[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Page 49596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17274]


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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; 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) 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 September 12, 2022.

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 0910-0339. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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; 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.
    In the Federal Register of January 28, 2022 (87 FR 4626), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received it was not 
responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                           Number of       Number of records     Total annual     Average burden per
                     21 CFR part                         recordkeepers     per recordkeeper         records          recordkeeping        Total hours
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Written procedures; 589.2000(e)(1)(iv)..............                225                   1                 225                  14               3,150
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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 of 1,330 hours. 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: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17274 Filed 8-10-22; 8:45 am]
BILLING CODE 4164-01-P


