Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65293 

importation of beef from Uruguay, 

contact Dr. Lynette Williams-McDuffie, 

Staff Veterinarian, Technical Trade 

Services—Products, National Center for 

Import and Export, VS, APHIS, 4700 

River Road Unit 40, Riverdale MD 

20737; (301) 734–3277. 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: Importation of Beef from 

Uruguay. 

OMB Number: 0579–xxxx. 

Type of Request: Approval of an 

information collection. 

Abstract: Under the Animal Health 

Protection Act (7 U.S.C. 8301 et seq.), 

the Animal and Plant Health Inspection 

Service (APHIS) of the United States 

Department of Agriculture is authorized, 

among other things, to prohibit or 

restrict the importation and interstate 

movement of animals and animal 

products to prevent the introduction 

into and dissemination within the 

United States of livestock diseases and 

pests. To carry out this mission, APHIS 

regulates the importation of animals and 

animal products into the United States. 

The regulations are contained in title 9, 

parts 92 through 98, of the Code of 

Federal Regulations. 

Part 94, § 94.22, allows the 

importation, subject to certain 

conditions, of beef from Uruguay. 

Among the conditions is a requirement 

for a certificate that must be completed 

by an authorized official of the 

Government of Uruguay with a 

statement that specific conditions have 

been met to protect the United States 

against the introduction of foot-andmouth disease. 

We are asking the Office of 

Management and Budget (OMB) to 

approve our use of these information 

collection activities for 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 

1.5004034 hours per response. 

Respondents: Federal animal health 

officials of the Government of Uruguay. 

Estimated annual number of 

respondents: 21. 

Estimated annual number of 

responses per respondent: 59. 

Estimated annual number of 

responses: 1,239. 

Estimated total annual burden on 

respondents: 1,859 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 

October 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–26749 Filed 10–21–10; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0098] 

Draft Guidelines on Pharmacovigilance 

of Veterinary Medicinal Products: 

Electronic Standards for Transfer of 

Data 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The International Cooperation 

on Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) 

has developed a draft guideline titled 

‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Electronic 

Standards for Transfer of Data.’’ This 

draft guideline provides information 

concerning the development of a single 

electronic message to transmit adverse 

event reports concerning veterinary 

biologics between regulatory authorities 

in the European Union, Japan, and the 

United States and marketing 

authorization holders (veterinary 

biologics licensees and permittees) in 

those regions. Because the draft 

guideline applies to pharmacovigilance 

and adverse event reporting on 

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 December 

21, 2010. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS2010-0098 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS–2010–0098, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2010–0098. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room 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) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Center for Veterinary 

Biologics—Policy Evaluation and 

Licensing, VS, APHIS, 4700 River Road 

Unit 148, Riverdale, MD 20737–1231; 

(301) 734–8245. 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES
65294 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

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 

‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Electronic 

Standards for Transfer of Data’’ (VICH 

Topic GL35) has been made available by 

the VICH Steering Committee for 

comments by interested parties. The 

guideline is intended to provide 

standards to construct a single 

electronic message to transmit the 

contents of adverse event reports 

concerning the use of veterinary 

medicinal products to all regions. 

Because the draft guideline applies to 

some veterinary biological products 

regulated by APHIS under the VirusSerum-Toxin Act—particularly with 

regard to electronic messages to transmit 

adverse event reports—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. 

The draft guideline reflects current 

APHIS thinking on the use of electronic 

messages to transmit adverse event 

reports concerning the use of veterinary 

medicinal products between marketing 

authorization holders (licensees/ 

permittees) and regulatory authorities in 

the three regions. In accordance with 

the VICH process, once a final draft of 

each 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 

versions of ‘‘Pharmacovigilance of 

Veterinary Medicinal Products: 

Electronic Standards for Transfer of 

Data’’ 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 paper 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 18th day of 

October 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–26748 Filed 10–21–10; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Rural Utilities Service 

Southern Maryland Electric 

Cooperative: Notice of Finding of No 

Significant Impact 

AGENCY: Rural Utilities Service, USDA. 

ACTION: Notice of Finding of No 

Significant Impact. 

SUMMARY: The Rural Utilities Service 

(RUS) has issued a Finding of No 

Significant Impact (FONSI) for the 

Environmental Assessment (EA) 

associated with the Holland Cliff to 

Hewitt Road 230 kV Transmission 

proposal in Calvert and St. Mary’s 

Counties, Maryland. The EA was 

prepared pursuant to the National 

Environmental Policy Act of 1969 

(NEPA) (U.S.C. 4231 et seq.) and in 

accordance with the Council on 

Environmental Quality’s (CEQ’s) 

regulations for implementing the 

procedural provisions of NEPA (40 CFR 

parts 1500–1508) and RUS’s NEPA 

implementing regulations (7 CFR part 

1794, Environmental Policies and 

Procedures). The purpose of the EA was 

to evaluate the potential environmental 

impacts of and alternatives to a 

Southern Maryland Electric Cooperative 

(SMECO) application for a RUS loan for 

the proposal. The proposal includes 

construction of a 30-mile 230 kilovolt 

(kV) transmission line, a new 230/69 kV 

switching station, and a 230/69 kV 

switching station expansion. 

ADDRESSES: To obtain copies of the 

FONSI or EA, or for further information, 

contact: Ms. Lauren McGee, 

Environmental Scientist, USDA, Rural 

Utilities Service, 1400 Independence 

Avenue, SW., Stop 1571, Room 2239–S, 

Washington, DC 20250–1571, telephone: 

(202) 720–1482, fax: (202) 690–0649, or 

e-mail: lauren.mcgee@wdc.usda.gov. A 

copy of the FONSI and EA can be 

viewed online at: http://www.usda.gov/ 

rus/water/ees/ea.htm. 

SUPPLEMENTARY INFORMATION: SMECO 

proposes to construct a 230 kV 

transmission line between the existing 

Holland Cliff Switching Station in 

Calvert County to the existing Hewitt 

Road Switching Station in St. Mary’s 

County, Maryland. The proposal has 

five segments and includes: (1) The 

installation of approximately 20 miles of 

new 230 kV single pole, double-circuit 

transmission line from the Holland Cliff 

switching station to a new switching 

station located in Southern Calvert; (2) 

the installation of the new Sollers Wharf 

230/69 kV switching station; (3) the 

installation of approximately 8 miles of 

new 230 kV single pole, double-circuit 

transmission line from the new 

Southern Calvert switching station to 

the existing Hewitt Road switching 

station; (4) the installation of 

approximately 2 miles of 230 kV 

underground transmission cable circuit 

across the lower Patuxent River; and (5) 

the expansion of the existing 230 kV 

ring bus at the Hewitt Road switching 

station to accommodate the new 230 kV 

transmission line from Southern 

Calvert. Throughout the right-of-way, 

the existing 69 kV poles would be 

removed, and new 230 kV poles would 

be installed. The existing 69 kV and 

new 230 kV lines would be installed on 

the new poles. This configuration would 

allow for the use of the existing 69 kV 

transmission line right-of-way and 

preclude the need for additional 

easement acquisition. The preferred site 


emcdonald on DSK2BSOYB1PROD with NOTICES