[Federal Register Volume 70, Number 50 (Wednesday, March 16, 2005)]
[Proposed Rules]
[Pages 12813-12814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5155]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 113

[Docket No. 93-039-4]


Viruses, Serums, Toxins, and Analogous Products; Standard 
Requirement for Escherichia Coli Bacterins

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal.

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SUMMARY: We are withdrawing a proposed rule to amend the Virus-Serum-
Toxin Act regulations by adding a Standard Requirement for Escherichia 
coli bacterins. The proposed rule would have provided uniform test 
methods, procedures, and criteria to be used by manufacturers of E. 
coli bacterins to ensure that such bacterins were immunogenic and 
potent. We are withdrawing the proposed rule after considering the 
comments we received following its publication.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, 
Operational Support Section, Center for

[[Page 12814]]

Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 
4700 River Road, Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION: On October 11, 1994, we published in the 
Federal Register (59 FR 51390-51392, Docket No. 93-039-1) a proposed 
rule to amend the regulations in 9 CFR part 113 to include a Standard 
Requirement for Escherichia coli bacterins. We solicited comments on 
the proposed rule for 60 days ending on December 12, 1994. We 
subsequently reopened the comment period, then extended the comment 
period again: The first notice, published in the Federal Register on 
May 17, 1995 (60 FR 26384, Docket No. 93-039-2), reopened the comment 
period until August 15, 1995, and the second notice, published in the 
Federal Register on August 22, 1995 (60 FR 43573-43574, Docket No. 93-
039-3), extended the comment period until September 14, 1995.
    We received a total of nine comments by the close of the extended 
comment period. The comments were from veterinary biologics 
manufacturers and a trade association representing veterinary biologics 
manufacturers. One commenter supported the concept of a standard test 
procedure for E. coli bacterin, but remarked that the proposed standard 
lacked sufficient detail concerning the test method. Another commenter 
identified provisions in the proposed rule that he believed conflicted 
with the provisions in an interrelated proposed rule concerning in 
vitro testing, and requested an indefinite extension of the comment 
period pending resolution of the conflicting provisions. The remaining 
commenters requested clarification of the various technical provisions 
of the rule and suggested alternative wording for our consideration.
    After considering all of the comments that we received, we have 
concluded that we will withdraw the proposed rule. Therefore, we are 
withdrawing the October 11, 1994, proposed rule referenced above. The 
concerns and recommendations of all of the commenters will be 
considered if any new proposed regulations concerning a Standard 
Requirement for E. coli bacterins are developed.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 10th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5155 Filed 3-15-05; 8:45 am]
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