Availability of an Environmental Assessment for Field Testing Foot-and-Mouth Disease Vaccine, Live Adenovirus Vector, 54589-54590 [2010-22365]

Download as PDF 54589 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Lynn Rodgers-Kuperman, Branch Chief, Program Analysis and Monitoring Branch, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 640, Alexandria, VA 22302. Comments will also be accepted through the Federal eRulemaking Portal. Go to https:// www.regulations.gov, and follow the online instructions for submitting comments electronically. All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5 p.m. Monday through Friday) at 3101 Park Center Drive, Room 640, Alexandria, Virginia 22302. All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record. during the school year beginning July 1, 1980, unless exemptions or waivers are met, as described in 7 CFR 210.17. FNS uses form FNS–13 to collect data on State revenue matching to meet the reporting required by 7 CFR 210.17(g). The form is an intrinsic part of the accounting system currently being used by the subject programs to ensure proper reimbursement as well as to facilitate adequate recordkeeping. The FNS–13 form is provided to States through a web-based Federal reporting system and 100 percent of the information is collected through electronic means. The instructions on FNS–13 are being updated and this is a minor change that did not increase the burden hours. The burden hours have not changed. Affected Public: State agencies. Estimated Number of Respondents: 57 State agencies. Estimated Number of Responses per Respondent: 1. Estimated Total Annual Responses: 57. Estimated Time per Response: 80 hours. Estimated Total Annual Burden on Respondents: 4,560 hours. See the table below for estimated total annual burden for each type of respondent. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of this information collection should be directed to Ms. Lynn RodgersKuperman at (703) 305–2590. SUPPLEMENTARY INFORMATION: Title: 7 CFR part 210, National School Lunch Program. OMB Number: 0584–0075, Form Number FNS–13. Expiration Date: 1/31/2011. Type of Request: Revision of a currently approved collection. Abstract: The Food and Nutrition Service administers the National School Lunch Program, the School Breakfast Program, and the Special Milk Program as mandated by the Richard B. Russell National School Lunch Act (NSLA), as amended (42 U.S.C. 1751 et seq.), and the Child Nutrition Act of 1966, as amended (42 U.S.C. 1771 et seq.). Information on school program operations is collected from State agencies on a yearly basis to monitor and make adjustments to State agency funding requirements. As provided in 7 CFR 210.17, each school year, State revenues must be appropriated or used specifically by the State for Federal school lunch program purposes. The amount that must be appropriated or used generally is at least 30% of the funds received by the State under Section 4 of the NSLA (42 U.S.C. 1753) Estimated number of respondents Respondent Responses annually per respondent Total annual responses (col. b x c) Estimated average number of hours per response Estimated total hours (col. d x e) Reporting Burden: State agency ................................................................. 57 1 57 80 4,560 Total Reporting Burden ......................................... ........................ ........................ ........................ ........................ 4,560 Dated: September 1, 2010. Jeffrey Tribiano, Acting Administrator, Food and Nutrition Service. [FR Doc. 2010–22374 Filed 9–7–10; 8:45 am] BILLING CODE 3410–30–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service jlentini on DSKJ8SOYB1PROD with NOTICES [Docket No. APHIS–2010–0011] Availability of an Environmental Assessment for Field Testing Footand-Mouth Disease Vaccine, Live Adenovirus Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: VerDate Mar<15>2010 16:41 Sep 07, 2010 Jkt 220001 We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment (EA) concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed foot-and-mouth disease vaccine, live adenovirus vector. The EA, 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 SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 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 EA and the issuance of a finding of no significant impact and the product meets all other requirements for licensing. We will consider all comments that we receive on or before October 8, 2010. 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=APHIS2010-0011) to submit or view comments DATES: E:\FR\FM\08SEN1.SGM 08SEN1 54590 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices and to view supporting and related materials available electronically. ∑ Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS-2010-0011, 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. APHIS2010-0011. 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 207371231; 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, Ames, IA 50010; phone (515) 337-6100, fax (515) 3377397. 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 conducted a risk analysis to assess the jlentini on DSKJ8SOYB1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:41 Sep 07, 2010 Jkt 220001 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: Per-Os USA Inc. under contract with GenVec, Inc. Product: Foot-and-mouth disease vaccine, live adenovirus vector. Field Test Locations: Nebraska, Missouri, and Michigan. The above-mentioned product consists of a live recombinant adenovirus vector expressing certain foot-and-mouth disease virus proteins. The vaccine is for use in cattle at 12 weeks of age or older, as an aid in the prevention of clinical signs of disease caused by foot-and-mouth disease virus. 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 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. PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 Done in Washington, DC, this 1st day of September 2010. Gregory L. Parham Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2010–22365 Filed 9–7–10: 8:45 am] BILLING CODE 3410–34–S DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS–NOP–10–0066; NOP–10–07] Notice of 2010 National Organic Certification Cost-Share Program Agricultural Marketing Service, USDA. ACTION: Notice of Funds Availability. Inviting Applications for the National Organic Certification Cost-Share Program. AGENCY: This Notice invites all States of the United States of America, its territories, the District of Columbia, and the Commonwealth of Puerto Rico, (collectively hereinafter called States) to submit an Application for Federal Assistance (Standard Form 424), and to enter into a cooperative agreement with the Agricultural Marketing Service (AMS) for the allocation of National Organic Certification Cost-Share Funds. The AMS has allocated $22.0 million for this organic certification cost-share program commencing in Fiscal Year 2008, and these funds will be annually allocated to States through cooperative agreements until exhausted. Funds are available under this program to States interested in providing cost-share assistance to organic producers and handlers certified under the National Organic Program (NOP). States interested in obtaining cost-share funds must submit an Application for Federal Assistance and enter into a cooperative agreement with AMS for allocation of funds. DATES: Completed applications for Federal assistance along with signed cooperative agreements must be received by September 24, 2010. ADDRESSES: Applications for Federal assistance and cooperative agreements shall be submitted to: Betsy Rakola, Grants Management Specialist, National Organic Program, USDA/AMS/NOP, Room 2640-South, Ag Stop 0268, 1400 Independence Avenue, SW., Washington, DC 20250–0268; Telephone: (202) 720–3252. Additional information can be found under ‘‘Organic Cost Share Program’’ on the National Organic Program’s homepage at https://www.ams.usda.gov/nop. SUMMARY: E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Notices]
[Pages 54589-54590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22365]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0011]


Availability of an Environmental Assessment for Field Testing 
Foot-and-Mouth Disease Vaccine, Live Adenovirus 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 (EA) 
concerning authorization to ship for the purpose of field testing, and 
then to field test, an unlicensed foot-and-mouth disease vaccine, live 
adenovirus vector. The EA, 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 EA 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 
October 8, 2010.

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-2010-0011) to submit or view comments

[[Page 54590]]

and to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2010-0011, 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-2010-0011.
    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, Ames, IA 50010; phone (515) 337-6100, fax (515) 337-7397.

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 conducted a risk analysis 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: Per-Os USA Inc. under contract with GenVec, Inc.
    Product: Foot-and-mouth disease vaccine, live adenovirus vector.
    Field Test Locations: Nebraska, Missouri, and Michigan.
    The above-mentioned product consists of a live recombinant 
adenovirus vector expressing certain foot-and-mouth disease virus 
proteins. The vaccine is for use in cattle at 12 weeks of age or older, 
as an aid in the prevention of clinical signs of disease caused by 
foot-and-mouth disease virus.
    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 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 1st day of September 2010.

Gregory L. Parham
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-22365 Filed 9-7-10: 8:45 am]
BILLING CODE 3410-34-S
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