Center for Scientific Review; Amended Notice of Meeting, 24295-24296 [E8-9561]

Download as PDF Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices Dated: April 18, 2008, Joan Ohl, Commissioner, Administration for Children, Youth and Families. [FR Doc. E8–9634 Filed 5–1–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–E–0282] (formerly Docket No. 2007E–0256) Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TEKTURNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. mstockstill on PROD1PC66 with NOTICES FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug VerDate Aug<31>2005 17:17 May 01, 2008 Jkt 214001 products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product TEKTURNA (aliskiren hemifumarate). TEKTURNA is indicated for treatment of hypertension. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TEKTURNA (U.S. Patent No. 5,559,111) from Novartis Corporation, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated November 21, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of TEKTURNA represented the first permitted commercial marketing or use of the product. Shortly, thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for TEKTURNA is 2,023 days. Of this time, 1,637 days occurred during the testing phase of the regulatory review period, while 386 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: August 22, 2001. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on August 22, 2001. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: February 13, 2006. FDA has verified the applicant’s claim that the new drug application (NDA) for TEKTURNA (NDA 21–985) was initially submitted on February 13, 2006. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 24295 3. The date the application was approved: March 5, 2007. FDA has verified the applicant’s claim that NDA 21–985 was approved on March 5, 2007. 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 2,022 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by July 1, 2008. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 29, 2008. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: April 21, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–9699 Filed 5–1–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Cardiac Contractility, Hypertrophy, and Failure Study E:\FR\FM\02MYN1.SGM 02MYN1 24296 Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices Section, June 12, 2008, 8 a.m. to June 13, 2008, 12 p.m., The Westin St. Francis, 335 Powell Street, San Francisco, CA, 94102 which was published in the Federal Register on April 22, 2008, 73 FR 21636–21639. The meeting will be held one day only June 12, 2008, from 8 a.m. to 7 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: April 24, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–9561 Filed 5–1–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on PROD1PC66 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Hematology and Vascular Biology. Date: May 20, 2008. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Manjit Hanspal, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7804, Bethesda, MD 20892, 301–435– 1195, hanspalm@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Shared Instrument Grant Program: Surface Plasmon Resonance (SPR) Instruments. Date: May 22, 2008. Time: 10:30 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. VerDate Aug<31>2005 17:17 May 01, 2008 Jkt 214001 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Stephen M. Nigida, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4212, MSC 7812, Bethesda, MD 20892, 301–435– 1222, nigidas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RMO8–004: New Methodologies for Natural Products Chemistry. Date: May 26–28, 2008. Time: 8 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Mike Radtke, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301–435– 1728, radtkem@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Prokaryotic Cell and Molecular Biology Study Section. Date: May 29–30, 2008. Time: 8:30 a.m. to 11 a.m. Agenda: To review and evaluate grant applications. Place: Carlyle Hotel, 1731 New Hampshire Avenue, Washington, DC 20009. Contact Person: Diane L. Stassi, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, 301–435– 2514, stassid@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Clinical Research and Field Studies of Infectious Diseases Study Section. Date: May 30, 2008. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Boston— Downtown, 821 Washington Street, Boston, MA 02111. Contact Person: Soheyla Saadi, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 0903, saadisoh@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Medical Imaging Study Section. Date: June 2, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. Contact Person: Xiang-Ning Li, PhD, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, 301–435– 1744, lixiang@csr.nih.gov. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 Name of Committee: Center for Scientific Review Special Emphasis Panel; Clinical Molecular Imaging. Date: June 3, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. Contact Person: Eileen W. Bradley, DSC, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5100, MSC 7854, Bethesda, MD 20892, (301) 435– 1179, bradleye@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Surgery, Anesthesiology and Trauma Study Section. Date: June 4–5, 2008. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Georgetown, 2101 Wisconsin Avenue, NW., Washington, DC 20007. Contact Person: Weihua Luo, MD, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD 20892, (301) 435– 1170, luow@csr.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Cognition and Perception Study Section. Date: June 5–6, 2008. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Georgetown Suites, 1000 29th Street, NW., Washington, DC 20007. Contact Person: Cheri Wiggs, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3180, MSC 7848, Bethesda, MD 20892, (301) 435– 1261, wiggsc@csr.nih.gov. Name of Committee: Immunology Integrated Review Group; Hypersensitivity, Autoimmune, and Immune-mediated Diseases Study Section. Date: June 5–6, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington National Airport, 1480 Crystal Drive, Arlington, VA 22202. Contact Person: Bahiru Gametchu, DVM, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4204, MSC 7812, Bethesda, MD 20892, 301–435– 1225, gametchb@csr.nih.gov. Name of Committee: Health of the Population Integrated Review Group; Kidney, Nutrition, Obesity and Diabetes Study Section. Date: June 5–6, 2008. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Sir Francis Drake Hotel, 450 Powell Street, San Francisco, CA 94102. E:\FR\FM\02MYN1.SGM 02MYN1

Agencies

[Federal Register Volume 73, Number 86 (Friday, May 2, 2008)]
[Notices]
[Pages 24295-24296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Cardiac 
Contractility, Hypertrophy, and Failure Study

[[Page 24296]]

Section, June 12, 2008, 8 a.m. to June 13, 2008, 12 p.m., The Westin 
St. Francis, 335 Powell Street, San Francisco, CA, 94102 which was 
published in the Federal Register on April 22, 2008, 73 FR 21636-21639.
    The meeting will be held one day only June 12, 2008, from 8 a.m. to 
7 p.m. The meeting location remains the same. The meeting is closed to 
the public.

    Dated: April 24, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
 [FR Doc. E8-9561 Filed 5-1-08; 8:45 am]
BILLING CODE 4140-01-M