Office of Operations

Mission

The Office of Operations (OO) provides leadership for operational activities, interaction and execution of program initiatives across the Office of the Commissioner (OC) and FDA centers, field offices and regions.  OO assures that the conduct of agency administrative and financial management activities effectively support program operations.

The Chief Operating Officer (COO) has agency-wide authority for strengthening the management of business programs and operations of the agency. The COO oversees day-to-day management issues, effective implementation of Congressional and Commissioner priorities and initiatives, and the delivery of quality services by the agency and its centers.

OO provides an array of agency-wide services including information technology, procurement, and facilities.  OO provides leadership and direction regarding delegation of authority, freedom of information, privacy act, and regulatory dockets management and ethics and conflict of interest matters.  OO provides executive administrative management services to the Office of the Commissioner nationwide staff. 

Major Functions:

• Provides executive direction, leadership, coordination, and guidance for the overall day-to-day administrative operations of the agency assuring the timely and effective implementation and high quality delivery of services across the agency and Centers.
• Advises and assists the Commissioner, Principle Deputy Commissioner, Deputy Commissioners, and other key officials on various administrative management and business activities of the agency.
• Chairs all agency user fee programs which oversees financial management and provides financial management support.
• Assures that the conduct of agency administrative and financial management activities, including budget, finance, acquisitions, information technology, human resources, organization, methods, and similar support activities, effectively support program operations  Utilizes a call center to address all administrative and information technology management issues, and monitors and analyzes operational performance and customer satisfaction.
• Plans, directs and coordinates a comprehensive financial management program for FDA encompassing the areas of automated financial systems, fiscal accounting, voucher audit, and financial reporting.  Issues periodic reports regarding the status of FDA's financial management and develops financial inputs for the agency's programs and financial plans.
• Provides leadership and direction regarding all aspects of a variety of agency management programs including organization management, OIG Liaison, delegations of authority, freedom of information, privacy act, and regulatory dockets management as well as programs related to ethics and conflict of interest matters.
• Advises the Commissioner and other key agency officials on administrative management and budget matters for components within the OC.  Provides advice and guidance with regard to formulation and development of administrative management policies, procedures, and controls.
• Advises and provides assistance to the Commissioner and senior management officials on information management resources and programs.  Establishes and oversees implementation of the FDA information management policy and governance, processes and policies to ensure the agency is in compliance with the Clinger/Cohen Act.  Establishes, directs and leads agency level programs and all strategic aspects of information management including: information technology infrastructure and systems, telecommunications, security, strategic planning, capital planning and investment control, and enterprise architecture.