This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

19955 

Vol. 80, No. 71 

Tuesday, April 14, 2015 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2015–0002] 

Availability of an Environmental 

Assessment for Field Testing a 

Marek’s Disease-Newcastle Disease 

Vaccine, Serotype 3, Live Marek’s 

Disease Vector 

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 Marek’s disease-Newcastle 

disease vaccine, serotype 3, live Marek’s 

disease vector. 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 

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 May 14, 

2015. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2015-0002. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2015–0002, 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-2015-0002 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. 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: Marek’s Disease-Newcastle 

Disease Vaccine, Serotype 3, Live 

Marek’s Disease Vector. 

Possible Field Test Locations: 

Arkansas, Georgia, Indiana, Iowa, 

Missouri, Ohio, Oklahoma, 

Pennsylvania, and Virginia. 

The above-mentioned product is a 

live Marek’s disease serotype 3 vaccine 

virus containing a gene from the 

Newcastle disease virus. The attenuated 

vaccine is intended for use in healthy 

18-day-old or older embryonated eggs or 

day-old chickens, as an aid in the 

prevention of Marek’s disease and 

Newcastle disease. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
19956 Federal Register / Vol. 80, No. 71 / Tuesday, April 14, 2015 / Notices 

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 8th day of 

April 2015. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2015–08602 Filed 4–13–15; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2015–0025] 

Secretary’s Advisory Committee on 

Animal Health; Meeting 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: This is a notice to inform the 

public of an upcoming meeting of the 

Secretary’s Advisory Committee on 

Animal Health. The meeting is being 

organized by the Animal and Plant 

Health Inspection Service to discuss 

matters of animal health. 

DATES: The meeting will be held on 

April 28 and 29, 2015, from 9 a.m. to 5 

p.m. each day. 

ADDRESSES: The meeting will be held at 

the Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

R.J. Cabrera, Designated Federal Officer, 

VS, APHIS, 4700 River Road Unit 34, 

Riverdale, MD 20737; phone (301) 851– 

3478, email SACAH.Management@

aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

The Secretary’s Advisory Committee 

on Animal Health (the Committee) 

advises the Secretary of Agriculture on 

matters of animal health, including 

means to prevent, conduct surveillance 

on, monitor, control, or eradicate animal 

diseases of national importance. In 

doing so, the Committee will consider 

public health, conservation of natural 

resources, and the stability of livestock 

economies. 

Tentative topics for discussion at the 

meeting include: 

• Follow-on discussion of 

antimicrobial resistance, mitigations, 

and the U.S. Department of Agriculture 

(USDA) action plan, 

• Comprehensive discussion on 

porcine epidemic diarrhea, 

• Follow-on discussion on foot-andmouth disease, 

• USDA draft framework for emerging 

diseases, 

• Proposed national list of reportable 

animal diseases, 

• Avian influenza, and 

• Bovine tuberculosis program— 

understanding the disease. 

A final agenda will be posted on the 

Committee Web site by April 13, 2015. 

Those wishing to attend the meeting 

in person must complete a brief 

registration form by clicking on the 

‘‘SACAH Meeting Sign-Up’’ button on 

the Committee’s Web site (http://

www.aphis.usda.gov/animalhealth/

sacah). Members of the public may also 

join the meeting via teleconference in 

‘‘listen-only’’ mode. Participants who 

wish to listen in on the teleconference 

may do so by dialing 1–888–469–3079 

and then entering the public passcode, 

2061888#. 

Due to time constraints, members of 

the public will not have an opportunity 

to participate in the Committee’s 

discussions. However, questions and 

written statements for the Committee’s 

consideration may be submitted up to 5 

working days before the meeting. They 

may be sent to SACAH.Management@

aphis.usda.gov or mailed to the person 

listed on the notice under FOR FURTHER

INFORMATION CONTACT. Statements filed 

with the Committee should specify that 

they pertain to the April 2015 

Committee meeting. 

This notice of meeting is given 

pursuant to section 10 of the Federal 

Advisory Committee Act (5 U.S.C. App. 

2). 

Done in Washington, DC, this 8th day of 

April 2015. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2015–08603 Filed 4–13–15; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2015–0003] 

Availability of an Environmental 

Assessment for Field Testing a 

Marek’s Disease Vaccine, Serotype 1, 

Live Virus 

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 Marek’s disease vaccine, 

serotype 1, live virus. 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 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 May 14, 

2015. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS–2015–0003. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2015–0003, 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://


asabaliauskas on DSK5VPTVN1PROD with NOTICES