Document ID: FDA-2016-S-0009-0002
Agency: fda
Document Type: Notice
Title: Office of Medical Products and Tobacco; Center for Drug Evaluation
and Research; Statement of Organization, Functions, and Delegations of Authority
Posted Date: 2016-04-27T04:00Z

[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Page 24822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Office of Medical Products and Tobacco; Center for Drug 
Evaluation and Research; 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 Medical 
Products and Tobacco, Center for Drug Evaluation and Research, Office 
of Medical Policy has modified its structure. This new organizational 
structure was approved by the Secretary of Health and Human Services on 
December 15, 2016, and effective on April 17, 2016.

FOR FURTHER INFORMATION CONTACT: Melanie Keller, Office of Management, 
Center for Drug Evaluation and Research, Office of Medical Products and 
Tobacco, Food and Drug Administration, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, 301-796-3291.

I. Summary

    This organization will expand current activities in the Office of 
Medical Policy and foster efficient oversight of clinical trials 
conducted through policy initiatives that build quality upfront and 
science-based inspectional approaches. This will provide an oversight 
and direction for new and ongoing policy initiatives in broad-based 
medical and clinical policy areas, including initiatives to improve 
science and efficiency trials.
    The Food and Drug Administration, Office of Medical Products and 
Tobacco, Center for Drug Evaluation and Research, Office of Medical 
Policy has been restructured as follows:
    DKKNF. ORGANIZATION. The Office of Medical Policy is headed by the 
Director, Office of Medical Policy and includes the following 
organizational units:

Office of Medical Policy
Office of Prescription Drug Promotion
Division of Advertising and Promotion Review I
Division of Advertising and Promotion Review II

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 Guides 
(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: April 19, 2016.
Sylvia M. Burwell,
Secretary of Health and Human Services.
[FR Doc. 2016-09761 Filed 4-26-16; 8:45 am]
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