[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17156-17157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0520]


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 May 3, 2021.

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. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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--21 CFR Part 589

OMB Control Number 0910-0627--Extension

    This information collection supports Agency regulations 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. BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). All TSEs affect the central nervous 
system of infected animals. Our regulation at Sec.  589.2001 (21 CFR 
589.2001), entitled ``Cattle materials prohibited in animal food or 
feed to prevent the transmission of bovine spongiform encephalopathy,'' 
is designed to further strengthen existing safeguards 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 on renderers of specifically 
defined cattle materials, including reporting and recordkeeping 
requirements. For purposes of the regulation, we define a renderer as 
any firm or individual that processes slaughter byproducts; animals 
unfit for human consumption, including carcasses of dead cattle; or 
meat scraps. 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.
    Reporting: Under our regulations, we may designate a country from 
which cattle materials are not considered CMPAF. Section 589.2001(f) 
provides that a country seeking to be so designated must send a written 
request to the Director of the Center for Veterinary Medicine. The 
country is required to submit information about its 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). We use the information 
to determine whether to grant a request for designation and to impose 
conditions if a request is granted. Section 589.2001(f) further states 
that countries designated under that section will be subject to our 
future review to determine whether their designations remain 
appropriate. As part of this process, we may ask designated countries 
from time to 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.
    Recordkeeping: 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 (Sec.  
589.2001(c)(2)(ii)). Renderers that receive, manufacture, process, 
blend, or distribute CMPAF are required to establish and maintain 
records sufficient to track the CMPAF to ensure that they are not 
introduced into animal feed (Sec.  589.2001(c)(2)(vi)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must establish and maintain records sufficient to 
demonstrate that material rendered for use in animal feed was not 
manufactured from, processed with, or does not otherwise contain, CMPAF 
(Sec.  589.2001(c)(3)(i)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must, if these materials were obtained from an 
establishment that segregates CMPAF from other materials, establish and 
maintain records to demonstrate that the supplier has adequate 
procedures in place to effectively exclude CMPAF from any materials 
supplied (Sec.  589.2001(c)(3)(i)). Records will meet this requirement 
if they include either: (1) Certification or other documentation from 
the supplier that materials supplied do not include CMPAF (Sec.  
589.2001(c)(3)(i)(A)), or (2) documentation of another method 
acceptable to FDA, such as third-party certification (Sec.  
589.2001(c)(3)(i)(B)).
    Description of Respondents: Respondents to this information 
collection include rendering facilities, feed manufacturers, livestock 
feeders, and foreign governments seeking designation under Sec.  
589.2001(f).

[[Page 17157]]

    In the Federal Register of December 17, 2020 (85 FR 81930), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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589.2001(f); request for                       1               1               1              80              80
 designation....................
589.2001(f); response to request               1               1               1              26              26
 for review by FDA..............
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    Total.......................  ..............  ..............  ..............  ..............             106
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
           21 CFR part               Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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589.2001(c)(2)(ii); maintain                  50               1              50              20           1,000
 written procedures.............
589.2001(c)(2)(vi) and                       175               1             175              20           3,500
 (c)(3)(i); maintain records....
589.2001(c)(3)(i)(A) and (B);                175               1             175              26           4,550
 certification or documentation
 from the supplier..............
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    Total.......................  ..............  ..............  ..............  ..............           9,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06706 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P