Notice2023-22495
Agency Information Collection Activities; Proposed Collection; 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
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70676-70678]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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: 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#b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="ecbcbeadbf988d8a8aac8a888dc284849fc28b839a">[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 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
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