[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59408-59410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24583]


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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.

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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 two offices and their substructures under the Office of 
Medical Policy: Office of Prescription Drug Promotion (OPDP) and Office 
of Medical Policy Initiatives (OMPI). OPDP will consist of the Division 
of Direct-to-Consumer Promotion and the Division of Professional 
Promotion. OMPI will consist of the Division of Medical Policy 
Development and Division of Medical Policy Programs.

FOR FURTHER INFORMATION CONTACT:  Karen Koenick, Center for Drug 
Evaluation and Research (HFD-063), Food and Drug Administration, 11919 
Rockville Pike, rm. 324, Rockville, MD 20852, 301-796-4422.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    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, August 30, 
2007; 76 FR 19376, April 7, 2011; and 76 FR 51039, August 17, 2011) is 
amended to reflect the restructuring of CDER that was approved by the 
Secretary of Health and Human Services on May 25, 2011, as follows:

II. Organization

    CDER is headed by the Director and includes the following 
organizational units:

Office of Medical Policy

    1. Provides Center oversight and leadership in the development of 
medical policy procedures and policy initiatives pertaining to drug 
development, drug approval, bioresearch monitoring, human subject 
protection, and postmarket surveillance.
    2. Provides scientific and regulatory leadership in ensuring 
accurate and effective communication of medical information to health 
care professionals and patients and compliance with applicable 
regulations.
    3. Fosters an interdisciplinary approach to medical policy 
development, implementation, and coordination through collaboration 
with other disciplines, program areas, and FDA Centers in a manner that 
enhances integration of evolving science and policy into drug 
development, regulatory review, and postmarket surveillance processes.

Office of Prescription Drug Promotion

    1. Formulates and establishes policy for the regulation of 
prescription drug promotion, including advertisements and promotion 
labeling, and other promotional activities.
    2. Plans and supervises research studies to evaluate the impact of 
health communication and prescription drug promotion directed to health 
care professionals and consumers.

Division of Direct-To-Consumer Promotion

    1. Reviews draft Direct-to-Consumer Promotion (DTCP) promotional 
materials and provides detailed written advisory comments to industry 
sponsors. Examples of draft materials include television ads, magazine 
ads, Internet Web sites, and patient brochures.
    2. Develops and issues enforcement actions against false and 
misleading DTCP materials and activities for prescription drugs.
    3. Reviews draft patient labeling for inappropriate promotional 
content.

Division of Professional Promotion

    1. Reviews draft promotional materials directed to health care 
professionals and provides detailed written advisory comments to 
industry sponsors. Examples of draft materials include journal ads, 
Internet Web sites, commercial exhibit hall materials, sales aids, and 
broadcast advertisements.
    2. Develops and issues enforcement actions against false and 
misleading prescription drug promotional materials and activities 
directed to health care professionals.
    3. Reviews draft professional labeling for inappropriate 
promotional content.

Office of Medical Policy Initiatives

    1. Provides oversight and direction for development of medical 
policies and procedures pertaining to drug development and drug 
approval and postmarket surveillance processes.
    2. Provides oversight and direction for new and ongoing policy 
initiatives in broad-based medical and clinical policy areas, including 
initiatives to develop active safety monitoring of marketed products, 
improve the science and efficiency of clinical trials, regulate 
biosimilars (or follow-on biologics), and enhance consumer-directed 
drug information.

Division of Medical Policy Development

    1. Responsible for the development of medical policy pertaining to 
drug development, drug approval, bioresearch monitoring, human subject 
protection, and postmarket surveillance processes in collaboration with 
appropriate program areas and coordinating committees. Develops issue 
papers, guidances, regulations, and operating procedures.
    2. Provides advice and assistance to FDA staff and external 
constituents concerning implementation or application of new and 
existing medical policies and procedures.
    3. Collaborates with the Office of Regulatory Policy to ensure 
timely and efficient clearance and dissemination of new and revised 
policy documents.

Division of Medical Policy Programs

    1. Implements the Sentinel Initiative, an innovative safety 
monitoring program for marketed medical products that employs active 
surveillance of automated health care databases.
    2. Coordinates with FDA Centers, external partners, and 
stakeholders to ensure efficient implementation of quality science and 
technology, and effective privacy and security strategies.
    3. Manages and coordinates policy development related to 
biosimilars legislation and resulting programs.
    4. Manages and coordinates clinical trial modernization policy and 
programs, including coordinating public-private partnerships dedicated 
to removing barriers to clinical trials participation, enhancing 
evidence derived from clinical trials, and optimizing the use of 
clinical trial resources.
    5. Manages and coordinates policy and program initiatives to 
improve quality and utility, and broaden dissemination, of consumer-
directed medical information.
    6. Manages and coordinates efforts to ensure that professional 
labeling is compliant with applicable regulations and is optimized as a 
tool for communicating about the safety and efficacy of drugs.
    7. Coordinates and collaborates with relevant program areas to 
ensure optimal FDA scientific and technical input for ongoing policy 
initiatives.
    8. Develops and manages new science and technology policy 
initiatives pertaining to drug development, drug approval, and 
postmarket surveillance processes.

III. Delegation 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

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they are consistent with this reorganization.

    Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24583 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P