[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28852-28853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11633]


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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; Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 extending OMB approval on the 
existing recordkeeping requirements for this information collection, 
regarding animal proteins prohibited in ruminant feed.

DATES: Submit either electronic or written comments on the collection 
of information by July 15, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this

[[Page 28853]]

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

    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 the Food and Drug 
Administration.
    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              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Maintaining written procedures               400               1             400              14            5600
 (Sec.   589.2000 (e)(1)(iv))...
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11633 Filed 5-15-13; 8:45 am]
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