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Controls over the Preparation and Receipt of Select Agent Shipments

Pursuant to 42 U.S.C. 262a and 7 U.S.C. 8401, select agents and toxins are a subset of biological agents and toxins that HHS and the U.S. Department of Agriculture have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products. Federal regulations at 42 CFR § 73.16 regulate the transfer of select agents. We will review National Institutes of Health's and Food and Drug Administration's controls for preparing and receiving select agent shipments. We will review controls in place at National Institutes of Health and Food and Drug Administration that are designed to ensure that shipments are made and received in accordance with regulations at 42 CFR § 73.11(a) covering written security plans and related supporting laboratory guidance or instruction.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
October 2017 Other Public Health Reviews Controls over the Preparation and Receipt of Select Agent Shipments Office of Audit Services W-00-16-52000; various reviews 2019