[Federal Register: January 16, 2004 (Volume 69, Number 11)]
[Notices]
[Page 2602-2603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja04-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002N-0273]
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 the
proposed collection of information listed below 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
February 17, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, Rockville, MD 20857, 301-827-1472.
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.
Title: 21 CFR Part 589--Substances Prohibited From Use in Animal Food
or Feed; Animal Proteins Prohibited in Ruminant Feed--(OMB Control
Number 0910-0339)--Extension
Epidemiological evidence gathered in the United Kingdom suggests
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.
Effective August 4, 1997, the FDA amended it regulations to create 21
CFR 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 distribute, or use feed or feed
ingredients that contain or may contain protein, that may be derived
from mammalian tissue.
In the Federal Register of October 3, 2003 (68 FR 57468), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Total
21 CFR No. of Frequency Annual Hours per Total
Sections Recordkeepers per Record Records Recordkeeper Hours
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589.2000( 400 1 400 14 5,600
e)(1)(iv
)
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
[[Page 2603]]
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: January 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1062 Filed 1-15-04; 8:45 am]
BILLING CODE 4160-01-S