[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Notices]
[Page 7490-7512]
[DOCID:fr19fe10-99]

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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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
reorganization of the Office of the Commissioner (OC). This
reorganization includes the organizations and their substructure
components as listed in this document. This notice was previously
published in the Federal Register of August 18, 2009, but it contained
several errors. For the convenience of the reader, the reorganization
is being published again in its entirety.

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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 18, 2009
(74 FR 41713), FDA published a notice announcing the reorganization of
the Office of the Commissioner (OC). This reorganization includes the
realignment of four Deputy-level offices within OC. They are as
follows: (1) The Office of the Chief Scientist; (2) the Office of
Administration (formerly titled the Office of Operations); (3) the
Office of Foods; and (4) the Office of Policy, Planning and Budget
(formerly titled the Office of Policy, Planning and Preparedness).
    Office of Chief of Staff: The Office of Chief of Staff will advise
and provide integrated policy analysis and strategic consultation to
the Commissioner, the Principal Deputy 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. This Office will
include the Executive Secretariat Staff. This Office will report
directly to the Commissioner.
    Office of Legislation: The Office of Legislation will be
restructured from the Office of the Chief of Staff. The Office of
Legislation will report directly to the Commissioner and have an
indirect reporting relationship to the Deputy Commissioner for Policy,
Planning and Budget.
    Office of Policy, Planning and Budget: The Office of Policy,
Planning and Budget will be retitled from the Office of Policy,
Planning and Preparedness. The Office of Policy, Planning and Budget
will be restructured to consist of the Office of Policy, the Office of
Planning and the Office of Budget (formerly the Office of Budget
Formulation and Presentation). The Office of Policy will consist of the
Policy Development and Coordination Staff, Regulations Policy and
Management Staff, and Regulations Editorial Section. The Office of
Planning will consist of the Planning Staff, Evaluation Staff, Economic
Staff, Risk Communication Staff, and Business Process Planning Staff.
The Office of Policy, Planning and Budget will report directly to the
Commissioner.
    Office of the Counselor to the Commissioner: The Office of the
Counselor to the Commissioner will be established to formulate and
render advice to the Commissioner that is related to policy
development, interpretation, and integration that cuts across program
lines or which is not well defined. This Office will include the Office
of Crisis Management. The Office of the Counselor to the Commissioner
will report directly to the Commissioner.
    Office of Women's Health: The Office of Women's Health will be
realigned from the Office of the Chief Scientist, Office of Science and
Health Coordination. The Office of Women's Health will report directly
to the Commissioner.
    Office of Special Medical Programs: The Office of Special Medical
Programs is a newly created Office within OC with functions and
substructure realigned from components of existing offices. The Office
of Special Medical Programs will consist of the following components:
Office of Pediatric Therapeutics, Office of Combination Products,
Office of Orphan Product Development, and Office of Good Clinical
Practice (formerly titled the Good Clinical Practice Program) which all
will be realigned from the Office of the Chief Scientist. The Office of
Special Medical Programs will also include the Advisory Committee
Management and Oversight Staff (formerly in the Office of Policy,
Planning, and Preparedness). This Office will report directly to the
Commissioner.
    Office of External Affairs: The Office of External Affairs will be
established to serve as a focal point for improving FDA's
communications to media, Congress, and the general public; and to also
advise the Commissioner on better internal communications within the
Agency. This Office will consist of the Office of External Relations,
the Office of Public Affairs and the Office of Special Health Issues.
This Office will report directly to the Commissioner.
    Office of Foods: The Office of Foods will be established to elevate
and empower our food safety activities. This office, led by the Deputy
Commissioner for Foods, will provide executive leadership and
management to all FDA food programs, and will be accountable

to the Commissioner for integrating the efforts of all food-related
programs in FDA, and for making optimal use of all available resources
and methods to improve the safety, nutritional quality, and labeling of
the food supply. The Office of Foods will provide executive leadership
and management to the Center for Food Safety and Applied Nutrition and
the Center for Veterinary Medicine (CVM). This Office will report
directly to the Commissioner.
    Office of the Chief Scientist: The Office of the Chief Scientist
will be restructured to facilitate the agency's focus on scientific
innovation, recruiting a new generation of scientists, better utilizing
our toxicological research center and improving our computing support
for our scientific programs. This office will be led by the Chief
Scientist. The offices within the Office of the Chief Scientist are as
follows: The Office of Counter-Terrorism and Emerging Threats, Office
of Critical Path Programs, the newly established Offices of Scientific
Integrity and Science and Innovation. Additionally, the National Center
for Toxicological Research has a direct reporting relationship to OC
and an indirect reporting relationship to the Chief Scientist.
    Office of Administration: The Office of Operations will be retitled
the Office of Administration. The Office of Administration 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 OC's executive
operations. The new substructure of the Office of Administration
consists of the Office of Acquisitions and Grants Services, the Office
of Executive Operations, establishment of the Office of Financial
Operations, the Office of Information Management and the Office of
Management. The Office of Equal Employment Opportunity and Diversity
Management will report directly to the Commissioner with a day-to-day
operational relationship to the Deputy Commissioner for Administration.
    Center for Tobacco Products: The Center for Tobacco Products will
be established to address the enactment of the Family Smoking
Prevention and Tobacco Control Act. This Office will consist of the
Office of the Center Director, Office of Management, Office of Policy,
Office of Regulations and Office of Science. This Center will report
directly to the Commissioner.
    [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 of Food and Drugs, 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, Principal Deputy and Deputy Commissioners
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 (DHHS).
    1. Is subject to the professional supervision and control of the
General Counsel, 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, Federal
Register notices and other documents prepared by FDA.
    5. Performs legal research and gives legal opinions on regulatory
issues, actions, and petitions submitted to FDA.
    6. Reviews proposed legislation affecting FDA that applies to DHHS
or on which Congress requests the views of DHHS.
    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, Principal Deputy, and 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 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, Principal Deputy,
and 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
(PHS), 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, Principal Deputy and

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, Principal Deputy
and 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.
    8. Serves as agency liaison to the Government Accountability Office
(GAO) and the DHHS Office of the Inspector General (OIG) and
coordinates agency engagement on GAO and OIG studies.
    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, DHHS, 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. Advises the Commissioner and other key agency officials on
matters relating to agency policy, regulations development, legislative
issues, budget formulation, risk communication, and planning and
evaluation activities.
    2. Provides strategic policy direction, planning, and data-driven
analysis for FDA to more effectively and efficiently protect and
promote public health.
    3. Develops significant and cross-cutting policy and engages in
strategic problem solving.
    4. Serves as FDA's focal point for the development, coordination,
oversight, and processing of regulations, guidance and other policy
documents.
    5. Conducts economic analyses, program evaluations, and special
studies.
    6. Leads overall FDA strategic, performance and business process
planning, including the development of performance measures.
    7. Leads and coordinates agency-wide efforts to plan, evaluate and
improve FDA risk communication.
    8. Leads overall FDA budget formulation and presentation.
    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.
    11. Works with the Office of Legislation to develop, coordinate and
provide technical assistance on legislative proposals.
    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.
    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 and 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 DHHS, 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. 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, and program
implementation plans.
    5. Leads the FDA Strategic Planning Council.
    6. Consults with and supports the Agency preparation of legislative
proposals, budget proposals, proposed rulemaking and technical
assistance to Congress.
    7. Conducts operations research, economic, social science 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. Coordinates the development of public health and program
outcome measures, and monitors and reports on the status of those
measures.
    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-wide performance
planning functions:
    a. Represents the Agency in DHHS and OMB performance planning
activities.
    b. Coordinates and reports the Agency's performance planning and
achievements in accordance with the Government Performance and Results
Act.
    c. Consults with the Office of Budget and collaborates with Agency
components in preparing and reporting the performance sections of the
Agency's budget.
    d. Coordinates the Agency long-range strategic and performance
planning in line with the DHHS strategic plan.
    e. Maintains, analyzes and reports Agency-wide performance
information and achievements to external stakeholders.
    2. Performs and coordinates the following Agency-wide program
performance tracking and management functions:
    a. 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.
    b. Coordinates the Agency short and long range performance planning
objectives and processes.
    c. Assists and consults with Agency components in their performance
planning for data, trends, targets and achievements.
    d. Maintains, analyzes and reports Agency-wide quarterly program
performance information.
    3. Performs and coordinates program advisory, planning, and
analysis services.
    a. Assists agency components in analyzing and improving their
planning processes, performance objectives and goals, as requested.
    b. Works with Agency components as requested to identify and
implement internal and external best practices to improve overall
performance.
    c. Analyzes information by applying mathematical disciplines and
principles to make available data and facilitate improved decision-
making.
    d. Conducts special operational analysis and planning related
studies as requested.
    e. Conducts analysis of resource requests submitted by Agency
components and develops recommendations for the Commissioner and
Principal Deputy Commissioner, to fulfill Agency, DHHS and OMB
requirements.
    4. Staffs the FDA Strategic Planning Council.
    5. Provides operations analysis and project management support to
the Agency committees and initiatives as needed.
    6. 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. Recommends and/or implements steps
to resolve these issues.
    4. Develops the annual evaluation plan for the Agency and
coordinates with DHHS.
    5. Conducts special evaluations, analytical and economic-related
studies, in support of Agency policy development and in resolution of
broad Agency problems.
    6. Evaluates the impact of external factors on Agency programs,
including consumer expectations and prospective legislation.
    7. Evaluates the impact of Agency operations and policies on
regulated industries and other Agency constituents.
    8. Provides process expertise to Agency components in designing

consensus sessions with internal and external stakeholders.
    9. Assists and consults with Agency components on the design and
execution of key program and process re-inventions.
    10. Assists and consults with Agency scientific review components
to enhance transparency, consistency, accountability, and continuous
improvement of review processes.
    11. Facilitates cross-organizational sharing of key program and
process improvements.
    Economics Staff:
    1. Performs economic analyses and special studies 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 cost-benefit 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-regulated industries as a basis
for forecasting trends, needs, and major problems affecting the Agency.
    8. Provides Agency representation to Congress, OMB, DHHS, 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.
    7. Staffs and co-leads FDA's Communications Council.
    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:
    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 DHHS in June,
Office of Management and Budget (OMB) in September, and to Congress in
February).
    3. Develops and presents required background exhibits, MAX input,
and supplemental budget requests as necessary; coordinates graphic
material for presentations; and coordinates budget passback appeals at
each level.
    4. Coordinates appropriation hearing preparation for FDA leadership
and conducts hearing follow-up related to transcripts, hearing
questions and other hearing record inserts. Tracks Appropriation
activities and bills affecting FDA resources through the legislative
process.
    5. Responds to requests for budget information and special reports
and exhibits.
    6. Reviews and analyzes potential budget impacts of congressional
or administrative proposals, providing expert opinion and
recommendations.
    7. Clears documents leaving the Agency that have budget 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 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. Provides strategic oversight of FDA's participation in internal
and external counter-terrorism and emergency exercises.
    6. Oversees the coordination of the Agency's 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 FDA in 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 and management of 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 DHHS Office of the
Assistant Secretary for Preparedness and Response (OASPR) and as
liaison to DHHS 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 DHHS procedures.
    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 (GIS) maps created by EON IMS's Geographical Mapping
System 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 (NRF) and its Emergency Support
Functions and the National Incident Management System (NIMS).
    7. Plans and conducts Agency exercises to test emergency operations
plans. Plans and coordinates FDA's participation in emergency exercises
sponsored by DHHS and other Departments and agencies, including
national and international level exercises.
    8. Develops agency training goals and initiatives to ensure that
agency emergency response staff and senior officials are informed of
the operational requirements of the NRF, NIMS, national level exercise
programs and other national emergency plans and preparedness efforts.
    9. 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.
    10. 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 Operations Center, CDC
Emergency Operations Center, USDA/FSIS Situation Room, and other
Federal EOCs as appropriate.
    11. 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.
    12. 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.
    13. 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 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. In direct coordination with individual headquarters and field
emergency coordination units, 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.
    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, intraAgency, 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. Responsible for staffing the operation of FDA's Emergency
Operations Center when activated.
    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 sex/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,
professional associations, and advocacy groups with regard to the
health of women.
    Office of Special Medical Programs:
    1. Serves as the Agency focal point for special programs and
initiatives that are cross-cutting and clinical, scientific, and/or
regulatory in nature.
    2. Provides for the coordination of internal and external review of
pediatric science, safety, ethics and international issues as mandated
by law and Agency activities.
    3. Oversees the implementation of the orphan products provisions of
the Federal Food, Drug and Cosmetic Act.
    4. Provides executive leadership to the Office of Good Clinical
Practice.
    5. Oversees the functions of the Office of Combination Products as
provided in Federal Food, Drug and Cosmetic Act.
    6. Leads Advisory Committee Oversight and Management Staff, working
in close collaboration with all FDA Centers to provide consistent
operations and seek continuous improvements in the Agency advisory
committee program.
    7. Serves as the liaison on advisory committee issues with the
Office of the Secretary, the DHHS Committee Management Office, all of
FDA's Center advisory committee support staff, and other organizations/
offices within FDA.
    8. Ensures that all FDA committee management activities are
consistent with the provisions of the Federal Advisory Committee Act,
the Federal Food, Drug, and Cosmetic Act, ethics provisions in the
criminal code, departmental policies, and related regulations and
statutes.
    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 OC.
    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 (i.e., when classification or assignment is unclear or in
dispute, classifies products as biologics, devices, drugs or
combination products and assigns them to the Agency centers with
primary jurisdiction).
    3. Advises the Commissioner and other key Agency officials on
policy formulation, execution, cross-cutting and precedent setting
issues involving combination products and involving the classification
of products as biologics, devices, drugs, or combination products.
    4. Develops regulations, guidances, policies, procedures, and
processes to facilitate classification and assignment of biologics,
devices, drugs, and combination products, and to facilitate the
Agency's regulation, review, and oversight of combination products.
    5. Reviews and updates agreements, guidance or practices specific
to classification or assignment of products as biologics, devices,
drugs or combination products.
    6. Serves as the focal point for employees and stakeholders to
resolve issues arising during assignment and premarket review of
combination products.
    7. Ensures consistency and appropriateness of postmarket regulation
of like products to the extent permitted by law and serves as the focal
point for employees and stakeholders to resolve issues relating to
postmarket regulation of such products.
    8. Ensures timely and effective premarket review of combination
products by overseeing the timeliness of Intercenter consultations and
assisting reviews involving more than one Agency Center when necessary.
    9. Prepares annual reports to Congress on the activities and impact
of the Office.
    Office of Orphan Products Development:
    1. Manages the implementation of the provisions of the Orphan Drug
Act and its amendments as well as implementation of provisions of the
statute related to humanitarian devices and pediatric devices 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 governmental committees, industry,
foreign regulatory bodies, professional organizations, patient
advocates, 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 promise for 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 and consortia
programs 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 FDA that may
have any effect on the population, the practice of pediatrics, or may
in any way involve pediatric issues.
    2. Coordinates and communicates the review of pediatric adverse
event reports for drugs, biologics and devices during the one-year
period after the date of a labeling change.
    3. Provides for the review of adverse event reports and other new
safety information and obtains recommendations from sources such as the
Pediatric Advisory Committee (PAC) regarding whether FDA should take
action. Additionally, OPT coordinates action by the PAC for dispute
resolution of pediatric safety labeling changes that are not agreed
upon by the sponsor and the Commissioner not later than 90 days after
referral
    4. Coordinates with all DHHS and FDA employees who exercise
responsibilities relating to pediatric therapeutics.
    5. Serves as the FDA focal point for all issues involving ethics
and science 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 and other key agency 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 DHHS 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 a liaison between FDA and health professional and
patient advocacy, organizations to solve problems and address concerns
these groups have with Agency policies and programs related to human
medical product development and safety.
    5. Coordinates and implements policies, programs and initiatives
related to MedWatch, including the MedWatch website and e-list.
    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 affect external stakeholder groups.
    3. Oversees and directs the Agency's stakeholder-related
communication functions to ensure coherence in decision making and the
efficient operation of these functions internally and across Agency
jurisdiction.
    4. Serves as the Agency's focal point to provide direction,
coordination and oversight of the Agency's consumer activities and
serves as the Agency's focal point for national consumer groups,
academia, trade associations, ethnic and minority groups, and Tribes.
    5. Coordinates speaker requests for industry programs that cover
multi-center issues; identifies potential conflict of interest speaker
requests.
    6. 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. Serves as the Agency's focal point for consumer health
communications activities. As such, manages the consumer health
information section of the FDA Web site, www.fda.gov.
    2. Creates and disseminates FDA consumer health information, which
includes timely and easy-to-read articles, videos and photo slide shows
containing the latest on all FDA-regulated products and practical
wellness and prevention information to empower consumers.
    3. Works closely with FDA centers and offices on developing
effective consumer health communications strategies and programs.
    4. Establishes and maintains partnerships with external
organizations and conducts other activities to increase the reach of
FDA consumer health information.
    5. Acts as the Agency's public information liaison with DHHS for
all publications and audiovisual needs; provides prepublication
clearance of publications, exhibits, and audiovisual materials in
accordance with procedures established by the Agency, PHS, DHHS, OMB,
and the White House.
    Office of Public Affairs:
    1. Advises and assists the Commissioner and other key officials on
all media information activities; serves as a liaison with the Public
Health Service and DHHS on media information activities.
    2. Serves as the Agency focal point for preparing, clearing, and
disseminating press releases and other media statements representing
Agency policy and responding to media inquiries; maintains liaison with
news media.
    3. Establishes policy for and coordinates all media information
activities, including media requests, news interviews and responses to
inquiries; prepares position and policy statements for use by Agency
employees in responding to media questions; tracks issues of potential
interest to the media.
    4. 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.
    5. Delegates Freedom of Information (FOI) denial authority to FOI
office for the Agency.
    6. Directs the effective use of all management resources by
coordinating the management, facilities, budget, and equipment
resources for the Office of Public Affairs.
    7. Reviews organizational, management, and administrative policies
of the Office to appraise the efficiency and effectiveness of
operations.
    8. Identifies potential management problems and/or needs and plans.
    9. Advises and assists top level Agency officials on all media
matters involving media communications.
    10. Plans, develops, and implements Agency wide multi-media
strategies for disseminating regulatory and educational materials to
the public through the media.
    11. Plans and coordinates all multi-media training for the Agency.
    12. Compiles and publishes to the FDA Web site the weekly FDA
Enforcement Report; maintains the FDA Daily Clipping Service; and
distributes the Daily Media Report to DHHS.
    Web Communication Staff:
    1. Responsible for directing the design, content management,
usability, and evaluation of the FDA Website (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
Management (OIM), which is responsible for the technical operations of
FDA's Web site.
    3. Serves as the focal point and contact with the Agency, DHHS, and
other Federal Government Web site programs and operations.
    4. Provides direction, strategic planning assistance, and
management coordination on Agency Web site programs.
    5. Works closely with the Web site contacts in each of the Centers
and principal offices within OC to plan, coordinate, execute and
evaluate the Agency's Web site operations.
    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 OIM and the Web site communications
and operations staffs in the centers and OC.
    8. Designs, develops, implements, monitors, and manages information
published on the Agency's Web site and external digital assets.
    9. Delivers the Agency's messages to the public via the Agency's
Web site and strategic online partnerships in the government, private,
and non-profit sectors.
    10. Directs Web 2.0 and social media services for the Agency and to
the public.
    Office of Special Health Issues:
    1. Advises the Commissioner and other key FDA officials on matters
related patient, patient advocacy, and health professional issues and
concerns; serious and life-threatening diseases; minority health; and
other special health issues

    2. Serves as a liaison between FDA and health professional and
patient advocacy organizations to solve problems and address concerns
these groups have with Agency policies and programs related to human
medical product development and safety.
    3. Assists in the planning, administration, development, and
evaluation of FDA policies related to patient advocacy and health
professional organizations, serious and life-threatening diseases, and
other special health issues
    4. Provides internal coordination on FDA activities related to
patient advocacy and health professional organizations, serious and
life-threatening diseases, and other special health issues.
    5. Serves as a focal point to coordinate contacts and activities
between FDA and other Federal agencies to ensure effective coordination
and communication regarding issues related to serious and life-
threatening diseases and other special health issues.
    6. Coordinates and implements policies, programs, and initiatives
related to MedWatch including the MedWatch web site, and the MedWatch
e-list.
    7. 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.
    8. Prepares, reviews, updates, and disseminates medical product
safety alerts and periodic safety labeling change summaries to
patients, patient advocates, and health professionals.
    9. Informs patients, patient advocates and health professional
organizations of upcoming public meetings, policy issues, and proposed
rules, so that they are aware of important issues and informed of
opportunities to comment.
    10. Assures that patient points of view are given a voice in drug
development and policy issues that affect patient communities, through
the patient representative and patient consultant programs.
    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 (CFSAN) and the
Center for Veterinary Medicine (CVM).
    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 DHHS, 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. In conjunction with the Office of International Programs,
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:
    Provides strategic leadership, coordination, and expertise to
support scientific excellence, innovation and capacity to achieve FDA's
public health mission. Key activities include:
    1. Fostering development and use of innovative technologies to meet
public health needs.
    2. 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 scientific interactions with universities and others.
    3. Providing strategic leadership and support for high quality,
collaborative, scientific activities that advance regulatory science
and address important public health issues concerning FDA-regulated
products, including their evaluation, quality, safety and
effectiveness.
    4. Providing support and guidance for the National Center for
Toxicological Research to serve as a national FDA resource for mission
driven regulatory science.
    5. Providing cross-Agency scientific coordination (e.g., for
emerging technologies, scientific issues involving multiple Agency
components, standards coordination, the FDA Science Board, and science
communication).
    6. Supporting scientific outreach, training, and collaboration,
including research, development and Critical Path activities that
engage other Agencies, global regulatory partners, academia,
innovators, and consumers.
    7. Supporting science and public health activities to effectively
anticipate and respond to counter-terrorism and emerging deliberate and
natural threats (e.g. chemical, biological, radiological and nuclear)
to U.S. and global health and security including through the Office of
Counter-terrorism and Emerging Threats.
    8. Providing core scientific leadership and technical expertise,
and ensuring Agency capacity, for advanced bioinformatics activities
needed to support FDA programs. Serve as an Agency and government
resource for excellence, methods development, outreach and partnerships
in advanced bioinformatics science.
    9. 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 counter-terrorism
strategy for FDA to identify and address gaps in current efforts to
safeguard 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 coordinates the implementation of comprehensive FDA
plans and strategies for pandemic influenza preparedness and other
emerging threats, in collaboration with the Centers and Offices and
with external partners.

    5. Provides policy leadership by promoting the goals and needs for
counter-terrorism and other emerging threats in the Agency budgeting
and priority-setting processes.
    6. Coordinates the portfolio of FDA counter-terrorism 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 interAgency communications on counter-terrorism policy and pandemic
influenza preparedness.
    Office of Critical Path Programs:
    1. Serves as the nexus for cutting-edge, cross-center scientific
and medical initiatives as well as policy development related to the
Critical Path (CP) initiative and CP-related activities in the Office
of the Commissioner.
    2. Assists the Chief Scientist in planning, executing, and
monitoring CP-related projects, including other agencies, academia, and
industry as identified by the Office of the Commissioner and DHHS.
    3. Performs project development, project management, and tracking,
policy and document development and clearance, and related tasks as
directed by the Chief Scientist.
    4. Manages Critical Path-related internal and external outreach
(e.g., presentations, reports, videos (DVDs), pod casts, brochures,
editorials, PR (public relations), Press kits, CPI (Critical Path
Initiatives) Web site updates, FDA intranet) across all communications
platforms.
    5. Supports cross-center bioinformatics activities, including
activities related to data management and analysis and safety
surveillance of FDA-regulated products. Supports Agency Bioinformatics
Board and Data Councils.
    6. Coordinates administrative activities with CP (e.g., personnel,
staffing, purchasing, and 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 facilitates resolution of 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
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. Determines 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.
    9. Oversees and directs the Agency's ombudsman and appeals to
ensure coherence in decision making and the efficient operation of
these functions internally and across Agency.
    Office of Science and Innovation:
    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:
    1. Supporting high quality, collaborative scientific activities to
address important public health and regulatory issues concerning FDA-
regulated products, including their evaluation, quality, safety and
effectiveness.
    2. Supporting core scientific capacity and infrastructure.
    3. Fostering development and use of innovative technologies in
product development and evaluation.
    4. 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 center
working groups, and other activities), and through scientific exchanges
and interactions with universities and others.
    5. 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.
    6. Supporting scientific outreach, training, and collaboration in
research and development activities that advance FDA's mission, that
engage other agencies, global regulatory partners, academia,
innovators, and consumers.
    7. 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 leader and focal point for all
international matters.
    2. Serves as the primary Agency liaison with other U.S. Government
components (involved in international issues), international
multinational organizations 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 final clearing
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 (including meetings at
FDA or abroad) with foreign counterpart regulatory agencies,
international organizations, foreign embassies, all foreign officials,
and with DHHS and all other U.S. Government components when
international issues are involved.
    7. Directs, manages, and leads Agency strategic planning, priority-
setting and resource allocation processes for FDA 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 and is the Agency final
clearing authority on policies and procedures for sharing public and
non-public information with international counterpart agencies, 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. 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.
    2. Advises and assists the Commissioner, Principal Deputy
Commissioner, Deputy Commissioners, and other key officials on various
administrative management and business activities of the Agency.
    3. Chairs all Agency user fee programs which oversees financial
management and provides financial management support.
    4. Assures that the conduct of Agency administrative and financial
management activities, including budget, finance, acquisitions,
information technology, human resources, organization, methods, and
similar support activities, effectively support program operations
Utilizes a call center to address all administrative and information
technology management issues, and monitors and analyzes operational
performance and customer satisfaction.
    5. 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.
    6. Provides leadership and direction regarding all aspects of a
variety of Agency management programs including organization
management, OIG Liaison, delegations of authority, freedom of
information, privacy act, and regulatory dockets management as well as
programs related to ethics and conflict of interest matters.
    7. Advises the Commissioner and other key Agency officials on
administrative management and budget matters for components within the
OC. Provides advice and guidance with regard to formulation and
development of administrative management policies, procedures, and
controls.
    8. 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 compliance 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.
    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
grievance processes.
    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.
    Office of Acquisitions and Grants Services:
    1. Provides management direction and leadership for acquisitions,
grants, cooperative agreements, technology transfers, and interAgency
agreements.
    2. Provides administrative management support to the four
operational Divisions in the areas of budget execution; staff and
organizational planning as well as advice and analysis of
administrative policy and procedures in order to assist managers in
accomplishing the mission of the organization.
    3. 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.
    4. Maintains liaison with DHHS on contracts and grants/assistance

management policy and procedural and operating matters.
    5. Provides the oversight function to all levels of the Agency in
the Small Business contracting program. Provides technical and policy
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 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. Provides customer relation support and administration of
acquisition systems.
    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 Inter-Agency Agreements (IAGs). Assigns
Memorandum of Understanding (MOU) tracking number and maintains MOU
files.
    5. Provides contract to support the State Contracts and Compliance
Program. This program commissions the states to conduct inspections to
ensure the quality and safety of the nations' food, animal feed and
medical devices.
    6. Responsible for acquisitions for the Office of Criminal
Investigations.
    Division of Acquisition Programs:
    1. Responsible for formulating FDA-wide acquisition policies
governing OAGS operational Divisions, providing advice and technical
assistance on matters related to FDA acquisition programs, and
monitoring the adoption of acquisition policies by the Department to
ensure consistent policy interpretation.
    2. Provides managerial oversight and administration of the Agency's
purchase card program. Liaison with the bank, processing administrative
functions, providing training and other assistance to ensure that
participants understand their responsibilities under the program.
    3. Responds to contract related FOIA requests, and ratifications of
unauthorized procurements.
    4. Provides field office and facility support, construction and
renovation, architect/engineering services contracts and simplified
acquisitions.
    5. Plans and manages all contracting activities related to National
Center for Toxicological Research (NCTR) acquisition programs.
    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
OC staff with regard to programmatic FDA and OC programmatic and
administrative management policies, procedures, and controls.
    2. Advises the OC officials on the formulation and execution of
administrative, financial and information management plans and
activities affecting OC offices.
    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.
    5. Establishes and maintains liaison with administrative staff
throughout the OC to keep abreast of current policies and procedures.
    6. Advises the OC offices on acquisitions and grants activities to
ensure compliance with Agency and federal contracting policies.
    7. Provides guidance and oversight concerning OC information
management activities, including those related to activities of FDA
Bioinformatics Board.
    8. Develops policy on OC web activities and ensures compliance with
Section 508 accessibility requirements.
    9. 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,
internal financial audit, financial services related to accounts
payable, travel support and payroll liaison, and financial reporting.
    2. Provides staff assistance in justifying budgets through
executive and congressional echelons. After appropriation, develops an
orderly expenditure plan.
    3. Administers and executes the Agency programs for accountable
property management functions.
    Office of Financial Management:
    1. Plans, directs, and coordinates a comprehensive financial
management program for FDA encompassing the areas of budget analysis,
execution, automated financial systems, fiscal accounting, internal
financial audit, and financial reporting.
    2. Provides staff assistance in justifying budgets through
executive and congressional echelons. After appropriation, develops an
orderly expenditure plan.
    3. Develops apportionment plans and issues allotments for
expenditures.
    4. Makes periodic reports regarding the status of FDA's financial
management.
    5. Develops financial inputs for the Agency's programs and
financial plans.
    Controls, Compliance, and Oversight Staff:
    1. Ensures compliance with applicable Agency, Department, and/or
Federal standards and policies.
    2. Manages Office of Financial Management (OFM) contracts.
    3. Manages the financial system investment and capital planning
process.
    4. Manages A-123 Program on behalf of the Agency.
    5. Conducts advisory committee financial operation plan (FOP)
reviews.
    6. Supports upgrades to the Oracle-based financial system.
    7. Manages OFM projects including the:
    a. OFM Financial Managers Financial Integrity Act (FMFIA) report.
    b. Most Efficient Organization (MEO) A-76 study.
    c. Project management of Exhibit 52-Report on Resources for
Financial Management Activities.
    8. Oversees and coordinates access to financial systems.
    Business Transformation, Administration and Management Staff:
    1. Provides financial system training, workforce and organizational
transition, and financial process documentation services, as well as
internal communications.
    2. Serves as the liaison to DHHS Division of Human Resources on
OFM-related human resource issues.
    3. Manages the ongoing administrative and management operations of
OFM, including user provisioning for financial systems.
    4. Provides administrative, human resources, and Agency guidance to
OFM staff.
    5. Supervises and coordinates the business transformation team's
(BTT) activities across FDA.

    6. Develops and tests the Office of Financial Management's (OFM)
emergency preparedness to ensure the Agency's financial infrastructure
and integrity.
    7. Manages the change review board (CRB) for changes to business
process and/or Unified Financial Management System (UFMS) and User Fee
System modifications.
    8. Supports testing required for maintenance, enhancements, and
upgrades to OFM's financial and feeder systems.
    User Fees 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, and maintains user fee systems.
    Financial Systems Support Staff:
    1. Manages and provides technical and functional guidance
associated with the Unified Financial Management System (UFMS), on
behalf of the Agency and its components.
    2. Ensures the financial integrity and stabilization of UFMS.
    3. Coordinates month-end, quarter-end, and year-end close of
financial operations within UFMS.
    4. Tests new functionality of the financial system.
    5. Serves as the liaison to FDA end users regarding UFMS issues.
    6. Leads upgrades of UFMS across FDA.
    Division of Accounting:
    1. Prepares the Agency's financial statements for submission to
DHHS and integration into the Department's consolidated financial
statements.
    2. Prepares and submits all required external reports required by
the Department of the Treasury that report various accounting events.
    3. Serves as liaison for the Agency's annual financial statement
audit; coordinating various tasks from the Department and the auditors.
    4. Responds to audit and A-123 findings by developing comprehensive
corrective action plans to address deficiencies.
    5. Reconciles all major sub-ledger accounts (such as accounts
payable, financial balance with Treasury, suspense) to the Agency's
general ledger.
    6. Serves as Agency lead for financial policy oversight, review,
and implementation.
    7. Plans, evaluates and coordinates activities to ensure FDA is in
compliance with Federal Government accounting policy and procedures.
    8. Serves as Agency Property management Officer, reviewing and
implementing property policy as well as managing the annual inventory.
    9. Prepares various sub ledgers to general ledger reconciliations
to ensure accuracy of financial data and identify possible issues that
could impact operations.
    10. Reconciles General Ledger's equipment account to Property
Management Information System (PMIS) to ensure all capital personal
property items are properly monitored and recorded.
    11. Develops and modifies, as needed, all accounting procedures for
FDA, both headquarters and field. Implement and control a reporting
structure to track and measure performance against a variety of
financial goals and objectives.
    12. Processes IPAC payments for Inter Agency Agreements (IAGs).
    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,
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 day-to-day operations for
financial services related to accounts payable, travel support and
payroll liaison.
    2. Manages the ITAS program, ensuring compliance and employee's
time and attendance data, tests all system upgrades.
    3. Provides training on ITAS and payroll policy to timekeepers and
approvers.
    Division of Payment Services:
    1. Maintains liaison with the Program Support Center (PSC) and the
Defense Financial Accounting System (DFAS) representatives on issues
relating to pay and leave. Monitors the processes to ensure the
successful payment to employees.
    2. Resolves payroll errors and assists employees with pay problems;
interprets policies and issues new procedures as needed.
    3. Participates in reengineering the payroll process to streamline
correction of errors and reduce first time errors; and participates in
timekeeper training.
    4. Processes and pays all accounts payable invoices (contract and
purchase orders) in accordance of the Prompt Pay Act and various
regulations and audit requirements. Maintains internal control over
processing of transactions to accounts, including application of batch
controls to ensure accurate coding and making necessary accounting
transaction adjustments and corrections.
    5. Monitors all phases of the payment records in the Unified
Financial Management System (UFMS) for issues that might prevent
payments to be processed.
    6. Performs the daily batching processes required for transmission
to Treasury.
    7. Researches returned payments, reprocessing if needed.
    8. Maintains roles and responsibilities to ensure conflict of
interest adherence.
    9. Troubleshoots and maintains additional vendor sites in UFMS.
    10. Tracks and monitors contract invoices for required signatures.
    11. Coordinates with vendor and center personnel in researching

payment information for issue resolution.
    12. Responds to all vendor inquiries as well as inquiries from
center personnel.
    13. Prepares various reconciliations to ensure that schedules are
properly accounted for and entered into the accounting system.
    14. Reviews and distributes reports and processes corrections, as
necessary.
    15. Serves as liaison with the Department of Treasury to initiate
check traces.
    16. Coordinates, reconciles and posts all Impac Card payments into
UFMS.
    Division of Travel Services:
    1. Oversees processing of vouchers and traveler's reimbursements.
    2. Oversees the functional integrity of the GovTrip system.
    3. Serves as liaison to the PSC eTravel Center of Excellence,
Northrup Grumman and Omega.
    4. Oversees and maintains the Agency's Travel Card and Centrally
Billed Account Programs.
    5. Creates, monitors and provides delinquency reports to program
offices.
    6. Monitors travel card holder activities for misuse, abuse or
illegal activity, suspending cards if necessary.
    7. Maintains UFMS traveler sites as requested.
    8. Oversees post audit of travel vouchers.
    9. Provides travel advice/guidance throughout the Agency, including
significant research on Comptroller General Decisions; participates in
training on travel procedures.
    10. Oversees contractor processing of all headquarters and field
Permanent Change of Station travel vouchers, processes complex tax
calculations and IRS reports.
    11. Processes and distributes required 1099 forms to employees that
receive gift cards.
    12. Field employees perform travel services directly for the Office
of Regulatory Affairs (ORA) and the National Center for Toxicological
Research (NCTR) to include NCTR travel, ORA international travel,
Federal Agency Travel Administration (FATA) responsibilities, data
calls, travel audits, 348 travel and conference reporting.
    13. Processes travel for all State Employees working in tandem with
ORA employees
    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.
    2. Provides advice and assistance to the Commissioner and senior
management officials on information technology resources and programs.
    3. Establishes and oversees implementation of the 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.
    4. Provides leadership and direction regarding all aspects of the
Agency records management program.
    5. Works in full partnership with FDA business areas, develops and
communicates the overall vision for the Agency's Information Technology
(IT) program.
    6. 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.
    7. Represents the Agency IT program on internal and external
meetings and workgroups on Agency information technology programs and
issues (e.g., DHHS, Chief Information Officer (CIO) Council, FDA
Leadership Council, FDA Level Review Boards, etc.).
    8. Establishes policies and procedures for system risk assessments
and system business continuity and contingency planning.
    Division of Business Partnership and 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 (non-government, e.g.,
PHRMA, BIO, DIA, ICH, etc) and PHS, Department, and other Federal
government IRM and ADP operations.
    2. Collaborates with other divisions within OIM to address Center/
Office issues and topics in question coordinates with the appropriate
parties to ensure project/investment formulation and execution.
    3. Oversees the governance of IT program and project management
activities of major IT initiatives following project management best
practices (Project Management, System Development, and Enterprise
Program life cycles), develops policies and procedures on all aspects
of project planning, and interacts with and coordinates the
implementation of DHHS EPLC processes.
    4. Coordinates development of Center/Offices IT budget and provides
support for budget execution and contract monitoring of information
resources.
    5. Oversees day-to-day operations of FDA web development, redesign,
web content management system and web hosting environment.
    6. Manages FDA Forms programs and is the lead for Agency Section
508 implementation and 508 guidance.
    7. Receives user requests, orders, and desktop-related tools and
equipment.
    8. Manages and oversees help desk services and user support for
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 OIM.
    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, conducts architectural reviews of IT investments 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 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.
    10. Develops and creates a variety of diverse graphic projects;
prepares publications, pamphlets, scientific posters, design posters,
display units, in-house laser award design/engraving and other custom
art projects.
    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 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 infrastructure is kept up to date with FDA
technology standards.
    9. Manages and oversees user support for and/or FDA-wide
applications for all FDA Field Offices, including the International
Offices (excludes Washington Metro area help desk which is part of the
Division of Business Partnership and Support).
    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 DHHS, 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, DHHS, 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:
    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 FDA'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.
    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.
    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 DHHS supplemental regulations (5 CFR
part 5501). 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, with relevant requirements, well-documented and timely.
Evaluates cooperative agreements developed by Agency components under
the Federal Technology Transfer Act and provides technical advice on
any related conflict of interest matters.
    2. 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.).
    3. Serves as liaison with other FDA components and the Agency
Office of General Counsel/Ethics Division to develop co-sponsorship
agreements.
    4. Provides executive and administrative support to the Conflict of
Interest Review Board. 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:
    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:
    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.
    2. Provides executive leadership and direction to coordinate and
operationalize the Agency's business

process improvement initiatives to increase quality, productivity, and
transparency.
    3. 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 operation and effectiveness of FDA resulting in productivity
and efficiency gains.
    Office of Management Programs:
    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:
    1. Provides management analysis support and advisory services to
the Office of the Commissioner and other Agency components.
    2. 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.
    3. 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 (MEO),
establishing policies, and advising senior leadership.
    4. 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.
    5. Provides leadership, direction, policy development, and oversees
the performance management programs covering the Senior Executive
Performance Management Program and the Performance Management Appraisal
Program.
    6. Provides leadership, direction, policy development and program
management for Agency workforce and succession planning activities.
    7. 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.
    8. 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)).
    9. 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.
    10. 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.
    11. Manages the Agency reward and recognition programs, including
the Agency Honor Awards Program.
    12. 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.
    13. 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.
    14. Provides leadership and direction on Agency workforce planning
and succession planning activities.
    15. 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.
    16. 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.
    17. 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.
    18. 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 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 DHHS 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 Agency wide 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 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 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 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.
    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 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:
    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:
    1. Provides information and services through a call center
environment to all 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:
    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 teams: 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:
    1. Provides leadership and direction for the operations of all of
the Agency information centers, including the FDA Biosciences Library,
the Division of Freedom of Information, the Division of Dockets
Management, and the Division of Dockets Management and Division of
Freedom of Information public reading rooms.
    2. Provides executive perspective on current policy objectives and
increases public understanding of the Agency's purpose and function.
    3. Establishes Agency wide policy and provides overall direction
and leadership for the Freedom of information (FOI) and Privacy Act
programs.
    4. Provides information, information services and research support
to FDA through access to information in various formats, via
information consulting and advisory services.
    5. Provides leadership and direction regarding all aspects of the
Agency's regulated dockets program.

    6. Increases public understanding of FDA's purpose and history, and
collects, preserves and manages exhibits for documents and artifacts
reflecting the Agency's history.
    Division of Dockets Management:
    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. 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. Provides electronic
access to these records, via the Internet and other means, as required
by the EFOIA.
    5. Provides information access via the Intranet and other means to