[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4626-4628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01731]


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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; 
Animal Proteins Prohibited in Ruminant Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 regarding 
animal proteins prohibited in ruminant feed.

DATES: Submit either electronic or written comments on the collection 
of information by March 29, 2022.

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 March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 29, 2022. 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

[[Page 4627]]

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 ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Substances Prohibited from Use in 
Animal Food or Feed; Animal Proteins Prohibited in Ruminant 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 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; Animal Proteins 
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv)

OMB Control Number 0910-0339--Extension

    Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) gives us the authority to issue regulations for 
the efficient enforcement of the FD&C Act. Our regulation at 21 CFR 
589.2000 provides that animal protein derived from mammalian tissue 
(with some exclusions) is not generally recognized as safe (GRAS) for 
use in ruminant feed and is a food additive subject to certain 
provisions of the FD&C Act (62 FR 30936, June 5, 1997).
    This information collection was established because epidemiological 
evidence gathered in the United Kingdom suggested that bovine 
spongiform encephalopathy (BSE), a progressively degenerative central 
nervous system disease, is spread to ruminant animals by feeding 
protein derived from ruminants infected with BSE. This regulation 
places general requirements on persons that manufacture, blend, 
process, and distribute products that contain, or may contain, protein 
derived from mammalian tissue, and feeds made from such products.
    Specifically, this regulation requires renderers, feed 
manufacturers, and others involved in feed and feed ingredient 
manufacturing and distribution to maintain written procedures 
specifying the cleanout procedures or other means and specifying the 
procedures for separating products that contain or may contain protein 
derived from mammalian tissue from all other protein products from the 
time of receipt until the time of shipment. These written procedures 
are intended to help the firm formalize consistent processes, and then 
to help inspection personnel confirm that the firm is conducting these 
processes in compliance with the regulation. Inspection personnel will 
evaluate the written procedure and confirm it is being followed when 
they are conducting an inspection.
    These written procedures must be maintained if the facility is 
operating in a manner that necessitates the record, and if the facility 
makes changes to an applicable procedure or process the record must be 
updated. Written procedures required by this section shall be made 
available for inspection and copying by FDA.
    Description of Respondents: Respondents include renderers, feed 
manufacturers, and others involved in feed and feed ingredient 
manufacturing and distribution.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 4628]]



                                                   Table 1--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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Written procedures; 589.2000(e)(1)(iv)........................              300                 1               300                14             4,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of the number of recordkeepers on inspectional 
data. Based on a review of the information collection since our last 
request for OMB approval we have adjusted our burden estimate, which 
has resulted in a decrease to the currently approved burden. Review of 
our inspection data suggests that the number of facilities that need to 
conduct these separation practices is gradually decreasing, therefore 
we have decreased the number of facilities who must comply, as well as 
the total number of hours needed to comply with this burden.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01731 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


