Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority, 41713-41734 [E9-19680]
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[FR Doc. E9–19663 Filed 8–17–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2009–N–0376]
Office of the Commissioner
Reorganization; Statement of
Organizations, Functions, and
Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has reorganized
the Office of the Commissioner (OC).
This reorganization includes the
organizations and their substructure
components as listed in this document.
This reorganization includes the realignment of four Deputy-level offices
within the Office of the Commissioner:
the Office of the Chief Scientist; the
Office of Administration (formerly titled
the Office of Operations); the Office of
Foods; and the Office of Policy,
Planning and Budget (formerly titled the
Office of Policy, Planning and
Preparedness).
FOR FURTHER INFORMATION CONTACT:
Vanessa Starks, Office of Management
Programs (HFA–400), Food and Drug
Administration, 5600 Fishers Lane, rm.
6B–42, Rockville, MD 20857, 301–827–
1463.
Office of the Chief Scientist: The
organizational change will allow the
agency to better focus the science and
research activities under the Chief
Scientist. Re-alignments under the
Office of the Chief Scientist will include
the Office of Counter-Terrorism and
Emerging Threats, Office of Critical Path
Programs, Office of Scientific Integrity,
and the Office of Science and
Innovation.
Office of Administration: The Office
of Operations will be re-titled the Office
of Administration. The Office of
Administration will be restructured to
strengthen agency wide management
programs, budget and shared services
operations, as well as the Office of the
Commissioner’s executive operations.
Realignments of the Office of
Acquisitions and Grants Services, the
Office of Executive Operations, the
Office of Information Management, the
Office of Management, the Office of
Equal Employment Opportunity and
Diversity Management, and the
establishment of the Office of Financial
Operations.
Office of Foods: The Office of Foods
will be realigned from the Office of
Operations and will report directly to
the Commissioner.
Office of Policy, Planning and Budget:
The Office of Policy, Planning and
Preparedness will be retitled the Office
of Policy, Planning and Budget. The
realignments from the Office of Policy,
Office of Planning, and the Office of
Budget Formulation (formerly titled the
Office of Budget Formulation and
Presentation, Office of Operations).
[Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
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41713
Department of Health and Human
Services (35 FR 3685, February 25,
1970, and 60 FR 56605, November 9,
1995, 64 FR 36361, July 6, 1999, 72 FR
50112, August 30, 2007) is amended to
reflect the restructuring of the Office of
the Commissioner (OC), Food and Drug
Administration (FDA) as follows].
I. Under Part D, Food and Drug
Administration, delete the Office of
Commissioner in its entirety and replace
with the following:
DA.10 ORGANIZATION. The Food
and Drug Administration (FDA) is
headed by the Commissioner, Food and
Drug, and includes the following
organizational units:
Office of the Commissioner
Office of the Chief Counsel
Office of the Chief of Staff
Office of Legislation
Office of Policy, Planning and Budget
Office of Counselor to the
Commissioner
Office of Women’s Health
Office of Special Medical Programs
Office of External Affairs
Office of Foods
Office of the Chief Scientist
Office of International Programs
Office of Administration
Office of Equal Employment
Opportunity and Diversity Management
Center for Tobacco Products
DA.20 FUNCTIONS.
Office of the Commissioner: The
Office of the Commissioner (OC)
includes the Commissioner and Deputy
Commissioner who are responsible for
the efficient and effective
implementation of the FDA mission.
Office of the Chief Counsel: The
Office of the Chief Counsel (OCC) is also
known as the Food and Drug Division,
Office of the General Counsel,
Department of Health and Human
Services. While administratively within
the Office of the Commissioner, the
Chief Counsel is part of the Office of the
General Counsel of the Department of
Health and Human Services.
1. Is subject to the professional
supervision and control of the General
Counsel, Department of Health and
Human Services (DHHS), and represents
FDA in court proceedings and
administrative hearings with respect to
programs administered by FDA.
2. Provides legal advice and policy
guidance for programs administered by
FDA.
3. Acts as liaison to the Department of
Justice and other Federal agencies for
programs administered by FDA.
4. Drafts or reviews all proposed and
final regulations and Federal Register
notices prepared by FDA.
5. Performs legal research and gives
legal opinions on regulatory issues,
actions, and petitions submitted to FDA.
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6. Reviews proposed legislation
affecting FDA that applies to HHS or on
which Congress requests the views of
the Department.
7. Provides legal advice and
assistance to the Office of the Secretary
on matters within the expertise of the
Chief Counsel.
Office of the Chief of Staff:
1. Advises and provides integrated
policy analysis and strategic
consultation to the Commissioner,
Deputy Commissioners, and other
senior FDA officials on activities and
issues that affect significant agency
programs, projects and initiatives. Often
this function involves the most difficult
problems, crisis situations and
extremely complex issues of the agency.
2. Provides leadership, coordination
and management of the Commissioner’s
priority policies and issues across the
Office of the Commissioner and agency
wide. Identifies triages, supervises and
tracks related actions from start to finish
in conjunction with senior leadership
across FDA.
3. Serves as the principal liaison to
the Department of Health and Human
Services (DHHS) and coordinates and
manages activities between FDA and
DHHS. Works with the FDA Centers/
Offices to ensure assignments or
commitments made related to these
activities are carried out.
4. Provides direct support to the
Commissioner, Deputy Commissioners,
and other FDA senior staff including
briefing materials, background
information for meetings, responses to
outside inquiries, and maintenance and
control of the Commissioner’s working
files.
5. Provides top level leadership and
guidance on issues and actions tied to
the agency’s communications with the
Public Health Service, DHHS, and the
White House, including correspondence
for Assistant Secretary for Health and
Secretarial signatures; controls for all
agency public correspondence directed
to the Commissioner; and the
development and operation of tracking
systems designed to identify and resolve
early warnings and bottleneck problems
with executive correspondence.
Executive Secretariat:
1. Advises the Commissioner and
other key agency officials on activities
that affect agency wide programs,
projects, and initiatives. Informs
appropriate agency staff of the decisions
and assignments made by the
Commissioner, the Deputy
Commissioners, the Chief of Staff and
the Associate Commissioners.
2. Develops and maintains
management information necessary for
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monitoring the Commissioner’s and
agency’s goals and priorities.
3. Assures that materials in support of
recommendations presented for the
Commissioner’s consideration are
comprehensive, accurate, fully
discussed and encompass the issues
involved.
4. Provides correspondence control
for the Commissioner and controls and
processes all agency public
correspondence directed to the
Commissioner. Develops and operates
tracking systems designed to identify
and resolve early warnings and
bottleneck problems with executive
correspondence.
5. Provides direct support to the
Commissioner, Deputy Commissioners,
Chief of Staff and Associate
Commissioners including briefing
materials, background information for
meetings, responses to outside inquiries,
and maintenance and control of the
Commissioner’s working files.
6. Performs agency wide assignments
involving complex problems and issues
related to agency programs, strategies
and activities, including preparation of
special reports for the Department.
7. Coordinates the agency’s
communications with the Public Health
Service, DHHS, and the White House
including correspondence for the
Assistant Secretary for Health and
Secretarial signatures.
Office of Legislation:
1. Advises and assists the
Commissioner and other key agency
officials concerning legislative needs,
pending legislation and oversight
activities that affect FDA.
2. Serves as the focal point for overall
legislative liaison activities within FDA
and between FDA, the Department, PHS
and other agencies; and analyzes the
legislative needs of FDA and drafts or
develops legislative proposals, position
papers, and departmental reports on
proposed legislation for approval by the
Commissioner.
3. Advises and assists members of
Congress and congressional committees
and staffs in consultation with the
Office of the Secretary on agency
actions, policies, and issues related to
legislation which may affect FDA.
Office of Policy, Planning and Budget:
1. Plans, organizes, and carries out
annual and multi-year budgeting in
support of FDA’s public health mission
and programs.
2. Produces three major budget
submissions a year (to Health and
Human Services (HHS) in June, Office of
Management and Budget (OMB) in
September, and to Congress in January).
3. Develops and presents required
background exhibits, MAX input, and
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supplemental requests as necessary;
coordinates graphic material for
presentations; and coordinates
budgetary passback appeals at each
level.
4. Tracks Appropriation activities and
bills affecting FDA through the
legislative process.
5. Responds to requests for budget
information and special reports and
exhibits.
6. Reviews and analyzes potential
budgetary impacts of congressional or
administrative proposals, providing
expert opinion and recommendations.
7. Clears documents leaving the
agency that have budgetary impact or
resource information.
8. Tracks special initiatives and
agency cross-cutting programs.
Office of Policy:
1. Leads agency wide strategic policy
initiatives.
2. Advises and assists the
Commissioner and other key agency
officials on matters relating to agency
policy, and on regulations and guidance
development.
3. Serves as the lead agency focal
point for developing broad agency
policy.
4. Provides strategic policy direction
and develops innovative policies for
FDA to more effectively and efficiently
protect and promote public health.
5. Develops significant and crosscutting policy and engages in strategic
problem solving.
6. Oversees, directs, and coordinates
the agency’s rulemaking and guidance
development activities.
7. Serves as the agency focal point for
communications and policies with
regard to development of regulations
and guidance.
8. Initiates new and more efficient
systems and procedures to accomplish
agency goals in the rulemaking and
guidance development processes.
9. Reviews agency policy documents
to ensure consistency in statements
regarding agency policies.
10. Provides strategic policy direction
for agency budget formulation.
Policy Development and
Coordination Staff:
1. Leads the development of crosscutting or broad agency policies and
serves as a cross-agency think tank to
develop innovative policies.
2. Advises and assists the
Commissioner and other key agency
officials concerning information that
may affect current or proposed FDA
policies.
3. Advises the Commissioner and
other key agency officials on the
formulation of broad agency policy.
4. Engages in strategic problem
solving.
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5. Serves as agency liaison for
intergovernmental policy development.
6. Coordinates the development,
review, and clearance of regulations and
guidances.
7. Manages the agency’s regulation,
guidance review and clearance
processes.
8. Reviews policy documents to assess
and achieve consistency in policies
across documents.
9. Establishes procedures for agency
policy formulation and coordinates
policy formulation activities throughout
the agency.
10. Negotiates the resolution of policy
issues involving more than one
component of the agency.
11. Coordinates the review and
analysis of policies.
12. Initiates and participates in
interagency discussions on agency
regulations, plans, and policies to
improve coordination of Federal, State,
or local agencies on a specific regulation
or in developing an effective alternative
approach.
13. Serves on agency task forces that
are critical elements in the initiation,
study, and resolution of priority policy
issues.
Regulations Policy and Management
Staff:
1. Serves as the agency’s focal point
with the Department of Health and
Human Services, Office of Management
and Budget, and other Federal agencies
for policies and programs concerning
regulations development and for the
receipt of and response to other agency
comments on FDA policy documents.
2. Reviews proposed regulations, final
regulations, and other agency
documents to be published in the
Federal Register. Ensures regulations
are necessary; consistent with
established agency policy; clearly
written; enforceable; coordinated with
other agency components, the Office of
the Chief Counsel, and Federal, State,
and local government agencies;
appropriately responsive to public
participation requirements and
applicable executive orders; and
responsive to any applicable
requirements for assessment of
economic and environmental effects.
3. Coordinates, with other agency
components, the evaluation of existing
regulations to determine whether they
are efficiently and/or effectively
accomplishing their intended purpose.
Identifies and makes recommendations
to address regulations that require
revision to correspond with current
standards and those that should be
revoked due to obsolescence.
4. Resolves regulatory policy
disagreements between agency
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components during the preparation of
Federal Register documents.
Regulations Editorial Section:
1. Serves as FDA’s official liaison
within the Office of the Federal Register.
Edits, processes, and prepares finished
manuscript material for the issuance of
agency proposed and final regulations
and other documents published in the
Federal Register.
2. Provides all Federal Register
document development support
functions (including cross-referencing,
record retention, incorporation by
reference, document tracking, and
agency master print books of current
Code of Federal Regulations (CFR)
materials. Controls numbering and
organization of agency codified material
to ensure proper structure of regulations
being issued.
Office of Planning:
1. Leads agency-wide strategic
planning initiatives.
2. Advises and assists the
Commissioner and other key agency
officials concerning the performance of
the FDA planning, evaluation and
economic analysis activities.
3. Develops program and planning
strategy through analysis and evaluation
of issues affecting policies and program
performance.
4. Develops, installs, and monitors the
agency wide planning system including
the long-term plans, strategic action
plans, functional and business
bioinformatics plans.
5. Leads the FDA Strategic Planning
Council.
6. Consults with and supports the
agency preparation of legislative
proposals, proposed rulemaking, and
technical assistance to Congress.
7. Conducts operations research,
economic, and special studies as a basis
for forecasting trends, needs, and major
problems requiring solutions, and
provides assistance and consultation in
these areas to operating units.
8. Evaluates impact of external factors
on FDA programs, including industry
economics, consumer expectations, and
prospective legislation. As necessary,
recommends new programs or changes
in existing programs and program
priorities.
9. Develops FDA evaluation programs
and systems to evaluate overall FDA
program accomplishments against
objectives and priorities, recommending
changes as necessary.
10. Estimates marginal impact of
funding changes on FDA performance
and ability to protect public health.
11. Leads effort to analyze agency
business processes for process
modernization and bioinformatics
support.
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12. Acts as FDA liaison to HHS and
other Federal activities under the Office
of the National Coordinator for Health
Information Technology.
13. Leads and coordinates agencywide effort to plan, evaluate and
improve FDA risk communication.
14. Leads and coordinates the
Prescription Drug User Fee Act program
initiative for Performance Management
and quality systems studies.
Planning Staff:
1. Performs and coordinates the
following agency’s performance
planning functions:
Represents the HHS in and OMB
performance planning activities.
Coordinates and reports the agency’s
performance planning and
achievements in accordance with the
Government Performance and Results
Act.
Consults with the Office of Budget
Formulation and collaborates with
agency components in preparing and
reporting the performance sections of
the agency’s budget.
Coordinates the agency long range
strategic and performance planning in
line with the HHS strategic plan.
Maintains, analyzes and reports
agency-wide performance information
and achievements to external
stakeholders.
2. Performs and coordinates the
following agency’s program
performance tracking and management
functions:
Coordinates the development and
improvement of the agency’s program
performance measures, data and goals
on a continuous basis to ensure
alignment to agency’s missions and
objectives.
Coordinates the agency short and long
range performance planning objectives
and processes.
Assists and consults with agency
components in their performance
planning for data, trends, targets and
achievements.
Maintains, analyzes and reports
agency-wide quarterly program
performance information.
Performs and coordinates program
advisory, planning, and analysis
services.
Assists agency components in
analyzing and improving their planning
processes, performance objectives and
goals, as requested.
Works with agency components as
requested to identify and implement
internal and external best practices to
improve overall performance.
Analyzes information by applying
mathematical disciplines and principles
to make available data and facilitate
improved decision-making.
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Conducts special operational analysis
and planning related studies as
requested.
Conducts analysis of resource
requests submitted by agency
components and develops
recommendations for the Commissioner,
to fulfill agency and agency
requirements.
Staffs the FDA Strategic Planning
Council.
Provides operations analysis and
project management support to the
agency committees and initiatives as
needed.
Provides operations analysis and
project management support to the
Prescription Drug User Fee program.
Evaluation Staff:
1. Prepares annual User Fee
performance reports to Congress.
2. Performs agency program and
policy evaluations and analytical
studies. Recommends alternative
courses of action to increase
effectiveness of agency allocation of
resources and to improve program and
project performance.
3. Performs analyses of significantly
broad agency issues identified in the
planning process.
4. Recommends and/or implements
steps to resolve these issues.
5. Develops the annual evaluation
plan for the agency and coordinates
with HHS.
6. Conducts special evaluations,
analytical and economic-related studies,
in support of agency policy
development and in resolution of broad
agency problems.
7. Evaluates the impact of external
factors on agency programs, including
consumer expectations and prospective
legislation.
8. Evaluates the impact of agency
operations and policies on regulated
industries and other agency
constituents.
9. Provides process expertise to
agency components in designing
consensus sessions with internal and
external stakeholders.
10. Assists and consults with agency
components on the design and
execution of key program and process
re-inventions.
11. Assists and consults with agency
scientific review components to
enhance transparency, consistency,
accountability, and continuous
improvement of review processes.
12. Facilitates cross-organizational
sharing of key program and process
improvements.
Economics Staff:
1. Performs economic analyses for use
by agency officials in decisions
regarding agency policies.
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2. Serves as the agency’s chief
resource for economic information.
3. Collects and interprets economic
data relevant to the agency’s publichealth mission.
4. Performs and reviews benefit-cost
and cost-effectiveness analyses of
agency regulations.
5. Advises and assists the
Commissioner and other key agency
officials on a day to day basis
concerning economic factors relating to
current and proposed agency activities.
6. Provides economic research
material for use by agency officials in
preparing testimony before
congressional committees and in
developing replies to inquiries directed
to the agency.
7. Conducts economic studies of FDA
related industries as a basis for
forecasting trends, needs, and major
problems affecting the agency.
8. Provides agency representation to
Congress, OMB, HHS, and others, as
appropriate, on economic issues relating
to agency regulations and other current
and proposed actions.
Risk Communication Staff:
1. Coordinates development of agency
policies on risk communication
practices.
2. Coordinates agency strategic
planning activities concerning risk
communications.
3. Coordinates agency research agenda
for risk communication methods.
4. Facilitates development and
sharing of risk communication best
practices and standard operating
procedures.
5. Conducts risk communications
research on methodological and crosscutting issues.
6. Leads management and
coordination of the FDA Risk
Communication Advisory Committee.
Business Process Planning Staff:
1. Coordinates the agency’s business
process planning function in support of
business process improvement and
automation efforts.
2. Provides business process
planning, operations analysis and
project management support to the FDA
Bioinformatics Board and its associated
Business Review Boards.
3. Coordinates and maintains the
strategic and performance layers of the
Enterprise Architecture, in support of
the Office of Information Management.
4. Establishes and maintains agency
standards for business process
modeling.
5. Provides business process
modeling, analysis, and planning
services to agency programs and
initiatives as needed.
Office of Budget Formulation:
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1. Plans, organizes, and carries out
annual and multi-year budgeting in
support of FDA’s public health mission
and programs.
2. Produces three major budget
submissions a year (to Health and
Human Services (HHS) in June, Office of
Management and Budget (OMB) in
September, and to Congress in January).
3. Develops and presents required
background exhibits, MAX input, and
supplemental requests as necessary;
coordinates graphic material for
presentations; and coordinates
budgetary passback appeals at each
level.
4. Tracks Appropriation activities and
bills affecting FDA through the
legislative process.
5. Responds to numerous requests for
budget information and special reports
and exhibits.
6. Reviews and analyzes potential
budgetary impacts of congressional or
administrative proposals, providing
expert opinion and recommendations.
7. Clears documents leaving the
agency that have budgetary impact or
resource information.
8. Tracks special initiatives and
agency cross-cutting programs.
Office of the Counselor to the
Commissioner:
1. Formulates and renders advice to
the Commissioner related to policy
development, interpretation and
integration that cuts across program
lines or which is not well defined.
2. Provides a leadership role in
advocating for and advancing the
Commissioner’s priorities.
3. Reviews recommendations for
actions and reviews other materials to
ensure that all points of view and
program interests are developed for
consideration and fully analyzed.
4. Provides top level leadership for
the development of, and management of
emergency and crisis management
policies and programs for FDA to ensure
that a structure exists for FDA to
respond rapidly to an emergency or
crisis situation in which FDA-regulated
products need to be utilized or
deployed.
5. Coordinates FDA participation in
internal and external counter-terrorism
and emergency exercises.
6. Implements the continuity of
operation plans and operation of the
emergency and the crisis operation
center.
7. Coordinates agency evaluation of
emergency and crisis situations to
determine appropriate internal and
external referrals for further action.
Office of Crisis Management:
1. Serves as the first responder for
Food and Drug Administration (FDA) in
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emergency and crisis situations
involving FDA regulated products or in
situations in which FDA regulated
products are needed to be utilized or
deployed.
2. Assists in the development of, and
will manage, emergency and crisis
management policies and programs for
FDA to ensure that a structure exists to
respond rapidly to an emergency or
crisis situation.
3. Serves as agency emergency
coordinator to HHS Office of the
Assistant Secretary for Preparedness
and Response (OASPR) and as liaison to
HHS Secretary’s Office of Security and
Strategic Information (OSSI). Provides
OASPR situational awareness of all
FDA-related emergencies and ensures
that FDA’s emergency operations
procedures are in alignment with
national and HHS procedures.
Participates in OSSI intelligence
briefings and provides secure fax
capability for the agency.
4. Participates in international
initiatives to ensure FDA’s capability
and readiness to work with foreign
counterparts in responding to
international emergencies involving or
impacting FDA-regulated products and
to share information with international
counterparts during such emergencies.
5. Manages the FDA Emergency
Operations Network Incident
Management System (EON IMS), a
system for capturing large amounts of
near real time information about
emergencies related to FDA-regulated
products for use by senior agency
decision makers in assessing and
managing response activities. Provides
Offices and Centers geographical
information system maps created by
EON IMS’s GIS mapping component for
use in strategic planning of agency
emergency response activities.
6. Develops and updates agency
emergency operations plans and
incident specific annexes, ensuring their
alignment and compliance with the
National Response Framework and its
Emergency Support Functions and the
National Incident Management System.
7. Plans and conducts agency
exercises to test emergency operations
plans. Plans and coordinates FDA’s
participation in emergency exercises
sponsored by other Departments and
agencies, including national and
international level exercises.
8. Oversees the FDA Emergency Call
Center which provides after normalhours service for responding to public
inquiries and reports related to FDAregulated products as well as surge
capacity service for managing increased
volumes of inquiries due to an event
involving an FDA-regulated product.
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9. Manages FDA’s Emergency
Operations Center (EOC), activating the
EOC with augmented staffing from
relevant Centers and Offices to monitor
emergency situations, triage complaints
and alerts, issue mission assignments to
organizational components, coordinate
overall agency response operations, and
communicate with external partners
requesting technical and material
support. FDA’s EOC serves as the
central point of contact with the
Department of Homeland Security’s
National Operations Center, DHHS
Secretary’s Operation Center, CDC
Emergency Operations Center, USDA/
FSIS Situation Room, and other Federal
EOCs as appropriate.
10. Coordinates agency evaluation of
emergency responses and crisis
situations to determine appropriate
internal and external referral for further
action and recommended changes in
agency procedures.
11. Oversees the work of the Office of
Emergency Operations.
Office of Emergency Operations:
1. Serves as the agency focal point for
emergency preparedness and response
operating the 24-hour, 7-day-a-week
emergency response system.
2. Provides support and assistance to
Food and Drug Administration (FDA)
offices in managing the agency’s
response to emergency incidents and
situations involving FDA regulated
products and disasters.
3. Assists in the development and
coordination of the agency’s emergency
preparedness and response activities.
4. Serves as the agency focal point for
the review and analysis of preliminary
information about threats and hazards,
and assists in the early recognition of
emergencies, outbreaks, natural
disasters, and terrorism or other
criminal acts, in direct coordination
with individual headquarters and field
emergency coordination units.
5. Coordinates FDA emergency
activities with other Federal agencies,
State, local and foreign government
officials and industry associations.
6. Identifies and advocates emergency
training needs for FDA personnel and
participates in the design,
implementation, and presentation of the
training programs.
7. Provides guidance to agency
emergency response staff in the use of
the Incident Command System to
manage single or multi-agency response
activities.
8. Represents the agency at
interagency, intra-agency, State, local
and foreign government and industry
association meetings and conferences on
emergency preparedness and response.
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9. Manages the National Consumer
Complaint System which monitors
reports of problems with FDA-regulated
products for potential emergencies.
10. Participates in daily National
Biosurveillance Integration Center
conference calls sponsored by
Department of Homeland Security to
provide a secure forum for interagency
information sharing for early
recognition of biological events of
national concern, both natural and manmade, to make a timely response
possible.
11. Oversees and tests the agency’s
ability to communicate through the
Government Electronic
Telecommunications Service (GETS)
which provides global
telecommunications (secure voice,
facsimile and data communications)
capability for organizations that perform
national security and emergency
preparedness functions.
Office of Women’s Health:
1. Serves as the principal advisor to
the Commissioner and other key
agency officials on scientific, ethical
and policy issues relating to women’s
health.
2. Provides leadership and policy
direction for the agency regarding issues
of women’s health and coordinates
efforts to establish and advance a
women’s health agenda for the agency.
3. Monitors the inclusion of women in
clinical trials and the implementation of
guidelines concerning the
representation of women in clinical
trials and the completion of gender
analysis.
4. Identifies and monitors the progress
of crosscutting and multidisciplinary
women’s health initiatives including
changing needs, areas that require study
and new challenges to the health of
women as they relate to FDA’s mission.
5. Serves as the agency’s liaison with
other agencies, industry, and
professional associations with regard to
the health of women.
Office of Special Medical Programs:
1. Serves as the agency focal point for
special programs that are cross-cutting
and medical in nature.
2. Manages the activities of the
agency’s effort to ensure that medical
products used in pediatric applications
are properly overseen.
3. Oversees the implementation of the
orphan products provisions of the
Federal Food, Drug and Cosmetic Act.
4. Administers and manages the
Office Good Clinical Practice.
5. Provides executive leadership to
the Office of Combination Products to
ensure that appropriate jurisdictional
decisions are made for the regulation of
those products.
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Office of Good Clinical Practice:
1. Advises and assists the
Commissioner, and other key officials
on Good Clinical Practice (including
human subject protection) issues arising
in clinical trials regulated by the FDA
that have an impact on policy, direction,
and long-range goals.
2. Supports and administers FDA’s
Human Subject Protection (HSP)/
Bioresearch Monitoring (BIMO) Council
that manages and sets agency policy on
Good Laboratory Practices, Bioresearch
Monitoring, and Good Clinical
Practices.
3. Represents the agency to other
government agencies, State and local
governments, industry, academia,
consumer organizations, Congress,
national and international
organizations, and the scientific
community on Good Clinical Practice
policy issues.
4. Provides leadership and direction
on human subject protection and Good
Clinical Practice matters and stimulates
the application of these principles in the
FDA.
5. Evaluates the adequacy of Good
Clinical Practice resources available to
the agency and initiates action as
appropriate.
6. Coordinates agency policies related
to the protection of human subjects in
research, including institutional review
and ethical considerations.
7. Plans training programs for external
use and for FDA staff on the agency’s
Good Clinical Practice policies.
8. Coordinates and provides oversight
of Good Clinical Practice policy working
groups developed on the
recommendation of the agency HSP/
BIMO Council.
9. Fosters the science of bioresearch
monitoring within the Centers and the
Office of Regulatory Affairs and
coordinates for the Office of the
Commissioner.
10. Serves as the agency coordinating
point for Good Clinical Practice
regulation, harmonization, and outreach
activities.
11. Serves as liaison between the
agency’s HSP/BIMO Council and the
agency’s Management Council.
12. Coordinates and assists in
implementation of regulations, policies,
operational initiatives, and program
priorities related to clinical bioresearch
monitoring as developed by the HSP/
BIMO Council.
13. Monitors agency activities and
leads the development of a quality
assurance and quality improvement
program to ensure uniform application
of clinical bioresearch monitoring
policies across the agency.
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14. Serves as a liaison with other
Federal agencies and outside
organizations, the regulated industry,
and public interest groups on clinical
bioresearch monitoring policy and
regulatory matters.
Office of Combination Products:
1. Serves as the agency focal point for
combination products (i.e., drug-device,
drug-biologic, device-biologic or drugbiologic-device products).
2. Serves as the agency Product
Jurisdiction Office and administers 21
CFR Part 3. (Assigns agency centers
with primary jurisdiction for
combination products.)
3. Advises the Commissioner and
other key agency officials on policy
formulation, execution, cross-cutting
and precedent setting issues involving
combination products.
4. Develops regulations, guidances,
policies, procedures, and processes to
facilitate the agency’s regulation,
review, and oversight of combination
products.
5. Reviews and updates agreements,
guidance or practices specific to
assignment of combination products.
Prepares reports to Congress on the
activities and impact of the Office.
6. Serves as the focal point for
employees and stakeholders to resolve
issues arising during assignment,
premarket review or postmarket
regulation of combination products.
7. Ensures timely and effective
premarket review by overseeing the
timeliness of and coordinating reviews
involving more than one agency center.
8. Ensures consistency and
appropriateness of postmarket
regulation of combination products.
9. Resolves disputes presented
regarding the timeliness of the
premarket review of a combination
product.
10. Advises the Chief Scientist on
disputes presented regarding the
substance of the premarket review of a
combination product.
11. Makes determinations as to
whether an individual component
product will be regulated as a human
drug, human biologic, or human
medical device.
Office of Orphan Products
Development
1. Manages the implementation of the
provisions of the Orphan Drug Act and
its amendments and manages a program
to encourage the development of drugs
of limited commercial value for use in
rare or common diseases and
conditions.
2. Develops and communicates
agency policy and makes decisions on
approval of sponsor requests and
incentives under the Federal Food,
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Drug, and Cosmetic Act, including
orphan drug protocol assistance per
section 525, orphan drug designation
per section 526, orphan drug exclusivity
per section 527, orphan drug grants and
contracts to support clinical research
and other areas of agency policy related
to the development of products for rare
disorders.
3. Represents the Commissioner or
serves as the agency’s principal
authority and spokesperson to the PHS
Orphan Products Board, other
governmental committees and industry,
professional, and consumer
associations, requesting agency
participation in orphan product
development activities.
4. Reviews investigational new drug
and biologics applications and
investigational device exemptions to
locate the existence of products under
investigational study that show
evidence of effectiveness for rare or
common diseases but lack commercial
sponsorship. Assists sponsors,
researchers, and investigators in
communicating with agency regulatory
officials and expediting solutions to
problems in obtaining investigational or
market approval status.
5. Manages an extramural program of
clinical research to evaluate safety and
effectiveness of orphan products by
funding grants and contracts, requesting
applications for funding, organizing
peer review of applications, monitoring
and guiding investigators, and
evaluating study results.
Office of Pediatric Therapeutics:
1. Coordinates and facilitates all
activities of the Food and Drug
Administration that may have any effect
on the population, the practice of
pediatrics, or may in any way involve
pediatric issues.
2. Coordinates the review of and
communicates internally and externally
any report of an adverse event of a drug
which received pediatric exclusivity.
3. Provides for the review of adverse
event reports and other new safety
information and obtains
recommendations whether FDA should
take action.
4. Coordinates with all Department of
Health and Human Service and FDA
employees who exercise responsibilities
relating to pediatric therapeutics.
5. Serves as the FDA focal point for
all issues involving ethics with respect
to the pediatric populations.
6. Coordinates with the Office of
International Programs while serving as
the agency focal point for international
pediatric activities.
Office of External Affairs:
1. Advises the Commissioner, Deputy
Commissioners and other key agency
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officials on FDA’s communications to
the media, Congress, and the general
public on issues that affect agency-wide
programs, projects, strategies,
partnerships and initiatives.
2. Advises and assists the
Commissioner and other key officials on
all public information programs; acts as
the focal point for disseminating news
on FDA activities and as a liaison with
the Public Health Service and the
Department on public information
programs.
3. Advises the Commissioner, Deputy
Commissioners and other senior staff
throughout FDA on sensitive and
controversial programs and initiatives
that impact external stakeholder groups.
4. Serves as an information resource
to FDA and provides advice to the
Commissioner and other key agency
officials on matters related to serious
and life-threatening diseases; patient
advocacy, and health professional
organizations; minority health and other
special health issues.
Office of External Relations:
1. Advises the Commissioner, Deputy
Commissioners and other key agency
officials on agency-level activities and
issues that affect agency wide programs,
projects, strategies, partnerships, and
initiatives.
2. Advises the Commissioner, Deputy
Commissioners and senior staff
throughout FDA on sensitive and
controversial programs and initiatives
that impact external stakeholder groups.
3. Coordinates activities involving
emergency or crises situations and
resolves complex problems and issues
related to agency programs that are
sensitive and controversial which
impact upon agency relations with other
Federal agencies and foreign
governments.
4. Oversees and directs the agency’s
ombudsman and editorial functions to
ensure coherence in decision making
and the efficient operation of these
functions internally and across agency
jurisdictions.
5. Provides leadership and direction
to assure the efficient and effective
planning, performance and evaluation
of oversight activities.
6. Provides direction, coordination
and oversight of the agency’s consumer
activities and serves as the agency’s
focal point for national consumer
groups.
7. Advises the Commissioner, Deputy
Commissioners and senior staff
throughout FDA on sensitive and
controversial programs and initiatives
that impact external stakeholder groups.
8. Serves as the agency’s focal point
to provide direction, coordination and
oversight of the agency’s stakeholder
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relations with national consumer
groups, patient advocacy organizations,
health professionals, academia, trade
associations, ethnic and minority
groups, and Tribes.
9. Coordinates speaker requests for
industry programs that cover multicenter issues; identifies potential
conflict of interest speaker requests.
10. Assists in the programmatic
design, development and planning with
internal and external organizations
regarding educational and informational
activities intended to educate regulated
industry.
Communications Staff:
1. Identifies consumer
communication and educational
requirements for the agency and creates,
implements, and coordinates
appropriate programs conducted
through the media, agency public affairs
specialists, and other communication
sources.
2. Plans, designs, produces, publishes,
and disseminates audiovisual materials,
exhibits, posters, publications, and
periodicals, including FDA Consumer;
participates in the planning and
development of all publications and
audiovisual aspects of communications
programs directed at mass audiences.
3. Provides centralized agency graphic
arts and editorial services for public
information materials.
4. Acts as the agency’s public
information liaison with the Department
for all publications and audiovisual
needs; provides prepublication
clearance of publications, exhibits, and
audiovisual materials in accordance
with procedures established by the
agency, PHS, the Department, OMB, and
the White House.
Office of Public Affairs:
1. Advises and assists the
Commissioner and other key officials on
all public information programs; acts as
the focal point for disseminating news
on FDA activities and as a liaison with
the Public Health Service and the
Department on public information
programs.
2. Plans, develops, implements, and
monitors policy and programs on
agency media relations, and consumer
information and education programs
conducted through the media, FDA’s
public affairs specialists, and other
communications sources.
3. Plans, develops, produces, and
publishes agency publications and
graphic arts materials.
4. Executes Freedom of Information
denial authority for the agency.
5. Directs the effective utilization of
all management resources by
coordinating the management, facilities,
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budget, and equipment resources for the
Office of Public Affairs.
6. Reviews organizational,
management, and administrative
policies of the Office to appraise the
efficiency and effectiveness of
operations.
7. Identifies potential management
problems and/or needs and plans,
develops and conducts management
studies.
8. Coordinates speaker requests for
industry programs that cover multicenter issues; identifies potential
conflict of interest speaker requests.
9. Assists in the programmatic design,
development, and planning with
internal and external organizations
regarding educational and informational
activities intended to educate regulated
industry.
10. Advises and assists top level
agency officials on electronic media
matters involving mass media
communications.
11. Plans, develops, and implements
agency wide broadcast media strategies
for disseminating regulatory and
educational materials to the public
through the mass media.
12. Serves as the agency focal point
for preparing, clearing and
disseminating electronic media requests
representing agency policy and
responding to electronic media
inquiries; maintains liaison with
broadcast media contacts.
13. Establishes policy for and
coordinates all broadcast media
information activities, including oncamera interviews and responses to
media inquiries; prepares position and
policy statements for use by agency
employees in responding to broadcast
media questions; tracks issues of
potential interest to the media.
14. Plans and coordinates all
broadcast media training for the agency.
Print Media Staff:
1. Advises and assists top level
agency officials on printed press matters
involving mass media communications.
2. Plans, develops, and implements
agency wide print media strategies for
disseminating regulatory and
educational material to the public
through the mass media.
3. Serves as the agency focal point for
preparing, clearing, and disseminating
press releases and other print media
statements representing agency policy
and responding to media inquiries;
maintains liaison with news media and
pertinent publications.
4. Establishes policy for and
coordinates all print media information
activities, including news interviews
and responses to inquiries; prepares
position and policy statements for use
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by agency employees in responding to
print media questions; tracks issues of
potential interest to the media.
5. Coordinates the research and
drafting of major public statements by
the Commissioner including transmittal
documents and supportive statements
for use in transactions with the
Department, other agencies, and the
White House; provides editorial
consultation and review for
manuscripts, articles, and speeches
written by the staff offices serving the
Commissioner to ensure consistency of
information and policy interpretation.
6. Compiles, publishes, and
distributes the weekly FDA Enforcement
Report and the FDA Public Calendar;
maintains the FDA Daily Clipping
Service; and coordinates the Daily
Media Report.
Web Site Management Staff:
1. Responsible for the content and
design of the FDA Web site
(www.fda.gov). Develops and interprets
the agency’s Web policies, and serves as
advocates for FDA’s Web presence and
catalysts for creative use of the Web by
the agency.
2. Works closely, as partners, with the
FDA Office of Information Resources
Management (OIRM), which is
responsible for the technical operations
of FDA’s Web site.
3. Works closely with the Web site
contacts in each of the Centers and
principal offices within the Office of the
Commissioner (OC) to plan, coordinate,
execute and evaluate the agency’s Web
site operations.
4. Serves as the focal point and
contact with the agency, Department,
and other Federal Government Web site
programs and operations.
5. Provides direction, strategic
planning assistance, and management
coordination on agency Web site
programs.
6. Establishes, manages, and monitors
the implementation of agency standards
and policies for information published
on agency Web sites.
7. Provides Web-related information
management strategy input through a
collaborative effort with OIRM and the
Web site operations staffs in the centers
and OC.
8. Designs, develops, implements,
monitors, and manages information
published on the agency’s Web site.
9. Delivers the agency’s messages to
the public through the agency’s Web
site.
10. Provides Web-related electronic
information dissemination services to
the agency and the public.
Office of Special Health Issues:
1. Serves as an information resource
to FDA and provides advice to the
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Commissioner and other key agency
officials on matters related to serious
and life-threatening diseases; patient
advocacy, and health professional
organizations; minority health and other
special health issues.
2. Coordinates interactions between
FDA and health professional
organizations and patient advocacy
groups dealing with serious and lifethreatening diseases and other special
health issues.
3. Serves as a focal point to coordinate
contacts between FDA and other Federal
agencies to ensure effective
coordination and communication on
serious and life-threatening diseases and
other special health issues.
4. Provides internal coordination on
FDA activities related to serious and
life-threatening diseases, patient
advocacy and health professional
organizations, and other special health
issues.
5. Assists in the planning,
administration, development, and
evaluation of FDA policies related to
serious and life-threatening diseases,
patient advocacy and health
professional organizations, and other
special health issues.
Medwatch Staff:
1. Coordinates and implements
policies and initiatives relating to
human medical product adverse events,
including the MedWatch Partners
Program, the MedWatch Web site, and
the MedWatch e-list.
2. Conducts outreach and education
to health professionals, patients and the
public to facilitate the reporting of
serious harm and injury associated with
the use of human medical products.
3. Reviews, updates, and disseminates
medical product safety alerts and safety
labeling changes.
Office of Foods:
1. Provides executive leadership and
management to all FDA food-related
programs.
2. Exercises, on behalf of the
Commissioner, direct line authority over
the Center for Food Safety and Applied
Nutrition and the Center for Veterinary
Medicine.
3. Exercises, on behalf of the
Commissioner, all food-related legal
authorities that the Commissioner is
empowered to exercise under the
Federal Food, Drug, and Cosmetic Act,
as amended, the Public Health Service
Act, and other applicable laws.
4. Directs efforts to integrate the
programs of CFSAN, CVM, and the
Office of Regulatory Affairs (ORA) and
thereby ensure the optimal use of all
available FDA resources and tools to
improve the safety, nutritional quality
and proper labeling of the food supply.
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5. Directs the development of
integrated strategies, plans, policies, and
budgets to build FDA’s food-related
scientific and regulatory capacities and
programs, including recruitment and
training of key personnel and
development of information systems.
6. Represents FDA on food-related
matters in dealings with the Office of
the Secretary of HHS, the Centers for
Disease Control and Prevention, the U.S.
Department of Agriculture, the White
House and other elements of the
executive branch.
7. Represents FDA on food-related
matters in dealings with Congress.
8. Represents FDA on food-related
matters in dealings with foreign
governments and international
organizations.
9. Directs FDA efforts to build an
integrated national food safety system in
collaboration with other Federal
agencies and State and local
governments.
10. Directs a program of public
outreach and communications on food
safety, nutrition, and other food-related
issues to advance FDA’s public health
and consumer protection goals.
Office of the Chief Scientist:
1. Provides strategic leadership,
innovation and expertise to enhance
and support scientific excellence,
integrity and capacity to achieve the
Food and Drug Administration’s public
heath mission. Key activities include:
Fostering development and use of
innovative technologies to meet public
health needs, including through its
Office of Science and Innovation, the
Critical Path Initiative and cross-Center
working groups.
Supporting scientific excellence and
the professional development of FDA
scientists in all areas (i.e. population/
statistical, review, laboratory and
manufacturing sciences), including
through the Commissioner’s Fellowship
Program, continuing education, and
through relationships and staff
exchanges with Universities and others.
Providing strategic leadership and
support for high quality, collaborative,
peer-reviewed scientific activities at
FDA that advance regulatory science
and address important public health
and regulatory issues concerning FDA
regulated products, including their
evaluation, quality, safety and
effectiveness. This includes support for
the National Center for Toxicological
Research to serve as a national FDA
resource for mission driven regulatory
science.
Supporting scientific outreach,
training, collaboration in research,
development and Critical Path activities
that advance FDA’s mission, with other
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Federal agencies, global regulatory
partners, academia (e.g., through
planned Centers of Excellence in
Regulatory Science), innovators, and
consumers.
Supporting science and public health
activities to effectively anticipate and
respond to emerging deliberate and
natural threats to U.S. and global health
and security including through the
Office of Counterterrorism and
Emerging Threats and a planned Center
for Innovation in Medicine and Public
Health.
Providing core scientific leadership
and technical expertise, and ensuring
agency capacity, for advanced
bioinformatics activities needed to
support FDA programs (e.g. scientific
computing to allow analysis of large
health care and safety datasets, genomic
and other complex laboratory data, and
simulation and modeling) . Serve as an
agency and government resource for
excellence, methods development,
outreach and partnerships in advanced
bioinformatics science.
Leading agency efforts to protect and
enhance scientific integrity, and, where
substantive scientific differences of
opinion arise and require review at the
FDA level, addressing them through
appropriate processes intended to
protect both FDA’s mission and the
integrity of its science.
Office of Counter-Terrorism and
Emerging Threats:
1. Develops and implements a
comprehensive counterterrorism
strategy for FDA to identify and address
gaps in current efforts to safeguard food
and medical products from adulteration
or disruption of supplies due to terrorist
activities.
2. Develops and coordinates the
implementation of crosscutting policies
to facilitate the availability of safe and
effective medical countermeasures
against chemical, biological,
radiological, and nuclear agents of
concern.
3. Provides policy leadership for
FDA’s Emergency Use Authorization
(EUA) activities for terrorism and public
health emergencies, including emerging
threats.
4. Develops and implements, in
collaboration with the Centers and
Offices and with external partners,
comprehensive FDA plans and
strategies for pandemic influenza
preparedness and other emerging
threats.
5. Provides policy leadership by
promoting the goals and needs for
counterterrorism and other emerging
threats in the agency budgeting and
priority-setting processes.
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6. Coordinates the portfolio of FDA
counterterrorism and pandemic
influenza policy and planning
initiatives and serves as the point of
entry to the agency on counter-terrorism
and emerging threats policy and
planning matters.
7. On behalf of the Office of the
Commissioner, facilitates intra- and
inter-agency communications on
counterterrorism policy and pandemic
influenza preparedness.
Office of Critical Path Programs:
1. Serves as the focus for cross-center
scientific and medical initiatives and
policy development related to the
Critical Path (CP) initiative and related
activities in the Office of the
Commissioner.
2. Assists the Chief Scientist in
planning, executing, and monitoring
projects, including, CP-related crosscenter and interagency projects and
collaborations with other agencies,
academia, and industry as identified by
the Office of the Commissioner and the
Department of Health and Human
Services.
3. Serves as the focus for cross center
bioinformatics activities, including data
management and analysis. Supports
agency Bioinformatics Board and Data
Councils.
4. Performs project development,
project management, policy and
document development and clearance,
and related tasks as directed by the
Chief Scientist.
5. Coordinates related administrative
activities (e.g., personnel,
communication, staffing, purchasing,
and CP-related travel).
Office of Scientific Integrity:
1. Helps ensure consistent
understanding, application and
implementation of regulatory standards
throughout FDA to ensure integrity and
accountability of FDA functions and
processes.
2. Provides advice and guidance to
the Commissioner, Chief Scientist, and
other key officials regarding premarket
approval processes for all FDAregulated products including
requirements pertaining to applications,
petitions, amendments and
supplements; and product, processing,
packaging and emerging product
technologies.
3. Advises and assists senior FDA
leadership in coordinating responses to
allegations of patterns of deviations by
FDA or its components from appropriate
standards of conduct and performance.
Also advises and assists senior FDA
leadership in preventing such
deviations.
4. Investigates and resolves informal
complaints and disagreements, whether
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generated internally or externally, with
respect to the administrative processing
of various applications for products
regulated by the agency as well as
regarding the fair and even-handed
application of agency policy and
procedures in this process.
5. Processes all formal appeals, or
requests for review, that are submitted
to the Office of the Commissioner,
whether generated internally or
externally, including requests for
hearings, appeals from administrative
actions, and requests to review
decisions at a lower level of the agency.
Examples include, but are not limited
to, requests for hearings in debarment
and disqualification proceedings,
requests to review decisions by the
Centers, the Office of Regulatory Affairs,
and elsewhere in the Office of the
Commissioner under 21 CFR 10.75,
appeals of formal or informal hearings,
and agency-level scientific dispute
resolution matters.
6. Advises and assists the Chief
Scientist and senior leadership in
evaluating and resolving all formal
appeals, requests for review, and
requests for hearings submitted to the
Office of the Commissioner and
coordinates responses to such appeals
and requests.
7. Develops regulations and
procedures to promote an efficient and
effective process for addressing and
resolving formal appeals, requests for
review, and requests for hearings, as
well as any other types of disputes
suitable for formal resolution in the
Office of the Commissioner.
8. Leads Advisory Committee
Oversight and Management Staff,
working in close collaboration with all
FDA Centers to provide consistency in
and continuously improve the
operations of agency advisory
committees.
9. Serves as the liaison between the
Office of the Secretary, the Department
Committee Management Office, all of
FDA’s Center advisory committee
support staff, and other organizations/
offices within FDA.
10. Ensures that all FDA committee
management activities are consistent
with the provisions of Federal Advisory
Committee Act, departmental policies,
and related regulations and statutes.
11. Coordinates with the Office of
Appeals, within the Office of Scientific
Integrity, to determine whether an
informal complaint should be construed
and treated as a request for formal
review by the Office of the
Commissioner under established
regulations or procedures.
Office of Science and Innovation:
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1. Provides strategic leadership,
coordination, infrastructure and support
for excellence and innovation in FDA
science that will advance the agency’s
ability to protect and promote the health
of the public. Key activities include:
Providing support for high quality,
collaborative, peer-reviewed scientific
activities throughout FDA that address
important public health and regulatory
issues concerning FDA regulated
products, including their evaluation,
quality, safety and effectiveness.
Fostering development and use of
innovative technologies to meet public
health needs, including through a
planned Center for Innovation in
Medicine and Public Health and
through core scientific capacity to
support FDA’s regulatory functions and
decision making.
Supporting excellence and the
professional development of FDA
scientists in all areas (i.e. population/
statistical, review, laboratory and
manufacturing sciences), including
through the Commissioner’s Fellowship
Program, continuing education and
professional activities (including
clinical activities, cross agency working
groups, and through relationships and
staff exchanges with Universities and
others.
Addressing scientific and public
health priorities through support of high
quality, peer reviewed scientific
research, programs and related
activities, both within and outside FDA
and collaboratively, and through
dissemination of new scientific
information, methods and approaches.
Supporting scientific outreach,
training, and collaboration in research
and development activities that advance
FDA’s mission, including with sister
agencies, global regulatory partners,
academia (e.g., through planned Centers
of Excellence in Regulatory Science),
innovators, and consumers.
Seeking input from both FDA
programs, stakeholders and outside
advisors, including the FDA Science
Board, to help define, review and meet
FDA scientific needs and priorities to
support our public health mission.
Office of International Programs:
1. Serves as the agency focal point for
all international matters.
2. Serves as the primary agency
liaison with other U.S. Government
components, international and foreign
governments (including Washington, DC
embassies) for policy formulation and
execution impacting FDA and FDA
regulated products.
3. Provides leadership to agency
program areas for international
activities.
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4. Serves as the focal point for the
agency and the authority for policies
and procedures pertaining to
international travel.
5. Serves as the focal point and final
clearing authority for all international
technical cooperation and assistance
activities.
6. Serves as the agency focal point
and final clearing authority for all
international programs and interactions
with foreign counterpart regulatory
agencies, international organizations,
foreign embassies, all foreign officials,
and with agency and all other United
States Government components when
international issues are involved.
7. Directs, manages, and leads agency
strategic planning, priority-setting and
resource allocation processes for agency
international programs.
8. Serves as the agency focal point
and final clearing authority for trade
issues involving e.g., North American
Free Trade Agreement (NAFTA), World
Trade Organization (WTO), Free Trade
Area of the Americas (FTAA), Asia
Pacific Economic Cooperation (APEC),
and United States Trade Representative
(USTR).
9. Serves as the agency focal point
and final clearing authority for formal
arrangements with foreign governments
e.g., memoranda of understanding
(MOU), mutual recognition agreements
(MRAs), exchange of letters,
partnerships, equivalence issues,
country assessments, and
confidentiality commitments.
10. Serves as the agency focal point
on policies and procedures for sharing
public and non-public information and,
in conjunction with the Office of
Regulatory Affairs, import/export policy
issues.
11. Manages the agency’s foreign
offices, including FDA staff deployed in
foreign locations and all related
budgeting, strategic planning, priority
setting and resource allocation.
Office of Administration:
1. The Office of Administration (OA)
will focus on enhancing agency wide
administrative operations and
overseeing a variety of agency-wide
management programs, information
management, financial and shared
services operations, as well as the Office
of the Commissioner’s executive
operations.
2. Provides executive direction,
leadership, coordination, and guidance
for the overall day-to-day administrative
operations of the agency assuring the
timely and effective implementation
and high quality delivery of services
across the agency and centers.
3. Advises and assists the
Commissioner, Deputy Commissioners,
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Chief of Staff, and other key agency
officials on various administrative
management and business activities of
the agency. Chairs the Prescription Drug
User Fee Act (PDUFA) Review Board,
which oversees financial management of
the PDUFA program.
4. Assures that the conduct of agency
administrative and financial
management activities, including
budget, finance, personnel,
organization, methods, and similar
support activities, effectively support
program operations.
5. Utilizes a call center to address all
administrative and information
technology management issues, and
monitors and analyzes operational
performance and customer satisfaction.
6. Plans, directs and coordinates a
comprehensive financial management
program for FDA encompassing the
areas of automated financial systems,
fiscal accounting, voucher audit, and
financial reporting. Issues periodic
reports regarding the status of FDA’s
financial management and develops
financial inputs for the agency’s
programs and financial plans.
7. Provides leadership and direction
regarding all aspects of a variety of
agency management programs including
organization management, delegations
of authority, freedom of information,
Privacy Act, and regulatory dockets
management as well as programs related
to ethics and conflict of interest matters.
8. Advises the Commissioner and
other key agency officials on
administrative management and budget
matters for components within the
Office of the Commissioner. Provides
advice and guidance with regard to
formulation and development of
administrative management policies,
procedures, and controls.
9. Provides advice and assistance to
the Commissioner and senior
management officials on information
management resources and programs.
Establishes and oversees
implementation of the FDA information
management policy and governance,
procedures and processes to ensure the
agency is in conformance with the
Clinger/Cohen Act. Establishes, directs
and leads agency level programs and all
strategic aspects of information
management including: information
technology (IT) shared services,
telecommunications, security, strategic
planning, capital planning and
investment control, and enterprise
architecture.
Office of Equal Employment
Opportunity and Diversity
Management:
1. Advises and assists the
Commissioner and other key officials on
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equal employment opportunity (EEO),
Diversity, and Civil Rights activities
which impact on policy development
and execution of program goals.
2. Serves as the agency focal point
and liaison to the Department, other
Federal agencies, State and local
governments, and other organizations
regarding EEO, Diversity, and Civil
Rights matters.
3. Develops and recommends policies
and priorities designed to implement
the intent of the Office of Personnel
Management, Equal Employment
Opportunity Commission, and Office of
Civil Rights, Department of Health and
Human Services requirements under
Executive Orders, regulations, EEO and
Civil Rights legislation.
4. Provides leadership, direction, and
technical guidance to the agency on
EEO, Diversity, and Civil Rights matters.
5. Examines the use and impact of
administrative mechanisms on work
assignments, pay systems, award
systems, performance appraisal systems,
promotion patterns, reorganization
impacts, delegations of authority,
management controls, information and
documentation systems, and similar
functions of management as they impact
upon equal employment opportunities
for all employees within the agency.
6. Issues policies, publications and
information dissemination services to
agency employees including
Commissioner Policy Statements,
brochures, the EEO Counselors Manual,
etc.
Compliance Staff:
1. Develops plans, programs, and
procedures designed to assure the
prompt adjudication of complaints of
alleged discrimination based on race,
color, sex, age, religion, national origin,
handicap, and sexual orientation.
2. Provides sign language interpreting
services and manages the interpreting
services contracts.
Conflict Prevention and Resolution
Staff:
1. Provides confidential, informal
assistance to employees and managers
in resolving work-related concerns.
2. Develops and coordinates effective
resolution processes and procedures.
3. Offers a variety of services and
programs to address likely sources of
conflict such as performance appraisals,
harassment, mentoring relationships,
and scientific collaboration.
4. Operates as a neutral, independent,
and confidential resource providing
informal assistance to FDA scientists,
administrators, and support staff in
addressing work-related issues. Assists
in resolving conflicts and addressing
concerns prior to and within established
grievances processes.
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5. Provides a neutral and impartial
resource where employees can candidly
discuss issues and explore options
informally.
6. Provides alternative dispute
resolution and mediation services as
needed.
7. Develops and maintains training
and technical assistance for agency EEO
specialists, counselors, special
emphasis/program representatives,
employees, supervisory personnel, and
other key officials.
Diversity Staff:
1. Develops and oversees agency
diversity initiatives and the diversity
databank.
2. Develops, implements, and
monitors the agency’s Affirmative
Employment Plan and directs the
agency’s Affirmative Employment
programs to achieve specific objectives.
3. Develops labor-management
partnerships on EEO and Diversity
matters. Provides sign language
interpreting services and manages the
interpreting services contracts.
Office of Acquisitions and Grants
Services:
1. Serves as the agency focal point for
developing, coordinating, and
implementing FDA policies and
procedures pertaining to acquisitions,
interagency agreements, technology
transfer and grants management;
coordinates all administrative matters
related to acquisitions, grants,
cooperative agreements, interagency
agreements, memoranda of
understanding and technology transfer.
2. Provides acquisition management
information and overall policy and
technical support to all levels of the
Office, agency, Department, and the
Federal government in the areas of
technology transfer, patents and
acquisition and assistance matters.
3. Maintains liaison with the
Department on contracts and grants/
assistance management policy and
procedural and operating matters; serves
as the FDA focal point for the
processing of audit reports and for
liaison with the agency Office of
Inspector General.
4. Provides the oversight function to
all levels of the agency in the Small
Business contracting program.
5. Provides technical and legal
guidance in all areas of the agency
printing management program.
6. Develops policy for printing to
insure timely and cost effective
implementation of the agency printing
program.
Division of Acquisition Operations:
1. Responsible for mission specific
contracts and simplified acquisitions,
including research and development
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requirements and lab supply and
equipment requirements.
2. Responsible for acquisition of
service contracts and simplified
acquisitions, including but not limited
to, furniture, security, events
management, temporary services,
moving, library support, custodial, etc.
Division of Acquisition Support And
Grants:
1. Develops acquisition policy.
Provides customer relation support,
responding to contract related FOIA
requests, and ratifying unauthorized
procurements.
2. Provides current policies and
procedures to assist the FDA
community to develop and transfer
Federal technology to the commercial
marketplace.
3. Negotiates, awards and monitors
Federal funds awarded through various
grant mechanisms.
4. Awards and administers Interagency Agreements (IAGs). Assigns
Memorandum of Understanding (MOU)
tracking number and maintains MOU
files.
5. Provides managerial oversight of
the agency’s purchase card program.
Serves as liaison with the bank,
processing administrative functions,
providing training and other assistance
to ensure that participants understand
their responsibilities under the program.
Division of Acquisition Programs:
1. Responsible for all information
technology related contracts and
simplified acquisitions related
requirements.
2. Provides facility support,
construction and renovation, architect/
engineering services contracts and
simplified acquisitions for all
headquarter locations, Irvine, San Juan,
and Dauphin Island.
3. Provides contracts to support the
MQSA, Food, Tissue and Medicated
Feed/BSE Programs. These contracts
commission the States to conduct
inspections to ensure the quality and
safety of the nations’ food, animal feed
and medical devices.
4. Responsible for simplified
acquisitions for ORA Headquarters and
the Office of Criminal Investigations.
Division of Information Technology:
1. Responsible for all information
technology related contracts and
simplified acquisitions related
requirements.
Office of Executive Operations:
1. Develops policy and provides
guidance, advice and oversight to Office
of the Commissioner (OC) staff with
regard to programmatic FDA and OC
administrative management policies,
procedures, and controls.
2. Advises the Commissioner and
other key agency officials on
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administrative, financial and
information management matters for
components within the Office of the
Commissioner (OC).
3. Manages the OC budget formulation
and execution activities. Provides
advice, guidance and direction on the
administration of the OC budget.
4. Manages a variety of program
administrative services including but
not limited to travel, space, time and
attendance, property, etc. for OC offices
with appropriate officials. Establishes
and maintains liaison with
administrative staff throughout the OC
to keep abreast of current policies and
procedures.
5. Serves as OC liaison for
acquisitions and grants activities
ensuring compliance with agency and
Federal contracting policies.
6. Coordinates and provides guidance
and oversight concerning OC
information management activities
including those related to activities of
FDA Bioinformatics Board.
7. Advises the Commissioner and
Deputy Commissioners and other senior
staff concerning all OC human capital
programs and activities.
Office of Financial Operations:
1. Plans, directs, and coordinates a
comprehensive financial management
operations program for FDA
encompassing the areas of budget
analysis, execution, automated financial
systems, fiscal accounting, voucher
audit, financial services related to
accounts payable, travel support and
payroll liaison, and financial reporting.
Provides staff assistance in justifying
budgets through executive and
congressional echelons. After
appropriation, develops an orderly
expenditure plan.
Office of Financial Management:
1. Plans, directs, and coordinates a
comprehensive financial management
program for FDA encompassing the
areas of budget analysis, formulation
and execution, automated financial
systems, fiscal accounting, voucher
audit, and financial reporting. Provides
staff assistance in justifying budgets
through executive and congressional
echelons. After appropriation, develops
an orderly expenditure plan.
2. Develops apportionment plans and
issues allotments for expenditures.
3. Makes periodic reports regarding
the status of FDA’s financial
management.
4. Develops financial inputs for the
agency’s programs and financial plans.
Division of Accounting:
1. Plan, evaluate and coordinate
activities to ensure Food and Drug
Administration (FDA) is in compliance
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with Federal government accounting
policy and procedures.
2. Principal contact to ensure FDA
compliance with Chief Financial
Officers Act (CFO) audit activities.
3. Devise and implement new and
creative mechanisms to streamline
administrative procedures; for example,
implementation or electronic
certification for treasury schedules
expansion of lock box techniques.
4. Operates the Prompt Pay System for
FDA, which pays over 50,000 invoices
annually, providing integrity checks
throughout the system from receipt of
the invoice to payment.
5. Maintains over 400 headquarters
and field users of automated financial
systems as they request assistance with
problems and special requests using
various systems and special reports.
6. Operates and maintains the FDA
District Electronic Certification System,
which processes payments for vendors
and travelers for all FDA districts while
complying with Treasury’s directive on
EFT payments.
7. Produces daily, biweekly, monthly
and yearly budgetary reports for field
and headquarters components.
8. Liaison with Shared Services
Organization.
User Fee Staff:
1. Manages and oversees the receipt,
deposit, and allocation of user fees paid
by industry.
2. Prepares annual revenue reports for
submission to Congress.
3. Reports on FDA’s compliance with
Congressional mandates.
4. Develops, manages user fee
systems.
Division of Budget Execution and
Control:
1. Provides guidance and advice on
the management and development of
the budgets for FDA’s Office of the
Commissioner and Headquarters.
Conducts analysis about agency-level
and cross-component accounts, trends,
and projects. Interpret agency
requirements and establish FDA policy/
procedures on all phases of budget
execution.
2. Apportions funds appropriated by
Congress among components and
oversees transfers of funds between
components.
3. Completes detailed reviews and
analyses of components’ financial
operating plans at the end of each
quarter. Ensures budgetary resources are
used in a manner consistent with the
agency’s mission and are not over spent
or obligated beyond appropriate limits.
4. Manages key agency-level accounts
and shared costs, such as FDA rent and
central accounts.
5. Assists in the preparation of
historical budget-related data,
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congressional inquiries, and data for
budget formulation and hearings.
6. Reviews and clears all Inter-agency
Agreements (IAG’s) to assure that they
comply with appropriation law and are
included in FDA resource plans;
monitor collection of reimbursable
earnings and identify and solve related
problems as necessary.
7. Maintains FDA staffing ceiling
records, proposes ceiling adjustments as
needed, monitors FTE usage, alerts
management to potential overburn/
underburn problems, and prepares
recurring reports and special analyses as
necessary on FTE levels.
8. Continuously surfaces, and
provides recommendations and support
to resolve PDUFA/MDUFMA issues
(design status of funds and FTE reports;
develop criteria to allocate collections).
Maintains tracking system for allocating
PDUFA/MDUFMA non-PDUFA, and
AIDS funds, and prepare reports.
9. Conducts year-end closeout of
appropriations with the Division of
Accounting, FDA Centers and Offices.
Prepares all necessary end-of-fiscal-year
budget and staffing reports by
organization and by program, and enter
all past-year data.
Office of Financial Services:
1. Plans, directs, and coordinates dayto-day operations for financial services
related to accounts payable, travel
support and payroll liaison.
Division of Payment Services:
1. Performs billing and collecting
services for headquarters accounts.
Maintains internal control over
processing of transactions to accounts,
including application of batch controls
to ensure accurate coding and making of
necessary accounting transaction
adjustments and corrections.
2. Maintains liaison with the
Department of Central Payroll on
headquarters payroll operations.
Reconciles payroll data with accounts.
Maintains tax withholding files. Issues
withholding statements.
3. Processes employee time records;
resolves payroll errors and assists
employees with pay problems; issues
new procedures as needed.
4. Participates in reengineering the
payroll process to streamline correction
of errors and reduce first time errors;
and participates in timekeeper training.
5. Processes all purchase orders,
receiving reports, and invoices for
commercial payments made by the Food
and Drug Administration (FDA)
headquarters, assuring compliance with
accounts and the Prompt Pay Act.
6. Coordinates with vendor and center
personnel in researching payment
information.
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7. Responds to all vendor inquiries as
well as inquiries from center personnel.
8. Prepares various reconciliations to
ensure that schedules are properly
accounted for and entered into the
accounting system.
9. Reviews and distributes monthly
accounting reports and processes
corrections, as necessary.
10. Liaison with the Department of
Treasury to initiate check traces.
Division of Travel Services:
1. Oversees processing of vouchers,
including audit, matching with
obligations, and scheduling for direct
deposit using Travel Manager Software.
2. Oversees post audit of travel
vouchers.
3. Provides travel advice/guidance
throughout the agency, including
significant research on Comptroller
General Decisions; participates in
training on travel procedures.
4. Oversees contractor processing of
all headquarters and field Permanent
Change of Station travel vouchers,
including complex tax calculations.
5. Coordinates with the General
Services Administration (GSA)
contractual travel agent to ensure the
Food and Drug Administration (FDA)
travel and transportation requirement
are met.
6. Field activities perform travel
services directly for ORA and NCTR to
include NCTR travel, ORA international
travel, FATA responsibilities, data calls,
travel audits, 348 travel and conference
reporting.
Office of Information Management:
1. Develops the architecture,
standards, policies, governance, best
practices and technology road map that
support the business priorities of the
agency, including managing information
technology infrastructure,
telecommunications, security, strategic
planning, capital planning and
investment control, enterprise
architecture, and applications
development and; management.
Provides advice and assistance to the
Commissioner and senior management
officials on information technology
resources and programs.
2. Establishes and oversees
implementation of the Food and Drug
Administration (FDA) information
technology policy and governance,
procedures and processes to bring the
agency in conformance with the
Clinger/Cohen Act and the Paperwork
Reduction Act. Provides leadership and
direction regarding all aspects of the
agency records management program.
3. Works in full partnership with FDA
business areas, develops and
communicates the overall vision for the
agency’s IT program.
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4. Provides expert technical
evaluation and recommendations for the
new and emerging technologies to
ensure the agency’s IT program can
proactively adjust to changing business
needs and technology drivers.
5. Represents the agency IT program
on internal and external meetings and
workgroups on agency information
technology programs and issues (e.g.,
Health and Human Services (HHS) Chief
Information Officer (CIO) Council, FDA
Leadership council, FDA level Review
boards, etc.).
6. Establishes policies and procedures
for system risk assessments and system
business continuity and contingency
planning.
Division of Business Partnership
Support:
1. Advocates, communicates,
provides, and manages liaison services
and provides management and technical
consultation resources regarding
information technology to FDA offices,
centers and other FDA stakeholders,
including parties external to FDA (nongovt, e.g., PHRMA, BIO, DIA, ICH, etc)
and PHS, Department, and other Federal
government IRM and ADP operations.
2. Collaborates with BIB and the BRBs
to prioritize new business requirements
and establish projects which will
require PM’s and designs, develops and
maintains the communication plan for
all Enterprise agency projects the BIB,
BRBs, and OIM.
3. Collaborates with other divisions
within OIM to review request for each
system; providing estimates for
implementation and to assist in the
establishment of priorities and
schedules (overarching timeline of all
projects/independencies), as well as
ensure project/investment formulation,
execution and actual information is
reported.
4. Oversees and manages IT program
and project management activities of
major IT initiatives following project
management best practices (Project
Management, System Development, and
Enterprise Program life cycles), in
collaboration with the Division of CIO
Support/Governance Branch, develops
policies and procedures on all aspects of
project planning, and interacts with and
coordinates responses to the Department
and OMB on all project management
related activities.
5. Coordinates development of
Center/Offices IT budget and provides
support for budget execution and
contract monitoring of information
resources.
6. Oversees day-to-day operations of
FDA web development, redesign, and
web hosting environment.
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7. Manages FDA Forms programs and
is the lead for agency Section 508
implementation.
8. Receives user requests, orders, and
issues desktop-related tools and
equipment.
9. Manages and oversees help desk
services and user support for
infrastructure Center and/or FDA-wide
applications (excludes field help desk
which is part of the Division for
Infrastructure Operations).
Division of Chief Information Officer
Support:
1. Establishes and maintains an
agency Enterprise Architecture (EA)
governance structure that includes
processes for systems, business, data,
applications, technology, and security
architectures.
2. Serves as a focal point within FDA
and as a liaison between FDA and
external public and private sector
organizations regarding enterprise
standards, IT architecture, investment
management practices and related
methodologies, data sharing and
support services, and regarding all
aspects of IT planning, development
and management.
3. Develops, tracks and maintains the
IT budget, operating plan, and
acquisition plan. Manages and
maintains an acquisition strategy policy
and implements all aspects of contract
administration and management for the
Office of Information Management.
4. Plans, organizes and manages
FDA’s IT investment management
process (CPIC) to ensure that IT
resources are acquired and managed
effectively, and to ensure effective
ongoing control of IT investments.
Additionally, architectural reviews of IT
investments are conducted to ensure
alignment with business functions,
avoid duplication of effort, reduce costs,
and improve the efficiency and
effectiveness of IT initiatives and to
ensure that the FDA IT enterprise
employs appropriate standards.
5. Coordinates the agency IT risk
management program, including
identification, analysis, and mitigation
and reporting of program and system
level weaknesses. The division also
maintains and audits compliance for
system risk assessments and system
business continuity and contingency
planning.
6. Establishes administrative policies
for OIM consistent with agency policies
and manages all administrative
activities including Administrative
Support, Travel and Timekeeping.
7. Develops, maintains and manages
the electronic records (e-records) policy
within the Office of Information
Management and coordinates as
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necessary with other business entities
within the FDA on records management
activities.
8. Provides management of all aspects
of human capital in the recruitment,
hiring, deployment, development,
management, training and evaluation of
the OIM workforce to ensure that
human capital programs are aligned
with organizational goals and agency
Human Resource requirements.
9. Develops and disseminates
administrative internal communications
and operational procedures for the OIM
in coordination with the
Communications Team. Keeps abreast of
agency and office rules, regulations,
procedures, policies and decisions
Division of Systems Management:
1. Designs, develops, implements, and
maintains all agency software
applications, IT systems, systems
support and maintenance, and their
integration with other Federal agencies,
State and foreign governments and
public and private entities.
2. Establishes and implements an
Enterprise IT Common Component
Framework containing modules/services
to be shared across FDA information
systems and maintains FDA enterprise
applications through effective
evaluation, streamlined application
development, monitoring, testing, and
control of agency-wide systems utilizing
e-platform initiatives and
interchangeable common components in
order to support FDA business process
needs and objectives efficiently and
effectively.
3. Validates requirements for and
directs the design, development and
implementation of new system
requirements, system enhancements and
system maintenance changes for the
agency, performs systems analyses to
develop and implement testing
strategies, procedures and
methodologies, especially automated
varieties, and develops and implements
system specifications, requirements,
procedures and guidelines.
4. Designs, develops, implements, and
maintains standards-based electronic IT
data systems and repositories that
provide the FDA with an integrated and
interoperable information environment
to receive, track, analyze, and
disseminate knowledge on FDA
business/program activities and directs
the development and implementation of
FDA Data Administration policies
standards and procedures to ensure
design consistency, including review of
work products for compliance with
standards.
5. Assists in the development and
implementation of technical
specifications and plans for
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procurement of IT equipment (HW/SW)
and support resources required for the
integrating of new system designs.
6. Develops and implements a
program risk management plan to
oversee and mitigate critical risks and
vulnerabilities in the execution of the
systems under its responsibility.
7. Assists CIO Support Division in
development and maintenance of FDA’s
policies and procedures for independent
verification and validation of IT
systems. Develops, implements and
provides problem management
processes for the FDA systems,
including trend analysis of problems.
Develops standard IT reports.
Division of Infrastructure Operations:
1. Manages agency wide LAN/WAN
computer environment, including
desktop, laptop, and Personal Digital
Assistants (PDAs), as well as utilizing
the computer environment for the
development, testing, validation and
integration of information technology
applications throughout the agency.
2. Oversees and manages day-to-day
operations of all FDA
telecommunications activities including
VoIP and customer support, mailbox
management and problem resolution
related to FDA Email services.
3. Oversees day-to-day operations and
performance of all FDA hardware,
including IT resources such as electrical
power, HVAC, etc.
4. Provides technical consultation to
the Systems Division in identifying
appropriate IT hardware, software and
infrastructure requirements for new IT
applications that support FDA business
process needs.
5. Assists CIO Support’s Procurement
Team in development and
implementation of technical
specifications and plans for
procurement of IT equipment, software
and support services.
6. Manages and coordinates the
integration of systems and business
applications, including testing of the
applications, and coordinates the
execution of services acquired by FDA
to implement new system design efforts
and their underlying infrastructure into
operations and maintenance.
7.Collaborates with the Systems
Management Division on the
development and implementation of
technical standards, policies and
procedures to ensure efficient
operations and controls of FDA IT
systems and that infrastructure services
are developed and operated.
8. Conducts studies and analyses and
performs capacity planning to
determine appropriate IT hardware,
software and infrastructure
requirements. Ensures agency
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infrastructure is kept up to date with
FDA technology standards.
Division of Technology:
1. Reviews and evaluates the
appropriateness of new and emerging
information technologies, including
those with potential science and
laboratory benefits and enterprise
architecture, for incorporation into
existing systems and applications and
for use in future agency supported
initiatives.
2. Oversees the establishment and
implementation of technology through
an enterprise approach of common IT
frameworks, connectivity and consistent
practices, standards and policies to
enable and support interoperability and
consistency throughout the agency.
3. Establishes and manages, through
an enterprise approach, the
development of standards, including
governance for reusable templates,
services and common functions for
application development.
4. Interacts with HHS, and other
interagency groups to guide and align
FDA to Government-wide initiatives
regarding information technology.
5. Regularly attends industry and
other technology meetings to stay
abreast of emerging trends and
technologies.
6. Directs and implements the FDA
information security program to ensure
that security controls for hardware,
software and telecommunications
solutions are: effective, facilitate the
continuity of operations for FDA
information systems, protect privacy,
confidentiality and availability of FDA
data; that they manage system security
policies and standards for FDA
information systems enterprise-wide in
accordance with the agency, HHS, GSA,
OMB and other Federal government
security requirements.
7. Directs and responds to security
audits and collaborates with assessment
teams and other agency groups to
develop and implement corrective
action plans.
8. Establishes and communicates
policies and procedures for system risk
assessments and system business
continuity and contingency planning.
9. Oversees disaster recovery planning
for data center operations and
coordinates with other divisions within
OIM to plan, monitor, and test recovery
plans for all applications throughout
FDA.
10. Develops and monitors scientific
workstation standards. Designs and
implements new IT methods and
applications for scientific computing for
Bioinformatics Board activities.
Office of Management:
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1. Advises and assists the
Commissioner, Deputy Commissioner,
Associate Commissioners and other key
agency officials on various management
and systems activities.
2. Assures that the conduct of agency
administrative, personnel, organization,
and similar support activities effectively
support program operations.
3. Provides leadership and direction
regarding all aspects of a variety of
agency management programs,
including ethics, dockets management,
organization management, delegations
of authority and special studies and
projects for the Office of the
Commissioner. Establishes agency-wide
policy and provides overall direction
and leadership for the Freedom of
Information (FOI) program and Privacy
Act program.
4. Integrates the agency’s technical,
programmatic and facilities
requirements into the overall budgetary
and development plan for the agency’s
consolidation. Implements relocation
planning needed to successfully
transition the agency into its new
location.
5. Provides Food and Drug
Administration’s administrative services
and facilities. Utilizes a call center to
address all administrative and
information technology management
issues, and monitors and analyzes
operational and customer satisfaction.
6. Provides leadership and direction
regarding all aspects of agency-wide
human resources management including
employment, recruitment, training,
career development, partnership
activities, quality of work life issues,
and executive services.
7. Provides program, technical and
resources management for the FDA
White Oak consolidation, logistics and
facilities operations and maintenance
services.
8. Provides leadership and guidance
to the agency for all aspects of physical
and personnel security including the
suitability and National Security
Information Program. Develops and
implements agency wide security
policy.
9. Manages and administers the
suitability and security program as
required by the Office of Personnel
Management as set forth in ‘‘Suitability’’
(5 CFR, Part 731), and ‘‘National
Security Positions’’ (5 CFR, Part 732).
Monitors the appropriate security
clearance levels for agency positions,
employees, and contract employees.
10. Processes clearance requests,
reviews investigative reports/findings
and makes suitability determinations
based on investigative findings.
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11. Develops and directs the agency
wide physical security programs and
provides professional leadership and
authoritative guidance.
12. Formulates policy and procedures
necessary to maintain the integrity of
privileged and trade secret information
submitted by industry.
13. Develops and manages the
agency’s contractor security program
when Automated Data Processing
services or non-public information is
released under contract agreement.
14. Serves as the single point of
contact and focus for the Operating
Division’s management of more than
800 PHS commissioned officers
assigned to approximately 150 duty
stations in 47 states.
15. Provides coordination between
FDA management and the Assistant
Secretary for Health’s Commissioned
Corps programs. Serves the FDA
Centers, special assignments and details
to other organizations and initiatives.
16. Develops and implements all
policies for utilization of all PHS
Commissioned Officers in FDA.
Coordinates all orders, billets,
Commissioned Officer Effectiveness
Reports, promotions, and awards for
commissioned officers.
Ethics and Integrity Staff:
1. Develops agency policy and
procedures implementing the
‘‘Standards of Ethical Conduct for
Employees of the Executive Branch’’ (5
CFR, Part 2635) including the
Department of Health and Human
Services (DHHS) supplemental
regulations (5 CFR, Part 5501).
2. Monitors employee compliance
with Federal regulations by reviewing
employees’ financial disclosure reports
and outside activity requests. Reviews,
prepares, evaluates and secures
appropriate approvals for waivers and
other determinations regarding financial
interest, conflict of interest and other
ethical issues. Counsels employees and
provides authoritative advice on the
statutory, regulatory, policy and
procedural requirements regarding
ethics and conflict-of-Interest issues.
Develops and conducts training for
supervisors, managers, administrative
staff, special government employees and
other agency employees. Provides
oversight and direction to the agency’s
Advisory Committee program as it
relates to special government
employees. Assures that conflicts of
interest waivers are consistent, legally
supportable, well-documented and
timely. Evaluates cooperative
agreements developed by agency
components under the Federal
Technology Transfer Act and provides
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technical advice on any related conflict
of interest matters.
3. Provides advice to employees to
ensure their compliance with applicable
regulations and statutes on the
following: (1) ‘‘Standards of Ethical
Conduct for Employees of the Executive
Branch’’ (5 CFR, Part 2635); (2)
‘‘Supplemental Standards of Conduct
for Employees of the Department of
Health and Human Services’’ (5 CFR,
Part 5501); (3) ‘‘Executive Branch
Financial Disclosure, Qualified Trusts,
Certificates of Divestiture’’ (5 CFR, Part
2634); and (4) Criminal Conflict of
Interest Statutes—Chapter 11—Bribery,
Graft, and Conflicts of Interest (Chapter
11 of Title 18 U.S.C.)
4. Serves as liaison with other FDA
components and the agency Office of
General Counsel/Ethics Division to
develop co-sponsorship agreements.
5. Provides executive and
administrative support to the Conflict of
Interest Review Board.
6. Coordinates Board activities,
prepares background materials, analyzes
recommendations and other
correspondence for Board members and
participates in Board decisions.
Implements decisions including
advising affected employees of Board
determinations.
Office of Business Operations and
Human Capital Programs:
1. The Office of Business Operations
and Human Capital Programs is
responsible for planning and directing
agency management programs to
include administering the FDA
administrative policy programs. The
following are specific functions within
the Office:
Provides leadership and direction
regarding all aspects of a variety of
agency management programs,
including strategic human capital,
organization management, delegations
of authority, competitive sourcing,
executive resources management,
performance management, rewards and
recognition, workforce development and
succession planning.
Provides executive leadership and
direction to coordinate and
operationalize the agency’s business
process improvement initiatives to
increase quality, productivity, and
transparency.
Oversees the development,
prioritization and implementation of
business process improvement
recommendations to provide
predictable, consistent and efficient
application of decision-making
standards, increase internal and external
process transparency resulting in
process clarity for internal and external
stakeholders and improve the overall
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operation and effectiveness of FDA
resulting in productivity and efficiency
gains.
Provides agency-wide leadership and
guidance for all aspects of physical and
personnel security including the
Suitability and National Security
Information program.
Develops and implements agency
wide security policy.
Office of Management Programs:
1. Provides leadership and direction
regarding all aspects of a variety of
agency management programs,
including strategic human capital,
organization management, delegations
of authority, competitive sourcing,
executive resources management,
performance management, rewards and
recognition, workforce development and
succession planning, and special studies
and projects for the Office of the
Commissioner. The following are
specific functions within the Office:
Provides management analysis
support and advisory services to the
Office of the Commissioner and other
agency components.
Serves as the agency focal point for
FDA’s organizational management and
delegations of authority program,
including monitoring of the
establishment, abolishment,
modification, transfer or consolidation
of agency organizational components
and their functional statements, and
administering the Standard
Administrative Code (SAC) system.
Provides direction and oversight for
the agency’s Competitive Sourcing
Program, including the development of
the FAIR Act Inventory, evaluating the
efficiencies of the Most Efficient
Organization, establishing policies, and
advising senior leadership.
Manages the agency’s human capital
program, ensuring that human capital
management programs are merit-based,
effective, efficient and supportive of
mission goals; alignment of human
capital strategies with agency mission/
goals; assessing workforce staffing
needs; ensuring continuity of effective
leadership to manage programs and
achieve goals; and identification of
mission-critical competency gaps and
strategies to close the gaps and hire/
retain necessary talent.
Provides leadership, direction, policy
development, and oversees the
performance management programs
covering the Senior Executive
Performance Management Program and
the Performance Management Appraisal
Program.
Provides leadership, direction, policy
development and program management
for agency workforce and succession
planning activities.
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Provides leadership, direction, policy
development and program management
for a variety of incentive programs,
including recruitment, retention and
relocation incentives, annual leave
service credit, student loan program,
Telework, etc.
Provides leadership, direction, policy
development, program management,
and training for special appointment
authorities, including the
Intergovernmental Personnel Act (IPA),
Senior Executive Service (SES), Title 38,
and Title 42, (including Service
Fellowship, Senior Science Managers,
and Senior Biomedical Research Service
(SBRS)).
Provides leadership, direction, policy
development and program management
for compensation programs including
the hiring and advancement within the
Senior Executive Service (SES), SBRS,
Title 38, Title 42, Service Fellowships,
as well as waiver of overpayments, etc.
Assists the Office of the Chief
Scientist in the management of peer
review processes for scientific positions
by: (1) Providing classification services
for peer reviewed positions, and (2)
providing staff support and advisory
services for the SBRS.
Manages the agency reward and
recognition programs, including the
agency Honor Awards Program.
Provides leadership and direction to
the agency for meeting the government’s
competitive sourcing program outlined
by OMB Circular A–76, Performance of
Commercial Activities.
Provides strategic management of
human capital in the recruitment,
deployment, development and
evaluation of the FDA workforce to
ensure human capital programs and
policies are aligned with organizational
goals.
Provides leadership and direction on
agency workforce planning and
succession planning activities.
Develops and coordinates the
implementation of policies, procedures,
and review activities for the agency’s
peer review program. Provides
classification services for research
scientists, medical officers, consumer
safety officers, and related positions.
Provides leadership and direction in the
effective and efficient use of resources
by conducting management and policy
studies and providing management
consulting services to the Office of the
Commissioner. Employs a variety of
data gathering and quantitative
analytical techniques to determine the
merit of current and proposed
management policies and procedures
and to assess the impact of new policies
and legislation.
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Provides management analysis
services to the Office of the
Commissioner to assess program and
management concerns, which may
include management studies, option
papers, reports, and working group
facilitation.
Provides organizational expertise and
policy advice, consultation, and support
to agency components and monitors the
establishment, abolishment,
modification, transfer, and/or
consolidation of the agency
organizational components and their
functional statements; controls the
assignment of standard administrative
codes for implementation of approved
organization proposals in the agency
and serves as the agency liaison with
the Department on SAC activities.
Plans, develops, modifies, and
coordinates the delegations of authority
program for the agency. Provides advice
and consultation on matters related to
delegations of authority.
Office of Security Operations:
1. Provides leadership and guidance
to Food and Drug Administration (FDA)
for all aspects of physical and personnel
security including the suitability and
National Security Information program.
2. Develops and implements agency
wide security policy.
3. Manages and administers the
Suitability and Security Program as
required by the Office of Personnel
Management as set forth in ‘‘Suitability’’
(5 CFR, Part 731), and ‘‘National
Security Positions’’ (5 CFR, Part 732).
Monitors the appropriate security
clearance levels for agency positions,
employees, and contract employees.
4. Processes clearance requests,
reviews investigative reports/findings
and makes suitability determinations
based on investigative findings.
5. Serves as liaison with the
Department’s drug testing officials and
coordinates the agency’s drug testing
program.
6. Carries out duties as outlined in the
Department of Health and Human
Services and the National Security
Information Manual. Serves as liaison
and coordinates with the Department
regarding the classified document
program.
7. Coordinates other agency checks for
all non-citizen personnel who work in
the agency’s facilities.
8. Develops and directs the agencywide physical security programs and
provides professional leadership and
authoritative guidance.
9. Provides physical, documentary,
and preventative security consultation
to FDA components.
10. Formulates policy and procedures
necessary to maintain the integrity of
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privileged and trade secret information
submitted by industry.
11. Develops and manages the
agency’s contractor security program
when Automated Data Processing
services or non-public information is
released under contract agreement.
Office of White Oak Services:
1. Provides program, technical and
resources management for the Food and
Drug Administration (FDA) White Oak
consolidation, logistics and facilities
operations and maintenance services.
2. Provides leadership and guidance
to FDA Headquarters’ staff offices and
Headquarters operating activities for
White Oak services.
3. Directs building operations
functions for all FDA facilities at the
White Oak Campus.
4. Provides direct interface with the
General Services Administration (GSA)
for White Oak services.
5. Serves as liaison with the
Department of Health and Human
Services (DHHS) and GSA for the
efficient management and operation of
facilities occupied by FDA programs at
White Oak.
6. Directs and manages over a $70
million appropriation for the operation,
construction, relocation, and
maintenance for the White Oak Campus.
7. Provides leadership and direction
to assure the efficient and effective
utilization of FDA’s resources dedicated
to engineering design, facility
improvements, and new construction of
FDA facilities at White Oak.
8. Furnishes project management
services including project planning, cost
estimating and design, and oversight of
construction until completion.
9. Ensures meaningful and continuous
communication with community
leaders and associations, other Federal
officials, State and local governments,
and business leaders and customers at
White Oak.
10. Develops multiple strategies for
addressing FDA’s long and short-range
facility plans at White Oak.
11. Develops agency plans, policy and
procedures consistent with new
regulatory requirements and agency
needs for White Oak.
Division of Logistics Services and
Facilities Operations:
1. Manages shared use conference and
training facilities at the White Oak
Campus.
2. Oversees transportation
management programs and services,
serves as the inter-governmental liaison
on transportation issues, manages
parking, ridesharing program, shuttle
services, fleet management and motor
pool management.
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3. Oversees and directs a variety of
commercial contracts to ensure smooth
and efficient delivery of services.
4. Participates in the development of
agency policy involving logistics
programs and services.
5. Provides guidance and assistance to
the agency operating activities on a
variety of logistics management issues.
6. Manages the warehousing program
for the White Oak facility to include
material receiving and distribution,
loading dock management, storage,
collection and processing excess
personal property, and labor services for
movement of personal property.
7. Manages the Food and Drug
Administration (FDA) mail room
program for FDA headquarters and field
organizations including mail room
management, locator services, courier
services, off-site mail screening and the
nationwide meter contract.
8. Actively participates in and
supports the continued development of
the White Oak Campus.
Division of White Oak Consolidation:
1. Evaluates and implements
strategies that enable the agency to
maximize efficiency through the
consolidation of specific and shared
functions.
2. Coordinates budget and schedule in
order to successfully implement project
phases.
3. Establishes management structure
and dialog with GSA, architectural and
engineering design and construction
contractors to ensure the FDA needs and
concerns are fully addressed.
4. Monitors construction progress as
individual projects proceed and
coordinates necessary changes.
5. Provides technical direction
interaction with design architects that
ensure engineering, architectural and
programmatic requirements are met in
new facilities.
6. Coordinates the various activities
required to successfully relocate the
agency to its new location including the
move, Information Technology (IT),
security, safety and building operations.
7. Participates in the development of
agency policy involving the
consolidation program.
Office of Shared Services:
1. Provides FDA’s administrative
services including communications,
facilities, library services, FDA
historical activities, Freedom of
Information (FOI) and Privacy Act
programs, and dockets management.
Utilizes a call center to address all
administrative and information
technology management issues, and
monitors and analyzes operational and
customer satisfaction.
Employee Resource and Information
Center:
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1. Provides information and services
through a call center environment to all
Food and Drug Administration (FDA)
employees for administrative and
information technology management
issues. Maintains and populates key
technology tools and monitors and
analyzes operational and customer
satisfaction.
2. Provides call center support to the
general public via the FDA Employee
Locator phone line.
3. Provides leadership policy
development, and coordination for
programs with a financial impact on
FDA employees including transit
subsidy and childcare subsidy
programs, fleet management and motor
pool management, Presidential
Management Fellows Program,
Emerging Leaders Program and new
employee orientation.
Office of Public Information and
Library Services:
1. The Office of Public Information
and Library Services (OPILS) is
responsible for planning and directing
agency information programs to set the
direction, coordinate, determine policy,
and provide oversight for the provision
of information services and information,
in a variety of formats and for a variety
of purposes, to FDA and the public.
OPILS includes the following divisions
and sections: Division of Dockets
Management (DDM), Division of
Freedom of Information (DFOI), FDA
Biosciences Library (FBSL), and the
FDA History Office. The following are
specific functions within the Office:
Provides leadership and direction for
the operations of all of the agency
information centers, including the FDA
Biosciences Library and the DFOI and
DDM public reading rooms.
Provides executive perspective on
current policy objectives and increases
public understanding of the agency’s
purpose and function.
Establishes agency-wide policy and
provides overall direction and
leadership for the Freedom of
information (FOI) and Privacy Act
programs.
Provides information, information
services and research support to FDA
through access to information in various
formats, via information consulting and
advisory services.
Provides leadership and direction
regarding all aspects of the agency’s
regulated dockets program.
Division of Dockets Management and
Freedom of Information:
1. The Division of Dockets
Management and Freedom of
Information is responsible for planning
and directing agency information
programs to set the direction,
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coordinate, determine policy, and
provide oversight for the provision of
services and information, in a variety of
formats and for a variety of purposes, to
FDA and the public for the services
provided by the Dockets Management
Branch (DMB) and the Freedom of
Information Branch (FOIB).
The following are specific functions
within the Office:
Provides leadership and direction for
the operations of the agency information
centers, including the FOIB and DMB
public reading rooms.
Provides executive perspective on
current policy objectives and increases
public understanding of the agency’s
purpose and function.
Establishes agency-wide policy and
provides overall direction and
leadership for the Freedom of
information (FOI) and Privacy Act
programs.
Provides information and support to
FDA through access to various
documents via consulting and advisory
services, and through proactive posting
to the FDA internet.
Provides leadership and direction
regarding all aspects of the agency’s
regulated dockets program.
Dockets Management Branch:
1. Receives, examines and processes
submissions required or permitted in
agency administrative proceedings;
establishes and maintains docket files
containing agency official records
relating to an administrative proceeding.
Disseminates submissions to
appropriate offices for action. Routinely
coordinates activities of the branch with
other appropriate components.
2. Serves as the agency expert on
requirements for submissions required
or permitted in agency administrative
proceedings. Participates in the
development of regulations and policy
impacting on agency administrative
proceedings and the release of
information under the Freedom of
Information Act (FOIA).
3. Provides staff support for agency
rulemaking activities. Determines
compliance of petitions, comments,
request for hearings, motions, briefs,
and objections with agency regulations.
4. Establishes agency-wide policy and
provides overall direction and
leadership for the Freedom of
information (FOI) and Privacy Act
programs.
5. Maintains and operates a public
reading room to make agency official
records available to any interested party,
and provides copies upon request,
under the provisions of the FOIA.
6. Provides electronic access to these
records, via the Internet, and other
means, as required by the EFOIA.
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7. Provides information access via the
Intranet and other means to FDA
personnel for Dockets Management
Branch materials and to copyrighted
documents.
8. Plans and conducts agency-wide
analytical reviews and studies to assess
and management information and
address concerns. Makes
recommendations and assists in the
implementation of the
recommendations.
Freedom of Information Branch:
1. Serves as the agency expert and
focal point for headquarters and field
personnel in the development and
implementation of effective policies and
procedures in accordance with the
FOIA, the Privacy Act, FDA regulations,
and other relevant statues.
2. Receives, reviews, controls,
coordinates and routes all FOI requests
to the proper action office; designs and
implements control mechanisms to
assure FOI and Privacy Act inquiries are
processed and responded to within
established timeframes.
3. Establishes agency-wide policy and
provides overall direction and
leadership for the Freedom of
information (FOI) and Privacy Act
programs.
4. Reviews all recommendations for
denials submitted by headquarters and
field FOI officers. 5. Determines the
need for supplemental information and/
or changes in the denial
recommendation and coordinates
required action with the submitting
office.
6. Analyzes, compiles, and prepares
reports on privacy and FOI activities in
the agency for the annual reports to the
Department and for other reporting
requirements.
7. Maintains copies of agency
manuals, indexes, and other records
required to be on public display in the
public reading room.
Division of FDA Biosciences Library:
1. The Division of the FDA
Biosciences Library is responsible for
planning and directing agency library
programs to set the direction,
coordinate, determine policy, and
provide oversight for the provision of
library services and information, in a
variety of formats and for a variety of
purposes to FDA and the public. The
following are specific functions within
the Office:
Provides research support to FDA
through delivery of information
consulting and advisory services,
literature searches, and document
delivery services in order for FDA to
carry out its public health mission.
Collaborates with FDA researchers on
research projects, bibliographies,
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internal publication databases,
copyright issues, digitization and more,
so FDA has the information it needs to
meet its scientific and regulatory
mission.
Plans, develops and conducts training
sessions to teach customers how to
access and best utilize the online
resources available to them to enhance
their research efforts.
Stewards of a unique, valuable,
extensive and specialized collection of
materials essential to FDA’s scientific,
legal, administrative and regulatory
staff. Collects, organizes, maintains and
preserves information resources, in
multiple formats, in all areas of FDA’s
research and products FDA regulates,
including: biologics, blood products,
cosmetics, devices, drugs, food
processing and safety, nutrition,
pharmacy, pharmacology, radiology,
tobacco, toxicology, and veterinary
medicine.
Promotes and markets services and
resources to customers. Leverages FDA’s
resources and increases awareness of
the library services, staff expertise, and
its valuable research collection.
Provides services and resources to
agency customers, other Federal
employees and the public on a limited
basis.
Selects, evaluates, acquires and/or
develops, and provides electronic access
to scientific and technical databases,
publications and other media
mechanisms in support of agency-wide
research needs.
Partners with libraries and
information centers, publishers,
consortia across the Federal
government, health related associations,
and other organizations, to enhance
resource sharing opportunities that
provide for cost savings, resource
sharing, sharing of skills and
knowledge, benchmarking best
practices, and collaboration on projects
that have a beneficial impact on the
library and FDA’s work.
Public Services Branch:
1. Maintains library operations and
staffs the public information desk,
responding to requests for information
from FDA and members of the public.
2. Provides information, information
services and research support to FDA
through access to information in various
formats.
3. Provides training to FDA on the
library’s subscribed electronic research
resources and tools.
4. Provides consulting and advisory
services to FDA staff, through briefings
and participation in scientific and
regulatory meetings.
5. Provides research support through
preparation of extensive literature
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searches and delivery of customized
information packages.
6. Provides articles and documents to
researchers via document delivery and
inter-library loan services.
7. Monitors and administers the
document delivery system, ILLiad, and
the customer relationship management
system, Ask a Librarian.
8. Interprets library and information
policy and copyright guidance for FDA
customers.
9. Manages and coordinates access to
bibliographic citation management
systems, Reference Manager and
EndNote, and consultants with
researchers to assist with preparation of
bibliographies and citations.
10. Delivers presentations and
briefings at New Employee Orientations,
Awareness Days, Open Houses, and
FDA center events to promote the
library resources and services.
Technical Services Branch:
1. Ensures the library collections, both
online and in print formats, are
responsive to customer research and
information needs.
2. Manages portfolio of the library’s
research resources.
3. Develops and implements the
library’s collection development policy
and interprets policy to customers to
justify purchase decisions, collection
scope and other criteria.
4. Collects usage data, customer
recommendations and feedback to
determine information resources to
maintain and to cancel; administers
acquisition of print and online
resources.
5. Establishes site licenses beneficial
to FDA research for all library
subscribed electronic resources.
6. Establishes pilot tests to evaluate
new electronic information resources;
analyzes feedback and makes
determinations for purchase decisions.
7. Administers the integrated library
system and its modules, including the
online public access catalog, the
federated search engine, and the
electronic resource management system.
8. Provides news pushes including
the Federal Register, and manages
listservs to provide daily email updates
to online newsletters of interest.
FDA History Office:
1. Provides expertise on the history of
FDA and its predecessors; is a key
resource for historical records and
resources used for agency
commemoratives, anniversaries and
milestones.
2. Responds to information requests
from FDA centers, scholars, the press,
consumers, government agencies,
industry, trade organizations, health
professionals, associations, and foreign
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sources. Presents information in
workshops, briefings, and seminars.
3. Conducts research and produces
publications, briefing reports, and
presentations interpretive of FDA.
Maintains an extensive office research
file.
4. Provides expertise and assesses the
historical value of agency resources, i.e.,
records, photographs, films, audiovisual records, and rare or out-of-print
monographs. Leverages FDA resources
through consultative partnerships with
FDA offices. Collaborates on
preservation of historical materials with
experts at the National Archives and
Records Administration, the National
Library of Medicine, the Smithsonian
Institution, and other government,
academic, and private institutions.
5. Collects, processes, and preserves
artifacts that capture the history of
FDA’s work, represent the commodities
it regulates, and document the breadth
of its responsibilities. Mounts a variety
of exhibits in collaboration with other
public and private institutions to
educate agency employees and the
public about the history and work of the
FDA.
6. Partners with the National Library
of Medicine, History of Medicine
Division, to create and make available
transcripts and recordings of an oral
history program that documents FDA’s
institutional history, through personal
interviews with key exiting FDA
employees.
Office of Real Property Services:
1. Provides leadership and guidance
to agency components for all aspects of
real property management functions.
2. Directs the management of
programs and systems leading to the
acquisition, alteration, maintenance,
and utilization of leased and owned
facilities nationwide, except for the
acquisition of buildings for the White
Oak Headquarters Consolidation.
3. Directs building operations
functions for all Food and Drug
Administration (FDA) facilities
nationwide.
4. Manages the program and provides
direct interface with General Services
Administration (GSA) for lease
acquisition and lease management for
all agency facilities nationwide.
5. Serves as liaison with the
Department of Health and Human
Services (DHHS) and GSA for general
facilities management issues and
specifically for the efficient
management and operation of facilities
occupied by FDA programs nationwide.
6. Directs and manages an excess of
$221 million dollar appropriation for
the acquisition, operation, construction,
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maintenance for the agency’s
nationwide real property portfolio.
7. Provides leadership and direction
to assure the efficient and effective
utilization of FDA’s resources dedicated
to engineering design, facility
improvements, and new construction of
FDA facilities nationwide.
8. Establishes management structure
and dialog with GSA and the
architectural engineering design and
construction contractors to ensure FDA
program needs and concerns are fully
addressed.
9. Ensures meaningful and continuous
communication with community
leaders and associations, State and local
governments, and business leaders in
areas where FDA proposes new
facilities.
10. Develops and implements
program plans, policies and procedures
designed to create and maintain a safe
and healthful environment for FDA
employees, visitors, and guest workers,
and to protect the environment.
11. Develops agency plans, policy and
procedures consistent with new
environmental health and safety
regulatory requirements and agency
needs. Provides fire protection, safety
engineering, and environmental health
consultation to the agency’s program
managers and engineering offices.
12. Leads the agency’s
decommissioning efforts to close FDA
laboratories and offices from an
environmental, safety and health
perspective.
13. Consults with program officials on
safety matters pertaining to changing
and emerging research programs.
14. Recommends special technical
studies to increase the knowledge of the
relationship between occupational
safety and environmental health and
laboratory programs of FDA.
15. Provides support to the FDA
Safety Advisory Board and conducts the
FDA Safety and Health Council
meetings.
16. Develops and implements a safety
management quality assurance program
for the agency’s multiple work sites
nationwide. Develops and implements a
similar headquarters program consistent
with the FDA Safety Advisory Board
recommendations and approval.
Jefferson Laboratories Complex Staff:
1. Provides leadership and direction
regarding all aspects of facilities
management.
2. Manages and coordinates all
aspects of the Jefferson Laboratories
long range facilities planning.
3. Develops renovation and
improvement project definitions and
priorities for inclusion in the agency’s
Annual Facilities Plan and budget.
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4. Provides leadership and direction
to assure the efficient and effective
utilization of Jefferson Laboratories
resources dedicated to engineering
design, facility improvements,
maintenance and new construction
projects.
Division of Engineering Services:
1. Manages and directs design and
construction requirements for facility
acquisitions within the agency. These
requirements may encompass the
following activities singularly or in
combination; preparation of proposals,
preparation of functional requirements,
program of requirements and criteria,
architect and engineering liaison, space
design and planning, functional and
technical reviews, preliminary site
selections, and project management for
facilities construction, renovation and
improvement projects.
2. Provides engineering guidance and
support for all activities related to
maintenance, alterations, and repairs for
agency facilities nationwide.
3. Directs and coordinates all agency
facilities programs concerned with
equipment specifications and
installation associated with facility
acquisitions. Assists the programs’ staffs
in developing compatible facilities and
equipment systems for the agency.
4. Provides overall engineering
services including: feasibility studies,
design criteria, concept, analysis, and
estimates. Schedules and tracks
building and facilities projects and
manages project design.
5. Manages the FDA energy
management program; develops agency
policy relating to the program; develops
and enforces supporting agency
standards that comply with stated goals
of the Department.
6. Oversight of structural,
architectural or mechanical
modifications to accommodate specific
requirements in the existing FDA
portfolio.
7. Prepares computer—aided design
(CAD) drawings for the agency and
maintains file of master drawings for
FDA portfolio.
8. Administers agency contract for
renovations/alterations of office space.
9. Provides space and alterations
project management for existing FDA
space to program components.
10. Develops, implements and
manages integration of facilities
technologies.
Environment, Safety and Strategic
Initiatives Staff:
1. Manages the agency’s Environment,
Safety and Health (EH&S) Program;
2. Oversees strategic management
initiatives and programs initiated at
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Government-wide, Departmental,
agency and Office levels.
3. Oversees and directs a variety of
commercial contracts or interagency
agreements to ensure smooth and
efficient delivery of services.
4. Participates in the development of
agency policy involving EH&S programs
and services.
5. Provides guidance and assistance to
the agency operating activities on a
variety of EH&S and Strategic
management issues.
6. Actively participates in and
supports the agency Facility
Management System used to manage
FDA’s Real Property Asset inventory.
7. Receives and implements new
initiatives for Real Property Services
(e.g. President Management Agenda
initiatives; Office of Management and
Budget Scorecards; Department
Objectives and agency initiatives)
Division of Facilities Operations:
1. Coordinates building operations
and facilities management functions for
all Food and Drug Administration (FDA)
owned facilities within the Washington
metropolitan area which includes:
Module 1 (MOD 1), and the Beltsville
Research Facility (BRF). Through
special delegations of authority from the
General Services Administration (GSA),
maintains responsibility for the total
management, operation, and
maintenance of Federal Building 8 (FB–
8) and Module 2 (MOD 2).
2. Oversees and directs a variety of
commercial contracts to ensure smooth
and efficient delivery of services.
3. Participates in the development of
agency policy involving building
management and operations.
4. Provides guidance and assistance to
the agency operating activities on a
variety of facilities operations issues.
5. Coordinates office and laboratory
relocations and provides technical
assistance to programs regarding
effective space utilization.
6. Provides guidance to program
personnel in identifying or developing
alternatives or emergency procedures
during scheduled and unscheduled
maintenance interruptions.
7. Administers agency contracts for
moving services and preventive
maintenance for government owned
property.
8. Manages and coordinates the
General Services Administration
Delegations of Authority program for
FDA nationwide. Responds, reviews,
and analyzes existing and proposed
Delegation Agreements, Interagency
Agreements, Memorandum of
Understandings regarding the agency’s
nationwide property holdings for
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operational planning processes and
improvement.
Portfolio Development Staff:
1. Plans and develops the agency
Annual Facilities Plan that includes
forecasts for long term, short term and
immediate space needs as well as
annual facilities budgets for rent,
operations and maintenance and
building and facilities.
2. Develops multiple strategies for
addressing FDA’s long and short range
facility plans.
3. Develops agency standards and
enforcement of occupied and vacant
space utilization. 4. 4. 4. Prepares
reports and space management analysis
of the agency’s real property holdings. 5.
5. Analyzes agency housing plans and
performs real property occupied and
vacant space 5. customer analysis.
6. Provides cost analysis support to
agency components concerned with
leasing, construction, and finance costs.
7. Manages the policy, acquisition,
management and administration of the
agency’s leased real property portfolio.
8. Provides guidance and assistance to
the agency operating activities on a
variety of nationwide real estate
management issues.
9. Serves as liaison with the
Department of Health and Human
Services (DHHS) and the General
Services Administration (GSA) for all
lease acquisition and lease management
of FDA nationwide facilities.
10. Conducts agency facility studies
and develops specific long-range facility
plans for both headquarters and field
operations.
11. Directs or participates in, the
preparation of the Program of
Requirements for new construction
projects.
Center for Tobacco Products:
1. The Center for Tobacco Products
will be established to address the
enactment of the Family Smoking and
Tobacco Control Act. This Office will
consist of an Office of Management, an
Office of Policy, an Office of Regulations
and an Office of Science.
Office of the Center Director:
1. Provides leadership and direction
for all Center activities and coordinates
programs within the agency,
Department and government agencies.
2. Plans, administers, coordinates,
evaluates and implements overall
Center scientific, regulatory,
compliance, enforcement and
management programs, policies and
plans.
3. Provides leadership and direction
for Center management, planning, and
evaluation systems to ensure optimum
utilization of personnel, financial
resources, and facilities.
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4. Establishes and manages a program
to maintain the highest level of quality
and integrity for all Center laboratory
studies and the processing of regulatory
samples, and ensures that all
laboratories are in compliance with
Good Laboratory Practice Regulations.
5. Coordinates and monitors the
Center’s overall research portfolio,
including all research-related activities
and inquiries and the development of
strategic research program plans.
6. Serves as the primary
representational role for relationships
with the department, OMB, the White
House, the Congress and the media.
Office of Management:
1. Provides support to the Center
Director and Deputy Directors,
including the coordination and
preparation of briefing materials and
background information for meetings,
responses to outside inquires, and
maintenance and control of the Center
Director’s working files.
2. Manages the Center’s Freedom of
Information Act activities, coordinating
responses with other Center technical,
regulatory, and policy units as well as
developing direct responses.
3. Provides correspondence control
for the Center and controls and
processes all agency public
correspondence directed to the Center
Director. Develops and operates tracking
systems designed to identify and resolve
early warnings and bottleneck problems
with executive correspondence.
4. Coordinates the Center’s
communications with the agency,
Department, and the other Federal
government agencies.
5. Provides authoritative advice and
guidance to the Center Director on
management policies, guidelines, issues
and concerns that directly impact
Center programs and initiatives.
6. Provides leadership, guidance and
directs the development of long-range
strategic and operational plans and
systems for Center activities and directs
technical support staff in providing
essential management services and
other critical support functions.
7. Provides leadership and guidance
as primary interface working with the
FDA Office of Shared Services to ensure
provision of a broad range of essential
technical support services.
8. Provides leadership and effective
coordination as the primary Center
liaison and expert with the Office of
Information Management for provision
and continuous improvement of
information and technology services for
the Center to include networking,
scientific computing software
engineering, systems, and
telecommunications.
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9. Administers and executes Center
program planning and performance
activities, budget formulation and
execution, payroll, accounting, fleet and
property management functions.
10. Analyzes, formulates and
develops annual budget for the Center
in accordance with FDA, DHHS, OMB
and Congressional guidelines. Provides
oversight and ensures compliance with
all regulations governing financial
processes as outlined in OMB, GAO,
DHHS and FDA policies.
11. Manages and maintains a
management system for center wide
research and support functions.
12. Develops, maintains, monitors,
analyzes and reports data to Center
management and program officials on
the Center’s budget/planning resource
monitoring and evaluations systems.
13. Manages, conducts, and analyzes
studies designed to improve Center
processes and resource utilization and
support requirements.
14. Provides leadership, guidance,
technical support and assistance to
Center managers, employees and shared
services staff on services including
timekeeping, payroll, fleet management,
personal property management, travel,
acquisitions and financial services.
15. Provides leadership within the
Center to assure compliance with
statutes, executive orders and
administrative directives, such as the
Chief Financial Officer Act (CFO) and
the Federal Financial Manager’s
Financial Integrity Act (FMFIA).
Office of Policy:
1. Advises the Center Director and
other key agency officials on matters
relating to agency policy, regulations
and guidance, legislative issues, and
planning and evaluation activities.
2. Participates with the Center
Director in the formulation of the basic
policies and operational philosophy,
which guide the agency in effectively
implementing its responsibilities.
3. Oversees and directs the Centers
planning and evaluation activities,
including the development of programs
and planning strategies through analysis
and evaluation of issues affecting
policies and program performance.
4. Advises and assists the Center
Director and other key agency officials
concerning legislative needs, pending
legislation and oversight activities that
affect FDA.
5. Serves as the focal point for overall
legislative liaison activities within
Center, FDA and between FDA, the
Department, PHS and other agencies
related to Tobacco; analyzes the
legislative needs of the Center and drafts
or develops legislative proposals,
position papers, and departmental
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41733
reports on proposed legislation for
approval by the Center Director and
Commissioner.
6. Advises and assists members of
Congress and congressional committees
and staffs in consultation with the
Office of the Secretary, on agency
actions, policies, and issues related to
legislation which may affect the Center.
Office of Regulations:
1. Provides Center oversight and
leadership in the development of
regulations, policies, procedures and
guidance for the review and regulation
of tobacco products, their labels, and
marketing, and in the development of
new legislation.
2. Provides Center oversight and
leadership in the administration of the
user fee billing and waiver program, and
registration and listing.
3. Coordinates, interprets, and
evaluates the Center’s overall
compliance efforts. As necessary,
establishes compliance policy or
recommends policy to the Center
Director.
4. Oversees and directs the agency’s
rulemaking activities and regulation and
guidance development system.
5. Serves as the agency focal point for
developing and maintaining
communications, policies, and programs
with regard to regulations development.
6. Stimulates awareness within the
agency of the need for prompt and
positive action to assure compliance by
regulated industries; works to assure an
effective and uniform balance between
voluntary and regulatory compliance
and agency responsiveness to consumer
needs.
7. Evaluates and coordinates all
proposed legal actions to ascertain
compliance with regulatory policy and
enforcement objectives.
8. Develops and/or recommends to
the Center Director policy, programs,
and plans for activities between the
agency and State and local agencies;
administers the Center’s overall FederalState program and policy; coordinates
the program aspects of agency contracts
with State and local counterpart
agencies.
Office of Science:
1. Serves as principal authority and
provides leadership for the Center’s
participation in the National Toxicology
Program (NTP).
2. Organizes, plans, and directs Center
research programs in accordance with
Center-wide strategic direction.
Implements Center-wide strategies for
achieving annual and long-range plans
for research.
3. Provides leadership and direction
for communications among scientific
and administrative staffs.
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4. Organizes, plans, and directs the
Center for research support in the areas
of Tobacco.
Directs the development methods
used to extrapolate test results from
animals to humans.
5. Coordinates research in Center
program areas with leading scientists in
other segments of FDA and the scientific
community at large and promotes and
coordinates the Center’s technology
transfer under the provisions of the
Federal Technology Transfer Act.
6. Coordinates with other Center and
agency components and top level
officials of other agencies to provide
input for long-term research planning in
responsible program areas.
7. Insures that programs implemented
are responsive to the Center’s portion of
the agency’s integrated research plan.
8. Provides scientific oversight of
Center research contracts and
agreements.
9. Advises and assists the Center
Director, Deputy Director, and other key
officials on scientific issues that have an
impact on policy, direction, and longrange goals.
10. Coordinates and provides
guidance on special and overall science
policy in program areas that cross major
agency component lines and scientific
aspects that are critical or controversial,
including agency risk assessment
policies.
11. Represents the Center with other
government agencies, state and local
governments, industry, academia,
consumer organizations, Congress,
national and international
organizations, and the scientific
community on tobacco science policy
and tobacco science issues.
12. Serves as the focal point for
overall management of Center activities
related to science priorities, resources,
and leveraging efforts, as well as peer
review of scientists and scientific
programs.
13. Advises the Commissioner,
Deputy Commissioner, and other key
officials on scientific facilities and
participates with other agency
components in planning such facilities.
14. Administers the Tobacco Advisory
Committee that advises the Center
Director, Deputy Director, and other key
officials regarding the quality and
direction of tobacco science and
scientific issues.
II. Delegation of Authority. Pending
further delegation, directives or orders
by the Commissioner of the 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
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redelegations, provided they are
consistent with this reorganization.
Food and Drug Administration
24, 2009. Persons without access to the
Internet can call 301–796–1300 to
register. Registration is free for the
public workshop, but interested parties
are encouraged to register early because
spaced is limited. Seating will be
available on a first-come, first-served
basis. Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Lori Benner (see
Contact Person) at least 7 days in
advance.
[Docket No. FDA–2009–N–0664]
SUPPLEMENTARY INFORMATION:
Dated: August 7, 2009.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. E9–19680 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Development of Antiviral Products for
Treatment of Smallpox and Related
Poxvirus Infections; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop regarding scientific
issues in clinical development of
antiviral drug products for treatment of
smallpox and related poxvirus
infections. This public workshop is
intended to provide information for and
gain perspective from health care
providers, academia, and industry on
various aspects of antiviral product
development for smallpox and related
poxvirus infections, including the status
of clinical understanding of smallpox
from pre-eradication experience, current
epidemiology of naturally occurring
poxvirus infections, potential effect of
antiviral treatment for smallpox and
related poxvirus infections, and issues
pertaining to animal models for
smallpox and related poxvirus
infections. The input from this public
workshop will help in developing topics
for further discussion.
Dates and Times: The public
workshop will be held on September 1,
2009, from 8:30 a.m. to 5:30 p.m. and on
September 2, 2009, from 8 a.m. to 4 p.m.
Location: The public workshop will
be held at the Crowne Plaza Silver
Spring, 8777 Georgia Ave., Silver
Spring, MD 20910.
Contact Person: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research, Food and Drug
Administration, Office of Antimicrobial
Products, New Hampshire Ave., Bldg.
22, rm. 6209, Silver Spring, MD 20993–
0002, 301–796–1300.
Registration: To register
electronically, e-mail registration
information (including name, title, firm
name, address, telephone, and fax
number) to
SmallpoxWkshp@fda.hhs.gov by August
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FDA is
announcing a public workshop
regarding antiviral drug development
for smallpox and related poxvirus
infections. This public workshop will
focus on scientific considerations in the
clinical development of products for
treatment of smallpox and related
poxvirus infections. This public
workshop is intended to provide
information regarding historical
perspectives on smallpox and current
perspectives on related poxvirus
infections in humans. The workshop
will explore approaches to assessing the
potential effect of antiviral treatment for
smallpox and related poxvirus
infections. Issues pertaining to animal
models for smallpox and related
poxvirus infection and their
relationship to disease in humans will
be discussed at the workshop. In
addition, the workshop will include
perspectives of public health
organizations on possible uses of an
antiviral product for poxvirus
infections.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 20 working days after the
public workshop, at a cost of 10 cents
per page. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm169065.htm approximately 45 days
after the workshop.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19781 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
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Agencies
[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Notices]
[Pages 41713-41734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19680]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0376]
Office of the Commissioner Reorganization; 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
Office of the Commissioner (OC). This reorganization includes the
organizations and their substructure components as listed in this
document. This reorganization includes the re-alignment of four Deputy-
level offices within the Office of the Commissioner: the Office of the
Chief Scientist; the Office of Administration (formerly titled the
Office of Operations); the Office of Foods; and the Office of Policy,
Planning and Budget (formerly titled the Office of Policy, Planning and
Preparedness).
FOR FURTHER INFORMATION CONTACT: Vanessa Starks, Office of Management
Programs (HFA-400), Food and Drug Administration, 5600 Fishers Lane,
rm. 6B-42, Rockville, MD 20857, 301-827-1463.
Office of the Chief Scientist: The organizational change will allow
the agency to better focus the science and research activities under
the Chief Scientist. Re-alignments under the Office of the Chief
Scientist will include the Office of Counter-Terrorism and Emerging
Threats, Office of Critical Path Programs, Office of Scientific
Integrity, and the Office of Science and Innovation.
Office of Administration: The Office of Operations will be re-
titled the Office of Administration. The Office of Administration will
be restructured to strengthen agency wide management programs, budget
and shared services operations, as well as the Office of the
Commissioner's executive operations. Realignments of the Office of
Acquisitions and Grants Services, the Office of Executive Operations,
the Office of Information Management, the Office of Management, the
Office of Equal Employment Opportunity and Diversity Management, and
the establishment of the Office of Financial Operations.
Office of Foods: The Office of Foods will be realigned from the
Office of Operations and will report directly to the Commissioner.
Office of Policy, Planning and Budget: The Office of Policy,
Planning and Preparedness will be retitled the Office of Policy,
Planning and Budget. The realignments from the Office of Policy, Office
of Planning, and the Office of Budget Formulation (formerly titled the
Office of Budget Formulation and Presentation, Office of Operations).
[Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
and 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR
50112, August 30, 2007) is amended to reflect the restructuring of the
Office of the Commissioner (OC), Food and Drug Administration (FDA) as
follows].
I. Under Part D, Food and Drug Administration, delete the Office of
Commissioner in its entirety and replace with the following:
DA.10 ORGANIZATION. The Food and Drug Administration (FDA) is
headed by the Commissioner, Food and Drug, and includes the following
organizational units:
Office of the Commissioner
Office of the Chief Counsel
Office of the Chief of Staff
Office of Legislation
Office of Policy, Planning and Budget
Office of Counselor to the Commissioner
Office of Women's Health
Office of Special Medical Programs
Office of External Affairs
Office of Foods
Office of the Chief Scientist
Office of International Programs
Office of Administration
Office of Equal Employment Opportunity and Diversity Management
Center for Tobacco Products
DA.20 FUNCTIONS.
Office of the Commissioner: The Office of the Commissioner (OC)
includes the Commissioner and Deputy Commissioner who are responsible
for the efficient and effective implementation of the FDA mission.
Office of the Chief Counsel: The Office of the Chief Counsel (OCC)
is also known as the Food and Drug Division, Office of the General
Counsel, Department of Health and Human Services. While
administratively within the Office of the Commissioner, the Chief
Counsel is part of the Office of the General Counsel of the Department
of Health and Human Services.
1. Is subject to the professional supervision and control of the
General Counsel, Department of Health and Human Services (DHHS), and
represents FDA in court proceedings and administrative hearings with
respect to programs administered by FDA.
2. Provides legal advice and policy guidance for programs
administered by FDA.
3. Acts as liaison to the Department of Justice and other Federal
agencies for programs administered by FDA.
4. Drafts or reviews all proposed and final regulations and Federal
Register notices prepared by FDA.
5. Performs legal research and gives legal opinions on regulatory
issues, actions, and petitions submitted to FDA.
[[Page 41714]]
6. Reviews proposed legislation affecting FDA that applies to HHS
or on which Congress requests the views of the Department.
7. Provides legal advice and assistance to the Office of the
Secretary on matters within the expertise of the Chief Counsel.
Office of the Chief of Staff:
1. Advises and provides integrated policy analysis and strategic
consultation to the Commissioner, Deputy Commissioners, and other
senior FDA officials on activities and issues that affect significant
agency programs, projects and initiatives. Often this function involves
the most difficult problems, crisis situations and extremely complex
issues of the agency.
2. Provides leadership, coordination and management of the
Commissioner's priority policies and issues across the Office of the
Commissioner and agency wide. Identifies triages, supervises and tracks
related actions from start to finish in conjunction with senior
leadership across FDA.
3. Serves as the principal liaison to the Department of Health and
Human Services (DHHS) and coordinates and manages activities between
FDA and DHHS. Works with the FDA Centers/Offices to ensure assignments
or commitments made related to these activities are carried out.
4. Provides direct support to the Commissioner, Deputy
Commissioners, and other FDA senior staff including briefing materials,
background information for meetings, responses to outside inquiries,
and maintenance and control of the Commissioner's working files.
5. Provides top level leadership and guidance on issues and actions
tied to the agency's communications with the Public Health Service,
DHHS, and the White House, including correspondence for Assistant
Secretary for Health and Secretarial signatures; controls for all
agency public correspondence directed to the Commissioner; and the
development and operation of tracking systems designed to identify and
resolve early warnings and bottleneck problems with executive
correspondence.
Executive Secretariat:
1. Advises the Commissioner and other key agency officials on
activities that affect agency wide programs, projects, and initiatives.
Informs appropriate agency staff of the decisions and assignments made
by the Commissioner, the Deputy Commissioners, the Chief of Staff and
the Associate Commissioners.
2. Develops and maintains management information necessary for
monitoring the Commissioner's and agency's goals and priorities.
3. Assures that materials in support of recommendations presented
for the Commissioner's consideration are comprehensive, accurate, fully
discussed and encompass the issues involved.
4. Provides correspondence control for the Commissioner and
controls and processes all agency public correspondence directed to the
Commissioner. Develops and operates tracking systems designed to
identify and resolve early warnings and bottleneck problems with
executive correspondence.
5. Provides direct support to the Commissioner, Deputy
Commissioners, Chief of Staff and Associate Commissioners including
briefing materials, background information for meetings, responses to
outside inquiries, and maintenance and control of the Commissioner's
working files.
6. Performs agency wide assignments involving complex problems and
issues related to agency programs, strategies and activities, including
preparation of special reports for the Department.
7. Coordinates the agency's communications with the Public Health
Service, DHHS, and the White House including correspondence for the
Assistant Secretary for Health and Secretarial signatures.
Office of Legislation:
1. Advises and assists the Commissioner and other key agency
officials concerning legislative needs, pending legislation and
oversight activities that affect FDA.
2. Serves as the focal point for overall legislative liaison
activities within FDA and between FDA, the Department, PHS and other
agencies; and analyzes the legislative needs of FDA and drafts or
develops legislative proposals, position papers, and departmental
reports on proposed legislation for approval by the Commissioner.
3. Advises and assists members of Congress and congressional
committees and staffs in consultation with the Office of the Secretary
on agency actions, policies, and issues related to legislation which
may affect FDA.
Office of Policy, Planning and Budget:
1. Plans, organizes, and carries out annual and multi-year
budgeting in support of FDA's public health mission and programs.
2. Produces three major budget submissions a year (to Health and
Human Services (HHS) in June, Office of Management and Budget (OMB) in
September, and to Congress in January).
3. Develops and presents required background exhibits, MAX input,
and supplemental requests as necessary; coordinates graphic material
for presentations; and coordinates budgetary passback appeals at each
level.
4. Tracks Appropriation activities and bills affecting FDA through
the legislative process.
5. Responds to requests for budget information and special reports
and exhibits.
6. Reviews and analyzes potential budgetary impacts of
congressional or administrative proposals, providing expert opinion and
recommendations.
7. Clears documents leaving the agency that have budgetary impact
or resource information.
8. Tracks special initiatives and agency cross-cutting programs.
Office of Policy:
1. Leads agency wide strategic policy initiatives.
2. Advises and assists the Commissioner and other key agency
officials on matters relating to agency policy, and on regulations and
guidance development.
3. Serves as the lead agency focal point for developing broad
agency policy.
4. Provides strategic policy direction and develops innovative
policies for FDA to more effectively and efficiently protect and
promote public health.
5. Develops significant and cross-cutting policy and engages in
strategic problem solving.
6. Oversees, directs, and coordinates the agency's rulemaking and
guidance development activities.
7. Serves as the agency focal point for communications and policies
with regard to development of regulations and guidance.
8. Initiates new and more efficient systems and procedures to
accomplish agency goals in the rulemaking and guidance development
processes.
9. Reviews agency policy documents to ensure consistency in
statements regarding agency policies.
10. Provides strategic policy direction for agency budget
formulation.
Policy Development and Coordination Staff:
1. Leads the development of cross-cutting or broad agency policies
and serves as a cross-agency think tank to develop innovative policies.
2. Advises and assists the Commissioner and other key agency
officials concerning information that may affect current or proposed
FDA policies.
3. Advises the Commissioner and other key agency officials on the
formulation of broad agency policy.
4. Engages in strategic problem solving.
[[Page 41715]]
5. Serves as agency liaison for intergovernmental policy
development.
6. Coordinates the development, review, and clearance of
regulations and guidances.
7. Manages the agency's regulation, guidance review and clearance
processes.
8. Reviews policy documents to assess and achieve consistency in
policies across documents.
9. Establishes procedures for agency policy formulation and
coordinates policy formulation activities throughout the agency.
10. Negotiates the resolution of policy issues involving more than
one component of the agency.
11. Coordinates the review and analysis of policies.
12. Initiates and participates in interagency discussions on agency
regulations, plans, and policies to improve coordination of Federal,
State, or local agencies on a specific regulation or in developing an
effective alternative approach.
13. Serves on agency task forces that are critical elements in the
initiation, study, and resolution of priority policy issues.
Regulations Policy and Management Staff:
1. Serves as the agency's focal point with the Department of Health
and Human Services, Office of Management and Budget, and other Federal
agencies for policies and programs concerning regulations development
and for the receipt of and response to other agency comments on FDA
policy documents.
2. Reviews proposed regulations, final regulations, and other
agency documents to be published in the Federal Register. Ensures
regulations are necessary; consistent with established agency policy;
clearly written; enforceable; coordinated with other agency components,
the Office of the Chief Counsel, and Federal, State, and local
government agencies; appropriately responsive to public participation
requirements and applicable executive orders; and responsive to any
applicable requirements for assessment of economic and environmental
effects.
3. Coordinates, with other agency components, the evaluation of
existing regulations to determine whether they are efficiently and/or
effectively accomplishing their intended purpose. Identifies and makes
recommendations to address regulations that require revision to
correspond with current standards and those that should be revoked due
to obsolescence.
4. Resolves regulatory policy disagreements between agency
components during the preparation of Federal Register documents.
Regulations Editorial Section:
1. Serves as FDA's official liaison within the Office of the
Federal Register. Edits, processes, and prepares finished manuscript
material for the issuance of agency proposed and final regulations and
other documents published in the Federal Register.
2. Provides all Federal Register document development support
functions (including cross-referencing, record retention, incorporation
by reference, document tracking, and agency master print books of
current Code of Federal Regulations (CFR) materials. Controls numbering
and organization of agency codified material to ensure proper structure
of regulations being issued.
Office of Planning:
1. Leads agency-wide strategic planning initiatives.
2. Advises and assists the Commissioner and other key agency
officials concerning the performance of the FDA planning, evaluation
and economic analysis activities.
3. Develops program and planning strategy through analysis and
evaluation of issues affecting policies and program performance.
4. Develops, installs, and monitors the agency wide planning system
including the long-term plans, strategic action plans, functional and
business bioinformatics plans.
5. Leads the FDA Strategic Planning Council.
6. Consults with and supports the agency preparation of legislative
proposals, proposed rulemaking, and technical assistance to Congress.
7. Conducts operations research, economic, and special studies as a
basis for forecasting trends, needs, and major problems requiring
solutions, and provides assistance and consultation in these areas to
operating units.
8. Evaluates impact of external factors on FDA programs, including
industry economics, consumer expectations, and prospective legislation.
As necessary, recommends new programs or changes in existing programs
and program priorities.
9. Develops FDA evaluation programs and systems to evaluate overall
FDA program accomplishments against objectives and priorities,
recommending changes as necessary.
10. Estimates marginal impact of funding changes on FDA performance
and ability to protect public health.
11. Leads effort to analyze agency business processes for process
modernization and bioinformatics support.
12. Acts as FDA liaison to HHS and other Federal activities under
the Office of the National Coordinator for Health Information
Technology.
13. Leads and coordinates agency-wide effort to plan, evaluate and
improve FDA risk communication.
14. Leads and coordinates the Prescription Drug User Fee Act
program initiative for Performance Management and quality systems
studies.
Planning Staff:
1. Performs and coordinates the following agency's performance
planning functions:
Represents the HHS in and OMB performance planning activities.
Coordinates and reports the agency's performance planning and
achievements in accordance with the Government Performance and Results
Act.
Consults with the Office of Budget Formulation and collaborates
with agency components in preparing and reporting the performance
sections of the agency's budget.
Coordinates the agency long range strategic and performance
planning in line with the HHS strategic plan.
Maintains, analyzes and reports agency-wide performance information
and achievements to external stakeholders.
2. Performs and coordinates the following agency's program
performance tracking and management functions:
Coordinates the development and improvement of the agency's program
performance measures, data and goals on a continuous basis to ensure
alignment to agency's missions and objectives.
Coordinates the agency short and long range performance planning
objectives and processes.
Assists and consults with agency components in their performance
planning for data, trends, targets and achievements.
Maintains, analyzes and reports agency-wide quarterly program
performance information.
Performs and coordinates program advisory, planning, and analysis
services.
Assists agency components in analyzing and improving their planning
processes, performance objectives and goals, as requested.
Works with agency components as requested to identify and implement
internal and external best practices to improve overall performance.
Analyzes information by applying mathematical disciplines and
principles to make available data and facilitate improved decision-
making.
[[Page 41716]]
Conducts special operational analysis and planning related studies
as requested.
Conducts analysis of resource requests submitted by agency
components and develops recommendations for the Commissioner, to
fulfill agency and agency requirements.
Staffs the FDA Strategic Planning Council.
Provides operations analysis and project management support to the
agency committees and initiatives as needed.
Provides operations analysis and project management support to the
Prescription Drug User Fee program.
Evaluation Staff:
1. Prepares annual User Fee performance reports to Congress.
2. Performs agency program and policy evaluations and analytical
studies. Recommends alternative courses of action to increase
effectiveness of agency allocation of resources and to improve program
and project performance.
3. Performs analyses of significantly broad agency issues
identified in the planning process.
4. Recommends and/or implements steps to resolve these issues.
5. Develops the annual evaluation plan for the agency and
coordinates with HHS.
6. Conducts special evaluations, analytical and economic-related
studies, in support of agency policy development and in resolution of
broad agency problems.
7. Evaluates the impact of external factors on agency programs,
including consumer expectations and prospective legislation.
8. Evaluates the impact of agency operations and policies on
regulated industries and other agency constituents.
9. Provides process expertise to agency components in designing
consensus sessions with internal and external stakeholders.
10. Assists and consults with agency components on the design and
execution of key program and process re-inventions.
11. Assists and consults with agency scientific review components
to enhance transparency, consistency, accountability, and continuous
improvement of review processes.
12. Facilitates cross-organizational sharing of key program and
process improvements.
Economics Staff:
1. Performs economic analyses for use by agency officials in
decisions regarding agency policies.
2. Serves as the agency's chief resource for economic information.
3. Collects and interprets economic data relevant to the agency's
public-health mission.
4. Performs and reviews benefit-cost and cost-effectiveness
analyses of agency regulations.
5. Advises and assists the Commissioner and other key agency
officials on a day to day basis concerning economic factors relating to
current and proposed agency activities.
6. Provides economic research material for use by agency officials
in preparing testimony before congressional committees and in
developing replies to inquiries directed to the agency.
7. Conducts economic studies of FDA related industries as a basis
for forecasting trends, needs, and major problems affecting the agency.
8. Provides agency representation to Congress, OMB, HHS, and
others, as appropriate, on economic issues relating to agency
regulations and other current and proposed actions.
Risk Communication Staff:
1. Coordinates development of agency policies on risk communication
practices.
2. Coordinates agency strategic planning activities concerning risk
communications.
3. Coordinates agency research agenda for risk communication
methods.
4. Facilitates development and sharing of risk communication best
practices and standard operating procedures.
5. Conducts risk communications research on methodological and
cross-cutting issues.
6. Leads management and coordination of the FDA Risk Communication
Advisory Committee.
Business Process Planning Staff:
1. Coordinates the agency's business process planning function in
support of business process improvement and automation efforts.
2. Provides business process planning, operations analysis and
project management support to the FDA Bioinformatics Board and its
associated Business Review Boards.
3. Coordinates and maintains the strategic and performance layers
of the Enterprise Architecture, in support of the Office of Information
Management.
4. Establishes and maintains agency standards for business process
modeling.
5. Provides business process modeling, analysis, and planning
services to agency programs and initiatives as needed.
Office of Budget Formulation:
1. Plans, organizes, and carries out annual and multi-year
budgeting in support of FDA's public health mission and programs.
2. Produces three major budget submissions a year (to Health and
Human Services (HHS) in June, Office of Management and Budget (OMB) in
September, and to Congress in January).
3. Develops and presents required background exhibits, MAX input,
and supplemental requests as necessary; coordinates graphic material
for presentations; and coordinates budgetary passback appeals at each
level.
4. Tracks Appropriation activities and bills affecting FDA through
the legislative process.
5. Responds to numerous requests for budget information and special
reports and exhibits.
6. Reviews and analyzes potential budgetary impacts of
congressional or administrative proposals, providing expert opinion and
recommendations.
7. Clears documents leaving the agency that have budgetary impact
or resource information.
8. Tracks special initiatives and agency cross-cutting programs.
Office of the Counselor to the Commissioner:
1. Formulates and renders advice to the Commissioner related to
policy development, interpretation and integration that cuts across
program lines or which is not well defined.
2. Provides a leadership role in advocating for and advancing the
Commissioner's priorities.
3. Reviews recommendations for actions and reviews other materials
to ensure that all points of view and program interests are developed
for consideration and fully analyzed.
4. Provides top level leadership for the development of, and
management of emergency and crisis management policies and programs for
FDA to ensure that a structure exists for FDA to respond rapidly to an
emergency or crisis situation in which FDA-regulated products need to
be utilized or deployed.
5. Coordinates FDA participation in internal and external counter-
terrorism and emergency exercises.
6. Implements the continuity of operation plans and operation of
the emergency and the crisis operation center.
7. Coordinates agency evaluation of emergency and crisis situations
to determine appropriate internal and external referrals for further
action.
Office of Crisis Management:
1. Serves as the first responder for Food and Drug Administration
(FDA) in
[[Page 41717]]
emergency and crisis situations involving FDA regulated products or in
situations in which FDA regulated products are needed to be utilized or
deployed.
2. Assists in the development of, and will manage, emergency and
crisis management policies and programs for FDA to ensure that a
structure exists to respond rapidly to an emergency or crisis
situation.
3. Serves as agency emergency coordinator to HHS Office of the
Assistant Secretary for Preparedness and Response (OASPR) and as
liaison to HHS Secretary's Office of Security and Strategic Information
(OSSI). Provides OASPR situational awareness of all FDA-related
emergencies and ensures that FDA's emergency operations procedures are
in alignment with national and HHS procedures. Participates in OSSI
intelligence briefings and provides secure fax capability for the
agency.
4. Participates in international initiatives to ensure FDA's
capability and readiness to work with foreign counterparts in
responding to international emergencies involving or impacting FDA-
regulated products and to share information with international
counterparts during such emergencies.
5. Manages the FDA Emergency Operations Network Incident Management
System (EON IMS), a system for capturing large amounts of near real
time information about emergencies related to FDA-regulated products
for use by senior agency decision makers in assessing and managing
response activities. Provides Offices and Centers geographical
information system maps created by EON IMS's GIS mapping component for
use in strategic planning of agency emergency response activities.
6. Develops and updates agency emergency operations plans and
incident specific annexes, ensuring their alignment and compliance with
the National Response Framework and its Emergency Support Functions and
the National Incident Management System.
7. Plans and conducts agency exercises to test emergency operations
plans. Plans and coordinates FDA's participation in emergency exercises
sponsored by other Departments and agencies, including national and
international level exercises.
8. Oversees the FDA Emergency Call Center which provides after
normal-hours service for responding to public inquiries and reports
related to FDA-regulated products as well as surge capacity service for
managing increased volumes of inquiries due to an event involving an
FDA-regulated product.
9. Manages FDA's Emergency Operations Center (EOC), activating the
EOC with augmented staffing from relevant Centers and Offices to
monitor emergency situations, triage complaints and alerts, issue
mission assignments to organizational components, coordinate overall
agency response operations, and communicate with external partners
requesting technical and material support. FDA's EOC serves as the
central point of contact with the Department of Homeland Security's
National Operations Center, DHHS Secretary's Operation Center, CDC
Emergency Operations Center, USDA/FSIS Situation Room, and other
Federal EOCs as appropriate.
10. Coordinates agency evaluation of emergency responses and crisis
situations to determine appropriate internal and external referral for
further action and recommended changes in agency procedures.
11. Oversees the work of the Office of Emergency Operations.
Office of Emergency Operations:
1. Serves as the agency focal point for emergency preparedness and
response operating the 24-hour, 7-day-a-week emergency response system.
2. Provides support and assistance to Food and Drug Administration
(FDA) offices in managing the agency's response to emergency incidents
and situations involving FDA regulated products and disasters.
3. Assists in the development and coordination of the agency's
emergency preparedness and response activities.
4. Serves as the agency focal point for the review and analysis of
preliminary information about threats and hazards, and assists in the
early recognition of emergencies, outbreaks, natural disasters, and
terrorism or other criminal acts, in direct coordination with
individual headquarters and field emergency coordination units.
5. Coordinates FDA emergency activities with other Federal
agencies, State, local and foreign government officials and industry
associations.
6. Identifies and advocates emergency training needs for FDA
personnel and participates in the design, implementation, and
presentation of the training programs.
7. Provides guidance to agency emergency response staff in the use
of the Incident Command System to manage single or multi-agency
response activities.
8. Represents the agency at interagency, intra-agency, State, local
and foreign government and industry association meetings and
conferences on emergency preparedness and response.
9. Manages the National Consumer Complaint System which monitors
reports of problems with FDA-regulated products for potential
emergencies.
10. Participates in daily National Biosurveillance Integration
Center conference calls sponsored by Department of Homeland Security to
provide a secure forum for interagency information sharing for early
recognition of biological events of national concern, both natural and
man-made, to make a timely response possible.
11. Oversees and tests the agency's ability to communicate through
the Government Electronic Telecommunications Service (GETS) which
provides global telecommunications (secure voice, facsimile and data
communications) capability for organizations that perform national
security and emergency preparedness functions.
Office of Women's Health:
1. Serves as the principal advisor to the Commissioner and other
key
agency officials on scientific, ethical and policy issues relating
to women's
health.
2. Provides leadership and policy direction for the agency
regarding issues of women's health and coordinates efforts to establish
and advance a women's health agenda for the agency.
3. Monitors the inclusion of women in clinical trials and the
implementation of guidelines concerning the representation of women in
clinical trials and the completion of gender analysis.
4. Identifies and monitors the progress of crosscutting and
multidisciplinary women's health initiatives including changing needs,
areas that require study and new challenges to the health of women as
they relate to FDA's mission.
5. Serves as the agency's liaison with other agencies, industry,
and professional associations with regard to the health of women.
Office of Special Medical Programs:
1. Serves as the agency focal point for special programs that are
cross-cutting and medical in nature.
2. Manages the activities of the agency's effort to ensure that
medical products used in pediatric applications are properly overseen.
3. Oversees the implementation of the orphan products provisions of
the Federal Food, Drug and Cosmetic Act.
4. Administers and manages the Office Good Clinical Practice.
5. Provides executive leadership to the Office of Combination
Products to ensure that appropriate jurisdictional decisions are made
for the regulation of those products.
[[Page 41718]]
Office of Good Clinical Practice:
1. Advises and assists the Commissioner, and other key officials on
Good Clinical Practice (including human subject protection) issues
arising in clinical trials regulated by the FDA that have an impact on
policy, direction, and long-range goals.
2. Supports and administers FDA's Human Subject Protection (HSP)/
Bioresearch Monitoring (BIMO) Council that manages and sets agency
policy on Good Laboratory Practices, Bioresearch Monitoring, and Good
Clinical Practices.
3. Represents the agency to other government agencies, State and
local governments, industry, academia, consumer organizations,
Congress, national and international organizations, and the scientific
community on Good Clinical Practice policy issues.
4. Provides leadership and direction on human subject protection
and Good Clinical Practice matters and stimulates the application of
these principles in the FDA.
5. Evaluates the adequacy of Good Clinical Practice resources
available to the agency and initiates action as appropriate.
6. Coordinates agency policies related to the protection of human
subjects in research, including institutional review and ethical
considerations.
7. Plans training programs for external use and for FDA staff on
the agency's Good Clinical Practice policies.
8. Coordinates and provides oversight of Good Clinical Practice
policy working groups developed on the recommendation of the agency
HSP/BIMO Council.
9. Fosters the science of bioresearch monitoring within the Centers
and the Office of Regulatory Affairs and coordinates for the Office of
the Commissioner.
10. Serves as the agency coordinating point for Good Clinical
Practice regulation, harmonization, and outreach activities.
11. Serves as liaison between the agency's HSP/BIMO Council and the
agency's Management Council.
12. Coordinates and assists in implementation of regulations,
policies, operational initiatives, and program priorities related to
clinical bioresearch monitoring as developed by the HSP/BIMO Council.
13. Monitors agency activities and leads the development of a
quality assurance and quality improvement program to ensure uniform
application of clinical bioresearch monitoring policies across the
agency.
14. Serves as a liaison with other Federal agencies and outside
organizations, the regulated industry, and public interest groups on
clinical bioresearch monitoring policy and regulatory matters.
Office of Combination Products:
1. Serves as the agency focal point for combination products (i.e.,
drug-device, drug-biologic, device-biologic or drug-biologic-device
products).
2. Serves as the agency Product Jurisdiction Office and administers
21 CFR Part 3. (Assigns agency centers with primary jurisdiction for
combination products.)
3. Advises the Commissioner and other key agency officials on
policy formulation, execution, cross-cutting and precedent setting
issues involving combination products.
4. Develops regulations, guidances, policies, procedures, and
processes to facilitate the agency's regulation, review, and oversight
of combination products.
5. Reviews and updates agreements, guidance or practices specific
to assignment of combination products. Prepares reports to Congress on
the activities and impact of the Office.
6. Serves as the focal point for employees and stakeholders to
resolve issues arising during assignment, premarket review or
postmarket regulation of combination products.
7. Ensures timely and effective premarket review by overseeing the
timeliness of and coordinating reviews involving more than one agency
center.
8. Ensures consistency and appropriateness of postmarket regulation
of combination products.
9. Resolves disputes presented regarding the timeliness of the
premarket review of a combination product.
10. Advises the Chief Scientist on disputes presented regarding the
substance of the premarket review of a combination product.
11. Makes determinations as to whether an individual component
product will be regulated as a human drug, human biologic, or human
medical device.
Office of Orphan Products Development
1. Manages the implementation of the provisions of the Orphan Drug
Act and its amendments and manages a program to encourage the
development of drugs of limited commercial value for use in rare or
common diseases and conditions.
2. Develops and communicates agency policy and makes decisions on
approval of sponsor requests and incentives under the Federal Food,
Drug, and Cosmetic Act, including orphan drug protocol assistance per
section 525, orphan drug designation per section 526, orphan drug
exclusivity per section 527, orphan drug grants and contracts to
support clinical research and other areas of agency policy related to
the development of products for rare disorders.
3. Represents the Commissioner or serves as the agency's principal
authority and spokesperson to the PHS Orphan Products Board, other
governmental committees and industry, professional, and consumer
associations, requesting agency participation in orphan product
development activities.
4. Reviews investigational new drug and biologics applications and
investigational device exemptions to locate the existence of products
under investigational study that show evidence of effectiveness for
rare or common diseases but lack commercial sponsorship. Assists
sponsors, researchers, and investigators in communicating with agency
regulatory officials and expediting solutions to problems in obtaining
investigational or market approval status.
5. Manages an extramural program of clinical research to evaluate
safety and effectiveness of orphan products by funding grants and
contracts, requesting applications for funding, organizing peer review
of applications, monitoring and guiding investigators, and evaluating
study results.
Office of Pediatric Therapeutics:
1. Coordinates and facilitates all activities of the Food and Drug
Administration that may have any effect on the population, the practice
of pediatrics, or may in any way involve pediatric issues.
2. Coordinates the review of and communicates internally and
externally any report of an adverse event of a drug which received
pediatric exclusivity.
3. Provides for the review of adverse event reports and other new
safety information and obtains recommendations whether FDA should take
action.
4. Coordinates with all Department of Health and Human Service and
FDA employees who exercise responsibilities relating to pediatric
therapeutics.
5. Serves as the FDA focal point for all issues involving ethics
with respect to the pediatric populations.
6. Coordinates with the Office of International Programs while
serving as the agency focal point for international pediatric
activities.
Office of External Affairs:
1. Advises the Commissioner, Deputy Commissioners and other key
agency
[[Page 41719]]
officials on FDA's communications to the media, Congress, and the
general public on issues that affect agency-wide programs, projects,
strategies, partnerships and initiatives.
2. Advises and assists the Commissioner and other key officials on
all public information programs; acts as the focal point for
disseminating news on FDA activities and as a liaison with the Public
Health Service and the Department on public information programs.
3. Advises the Commissioner, Deputy Commissioners and other senior
staff throughout FDA on sensitive and controversial programs and
initiatives that impact external stakeholder groups.
4. Serves as an information resource to FDA and provides advice to
the Commissioner and other key agency officials on matters related to
serious and life-threatening diseases; patient advocacy, and health
professional organizations; minority health and other special health
issues.
Office of External Relations:
1. Advises the Commissioner, Deputy Commissioners and other key
agency officials on agency-level activities and issues that affect
agency wide programs, projects, strategies, partnerships, and
initiatives.
2. Advises the Commissioner, Deputy Commissioners and senior staff
throughout FDA on sensitive and controversial programs and initiatives
that impact external stakeholder groups.
3. Coordinates activities involving emergency or crises situations
and resolves complex problems and issues related to agency programs
that are sensitive and controversial which impact upon agency relations
with other Federal agencies and foreign governments.
4. Oversees and directs the agency's ombudsman and editorial
functions to ensure coherence in decision making and the efficient
operation of these functions internally and across agency
jurisdictions.
5. Provides leadership and direction to assure the efficient and
effective planning, performance and evaluation of oversight activities.
6. Provides direction, coordination and oversight of the agency's
consumer activities and serves as the agency's focal point for national
consumer groups.
7. Advises the Commissioner, Deputy Commissioners and senior staff
throughout FDA on sensitive and controversial programs and initiatives
that impact external stakeholder groups.
8. Serves as the agency's focal point to provide direction,
coordination and oversight of the agency's stakeholder relations with
national consumer groups, patient advocacy organizations, health
professionals, academia, trade associations, ethnic and minority
groups, and Tribes.
9. Coordinates speaker requests for industry programs that cover
multi-center issues; identifies potential conflict of interest speaker
requests.
10. Assists in the programmatic design, development and planning
with internal and external organizations regarding educational and
informational activities intended to educate regulated industry.
Communications Staff:
1. Identifies consumer communication and educational requirements
for the agency and creates, implements, and coordinates appropriate
programs conducted through the media, agency public affairs
specialists, and other communication sources.
2. Plans, designs, produces, publishes, and disseminates
audiovisual materials, exhibits, posters, publications, and
periodicals, including FDA Consumer; participates in the planning and
development of all publications and audiovisual aspects of
communications programs directed at mass audiences.
3. Provides centralized agency graphic arts and editorial services
for public information materials.
4. Acts as the agency's public information liaison with the
Department for all publications and audiovisual needs; provides
prepublication clearance of publications, exhibits, and audiovisual
materials in accordance with procedures established by the agency, PHS,
the Department, OMB, and the White House.
Office of Public Affairs:
1. Advises and assists the Commissioner and other key officials on
all public information programs; acts as the focal point for
disseminating news on FDA activities and as a liaison with the Public
Health Service and the Department on public information programs.
2. Plans, develops, implements, and monitors policy and programs on
agency media relations, and consumer information and education programs
conducted through the media, FDA's public affairs specialists, and
other communications sources.
3. Plans, develops, produces, and publishes agency publications and
graphic arts materials.
4. Executes Freedom of Information denial authority for the agency.
5. Directs the effective utilization of all management resources by
coordinating the management, facilities, budget, and equipment
resources for the Office of Public Affairs.
6. Reviews organizational, management, and administrative policies
of the Office to appraise the efficiency and effectiveness of
operations.
7. Identifies potential management problems and/or needs and plans,
develops and conducts management studies.
8. Coordinates speaker requests for industry programs that cover
multi-center issues; identifies potential conflict of interest speaker
requests.
9. Assists in the programmatic design, development, and planning
with internal and external organizations regarding educational and
informational activities intended to educate regulated industry.
10. Advises and assists top level agency officials on electronic
media matters involving mass media communications.
11. Plans, develops, and implements agency wide broadcast media
strategies for disseminating regulatory and educational materials to
the public through the mass media.
12. Serves as the agency focal point for preparing, clearing and
disseminating electronic media requests representing agency policy and
responding to electronic media inquiries; maintains liaison with
broadcast media contacts.
13. Establishes policy for and coordinates all broadcast media
information activities, including on-camera interviews and responses to
media inquiries; prepares position and policy statements for use by
agency employees in responding to broadcast media questions; tracks
issues of potential interest to the media.
14. Plans and coordinates all broadcast media training for the
agency.
Print Media Staff:
1. Advises and assists top level agency officials on printed press
matters involving mass media communications.
2. Plans, develops, and implements agency wide print media
strategies for disseminating regulatory and educational material to the
public through the mass media.
3. Serves as the agency focal point for preparing, clearing, and
disseminating press releases and other print media statements
representing agency policy and responding to media inquiries; maintains
liaison with news media and pertinent publications.
4. Establishes policy for and coordinates all print media
information activities, including news interviews and responses to
inquiries; prepares position and policy statements for use
[[Page 41720]]
by agency employees in responding to print media questions; tracks
issues of potential interest to the media.
5. Coordinates the research and drafting of major public statements
by the Commissioner including transmittal documents and supportive
statements for use in transactions with the Department, other agencies,
and the White House; provides editorial consultation and review for
manuscripts, articles, and speeches written by the staff offices
serving the Commissioner to ensure consistency of information and
policy interpretation.
6. Compiles, publishes, and distributes the weekly FDA Enforcement
Report and the FDA Public Calendar; maintains the FDA Daily Clipping
Service; and coordinates the Daily Media Report.
Web Site Management Staff:
1. Responsible for the content and design of the FDA Web site
(www.fda.gov). Develops and interprets the agency's Web policies, and
serves as advocates for FDA's Web presence and catalysts for creative
use of the Web by the agency.
2. Works closely, as partners, with the FDA Office of Information
Resources Management (OIRM), which is responsible for the technical
operations of FDA's Web site.
3. Works closely with the Web site contacts in each of the Centers
and principal offices within the Office of the Commissioner (OC) to
plan, coordinate, execute and evaluate the agency's Web site
operations.
4. Serves as the focal point and contact with the agency,
Department, and other Federal Government Web site programs and
operations.
5. Provides direction, strategic planning assistance, and
management coordination on agency Web site programs.
6. Establishes, manages, and monitors the implementation of agency
standards and policies for information published on agency Web sites.
7. Provides Web-related information management strategy input
through a collaborative effort with OIRM and the Web site operations
staffs in the centers and OC.
8. Designs, develops, implements, monitors, and manages information
published on the agency's Web site.
9. Delivers the agency's messages to the public through the
agency's Web site.
10. Provides Web-related electronic information dissemination
services to the agency and the public.
Office of Special Health Issues:
1. Serves as an information resource to FDA and provides advice to
the Commissioner and other key agency officials on matters related to
serious and life-threatening diseases; patient advocacy, and health
professional organizations; minority health and other special health
issues.
2. Coordinates interactions between FDA and health professional
organizations and patient advocacy groups dealing with serious and
life-threatening diseases and other special health issues.
3. Serves as a focal point to coordinate contacts between FDA and
other Federal agencies to ensure effective coordination and
communication on serious and life-threatening diseases and other
special health issues.
4. Provides internal coordination on FDA activities related to
serious and life-threatening diseases, patient advocacy and health
professional organizations, and other special health issues.
5. Assists in the planning, administration, development, and
evaluation of FDA policies related to serious and life-threatening
diseases, patient advocacy and health professional organizations, and
other special health issues.
Medwatch Staff:
1. Coordinates and implements policies and initiatives relating to
human medical product adverse events, including the MedWatch Partners
Program, the MedWatch Web site, and the MedWatch e-list.
2. Conducts outreach and education to health professionals,
patients and the public to facilitate the reporting of serious harm and
injury associated with the use of human medical products.
3. Reviews, updates, and disseminates medical product safety alerts
and safety labeling changes.
Office of Foods:
1. Provides executive leadership and management to all FDA food-
related programs.
2. Exercises, on behalf of the Commissioner, direct line authority
over the Center for Food Safety and Applied Nutrition and the Center
for Veterinary Medicine.
3. Exercises, on behalf of the Commissioner, all food-related legal
authorities that the Commissioner is empowered to exercise under the
Federal Food, Drug, and Cosmetic Act, as amended, the Public Health
Service Act, and other applicable laws.
4. Directs efforts to integrate the programs of CFSAN, CVM, and the
Office of Regulatory Affairs (ORA) and thereby ensure the optimal use
of all available FDA resources and tools to improve the safety,
nutritional quality and proper labeling of the food supply.
5. Directs the development of integrated strategies, plans,
policies, and budgets to build FDA's food-related scientific and
regulatory capacities and programs, including recruitment and training
of key personnel and development of information systems.
6. Represents FDA on food-related matters in dealings with the
Office of the Secretary of HHS, the Centers for Disease Control and
Prevention, the U.S. Department of Agriculture, the White House and
other elements of the executive branch.
7. Represents FDA on food-related matters in dealings with
Congress.
8. Represents FDA on food-related matters in dealings with foreign
governments and international organizations.
9. Directs FDA efforts to build an integrated national food safety
system in collaboration with other Federal agencies and State and local
governments.
10. Directs a program of public outreach and communications on food
safety, nutrition, and other food-related issues to advance FDA's
public health and consumer protection goals.
Office of the Chief Scientist:
1. Provides strategic leadership, innovation and expertise to
enhance and support scientific excellence, integrity and capacity to
achieve the Food and Drug Administration's public heath mission. Key
activities include:
Fostering development and use of innovative technologies to meet
public health needs, including through its Office of Science and
Innovation, the Critical Path Initiative and cross-Center working
groups.
Supporting scientific excellence and the professional development
of FDA scientists in all areas (i.e. population/statistical, review,
laboratory and manufacturing sciences), including through the
Commissioner's Fellowship Program, continuing education, and through
relationships and staff exchanges with Universities and others.
Providing strategic leadership and support for high quality,
collaborative, peer-reviewed scientific activities at FDA that advance
regulatory science and address important public health and regulatory
issues concerning FDA regulated products, including their evaluation,
quality, safety and effectiveness. This includes support for the
National Center for Toxicological Research to serve as a national FDA
resource for mission driven regulatory science.
Supporting scientific outreach, training, collaboration in
research, development and Critical Path activities that advance FDA's
mission, with other
[[Page 41721]]
Federal agencies, global regulatory partners, academia (e.g., through
planned Centers of Excellence in Regulatory Science), innovators, and
consumers.
Supporting science and public health activities to effectively
anticipate and respond to emerging deliberate and natural threats to
U.S. and global health and security including through the Office of
Counterterrorism and Emerging Threats and a planned Center for
Innovation in Medicine and Public Health.
Providing core scientific leadership and technical expertise, and
ensuring agency capacity, for advanced bioinformatics activities needed
to support FDA programs (e.g. scientific computing to allow analysis of
large health care and safety datasets, genomic and other complex
laboratory data, and simulation and modeling) . Serve as an agency and
government resource for excellence, methods development, outreach and
partnerships in advanced bioinformatics science.
Leading agency efforts to protect and enhance scientific integrity,
and, where substantive scientific differences of opinion arise and
require review at the FDA level, addressing them through appropriate
processes intended to protect both FDA's mission and the integrity of
its science.
Office of Counter-Terrorism and Emerging Threats:
1. Develops and implements a comprehensive counterterrorism
strategy for FDA to identify and address gaps in current efforts to
safeguard food and medical products from adulteration or disruption of
supplies due to terrorist activities.
2. Develops and coordinates the implementation of crosscutting
policies to facilitate the availability of safe and effective medical
countermeasures against chemical, biological, radiological, and nuclear
agents of concern.
3. Provides policy leadership for FDA's Emergency Use Authorization
(EUA) activities for terrorism and public health emergencies, including
emerging threats.
4. Develops and implements, in collaboration with the Centers and
Offices and with external partners, comprehensive FDA plans and
strategies for pandemic influenza preparedness and other emerging
threats.
5. Provides policy leadership by promoting the goals and needs for
counterterrorism and other emerging threats in the agency budgeting and
priority-setting processes.
6. Coordinates the portfolio of FDA counterterrorism and pandemic
influenza policy and planning initiatives and serves as the point of
entry to the agency on counter-terrorism and emerging threats policy
and planning matters.
7. On behalf of the Office of the Commissioner, facilitates intra-
and inter-agency communications on counterterrorism policy and pandemic
influenza preparedness.
Office of Critical Path Programs:
1. Serves as the focus for cross-center scientific and medical
initiatives and policy development related to the Critical Path (CP)
initiative and related activities in the Office of the Commissioner.
2. Assists the Chief Scientist in planning, executing, and
monitoring projects, including, CP-related cross-center and interagency
projects and collaborations with other agencies, academia, and industry
as identified by the Office of the Commissioner and the Department of
Health and Human Services.
3. Serves as the focus for cross center bioinformatics activities,
including data management and analysis. Supports agency Bioinformatics
Board and Data Councils.
4. Performs project development, project management, policy and
document development and clearance, and related tasks as directed by
the Chief Scientist.
5. Coordinates related administrative activities (e.g., personnel,
communication, staffing, purchasing, and CP-related travel).
Office of Scientific Integrity:
1. Helps ensure consistent understanding, application and
implementation of regulatory standards throughout FDA to ensure
integrity and accountability of FDA functions and processes.
2. Provides advice and guidance to the Commissioner, Chief
Scientist, and other key officials regarding premarket approval
processes for all FDA-regulated products including requirements
pertaining to applications, petitions, amendments and supplements; and
product, processing, packaging and emerging product technologies.
3. Advises and assists senior FDA leadership in coordinating
responses to allegations of patterns of deviations by FDA or its
components from appropriate standards of conduct and performance. Also
advises and assists senior FDA leadership in preventing such
deviations.
4. Investigates and resolves informal complaints and disagreements,
whether generated internally or externally, with respect to the
administrative processing of various applications for products
regulated by the agency as well as regarding the fair and even-handed
application of agency policy and procedures in this process.
5. Processes all formal appeals, or requests for review, that are
submitted to the Office of the Commissioner, whether generated
internally or externally, including requests for hearings, appeals from
administrative actions, and requests to review decisions at a lower
level of the agency. Examples include, but are not limited to, requests
for hearings in debarment and disqualification proceedings, requests to
review decisions by the Centers, the Office of Regulatory Affairs, and
elsewhere in the Office of the Commissioner under 21 CFR 10.75, appeals
of formal or informal hearings, and agency-level scientific dispute
resolution matters.
6. Advises and assists the Chief Scientist and senior leadership in
evaluating and resolving all formal appeals, requests for review, and
requests for hearings submitted to the Office of the Commissioner and
coordinates responses to such appeals and requests.
7. Develops regulations and procedures to promote an efficient and
effective process for addressing and resolving formal appeals, requests
for review, and requests for hearings, as well as any other types of
disputes suitable for formal resolution in the Office of the
Commissioner.
8. Leads Advisory Committee Oversight and Management Staff, working
in close collaboration with all FDA Centers to provide consistency in
and continuously improve the operations of agency advisory committees.
9. Serves as the liaison between the Office of the Secretary, the
Department Committee Management Office, all of FDA's Center advisory
committee support staff, and other organizations/offices within FDA.
10. Ensures that all FDA committee management activities are
consistent with the provisions of Federal Advisory Committee Act,
departmental policies, and related regulations and statutes.
11. Coordinates with the Office of Appeals, within the Office of
Scientific Integrity, to determine whether an informal complaint should
be construed and treated as a request for formal review by the Office
of the Commissioner under established regulations or procedures.
Office of Science and Innovation:
[[Page 41722]]
1. Provides strategic leadership, coordination, infrastructure and
support for excellence and innovation in FDA science that will advance
the agency's ability to protect and promote the health of the public.
Key activities include:
Providing support for high quality, collaborative, peer-reviewed
scientific activities throughout FDA that address important public
health and regulatory issues concerning FDA regulated products,
including their evaluation, quality, safety and effectiveness.
Fostering development and use of innovative technologies to meet
public health needs, including through a planned Center for Innovation
in Medicine and Public Health and through core scientific capacity to
support FDA's regulatory functions and decision making.
Supporting excellence and the professional development of FDA
scientists in all areas (i.e. population/statistical, review,
laboratory and manufacturing sciences), including through the
Commissioner's Fellowship Program, continuing education and
professional activities (including clinical activities, cross agency
working groups, and through relationships and staff exchanges with
Universities and others.
Addressing scientific and public health priorities through support
of high quality, peer reviewed scientific research, programs and
related activities, both within and outside FDA and collaboratively,
and through dissemination of new scientific information, methods and
approaches.
Supporting scientific outreach, training, and collaboration in
research and development activities that advance FDA's mission,
including with sister agencies, global regulatory partners, academia
(e.g., through planned Centers of Excellence in Regulatory Science),
innovators, and consumers.
Seeking input from both FDA programs, stakeholders and outside
advisors, including the FDA Science Board, to help define, review and
meet FDA scientific needs and priorities to support our public health
mission.
Office of International Programs:
1. Serves as the agency focal point for all international matters.
2. Serves as the primary agency liaison with other U.S. Government
components, international and foreign governments (including
Washington, DC embassies) for policy formulation and execution
impacting FDA and FDA regulated products.
3. Provides leadership to agency program areas for international
activities.
4. Serves as the focal point for the agency and the authority for
policies and procedures pertaining to international travel.
5. Serves as the focal point and final clearing authority for all
international technical cooperation and assistance activities.
6. Serves as the agency focal point and final clearing authority
for all international programs and interactions with foreign
counterpart regulatory agencies, international organizations, foreign
embassies, all foreign officials, and with agency and all other United
States Government components when international issues are involved.
7. Directs, manages, and leads agency strategic planning, priority-
setting and resource allocation processes for agency international
programs.
8. Serves as the agency focal point and final clearing authority
f