
[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19376-19378]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8313]


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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.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has reorganized the 
Center for Drug Evaluation and Research (CDER), Office of Surveillance 
and Epidemiology (OSE). This reorganization includes the organizations 
and their substructure components as listed in this document. This 
reorganization includes the establishment of six Staffs: Executive 
Operations and Strategic Planning Staff, Regulatory Science Staff, 
Regulatory Affairs Staff, Program Management and Analysis Staff, 
Project Management Staff, and Technical Information Staff. It will also 
include Office of Medication Error Prevention and Risk Management 
(OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under 
OSE. OMEPRM will consist of the Division of Risk Management and the 
Division of Medication Error Prevention and Analysis. OPE will consist 
of the Division of Epidemiology I and Division of Epidemiology II and 
the Division of Pharmacovigilance I and Division of Pharmacovigilance 
II. Also included are the abolishment of Business Process Improvement 
Staff, Regulatory Policy Staff, and Review Management Staff within OSE 
Immediate Office.

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.

I. Summary

    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 56605, November 9, 1995; 64 FR 36361, July 6, 
1999; and 72 FR 50112, August 30, 2007) is amended to reflect the 
restructuring of CDER, FDA as follows.

II. Organization

    CDER is headed by the Director, and includes the following 
organizational unit:

Office of Surveillance and Epidemiology

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of Divisions and Staffs; and premarketing and 
postmarketing risk assessment program operations.
    2. Develops and maintains international and national contact with 
regulators.
    3. Develops, coordinates, and implements postmarket risk assessment 
policy, guidance, and interpretations.
    4. Initiates regulation development and enhancement.
    5. Coordinates and implements policies and initiatives, including 
information management initiatives across the Agency.

Regulatory Science Staff

    1. Provides leadership, direction, and coordination for OSE 
regulatory research activities.
    2. Develops and manages relationships with outside scientific 
groups that interface with OSE scientists on a variety of projects that 
relate to OSE's drug safety mission. These outside groups include 
academic organizations, private organizations, and other Federal 
Agencies.
    3. Coordinates the access to large databases for 
pharmacoepidemiologic and pharmacovigilance studies, as well as to the 
outside scientists with drug safety expertise to collaborate with CDER.
    4. Develops regulatory research programs that will support OSE as a 
whole, including risk management, pharmacovigilance, and medication 
error detection and prevention; in addition to epidemiology.

Regulatory Affairs Staff

    1. Responsible for the coordination and implementation of 
regulatory policies by staff within OSE by coordinating the development 
and upkeep of guidances, MAPPs, and standard operating procedures, 
answering regulatory questions, managing the process for waivers of

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postmarketing safety reporting requirements and citizen petition 
responses, and being involved in the development of safety regulations.
    2. Provides leadership on initiatives related to the Medical 
Dictionary for Regulatory Activities (MedDRA).

Executive Operations & Strategic Planning Staff

    1. Creates and maintains professional and skills training programs 
for OSE personnel.
    2. Plans and tracks goals and objectives of all OSE Offices and 
Divisions.
    3. Evaluates OSE work products and communications using quality 
control technology.
    4. Interacts with Executive Secretariat, Press Office, and etc.

Technical Information Staff

    1. Provides coordination, development and assessment of policies, 
procedures, and best practices related to OSE data and information 
system management within OSE.
    2. Provides representation for OSE on Center and Agency best 
practices boards associated with staff responsibilities.
    3. Represents OSE in Center and Agency boards or workgroups that 
address business process improvements and information technology 
related to postmarket drug safety.
    4. Ensures that OSE's informatics systems (e.g., Adverse Event 
Reporting System, Phonetic Orthographic Computer Analysis, and Phonetic 
Orthographic Computer Analysis) serve OSE's needs.

Program Management and Analysis Staff

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of programs related to the OSE office administration 
and contracts management.
    2. Provides guidance and support services to the OSE on all aspects 
of administrative, budget, and facilities management and provides 
service and support on human resource, personnel operations services, 
and recruitment activities.
    3. Provides management, tracking and facilitation of projects 
related to office administration and contracts management within OSE.
    4. Provides coordination, development, and assessment of policies, 
procedures, and best practices related to OSE office administration and 
contract management within OSE.
    5. Provides representation for OSE on center and Agency best 
practices boards associated with staff responsibilities.

Project Management Staff

    1. Provides leadership, direction, planning, management, and 
supervision of programs related to drug safety reviews and staff.
    2. Provides management, tracking, and facilitation of projects 
related to drug safety reviews within OSE.
    3. Provides coordination, development, and assessment of policies 
and procedures related to drug safety reviews, review templates, and 
other best practices related to drug safety reviews within OSE.
    4. Provides representation for OSE on Center best practices 
associated with staff responsibilities.

Office of Medication Error Prevention and Risk Management

    1. Directs and supports the Divisions of Medication Error 
Prevention and Analysis and Risk Management.
    2. Leads OSE review of proposed and implemented Risk Minimization 
Action Plans (RiskMAPs)/Risk Evaluation and Mitigation Strategies 
(REMS).
    3. Coordinates risk communication components of drug safety risk 
management programs.
    4. Coordinates reviews of proposed proprietary trade names for 
their potential to result in sound-alike or look-alike medication 
errors.
    5. Performs root-cause analyses of postmarketing medication error 
reports.

Division of Medication Error Prevention and Analysis

    1. Plans, directs, and provides information technology support to 
the OSE.
    2. Develops and maintains necessary software, processes, 
procedures, training, and security or databases available to OSE.
    3. Acts as focal point for all hardware, software, and other 
information systems issues.
    4. In conjunction with the OSE programs, evaluates extant 
information resources for utility and value to the OSE missions. 
Arranges for necessary accesses, training, and other needs related to 
effective use of those resources.
    5. Develops and maintains the OSE Center for Drug Evaluation and 
Research Network (CDERNET) Web pages and works with other Agency 
programs to develop and maintain Internet pages related to office 
programs.
    6. Serves as the primary OSE contact for World Health Organization 
(WHO) searches, Freedom of Information (FOI) and National Technical 
Information Services (NTIS) issues, and for database searches.
    7. Reviews proposed proprietary trade names for their potential to 
result in sound-alike or look-alike medication errors.
    8. Analyzes and performs root-cause analyses of postmarketing 
medication error reports.
    9. Develops and implements internal MAPPs and guidance on 
medication error and patient safety initiatives.

Division of Risk Management

    1. Plans and directs all risk management activities in the OSE.
    2. Provides risk management expertise to OSE and the center.
    3. Reviews all proposed Risk Minimization Action Plans (RiskMAPs) 
or Risk Management Plans (RMPs) for conformance with FDA's standards.
    4. Conducts postmarketing monitoring of all products with approved 
RiskMAPs.
    5. Conducts evaluations of the performance of RiskMAPs.
    6. In conjunction with Office of New Drugs (OND), conducts 
premarketing risk assessments for some products.
    7. Helps develop and maintain the Agency's OSE CDERNET RiskMAP Web 
pages and works with other Agency programs to develop and maintain 
RiskMAP Internet pages.
    8. Develops and implements internal MAPPs and guidance on risk 
management initiatives.

Office of Pharmacovigilance and Epidemiology

    1. Directs and supports the Divisions of Pharmacovigilance and 
Epidemiology.
    2. Evaluates the safety of marketed drugs.
    3. Reviews adverse event reports with OND.
    4. Collaborates with other offices to recommend appropriate 
actions.
    5. Provides recommendations on risk management programs and REMS.
    6. Coordinates the review and analysis of epidemiologic study 
protocols and results of epidemiologic studies submitted by industry, 
from the literature or other sources that are related to the 
postmarketing safety of drugs.

Division of Epidemiology I

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of Division programs and staff.
    2. Reviews and provides analyses of epidemiologic study protocols 
and results of epidemiologic studies submitted by industry, from the 
literature or other sources that are related to the postmarketing 
safety of drugs.

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    3. Provides development and assessment of methodologies and best 
practices for active and passive surveillance systems and for 
incorporating such data, when appropriate, into the review of the 
postmarketing safety of drugs.
    4. Reviews and analyzes drug utilization information.
    5. Performs epidemiologic research on drug safety issues.
    6. Provides epidemiologic and drug utilization expertise to support 
medical review divisions in areas of responsibility, as well as, for 
Advisory Committee presentations and related documents.
    7. Provides input on epidemiologic and drug utilization aspects of 
information for the public related to significant postmarketing safety 
information regarding drugs, biologics, devices, and foods.
    8. Develops and implements internal MAPPs and guidance on 
epidemiologic and drug utilization initiatives.

Division of Epidemiology II

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of Division programs and staff.
    2. Reviews and analyzes epidemiologic study protocols and results 
of epidemiologic studies submitted by industry from the literature or 
other sources that are related to the postmarketing safety of drugs.
    3. Provides for the development and assessment of methodologies and 
best practices for scientifically-sound observational studies related 
to postmarketing safety of drugs.
    4. Reviews and analyzes drug utilization information.
    5. Performs epidemiologic research on drug safety issues.
    6. Provides epidemiologic and drug utilization expertise to support 
medical review divisions in areas of responsibility, as well as, for 
Advisory Committee presentations and related documents.
    7. Provides input on epidemiologic and drug utilization aspects of 
information for the public related to significant postmarketing safety 
information regarding drugs, biologics, devices, and foods.
    8. Develops and implements internal MAPPs and guidance on 
epidemiologic and drug utilization initiatives.

Division of Pharmacovigilance I

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of Division programs and staff.
    2. Reviews and provides analysis of adverse event reports from 
industry submissions and from reports submitted directly to FDA related 
to marketed drugs in order to detect safety signals and evaluate risk; 
and performs followup when such signals are detected.
    3. Provides development and assessments of methodologies and best 
practices for scientifically-sound safety signal detection and drug 
risk evaluation related to the postmarketing safety of drugs.
    4. Provides safety signal detection and drug risk evaluation 
support to medical review divisions in areas of responsibility, as well 
as, for Advisory Committee presentations.
    5. Provides recommendations on safety signal detection and drug 
risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
    6. Provides input on signal detection and drug risk evaluation 
included in information for the public related to significant safety 
information regarding drugs, biologics, devices, and foods.
    7. Develops and implements internal MAPPs and guidance on safety 
signal detection and drug risk evaluation initiatives.

Division of Pharmacovigilance II

    1. Provides leadership, direction, planning, budgeting, management, 
and supervision of Division programs and staff.
    2. Reviews and provides analyses of adverse event reports from 
industry submissions and from reports submitted directly to FDA related 
to marketed drugs in order to detect safety signals and evaluate risk; 
performs followup when such signals are detected.
    3. Provides development and assessment of methodologies and best 
practices for scientifically-sound safety signal detection and drug 
risk evaluation related to the postmarketing safety of drugs.
    4. Provides safety signal detection and drug risk evaluation 
support to medical review divisions in areas of responsibility, as well 
as, for Advisory Committee presentations.
    5. Provides recommendations on safety signal detection and drug 
risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
    6. Provides input on signal detection and drug risk evaluation 
included in information for the public related to significant safety 
information regarding drugs, biologics, devices, and foods.
    7. Develops and implements internal MAPPs and guidance on safety 
signal detection and drug risk evaluation initiatives.

III. Delegation of Authority

    Pending further delegation, directives or orders by the 
Commissioner of the Food and Drugs or the Center Director, CDER, 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.

    Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8313 Filed 4-6-11; 8:45 am]
BILLING CODE 4160-01-P


