[Federal Register Volume 71, Number 53 (Monday, March 20, 2006)]
[Notices]
[Pages 13980-13986]
From the Federal Register Online via the Government Publishing 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.

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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]
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