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Developing, Issuing and Maintaining Standard …
MANUAL OF POLICIES AND procedures CENTER FOR DRUG EVALUATION AND RESEARCH MAPP Originating Office: Office of Management Effective Date: 01/12/15 Page 1 of 6 POLICY OFFICE OF MANAGEMENT developing , Issuing and Maintaining Standard operating procedures for CDER Table of Contents PURPOSE ..1 BACKGROUND ..1 POLICY ..2 RESPONSIBILITIES ..3 DEFINITIONS ..3 REFERENCES ..4 EFFECTIVE DATE ..4 CHANGE CONTROL TABLE ..4 ATTACHMENT 1: Guidelines to differentiate MAPPs from SOPs ..5 PURPOSE This MAPP specifies the factors to consider when making a determination on whether to develop a Manual of Policies and procedures (MAPP) or a S tandard operating Procedure (SOP) when delineating CDER policies and procedures . The MAPP also addresses requirements for Maintaining access to, and currency of, SOPs. BACKGROUND The CDER Manual of Policies and procedures (MAPP) is the official repository for CDER directives (internal policies and procedures ), and meets all Office of Management and Budget (OMB) and National Archives and Records Administration (NARA) requirements for developing and archiving directives.
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