81_FR_12906 81 FR 12858 - Availability of an Environmental Assessment for Field Testing a Canine Osteosarcoma Vaccine, Live Listeria Vector

81 FR 12858 - Availability of an Environmental Assessment for Field Testing a Canine Osteosarcoma Vaccine, Live Listeria Vector

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 48 (March 11, 2016)

Page Range12858-12859
FR Document2016-05533

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 Canine Osteosarcoma Vaccine, Live Listeria Vector. The environmental assessment, 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 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, 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 environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing.

Federal Register, Volume 81 Issue 48 (Friday, March 11, 2016) 
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12858-12859]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05533]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / 
Notices

[[Page 12858]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0100]


Availability of an Environmental Assessment for Field Testing a 
Canine Osteosarcoma Vaccine, Live Listeria Vector

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

-----------------------------------------------------------------------

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 Canine Osteosarcoma Vaccine, Live Listeria 
Vector. The environmental assessment, 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 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, 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 environmental assessment 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 April 
11, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0100.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0100, 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-2015-
0100 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. 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. Using the 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: Canine Osteosarcoma Vaccine, Live Listeria Vector.
    Possible Field Test Locations: Arizona, California, Connecticut, 
Maryland, New Jersey, Nevada, New York, and Pennsylvania.
    The above-mentioned product consists of a highly attenuated 
Listeria monocytogenes strain that expresses a HER2/neu chimeric 
protein. It induces a strong cell-mediated immune response as an aid in 
the treatment of dogs with osteosarcoma. It will be administered only 
in a veterinary clinic or veterinary oncology center by trained 
personnel.
    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 (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

[[Page 12859]]

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 7th day of March 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-05533 Filed 3-10-16; 8:45 am]
 BILLING CODE 3410-34-P

12858 Notices Federal Register Vol. 81, No. 48 Friday, March 11, 2016 This section of the FEDERAL REGISTER DATES: We will consider all comments authorization to ship the product for contains documents other than rules or that we receive on or before April 11, field testing. proposed rules that are applicable to the 2016. To determine whether to authorize public. Notices of hearings and investigations, shipment and grant approval for the committee meetings, agency decisions and ADDRESSES: You may submit comments by either of the following methods: field testing of the unlicensed product rulings, delegations of authority, filing of referenced in this notice, APHIS petitions and applications and agency • Federal eRulemaking Portal: Go to statements of organization and functions are considers the potential effects of this http://www.regulations.gov/ examples of documents appearing in this product on the safety of animals, public #!docketDetail;D=APHIS-2015-0100. section. health, and the environment. Using the • Postal Mail/Commercial Delivery: risk analysis and other relevant data, Send your comment to Docket No. APHIS has prepared an environmental APHIS–2015–0100, Regulatory Analysis DEPARTMENT OF AGRICULTURE assessment (EA) concerning the field and Development, PPD, APHIS, Station testing of the following unlicensed Animal and Plant Health Inspection 3A–03.8, 4700 River Road Unit 118, veterinary biological product: Service Riverdale, MD 20737–1238. Requester: Antelope Valley Bios, Inc. Supporting documents and any Product: Canine Osteosarcoma [Docket No. APHIS–2015–0100] comments we receive on this docket Vaccine, Live Listeria Vector. may be viewed at http:// Possible Field Test Locations: Availability of an Environmental www.regulations.gov/ Arizona, California, Connecticut, Assessment for Field Testing a Canine #!docketDetail;D=APHIS-2015-0100 or Maryland, New Jersey, Nevada, New Osteosarcoma Vaccine, Live Listeria in our reading room, which is located in York, and Pennsylvania. Vector room 1141 of the USDA South Building, The above-mentioned product 14th Street and Independence Avenue AGENCY: Animal and Plant Health consists of a highly attenuated Listeria SW., Washington, DC. Normal reading Inspection Service, USDA. monocytogenes strain that expresses a room hours are 8 a.m. to 4:30 p.m., ACTION: Notice of availability. HER2/neu chimeric protein. It induces a Monday through Friday, except strong cell-mediated immune response holidays. To be sure someone is there to SUMMARY: We are advising the public as an aid in the treatment of dogs with help you, please call (202) 799–7039 that the Animal and Plant Health osteosarcoma. It will be administered before coming. Inspection Service has prepared an only in a veterinary clinic or veterinary environmental assessment concerning FOR FURTHER INFORMATION CONTACT: Dr. oncology center by trained personnel. authorization to ship for the purpose of Donna Malloy, Operational Support The EA has been prepared in field testing, and then to field test, an Section, Center for Veterinary Biologics, accordance with: (1) The National unlicensed Canine Osteosarcoma Policy, Evaluation, and Licensing, VS, Environmental Policy Act of 1969 Vaccine, Live Listeria Vector. The APHIS, 4700 River Road Unit 148, (NEPA), as amended (42 U.S.C. 4321 et environmental assessment, which is Riverdale, MD 20737–1231; phone (301) seq.), (2) regulations of the Council on based on a risk analysis prepared to 851–3426, fax (301) 734–4314. Environmental Quality for assess the risks associated with the field For information regarding the implementing the procedural provisions testing of this vaccine, examines the environmental assessment or the risk of NEPA (40 CFR parts 1500–1508), (3) potential effects that field testing this analysis, or to request a copy of the USDA regulations implementing NEPA veterinary vaccine could have on the environmental assessment (as well as (7 CFR part 1b), and (4) APHIS’ NEPA quality of the human environment. the risk analysis with confidential Implementing Procedures (7 CFR part Based on the risk analysis and other business information removed), contact 372). relevant data, we have reached a Dr. Patricia L. Foley, Risk Manager, Unless substantial issues with adverse preliminary determination that field Center for Veterinary Biologics, Policy, environmental impacts are raised in testing this veterinary vaccine will not Evaluation, and Licensing, VS, APHIS, response to this notice, APHIS intends have a significant impact on the quality 1920 Dayton Avenue, P.O. Box 844, to issue a finding of no significant of the human environment, and that an Ames, IA 50010; phone (515) 337–6100, impact (FONSI) based on the EA and environmental impact statement need fax (515) 337–6120. authorize shipment of the above product not be prepared. We intend to authorize SUPPLEMENTARY INFORMATION: Under the for the initiation of field tests following shipment of this vaccine for field testing Virus-Serum-Toxin Act (21 U.S.C. 151 the close of the comment period for this following the close of the comment et seq.), a veterinary biological product notice. period for this notice unless new must be shown to be pure, safe, potent, Because the issues raised by field substantial issues bearing on the effects and efficacious before a veterinary testing and by issuance of a license are of this action are brought to our biological product license may be identical, APHIS has concluded that the asabaliauskas on DSK3SPTVN1PROD with NOTICES attention. We also intend to issue a U.S. issued. A field test is generally EA that is generated for field testing Veterinary Biological Product license for necessary to satisfy prelicensing would also be applicable to the this vaccine, provided the field test data requirements for veterinary biological proposed licensing action. Provided that support the conclusions of the products. Prior to conducting a field test the field test data support the environmental assessment and the on an unlicensed product, an applicant conclusions of the original EA and the issuance of a finding of no significant must obtain approval from the Animal issuance of a FONSI, APHIS does not impact and the product meets all other and Plant Health Inspection Service intend to issue a separate EA and FONSI requirements for licensing. (APHIS), as well as obtain APHIS’ to support the issuance of the product VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1

Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices 12859 license, and would determine that an Monday through Friday, except must inform the public by publishing an environmental impact statement need holidays. To be sure someone is there to annual notice in the Federal Register not be prepared. APHIS intends to issue help you, please call (202) 7997039 that provides the following information: a veterinary biological product license before coming. (1) The SPS standards under for this vaccine following completion of FOR FURTHER INFORMATION CONTACT: For consideration or planned for the field test provided no adverse general information on the topics consideration by the international impacts on the human environment are covered in this notice, contact Ms. standard-setting organization; and (2) identified and provided the product Jessica Mahalingappa, Assistant Deputy for each SPS standard specified, a meets all other requirements for Administrator for Trade and Capacity description of the consideration or licensing. Building, International Services, APHIS, planned consideration of that standard, Authority: 21 U.S.C. 151–159. Room 1132, USDA South Building, 14th a statement of whether the United States Street and Independence Avenue SW., is participating or plans to participate in Done in Washington, DC, this 7th day of the consideration of that standard, the March 2016. Washington, DC 20250; (202) 799–7121. For specific information regarding agenda for U.S. participation, if any, and Kevin Shea, the agency responsible for representing standard-setting activities of the World Administrator, Animal and Plant Health the United States with respect to that Inspection Service. Organization for Animal Health, contact Dr. Michael David, Director, standard. [FR Doc. 2016–05533 Filed 3–10–16; 8:45 am] International Animal Health Standards ‘‘International standard’’ is defined in BILLING CODE 3410–34–P Team, National Import Export Services, 19 U.S.C. 2578b as any standard, VS, APHIS, 4700 River Road Unit 33, guideline, or recommendation: (1) Riverdale, MD 20737–1231; (301) 851– Adopted by the Codex Alimentarius DEPARTMENT OF AGRICULTURE Commission (Codex) regarding food 3302. For specific information regarding the safety; (2) developed under the auspices Animal and Plant Health Inspection of the World Organization for Animal Service standard-setting activities of the Health (OIE, formerly known as the International Plant Protection [Docket No. APHIS–2015–0105] Office International des Epizooties) Convention, contact Dr. Marina Zlotina, regarding animal health and welfare, IPPC Technical Director, International International Sanitary and and zoonoses; (3) developed under the Phytosanitary Standards, PPQ, APHIS, Phytosanitary Standard-Setting auspices of the Secretariat of the 4700 River Road Unit 130, Riverdale, Activities International Plant Protection MD 20737, (301) 851–2200. Convention (IPPC) in cooperation with AGENCY: Animal and Plant Health For specific information on the North the North American Plant Protection Inspection Service, USDA. American Plant Protection Organization, Organization (NAPPO) regarding plant ACTION: Notice and request for contact Ms. Patricia Abad, NAPPO health; or (4) established by or comments. Technical Director, International developed under any other international Phytosanitary Standards, PPQ, APHIS, organization agreed to by the member SUMMARY: In accordance with legislation 4700 River Road Unit 130, Riverdale, countries of the North American Free implementing the results of the Uruguay MD, 20737, (301) 851–2264. Trade Agreement (NAFTA) or the Round of negotiations under the General SUPPLEMENTARY INFORMATION: member countries of the WTO. Agreement on Tariffs and Trade, we are The President, pursuant to informing the public of the international Background Proclamation No. 6780 of March 23, standard-setting activities of the World The World Trade Organization (WTO) 1995 (60 FR 15845), designated the Organization for Animal Health, the was established as the common Secretary of Agriculture as the official Secretariat of the International Plant international institutional framework for responsible for informing the public of Protection Convention, and the North governing trade relations among its the SPS standard-setting activities of American Plant Protection Organization, members in matters related to the Codex, OIE, IPPC, and NAPPO. The and we are soliciting public comment Uruguay Round Agreements. The WTO United States Department of on the standards to be considered. is the successor organization to the Agriculture’s (USDA’s) Food Safety and ADDRESSES: You may submit comments General Agreement on Tariffs and Inspection Service (FSIS) informs the by either of the following methods: Trade. U.S. membership in the WTO public of Codex standard-setting • Federal eRulemaking Portal: Go to was approved by Congress when it activities, and USDA’s Animal and http://www.regulations.gov/ enacted the Uruguay Round Agreements Plant Health Inspection Service (APHIS) #!docketDetail;D=APHIS-2015-0105. Act (Pub. L. 103–465), which was informs the public of OIE, IPPC, and • Postal Mail/Commercial Delivery: signed into law on December 8, 1994. NAPPO standard-setting activities. Send your comment to Docket No. The WTO Agreements, which FSIS publishes an annual notice in APHIS–2015–0105, Regulatory Analysis established the WTO, entered into force the Federal Register to inform the and Development, PPD, APHIS, Station with respect to the United States on public of SPS standard-setting activities 3A–03.8, 4700 River Road Unit 118, January 1, 1995. The Uruguay Round for Codex. Codex was created in 1962 by Riverdale, MD 20737–1238. Agreements Act amended Title IV of the two United Nations organizations, the Supporting documents and any Trade Agreements Act of 1979 (19 Food and Agriculture Organization comments we receive on this docket U.S.C. 2531 et seq.). Section 491 of the (FAO) and the World Health asabaliauskas on DSK3SPTVN1PROD with NOTICES may be viewed at http:// Trade Agreements Act of 1979, as Organization. It is the major www.regulations.gov/ amended (19 U.S.C. 2578), requires the international organization for #!docketDetail;D=APHIS-2015-0105 or President to designate an agency to be encouraging international trade in food in our reading room, which is located in responsible for informing the public of and protecting the health and economic room 1141 of the USDA South Building, the sanitary and phytosanitary (SPS) interests of consumers. 14th Street and Independence Avenue standard-setting activities of each APHIS is responsible for publishing SW., Washington, DC. Normal reading international standard-setting an annual notice of OIE, IPPC, and room hours are 8 a.m. to 4:30 p.m., organization. The designated agency NAPPO activities related to VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1


Document Created: 2016-03-11 01:51:36
Document Modified: 2016-03-11 01:51:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesWe will consider all comments that we receive on or before April 11, 2016.
ContactDr. 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.
FR Citation81 FR 12858 
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