Notice2022-17274
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
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
August 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 154 (Thursday, August 11, 2022)</title>
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[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Page 49596]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#38686a796b4c595e5e785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="47171506143326212107212326692f2f3469202831">[email protected]</span></a>.
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
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