Department of Health and Human Services August 29, 2012 – Federal Register Recent Federal Regulation Documents

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward.'' This workshop, the third in a series of specialized vaccine workshops, will review new methods and approaches for acellular pertussis (aP) vaccine safety testing that incorporate innovations in science and technology. These scientific innovations should improve test accuracy, precision, and efficiency while also reducing or replacing the use of animals in vaccine safety testing. The goal is to address the path toward global validation, acceptance, and implementation of scientifically valid alternative methods for aP vaccines. The workshop is open to the public at no charge with attendance limited only by the available space; however, advance registration is required (see DATES). NICEATM also invites submission of abstracts for scientific posters for display at the workshop (see SUPPLEMENTARY INFORMATION).

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. (Lallemand).