Federal Register / Vol. 78, No. 251 / Tuesday, December 31, 2013 / Notices 79657 

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 

37.04 hours per response. 

Respondents: State, university, and 

private laboratories. 

Estimated annual number of 

respondents: 12. 

Estimated annual number of 

responses per respondent: 41.25. 

Estimated annual number of 

responses: 495. 

Estimated total annual burden on 

respondents: 18,336 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 20th day of 

December 2013. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–31245 Filed 12–30–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2013–0093] 

Availability of an Environmental 

Assessment for Issuance of a Permit 

for Distribution and Sale of an 

Infectious Hematopoietic Necrosis 

Virus 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 import under permit, 

for distribution and sale, an Infectious 

Hematopoietic Necrosis Virus Vaccine, 

DNA. The environmental assessment, 

which is based on a risk analysis 

prepared to assess the risks associated 

with the use of this vaccine, examines 

the potential effects that 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 use of 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 under permit for distribution 

and sale in the United States 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 and provided 

the product meets all requirements for 

approval. 

DATES: We will consider all comments 

that we receive on or before January 30, 

2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!documentDetail;D=APHIS-2013-0093- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2013–0093, 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-2013-0093 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: 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. Prior to importing an unlicensed 

product, an applicant must obtain 

approval from the Animal and Plant 

Health Inspection Service (APHIS) to 

ship the product under permit for 

distribution and sale. 

To determine whether to authorize 

shipment and approval for the use of the 

imported product referenced in this 

notice, APHIS has considered the 

potential effects of this product on the 

safety of animals, public health, and the 

environment. Using a risk analysis and 

other relevant data, APHIS has prepared 

an environmental assessment (EA) 

concerning the use of the following 

imported veterinary biological product: 

Requester: Novartis Animal Health 

US, Inc. 

Product: Infectious Hematopoietic 

Necrosis Virus Vaccine, DNA. 

The above-mentioned product is a 

replication-incompetent DNA vaccine 

consisting of a plasmid vector with an 

inserted immunogenic gene. The 

vaccine is intended for the 

immunization of salmonids as an aid in 

the prevention of disease due to 

infectious hematopoietic necrosis 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 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 based on the EA and authorize 

shipment of the above product for 

distribution and sale following the close 

of the comment period for this notice, 

provided the product meets all other 

requirements for approval. 

Authority: 21 U.S.C. 151–159. 

Done in Washington, DC, this 20th day of 

December 2013. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–31191 Filed 12–30–13; 8:45 am] 

BILLING CODE 3410–34–P 


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