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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

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by February 17, 2004.


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.

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Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 4B-41, Rockville, MD 20857, 301-827-1472.

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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 Burden1

21 CFR SectionsNo. of RecordkeepersAnnual Frequency per RecordTotal Annual RecordsHours per RecordkeeperTotal Hours
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.

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Dated: January 9, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-1062 Filed 1-15-04; 8:45 am]