[Federal Register: January 16, 2004 (Volume 69, Number 11)]
[Page 2602-2603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

             Table 1.--Estimated Annual Reporting Burden\1\
                             Annual      Total
  21 CFR       No. of       Frequency    Annual     Hours per     Total
 Sections   Recordkeepers  per Record   Records   Recordkeeper    Hours
589.2000(   400            1           400        14            5,600
\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]