[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Notices]
[Pages 54589-54590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22365]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0011]
Availability of an Environmental Assessment for Field Testing
Foot-and-Mouth Disease Vaccine, Live Adenovirus 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 (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.
DATES: We will consider all comments that we receive on or before
October 8, 2010.
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-2010-0011) to submit or view comments
[[Page 54590]]
and to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2010-0011, 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-2010-0011.
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, Ames, IA 50010; phone (515) 337-6100, fax (515) 337-7397.
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: Per-Os USA Inc. under contract with GenVec, Inc.
Product: Foot-and-mouth disease vaccine, live adenovirus vector.
Field Test Locations: Nebraska, Missouri, and Michigan.
The above-mentioned product consists of a live recombinant
adenovirus vector expressing certain foot-and-mouth disease virus
proteins. The vaccine is for use in cattle at 12 weeks of age or older,
as an aid in the prevention of clinical signs of disease caused by
foot-and-mouth disease 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 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 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 1st day of September 2010.
Gregory L. Parham
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-22365 Filed 9-7-10: 8:45 am]
BILLING CODE 3410-34-S