Use of ozone-depleting substances; removal of essential use designations; confirmation of effective date. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) is confirming the effective date of April 23, 2007, for the direct final rule that appeared in the Federal Register of December 7, 2006 (71 FR 70870). The direct final rule amends the regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, used in oral pressurized metered-dose inhalers, from the list of essential uses of ozone-depleting substances. None of these products is currently being marketed. This document confirms the effective date of the direct final rule.     

Medical devices; hematology and pathology devices: reclassification of automated blood cell separator device operating by centrifugal separation principle. Final rule

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.