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22495 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P