Privacy Act of 1974; Altered System of Records, Including Addition of Routine Use(s) to an Existing System of Records

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In accordance with the requirements of the Privacy Act of 1974 (Privacy Act), the Department of Health and Human Services (HHS) is publishing notice of a proposal to alter Privacy Act System of Records 09-10-0010 for the ``Bioresearch Monitoring Information System, HHS/FDA,'' including the addition of a new routine use. The major purposes of the proposed alterations are to add the names of the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM), and related information regarding these Centers, to ensure that the system covers all of the Food and Drug Administration's (FDA's) Centers; update the relevant statutory and regulatory citations; and modify the routine uses section of the existing system notice by removing unnecessary routine uses, revising other routine uses to bring them in conformance with case law, and adding a new routine use providing for disclosure of covered records to sponsors and Institutional Review Boards (IRB's) involved with studies affected by a clinical investigator's violative or potentially violative conduct. DATES: Submit written comments on the proposed alterations, including the new routine use, by Novembe