Department of Health and Human Services August 19, 2009 – Federal Register Recent Federal Regulation Documents

AHRQ is announcing the Agency's intention to support new CER projects, with funding from the American Recovery and Reinvestment Act (ARRA). The ARRA appropriated $300 million to AHRQ for support of CER. ARRA funding will focus, initially, on 14 priority conditions established by the Secretary of the Department of Health and Human Services under Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. These priority conditions were identified through a process involving discussion with, and extensive input from, the public as well as Federal agencies. The list of priority conditions is relevant to the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) programs, and can be found at: https://effectivehealthcare.ahrq.gov/ aboutUs.cfm?abouttype=program#Conditions.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Methodologies for Post-Approval Studies of Medical Devices.'' The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to methodologies for post-approval studies of medical devices. The target audiences for this workshop are Epidemiologists, Statisticians, Clinicians and Regulatory Affairs Specialists.