[Federal Register Volume 68, Number 113 (Thursday, June 12, 2003)]
[Notices]
[Pages 35233-35234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0727]


Interpretation of On-Farm Feed Manufacturing and Mixing 
Operations; Withdrawal of Draft Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal of draft guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance for industry ([numsign]77) entitled 
``Interpretation of On-farm Feed Manufacturing and Mixing Operations,'' 
that was issued on September 23, 1998. FDA has decided to withdraw the 
draft guidance. FDA has decided that the draft guidance did not address 
adequately the industry

[[Page 35234]]

practices of on-farm mixers. Instead, the agency directs you to FDA 
guidance for industry ([numsign]69) entitled ``Small Entities 
Compliance Guide for Feeders of Ruminant Animals With On-farm Feed 
Mixing Operations,'' which addresses on-farm mixing practices more 
completely.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine (HFV-214), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0163, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of September 23, 1998 
(63 FR 50918), FDA announced the availability of a draft guidance for 
industry ([numsign]77) entitled ``Interpretation of On-farm Feed 
Manufacturing and Mixing Operations.'' The draft guidance discusses the 
applicability of certain paragraphs of 21 CFR 589.2000 Animal proteins 
prohibited in ruminant feed. Written comments were to be received by 
November 23, 1998.
    FDA received one letter containing several comments from an 
industry association on the draft guidance. The comments from the 
association expressed that they were ``extremely concerned'' that the 
draft guidance would be ``extremely difficult to monitor and 
administer'' in the section concerning commingling or cross-
contamination of prohibited with nonprohibited mammalian protein. The 
comment further indicated that the draft guidance did not capture the 
regulation's requirements regarding equipment clean-out procedures.
    After further consideration, FDA has decided to withdraw the draft 
guidance. FDA has decided that the draft guidance did not address 
adequately the industry practices of on-farm mixers. Instead, the 
agency directs you to FDA guidance for industry ([numsign]69) entitled 
``Small Entities Compliance Guide for Feeders of Ruminant Animals With 
On-farm Feed Mixing Operations,'' which addresses on-farm mixing 
practices more completely.

II. Electronic Access

    Persons with access to the Internet may obtain FDA guidance for 
industry [numsign]69 at http://www.fda.gov/cvm/guidance/guidance.html.

    Dated: June 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14820 Filed 6-11-03; 8:45 am]
BILLING CODE 4160-01-S