[Federal Register: February 18, 2003 (Volume 68, Number 32)]
[Notices]
[Page 7761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe03-19]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[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 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.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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