Availability of an Environmental Assessment for Field Testing Canine Melanoma Vaccine, DNA, 69306-69307 [E5-6297]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 70, Number 219 (Tuesday, November 15, 2005)]
[Notices]
[Pages 69306-69307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-6297]


========================================================================
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.

========================================================================


Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / 
Notices

[[Page 69306]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 05-082-1]


Availability of an Environmental Assessment for Field Testing 
Canine Melanoma Vaccine, DNA

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

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 Canine Melanoma Vaccine, DNA, for use in 
dogs. 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 
December 15, 2005.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Animal and Plant Health Inspection Service'' from the agency 
drop-down menu, then click on ``Submit.'' In the Docket ID column, 
select APHIS-2005-0104 to submit or view public comments and to view 
supporting and related materials available electronically. After the 
close of the comment period, the docket can be viewed using the 
``Advanced Search'' function in Regulations.gov.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 05-082-1, 
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. 05-082-1.
    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 https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; (301) 734-8245.
    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: 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: Merial, Inc.
    Product: Canine Melanoma Vaccine, DNA.
    Field Test Locations: Washington, Arizona, New York, North 
Carolina, and Texas.
    The above-mentioned product is a replication-incompetent DNA 
vaccine consisting of a plasmid vector and an inserted therapeutic 
gene. The vaccine is for use in dogs as an adjunct therapy for canine 
melanoma.
    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 provision 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

[[Page 69307]]

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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 8th day of November 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E5-6297 Filed 11-14-05; 8:45 am]
BILLING CODE 3410-34-P