Privacy Act of 1974; Report of an Altered System of Records, Including Addition of Routine Uses to an Existing System of Records; Bioresearch Monitoring Information System

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The Food and Drug Administration (FDA) is announcing an alteration to an existing System of Records (System) titled "Bioresearch Monitoring Information System, HHS/FDA" (System No. 09- 10-0010). Among other updates, this alteration adds new routine uses for disclosures of certain relevant information to Agencies, authorities, and organizations with responsibilities related to clinical investigations and/or clinical investigators; persons who require access to records to perform services for FDA; and individual research subjects.