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Effective Date: September 26, 2007
1. AUTHORITY DELEGATED.
To approve all reorganization proposals within FDA, except as reserved in Limitations below.
2. TO WHOM DELEGATED.
A. The Commissioner retains the authority to approve all first and second echelon reorganizations.
B. Third echelon reorganization proposals are redelegated to Deputy Commissioners; Associate and Assistant Commissioners; Chief Counsel and Deputies; Chief of Staff, and Center Directors and Deputies.
C. Fourth echelon and below reorganization approvals are redelegated to the Office Directors and Deputies within the Office of the Commissioner (OC); Director, Office of Management, CDER; Director, Office of Management, CBER; Director, Office of Management and Systems, CFSAN; Associate Director for Management Operations, CDRH; Director, Office of Management, CVM; Director, Office of Management, NCTR; Director, Office of Resource Management, ORA; and Executive Officer, (OC).
All previous delegations of authority inconsistent with the provisions of this delegation are superseded.
3. LIMITATIONS.
A. The Secretary has retained the authority to approve all reorganizations that involve the following:
1. More than one Operating Division (OPDIV). This would include the transfer of a function, program, or component from one OPDIV to another.
2. A statutorily based organization. This would include: a) the establishment of an organizational unit which must be approved by Congress; b) the abolition of a statutorily based organizational unit; and c) the elimination of a function mandated to be included in such an organizational unit.
3. A significant reorganization which may affect the public.
For reorganizations going to the Secretary for approval, if no decision is made within 30 days of receipt in the Office of the Secretary (except for a reorganization requiring Congressional approval), the OPDIV Head may approve the reorganization. For reorganizations involving more than one OPDIV, both OPDIV Heads must approve the reorganization before it becomes effective.
B. Each OPDIV must publish a Federal Register notice of any organizational changes that affect a component reporting directly to the OPDIV Head. In addition, each OPDIV must maintain an organizational manual, which includes, at a minimum, the functional statement of all components reporting directly to the OPDIV Head.
C. The Office of Management Programs and the appropriate personnel contact in the Rockville Human Resources Center should be consulted concerning procedural and regulatory classification and staff requirements prior to submission of reorganization proposals to the approving official.
D. Officials delegated any of the Commissioner’s authorities in this area must, within three working days of approval, provide a copy of the approval document and supporting documentation to the Office of Management Programs for Standard Administrative Code control purposes, and Federal Register and SMG updates, when appropriate.
4. REDELEGATION AND CERTIFICATION.
Only the authority to redelegate fourth and below echelon organization approvals may be redelegated. Any redelegations must be in writing and specify the nature and extent of the authority redelegated. Delegates must be certified as knowledgeable about the legal, regulatory, and policy requirements regarding the subject authority. A copy of the redelegation of this authority must be furnished to the Office of Management Programs (OMP). Delegates are subject to compliance audits.
5. EFFECTIVE DATE.
This delegation of authority was signed by John Dyer, 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 |