Federal Register / Vol. 74, No. 142 / Monday, July 27, 2009 / Notices 36999 

1A list of pest-free-areas currently recognized by 

APHIS can be found at http://www.aphis.usda.gov/ 

import_export/plant/manuals/ports/downloads/ 

DesignatedPestFreeAeas.pdf. 

• Animal identification. Do you have 

any suggestions on how to make animal 

identification practical and useful to 

stakeholders while simultaneously 

meeting the needs of animal health 

officials who must conduct disease 

tracebacks? 

• Animal tracing. Do you have any 

suggestions on how to make the animal 

tracing component practical, in 

particular the reporting of animal 

movements to other premises, while 

meeting the needs of animal health 

officials who must conduct disease 

tracebacks? 

During the time that the public 

meetings were being held, we provided 

members of the public who were not 

able to attend a meeting with the option 

of submitting comments via the 

Regulations.gov Web site. The last 

meeting was held on June 30, 2009, and 

it was our intention to continue to 

provide the public with the option of 

submitting written comments for at least 

30 days following that final meeting. As 

noted in the heading DATES at the 

beginning of this notice, we will 

consider all comments that we receive 

on or before August 3, 2009. 

Done in Washington, DC, this 21st day of 

July 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–17797 Filed 7–24–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2009–0037] 

Determination of Pest-Free Areas in 

the Republic of South Africa; Request 

for Comments 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that we have received a request from the 

Government of the Republic of South 

Africa to recognize 16 additional 

magisterial districts in 3 provinces as 

pest-free areas for citrus black spot. 

After reviewing the documentation 

submitted in support of this request, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that these areas meet the 

criteria in our regulations for 

recognition as pest-free areas. We are 

making that determination, as well as an 

evaluation document we have prepared 

in connection with this action, available 

for review and comment. 

DATES: We will consider all comments 

we receive on or before September 25, 

2009. 

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=APHIS2009-0037 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2009–0037, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3C71, 4700 River 

Road Unit 118, Riverdale, MD 20737– 

1238. Please state that your comment 

refers to Docket No. APHIS–2009–0037. 

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: Mr. 

Phillip B. Grove, Regulatory 

Coordination Specialist, Regulatory 

Coordination and Compliance, APHIS, 

4700 River Road Unit 156, Riverdale, 

MD 20737; (301) 734–6280. 

SUPPLEMENTARY INFORMATION: Under the 

regulations in ‘‘Subpart-Fruits and 

Vegetables’’ (7 CFR 319.56 through 

319.56–49, referred to below as the 

regulations), the Animal and Plant 

Health Inspection Service (APHIS) of 

the U.S. Department of Agriculture 

prohibits or restricts the importation of 

fruits and vegetables into the United 

States from certain parts of the world to 

prevent plant pests from being 

introduced into and spread within the 

United States. 

Section 319.56–4 of the regulations 

contains a performance-based process 

for approving the importation of 

commodities that, based on the findings 

of a pest risk analysis, can be safely 

imported subject to one or more of the 

designated phytosanitary measures 

listed in paragraph (b) of that section. 

One of the designated phytosanitary 

measures is that the fruits or vegetables 

are imported from a pest-free area in the 

country of origin that meets the 

requirements of § 319.56–5 for freedom 

from that pest and are accompanied by 

a phytosanitary certificate stating that 

the fruits or vegetables originated in a 

pest-free area in the country of origin. 

Under the regulations in § 319.56–5, 

APHIS requires that determinations of 

pest-free areas be made in accordance 

with the criteria for establishing 

freedom from pests found in 

International Standard for Phytosanitary 

Measures (ISPM) No. 4, ‘‘Requirements 

for the establishment of pest-free areas.’’ 

The international standard was 

established by the International Plant 

Protection Convention of the United 

Nations’ Food and Agriculture 

Organization and is incorporated by 

reference in our regulations in 7 CFR 

300.5. In addition, APHIS must also 

approve the survey protocol used to 

determine and maintain pest-free status, 

as well as protocols for actions to be 

performed upon detection of a pest. 

Pest-free areas are subject to audit by 

APHIS to verify their status. 

APHIS has received a request from the 

Government of the Republic of South 

Africa to recognize additional areas of 

that country as being free of Guignardia 

citricarpa, citrus black spot.1 Currently, 

we only allow importation of citrus fruit 

from the Republic of South Africa when 

it is grown in the Western Cape 

Province and the magisterial districts of 

Hartswater and Warrenton of the 

Northern Cape Province, which are 

areas that APHIS has determined to be 

free of citrus black spot.2 Specifically, 

the Government of the Republic of 

South Africa asked that we recognize 

the magisterial districts of Boshof, 

Fauresmith, Jacobsdal, Koffiefontein, 

and Philippolis in the Free State 

Province; Christiania and Taung in the 

North West Province; and Barkly-wes/ 

west, Gordonia, Hay, Herbert, 

Hopetown, Kenhardt, Kimberely, 

Namakwaland, and Prieska in the 

Northern Cape Province as areas that are 

free of citrus black spot. 

In accordance with our regulations 

and the criteria set out in ISPM No. 4, 

we have reviewed and approved the 

survey protocols and other information 

provided by the Republic of South 

Africa relative to its system to establish 

freedom, phytosanitary measures to 

maintain freedom, and system for the 

verification of the maintenance of 

freedom. Because this action concerns 

the expansion of a currently recognized 

pest-free area in the Republic of South 


jlentini on DSKJ8SOYB1PROD with NOTICES
37000 Federal Register / Vol. 74, No. 142 / Monday, July 27, 2009 / Notices 

Africa from which citrus fruit is 

authorized for importation into the 

United States, our review of the 

information presented by the Republic 

of South Africa in support of its request 

is examined in a commodity import 

evaluation document (CIED) titled 

‘‘Recognition of Additional Magisterial 

Districts as Citrus Black Spot Pest-Free 

Areas for the Republic of South Africa.’’ 

The CIED 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 

CIED by calling or writing to the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

Therefore, in accordance with 

§ 319.56–5(c), we are announcing the 

Administrator’s determination that the 

magisterial districts of Boshof, 

Fauresmith, Jacobsdal, Koffiefontein, 

and Philippolis in the Free State 

Province; Christiania and Taung in the 

North West Province; and Barkly-wes/ 

west, Gordonia, Hay, Herbert, 

Hopetown, Kenhardt, Kimberely, 

Namakwaland, and Prieska in the 

Northern Cape Province meet the 

criteria of § 319.56–5(a) and (b) with 

respect to freedom from citrus black 

spot. After reviewing the comments we 

receive on this notice, we will announce 

our decision regarding the status of 

these areas with respect to their freedom 

from citrus black spot. If the 

Administrator’s determination remains 

unchanged, we will add these areas in 

the Republic of South Africa to the list 

of pest-free areas. 

Done in Washington, DC, this 21st day of 

July 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–17794 Filed 7–24–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2009–0056] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NAHVAX® Marek’s Disease 

Vaccine 

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 determined the 

regulatory review period for NAHVAX®

Marek’s Disease Vaccine and is 

publishing this notice of that 

determination as required by law. We 

have made this determination in 

response to the submission of an 

application to the Commissioner of 

Patents and Trademarks, Department of 

Commerce, for the extension of a patent 

that claims that veterinary biologic. 

DATES: We will consider all requests for 

revision of the regulatory review period 

determination that we receive on or 

before August 26, 2009. We will 

consider all due diligence petitions that 

we receive on or before January 25, 

2010. 

ADDRESSES: You may submit revision 

requests and due diligence petitions by 

either of the following methods: 

• Federal eRulemaking Portal: Go to 

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

component/ 

main?main=DocketDetail&d=APHIS2009-0056 to submit or view revision 

requests and due diligence petitions and 

to view supporting and related materials 

available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your request 

or petition to Docket No. APHIS–2009– 

0056, Regulatory Analysis and 

Development, PPD, APHIS, Station 3A– 

03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. Please state 

that your revision request or due 

diligence petition refers to Docket No. 

APHIS–2009–0056. 

Reading Room: A copy of the 

regulatory review period determination 

and any revision requests or due 

diligence petitions that we receive on 

this determination are available for 

public inspection 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, 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) 734–8245; fax (301) 

734–4314. 

For information concerning the 

regulatory review period determination 

contact Dr. Patricia L. Foley, Center for 

Veterinary Biologics, Policy Evaluation 

and Licensing, VS, APHIS, 510 South 

17th Street, Suite 104, Ames, IA 50010; 

phone (515) 232–5785, fax (515) 232– 

7120. 

SUPPLEMENTARY INFORMATION: The 

provisions of 35 U.S.C. 156, ’’ Extension 

of patent term,’’ provide, generally, that 

a patent for a product may be extended 

for a period of up to 5 years as long as 

the patent claims a product that, among 

other things, was subject to a regulatory 

review period before its commercial 

marketing or use. (The term ‘‘product’’ 

is defined in that section as ‘‘a drug 

product’’ [which includes veterinary 

biological products] or ‘‘any medical 

device, food additive, or color additive 

subject to regulation under the Federal 

Food, Drug, and Cosmetic Act.’’) A 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

The regulations in 9 CFR part 124, 

‘‘Patent Term Restoration’’ (referred to 

below as the regulations), set forth 

procedures and requirements for the 

Animal and Plant Health Inspection 

Service’s (APHIS) review of applications 

for the extension of the term of certain 

patents for veterinary biological 

products pursuant to 35 U.S.C. 156. As 

identified in the regulations, the 

responsibilities of APHIS include: 

• Assisting Patent and Trademark 

Office of the U.S. Department of 

Commerce in determining eligibility for 

patent term restoration; 

• Determining the length of a 

product’s regulatory review period; 

• If petitioned, reviewing and ruling 

on due diligence challenges to APHIS’ 

regulatory review period 

determinations; and 

• Conducting hearings to review 

initial APHIS findings on due diligence 

challenges. 

The regulations are designed to be 

used in conjunction with regulations 

issued by the Patent and Trademark 

Office concerning patent term 

extension, which may be found at 37 

CFR 1.710 through 1.791. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For veterinary 

biologics, the testing phase begins on 

the date the authorization to prepare an 

experimental veterinary biologic became 

effective and runs until the approval 

phase begins. The approval phase 

begins on the date an application for a 

license was initially submitted for 

approval and ends on the date such 

license was issued. Although only a 

portion of a regulatory review period 


jlentini on DSKJ8SOYB1PROD with NOTICES