Availability of an Environmental Assessment for Field Testing Fowl Laryngotracheitis-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector, 12932-12933 [2011-5341]

Download as PDF 12932 Notices Federal Register Vol. 76, No. 46 Wednesday, March 9, 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–2011–0011] Availability of an Environmental Assessment for Field Testing Fowl Laryngotracheitis-Marek’s Disease Vaccine, 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 Fowl LaryngotracheitisMarek’s Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. The environmental assessment, which is based on a risk analysis prepared for 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. Emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:04 Mar 08, 2011 Jkt 223001 We will consider all comments that we receive on or before April 8, 2011. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/ component/ main?main=DocketDetail&d=APHIS– 2011–0011 to submit or view comments and to view supporting and related materials available electronically. • Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS–2011–0011, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. APHIS– 2011–0011. Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room 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. Other Information: Additional information about APHIS and its programs is available on the Internet at https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, 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 DATES: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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: Fowl LaryngotracheitisMarek’s Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. Field Test Locations: Alabama, Delaware, Pennsylvania, and Texas. The above-mentioned product consists of a live recombinant Marek’s disease virus vector expressing certain fowl laryngotracheitis virus proteins. 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 infectious laryngotracheitis. 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 E:\FR\FM\09MRN1.SGM 09MRN1 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 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 4th day of March 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–5341 Filed 3–8–11; 8:45 am] BILLING CODE 3410–34–P individuals will have the opportunity to address the Committee at that time. [FR Doc. 2011–5295 Filed 3–8–11; 8:45 am] BILLING CODE 3410–11–P Forest Service Dixie Resource Advisory Committee ACTION: Forest Service, USDA. Notice of meetings. The Dixie Resource Advisory Committee will meet in Cedar City, Utah. The committee is meeting as authorized under the Secure Rural Schools and Community SelfDetermination Act (Pub. L. 110–343) and in compliance with the Federal Advisory Committee Act. The purpose of this meeting is to make recommendations for Title II projects. The March 16, 2011 meeting has been cancelled. SUMMARY: Forest Service ADDRESSES: ACTION: Emcdonald on DSK2BSOYB1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: The Prince of Wales Resource Advisory Committee will meet in Thorne Bay, Alaska, March 28, 2011. The purpose of this meeting is to discuss potential projects under the Secure Rural Schools and Community Self-Determination Act of 2008. DATES: The meeting will be held March 28, 2011 from 10 a.m. to 4 p.m. ADDRESSES: The meeting will be held at the Thorne Bay Ranger District 1312 Federal Way Thorne Bay, Alaska. Send written comments to Prince of Wales Resource Advisory Committee, c/o District Ranger, USDA Forest Service, P.O. Box 500, Craig, AK 99921, or electronically to Rebecca Sakraida, RAC Coordinator at rsakraida@fs.fed.us. FOR FURTHER INFORMATION CONTACT: Rebecca Sakraida, RAC Coordinator Craig Ranger District, Tongass National Forest, (907) 826–1601. SUPPLEMENTARY INFORMATION: The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, public input opportunity will be provided and SUMMARY: VerDate Mar<15>2010 18:04 Mar 08, 2011 Jkt 223001 Wednesday, March 30, 2011. The meeting will be held at Paiute Tribe of Utah Headquarters, 440 North Paiute Drive (200 East), Cedar City, Utah. The public is invited to attend the meetings. Forest Service, USDA. Notice of meeting. Kenton Call, RAC Coordinator, Dixie National Forest, (435) 865–3730; e-mail: ckcall@fs.fed.us. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday. The meeting is open to the public. The following business will be conducted: (1) Welcome and committee introductions; (2) review of category voting from previous meeting; (3) discussion of RAC project recommendations; and (4) public comment on any proposals. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input will be accepted by the RAC during the meetings. SUPPLEMENTARY INFORMATION: Dated: March 3, 2011. Robert G. MacWhorter, Forest Supervisor. [FR Doc. 2011–5297 Filed 3–8–11; 8:45 am] BILLING CODE 3410–11–P PO 00000 Frm 00002 Fmt 4703 Forest Service, USDA. Notice of meetings. AGENCY: DEPARTMENT OF AGRICULTURE DATES: AGENCY: North Central Idaho Resource Advisory Committee ACTION: DEPARTMENT OF AGRICULTURE Prince of Wales Resource Advisory Committee DEPARTMENT OF AGRICULTURE Forest Service Francisco B. Sanchez, District Ranger. AGENCY: 12933 Sfmt 4703 The North Central Idaho RAC will meet in Grangeville, Idaho. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110–343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to select projects for 2011 and hear presentations on 2012 projects. The February 23–24 RAC meeting was cancelled due to inclement weather. DATES: The meeting will be held on March 24th and 25th 2011, at 10 a.m. (PST). ADDRESSES: The meeting will be held at the Nez Perce National Forest Supervisors Office, 104 Airport Road, Grangeville, Idaho. Written comments should be sent to Laura Smith at 104 Airport Road in Grangeville, Idaho 83530. Comments may also be sent via e-mail to lasmith@fs.fed.us or via facsimile to Laura at 208–983–4099. FOR FURTHER INFORMATION CONTACT: Laura Smith, Designated Forest Official at 208–983–5143. SUPPLEMENTARY INFORMATION: The meeting is open to the public. A public forum will begin at 3:15 p.m. (PST) on the first meeting day. The following business will be conducted: Comments and questions from the public to the committee. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. SUMMARY: Dated: March 1, 2011. Rick Brazell, Forest Supervisor. [FR Doc. 2011–5106 Filed 3–8–11; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35). Agency: Bureau of Industry and Security. E:\FR\FM\09MRN1.SGM 09MRN1

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[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12932-12933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5341]


========================================================================
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. 46 / Wednesday, March 9, 2011 / 
Notices

[[Page 12932]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0011]


Availability of an Environmental Assessment for Field Testing 
Fowl Laryngotracheitis-Marek's Disease Vaccine, 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 Fowl Laryngotracheitis-Marek's Disease 
Vaccine, Serotype 3, Live Marek's Disease Vector. The environmental 
assessment, which is based on a risk analysis prepared for 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 April 
8, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2011-0011 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2011-0011, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2011-0011.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room 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.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, 
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: Fowl Laryngotracheitis-Marek's Disease Vaccine, Serotype 
3, Live Marek's Disease Vector.
    Field Test Locations: Alabama, Delaware, Pennsylvania, and Texas.
    The above-mentioned product consists of a live recombinant Marek's 
disease virus vector expressing certain fowl laryngotracheitis virus 
proteins. 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 infectious 
laryngotracheitis.
    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

[[Page 12933]]

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 4th day of March 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-5341 Filed 3-8-11; 8:45 am]
BILLING CODE 3410-34-P
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