[Federal Register Volume 67, Number 148 (Thursday, August 1, 2002)]
[Proposed Rules]
[Pages 49891-49892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19422]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 112 and 113

[Docket No. 93-129-2]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of reopening and extension of comment period.

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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 [email protected]. 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.

[[Page 49892]]


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.

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]
BILLING CODE 3410-34-P