Department of Health and Human Services September 17, 2008 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) will be providing temporary critical HIV medical care and treatment services through GLH Magnolia Medical Clinic to avoid a disruption of HIV clinical care to clients in Bolivar, Sunflower and Washington counties in Mississippi.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Animal Health Pharmaceuticals, LLC. The supplemental NADA provides for a revised human food safety warning on labeling for an oral suspension of sulfadiazine and pyrimethamine used for the treatment of equine protozoal myeloencephalitis (EPM).

The Food and Drug Administration (FDA) is proposing to amend its bottled water regulations to require that source water, which is currently subject to weekly microbiological testing, be tested specifically for total coliform as is done for finished bottled water products. Further, FDA is proposing that if any coliform organisms are detected in source water or finished bottled water products, bottled water manufacturers would be required to test for the bacterium Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is proposing to amend the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli would be considered adulterated, and source water containing E. coli would not be considered to be of a safe, sanitary quality and would be prohibited from use in the production of bottled water. In addition, this rule would require bottlers to rectify or eliminate the source of E. coli contamination in source water and keep records of such actions. Existing regulatory provisions would require bottled water manufacturers to keep records of new testing required by this rule. FDA tentatively concludes that this proposed rule, if finalized, will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.

In FY 2006, ORR awarded a competitive Services for Survivors of Torture grant to the Center for Multicultural Human Services (CMHS) in Falls Church, Virginia. The original project period was from September 30, 2006 through September 29, 2009. CMHS served as fiscal sponsor and legal entity of the approved project. As of March 31, 2008, CMHS ceased operations. CMHS has requested permission for Northern Virginia Family Service to assume the grant. Northern Virginia has agreed to this request. The effect of this deviation request is to transfer the grant from the initial grantee to a new grantee with the scope and operations of the grant remaining unchanged.