Availability of an Environmental Assessment for Field Testing Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live Marek's Disease Vector, 66032-66033 [2011-27555]

Download as PDF 66032 Notices Federal Register Vol. 76, No. 206 Tuesday, October 25, 2011 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 Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0094] Availability of an Environmental Assessment for Field Testing Avian Influenza-Marek’s Disease Vaccine, H5 Subtype, Serotype 3, Live Marek’s Disease Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice. 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 Avian Influenza-Marek’s Disease Vaccine, H5 Subtype, Serotype 3, Live Marek’s Disease 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, 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. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:10 Oct 24, 2011 Jkt 226001 We will consider all comments that we receive on or before November 25, 2011. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS–2011– 0094–0001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2011–0094, 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS–2011–0094 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) 690–2817 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) 734–8245, 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’ DATES: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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, a risk analysis has been prepared to assess the potential effects of this product on the safety of animals, public health, and the environment. Based on the risk analysis, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: Biomune Company. Product: Avian Influenza-Marek’s Disease Vaccine, H5 Subtype, Serotype 3, Live Marek’s Disease Vector. Field Test Locations: Delaware and Kansas. The above-mentioned product consists of a live recombinant Marek’s disease virus vector expressing an avian influenza virus protein. The vaccine is for in ovo vaccination of 18-day-old chick embryos or for the subcutaneous vaccination of healthy day-of-age chicks as an aid in the prevention of Marek’s Disease and avian influenza. 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 provision 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 license, and would determine that an E:\FR\FM\25OCN1.SGM 25OCN1 Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / Notices 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 19th day of October 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–27555 Filed 10–24–11; 8:45 am] BILLING CODE 3410–34–P 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS-2011-0072 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) 690–2817 before coming. Dr. Arnold Tschanz, Senior Plant Pathologist/Senior Risk Manager, Plants for Planting Policy, RPM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737–1236; (301) 734–0627. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0072] Plants for Planting Whose Importation Is Not Authorized Pending Pest Risk Analysis; Notice of Availability of Data Sheets for Taxa of Plants for Planting That Are Quarantine Pests or Hosts of Quarantine Pests Animal and Plant Health Inspection Service, USDA. ACTION: Notice; reopening of comment period. AGENCY: We are reopening the comment period for a notice that advised the public that we have determined that 41 taxa of plants for planting are quarantine pests and 107 taxa of plants for planting are hosts of 13 quarantine pests and therefore should be added to our lists of taxa of plants for planting whose importation is not authorized pending pest risk analysis. The notice also made available to the public for review and comment data sheets that detail the scientific evidence we evaluated in making the determination that the taxa are quarantine pests or hosts of quarantine pests. This action will allow interested persons additional time to prepare and submit comments. DATES: We will consider all comments that we receive on or before November 25, 2011. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2011-00720001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2011–0072, Regulatory Analysis sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:10 Oct 24, 2011 Jkt 226001 SUPPLEMENTARY INFORMATION: On July 26, 2011, we published in the Federal Register (76 FR 44572–44573, Docket No. APHIS–2011–0072) a notice advising the public that we have determined that 41 taxa of plants for planting are quarantine pests and 107 taxa of plants for planting are hosts of 13 quarantine pests and therefore should be added to our lists of taxa of plants for planting whose importation is not authorized pending pest risk analysis. The notice also made available to the public for review and comment data sheets that detail the scientific evidence we evaluated in making the determination that the taxa are quarantine pests or hosts of quarantine pests. Comments on the notice were required to be received on or before September 26, 2011. We are reopening the comment period on Docket No. APHIS–2011–0072 for an additional 30 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between September 27, 2011, and the date of this notice. 66033 DEPARTMENT OF AGRICULTURE Forest Service Madera County Resource Advisory Committee Forest Service, USDA. Notice of meeting. AGENCY: ACTION: The Madera County Resource Advisory Committee will be meeting in North Fork, California on November 15, 2011. The purpose of the meeting will be to to update the committee on the status and monitoring of projects that were recommended for funding at the March 30, 2011 meeting, as authorized under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L.110–343) for expenditure of Payments to States Madera County Title II funds. DATES: The meeting will be held on November 15, 2011. ADDRESSES: The meeting will be held at the Bass Lake Ranger District, 57003 Road 225, North Fork, California, 93643. Send written comments to Julie Roberts, Madera County Resource Advisory Committee Coordinator, c/o Sierra National Forest, Bass Lake Ranger District, at the above address, or electronically to jaroberts@fs.fed.us. FOR FURTHER INFORMATION CONTACT: Julie Roberts, Madera County Resource Advisory Committee Coordinator, (559) 877–2218 ext. 3159. SUPPLEMENTARY INFORMATION: The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, persons who wish to bring Payments to States Madera County Title II project matters to the attention of the Committee may file written statements with the Committee staff before or after the meetings. SUMMARY: Dated: October 18, 2011. Dave Martin, District Ranger. [FR Doc. 2011–27608 Filed 10–24–11; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF AGRICULTURE Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Forest Service Done in Washington, DC, this 19th day of October 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. AGENCY: [FR Doc. 2011–27559 Filed 10–24–11; 8:45 am] BILLING CODE 3410–34–P PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 Sabine Resource Advisory Committee ACTION: Forest Service, USDA. Notice of meeting cancellation. The Sabine-Angelina Resource Advisory Committee was scheduled to meet October 20, 2011 in Hemphill, Texas. The committee is authorized under the Secure Rural SUMMARY: E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66032-66033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27555]


========================================================================
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.

========================================================================


Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / 
Notices

[[Page 66032]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0094]


Availability of an Environmental Assessment for Field Testing 
Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live 
Marek's Disease Vector

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

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 Avian Influenza-Marek's Disease Vaccine, H5 
Subtype, Serotype 3, Live Marek's Disease 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, 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 
November 25, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2011-0094-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2011-0094, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0094 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) 690-2817 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) 734-8245, 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, 
a risk analysis has been prepared to assess the potential effects of 
this product on the safety of animals, public health, and the 
environment. Based on the risk analysis, APHIS has prepared an 
environmental assessment (EA) concerning the field testing of the 
following unlicensed veterinary biological product:
    Requester: Biomune Company.
    Product: Avian Influenza-Marek's Disease Vaccine, H5 Subtype, 
Serotype 3, Live Marek's Disease Vector.
    Field Test Locations: Delaware and Kansas.
    The above-mentioned product consists of a live recombinant Marek's 
disease virus vector expressing an avian influenza virus protein. The 
vaccine is for in ovo vaccination of 18-day-old chick embryos or for 
the subcutaneous vaccination of healthy day-of-age chicks as an aid in 
the prevention of Marek's Disease and avian influenza.
    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 provision 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 license, and would determine that an

[[Page 66033]]

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 19th day of October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-27555 Filed 10-24-11; 8:45 am]
BILLING CODE 3410-34-P
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