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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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RPM News 2014

  • 03/19/2014: RPM Chapter 1 Regulatory Procedures Manual (RPM) was revised and updated, as detailed below.
    • Section 1-2, Office of Regulatory Affairs (ORA), is being updated to reflect the 2012 ORA re-organization.
    • Section 1-3, Center for Biologics Evaluation and Research (CBER), is being updated to reflect CBER’s Staff Manual Guides (SMG).
    • Section 1-4, Center for Drug Evaluation and Research (CDER), is being updated to reflect the 2011 CDER re-organization.
    • Section 1-6, Center for Food Safety and Applied Nutrition (CFSAN), is being updated to reflect CFSAN’s SMGs.
    • Section 1-8, Center for Tobacco Products (CTP), is being updated to include the functional statements for the CTP/Office of Compliance and Enforcement.
    • Section 1-9, Enforcement Policy Directory, is being updated to reflect ORA’s Headquarters; CDER’s Office of Compliance, and CFSAN’s Office of Compliance current telephone lists.