Department of Health and Human Services September 30, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the Web location where the agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development in fiscal year (FY) 2009. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Application 60/891,856 filed February 27, 2007 (E-084-2007/0-US-01) and International Application PCT/US2008/055149 filed February 27, 2008 (E-084-2007/0- PCT-02), entitled ``Use of Histone Deacetylase Inhibitors for the Treatment of Central Nervous System Metastases,'' to Waypharm S.A.S. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be the United States and Europe, and the field of use may be limited to therapeutics based on CNS metastases of extra-CNS origin cancers.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This Federal Register notice sets forth the supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). OIG is supplementing its prior CPG for nursing facilities issued in 2000. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas. The supplemental CPG takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. The supplemental CPG provides voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.