Availability of an Environmental Assessment for Field Testing of a DNA Immunostimulant, 58514-58515 [2013-23175]

Download as PDF 58514 Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices We will consider all comments that we receive on or before November 25, 2013. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/#!document Detail;D=APHIS–2013–0072–0001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2013–0072, 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 http://www. regulations.gov/#!docketDetail;D= APHIS–2013–0072 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) 799–7039 before coming. DATES: For information on the regulations for the interstate movement of horses that have tested positive for equine infectious anemia, contact Dr. Rory Carolan, Equine Specialist, Aquaculture, Swine, Equine, and Poultry Programs, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737; (301) 851–3558. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS’ Information Collection Coordinator, at (301) 851–2908. SUPPLEMENTARY INFORMATION: Title: Communicable Diseases in Horses. OMB Number: 0579–0127. Type of Request: Extension of approval of an information collection. Abstract: Under the authority of the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) regulates the importation and interstate movement of animals and animal products, and conducts various other activities to protect the health of U.S. livestock and poultry. Equine infectious anemia (EIA) is an infectious and potentially fatal viral disease of equines. There is no vaccine or treatment for the disease. It is often difficult to differentiate from other fever-producing diseases, including anthrax, influenza, and equine encephalitis. The regulations in 9 CFR 75.4 govern the interstate movement of equines that mstockstill on DSK4VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 19:49 Sep 23, 2013 Jkt 229001 have tested positive to an official test for EIA (EIA reactors) and provide for the approval of laboratories, diagnostic facilities, and research facilities. Ensuring the safe movement of these horses requires the use of information collection activities, including an EIA laboratory test form, a certificate or permit for the interstate movement of an EIA reactor, a supplemental investigation form if a horse tests positive for EIA, agreements, request for hearing, and written notification of withdrawal of approval. Since the last approval of these collection activities, APHIS has adjusted the estimates of burden, responses, and respondents. We have decreased the estimated total annual burden hours from 163,949 to 139,547 based on refinements to our calculations. For instance, as part of the last approval, we instituted the use of a permit for the movement of EIA-positive horses. However, we discovered that we overcalculated the number of respondents who would use the form. Similarly, the estimated number of respondents and responses per respondent for the EIA laboratory test form have been adjusted to more accurately reflect the use of the form. Lastly, we decreased our estimates as to the use of the supplemental investigation form, agreements, requests for hearing, and written notification of approval withdrawal because we have received fewer requests than we estimated for these processes. We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us: (1) Evaluate 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; (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.083 hours per response. Respondents: Accredited and State veterinarians; laboratory, diagnostic, and research facility personnel; stockyard personnel; and owners and shippers of horses. Estimated annual number of respondents: 253,785. Estimated annual number of responses per respondent: 6.6. Estimated annual number of responses: 1,681,142. Estimated total annual burden on respondents: 139,547 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) 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. Done in Washington, DC, this 18th day of September 2013. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–23192 Filed 9–23–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2013–0077] Availability of an Environmental Assessment for Field Testing of a DNA Immunostimulant Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. 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 DNA Immunostimulant recommended for reduction in morbidity and mortality due to Escherichia coli in chickens and reduction in bovine respiratory disease due to Mannheimia haemolytica in cattle. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this veterinary biological product and related information, examines the potential effects that field testing this product could have on the quality of the human environment. Based on the risk analysis SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices and other relevant data, we have reached a preliminary determination that field testing this product 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 product 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 product, 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 October 24, 2013. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!documentDetail;D=APHIS-2013-00770001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2013–0077, 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 http:// www.regulations.gov/ #!docketDetail;D=APHIS-2013-0077 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, 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) 851–3426, fax (301) 734–4314; email: Donna.L.Malloy@aphis.usda.gov. For information regarding the environmental assessment or the risk analysis, or to request a copy of the environmental assessment or the risk analysis (with confidential business information redacted), contact Dr. Patricia Foley, Risk Manager, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; VerDate Mar<15>2010 19:49 Sep 23, 2013 Jkt 229001 phone (515) 337–6100, fax (515) 337– 6120 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 evaluate 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 product: Requester: Bayer HealthCare LLC, Animal Health Division. Product: DNA Immunostimulant. Possible Field Test Locations: Texas, Mississippi, and Georgia for poultry; Nebraska, Indiana, and Missouri for cattle. The above mentioned product consists of non-replicating plasmid DNA in an immunogenic complex for use as an immunostimulant. This product will be recommended for the reduction in morbidity and mortality due to Escherichia coli in chickens and reduction in bovine respiratory disease due to Mannheimia haemolytica in cattle. 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 58515 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 veterinary biological 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 product 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 September 2013. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–23175 Filed 9–23–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2013–0063] Supplemental Environmental Impact Statement for the Bird Hazard Reduction Program at John F. Kennedy International Airport Animal and Plant Health Inspection Service, USDA. ACTION: Notice of intent and public scoping process. AGENCY: We are advising the public that a supplemental environmental impact statement will be prepared by the Animal and Plant Health Inspection Service to analyze a proposed method for managing hazards to aircraft at John F. Kennedy International Airport associated with non-native mute swans in the Gateway National Recreation Area. This action is a supplement to the Gull Hazard Reduction Program at John F. Kennedy International Airport Final Environmental Impact Statement (EIS), May 1994, and the Supplemental EIS, June 2012. DATES: We will consider all comments that we receive on or before October 24, 2013. ADDRESSES: You may submit comments by either of the following methods: SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58514-58515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23175]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0077]


Availability of an Environmental Assessment for Field Testing of 
a DNA Immunostimulant

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 DNA Immunostimulant recommended for reduction 
in morbidity and mortality due to Escherichia coli in chickens and 
reduction in bovine respiratory disease due to Mannheimia haemolytica 
in cattle. The environmental assessment, which is based on a risk 
analysis prepared to assess the risks associated with the field testing 
of this veterinary biological product and related information, examines 
the potential effects that field testing this product could have on the 
quality of the human environment. Based on the risk analysis

[[Page 58515]]

and other relevant data, we have reached a preliminary determination 
that field testing this product 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 
product 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 product, 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 
October 24, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0077-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0077, 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 http://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0077 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, 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) 851-3426, fax (301) 734-4314; 
email: Donna.L.Malloy@aphis.usda.gov. For information regarding the 
environmental assessment or the risk analysis, or to request a copy of 
the environmental assessment or the risk analysis (with confidential 
business information redacted), contact Dr. Patricia 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 conducted a risk analysis to evaluate 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 product:
    Requester: Bayer HealthCare LLC, Animal Health Division.
    Product: DNA Immunostimulant.
    Possible Field Test Locations: Texas, Mississippi, and Georgia for 
poultry; Nebraska, Indiana, and Missouri for cattle.
    The above mentioned product consists of non-replicating plasmid DNA 
in an immunogenic complex for use as an immunostimulant. This product 
will be recommended for the reduction in morbidity and mortality due to 
Escherichia coli in chickens and reduction in bovine respiratory 
disease due to Mannheimia haemolytica in cattle.
    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 veterinary biological 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 product 
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 September 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-23175 Filed 9-23-13; 8:45 am]
BILLING CODE 3410-34-P