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SMG 1005.2

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

ORGANIZATIONAL CHANGES - POLICY AND PROCEDURES

GUIDELINES FOR EDITING/CREATING ORGANIZATIONAL CHARTS

Effective Date: September 26, 2007 

[PDF version]

1. Purpose
2. Policy
3. Responsibilities and Procedures
4. References
5. Required Content and Format
6. Authority and Effective Date
7. Document History

Attachment A - FDA Staff Manual Guide 1005.1
Attachment B - FDA Staff Manual Guide 1415.5
Attachment C - Flowchart

1. PURPOSE. 

This guide establishes Agency-wide policies and procedures for editing and creating Agency organizational charts on an ad hoc and quarterly basis for publication via print or electronic media format.

2. POLICY. 

All FDA employees are requested to cooperate fully with the structure and content of the Agency’s system for organizational charts. In responding to reorganizations and changes to organizational elements, a designated FDA Liaison will contact the affected Center/Office Liaisons on a quarterly or ad hoc basis. The FDA Liaison coordinates, in collaboration with Center/Office Liaisons in the revision and creation of organizational charts that will ultimately be posted on the internet and the FDA intranet. Organizational charts serve as a reference to Congress, the Office of Management and Budget, the Department, academia, industry, the general public, and FDA managers. All organizational charts created as a result of reorganization must receive the appropriate approval prior to being posted.

3. RESPONSIBILITIES AND PROCEDURES. 

A. Food and Drug Administration

1. Associate Commissioner for Management

a. Reviews changes and additions to all organizational charts; and

b. Serves as the Agency’s ultimate approving authority for organizational charts.

2. Office of Management Programs (OMP)

a. Reviews and approves FDA organizational charts under authority delegated by the Associate Commissioner for Management;

b. Verifies names and titles of senior staff General Schedule (GS) -15 and Senior Executive Service (SES), identifying any titles as “acting”;

c. Forwards organizational charts to Office Director for approval;

d. Sends quarterly data or ad hoc requests to FDA Center/Office to update organizational charts based on current organizational structure, key officials, and reporting chain or hierarchy;

e. Assigns Standard Administrative Codes (SAC) which uniquely identify an organizational element of FDA and its hierarchical relationships;

f. Reviews Center/Office requests for changes and updates to organizational charts;

g. Verifies information posted on the internet and intranet is correct.

3. FDA Centers, Office of Regulatory Affairs, Office of the Commissioner. Required to designate a contact that is responsible for acting as the Liaison with OMP. This person is responsible for coordinating with and assisting the OMP Liaison in keeping all organizational charts updated to reflect the current organizational structure. Responsibilities include:

a. Responding to quarterly or ad hoc requests for updated organizational information: names, hierarchy, titles, etc.;

b. Submitting ad hoc requests for changes to organizational charts to OPM Liaison; and

c. Forwarding Office/Division Director approved organizational charts to OPM Liaison.

4. Office of Public Affairs, Website Management Staff

a. Receives quarterly and ad hoc requests to post updated or new organizational charts;

b. Verifies information is compliant with FDA policies and procedures for posting, including ensuring Sec. 508 compliance; and

c. Maintains the Agency’s official organizational chart web-page: http://www.fda.gov/oc/orgcharts/orgchart.html

4. REFERENCES. 

A. HHS General Administration Manual (GAM), revised November 2006. Chapter 8-60, Securing Approval of Organizational Changes. The HHS GAM is available on the HHS Intranet.

B. FDA Staff Manual Guide 1005.1 - Policies and Procedures Regarding Organizational Changes. Provides policy and procedures governing the development, evaluation, coordination, review, and approval of all organizational changes within the Food and Drug Administration (FDA).

C. FDA Staff Manual Guide 1415.5 - Authority to Approve Organization Structure and Functional Statements. Delegates the Authority to approve all reorganization proposals.

5. REQUIRED CONTENT AND FORMAT. 

A. Each chart should contain a header, aligned in the center of the page, with the correct reporting echelon starting at the Department level (18pt font), followed by the Agency (14pt font), and working down to the specific Office/Center (14pt font) for which the chart is being developed.

B. The title of the organizational component and all senior managers and their official position titles should be located in the box directly below the header. This is the only box where the text should be aligned in the center.

C. Aside from the header, all text should be in Times New Roman 10pt font.

D. There should be a communications box on the top right containing the phone number, fax, and mailing address of the Office/Center depicted.

E. Each box in the organizational chart should contain the Office/Center/Division name (bold and all capitals) in the top left.

F. The bottom left of each box, below the Office/Center/Division name, should contain the official position title (bold and all capitals) and the employee name (regular font) directly below.

G. Employee names should contain the first, middle, and last names, as well as any titles such as PhD or M.D. Employee names must also indicate “acting” status in parentheses if not officially assigned to the position.

H. Standard Administrative Code should be located in the bottom right of each box.

I. Agency charts must only go down to the Division level.

J. Staff organizational components should only be depicted at the Office level.

K. All positions listed must be supervisors of organizations or programs.

L The name of the organization that prepared and approved the chart should be located at the bottom right of the page.

M. All electronic charts submitted must be prepared using PageMaker version 6.5 or greater.

6. AUTHORITY AND EFFECTIVE DATE. 

This guide was approved by the Deputy Commissioner for Operations and Chief Operating Officer, effective September 26, 2007.

 
 7. Document History -- SMG 1005.2, Guidelines for Editing/Creating Organizational Charts
STATUS (I, R, C) DATE APPROVED LOCATION OF CHANGE HISTORY CONTACT APPROVING OFFICIAL
Initial 09/26/2007 n/a FDA Office of the Commissioner, Office of Management John R. Dyer, Deputy Commissioner for Operations and Chief Operating Officer
    
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