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- Public Inspection
We are proposing to add Chapare virus to the list of HHS select agents and toxins. We are proposing this action because Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other currently regulated South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.
This document contains a technical correction to the list of select agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) published on October 16, 2008, in the Federal Register (73 FR 61363). This...
This document completes the biennial review and republication of the lists of biological agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA). Because USDA has chosen to no longer regulate ten...
Possession, Use, and Transfer of Select Agents and Toxins-Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments
We are adding reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. We are taking this action for several reasons. First the pandemic influenza virus of 1918-19 killed up to 50 million people worldwide,...
Medicare, Medicaid, and CLIA Programs; Qualification Requirements for Directors of Laboratories Performing High Complexity Testing
This proposed rule would revise and expand the qualification requirements by which an individual with a doctoral degree may qualify to serve as a director of a laboratory that performs high complexity testing.
Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA
This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests...