[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.
[[Page 59409]]
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
[[Page 59410]]
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