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SMG 1117.3

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF ADMINISTRATION

OFFICE OF MANAGEMENT

Effective Date: 08/07/2009

[PDF Version]

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 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-wide 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.

H. Provides leadership and guidance to the agency for all aspects of physical and personnel security including the suitability and National Security Information Program.

I. Manages and administers the suitability and security program as required by the Office of Personnel Management as set forth in “Suitability” (5 CFR, Part 731), and “National Security Positions” (5 CFR, Part 732). Monitors the appropriate security clearance levels for Agency positions, employees, and contract employees.

J. Processes clearance requests, reviews investigative reports/findings and makes suitability determinations based on investigative findings.

K. Develops and directs the Agency wide physical security programs and provides professional leadership and authoritative guidance.

L. Formulates policy and procedures necessary to maintain the integrity of privileged and trade secret information submitted by industry.

M. Develops and manages the Agency’s contractor security program when Automated Data Processing services or non-public information is released under contract agreement.

N. Serves as the single point of contact and focus for the Operating Division’s management of more than 800 PHS commissioned officers assigned to approzimately 150 duty stations in 47 states.

O. Provides coordination between FDA management and the Assistant Secretary for Health's commissioned corps programs.

P. Develops and implements all policies for utilization of all PHS commissioned officers in FDA. Coordinates all orders, billets, COERs, promotions, and awards for commissioned officers.

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 any related conflict of interest matters.

B.Provides advice to employees to ensure their compliance with applicable regulations and statutes on the following: (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 HHS 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, analyzes recommendations and other correspondence for Board members and participates in Board decisions. Implements decisions including advising affected employees of Board determinations.

3.  AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Secretary of Health and Human Services on August 7, 2009.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial08/23/2007N/aOC/OO/OM/OMPSecretary of the Department of Health and Human Services
Revision01/13/2009N/aOC/OO/OM/OMPCommissioner of the Food and Drug Administration
Revision08/07/2009N/aOC/OA/OM/OBOHCP/OMPSecretary of the Department of Health and Human Services