Department of Health and Human Services September 22, 2009 – Federal Register Recent Federal Regulation Documents

HRSA has issued a non-competitive replacement award under the Rural Health Network Development Program to White River Rural Health Center, Inc. (WRRHC). The original grantee, Siloam Springs Memorial Hospital, is no longer eligible to serve as the lead entity for this network of rural health care providers serving a five county area in Arkansas and Oklahoma. This replacement award will ensure that the medically underserved residents of western Benton and Washington counties in Arkansas and Adair, Cherokee, and Delaware counties in Oklahoma continue receiving necessary medical care and services without disruption.

Concerns about the emergence of a pandemic influenza virus have spurred research on influenza viruses that have either caused pandemics or are believed to have the potential to cause a pandemic. These viruses include human H2N2 virus, which circulated from 1957- 1968, the 1918-1919 H1N1, which caused the deadliest pandemic in the past century, and the Highly Pathogenic Avian Influenza (HPAI) H5N1 virus that is thought to have pandemic potential. The public health benefits of this research include developing a better understanding of the pathogenicity of pandemic influenza viruses, their virulence mechanisms, mechanisms of host adaptation, and ultimately the development of vaccines and antiviral drugs. These benefits are balanced against the potential risks that might include the inadvertent release of a highly transmissible and potentially virulent influenza virus. Consequently, explicit and uniform biosafety containment practices are critical to the safe conduct of research with these agents. The NIH Guidelines provide a framework for assessing the risks of such research. However, after extensive consultation with the NIH Recombinant DNA Advisory Committee (RAC), experts in biosafety and influenza, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA), the NIH Office of Biotechnology Activities (OBA) concluded that more specific guidance in the NIH Guidelines is warranted to promote uniform biosafety practices for recombinant research with these viruses.