[Federal Register: October 3, 2003 (Volume 68, Number 192)]
[Notices]
[Page 57468-57469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc03-85]
[[Page 57468]]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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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]
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