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Proposed Rule

Viruses, Serums, Toxins, and Analogous Products; Equine Influenza Vaccine, Killed Virus

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of reopening and extension of comment period.

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.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 93-129-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 93-129-1. If you use e-mail, address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 93-129-1” on the subject line.

You may read any comments that we receive on Docket No. 93-129-1 in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

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FOR FURTHER INFORMATION CONTACT:

Dr. Albert P. Morgan, Chief of Operational Support, Center for Veterinary Biologics, Licensing and Policy Development, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.

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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.

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

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Done in Washington, DC, this 23rd day of July, 2002.

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 02-19422 Filed 7-31-02; 8:45 am]

BILLING CODE 3410-34-P