[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81930-81932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, 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 recordkeeping requirements 
for substances prohibited from use in animal food or feed.

DATES: Submit either electronic or written comments on the collection 
of information by February 16, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 16, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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-2013-N-0520 for ``Substances 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White

[[Page 81931]]

Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 
301-796-7726, [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.

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).
    FDA estimates the burden of this collection of information as 
follows:

[[Page 81932]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
           21 CFR part               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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 burden
           21 CFR part               Number of      records per    Total annual         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: December 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27746 Filed 12-16-20; 8:45 am]
BILLING CODE 4164-01-P