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
Federal Register / Vol. 74, No. 142 / Monday, July 27, 2009 / Notices 37001 

1See Petition for the Imposition of Antidumping 

Duties: Certain Woven Electric Blankets from the 

People’s Republic of China, dated June 30, 2009 

(‘‘Petition’’). 

2See Memorandum from Dana Griffies to the File, 

regarding Petition for the Imposition of 

Antidumping Duties on Certain Woven Electric 

Blankets from the People’s Republic of China: 

Suggested Scope Changes, dated July 16, 2009, and 

Memorandum from Howard Smith to the File, 

regarding Telephone Conversations with Petitioner, 

dated July 16, 2009, and Memorandum from Drew 

Jackson to the File, regarding Petition for the 

Imposition of Antidumping Duties on Certain 

Woven Electric Blankets from the People’s Republic 

of China: Suggested Scope Changes, dated July 17, 

2009. 

may count toward the actual amount of 

extension that the Commissioner of 

Patents and Trademarks may award, 

APHIS’ determination of the length of a 

regulatory review period for a veterinary 

biologic will include all of the testing 

phase and approval phase as specified 

in 35 U.S.C. 156(g)(5)(B). 

APHIS recently licensed for 

production and marketing the veterinary 

biologic NAHVAX® Marek’s Disease 

Vaccine. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for NAHVAX® Marek’s 

Disease Vaccine (U.S. Patent No. 5, 965, 

138) from Schering Plough Animal 

Health Corporation, and the Patent and 

Trademark Office requested APHIS’ 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated February 2, 2009, APHIS 

advised the Patent and Trademark 

Office that this veterinary biologic had 

undergone a regulatory review period 

and that the approval of NAHVAX®

Marek’s Disease Vaccine (Marek’s 

Disease Vaccine, Serotypes 1 & 3, Live 

Herpesvirus Chimera) represented the 

first permitted commercial licensing or 

use of the product. Subsequently, the 

Patent and Trademark Office requested 

that APHIS determine the product’s 

regulatory review period. 

APHIS has determined that the 

applicable regulatory review period for 

NAHVAX® Marek’s Disease Vaccine is 

1,539 days. Of this time, 0 days 

occurred during the testing phase of the 

regulatory review period, and 1,539 

days occurred during the approval 

phase. These periods were derived from 

the following dates: 

1. The date the application for a 

license was initially submitted for 

approval under the Virus-Serum-Toxin 

Act: July 14, 2004. APHIS has verified 

the applicant’s claim that the 

application was initially submitted on 

July 14, 2004. 

2. The date the license was issued: 

September 29, 2008. APHIS has verified 

the applicant’s claim that the license for 

the commercial marketing of the vaccine 

was issued on September 29, 2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,539 days of patent 

term extension. 

Section 124.22 of the regulations 

provides that any interested person may 

request a revision of the regulatory 

review period determination within 30 

days of the date of this notice (see DATES

above). The request must specify the 

following: 

• The identity of the product; 

• The identity of the applicant for 

patent term restoration; 

• The docket number of this notice; 

and 

• The basis for the request for 

revision, including any documentary 

evidence. 

Further, under § 124.30 of the 

regulations, any interested person may 

file a petition with APHIS, no later than 

180 days after the date of this notice (see 

DATES above), alleging that a license 

applicant did not act with due diligence 

in seeking APHIS approval of the 

product during the regulatory review 

period. The filing, format, and content 

of a petition must be as described in the 

regulations in ‘‘Subpart D–Due 

Diligence Petitions’’ (§§ 124.30 through 

124.33). 

Authority: 35 U.S.C. 156. 

Done in Washington, DC, this 21st day of 

July 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–17795 Filed 7–24–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF COMMERCE 

International Trade Administration 

[A–570–951] 

Certain Woven Electric Blankets From 

the People’s Republic of China: 

Initiation of Antidumping Duty 

Investigation 

AGENCY: Import Administration, 

International Trade Administration, 

Department of Commerce. 

DATES: Effective Date: July 27, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Drew Jackson at (202) 482–4406 or 

Rebecca Pandolph at (202) 482–3627, 

AD/CVD Operations, Office 4, Import 

Administration, International Trade 

Administration, U.S. Department of 

Commerce, 14th Street and Constitution 

Avenue, NW., Washington, DC 20230. 

SUPPLEMENTARY INFORMATION: 

The Petition 

On June 30, 2009, the Department of 

Commerce (‘‘Department’’) received an 

antidumping duty (‘‘AD’’) petition 

concerning imports of certain woven 

electric blankets (‘‘woven electric 

blankets’’) from the People’s Republic of 

China (‘‘PRC’’) filed in proper form by 

Jarden Consumer Solutions 

(‘‘Petitioner’’).1 On July 2, 2009, the 

Department issued a request to 

Petitioner for additional information 

and for clarification of certain areas of 

the Petition. Based on the Department’s 

request, Petitioner filed a supplement to 

the Petition on July 8, 2009 

(‘‘Supplement to the Petition’’). On July 

10, 2009, the Department requested 

further information from Petitioner, 

including suggested refinements to the 

scope. Based on the Department’s 

request, Petitioner filed a second 

supplement to the Petition on July 14, 

2009 (‘‘Second Supplement to the 

Petition’’). Based on conversations with 

Petitioner regarding scope and certain 

other clarifications, Petitioner filed a 

supplement to the Petition on July 15, 

2009 (‘‘Third Supplement to the 

Petition’’).2 On July 17, 2009, we 

received a submission on behalf of a 

U.S. importer of woven electric blankets 

and its affiliated Chinese producer and 

exporter, both interested parties to this 

proceeding as defined in section 

771(9)(A) of the Act. This submission 

challenged the definition of the 

domestic like product. Petitioner filed 

its reply to this challenge on July 20, 

2009. 

In accordance with section 732(b) of 

the Tariff Act of 1930, as amended 

(‘‘Act’’), Petitioner alleges that imports 

of woven electric blankets from the PRC 

are being, or are likely to be, sold in the 

United States at less than fair value, 

within the meaning of section 731 of the 

Act, and that such imports materially 

injure, and threaten further material 

injury to, an industry in the United 

States. 

The Department finds that Petitioner 

filed the Petition on behalf of the 

domestic industry because Petitioner is 

an interested party, as defined in section 

771(9)(C) of the Act, and has 

demonstrated sufficient industry 

support with respect to the investigation 

that it requests the Department to 

initiate (see ‘‘Determination of Industry 

Support for the Petition’’ below). 


jlentini on DSKJ8SOYB1PROD with NOTICES