[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Page 79657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-31191]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2013-0093]
Availability of an Environmental Assessment for Issuance of a
Permit for Distribution and Sale of an Infectious Hematopoietic
Necrosis Virus Vaccine, DNA
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability.
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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 import under permit, for distribution and sale, an
Infectious Hematopoietic Necrosis Virus Vaccine, DNA. The environmental
assessment, which is based on a risk analysis prepared to assess the
risks associated with the use of this vaccine, examines the potential
effects that this veterinary vaccine could have on the quality of the
human environment. Based on the risk analysis and other relevant data,
we have reached a preliminary determination that use of 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 under permit
for distribution and sale in the United States 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 and
provided the product meets all requirements for approval.
DATES: We will consider all comments that we receive on or before
January 30, 2014.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0093-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2013-0093, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0093 or in our reading room, which 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) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support
Section, Center for Veterinary Biologics, Policy, Evaluation, and
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; phone (301) 851-3426, 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. Prior to importing an unlicensed product, an
applicant must obtain approval from the Animal and Plant Health
Inspection Service (APHIS) to ship the product under permit for
distribution and sale.
To determine whether to authorize shipment and approval for the use
of the imported product referenced in this notice, APHIS has considered
the potential effects of this product on the safety of animals, public
health, and the environment. Using a risk analysis and other relevant
data, APHIS has prepared an environmental assessment (EA) concerning
the use of the following imported veterinary biological product:
Requester: Novartis Animal Health US, Inc.
Product: Infectious Hematopoietic Necrosis Virus Vaccine, DNA.
The above-mentioned product is a replication-incompetent DNA
vaccine consisting of a plasmid vector with an inserted immunogenic
gene. The vaccine is intended for the immunization of salmonids as an
aid in the prevention of disease due to infectious hematopoietic
necrosis 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 based on the EA and authorize shipment of the
above product for distribution and sale following the close of the
comment period for this notice, provided the product meets all other
requirements for approval.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 20th day of December 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-31191 Filed 12-30-13; 8:45 am]
BILLING CODE 3410-34-P