2011-20859. 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) by establishing four new Divisions under the Office of Generic Drugs. This reorganization includes the organization and their substructure components as listed in this document. This document is announcing the 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, 1919 Rockville Pike, Rm. 324, Rockville, MD 20852, 301-796-4422.

SUPPLEMENTARY INFORMATION:

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 that was approved by the Secretary of Health and Human Services on May 25, 2011. This reorganization is explained in Staff Manual Guide 1264.31, 1264.36, 1264.37, 1264.38, and 1264.39, and includes the establishment of the Division of Bioequivalence II, Division of Microbiology, Division of Clinical Review, and Division of Chemistry IV. In addition, CDER is retitling the Division of Bioequivalence to the Division of Bioequivalence I.

II. Delegation of Authority

Pending further delegation, directives or orders by the Commissioner of Food and Drugs or the 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

Person 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: August 10, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.