2010-19772. Memorandum of Understanding Between United States Food and Drug Administration and the Centers for Medicare and Medicaid Services

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Centers for Medicare and Medicaid Services (CMS), both part of the U.S. Department of Health and Human Services. The purpose of the MOU is to promote collaboration and enhance knowledge of efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to further enhance information sharing efforts through more efficient and robust inter-agency activities; promote efficient utilization of tools and expertise for product analysis, validation, and risk identification; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.

DATES:

The agreement became effective June 25, 2010.

FOR FURTHER INFORMATION CONTACT:

David H. Dorsey, Office of Policy, Planning and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4222, Silver Spring, MD 20993, 301-796-4800.

SUPPLEMENTARY INFORMATION:

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

Dated: August 4, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.