Document ID: FDA-2011-N-0013-0002
Agency: fda
Document Type: Notice
Title: Statements of Organizations, Functions, and Delegations of Authority
Posted Date: 2011-06-24T04:00Z

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37131-37132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15801]

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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), 
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,

[[Page 37132]]

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.
[FR Doc. 2011-15801 Filed 6-23-11; 8:45 am]
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