Availability of an Environmental Assessment for Field Testing Mannheimia Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live Culture, 24213-24214 [E8-9636]

Download as PDF Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices EFFECTIVE DATE: May 2, 2008. FOR FURTHER INFORMATION CONTACT: Vincent J. Fusaro, Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Room 1661, South Building, Stop 0240, Washington, DC 20250–0240, Fax (202) 720–8871, Phone (202) 720–2185, or E-mail Vinny.Fusaro@usda.gov. SUPPLEMENTARY INFORMATION: This document provides correcting amendments to the United States Standards for Grades of Pineapples, which is available at the address cited in the FOR FURTHER INFORMATION CONTACT section or by accessing the AMS, Fresh Products Branch Web site at: https://www.ams.usda.gov/standards/ stanfrfv.htm. Accordingly, the United States Standards for Grades of Pineapples is corrected by changing section 51.1489, Application of Tolerance as follows: ‘‘The contents of individual samples in the lot, are subject to the following limitations: (a) Individual samples shall have not more than double a specified tolerance except that at least two defective specimens may be permitted in any sample: Provided, That no more than one specimen affected by decay be permitted in any sample, and provided further, that the averages for the entire lot are within the tolerances specified for the grades.’’ Dated: April 28, 2008. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E8–9649 Filed 5–1–08; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2008–0051] Availability of an Environmental Assessment for Field Testing Mannheimia Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live Culture Animal and Plant Health Inspection Service, USDA. ACTION: Notice. mstockstill on PROD1PC66 with NOTICES AGENCY: 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 Mannheimia Haemolytica- VerDate Aug<31>2005 17:52 May 01, 2008 Jkt 214001 Pasteurella Multocida Vaccine, Avirulent Live Culture. 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 June 2, 2008. 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-2008-0051 to submit or view comments and to view supporting and related materials available electronically. • Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS–2008–0051, 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– 2008–0051. 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, PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 24213 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, 510 South 17th Street, Suite 104, Ames, IA 50010; phone (515) 232–5785, fax (515) 232–7120. 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: Schering-Plough Animal Health Corporation. Product: Mannheimia HaemolyticaPasteurella Multocida Vaccine, Avirulent Live Culture. Field Test Locations: Colorado, Nebraska, Michigan, Missouri, Wisconsin, California, and New York. The above-mentioned product consists of two live gene deleted bacterial strains, one an avirulent strain of Mannheimia haemolytica, the other an avirulent strain of Pasteurella multocida. The vaccine is for use in cattle as an aid in the prevention and/ or reduction of pneumonic lesions associated with bovine pneumonic pasteurellosis, commonly known as shipping fever. The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 E:\FR\FM\02MYN1.SGM 02MYN1 24214 Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices (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 24th day of April 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8–9636 Filed 5–1–08; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection: Comment Request: FNS–583, Food Stamp Program Employment and Training Program Activity Report Food and Nutrition Service (FNS), USDA. ACTION: Notice. mstockstill on PROD1PC66 with NOTICES AGENCY: In accordance with the Paperwork Reduction Act, this notice invites the general public and other public agencies to comment on a proposed adjustment to the information collection burden for the Food Stamp SUMMARY: VerDate Aug<31>2005 17:17 May 01, 2008 Jkt 214001 Program (FSP) Employment and Training Program, currently approved under OMB No. 0584–0339. This notice proposes to reduce the currently approved burden of 31,721 by 9,966 hours. The adjusted burden is 21,755 hours. The reduction is based on changes in annual estimates for reporting on Employment and Training activities. DATES: Written comments must be submitted on or before July 1, 2008. ADDRESSES: The Food and Nutrition Service invites interested persons to submit comments on this proposed information collection. Send comments to Dale Walton, Program Analyst, Program Design Branch, Program Development Division, FSP, FNS, 3101 Park Center Drive, Room 810, Alexandria, Virginia 22302–1594. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency’s estimate of burden of the proposed collection of information, including validity of the methodology and assumptions used; (c) ways to enhance the 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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other form of information technology. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. FOR FURTHER INFORMATION CONTACT: Dale Walton at (703) 305–2404, or send comment to dale.walton@fns.usda.gov via the Internet. SUPPLEMENTARY INFORMATION: Title: Employment and Training Program Activity Report. OMB Number: 0584–0339. Expiration Date: August 31, 2008. Type of Request: Revision of a currently approved collection. Abstract: 7 CFR 273.7(c)(9) requires State agencies to submit quarterly Employment and Training (E&T) Program Activity Reports containing monthly figures for participation in the program. The Food and Nutrition Service (FNS) uses Form FNS–583 to collect participation data. The information collected on the FNS–583 report includes: • On the first quarter report, the number of work registrants receiving PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 food stamps as of October 1 of the new fiscal year; • On each quarterly report, by month, the number of new work registrants; the number of able-bodied adults without dependents (ABAWDs) applicants and recipients participating in qualifying components; the number of all other applicants and recipients (including ABAWDs involved in non-qualifying activities participating in components; and the number of ABAWDs exempt under the State agency’s 15% exemption allowance. • On the fourth quarter report, the total number of individuals who participated in each component, which is also sorted by ABAWD and nonABAWD participants, and the number of individuals who participated in the E&T Program during the fiscal year. 7 CFR 273.7(d)(1)(i)(D) provides that if a State agency will not expend all of the funds allocated to it for a fiscal year, FNS will reallocate unexpended funds to other State agencies during the fiscal year or the subsequent fiscal year as FNS considers appropriate and equitable. After initial E&T allocations are made, State agencies may request more funds, as needed. Typically, FNS receives ten such requests per year. The burden for the time it takes to prepare these requests is included in the burden. After receiving the State requests, FNS will reallocate unexpended funds as provided above. Following is the revised estimated burden for E&T reporting including the burden for State agencies to request additional funds. Current FNS–583 Report Reporting Frequency: 4. Affected Public: State Agency. Number of Respondents: 53. Number of Responses: 212. Estimated Time per Response: 102.43 hours per State agency. Estimated Total Annual Reporting Burden: 21,715.16 hours. Recordkeeping Number of Respondents: 53. Number of Records: 212. Number of Hours per Record: 0.137 hours. Estimated Total Annual Recordkeeping Burden: 29.044 hours. Requests for Additional Funds Reporting Frequency: 1. Affected Public: State Agency. Number of Respondents: 53. Number of Responses: 10. Estimated Time per Response: 1.00 hour per request. E:\FR\FM\02MYN1.SGM 02MYN1

Agencies

[Federal Register Volume 73, Number 86 (Friday, May 2, 2008)]
[Notices]
[Pages 24213-24214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9636]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0051]


Availability of an Environmental Assessment for Field Testing 
Mannheimia Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live 
Culture

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 Mannheimia Haemolytica-Pasteurella Multocida 
Vaccine, Avirulent Live Culture. 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 June 
2, 2008.

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-2008-0051 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0051, 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-2008-0051.
    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, 510 South 17th 
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.

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: Schering-Plough Animal Health Corporation.
    Product: Mannheimia Haemolytica-Pasteurella Multocida Vaccine, 
Avirulent Live Culture.
    Field Test Locations: Colorado, Nebraska, Michigan, Missouri, 
Wisconsin, California, and New York.
    The above-mentioned product consists of two live gene deleted 
bacterial strains, one an avirulent strain of Mannheimia haemolytica, 
the other an avirulent strain of Pasteurella multocida. The vaccine is 
for use in cattle as an aid in the prevention and/or reduction of 
pneumonic lesions associated with bovine pneumonic pasteurellosis, 
commonly known as shipping fever.
    The EA has been prepared in accordance with: (1) The National 
Environmental Policy Act of 1969

[[Page 24214]]

(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 24th day of April 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-9636 Filed 5-1-08; 8:45 am]
BILLING CODE 3410-34-P
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