Department of Health and Human Services July 26, 2006 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The ACBSA will meet to review progress and solicit additional input regarding numerous recommendations made during the past year, specifically biovigilance of blood components and its derivatives, cells, tissues, and organs. Vigilance is recognized as a necessary step in monitoring outcomes in a quality assurance process toward the goal of providing safe and available biological products (i.e., blood components and derivatives, cells, tissues and organs) and improvement of care of the donor and recipient. Elements necessary for vigilant surveillance are detection, analysis, reporting, utilizations, research, education, and management of outcomes, including emerging or re-emerging infectious and non-infectious events of transfusion and/or transplantation, will be discussed.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Diethylhexyl butamido triazone, up to 3 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRASE) for its proposed OTC use.