Department of Health and Human Services September 25, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on reagents for detection of specific novel influenza A viruses.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion'' dated September 2012. The guidance document provides blood establishments with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled ``Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products.''