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

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.

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

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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