Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Infectious Laryngotracheitis, Marek's Disease, and Newcastle Disease, 29522-29523 [2016-11148]

Download as PDF 29522 Notices Federal Register Vol. 81, No. 92 Thursday, May 12, 2016 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. DEPARTMENT OF AGRICULTURE Office of the Secretary Meeting Notice of the National Agricultural Research, Extension, Education, and Economics Advisory Board Research, Education, and Economics, USDA. ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, Section 1408 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3123), and the Agricultural Act of 2014, the United States Department of Agriculture (USDA) announces an open meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board. DATES: The National Agricultural Research, Extension, Education, and Economics Advisory Board will meet from 8:30 a.m. until 5:00 p.m. EDT on May 23, 2016, and May 24, 2016. ADDRESSES: The meeting will be held at the Grand Hyatt Washington, 1000 H Street NW., Washington, DC. Written comments from the public may be sent to: The National Agricultural Research, Extension, Education, and Economics Advisory Board Office, Room 332A, Whitten Building, United States Department of Agriculture, STOP 0321, 1400 Independence Avenue SW., Washington, DC 20250–0321. FOR FURTHER INFORMATION CONTACT: Michele Esch, Executive Director, or Shirley Morgan-Jordan, Program Support Coordinator, National Agricultural Research, Extension, Education, and Economics Advisory Board; telephone: (202) 720–3684; fax: (202) 720–6199; or email: michele.esch@ usda.gov or Shirley.Morgan@ ars.usda.gov. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:02 May 11, 2016 Jkt 238001 SUPPLEMENTARY INFORMATION: Purpose of the Meeting: To provide advice and recommendations on the top priorities and policies for food and agricultural research, education, extension and economics. Tentative Agenda: The agenda can be found at https://nareeeab.ree.usda.gov/ meetings/general-meetings will include the following items: • Discussion and deliberation on the draft report of recommendations on the mandatory annual relevance and adequacy review of the food safety and human nutrition programs and activities of the Research, Education, and Economics mission area and to establish the relevance and adequacy committee for the 2017 review on responding to climate and energy needs. • Discussion on establishing national priorities and on reviewing the mechanism for technology assessment in USDA. • Updates on the activities of the Research, Education, and Economics mission area. • Updates from the permanent subcommittees and working groups of the NAREEE Advisory Board, including the presentation and deliberation of the letter of Recommendations of the Citrus Disease Subcommittee on the annual consultation with the National Institute of Food and Agriculture. Public Participation: This meeting is open to the public and any interested individuals wishing to attend. Opportunity for public comment will be offered each day of the meeting. To attend the meeting and/or make oral statements regarding any items on the agenda, you must contact Shirley Morgan-Jordan at 202–720–3684; email: shirley.morgan@ars.usda.gov at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. The Chair will conduct the meeting to facilitate the orderly conduct of business. Written comments by attendees or other interested stakeholders will be welcomed for the public record before and up to two weeks following the Board meeting (by close of business Friday, June 10, 2016). All written statements must be sent to Michele Esch, Designated Federal Officer and Executive Director, at the address listed above or via email nareee@ars.usda.gov. All statements will become a part of the PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 official record of the National Agricultural Research, Extension, Education, and Economics Advisory Board and will be kept on file for public review in the Research, Education, and Economics Advisory Board Office. Done at Washington, DC, this 4th day of May 2016. Ann M. Bartuska, Deputy Under Secretary, Research, Education and Economics. [FR Doc. 2016–11211 Filed 5–11–16; 8:45 am] BILLING CODE 3410–03–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2016–0028] Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Infectious Laryngotracheitis, Marek’s Disease, and Newcastle Disease Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. AGENCY: 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 Infectious LaryngotracheitisMarek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. 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 June 13, 2016. SUMMARY: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2016-0028. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2016–0028, Regulatory Analysis and Development, PPD, APHIS, Station ADDRESSES: E:\FR\FM\12MYN1.SGM 12MYN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Notices 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS-2016-0028 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) 7997039 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 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 VerDate Sep<11>2014 17:02 May 11, 2016 Jkt 238001 product, an applicant must obtain approval from 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 provided by the requester and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: Merck Animal Health, Intervet Inc. Product: Infectious LaryngotracheitisMarek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. Possible Field Test Locations: Arkansas, South Carolina, and Georgia. The above-mentioned product is a live Marek’s Disease serotype 3 vaccine virus containing a gene from the Newcastle disease virus and two genes from the infectious laryngotracheitis virus. The attenuated vaccine is intended for use in healthy 18-day-old or older embryonated eggs or day-old chickens, as an aid in the prevention of infectious laryngotracheitis, Marek’s disease, and Newcastle disease. 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 proposed licensing action. Provided that the field test data support the PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 29523 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 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 6th day of May 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2016–11148 Filed 5–11–16; 8:45 am] BILLING CODE 3410–34–P 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. AGENCY: 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 SUMMARY: E:\FR\FM\12MYN1.SGM 12MYN1

Agencies

[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Notices]
[Pages 29522-29523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11148]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0028]


Availability of an Environmental Assessment for Field Testing of 
a Vaccine for Use Against Infectious Laryngotracheitis, Marek's 
Disease, and Newcastle Disease

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 Infectious Laryngotracheitis-Marek's Disease-
Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease Vector. 
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 June 
13, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2016-0028.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0028, Regulatory Analysis and Development, PPD, 
APHIS, Station

[[Page 29523]]

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 https://www.regulations.gov/#!docketDetail;D=APHIS-2016-
0028 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) 7997039 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 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 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 
provided by the requester and other relevant data, APHIS has prepared 
an environmental assessment (EA) concerning the field testing of the 
following unlicensed veterinary biological product:
    Requester: Merck Animal Health, Intervet Inc.
    Product: Infectious Laryngotracheitis-Marek's Disease-Newcastle 
Disease Vaccine, Serotype 3, Live Marek's Disease Vector.
    Possible Field Test Locations: Arkansas, South Carolina, and 
Georgia.
    The above-mentioned product is a live Marek's Disease serotype 3 
vaccine virus containing a gene from the Newcastle disease virus and 
two genes from the infectious laryngotracheitis virus. The attenuated 
vaccine is intended for use in healthy 18-day-old or older embryonated 
eggs or day-old chickens, as an aid in the prevention of infectious 
laryngotracheitis, Marek's disease, and Newcastle disease.
    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 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 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 6th day of May 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-11148 Filed 5-11-16; 8:45 am]
BILLING CODE 3410-34-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.