81_FR_29615 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

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)

Page Range29523-29524
FR Document2016-11149

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 Issue 92 (Thursday, May 12, 2016) 
[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

Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Notices 29523 3A–03.8, 4700 River Road Unit 118, product, an applicant must obtain conclusions of the original EA and the Riverdale, MD 20737–1238. approval from APHIS, as well as obtain issuance of a FONSI, APHIS does not Supporting documents and any APHIS’ authorization to ship the intend to issue a separate EA and FONSI comments we receive on this docket product for field testing. to support the issuance of the product may be viewed at http:// To determine whether to authorize license, and would determine that an www.regulations.gov/ shipment and grant approval for the environmental impact statement need #!docketDetail;D=APHIS-2016-0028 or field testing of the unlicensed product not be prepared. APHIS intends to issue in our reading room, which is located in referenced in this notice, APHIS a veterinary biological product license room 1141 of the USDA South Building, considers the potential effects of this for this vaccine following completion of 14th Street and Independence Avenue product on the safety of animals, public the field test provided no adverse SW., Washington, DC. Normal reading health, and the environment. Based impacts on the human environment are room hours are 8 a.m. to 4:30 p.m., upon a risk analysis provided by the identified and provided the product Monday through Friday, except requester and other relevant data, meets all other requirements for holidays. To be sure someone is there to APHIS has prepared an environmental licensing. help you, please call (202) 7997039 assessment (EA) concerning the field Authority: 21 U.S.C. 151–159. before coming. testing of the following unlicensed veterinary biological product: Done in Washington, DC, this 6th day of FOR FURTHER INFORMATION CONTACT: Dr. Requester: Merck Animal Health, May 2016. Donna Malloy, Operational Support Intervet Inc. Kevin Shea, Section, Center for Veterinary Biologics, Product: Infectious Laryngotracheitis- Administrator, Animal and Plant Health Policy, Evaluation, and Licensing, VS, Marek’s Disease-Newcastle Disease Inspection Service. APHIS, 4700 River Road Unit 148, Vaccine, Serotype 3, Live Marek’s [FR Doc. 2016–11148 Filed 5–11–16; 8:45 am] Riverdale, MD 20737–1231; phone (301) Disease Vector. BILLING CODE 3410–34–P 851–3426, fax (301) 734–4314. Possible Field Test Locations: For information regarding the Arkansas, South Carolina, and Georgia. environmental assessment or the risk The above-mentioned product is a DEPARTMENT OF AGRICULTURE analysis, or to request a copy of the live Marek’s Disease serotype 3 vaccine environmental assessment (as well as virus containing a gene from the Animal and Plant Health Inspection the risk analysis with confidential Newcastle disease virus and two genes Service business information removed), contact from the infectious laryngotracheitis Dr. Patricia L. Foley, Risk Manager, [Docket No. APHIS–2016–0020] virus. The attenuated vaccine is Center for Veterinary Biologics, Policy, intended for use in healthy 18-day-old Evaluation, and Licensing, VS, APHIS, Availability of an Environmental or older embryonated eggs or day-old Assessment for Issuance of a Permit 1920 Dayton Avenue, P.O. Box 844, chickens, as an aid in the prevention of Ames, IA 50010; phone (515) 337–6100, for Distribution and Sale for infectious laryngotracheitis, Marek’s Emergency Use of a Classical Swine fax (515) 337–6120. disease, and Newcastle disease. Fever Virus Vaccine, Live Pestivirus SUPPLEMENTARY INFORMATION: Under the The EA has been prepared in Vector Virus-Serum-Toxin Act (21 U.S.C. 151 accordance with: (1) The National et seq.), the Animal and Plant Health Environmental Policy Act of 1969 AGENCY: Animal and Plant Health Inspection Service (APHIS) is (NEPA), as amended (42 U.S.C. 4321 et Inspection Service, USDA. authorized to promulgate regulations seq.), (2) regulations of the Council on ACTION: Notice of availability. designed to ensure that veterinary Environmental Quality for biological products are pure, safe, implementing the procedural provisions SUMMARY: We are advising the public potent, and efficacious before a of NEPA (40 CFR parts 1500–1508), (3) that the Animal and Plant Health veterinary biological product license USDA regulations implementing NEPA Inspection Service has prepared an may be issued. Veterinary biological (7 CFR part 1b), and (4) APHIS’ NEPA environmental assessment concerning products include viruses, serums, Implementing Procedures (7 CFR part authorization to import under permit, toxins, and analogous products of 372). for distribution and sale for emergency natural or synthetic origin, such as We are publishing this notice to use, a Classical Swine Fever Virus vaccines, antitoxins, or the immunizing inform the public that we will accept Vaccine, Live Pestivirus Vector. The components of microorganisms written comments regarding the EA environmental assessment, which is intended for the diagnosis, treatment, or from interested or affected persons for a based on a risk analysis prepared to prevention of diseases in domestic period of 30 days from the date of this assess the risks associated with the use animals. notice. Unless substantial issues with of this vaccine, examines the potential APHIS issues licenses to qualified adverse environmental impacts are effects that this veterinary vaccine could establishments that produce veterinary raised in response to this notice, APHIS have on the quality of the human biological products and issues permits intends to issue a finding of no environment. Based on the risk analysis to importers of such products. APHIS significant impact (FONSI) based on the and other relevant data, we have also enforces requirements concerning EA and authorize shipment of the above reached a preliminary determination production, packaging, labeling, and product for the initiation of field tests that use of this veterinary vaccine will shipping of these products and sets following the close of the comment not have a significant impact on the asabaliauskas on DSK3SPTVN1PROD with NOTICES standards for the testing of these period for this notice. quality of the human environment, and products. Regulations concerning Because the issues raised by field that an environmental impact statement veterinary biological products are testing and by issuance of a license are need not be prepared. We intend to contained in 9 CFR parts 101 to 124. identical, APHIS has concluded that the authorize shipment of this vaccine A field test is generally necessary to EA that is generated for field testing under permit for distribution and sale satisfy prelicensing requirements for would also be applicable to the for emergency use in the United States veterinary biological products. Prior to proposed licensing action. Provided that following the close of the comment conducting a field test on an unlicensed the field test data support the period for this notice unless new VerDate Sep<11>2014 17:02 May 11, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\12MYN1.SGM 12MYN1

29524 Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Notices substantial issues bearing on the effects APHIS issues licenses to qualified seq.), (2) regulations of the Council on of this action are brought to our establishments that produce veterinary Environmental Quality for attention and provided the product biological products and issues permits implementing the procedural provisions meets all requirements for approval. to importers of such products. APHIS of NEPA (40 CFR parts 1500–1508), (3) DATES: We will consider all comments also enforces requirements concerning USDA regulations implementing NEPA that we receive on or before June 13, production, packaging, labeling, and (7 CFR part 1b), and (4) APHIS’ NEPA 2016. shipping of these products and sets Implementing Procedures (7 CFR part standards for the testing of these 372). ADDRESSES: You may submit comments products. Regulations concerning Unless substantial issues with adverse by either of the following methods: veterinary biological products are environmental impacts are raised in • Federal eRulemaking Portal: Go to contained in 9 CFR parts 101 to 124. response to this notice, APHIS intends http://www.regulations.gov/ Veterinary biological products to issue a finding of no significant #!docketDetail;D=APHIS-2016-0020. meeting the requirements of the impact based on the EA and authorize • Postal Mail/Commercial Delivery: regulations may be considered for the importation under permit of the Send your comment to Docket No. addition to the U.S. National Veterinary above product for distribution and sale APHIS–2016–0020, Regulatory Analysis Stockpile (NVS). The NVS is the for emergency use following the close of and Development, PPD, APHIS, Station nation’s repository of vaccines and other the comment period for this notice, 3A–03.8, 4700 River Road Unit 118, critical veterinary supplies and provided the product meets all other Riverdale, MD 20737–1238. equipment. It exists to augment State requirements for approval. Supporting documents and any and local resources in responding to comments we receive on this docket Authority: 21 U.S.C. 151–159. high-consequence livestock diseases may be viewed at http:// that could potentially devastate U.S. Done in Washington, DC, this 6th day of www.regulations.gov/#!docketDetail; agriculture, seriously affect the May 2016. D=APHIS-2016-0020 or in our reading economy, and threaten public health. Kevin Shea, room, which is located in Room 1141 of The NVS vaccines would be used in Administrator, Animal and Plant Health the USDA South Building, 14th Street APHIS programs or under U.S. Inspection Service. and Independence Avenue SW., Department of Agriculture control or [FR Doc. 2016–11149 Filed 5–11–16; 8:45 am] Washington, DC. Normal reading room supervision. The manufacturer of BILLING CODE 3410–34–P hours are 8 a.m. to 4:30 p.m., Monday Classical Swine Fever Virus Vaccine, through Friday, except holidays. To be Live Pestivirus Vector, has been sure someone is there to help you, awarded a contract to supply the DEPARTMENT OF AGRICULTURE please call (202) 799–7039 before vaccine to the NVS for emergency use coming. in the United States. The addition of Animal and Plant Health Inspection this vaccine to the stockpile would not Service FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support preclude private development and use [Docket No. APHIS–2015–0042] Section, Center for Veterinary Biologics, of other vaccines meeting the Policy, Evaluation, and Licensing, VS, requirements of the Virus-Serum-Toxin Notice of Availability of an Evaluation APHIS, 4700 River Road Unit 148, Act. of the Fever Tick Status of the State of Riverdale, MD 20737–1231; phone (301) To determine whether to authorize Chihuahua, Excluding the 851–3426, fax (301) 734–4314. shipment and grant approval for the use Municipalities of Guadalupe y Calvo For information regarding the of the imported product referenced in and Morelos environmental assessment or the risk this notice, APHIS has considered the AGENCY: Animal and Plant Health analysis, or to request a copy of the potential effects of this product on the Inspection Service, USDA. environmental assessment (as well as safety of animals, public health, and the environment. Using a risk analysis and ACTION: Notice of availability. the risk analysis with confidential business information removed), contact other relevant data, APHIS has prepared SUMMARY: We are notifying the public Dr. Patricia L. Foley, Risk Manager, an environmental assessment (EA) that we have prepared an evaluation of Center for Veterinary Biologics, Policy, concerning the safety testing of the the State of Chihuahua, excluding the Evaluation, and Licensing, VS, APHIS, following unlicensed veterinary municipalities of Guadalupe y Calvo 1920 Dayton Avenue, P.O. Box 844, biological product: and Morelos, for fever ticks. The Requester: Zoetis, Inc. evaluation concludes that this region is Ames, IA 50010; phone (515) 337–6100, Product: Classical Swine Fever Virus fax (515) 337–6120. free from fever ticks, and that ruminants Vaccine, Live Pestivirus Vector. imported from the area pose a low risk SUPPLEMENTARY INFORMATION: Under the The above-mentioned product is a Virus-Serum-Toxin Act (21 U.S.C. 151 of exposing ruminants within the single-dose 1-mL modified live product et seq.), the Animal and Plant Health United States to fever ticks. We are for emergency vaccination in an Inspection Service (APHIS) is making the evaluation available for outbreak situation. The proposed authorized to promulgate regulations review and comment. indication is intramuscular designed to ensure that veterinary administration to healthy swine 6 weeks DATES: We will consider all comments biological products are pure, safe, of age or older as an aid in preventing that we receive on or before July 11, potent, and efficacious. Veterinary 2016. asabaliauskas on DSK3SPTVN1PROD with NOTICES mortality and viremia caused by biological products include viruses, classical swine fever virus. ADDRESSES: You may submit comments serums, toxins, and analogous products Possible Field Use Locations: Where by either of the following methods: of natural or synthetic origin, such as Federal and State authorities agree on • Federal eRulemaking Portal: Go to vaccines, antitoxins, or the immunizing use. http://www.regulations.gov/ components of microorganisms The EA has been prepared in #!docketDetail;D=APHIS-2015-0042. intended for the diagnosis, treatment, or accordance with: (1) The National • Postal Mail/Commercial Delivery: prevention of diseases in domestic Environmental Policy Act of 1969 Send your comment to Docket No. animals. (NEPA), as amended (42 U.S.C. 4321 et APHIS–2015–0042, Regulatory Analysis VerDate Sep<11>2014 17:02 May 11, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 E:\FR\FM\12MYN1.SGM 12MYN1


Document Created: 2016-05-12 01:07:15
Document Modified: 2016-05-12 01:07:15
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 June 13, 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 29523 
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