Proposed Rules. Notice of reopening and extension of comment period

Agency: Animal and Plant Health Inspection Service, USDA
Action: Notice of reopening and extension of comment period
Citation: FR Doc. 02-19422 · Docket No. 93-129-2 · 9 CFR 112, 113

Summary

We are reopening and extending the comment period for a proposed rule to amend the Virus-Serum-Toxin Act regulations concerning Standard Requirements for veterinary biologics by adding a Standard Requirement for Equine Influenza Vaccine, Killed Virus. This action will allow interested persons additional time to prepare and submit comments.

Dates

We will consider all comments that we receive on or before August 15, 2002.

Supplementary Information

Background On May 15, 2002, we published in the Federal Register (67 FR 34630-34633, Docket No. 93-129-1) a proposed rule to amend the Virus-Serum-Toxin Act regulations concerning Standard Requirements for veterinary biologics by adding a Standard Requirement for Equine Influenza Vaccine, Killed Virus. In that document, we proposed to require that such vaccines be shown to protect vaccinates for at least 60 days based on a vaccination-challenge study conducted in horses. In addition, we proposed to establish a serum hemagglutination inhibition test in guinea pigs as the serial release potency test for the vaccine; establish procedures for adding and removing strains of virus based on evidence of changes in the antigenic character of the equine influenza viruses in current circulation; and add labeling requirements to the regulations. Comments on the proposed rule were required to be received or postmarked by July 15, 2002. Based on a request received during the comment period, we are reopening and extending the comment period for the proposed rule until August 15, 2002. This action will allow interested persons additional time to prepare and submit comments. Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 23rd day of July, 2002. Peter Fernandez, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 02-19422 Filed 7-31-02; 8:45 am]