81 FR 29523 - Availability of an Environmental Assessment for Issuance of a Permit for Distribution and Sale for Emergency Use of a Classical Swine Fever Virus Vaccine, Live Pestivirus Vector

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 92 (May 12, 2016)

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 for emergency use, a Classical Swine Fever Virus Vaccine, Live Pestivirus Vector. 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 for emergency use 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.

[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Notices]
[Pages 29523-29524]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11149]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0020]


Availability of an Environmental Assessment for Issuance of a 
Permit for Distribution and Sale for Emergency Use of a Classical Swine 
Fever Virus Vaccine, Live Pestivirus Vector

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 for 
emergency use, a Classical Swine Fever Virus Vaccine, Live Pestivirus 
Vector. 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 for emergency use in the 
United States following the close of the comment period for this notice 
unless new

[[Page 29524]]

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 June 
13, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0020.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0020, 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-2016-
0020 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.), the Animal and Plant Health Inspection Service (APHIS) is 
authorized to promulgate regulations designed to ensure that veterinary 
biological products are pure, safe, potent, and efficacious. Veterinary 
biological products include viruses, serums, toxins, and analogous 
products of natural or synthetic origin, such as vaccines, antitoxins, 
or the immunizing components of microorganisms intended for the 
diagnosis, treatment, or prevention of diseases in domestic animals.
    APHIS issues licenses to qualified establishments that produce 
veterinary biological products and issues permits to importers of such 
products. APHIS also enforces requirements concerning production, 
packaging, labeling, and shipping of these products and sets standards 
for the testing of these products. Regulations concerning veterinary 
biological products are contained in 9 CFR parts 101 to 124.
    Veterinary biological products meeting the requirements of the 
regulations may be considered for addition to the U.S. National 
Veterinary Stockpile (NVS). The NVS is the nation's repository of 
vaccines and other critical veterinary supplies and equipment. It 
exists to augment State and local resources in responding to high-
consequence livestock diseases that could potentially devastate U.S. 
agriculture, seriously affect the economy, and threaten public health. 
The NVS vaccines would be used in APHIS programs or under U.S. 
Department of Agriculture control or supervision. The manufacturer of 
Classical Swine Fever Virus Vaccine, Live Pestivirus Vector, has been 
awarded a contract to supply the vaccine to the NVS for emergency use 
in the United States. The addition of this vaccine to the stockpile 
would not preclude private development and use of other vaccines 
meeting the requirements of the Virus-Serum-Toxin Act.
    To determine whether to authorize shipment and grant 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 safety testing of the following unlicensed 
veterinary biological product:
    Requester: Zoetis, Inc.
    Product: Classical Swine Fever Virus Vaccine, Live Pestivirus 
Vector.
    The above-mentioned product is a single-dose 1-mL modified live 
product for emergency vaccination in an outbreak situation. The 
proposed indication is intramuscular administration to healthy swine 6 
weeks of age or older as an aid in preventing mortality and viremia 
caused by classical swine fever virus.
    Possible Field Use Locations: Where Federal and State authorities 
agree on use.
    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 the importation 
under permit of the above product for distribution and sale for 
emergency use 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 6th day of May 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-11149 Filed 5-11-16; 8:45 am]
 BILLING CODE 3410-34-P