2011-15801. Statement of Organizations, Functions, and Delegations of Authority

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER), Office of Compliance. This reorganization includes the organizations and substructure components as listed in this document. This document is announcing availability of the Staff Manual Guide that explains the details of this reorganization.

FOR FURTHER INFORMATION CONTACT:

Karen Koenick, Center for Drug Evaluation and Research (HFD-063), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-796-4422.

I. Summary

The Statement of Organization, Functions, and Delegations of Authority for CDER (35 FR 3685, February 25, 1970, 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, and 76 FR 19376, April 7, 2011) is amended to reflect the restructuring of CDER, FDA. This reorganization is explained in Staff Manual Guides 1262.1, 1262.3, 1262, 31, 1262.32, 1262.4, 1262.41, 1262.42, 1262.43, 1262.44, 1262.5, 1262.51, 1262.52, 1262.53, 1262.6, 1262.61, and 1262.62. This reorganization includes establishing four Offices and their substructures under the Office of Compliance: Office of Drug Security, Integrity and Recalls (ODSIR), Office of Unapproved Drugs and Labeling Compliance (OUDLC), Office of Manufacturing and Product Quality (OMPQ), and Office of Scientific Investigations (OSI). ODSIR will consist of the Division of Import Operations and Recalls and the Division of Supply Chain Integrity. OUDLC will consist of the Division of Prescription Drugs and the Division of Non-Prescription Drugs and Health Fraud. OMPQ will consist of the Division of International Drug Quality, the Division of Domestic Drug Quality, the Division of Policy, Collaboration and Data Operations, and the Division of GMP Assessment. OSI will consist of the Division of Bioequivalence and Good Laboratory Practice Compliance, the Division of Good Clinical Practice Compliance, and the Division of Safety Compliance. Also included is the abolishment of the Division of Compliance Risk Management.

II. Delegations of Authority

Pending further delegation, directives or orders by the Commissioner of Food and Drugs or Center Director, CDER, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.

III. Electronic Access

Persons interested in seeing the complete Staff Manual Guide can find it on FDA's Web site at: http://www.fda.gov/​AboutFDA/​ReportsManualsForms/​StaffManualGuides/​default.htm.

Dated: June 20, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.