[Federal Register Volume 68, Number 32 (Tuesday, February 18, 2003)]
[Notices]
[Page 7761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3838]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 68, No. 32 / Tuesday, February 18, 2003 / 
Notices  

[[Page 7761]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 03-020-1]


Availability of an Environmental Assessment for Licensing of 
Brucella Abortus Vaccine, Strain RB-51, Live Culture

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that an environmental assessment 
has been prepared by the Animal and Plant Health Inspection Service 
relative to the licensing of Brucella Abortus Vaccine, Strain RB-51, 
Live Culture. The environmental assessment, which is based on a risk 
analysis prepared to assess the risks associated with the licensing of 
this vaccine, examines the potential effects that the licensing of this 
veterinary vaccine could have on the quality of the human environment. 
Based on the environmental assessment, we have reached a preliminary 
determination that the licensing of this veterinary vaccine will not 
have a significant impact on the quality of the human environment, and 
that an environmental impact statement need not be prepared. We intend 
to issue a U.S. Veterinary Biological Product license for this vaccine 
for use in cattle after the close of the comment period for this notice 
unless new, substantial issues bearing on the effects of this action 
are brought to our attention.

DATES: We will consider all comments that we receive on or before March 
20, 2003.

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. 03-020-1, 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. 03-020-1. 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. 
03-020-1'' on the subject line.
    You may request a copy of the environmental assessment (as well as 
the risk analysis with confidential business information removed) by 
writing to Dr. Connie S. Smellich-Sandage, USDA, APHIS, VS, CVB-LPD, 
510 South 17th Street, Suite 104, Ames, IA 50010, or by calling (515) 
232-5785. Please refer to the docket number, date and complete title of 
this notice when requesting copies.
    A copy of the environmental assessment (as well as the risk 
analysis with confidential business information removed) and any 
comments that we receive on this docket are available for public 
inspection 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.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Licensing and Policy Development, VS, APHIS, USDA, 4700 River Road, 
Unit 148, Riverdale, MD 20737-1231; phone (301) 734-8245; fax (301) 
734-4314. For information regarding the environmental assessment or the 
risk analysis, contact Dr. Connie S. Smellich-Sandage, USDA, APHIS, VS, 
CVB-LPD, 510 South 17th Street, Suite 104, Ames, IA 50010; (515) 232-
5785.

SUPPLEMENTARY INFORMATION: Under the Virus-Serum-Toxin Act (21 U.S.C. 
151 et seq.), a veterinary biological product must be shown to be pure, 
safe, potent, and efficacious before a veterinary biological product 
license may be issued. In determining whether to issue a veterinary 
biological product license for the vaccine referenced in this notice, 
APHIS conducted a risk analysis to assess the potential effect of this 
product on the safety of animals, public health, and the environment. 
Based on the risk analysis, APHIS has prepared an environmental 
assessment (EA) concerning the licensing of the following product:
    Requester: Colorado Serum Company.
    Product: Brucella Abortus Vaccine, Strain RB-51, Live Culture, Code 
1261.00.
    Action: Issuance of product license.
    The above-mentioned vaccine is for use in cattle as an aid in the 
prevention of clinical signs due to Brucella abortus. The vaccine is 
prepared from a naturally occuring, rifampicin resistant mutant strain 
of the organism.
    The EA has been prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    We have reached a preliminary determination that the licensing of 
this veterinary vaccine will not have a significant impact on the 
quality of the human environment, and that an environmental impact 
statement need not be prepared. Unless substantial issues with adverse 
environmental impacts are raised in response to this notice, APHIS 
intends to issue a finding of no significant impact based on the EA and 
issue a veterinary biological product license for this vaccine 
following the close of the comment period for this notice.

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 11th day of February, 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-3838 Filed 2-14-03; 8:45 am]
BILLING CODE 3410-34-P