SMG 1117.3

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF OPERATIONS

OFFICE OF MANAGEMENT

Effective Date: 01/13/2009

1. OFFICE OF MANAGEMENT (DAMB).

A. Advises and assists the Commissioner, Deputy Commissioner, Associate Commissioners and other key Agency officials on various management and systems activities.

B. Assures that the conduct of Agency administrative, personnel, organization, and similar support activities, effectively support program operations.

C. Provides leadership and direction regarding all aspects of a variety of Agency management programs, including ethics, dockets management, organization management, delegations of authority and special studies and projects for the Office of the Commissioner. Establishes agency wide policy and provides overall direction and leadership for the Freedom of Information (FOI) program and Privacy Act program.

D. Integrates the Agency’s technical, programmatic and facilities requirements into the overall budgetary and development plan for the Agency’s consolidation. Implements relocation planning needed to successfully transition the Agency into its new location.

E. Provides Food and Drug Administration’s (FDA) administrative services and facilities. Utilizes a call center to address all administrative and information technology management issues, and monitors and analyzes operational and customer satisfaction.

F. Provides leadership and direction regarding all aspects of Agency human resources management including employment, recruitment, training, career development, partnership activities, quality of work life issues, and executive services.

G. Provides program, technical and resources management for the FDA White Oak consolidation, logistics and facilities operations and maintenance services.

2. ETHICS AND INTEGRITY STAFF (DAMB1).

A. Develops Agency policy and procedures implementing the “Standards of Ethical Conduct for Employees of the Executive Branch” (5 C.F.R., Part 2635) including the Department of Health and Human Services (DHHS) supplemental regulations (5 C.F.R., Part 5501). Monitors employee compliance with Federal regulations by reviewing employees’ financial disclosure reports and outside activity requests. Reviews, prepares, evaluates and secures appropriate approvals for waivers and other determinations regarding financial interest, conflict of interest and other ethical issues. Counsels employees and provides authoritative advice on the statutory, regulatory, policy and procedural requirements regarding ethics and conflict-of-Interest issues. Develops and conducts training for supervisors, managers, administrative staff, special government employees and other agency employees. Provides oversight and direction to the Agency’s Advisory Committee program as it relates to special government employees. Assures that COI waivers are consistent, legally supportable, well documented and timely. Evaluates cooperative agreements developed by Agency components under the Federal Technology Transfer Act and provides technical advice on conflict of interest matters related thereto.

B. Provides advice to employees to ensure their compliance with applicable regulations and statutes on : (1) “Standards of Ethical Conduct for Employees of the Executive Branch” (5 C.F.R., Part 2635); (2) “Supplemental Standards of Conduct for Employees of the Department of Health and Human Services” (5 C.F.R., Part 5501); (3) “Executive Branch Financial Disclosure, Qualified Trusts, Certificates of Divestiture” (5 C.F.R., Part 2634); and (4) Criminal Conflict of Interest Statutes – Chapter 11 – Bribery, Graft, and Conflicts of Interest (Chapter 11 of Title 18 U.S.C.)

C. Serves as liaison with other FDA components and the DHHS Office of General Counsel/Ethics Division to develop co-sponsorship agreements.

D. Provides executive and administrative support to the Conflict of Interest Review Board. Coordinates Board activities, prepares background materials, analyses recommendations and other correspondence for Board members and participates in Board decisions. Implements decisions including advising affected employees of Board determination.

3. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Commissioner, Food and Drug Administration 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