[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19376-19378]
From the Federal Register Online via the Government Publishing 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