Statement of Organizations, Functions, and Delegations of Authority, 19376-19378 [2011-8313]
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19376
Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
made on a space available basis at the
Bethesda Marriott Pooks Hill (see
Location).
Registration: You are encouraged to
register at your earliest convenience.
A registration fee will be charged to
help defray the costs of rental of the
meeting spaces, meals and snacks
provided, and to cover travel costs
incurred by invited speakers, and other
costs. The cost of registration is as
follows:
One-Day Rates:
Government: $475
Academic: $795
Industry: $895
Two-Day Rates:
Government: $875
Academic: $1,495
Industry: $1,695
Registration fees will be waived for
invited speakers and members of the
working group. If you need special
accommodations due to a disability,
please contact Margaret Bogie or
Cathleen Michaloski (see Contact) at
least 7 days in advance of the meeting.
Registration Instructions: For further
details on how to register for the public
meeting, contact Margaret Bogie or
Cathleen Michaloski (see Contact).
SUPPLEMENTARY INFORMATION: Insomnia
is a common disorder in the United
States, yet it remains relatively poorly
understood. Questions remain, for
example, about the definition of
insomnia and the classification of
patients with the disorder. A better
understanding of insomnia should help
lead to safer and more effective
treatment. A number of medications
have been approved for insomnia, and
many experimental medications are
currently in development. New
concerns have arisen about the most
appropriate way to evaluate both the
safety and the efficacy of medications
for insomnia, particularly given that
they may differ in important
characteristics, including both
pharmacodynamic and pharmacokinetic
properties.
DNP and PERI plan for the first day
of the meeting to center on issues of
efficacy, including the evolving
definition of insomnia, the classification
of patients with this disorder, and the
measurement of clinically relevant
outcomes, including the choice of
endpoints, subjective versus objective
assessments, and duration of effect. The
second day of the meeting will center on
safety issues of hypnotic drugs,
including the nature and prevalence of
adverse events (AEs) related to the use
of hypnotic drugs and evaluation of
these AEs with a concentration on
psychovigilance testing and drivingrelated tests.
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Additional information on the
conference, program, and registration
procedures is available on the Internet
at https://peri.org/
course_details.cfm?course=2072. FDA
has verified the PERI Web site address,
but FDA is not responsible for any
subsequent changes to the Web site after
this document publishes in the Federal
Register.
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.
Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
II. Organization
CDER is headed by the Director, and
includes the following organizational
unit:
[FR Doc. 2011–8285 Filed 4–6–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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.
SUMMARY:
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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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07APN1
Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
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.
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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.
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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.
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19377
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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07APN1
19378
Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
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.
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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.
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19:53 Apr 06, 2011
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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.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel, Baseline Study For Arsenic
Exposure.
Date: April 27, 2011.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709, (Telephone
Conference Call).
Contact Person: Sally Eckert-Tilotta, Ph.D.,
Scientific Review Administrator, Nat.
Institute of Environmental Health Sciences,
Office of Program Operations, Scientific
Review Branch, P.O. Box 12233 MD EC–30,
Research Triangle Park, NC 27709, (919) 541–
1446, eckertt1@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel, Loan Repayment Program.
Date: May 2, 2011.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 19377]]
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.
[[Page 19378]]
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
