FDA/NCI/CMS Oncology Biomarker Qualification Initiative

March 20, 2006

FDA/NCI/CMS Oncology Biomarker Qualification Initiative

The following was announced in the March 20, 2006 Federal Register...

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 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.

See related .pdf item below for the Memorandum of Understanding.

Download and Read the MOU (.Pdf file)