[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3075-3076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-980]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0126]
Availability of an Environmental Assessment for Field Testing
Feline Leukemia Vaccine, Live Canarypox Vector
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared an environmental assessment concerning
authorization to ship for the purpose of field testing, and then to
field test, an unlicensed Feline Leukemia Vaccine, Live Canarypox
Vector. The environmental assessment, which is based on a risk analysis
prepared to assess the risks associated with the field testing of this
vaccine, examines the potential effects that field testing this
veterinary vaccine could have on the
[[Page 3076]]
quality of the human environment. Based on the risk analysis, we have
reached a preliminary determination that field testing 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 authorize shipment of this vaccine for field
testing following 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. We also intend to issue a U.S. Veterinary
Biological Product license for this vaccine, provided the field test
data support the conclusions of the environmental assessment and the
issuance of a finding of no significant impact and the product meets
all other requirements for licensing.
DATES: We will consider all comments that we receive on or before
February 18, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0126 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2010-0126, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2010-0126.
Reading Room: You may read any comments that we receive on this
docket 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy,
Evaluation, and Licensing, VS, APHIS, 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, or to request a copy of the environmental assessment (as well
as the risk analysis with confidential business information removed),
contact Dr. Patricia L. Foley, Risk Manager, Center for Veterinary
Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton
Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100, fax (515)
337-6120.
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. A field test is generally necessary to satisfy
prelicensing requirements for veterinary biological products. Prior to
conducting a field test on an unlicensed product, an applicant must
obtain approval from the Animal and Plant Health Inspection Service
(APHIS), as well as obtain APHIS' authorization to ship the product for
field testing.
To determine whether to authorize shipment and grant approval for
the field testing of the unlicensed product referenced in this notice,
a risk analysis was prepared to assess the potential effects 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) \1\ concerning the field testing of the following
unlicensed veterinary biological product:
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\1\ The risk analysis (with confidential business information
removed) and the EA may be viewed on Regulations.gov (see ADDRESSES
above for a link to Regulations.gov).
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Requester: Merial, Inc.
Product: Feline Leukemia Vaccine, Live Canarypox Vector.
Field Test Locations: Alabama, California, Florida, Georgia,
Missouri, and Tennessee.
The above-mentioned product consists of a live recombinant
canarypox vector expressing certain feline leukemia virus proteins. The
vaccine is for use in healthy cats at 8 weeks of age or older as an aid
in the prevention of disease due to feline leukemia virus.
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).
Unless substantial issues with adverse environmental impacts are
raised in response to this notice, APHIS intends to issue a finding of
no significant impact (FONSI) based on the EA and authorize shipment of
the above product for the initiation of field tests following the close
of the comment period for this notice.
Because the issues raised by field testing and by issuance of a
license are identical, APHIS has concluded that the EA that is
generated for field testing would also be applicable to the proposed
licensing action. Provided that the field test data support the
conclusions of the original EA and the issuance of a FONSI, APHIS does
not intend to issue a separate EA and FONSI to support the issuance of
the product license, and would determine that an environmental impact
statement need not be prepared. APHIS intends to issue a veterinary
biological product license for this vaccine following completion of the
field test provided no adverse impacts on the human environment are
identified and provided the product meets all other requirements for
licensing.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 12th day of January 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-980 Filed 1-18-11; 8:45 am]
BILLING CODE 3410-34-P