[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40419-40420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17478]


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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: Fax written comments on the collection of information by 
September 13, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0339. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10 
a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, PRAStaff@fda.hhs.gov.

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 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 their processes, and then to 
help inspection personnel confirm that the firm is operating 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 as long as 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 December 21, 2018 (83 FR 65681), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received in support of the 
collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                      21 CFR section; activity                          Number of       records per     Total  annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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589.2000(e)(1)(iv); written procedures.............................             320                1              320               14            4,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 40420]]

    We base our estimates on our experience with similar requirements 
to maintain written procedures. 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 
made no adjustments to our burden estimate.

    Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17478 Filed 8-13-19; 8:45 am]
BILLING CODE 4164-01-P


