[Federal Register Volume 65, Number 119 (Tuesday, June 20, 2000)]
[Notices]
[Page 38292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0505]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Substances Prohibited From Use in Animal Food 
or Feed; Animal Protein 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 (the PRA).

DATES: Submit written comments on the collection of information by July 
20, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, 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: Substances Prohibited From Use in Animal Food or Feed; 
Animal Proteins Prohibited in Ruminant Feed--21 CFR Part 589--(OMB 
Control No. 0910-0339)--Extension

    Description: This rule (Sec. 589.2000 (21 CFR 589.2000)) provides 
that protein derived from mammalian tissue (with some exceptions) for 
use in ruminant feed is a food additive subject to section 409 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348). 
Proteins derived from animal tissues contained in such feed ingredients 
in distribution cannot be readily identified (i.e., species), by 
recipients engaged in the manufacture, processing and distribution, and 
use of animal feeds and feed ingredients.
    Thus, under the agency's authority in section 701(a) of the act (21 
U.S.C. 371(a)), to issue regulations for the efficient enforcement of 
the act, this rule places three general requirements on persons that 
manufacture, blend, process, distribute, or use products that contain 
or may contain protein derived from mammalian tissues and feeds made 
from such products. The first requirement is for cautionary labeling of 
these products with direct language developed by FDA. This labeling 
requirement is exempt from the scope of the PRA because it is a 
``public disclosure of information originally supplied by the Federal 
Government for the purpose of disclosure to the public'' (5 CFR 
1329.3(c)(2)).
    The second requirement is for establishments to maintain and make 
available to FDA, records that are sufficient to track any material 
that contains protein derived from mammalian tissues (as defined in 
Sec. 589.2000(a)(1)), throughout the material's receipt, processing, 
and distribution. Based on available information, FDA believes that 
maintenance of these records is a usual and customary part of normal 
business practices for these firms. Therefore, this recordkeeping 
requirement creates no additional paperwork burden.
    The third requirement is that individuals or firms that 
manufacture, blend, process, or distribute both mammalian and 
nonmammalian materials must maintain written procedures to prevent 
commingling and cross-contamination. An estimate of the burden 
resulting from this recordkeeping requirement is provided in table 1 of 
this document. The estimate is based on the time required to develop 
written procedures.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                Table1.--Estimated Annual Recordkeeping Burden 1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers     Response         Records         Record
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589.2000(e)(1)(iv)                  1,030               1           1,030              14         14,420
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated number of respondents, 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 records and communication with industry.

    Dated: June 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-15430 Filed 6-19-00; 8:45 am]
BILLING CODE 4160-01-F