[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50884-50885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21926]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / 
Notices  

[[Page 50884]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0042]


Availability of an Environmental Assessment for Field Testing of 
a Swine Influenza 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 ship for the purpose of field testing, and then to 
field test, an unlicensed Swine Influenza Vaccine, DNA. Based on the 
environmental assessment, risk analysis, and other relevant data, 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. We are making the documents available to the 
public for review and comment.

DATES: We will consider all comments that we receive on or before 
November 9, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0042.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0042, 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-2018-
0042 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 redacted), 
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 before a 
veterinary biological product license may be issued. 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.
    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 considers the potential effects of this product on the safety of 
animals, public health, and the environment. Based upon a risk analysis 
and other relevant data, APHIS has prepared an environmental assessment 
(EA) concerning the field testing of the following unlicensed 
veterinary biological product:
    Requester: Antelope Valley Bios, Inc.
    Product: Swine Influenza Vaccine, DNA.
    Possible Field Test Locations: Minnesota, North Carolina, and 
Oklahoma.
    The above-mentioned product is a DNA vaccine containing a 
hemagglutinin gene from swine influenza virus, subtype H3. The vaccine 
is intended for use in healthy swine 3 weeks of age or older, 
administered by intramuscular inoculation, as an aid in the prevention 
of disease due to swine influenza virus, subtype H3.
    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).
    We are publishing this notice to inform the public that we will 
accept written comments regarding the EA from interested or affected 
persons for a period of 30 days from the date of this notice. 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

[[Page 50885]]

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 associated 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 satisfactory 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 3rd day of October 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-21926 Filed 10-9-18; 8:45 am]
 BILLING CODE 3410-34-P