Availability of an Environmental Assessment for Field Testing a Canine Lymphoma Vaccine, DNA, 29698-29699 [2013-12074]

Download as PDF 29698 Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Notices Rural Utilities Service Total Burden Hours: 3,704. Charlene Parker, Departmental Information Collection Clearance Officer. [FR Doc. 2013–12045 Filed 5–20–13; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request TKELLEY on DSK3SPTVN1PROD with NOTICES May 15, 2013. The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments regarding (a) whether the 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 including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (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 forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, 725 - 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@OMB.EOP.GOV or fax (202) 395–5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250– 7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling (202) 720–8681. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. VerDate Mar<15>2010 17:07 May 20, 2013 Jkt 229001 DEPARTMENT OF AGRICULTURE Title: Request for Release of Lien and/ or Approval of Sale. OMB Control Number: 0572–0041. Summary of Collection: The Rural Utilities Service (RUS) is a credit agency of the U.S. Department of Agriculture (USDA) that makes mortgage loans and loan guarantees to finance electric, telecommunications, and water and waste facilities in rural areas. RUS manages loan programs in accordance with the Rural Electrification Act (RE Act) of 1936, 7 U.S.C. 901 et seq., as amended (RE Act). A 1949 amendment to the RE Act established the telephone program in RUS with the purpose of making loans to furnish and improve rural telephone service. Section 201 of the RE Act provides that loans shall not be made unless RUS finds and certifies that the security for the loan is reasonably adequate and that the loan will be repaid within the time agreed. In addition to providing loans and loan guarantees, one of RUS main objectives is to safeguard loan security until the loan is repaid. Need and Use of the Information: A borrower’s assets provide the security for a Government loan. The selling of assets reduces the security and increases the risk of loss to the Government. A borrower seeking permission to sell some of its assets uses RUS Form 793. The form contains detailed information regarding the proposed sale. If the information in Form 793 is not collected when capital assets are sold, the capital assets securing the Government’s loans could be liquidated and the Government’s security either eliminated entirely or diluted to an undesirable level. This increases the risk of loss to the Government in the case of a default. Description of Respondents: Not-forprofit institutions; State, Local or Tribal Government. Number of Respondents: 40. Frequency of Responses: Reporting: On occasion. Total Burden Hours: 110. Animal and Plant Health Inspection Service Charlene Parker, Departmental Information Collection Clearance Officer. [FR Doc. 2013–12046 Filed 5–20–13; 8:45 am] BILLING CODE 3410–15–P PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 [Docket No. APHIS–2013–0033] Availability of an Environmental Assessment for Field Testing a Canine Lymphoma Vaccine, DNA Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. 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 Canine Lymphoma Vaccine, DNA. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine and related information, examines the potential effects that field testing 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 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 20, 2013. You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2013-00330001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2013–0033, 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:// ADDRESSES: E:\FR\FM\21MYN1.SGM 21MYN1 TKELLEY on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Notices www.regulations.gov/ #!docketDetail;D=APHIS-2013-0033 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.), 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 considers the potential effects of this product on the safety of animals, public health, and the environment. Using the risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: Merial, Inc. Product: Canine Lymphoma Vaccine, DNA. Possible Field Test Locations: Arizona, Florida, Georgia, New York, North Carolina, Tennessee, and Texas. The above-mentioned product is a replication-incompetent DNA vaccine consisting of a plasmid vector with an inserted therapeutic gene. The vaccine VerDate Mar<15>2010 17:07 May 20, 2013 Jkt 229001 is intended for the therapeutic immunization of dogs diagnosed with Bcell lymphoma concurrent with or following chemotherapy. 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). 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. [FR Doc. 2013–12074 Filed 5–20–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Transfer of Administrative Jurisdiction: Marine Corps Mountain Warfare Training Center Interchange Humboldt-Toiyabe National Forest, CA PO 00000 Forest Service, USDA. Frm 00003 Fmt 4703 Sfmt 4703 Notice of Joint Jurisdictional Interchange of lands between the Forest Service and the Department of the Navy. ACTION: SUMMARY: On October 22, 2012, and March 18, 2013, respectively, the Acting Principal Deputy Assistant Secretary of Navy, Energy, Installations & Environment and the Secretary of Agriculture signed a joint interchange order authorizing the transfer of administrative jurisdiction from the Department of Agriculture to the Department of the Navy for 346.49 acres, more or less located in Mono County, California and generally described as: Portions of Sections 13, 23, and 24, Township 6 North, Range 22 East, Mount Diablo Meridian, lying within the Marine Corps Mountain Warfare Training Center and the Humboldt-Toiyabe National Forest and more particularly described according to the map and legal description on file in the Forest Service office noted below. Furthermore, the order transfers jurisdiction from the Department of the Navy to the Department of Agriculture for inclusion in the Humboldt-Toiyabe National Forest, being 240 acres, more or less located in Mono County, California and generally described as: Portions of Section 14 and 15, Township 7 North, Range 22 East, Mount Diablo Meridian, within the proclamation boundaries of the Humboldt-Toiyabe National Forest, and more particularly described according to the map and legal description on file in the Forest Service office noted below. The 45-day Congressional oversight requirement of the Act of July 26, 1956 (70 Stat. 656; 16 U.S.C. 505a, 505b) has been met. The order is effective May 21, 2013. DATES: Copies of the maps with adjoining legal descriptions showing the lands included in this joint interchange are on file and available for public inspection in the Office of the Regional Forester, Intermountain Region, USDA, Forest Service, 324 25th Street, Ogden, UT 84401, between the hours of 8:30 a.m. and 4:30 p.m. on business days. Those wishing to inspect the maps with adjoining legal descriptions are encouraged to call ahead to (801) 625– 5800. ADDRESSES: Done in Washington, DC, this 15th day of May 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. AGENCY: 29699 A.L. Richard, Washington Office Lands and Realty Staff, USDA, Forest Service, 201 14th Street SW., Washington, DC 20250, Telephone: (202) 205–1792 or arichard@fs.fed.us. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29698-29699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12074]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0033]


Availability of an Environmental Assessment for Field Testing a 
Canine Lymphoma Vaccine, DNA

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 Canine Lymphoma Vaccine, DNA. The 
environmental assessment, which is based on a risk analysis prepared to 
assess the risks associated with the field testing of this vaccine and 
related information, examines the potential effects that field testing 
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 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 
20, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2013-0033-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0033, 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://

[[Page 29699]]

www.regulations.gov/!docketDetail;D=APHIS-2013-0033 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.), 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 considers the potential effects of this product on the safety of 
animals, public health, and the environment. Using the risk analysis 
and other relevant data, APHIS has prepared an environmental assessment 
(EA) concerning the field testing of the following unlicensed 
veterinary biological product:
    Requester: Merial, Inc.
    Product: Canine Lymphoma Vaccine, DNA.
    Possible Field Test Locations: Arizona, Florida, Georgia, New York, 
North Carolina, Tennessee, and Texas.
    The above-mentioned product is a replication-incompetent DNA 
vaccine consisting of a plasmid vector with an inserted therapeutic 
gene. The vaccine is intended for the therapeutic immunization of dogs 
diagnosed with B-cell lymphoma concurrent with or following 
chemotherapy.
    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).
    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 15th day of May 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-12074 Filed 5-20-13; 8:45 am]
BILLING CODE 3410-34-P
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