About FDA

SMG 1005.1




Effective Date: 09/25/2012

[PDF version]

 I. Purpose
 II. References
 III. Definitions
 IV. Organizational Change Policy
 V. Organizational Nomenclature
 VI. Approval Authority
 VII. Reorganization Effective Date
 VIII. Effective Date
 IX. Document History

Attachment A - Organizational Echelon Chart
Attachment B - Standard Operating Procedures for FDA Reorganizations


This Guide provides policy and procedures governing the development, evaluation, coordination, review, and approval of all organizational changes within the Food and Drug Administration (FDA).


This Guide supplements policy and procedures set forth in the following directives:

A. General Administrative Manual Chapter HHS: 8-60, “Securing Approval of Organizational Changes”;

B. General Administrative Manual Chapter HHS: 8-65, “Organizational Nomenclature”;

C. General Administrative Manual Chapter HHS: 8-69, “Standard Administrative Code”;

D. Organization and Delegations Staff Manual Guide FDA 1415.5, "Authority to Approve Organization Structure and Functional Statements"; and

F. Agency Organization are available on the FDA Internet site located at: http://inside.fda.gov:9003/PolicyProcedures/StaffManualGuide/VolumeIOrganizationsandFunctions/default.htm


A. Organizational Component. Any part of the FDA organization that is separately established as an organizational entity by law, regulation, the Secretary, or an official who has been delegated authority; and, has formally assigned functions and an approved Standard Administrative Code (SAC) and title. Informal organizations such as teams, task forces, and working groups are generally not considered to be organizational components.

B. Organizational Change. The term "organizational change" includes the establishment, abolishment, transfer, realignment or consolidation of an organizational component; name change; change in reporting relationships; and/or, addition, modification, abolishment, or transfer of function(s).


C. Functional Statement. A formal description of the mission assigned to an organizational component, all inherent responsibilities, and the activities conducted within the component to accomplish that mission. It describes the purpose, scope, and nature of the work proposed within each organization.

D. Standard Administrative Code (SAC). A unique identifier assigned to each organization.  The SAC is the common organizational identifier for all organizations in the Department of Health and Human Services (HHS).  The HHS General Administrative Manual (GAM) 8-69 specifies the code structure.

E. Notification of Organizational Approval. The official document (FDA form 2755A) which adjusts central organizational records and informs the appropriate officials of the organizational change.

F. Echelon. The hierarchical location (organizational level) of an organizational component, regardless of its title, that is based on the reporting relationships specified below. (See Attachment A.)

1. First Echelon. The level of an organizational component whose head reports directly to the Secretary.

2. Second Echelon. The level of an organizational component whose head reports directly to the Commissioner.

3. Third Echelon. The level of an organizational component whose head reports directly to a direct report to the Commissioner.

4. Subsequent Echelons. For each level of an organizational component, heads report directly to the previous level head, e.g., a fourth echelon head reports to a third echelon head.


A. Overall Policy. The Agency will utilize structures that provide efficient and effective means for accomplishing assigned functions within the realm of available resources. Organizations must subdivide into two or more elements.

B. Criteria. Organizational changes should enhance productivity and effectiveness in accomplishing current and long-range goals of the organizational component. The following must be factored into the consideration of proposed organizational changes: budget implications (such as appropriations; reprogramming; and/or limitations); position management; and restrictions on hiring and promotions.

It is a managerial responsibility to structure organizations so that supervisory layering is avoided. This can be accomplished by increasing supervisory spans of control, using informal “teams” rather than formal organizations, reducing layers of oversight, and empowering lower organizational echelons. Organizational structures should be as simple as possible while maintaining responsive customer service and high productivity. As a general rule, formal organizations should not be created below the fifth echelon. The guiding principles related to organizational components are:

1. Component Functions. The proposed functions of the new organization must be clearly distinct; and/or; the type, difficulty, and volume of work to be assigned to the new organization are such that redistribution of tasks between existing organizations is not feasible. In addition, the consolidation of organizational components should be fully considered when supervisory positions are vacated.

2. Component Size. Offices and Divisions must contain at least 16 FTE positions (including funded vacancies), and Branches and Staffs must contain at least 8* FTE positions (including funded vacancies). Contractors are excluded.

3. Organizational Layering. Organizational layering typically includes Offices, Divisions and Branches. If sub-organizational layering is necessary there must be at least two components.

4. Supervisory Layering. Supervisory layering typically includes positions of supervision within organizational components and their respective reporting relationships. Layering is too many supervisory levels in the chain of command.

5. Management Factors. Other considerations include maintaining a reasonable span of control, centralizing or decentralizing, maintaining appropriate lines of authority and responsibility, providing for optimal personnel utilization, keeping line and staff functions in separate components, and ensuring that the rights of employees are not violated.

6. Employee Utilization.Organize components and structure work to fully utilize and leverage existing staff talent. Positions should span several grade levels to provide for internal promotions and job recruitment at the entry level.

7. Policy or Public Interest Implications. The Office of Budget (OB) and Office of Operations (OO) should be notified, within five (5) working days, about organizational changes that have statutory mandates, policy or public interest implications. These changes involve HHS interorganizational relationships on health policy; significant changes in programmatic interrelationships with local, State, and/or other Federal government organizations; members of Congress, OMB, the press, advocacy groups, institutions, labor unions, etc.; or present the potential for inquiry or complaint addressed to the Secretary.

8. Moratoriums. A duration period of one year starting from the effective date of an organizational component’s last approved reorganization must pass before another reorganization proposal may be submitted for approval.

    *Based on the HHS guidelines for supervisor ratios.

c. Preparing Reorganization Packages. The Office of Operations has coordination and oversight responsibility for reorganizations within FDA. Standard Operating Procedures (SOP) for preparing reorganization packages may be found in Attachment B of this SMG. The SOP outlines roles and responsibilities and includes samples and templates.


An organizational component's title should be descriptive of the component's basic functions. FDA's organization will normally conform to the following nomenclature:

A. Line Organizations:

Center/OfficeOffice of Regulatory Affairs
OfficeOffice/Regional Office
DivisionDistrict Office/Regional Laboratory
 Resident Post

B. Special Instructions Concerning Use of the Designation "Staff". The designation "staff" should be utilized to recognize organizational components not suitable for designation as an Office or Division and with a minimum of 8 positions. It may occur at various organizational levels.

C. Special Instructions Concerning Use of the Designation "Team". The designation "team" should be utilized to identify informal organizational components with fewer than 8 positions. A team allows more flexibility than a formal organization; it can be established or disbanded without preparing a formal reorganization proposal.

D. Exceptions. Exceptions to the recommended nomenclature include, but are not limited to:

1. Organizations prescribed by statute or legislatively mandated; and

2. Area offices, libraries, laboratories, etc.

3. Resident Posts may not have a function separate from the Investigations Branch.

4. An Office/Center may request an exception or special waiver by submitting a justification memorandum to the Commissioner through the Chief Operating Officer (COO). The justification must include the purpose, benefit, and the negative impact if the exception is not granted.


A. Secretarial Approval. The Secretary retains the authority to approve all organizational changes that involve:

1. More than one organizational component with an operational mission or function.

2. A statutorily-based or legislatively mandated organization (Consult with the Office of Chief Counsel (OCC) for more information on applicability).

3. A significant reorganization which may affect the public. Examples include the reorganization of multiple offices within the Commissioner’s Office or the realignment of functions that have a direct impact on the public.

B. FDA Commissioner Approval. The FDA Commissioner retains the authority to approve all 1st and 2nd echelon reorganizations, except those noted in VI.A. above.

C. Deputy Commissioner, Chief Scientist, Chief Operating Officer (COO) and Center Directors/Associate Commissioner for Regulatory Affairs (ACRA).Deputy Commissioners, Chief Scientist, COO and Center Directors/ACRA are delegated authority to approve all third echelon and below reorganizations with prior review and concurrence by the Director, Office of Business Services/Management Analysis Staff with the exception of those noted in VI.A. above.


The reorganization effective date is the date the authorized approving official (i.e., the Secretary, Commissioner, or Center Director/ACRA as previously determined), by virtue of his/her signature, signs and dates the official request.

Note: Although the request for reorganization has been approved, no movement of employees or filling of positions in the new organization may occur until OHR has approved and keyed in the SAC(s) into the OHR personnel database. Once this process has occurred, OHR begins processing the movement of employees to new positions and to new administrative codes.


Approved by the Chief Operating Officer, effective on September 25, 2012.

IX. Document History -- SMG 1005.1, Policy Regarding Organizational Changes 



09/26/2007N/aFDA Office of the Commissioner, Office of ManagementJohn R. Dyer, Deputy Commissioner for Operations and Chief Operating Officer
Revision04/23/2010N/aFDA Office of the Commissioner, Office of Management ProgramsRussell J. Abbott, Deputy Commissioner for Administration
Revision09/25/2012N/aFDA Office of Operations

Walter S. Harris,

Chief Operating Officer


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