SMG 1117.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF OPERATIONS

Effective Date: 01/13/2009

	1. Office of Operations
	2. Bioinformatics Board Staff
	3. Authority and Effective Date

1. OFFICE OF OPERATIONS (DAM). 

A. Provides executive direction, leadership, coordination, and guidance for the overall day-to-day operations of the agency assuring the timely and effective implementation of operations and high quality delivery of services across the agency and Centers.

B. Oversees the day-to-day operational activities and the interaction and execution of new program initiatives across all Centers, Field offices, Regions, and the Office of the Commissioner.

C. Advises and assists the Commissioner, Deputy Commissioners, Chief of Staff, Chief Scientist, Chief Counsel, Center Directors, and other key Agency officials on various management and business processes, compliance-oriented and legislative matters of the agency.

D. Works with other senior agency leadership to make decisions that are consistent with broad conceptual guidelines of the Commissioner, to meet the changing needs of the Agency and new legislation.

E. Chairs the Prescription Drug User Fee Act (PDUFA) Review Board, which oversees financial management of the PDUFA program.

F. Coordinates and operationalizes the agency’s business process improvement initiatives to increase quality, productivity, and transparency.

G. Provides executive leadership to the Centers, OC and ORA in identifying areas to target and prioritize for improvement; developing improvement recommendations; and, in coordination with the Bioinformatics Board (BiB) and Office of Information Management, and other agency components, as appropriate, providing implementation strategies to agency business programs. These process improvement initiatives may be short- or long-term, cross-cutting or Center specific. The OO may also support the execution of initiative implementation strategies.

H. Provides executive leadership and operational oversight to the Office of the Commissioner.

I. Assures that the conduct of Agency administrative and financial management activities, including budget, finance, personnel, organization, methods, and similar support activities, effectively support program operations.

J. Provides FDA’s administrative management services including information technology, communications, financial transaction functions, procurement, facilities, and equal employment opportunity and diversity management. Utilizes a call center to address all administrative and information technology management issues, and monitors and analyzes operational performance and customer satisfaction.

K. 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.

L. Provides leadership and direction regarding all aspects of a variety of Agency management programs including organization management, delegations of authority, freedom of information, privacy act, and regulatory dockets management as well as programs related to ethics and conflict of interest matters.

M. Advises the Commissioner and other key Agency officials on administrative management and budget matters for components within the Office of the Commissioner (OC). Provides advice and guidance with regard to formulation and development of administrative management policies, procedures, and controls.

N. Provides advice and 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, procedures and processes to ensure the Agency is in conformance with the Clinger/Cohen Act. Establishes, directs and leads Agency level programs and all strategic aspects of information management including: information technology (IT) shared services, telecommunications, security, strategic planning, capital planning and investment control, and enterprise architecture.

O. Plans, organizes, and carries out annual and multi-year budgeting in support of FDA’s public health mission and programs. Provides staff assistance in justifying budgets through executive and congressional echelons. After appropriation, develops an orderly expenditure plan.

P. Serves as the first responder for FDA in emergency and crisis situations involving FDA regulated products or in situations where FDA regulated products are needed to be utilized or deployed.

2. BIOINFORMATICS BOARD STAFF (DAM1). 

A. Provides leadership and direct support to the Bioinformatics Board’s co-chairs, to ensure the BiB can meet the functions of its Charter.

B. Coordinates the work of the Business Review Boards (BRBs); monitoring all BRB content and progress on activities, elevating issues that require BiB attention; and ensuring the BiB directions are appropriately executed by the BRBs.

C. Coordinates business decisions on priority, planning and execution of Agency cross-cutting information management projects, and coordinates with the Office of Planning on the related business process analyses.

D. Coordinates planning activities to ensure harmonization between data and terminology standards development, regulatory analysis and modifications, business process analysis, application software requirements, and information technology requirements as they relate to business automation activities of the BiB.

E. Facilitates the exchange of best practices across Centers/Offices to ensure successful mission development and implementation.

3. AUTHORITY AND EFFECTIVE DATE. 

The function statements for the Office of Operations were approved by the Commissioner of Food and Drugs effective January 13, 2009.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2007	N/a	OC/OO/OM/OMP	Secretary of the Department of Health and Human Services
Revision	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration