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  1. Office of Policy

Policy Development and Coordination Staff


Catherine Lorraine, Director

Main Functions

  • Advises and assists the Commissioner concerning information that may affect current or proposed FDA policies.
  • Advises the Commissioner and other key agency officials on the formulation of broad agency regulatory policy.
  • Establishes procedures for agency policy formulation and monitors policy formulation activities throughout the agency.
  • Negotiates the resolution of policy issues involving more than one component of the agency.
  • At times is the lead for writing regulations and other policy initiatives that involve more than one component of the agency.
  • Develops and coordinates the review and analysis of policy.
  • Initiates and participates in interagency discussions on agency regulations, plans, and policies to improve coordination of Federal, State, or local agencies on a specific regulation or in developing an effective alternative approach.
  • Leads and serves on agency task forces that are critical elements in the initiation, study, and resolution of priority policy issues.
  • Serves as agency liaison for intergovernmental policy development.