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

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 Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same increased dose levels approved for single-ingredient Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate or monensin in two-way, combination drug Type C medicated feeds containing melengestrol acetate and monensin.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus''. This draft guidance provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture Whole Blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes.