United States Government Printing Office printer prt distributor dst United States National Archives and Records Administration Federal Register Office author aut Government Organization text government publication eng FR Regulatory Information 2010_register executive 2010-09-08 article Notices D09002ee18070ff41 D09002ee18070ff9e United States Department of Agriculture originator org United States Government Agency or Subagency United States Animal and Plant Health Inspection Service originator org United States Government Agency or Subagency We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment (EA) concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed foot-and-mouth disease vaccine, live adenovirus vector. The EA, 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 EA and the issuance of a finding of no significant impact and the product meets all other requirements for licensing. 75 FR 54589 http://www.gpo.gov/fdsys/granule/FR-2010-09-08/2010-22365 2010-22365 FR08SE10-37 3410-34-S Docket No. APHIS-2010-0011 http://www.gpo.gov/fdsys/granule/FR-2010-09-08/2010-22365/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-2010-09-08/html/2010-22365.htm http://www.gpo.gov/fdsys/pkg/FR-2010-09-08/pdf/2010-22365.pdf 2 p. 54589 54590 75 FR 54589 Availability of an Environmental Assessment for Field Testing Foot-and-Mouth Disease Vaccine, Live Adenovirus Vector; Federal Register Vol. 75, Issue NOTICE 2010-22365 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 2010-10-08 Docket No. APHIS-2010-0011 3410-34-S 2010-22365 Notice.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment (EA) concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed foot-and-mouth disease vaccine, live adenovirus vector. The EA, 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 EA and the issuance of a finding of no significant impact and the product meets all other requirements for licensing.

We will consider all comments that we receive on or before October 8, 2010. 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. Environmental Assessments; Availability, etc.: Field Testing Foot-and-Mouth Disease Vaccine, Live Adenovirus Vector , http://www.aphis.usda.gov http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0011 Vol. 75, no. 173 Office of the Federal Register, National Archives and Records Administration 2010-09-08 continuing daily deposited born digital 306 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 http://www.gpo.gov/fdsys/pkg/FR-2010-09-08 P0b002ee18070f8ff 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR08SE10 http://www.gpo.gov/fdsys/pkg/FR-2010-09-08/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-2010-09-08/pdf/FR-2010-09-08.pdf http://www.gpo.gov/fdsys/pkg/FR-2010-09-08/xml/FR-2010-09-08.xml fdlp 54461 54758 DGPO 2010-09-08 2010-09-08 FR-2010-09-08 machine generated eng FR FR-2010-09-08 75 173