Document ID: FDA-2011-N-0013-0004
Agency: fda
Document Type: Notice
Title: Statements of Organizations, Functions, and Delegations of Authority
Posted Date: 2011-08-17T04:00Z

[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51039-51040]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20859]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0013]

Statement of Organizations, Functions, and Delegations of 
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 51040]]

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.
[FR Doc. 2011-20859 Filed 8-16-11; 8:45 am]
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