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

---
identifier: "/us/fr/06-2656"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services"
title_number: 0
title_name: "Federal Register"
section_number: "06-2656"
section_name: "Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services"
positive_law: false
currency: "2006-03-20"
last_updated: "2006-03-20"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "06-2656"
document_type: "notice"
publication_date: "2006-03-20"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "71 FR 13980"
fr_volume: 71
docket_ids:
  - "FDA 225-06-8001"
effective_date: "2006-01-23"
fr_action: "Notice."
---


#  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.