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SMG 1005.1
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
ORGANIZATIONAL CHANGES - POLICY AND PROCEDURES
POLICY AND PROCEDURES REGARDING ORGANIZATIONAL CHANGES
Effective Date: September 26, 2007
1. Purpose
2. References
3. Definitions
4. Organization Planning Policy
5. Organizational Nomenclature
6. Specific Organizational Considerations
7. Approval Authority/Clearance
8. Documentation Requirements
9. Responsibilities for Effecting Organizational Changes
10. Approval of Organizations
11. Effective Date of Reorganization
12. Published Sources of Approved Organizations
13. Effective Date
14. Document History
Attachment A - Organizational Echelon Chart
Attachment B - Checklist for Submission of Organization Proposals
Attachment C - Form FDA 2755 "Notification of Organizational Approval" (sample)
Attachment D - Form FDA 2306 "Clearance Record" (sample)
1. PURPOSE.
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).
2. REFERENCES.
This Guide supplements policy and procedures set forth in the following directives:
1. General Administrative Manual Chapter HHS: 8-60, “Securing Approval of Organizational Changes”, which is available on the HHS Intranet;
2. General Administrative Manual Chapter HHS: 8-65, “Organizational Nomenclature”, which is available on the HHS Intranet;
3. General Administrative Manual Chapter HHS: 8-69, “Standard Administrative Code”, which is available on the HHS Intranet;
4. Organization and Delegations Staff Manual Guide FDA 1415.5, "Authority to Approve Organization Structure and Functional Statements"; and
5. Secretary of Health and Human Services (HHS) memo of September 27, 1995, “Delegation of Authority to Approve Reorganizations.” This memo is available by contacting the FDA Office of Management Programs, HFA-340.
3. DEFINITIONS.
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, or consolidation of an organizational component; name changes; changes in reporting relationships; and/or, additions, modifications, 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. Each organization must have a functional statement.
D. Standard Administrative Code. 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 which adjusts central organizational records and informs the appropriate officials of the organizational change. (See Attachment C, Notification of Organizational Approval, Form FDA 2755.)
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 Commissioner.
2. Second Echelon. The level of an organizational component whose head reports directly to an Associate Commissioner, Assistant Commissioner, Deputy Commissioner, Chief of Staff, Chief Counsel and the Associate Commissioner for Regulatory Affairs, or a Center Director.
3. Subsequent Echelons. For each level of an organizational component, heads report directly to the previous level head, e.g., a third echelon head reports to a second echelon head.
4. ORGANIZATION PLANNING POLICY.
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, never into one.
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.
C. Proposal Development. The Office of Management Programs (OMP), (HFA-400), Office of Management (OM), provides support for analytical studies of organizational mission, structure, workload and resources. The Rockville Human Resources Center’s Labor and Employee Relations Division ensures that changes to conditions of employment resulting from organizational changes are implemented consistent with the Labor Relations Statute and provisions of applicable collective bargaining agreements. The Rockville Human Resources Center (RHRC) provides support for position management considerations and position classifications. Management officials should utilize this support as early as possible in the development of an organizational proposal. Requests for organizational change studies should be directed to the Director, OMP.
5. ORGANIZATIONAL NOMENCLATURE.
An organizational component's title should be descriptive of the component's basic functions. FDA's organization will normally conform to the following nomenclature:
1. Line Organizations:
| Headquarters | Field |
| Center | Regional Office |
| Office | District Office |
| Division | Branch |
| Branch | Resident Post |
2. Staff Organizations:
| Agency wide |
| Office |
| Division |
| Branch |
3. Special Instructions Concerning Use of the Designation "Staff". The designation "staff" should be utilized to recognize organizational components not suitable for designation as office, division, branch, etc. It may occur at various organizational levels and in both staff and line-oriented organizations.
4. Special Instructions Concerning Use of the Designation "Team". The designation "team" should be utilized to identify informal organizational components with fewer than 10 positions. "Teams" allow for more flexibility than formal organizations; they can be established or disbanded without preparing formal reorganization proposals.
5. Exceptions. Exceptions to the recommended nomenclature include:
a. Organizations prescribed by statute; and
b. Area offices, libraries, laboratories, etc.
Other exceptions at any organizational level should be discussed with OMP before organizational proposals are finalized.
6. SPECIFIC ORGANIZATIONAL CONSIDERATIONS.
A. Structure. 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” instead of formal organizations, reducing layers of oversight, and empowering lower organizational echelons. Organizational structures should be as simple as possible within the context of being responsive to functional responsibilities. As a general rule, formal organizations should not be created below the fourth echelon. The guiding principle is that separate organizational components are appropriate when:
1. The proposed functions of the new organization are clearly distinct; and/or;
2. The type, difficulty, and volume of work to be assigned to the new organization is 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.
B. Component Size. The overall goal is that there will normally be no fewer than 10 full-time equivalent (FTE) positions assigned to any separate organizational component created within the Agency. In addition, offices and divisions normally should contain a minimum of 20 FTE positions, and branches and staffs normally should contain a minimum of 10 FTE positions.
Deviations from these goals are matters of managerial responsibility, within the context of structure considerations outlined above.
C. Organizational Layering. There should be a minimum of two organizational components reporting to a single Office/Division. Streamlining and delayering techniques help utilize existing personnel and resources to their fullest potential.
D. 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.
E. Employee Utilization. Organize components and structure work so that existing staff are utilized to their full potential. Positions should span several grade levels to provide for internal promotions and job recruitment at the entry level.
F. Policy or Public Interest Implications. OMP should be notified as soon as possible about organizational changes that have statutory mandates, policy or public interest implications. These are issues which involve HHS interorganizational relationships on health policy; significant changes in programmatic interrelationships with local, State, and/or other Federal government organizations; Members of Congress, Office of Management and Budget, the press, advocacy groups, institutions, labor unions, etc.; or, present the potential for inquiry or complaint addressed to the Secretary.
7. APPROVAL AUTHORITY/CLEARANCE.
A. Attachment A specifies approval levels for each FDA organizational echelon.
B. Reference E outlines the Secretary’s delegated authority to approve reorganizations.
8. DOCUMENTATION REQUIREMENTS.
A. Documentation Requirements for Organizational Changes. The organizational component requesting the change should provide OMP with documentation (including signature of appropriate official) that highlights the principal aspects of the organizational proposal, states policy issues, and includes the following:
1. Clearance Record (Form FDA 2306) that includes, current and proposed supervisory ratios for each Division and Office affected by reorganization; a streamlining statement stating whether or not the ratio has improved; and clearance signatures from the Team Leader, RHRC; senior management as determined by the Center/Office, the head of the component(s) requesting the change; and at least one hierarchy above all affected components;
2. A brief statement of the proposed organizational changes including the changes in the functions or the assignments of functions (general, concise statements, normally limited to five). Functional statements should be forwarded to the affected Offices and Divisions for comments and revisions before clearance is obtained. New and revised functional statements should be in Word format when sent to OMP. These statements will eventually be published in the Staff Manual Guide;
3. A statement of the purpose and justification of the changes;
4. A brief statement of the impact of the proposed change on other organizational components;
5. A statement that all personnel matters have been concurred with the respective personnel component including information about the effect of proposed changes on supervisory ratios, position classification/grade levels, employment ceilings, labor unions agreements, promotions or reassignments that are contingent upon the approval of the proposed organizational change, and any EEO considerations;
6. A statement that justifies the establishment of a reorganization that adversely affects the supervisory ratios of a major component and/or for a proposal with components of fewer than 10 FTEs at any organizational level (including branch and staff) and fewer than 20 FTEs at the office or division level;
7. A statement that certifies that any budget appropriations, reprogramming, and/or limitations that may occur as a result of this reorganization have been addressed with appropriate representatives of the Office of Financial Management;
8. Current and proposed staffing charts, including names of individuals, job titles, pay plan, vacancy, proposed position, job series and current grades, proposed grade, the name of the SAC for the organization where the employee is currently assigned, and organization locations. Staffing data should be summarized by component for Senior Executive Service (SES), Commissioned Corps, professional, and support personnel. This Data should be provided in Excel table format when sent to RHRC and OMP;
9. Current and proposed organizational charts to illustrate the complete breakdown of all affected components of the new organization;
10. A statement that certifies that all statutory and contractual collective bargaining obligations have been satisfied; and
11. A statement that certifies prior delegations of authority have been met - "Pending further delegations, directives, or orders by the Commissioner of Food and Drugs, all delegations of authority to positions of the affected organizations in effect prior to this date shall continue in effect in them or their successors."
B. Documentation Required for Title Changes. The organizational component should provide OMP and the appropriate personnel component with a copy of the approval document that should state no functional statements will be modified or any personnel realigned. If, however, functional statements will change or personnel will be realigned, the documentation should be prepared as outlined in 8a.
C. Effective Date of Approvals. Unless otherwise specified, the effective date for any organizational change will be the date of signature of the approving official.
9. RESPONSIBILITIES FOR EFFECTING ORGANIZATIONAL CHANGES.
The major responsibilities for effecting organizational changes belong to the component proposing the organizational change and the components within the Office of Management as stipulated below.
1. Responsibilities of Office of Management Programs, OMP. Provides FDA managers with the following management services:
a. Advice and Management Expertise. Consults with FDA managers regarding the content of organizational proposals, organizational management theory and practice, and reviews HHS and FDA organizational policy and interpretation.
b. Analytical Studies. On request, conducts analytical studies of components to determine the best organizational structure.
c. Review and Concurrence of Approved Reorganizations.
(1) Review and approve all organizational changes of Center Directors, Directors, and Offices;
(2) Ensures internal coordination and clearances from other FDA organizational components;
(3) Ensures the Office of Financial Management has been informed of any reorganization that impacts budget appropriations, reprogramming and/or limitations;
(4) Compiles and coordinates the final reorganization package including memoranda, staffing data, functional statements, and the proposed Federal Register notice;
(5) Prepares, evaluates, and coordinates proposals subject to approval by the Secretary, Commissioner, Deputy Commissioner, Associate Commissioners, Chief Counsel, Assistant Commissioners, Center Directors, and/or Associate Commissioner for Regulatory Affairs;
(6) Prepare official reorganization packets for Congressional Approval, depending on the extent of the changes proposed;
(7) Assigns SACs to newly approved organizations;
(8) Forwards pertinent Staff Manual Guides to the Paperwork Reduction Act and Records Management Staff, Office of the Chief Information Officer (OCIO) for publication and distribution;
(9) Prepares and forward the Notification of Organizational Approval and/or Standard Administrative Code Assignment (Form FDA 2755) to the appropriate Agency and Center components;
(10) Forwards completed Clearance Record (Form FDA 2306) to appropriate Agency and Center components;
(11) Prepare the Federal Registers notice. The purpose of the Federal Register notice is to notify the public that an organizational change has taken place. For organizational changes that are sent to the FDA Commissioner or a higher level official for approval, a Federal Register notice is necessary;
(12) Publish new or updated functional statements in the FDA Staff Manual Guide;
(13) Posts updated organizational charts on Agency website; and
(14) Maintains a record of all approved reorganization packages.
2. Responsibilities of the Component Proposing Organizational Changes. Appropriate staff offices (e.g., Executive Offices) should be involved in the preparation and review of organization proposals. Executive Officers should identify changes that are statutorily based, involve more than one operating division, or are significant enough to affect the public; and ensure that these changes are endorsed by the Center Director and/or appropriate official. The Department retains the ultimate approval authority for such changes. Components are also responsible for:
a. Following the policy and procedures in this Guide when considering organizational changes;
b. Working closely with OMP management analysts to ensure full consideration of organizational policy and impact;
c. Working closely with the designated the Human Resources representative to ensure full consideration of personnel impact including appropriateness of grade and title;
d. Concurrently submitting organizational proposals to OMP and the designated personnel generalist for review and clearance;
e. Providing designated personnel generalists, as appropriate, with any additional documentation requested during their evaluation of proposed organizational changes;
f. Working closely with RHRC’s Labor and Employee Relations Division to satisfy statutory and contractual bargaining obligations, and to negotiate changes in conditions of employment as applicable prior to the implementation of the change; and
g. Working closely with OFM representatives to ensure consideration of any budget implications such as appropriations, reprogramming, and/or limitations.
3. Responsibilities of the RHRC. Human Resources ensures the involvement of other agency staff, as appropriate. The following staff assistance from Human Resources should be available:
a. All Organizational Changes. Clearance by the designated Human Resources representative is required prior to the approval of the appropriate approving official and prior to receipt by OMP. This clearance indicates that the Human Resources representative has considered issues as specified below and is working with the component to resolve all personnel issues.
(1) On all proposals, the Human Resources representative will respond in a timely manner to identify personnel and position management considerations. When they disagree with proposed grade levels or position classification in proposals, they will note that concern on the Clearance Record (Form FDA 2306) but not hold up further action on the proposal. If they disagree with the proposed staffing because of adverse impact on current grade structure, non-concurrence should be noted.
(2) When requested, the Human Resources representative will evaluate current and proposed staffing, and furnish a written report on the following:
(a) Probable impact on present and proposed grade levels, appeal rights of current employees, applicable union contracts, and the potential need to initiate reduction-in-force procedures;
(b) Position descriptions that need to be revised or abolished;
(c) Identification of new positions which need to be established (and their probable classification);
(d) Effects on existing SES, Senior Biomedical Research (SBRS), and Commissioned Corps positions, and a brief summary of the procedures and time required to update the positions;
(e) Proposed new SES and SBRS positions, including the merits and the likelihood of establishing these positions;
(f) Personnel documents (e.g., revised position descriptions) which the component proposing the change must transmit to RHRC; and
(g) Recommendations.
(3) Once the reorganization is approved, Human Resources processes all relevant personnel changes.
10. APPROVAL OF ORGANIZATIONS.
Refer to SMG 1415.5 and Attachment A for additional details. If you have any questions please contact OMP. Additionally, Congress may create any organization from legislation. Some examples include the Office of Pediatrics, the Office of Counter Terrorism, and the Office of Combination Products. Any changes to these organizations must be reported to Congress for approval. In addition, any organization receiving appropriated funds from Congress that have a specific designation, must also receive approval from Congress for any changes to their organization.
11. EFFECTIVE DATE OF REORGANIZATION.
The effective date of the reorganization may not correspond to the date of approval.
12. PUBLISHED SOURCES OF APPROVED ORGANIZATIONS.
A. Federal Register. Functional statements for organizations at the second echelon and above may be published in the Federal Register after approval by the appropriate official.
B. FDA Organization and Delegations Staff Manual Guides. These guides contain a complete description of the Agency's approved components and their functional statements above the fourth echelon.
C. FDA Agency Organizational Charts. These charts illustrate approved organizational components at the fourth echelon and above. Charts are updated by analysts in OMP and are available on the FDA's Internet site at http://www.fda.gov/oc/orgcharts/orgchart.html.
13. EFFECTIVE DATE.
Approved by the Deputy Commissioner for Operations and Chief Operating Officer, effective September 26, 2007.
| STATUS (I, R, C) | DATE APPROVED | LOCATION OF CHANGE HISTORY | CONTACT | APPROVING OFFICIAL |
|---|---|---|---|---|
| Revision | 09/26/2007 | n/a | FDA Office of the Commissioner, Office of Management | John R. Dyer, Deputy Commissioner for Operations and Chief Operating Officer |