Document ID: FDA-2017-N-0009-0003
Agency: fda
Document Type: Notice
Title: Statements of Organization, Functions, and Delegations of Authority
Posted Date: 2017-07-27T04:00Z

[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 34956-34957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Office of the Commissioner; 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), Office of the Medical 
Products and Tobacco (OMPT), has modified its structure. This new 
organizational structure was approved by the Secretary of Health and 
Human Services on December 22, 2016, and became effective on that date.

[[Page 34957]]

FOR FURTHER INFORMATION CONTACT: Rachel Sherman, M.D., Deputy 
Commissioner for Medical Products and Tobacco, Office of Medical 
Products and Tobacco, Food and Drug Administration, White Oak Bldg. 1, 
HFD-40, Room 2307, Silver Spring, Maryland, 20993. Phone: 240-402-4474.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    Part D, Chapter D-B, (Food and Drug Administration), the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (35 FR 3685, February 25, 1970; 
60 FR 56606, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112, 
August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July 
28, 2011) is amended to reflect the reorganization of the Office of 
Medical Products and Tobacco.
    This reorganization establishes the Oncology Center of Excellence 
(OCE) to optimize an integrated cross-center regulatory approach and 
enhance the coordination of medical product development in oncology. 
Located within OMPT, OCE will work closely with the directors of the 
centers, the Center for Biologics Evaluation and Research (CBER), the 
Center for Drug Evaluation and Research (CDER), the Center for Devices 
and Radiological Health (CDRH), and all FDA staff involved in oncology 
efforts. The OCE will be responsible, in accordance with an Inter-
Center Agreement between OCE, CBER, CDER, and CDRH, for the clinical 
portion of medical oncology and malignant hematology applications 
involving drugs, biologics, and devices. Other functions of the OCE 
include: Harmonization of cancer-specific regulatory approaches; 
coordination of oncology-specific regulatory science initiatives and 
outreach; implementation of cross-center oncology-focused meetings; 
stakeholder engagement to the external community of other government 
agencies, industry, academia, professional societies, and patient 
advocacy groups; and communication with international regulatory 
agencies.
    The Food and Drug Administration (FDA), Office of Medical Products 
and Tobacco (OMPT), has been restructured as follows:
    DKK. Organization. The Office of Medical Products and Tobacco is 
headed by the Deputy Commissioner for Medical Products and Tobacco and 
includes the following organizational units and FDA Centers that, under 
the current structure, officially report to OMPT:

Office of Medical Products and Tobacco (DKK)
Office of Special Medical Products (DKKA)
Office of Pediatric Therapeutics (DKKAA)
Office of Orphan Products Development (DKKAB)
Office of Combination Products (DKKAD)
Center for Biologics Evaluation and Research (DKKB)
Center for Tobacco Products (DKKI)
Center for Drug Evaluation and Research (DKKN)
Center for Devices and Radiological Health (DKKW)
Oncology Center of Excellence (DKKX)

II. Delegations of Authority

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

    This reorganization is reflected in FDA's Staff Manual Guide (SMG). 
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.

    Authority:  44 U.S.C. 3101.

    Dated: July 17, 2017.
Thomas E. Price,
Secretary of Health and Human Services.
[FR Doc. 2017-15443 Filed 7-26-17; 8:45 am]
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