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

37000 Federal Register / Vol. 74, No. 142 / Monday, July 27, 2009 / Notices Africa from which citrus fruit is Inspection Service has determined the contact Dr. Patricia L. Foley, Center for authorized for importation into the regulatory review period for NAHVAX® Veterinary Biologics, Policy Evaluation United States, our review of the Marek’s Disease Vaccine and is and Licensing, VS, APHIS, 510 South information presented by the Republic publishing this notice of that 17th Street, Suite 104, Ames, IA 50010; of South Africa in support of its request determination as required by law. We phone (515) 232–5785, fax (515) 232– is examined in a commodity import have made this determination in 7120. evaluation document (CIED) titled response to the submission of an SUPPLEMENTARY INFORMATION: The ‘‘Recognition of Additional Magisterial application to the Commissioner of provisions of 35 U.S.C. 156, ’’ Extension Districts as Citrus Black Spot Pest-Free Patents and Trademarks, Department of of patent term,’’ provide, generally, that Areas for the Republic of South Africa.’’ Commerce, for the extension of a patent a patent for a product may be extended The CIED may be viewed on the that claims that veterinary biologic. for a period of up to 5 years as long as Regulations.gov Web site or in our DATES: We will consider all requests for the patent claims a product that, among reading room (see ADDRESSES above for revision of the regulatory review period instructions for accessing other things, was subject to a regulatory determination that we receive on or review period before its commercial Regulations.gov and information on the before August 26, 2009. We will location and hours of the reading room). marketing or use. (The term ‘‘product’’ consider all due diligence petitions that is defined in that section as ‘‘a drug You may request paper copies of the we receive on or before January 25, CIED by calling or writing to the person product’’ [which includes veterinary 2010. biological products] or ‘‘any medical listed under FOR FURTHER INFORMATION ADDRESSES device, food additive, or color additive CONTACT. : You may submit revision Therefore, in accordance with requests and due diligence petitions by subject to regulation under the Federal either of the following methods: Food, Drug, and Cosmetic Act.’’) A § 319.56–5(c), we are announcing the • Administrator’s determination that the Federal eRulemaking Portal: Go to product’s regulatory review period magisterial districts of Boshof, http://www.regulations.gov/fdmspublic/ forms the basis for determining the Fauresmith, Jacobsdal, Koffiefontein, component/ amount of extension an applicant may and Philippolis in the Free State main?main=DocketDetail&d=APHIS- receive. Province; Christiania and Taung in the 2009-0056 to submit or view revision The regulations in 9 CFR part 124, North West Province; and Barkly-wes/ requests and due diligence petitions and ‘‘Patent Term Restoration’’ (referred to west, Gordonia, Hay, Herbert, to view supporting and related materials below as the regulations), set forth available electronically. procedures and requirements for the Hopetown, Kenhardt, Kimberely, • Namakwaland, and Prieska in the Postal Mail/Commercial Delivery: Animal and Plant Health Inspection Northern Cape Province meet the Please send two copies of your request Service’s (APHIS) review of applications criteria of § 319.56–5(a) and (b) with or petition to Docket No. APHIS–2009– for the extension of the term of certain respect to freedom from citrus black 0056, Regulatory Analysis and patents for veterinary biological spot. After reviewing the comments we Development, PPD, APHIS, Station 3A– products pursuant to 35 U.S.C. 156. As receive on this notice, we will announce 03.8, 4700 River Road, Unit 118, identified in the regulations, the Riverdale, MD 20737–1238. Please state responsibilities of APHIS include: our decision regarding the status of • these areas with respect to their freedom that your revision request or due Assisting Patent and Trademark from citrus black spot. If the diligence petition refers to Docket No. Office of the U.S. Department of Administrator’s determination remains APHIS–2009–0056. Commerce in determining eligibility for Reading Room: A copy of the unchanged, we will add these areas in patent term restoration; regulatory review period determination • the Republic of South Africa to the list Determining the length of a and any revision requests or due of pest-free areas. product’s regulatory review period; diligence petitions that we receive on • If petitioned, reviewing and ruling Done in Washington, DC, this 21st day of this determination are available for on due diligence challenges to APHIS’ July 2009. public inspection in our reading room. regulatory review period Kevin Shea, The reading room is located in room determinations; and Acting Administrator, Animal and Plant 1141 of the USDA South Building, 14th • Conducting hearings to review Health Inspection Service. Street and Independence Avenue SW., initial APHIS findings on due diligence [FR Doc. E9–17794 Filed 7–24–09; 8:45 am] Washington, DC. Normal reading room challenges. BILLING CODE 3410–34–P hours are 8 a.m. to 4:30 p.m., Monday The regulations are designed to be through Friday, except holidays. To be used in conjunction with regulations sure someone is there to help you, issued by the Patent and Trademark DEPARTMENT OF AGRICULTURE please call (202) 690–2817 before Office concerning patent term coming. Animal and Plant Health Inspection extension, which may be found at 37 Other Information: Additional Service CFR 1.710 through 1.791. information about APHIS and its A regulatory review period consists of [Docket No. APHIS–2009–0056] programs is available on the Internet at two periods of time: A testing phase and http://www.aphis.usda.gov. an approval phase. For veterinary Determination of Regulatory Review FOR FURTHER INFORMATION CONTACT: Dr. biologics, the testing phase begins on Period for Purposes of Patent ® Albert P. Morgan, Section Leader, the date the authorization to prepare an Extension; NAHVAX Marek’s Disease Operational Support Section, Center for experimental veterinary biologic became Vaccine Veterinary Biologics, Policy Evaluation effective and runs until the approval AGENCY: Animal and Plant Health and Licensing, VS, APHIS, 4700 River phase begins. The approval phase Inspection Service, USDA. Road, Unit 148, Riverdale, MD 20737– begins on the date an application for a ACTION: Notice. 1231; phone (301) 734–8245; fax (301) license was initially submitted for 734–4314. approval and ends on the date such SUMMARY: We are advising the public For information concerning the license was issued. Although only a that the Animal and Plant Health regulatory review period determination portion of a regulatory review period VerDate Nov<24>2008 19:02 Jul 24, 2009 Jkt 217001 PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1 jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 74, No. 142 / Monday, July 27, 2009 / Notices 37001 may count toward the actual amount of days of the date of this notice (see DATES (‘‘Petitioner’’).1 On July 2, 2009, the extension that the Commissioner of above). The request must specify the Department issued a request to Patents and Trademarks may award, following: Petitioner for additional information APHIS’ determination of the length of a • The identity of the product; and for clarification of certain areas of regulatory review period for a veterinary • The identity of the applicant for the Petition. Based on the Department’s biologic will include all of the testing patent term restoration; request, Petitioner filed a supplement to phase and approval phase as specified • The docket number of this notice; the Petition on July 8, 2009 in 35 U.S.C. 156(g)(5)(B). and (‘‘Supplement to the Petition’’). On July APHIS recently licensed for • The basis for the request for 10, 2009, the Department requested production and marketing the veterinary revision, including any documentary ® further information from Petitioner, biologic NAHVAX Marek’s Disease evidence. including suggested refinements to the Vaccine. Subsequent to this approval, Further, under § 124.30 of the scope. Based on the Department’s the Patent and Trademark Office regulations, any interested person may request, Petitioner filed a second received a patent term restoration file a petition with APHIS, no later than ® supplement to the Petition on July 14, application for NAHVAX Marek’s 180 days after the date of this notice (see 2009 (‘‘Second Supplement to the Disease Vaccine (U.S. Patent No. 5, 965, DATES above), alleging that a license Petition’’). Based on conversations with 138) from Schering Plough Animal applicant did not act with due diligence Petitioner regarding scope and certain Health Corporation, and the Patent and in seeking APHIS approval of the other clarifications, Petitioner filed a Trademark Office requested APHIS’ product during the regulatory review supplement to the Petition on July 15, assistance in determining this patent’s period. The filing, format, and content 2009 (‘‘Third Supplement to the eligibility for patent term restoration. In of a petition must be as described in the Petition’’).2 On July 17, 2009, we a letter dated February 2, 2009, APHIS regulations in ‘‘Subpart D–Due advised the Patent and Trademark received a submission on behalf of a Diligence Petitions’’ (§§ 124.30 through U.S. importer of woven electric blankets Office that this veterinary biologic had 124.33). undergone a regulatory review period and its affiliated Chinese producer and and that the approval of NAHVAX® Authority: 35 U.S.C. 156. exporter, both interested parties to this Marek’s Disease Vaccine (Marek’s Done in Washington, DC, this 21st day of proceeding as defined in section Disease Vaccine, Serotypes 1 & 3, Live July 2009. 771(9)(A) of the Act. This submission Herpesvirus Chimera) represented the Kevin Shea, challenged the definition of the first permitted commercial licensing or Acting Administrator, Animal and Plant domestic like product.

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