
[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45270-45271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19111]



[[Page 45270]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Statement of Organization, Functions, and Delegations of 
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has conducted a 
reorganization to modify its structure, to align similar functions 
under common executive leadership, and to reduce and change the 
reporting relationships to the Agency head. The reorganization creates 
four ``directorates'' within which most of FDA's activities will 
reside--Administrative operations, food and veterinary medicine, 
medical products and tobacco, and foreign and domestic regulatory 
operations. However, this restructuring will not change the basic form 
of FDA's programs, which will continue to reside in the Agency's seven 
operating Centers and the Office of Regulatory Affairs. It is intended 
to provide a more efficient span of control for executive leadership 
and to organize like activities together, not to change the essential 
programmatic activities under which FDA implements the Federal Food, 
Drug, and Cosmetic Act.

FOR FURTHER INFORMATION CONTACT:  Kimberly A. Holden, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4239, Silver 
Spring, MD 20993-0002, 301-796-4750.

I. Summary

    Part D, Chapter D-B (Food and Drug Administration), Statement of 
Organization, Functions and Delegations of Authority for the Department 
of Health and Human Services (35 FR 3685, February 25, 1970, and 60 FR 
56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 
30, 2007, 74 FR 41713, August 18, 2009) is amended to reflect the 
restructuring of the Office of the Commissioner and other components, 
FDA that was approved by the Secretary of Health and Human Services on 
July 8, 2011 as follows. This reorganization is explained in Staff 
Manual Guide 1111.1, 1118.1, 1140.1, 1114.1, 1117.1, 1160.1, 1180.1, 
and 1115.1.
    Under Part D, FDA, the Office of the Commissioner has been 
restructured as follows:
    DA. ORGANIZATION--FDA is headed by the Commissioner of Food and 
Drugs (the Commissioner) and includes the following organizational 
units that report to the Commissioner:

Office of the Commissioner
Office of the Counselor to the Commissioner
Office of Legislation
Office of Policy and Planning
Office of External Affairs
Office of the Chief Scientist
Office of Operations
Office of Foods
Office of Medical Products and Tobacco
Office of Global Regulatory Operations and Policy
Office of Women's Health
Office of Minority Health

    The following organizations remain substantively unchanged: Center 
for Veterinary Medicine, Center for Food Safety and Applied Nutrition, 
Center for Devices and Radiological Health, Center for Drug Evaluation 
and Research, Center for Biologics Evaluation and Research, Center for 
Tobacco Products, National Center for Toxicological Research, Office of 
Regulatory Affairs, Office of International Programs, and Office of 
Special Medical Programs.
    However, some organizations will have different reporting 
relationships under the new organizational structure, as follows:

Office of the Commissioner

    Headed by the Commissioner, the Office of the Commissioner will be 
comprised of the Office of the Counselor to the Commissioner, the 
Office of Legislation, the Office of Policy and Planning, the Office of 
External Affairs, the Office of the Chief Scientist, the Office of 
Women's Health, and the Office of Minority Health. Those offices will 
remain unchanged, with the exception of the realignment of functions of 
the Office of Budget from the Office of Policy, Planning and Budget 
(OPPB) to the Office of Operations, and the renaming of OPPB to the 
Office of Policy and Planning. The administrative functions that were 
formerly within the Office of the Commissioner will be relocated to the 
new Office of Operations. Although the National Center for 
Toxicological Research will remain unchanged as an operating Center, 
the Chief Scientist will assume direct line authority over the Center.

Office of Operations

    Directed by a Chief Operating Officer (COO), the Office of 
Operations will assume the functions previously overseen by the Deputy 
Commissioner for Administration. The COO will, on behalf of the 
Commissioner, have Agency-wide authority for strengthening the 
management of business programs and operations of the Agency. The COO 
oversees day-to-day management issues, effective implementation of 
Congressional and Commissioner priorities and initiatives, and the 
delivery of quality services by the Agency and its Centers. Under this 
new structure, the COO will have direct line authority over the Office 
of Information Management, the Office of Management, the Office of 
Equal Employment Opportunity, and a new Office of Finance, Budget and 
Acquisition (which will receive the Office of Budget from the former 
Office of Policy, Planning and Budget). The Offices overseen by the COO 
were previously located within the Office of the Commissioner.

Office of Foods

    This office, headed by a Deputy Commissioner for Foods is 
unchanged. The Center for Veterinary Medicine and Center for Food 
Safety and Applied Nutrition remain within this Office and are 
unchanged. This Deputy Commissioner will continue the goal established 
in the 2009 creation of this Office to integrate all of FDA's food-
related functions into one seamless enterprise, as well as provide 
executive direction to the two Centers under the Deputy Commissioner's 
direction.

Office of Medical Products and Tobacco

    This new Office will be comprised of four Centers that previously 
reported directly to the Commissioner--the Center for Devices and 
Radiological Health, the Center for Biologics Evaluation and Research, 
the Center for Drug Evaluation and Research, and the Center for Tobacco 
Products. Directed by the Deputy Commissioner for Medical Products and 
Tobacco, it will also oversee the Office of Special Medical Programs, 
which contains four Offices that were previously in the Office of the 
Commissioner (the Office of Orphan Product Development, the Office of 
Pediatric Therapeutics, the Office of Combination Products, and the 
Office of Good Clinical Practice). The newly created position of Deputy 
Commissioner for Medical Products and Tobacco will have direct line 
authority over the four medical product Centers and the special medical 
programs and, as such, will provide advice and counsel to the 
Commissioner on all FDA medical product and tobacco-related programs 
and issues. The Centers and special medical programs remain unchanged 
in this reorganization.

Office of Global Regulatory Operations and Policy

    This new office, directed by a Deputy Commissioner for Global 
Regulatory Operations and Policy, will be

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comprised of two existing organizations that will otherwise remain 
unchanged--the Office of Regulatory Affairs and the Office of 
International Programs. In addition to exercising direct line authority 
over those two existing Offices, this new Deputy Commissioner will 
provide executive oversight, strategic leadership, and policy direction 
to FDA's domestic and international product quality and safety efforts, 
including global collaboration, global data-sharing, development and 
harmonization of standards, field operations, compliance, and 
enforcement activities.

II. Delegations of Authority

    Pending further delegation, directives, or orders by the 
Commissioner, 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: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19111 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P


