[Federal Register: September 18, 2008 (Volume 73, Number 182)]
[Notices]
[Page 54134-54135]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18se08-32]
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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 54134]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2008-0099]
Availability of an Environmental Assessment for Field Testing
Rabies Vaccine, Live Raccoon Poxvirus 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 Rabies Vaccine, Live Raccoon Poxvirus 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 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
October 20, 2008.
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-2008-0099 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2008-0099, 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-2008-0099.
Reading Room: You may read any comments that we receive on the
environmental assessment 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, 510 South 17th
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.
SUPPLEMENTARY INFORMATION:
Background
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,
APHIS conducted a risk analysis 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) concerning the field testing of the following
unlicensed veterinary biological product:
Requester: Fort Dodge Animal Health, Division of Wyeth Corporation.
Product: Rabies Vaccine, Live Raccoon Poxvirus Vector.
Field Test Locations: Iowa, Indiana, Texas, North Carolina,
Oklahoma, Wisconsin, New York, Illinois, Minnesota, and Kansas.
The above-mentioned product consists of a live recombinant raccoon
poxvirus vector expressing rabies glycoprotein. The vaccine is for use
in cats and dogs as an aid in the prevention of rabies virus infection.
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 1), 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
[[Page 54135]]
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 September 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-21820 Filed 9-17-08; 8:45 am]
BILLING CODE 3410-34-P