58514 Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices 

DATES: 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. 

FOR FURTHER INFORMATION CONTACT: 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 

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. 

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 

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 

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Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices 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 

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 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of intent and public 

scoping process. 

SUMMARY: 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: 

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