Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services, 13980-13986 [06-2656]

Download as PDF 13980 Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices wwhite on PROD1PC61 with NOTICES 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: March 29, 1998. The applicant claims February 26, 1998, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was March 29, 1998, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: April 29, 2002. FDA has verified the applicant’s claim that the new drug application (NDA) for MYCAMINE (NDA 21–506) was initially submitted on April 29, 2002. 3. The date the application was approved: March 16, 2005. FDA has verified the applicant’s claim that NDA 21–506 was approved on March 16, 2005. 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 1,814 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 byMay 19, 2006. 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 VerDate Aug<31>2005 20:35 Mar 17, 2006 Jkt 208001 September 18, 2006. 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 are to 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. Dated: February 13, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–3956 Filed 3–19–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–06–8001] Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 the Centers for Medicare and Medicaid Services (CMS) to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of improving the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies. This collaboration among FDA, NCI, and CMS shall be known as the Oncology Biomarker Qualification Initiative. DATES: The agreement became effective January 23, 2006. FOR FURTHER INFORMATION CONTACT: For FDA: Wendy R. Sanhai, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane (HF–1), Rockville, MD 20857, 301– 827–7861, FAX: 301–443–9718. For NCI: Gregory J. Downing, Office of Technology and Industrial Relations, Office of the Director, National Cancer Institute, 31 Center Dr., MSC 2580—rm. 10A52, Bethesda, MD 20892, 301–496– 1550, FAX: 301–496–7807. For CMS: Peter Bach, Centers for Medicare and Medicaid Services, 20 Independence Ave., SW. (rm. 314G), Washington, DC 20201, 202– 205–5610, FAX: 202–690–6262. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and MOU’s between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. Dated: March 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\20MRN1.SGM 20MRN1 VerDate Aug<31>2005 20:35 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\20MRN1.SGM 20MRN1 13981 EN20MR06.012</GPH> wwhite on PROD1PC61 with NOTICES Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices 20:35 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\20MRN1.SGM 20MRN1 EN20MR06.013</GPH> wwhite on PROD1PC61 with NOTICES 13982 VerDate Aug<31>2005 20:35 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\20MRN1.SGM 20MRN1 13983 EN20MR06.014</GPH> wwhite on PROD1PC61 with NOTICES Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices 20:35 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\20MRN1.SGM 20MRN1 EN20MR06.015</GPH> wwhite on PROD1PC61 with NOTICES 13984 VerDate Aug<31>2005 20:35 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\20MRN1.SGM 20MRN1 13985 EN20MR06.016</GPH> wwhite on PROD1PC61 with NOTICES Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices Federal Register / Vol. 71, No. 53 / Monday, March 20, 2006 / Notices [FR Doc. 06–2656 Filed 3–17–06; 8:45 am] BILLING CODE 4160–01–C VerDate Aug<31>2005 20:39 Mar 17, 2006 Jkt 208001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1 EN20MR06.017</GPH> wwhite on PROD1PC61 with NOTICES 13986

Agencies

[Federal Register Volume 71, Number 53 (Monday, March 20, 2006)]
[Notices]
[Pages 13980-13986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-06-8001]


Memorandum of Understanding Between the United States Food and 
Drug Administration, the National Cancer Institute, and the Centers for 
Medicare and Medicaid Services

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to 
set forth an agreement between the Food and Drug Administration (FDA), 
the National Cancer Institute (NCI), and the Centers for Medicare and 
Medicaid Services (CMS) to develop strategic plans, set priorities, and 
leverage resources and expertise from multiple sources, including the 
private sector, toward the goal of improving the clinical utility of 
biomarker technologies as diagnostic and assessment tools that 
facilitate the development of safer and more effective cancer 
therapies. This collaboration among FDA, NCI, and CMS shall be known as 
the Oncology Biomarker Qualification Initiative.

DATES: The agreement became effective January 23, 2006.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Wendy R. Sanhai, Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane (HF-1), Rockville, MD 20857, 301-827-
7861, FAX: 301-443-9718.
    For NCI: Gregory J. Downing, Office of Technology and Industrial 
Relations, Office of the Director, National Cancer Institute, 31 Center 
Dr., MSC 2580--rm. 10A52, Bethesda, MD 20892, 301-496-1550, FAX: 301-
496-7807.
    For CMS: Peter Bach, Centers for Medicare and Medicaid Services, 20 
Independence Ave., SW. (rm. 314G), Washington, DC 20201, 202-205-5610, 
FAX: 202-690-6262.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOU's between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: March 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-2656 Filed 3-17-06; 8:45 am]
BILLING CODE 4160-01-C
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