Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22283 

the presence of Mycoplasma 

contamination. Because the guidelines 

apply to final product and master seed/ 

cell testing in veterinary vaccines 

regulated by the Animal and Plant 

Health Inspection Service under the 

Virus-Serum-Toxin Act, we are 

requesting comments on the scope of 

the guideline and its provisions so that 

we may include any relevant public 

input on the draft in the Agency’s 

comments to the VICH Steering 

Committee. 

DATES: We will consider all comments 

that we receive on or before June 12, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0022- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0022, 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-2012-0022 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 L. Malloy, Section Leader, 

Operational Support, Center for 

Veterinary Biologics, Policy, Evaluation, 

and Licensing, VS, APHIS, 4700 River 

Road Unit 148, Riverdale Maryland 

20737–1231; (301) 851–3426. 

SUPPLEMENTARY INFORMATION: The 

International Cooperation on 

Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) is 

a unique project conducted under the 

auspices of the World Organization for 

Animal Health that brings together the 

regulatory authorities of the European 

Union, Japan, and the United States and 

representatives from the animal health 

industry in the three regions. The 

purpose of VICH is to harmonize 

technical requirements for veterinary 

products (both drugs and biologics). 

Regulatory authorities and industry 

experts from Australia and New Zealand 

participate in an observer capacity. The 

World Federation of the Animal Health 

Industry (COMISA, the Confederation 

Mondiale de L’Industrie de la Sante 

Animale) provides the secretarial and 

administrative support for VICH 

activities. 

The United States Government is 

represented in VICH by the Food and 

Drug Administration (FDA) and the 

Animal and Plant Health Inspection 

Service (APHIS). The FDA provides 

expertise on veterinary drugs, while 

APHIS fills a corresponding role for 

veterinary biological products. As VICH 

members, APHIS and FDA participate in 

efforts to enhance harmonization and 

have expressed their commitment to 

seeking scientifically based, harmonized 

technical requirements for the 

development of veterinary drugs and 

biological products. One of the goals of 

harmonization is to identify and reduce 

the differences in technical 

requirements for veterinary drugs and 

biologics among regulatory agencies in 

different countries. 

The draft guideline ‘‘Testing for the 

Detection of Mycoplasma 

Contamination’’ (VICH Topic GL34) has 

been made available by the VICH 

Steering Committee for comments by 

interested parties. Mycoplasma 

contaminants may be introduced into 

cell culture and in ovo origin biological 

products through the master seeds, the 

master cell seed (stock), starting 

materials of animal origin, and in 

processing of biological materials during 

passage and product assembly. 

Therefore, it is necessary to demonstrate 

through testing that Mycoplasmas are 

not present, within the limits of the test, 

in the final product, working seeds and 

cells and harvests, and starting materials 

such as the master seed, master cell 

seed, and ingredients of animal origin. 

The draft guideline establishes stages of 

manufacture to be tested and test 

procedures to detect the presence of 

Mycoplasma contamination and would 

provide a unified standard to facilitate 

the mutual acceptance of test data by 

the relevant regulatory authorities. 

Because the draft guideline would apply 

to final product and master seed/cell 

testing in veterinary vaccines regulated 

by the APHIS under the Virus-SerumToxin Act (VSTA), we are requesting 

comments on its provisions so that we 

may include any relevant public input 

on the draft in the Agency’s comments 

to the VICH Steering Committee. 

In accordance with the VICH process, 

once a final draft of the document has 

been approved, the guideline will be 

recommended for adoption by the 

regulatory bodies of the European 

Union, Japan, and the United States. As 

with all VICH documents, each final 

guideline will not create or confer any 

rights for or on any person and will not 

operate to bind APHIS or the public. 

Further, the VICH guidelines 

specifically provide for the use of 

alternative approaches if those 

approaches satisfy applicable regulatory 

requirements. 

Ultimately, APHIS intends to consider 

the VICH Steering Committee’s final 

guideline for use by U.S. veterinary 

biologics licensees, permittees, and 

applicants. In addition, we may 

consider using the final guideline as the 

basis for proposed amendments to the 

regulations in 9 CFR chapter I, 

subchapter E (Viruses, Serums, Toxins, 

and Analogous Products; Organisms and 

Vectors). Because we anticipate that 

applicable provisions of the final 

version of ‘‘Testing for the Detection of 

Mycoplasma Contamination’’ may be 

introduced into APHIS’ veterinary 

biologics regulatory program in the 

future, we encourage your comments on 

the draft guideline. 

The draft guideline may be viewed on 

the Regulations.gov Web site or in our 

reading room (see ADDRESSES above for 

instructions for accessing 

Regulations.gov and information on the 

location and hours of the reading room). 

You may request copies of the draft 

guideline by calling or writing to the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

Authority: 21 U.S.C. 151 et seq. 

Done in Washington, DC, this 9th day of 

April 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–8908 Filed 4–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0017] 

Availability of an Environmental 

Assessment for Field Testing Feline 

Interleukin-2 Immunomodulator, Live 

Canarypox Vector 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

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 Feline Interleukin-2 


pmangrum on DSK3VPTVN1PROD with NOTICES
22284 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

Immunomodulator, Live Canarypox 

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, 

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, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0017- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0017, 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-2012-0017 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 

conducted a risk analysis to assess the 

potential effects of this product on the 

safety of animals, public health, and the 

environment. Based on the risk analysis, 

APHIS has prepared an environmental 

assessment (EA) concerning the field 

testing of the following unlicensed 

veterinary biological product: 

Requester: Merial, Inc. 

Product: Feline Interleukin-2 

Immunomodulator, Live Canarypox 

Vector. 

Field Test Locations: Georgia, North 

Carolina, New York, Tennessee, Florida, 

and Arizona. 

The product consists of a live 

recombinant canarypox virus vector 

expressing the feline interleukin-2 

cytokine. The vaccine is for 

subcutaneous vaccination of adult cats 

diagnosed with Stage I fibrosarcoma as 

an aid in delaying post-surgical 

recurrence following excision of the 

tumor. 

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 9th day of 

April 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–8912 Filed 4–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0013] 

Notice of Establishment of a Veterinary 

Services Stakeholder Registry 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of a new Veterinary Services 

email subscription service. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

R.J. Cabrera, Writing, Editing, and 

Regulatory Coordination, VS, APHIS, 

4700 River Road Unit 35, Riverdale, MD 

20737–1231; (301) 851–3478. 

SUPPLEMENTARY INFORMATION: The 

Animal and Plant Health Inspection 

Service (APHIS) has established a 

Veterinary Services (VS) Stakeholder 

Registry, an email subscription service 

for individuals and organizations 

interested in receiving updates 

regarding APHIS and VS issues. 

Subscribers will be able to choose from 

an array of topics such as VS spotlights 


pmangrum on DSK3VPTVN1PROD with NOTICES