[Federal Register Volume 68, Number 192 (Friday, October 3, 2003)]
[Notices]
[Pages 57468-57469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25042]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0425]


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) 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 for 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 
placed on handlers of ruminant protein to prevent the establishment and 
amplification of bovine spongiform encephalopathy (BSE) in the United 
States by ensuring that ruminant animal feed does not contain animal 
protein derived from mammalian tissue.

DATES: Submit written or electronic comments on the collection of 
information by December 2, 2003.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. 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:  Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 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 Part 589 (OMB Control Number 0910-
0339)--Extension

    Epidemiological evidence gathered in the United Kingdom suggests 
that BSE, a progressively degenerative central nervous system disease, 
is spread to ruminant animals by feeding protein derived from ruminants 
infected with BSE. While BSE has yet to be diagnosed in the United 
States, measures were necessary to prevent the establishment and 
amplification of this fatal disease in this country. Effective August 
4, 1997, FDA amended its regulations in part 589 (21 CFR part 589) to 
create new Sec.  589.2000 to regulate handlers of certain animal 
protein intended for use in ruminant feed. The regulation was designed 
to ensure that ruminant feed does not contain protein derived from 
mammalian tissue. It requires that firms that manufacture, blend, 
process or distribute both mammalian and nonmammalian materials 
intended for use in ruminant feed maintain written procedures to 
prevent commingling and cross-contamination of these materials.
    Respondents to this collection of information are individuals or 
firms that manufacture, blend, process or distribute, or use feed or 
feed ingredients that contain or may contain protein that may be 
derived from mammalian tissue.
    FDA estimates the burden of this collection of information as 
follows:

           Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                  Annual        Total    Hours
   21 CFR         No. of       Frequency of    Annual     per     Total
   Section     Recordkeepers   Recordkeeping   Records   Record   Hours
------------------------------------------------------------------------
589.2000(e)(  400             1               400       14       5,600
 1)(iv)
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\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.


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    The estimated number of recordkeepers, i.e., persons that separate 
mammalian and nonmammalian materials, is derived from inspections of 
firms handling animal protein intended for use in animal feed. The 
estimate of the time required for this recordkeeping requirement is 
based on agency communication with industry.

    Dated: September 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25042 Filed 10-2-03; 8:45 am]
BILLING CODE 4160-01-S