[Federal Register: August 18, 2009 (Volume 74, Number 158)]
[Notices]
[Page 41713-41734]
[DOCID:fr18au09-62]

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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) has reorganized the
Office of the Commissioner (OC). This reorganization includes the
organizations and their substructure components as listed in this
document. This reorganization includes the re-alignment of four Deputy-
level offices within the Office of the Commissioner: the Office of the
Chief Scientist; the Office of Administration (formerly titled the
Office of Operations); the Office of Foods; and the Office of Policy,
Planning and Budget (formerly titled the Office of Policy, Planning and
Preparedness).

FOR FURTHER INFORMATION CONTACT: Vanessa Starks, Office of Management
Programs (HFA-400), Food and Drug Administration, 5600 Fishers Lane,
rm. 6B-42, Rockville, MD 20857,<PHONE_NUMBER>.
    Office of the Chief Scientist: The organizational change will allow
the agency to better focus the science and research activities under
the Chief Scientist. Re-alignments under the Office of the Chief
Scientist will include the Office of Counter-Terrorism and Emerging
Threats, Office of Critical Path Programs, Office of Scientific
Integrity, and the Office of Science and Innovation.
    Office of Administration: The Office of Operations will be re-
titled the Office of Administration. The Office of Administration will
be restructured to strengthen agency wide management programs, budget
and shared services operations, as well as the Office of the
Commissioner's executive operations. Realignments of the Office of
Acquisitions and Grants Services, the Office of Executive Operations,
the Office of Information Management, the Office of Management, the
Office of Equal Employment Opportunity and Diversity Management, and
the establishment of the Office of Financial Operations.
    Office of Foods: The Office of Foods will be realigned from the
Office of Operations and will report directly to the Commissioner.
    Office of Policy, Planning and Budget: The Office of Policy,
Planning and Preparedness will be retitled the Office of Policy,
Planning and Budget. The realignments from the Office of Policy, Office
of Planning, and the Office of Budget Formulation (formerly titled the
Office of Budget Formulation and Presentation, Office of Operations).
    [Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
and 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR
50112, August 30, 2007) is amended to reflect the restructuring of the
Office of the Commissioner (OC), Food and Drug Administration (FDA) as
follows].
    I. Under Part D, Food and Drug Administration, delete the Office of
Commissioner in its entirety and replace with the following:
    DA.10 ORGANIZATION. The Food and Drug Administration (FDA) is
headed by the Commissioner, Food and Drug, and includes the following
organizational units:
    Office of the Commissioner
    Office of the Chief Counsel
    Office of the Chief of Staff
    Office of Legislation
    Office of Policy, Planning and Budget
    Office of Counselor to the Commissioner
    Office of Women's Health
    Office of Special Medical Programs
    Office of External Affairs
    Office of Foods
    Office of the Chief Scientist
    Office of International Programs
    Office of Administration
    Office of Equal Employment Opportunity and Diversity Management
    Center for Tobacco Products
    DA.20 FUNCTIONS.
    Office of the Commissioner: The Office of the Commissioner (OC)
includes the Commissioner and Deputy Commissioner who are responsible
for the efficient and effective implementation of the FDA mission.
    Office of the Chief Counsel: The Office of the Chief Counsel (OCC)
is also known as the Food and Drug Division, Office of the General
Counsel, Department of Health and Human Services. While
administratively within the Office of the Commissioner, the Chief
Counsel is part of the Office of the General Counsel of the Department
of Health and Human Services.
    1. Is subject to the professional supervision and control of the
General Counsel, Department of Health and Human Services (DHHS), and
represents FDA in court proceedings and administrative hearings with
respect to programs administered by FDA.
    2. Provides legal advice and policy guidance for programs
administered by FDA.
    3. Acts as liaison to the Department of Justice and other Federal
agencies for programs administered by FDA.
    4. Drafts or reviews all proposed and final regulations and Federal
Register notices prepared by FDA.
    5. Performs legal research and gives legal opinions on regulatory
issues, actions, and petitions submitted to FDA.

    6. Reviews proposed legislation affecting FDA that applies to HHS
or on which Congress requests the views of the Department.
    7. Provides legal advice and assistance to the Office of the
Secretary on matters within the expertise of the Chief Counsel.
    Office of the Chief of Staff:
    1. Advises and provides integrated policy analysis and strategic
consultation to the Commissioner, Deputy Commissioners, and other
senior FDA officials on activities and issues that affect significant
agency programs, projects and initiatives. Often this function involves
the most difficult problems, crisis situations and extremely complex
issues of the agency.
    2. Provides leadership, coordination and management of the
Commissioner's priority policies and issues across the Office of the
Commissioner and agency wide. Identifies triages, supervises and tracks
related actions from start to finish in conjunction with senior
leadership across FDA.
    3. Serves as the principal liaison to the Department of Health and
Human Services (DHHS) and coordinates and manages activities between
FDA and DHHS. Works with the FDA Centers/Offices to ensure assignments
or commitments made related to these activities are carried out.
    4. Provides direct support to the Commissioner, Deputy
Commissioners, and other FDA senior staff including briefing materials,
background information for meetings, responses to outside inquiries,
and maintenance and control of the Commissioner's working files.
    5. Provides top level leadership and guidance on issues and actions
tied to the agency's communications with the Public Health Service,
DHHS, and the White House, including correspondence for Assistant
Secretary for Health and Secretarial signatures; controls for all
agency public correspondence directed to the Commissioner; and the
development and operation of tracking systems designed to identify and
resolve early warnings and bottleneck problems with executive
correspondence.
    Executive Secretariat:
    1. Advises the Commissioner and other key agency officials on
activities that affect agency wide programs, projects, and initiatives.
Informs appropriate agency staff of the decisions and assignments made
by the Commissioner, the Deputy Commissioners, the Chief of Staff and
the Associate Commissioners.
    2. Develops and maintains management information necessary for
monitoring the Commissioner's and agency's goals and priorities.
    3. Assures that materials in support of recommendations presented
for the Commissioner's consideration are comprehensive, accurate, fully
discussed and encompass the issues involved.
    4. Provides correspondence control for the Commissioner and
controls and processes all agency public correspondence directed to the
Commissioner. Develops and operates tracking systems designed to
identify and resolve early warnings and bottleneck problems with
executive correspondence.
    5. Provides direct support to the Commissioner, Deputy
Commissioners, Chief of Staff and Associate Commissioners including
briefing materials, background information for meetings, responses to
outside inquiries, and maintenance and control of the Commissioner's
working files.
    6. Performs agency wide assignments involving complex problems and
issues related to agency programs, strategies and activities, including
preparation of special reports for the Department.
    7. Coordinates the agency's communications with the Public Health
Service, DHHS, and the White House including correspondence for the
Assistant Secretary for Health and Secretarial signatures.
    Office of Legislation:
    1. Advises and assists the Commissioner and other key agency
officials concerning legislative needs, pending legislation and
oversight activities that affect FDA.
    2. Serves as the focal point for overall legislative liaison
activities within FDA and between FDA, the Department, PHS and other
agencies; and analyzes the legislative needs of FDA and drafts or
develops legislative proposals, position papers, and departmental
reports on proposed legislation for approval by the Commissioner.
    3. Advises and assists members of Congress and congressional
committees and staffs in consultation with the Office of the Secretary
on agency actions, policies, and issues related to legislation which
may affect FDA.
    Office of Policy, Planning and Budget:
    1. Plans, organizes, and carries out annual and multi-year
budgeting in support of FDA's public health mission and programs.
    2. Produces three major budget submissions a year (to Health and
Human Services (HHS) in June, Office of Management and Budget (OMB) in
September, and to Congress in January).
    3. Develops and presents required background exhibits, MAX input,
and supplemental requests as necessary; coordinates graphic material
for presentations; and coordinates budgetary passback appeals at each
level.
    4. Tracks Appropriation activities and bills affecting FDA through
the legislative process.
    5. Responds to requests for budget information and special reports
and exhibits.
    6. Reviews and analyzes potential budgetary impacts of
congressional or administrative proposals, providing expert opinion and
recommendations.
    7. Clears documents leaving the agency that have budgetary impact
or resource information.
    8. Tracks special initiatives and agency cross-cutting programs.
    Office of Policy:
    1. Leads agency wide strategic policy initiatives.
    2. Advises and assists the Commissioner and other key agency
officials on matters relating to agency policy, and on regulations and
guidance development.
    3. Serves as the lead agency focal point for developing broad
agency policy.
    4. Provides strategic policy direction and develops innovative
policies for FDA to more effectively and efficiently protect and
promote public health.
    5. Develops significant and cross-cutting policy and engages in
strategic problem solving.
    6. Oversees, directs, and coordinates the agency's rulemaking and
guidance development activities.
    7. Serves as the agency focal point for communications and policies
with regard to development of regulations and guidance.
    8. Initiates new and more efficient systems and procedures to
accomplish agency goals in the rulemaking and guidance development
processes.
    9. Reviews agency policy documents to ensure consistency in
statements regarding agency policies.
    10. Provides strategic policy direction for agency budget
formulation.
    Policy Development and Coordination Staff:
    1. Leads the development of cross-cutting or broad agency policies
and serves as a cross-agency think tank to develop innovative policies.
    2. Advises and assists the Commissioner and other key agency
officials concerning information that may affect current or proposed
FDA policies.
    3. Advises the Commissioner and other key agency officials on the
formulation of broad agency policy.
    4. Engages in strategic problem solving.

    5. Serves as agency liaison for intergovernmental policy
development.
    6. Coordinates the development, review, and clearance of
regulations and guidances.
    7. Manages the agency's regulation, guidance review and clearance
processes.
    8. Reviews policy documents to assess and achieve consistency in
policies across documents.
    9. Establishes procedures for agency policy formulation and
coordinates policy formulation activities throughout the agency.
    10. Negotiates the resolution of policy issues involving more than
one component of the agency.
    11. Coordinates the review and analysis of policies.
    12. Initiates and participates in interagency discussions on agency
regulations, plans, and policies to improve coordination of Federal,
State, or local agencies on a specific regulation or in developing an
effective alternative approach.
    13. Serves on agency task forces that are critical elements in the
initiation, study, and resolution of priority policy issues.
    Regulations Policy and Management Staff:
    1. Serves as the agency's focal point with the Department of Health
and Human Services, Office of Management and Budget, and other Federal
agencies for policies and programs concerning regulations development
and for the receipt of and response to other agency comments on FDA
policy documents.
    2. Reviews proposed regulations, final regulations, and other
agency documents to be published in the Federal Register. Ensures
regulations are necessary; consistent with established agency policy;
clearly written; enforceable; coordinated with other agency components,
the Office of the Chief Counsel, and Federal, State, and local
government agencies; appropriately responsive to public participation
requirements and applicable executive orders; and responsive to any
applicable requirements for assessment of economic and environmental
effects.
    3. Coordinates, with other agency components, the evaluation of
existing regulations to determine whether they are efficiently and/or
effectively accomplishing their intended purpose. Identifies and makes
recommendations to address regulations that require revision to
correspond with current standards and those that should be revoked due
to obsolescence.
    4. Resolves regulatory policy disagreements between agency
components during the preparation of Federal Register documents.
    Regulations Editorial Section:
    1. Serves as FDA's official liaison within the Office of the
Federal Register. Edits, processes, and prepares finished manuscript
material for the issuance of agency proposed and final regulations and
other documents published in the Federal Register.
    2. Provides all Federal Register document development support
functions (including cross-referencing, record retention, incorporation
by reference, document tracking, and agency master print books of
current Code of Federal Regulations (CFR) materials. Controls numbering
and organization of agency codified material to ensure proper structure
of regulations being issued.
    Office of Planning:
    1. Leads agency-wide strategic planning initiatives.
    2. Advises and assists the Commissioner and other key agency
officials concerning the performance of the FDA planning, evaluation
and economic analysis activities.
    3. Develops program and planning strategy through analysis and
evaluation of issues affecting policies and program performance.
    4. Develops, installs, and monitors the agency wide planning system
including the long-term plans, strategic action plans, functional and
business bioinformatics plans.
    5. Leads the FDA Strategic Planning Council.
    6. Consults with and supports the agency preparation of legislative
proposals, proposed rulemaking, and technical assistance to Congress.
    7. Conducts operations research, economic, and special studies as a
basis for forecasting trends, needs, and major problems requiring
solutions, and provides assistance and consultation in these areas to
operating units.
    8. Evaluates impact of external factors on FDA programs, including
industry economics, consumer expectations, and prospective legislation.
As necessary, recommends new programs or changes in existing programs
and program priorities.
    9. Develops FDA evaluation programs and systems to evaluate overall
FDA program accomplishments against objectives and priorities,
recommending changes as necessary.
    10. Estimates marginal impact of funding changes on FDA performance
and ability to protect public health.
    11. Leads effort to analyze agency business processes for process
modernization and bioinformatics support.
    12. Acts as FDA liaison to HHS and other Federal activities under
the Office of the National Coordinator for Health Information
Technology.
    13. Leads and coordinates agency-wide effort to plan, evaluate and
improve FDA risk communication.
    14. Leads and coordinates the Prescription Drug User Fee Act
program initiative for Performance Management and quality systems
studies.
    Planning Staff:
    1. Performs and coordinates the following agency's performance
planning functions:
    Represents the HHS in and OMB performance planning activities.
    Coordinates and reports the agency's performance planning and
achievements in accordance with the Government Performance and Results
Act.
    Consults with the Office of Budget Formulation and collaborates
with agency components in preparing and reporting the performance
sections of the agency's budget.
    Coordinates the agency long range strategic and performance
planning in line with the HHS strategic plan.
    Maintains, analyzes and reports agency-wide performance information
and achievements to external stakeholders.
    2. Performs and coordinates the following agency's program
performance tracking and management functions:
    Coordinates the development and improvement of the agency's program
performance measures, data and goals on a continuous basis to ensure
alignment to agency's missions and objectives.
    Coordinates the agency short and long range performance planning
objectives and processes.
    Assists and consults with agency components in their performance
planning for data, trends, targets and achievements.
    Maintains, analyzes and reports agency-wide quarterly program
performance information.
    Performs and coordinates program advisory, planning, and analysis
services.
    Assists agency components in analyzing and improving their planning
processes, performance objectives and goals, as requested.
    Works with agency components as requested to identify and implement
internal and external best practices to improve overall performance.
    Analyzes information by applying mathematical disciplines and
principles to make available data and facilitate improved decision-
making.

    Conducts special operational analysis and planning related studies
as requested.
    Conducts analysis of resource requests submitted by agency
components and develops recommendations for the Commissioner, to
fulfill agency and agency requirements.
    Staffs the FDA Strategic Planning Council.
    Provides operations analysis and project management support to the
agency committees and initiatives as needed.
    Provides operations analysis and project management support to the
Prescription Drug User Fee program.
    Evaluation Staff:
    1. Prepares annual User Fee performance reports to Congress.
    2. Performs agency program and policy evaluations and analytical
studies. Recommends alternative courses of action to increase
effectiveness of agency allocation of resources and to improve program
and project performance.
    3. Performs analyses of significantly broad agency issues
identified in the planning process.
    4. Recommends and/or implements steps to resolve these issues.
    5. Develops the annual evaluation plan for the agency and
coordinates with HHS.
    6. Conducts special evaluations, analytical and economic-related
studies, in support of agency policy development and in resolution of
broad agency problems.
    7. Evaluates the impact of external factors on agency programs,
including consumer expectations and prospective legislation.
    8. Evaluates the impact of agency operations and policies on
regulated industries and other agency constituents.
    9. Provides process expertise to agency components in designing
consensus sessions with internal and external stakeholders.
    10. Assists and consults with agency components on the design and
execution of key program and process re-inventions.
    11. Assists and consults with agency scientific review components
to enhance transparency, consistency, accountability, and continuous
improvement of review processes.
    12. Facilitates cross-organizational sharing of key program and
process improvements.
    Economics Staff:
    1. Performs economic analyses for use by agency officials in
decisions regarding agency policies.
    2. Serves as the agency's chief resource for economic information.
    3. Collects and interprets economic data relevant to the agency's
public-health mission.
    4. Performs and reviews benefit-cost and cost-effectiveness
analyses of agency regulations.
    5. Advises and assists the Commissioner and other key agency
officials on a day to day basis concerning economic factors relating to
current and proposed agency activities.
    6. Provides economic research material for use by agency officials
in preparing testimony before congressional committees and in
developing replies to inquiries directed to the agency.
    7. Conducts economic studies of FDA related industries as a basis
for forecasting trends, needs, and major problems affecting the agency.
    8. Provides agency representation to Congress, OMB, HHS, and
others, as appropriate, on economic issues relating to agency
regulations and other current and proposed actions.
    Risk Communication Staff:
    1. Coordinates development of agency policies on risk communication
practices.
    2. Coordinates agency strategic planning activities concerning risk
communications.
    3. Coordinates agency research agenda for risk communication
methods.
    4. Facilitates development and sharing of risk communication best
practices and standard operating procedures.
    5. Conducts risk communications research on methodological and
cross-cutting issues.
    6. Leads management and coordination of the FDA Risk Communication
Advisory Committee.
    Business Process Planning Staff:
    1. Coordinates the agency's business process planning function in
support of business process improvement and automation efforts.
    2. Provides business process planning, operations analysis and
project management support to the FDA Bioinformatics Board and its
associated Business Review Boards.
    3. Coordinates and maintains the strategic and performance layers
of the Enterprise Architecture, in support of the Office of Information
Management.
    4. Establishes and maintains agency standards for business process
modeling.
    5. Provides business process modeling, analysis, and planning
services to agency programs and initiatives as needed.
    Office of Budget Formulation:
    1. Plans, organizes, and carries out annual and multi-year
budgeting in support of FDA's public health mission and programs.
    2. Produces three major budget submissions a year (to Health and
Human Services (HHS) in June, Office of Management and Budget (OMB) in
September, and to Congress in January).
    3. Develops and presents required background exhibits, MAX input,
and supplemental requests as necessary; coordinates graphic material
for presentations; and coordinates budgetary passback appeals at each
level.
    4. Tracks Appropriation activities and bills affecting FDA through
the legislative process.
    5. Responds to numerous requests for budget information and special
reports and exhibits.
    6. Reviews and analyzes potential budgetary impacts of
congressional or administrative proposals, providing expert opinion and
recommendations.
    7. Clears documents leaving the agency that have budgetary impact
or resource information.
    8. Tracks special initiatives and agency cross-cutting programs.
    Office of the Counselor to the Commissioner:
    1. Formulates and renders advice to the Commissioner related to
policy development, interpretation and integration that cuts across
program lines or which is not well defined.
    2. Provides a leadership role in advocating for and advancing the
Commissioner's priorities.
    3. Reviews recommendations for actions and reviews other materials
to ensure that all points of view and program interests are developed
for consideration and fully analyzed.
    4. Provides top level leadership for the development of, and
management of emergency and crisis management policies and programs for
FDA to ensure that a structure exists for FDA to respond rapidly to an
emergency or crisis situation in which FDA-regulated products need to
be utilized or deployed.
    5. Coordinates FDA participation in internal and external counter-
terrorism and emergency exercises.
    6. Implements the continuity of operation plans and operation of
the emergency and the crisis operation center.
    7. Coordinates agency evaluation of emergency and crisis situations
to determine appropriate internal and external referrals for further
action.
    Office of Crisis Management:
    1. Serves as the first responder for Food and Drug Administration
(FDA) in

emergency and crisis situations involving FDA regulated products or in
situations in which FDA regulated products are needed to be utilized or
deployed.
    2. Assists in the development of, and will manage, emergency and
crisis management policies and programs for FDA to ensure that a
structure exists to respond rapidly to an emergency or crisis
situation.
    3. Serves as agency emergency coordinator to HHS Office of the
Assistant Secretary for Preparedness and Response (OASPR) and as
liaison to HHS Secretary's Office of Security and Strategic Information
(OSSI). Provides OASPR situational awareness of all FDA-related
emergencies and ensures that FDA's emergency operations procedures are
in alignment with national and HHS procedures. Participates in OSSI
intelligence briefings and provides secure fax capability for the
agency.
    4. Participates in international initiatives to ensure FDA's
capability and readiness to work with foreign counterparts in
responding to international emergencies involving or impacting FDA-
regulated products and to share information with international
counterparts during such emergencies.
    5. Manages the FDA Emergency Operations Network Incident Management
System (EON IMS), a system for capturing large amounts of near real
time information about emergencies related to FDA-regulated products
for use by senior agency decision makers in assessing and managing
response activities. Provides Offices and Centers geographical
information system maps created by EON IMS's GIS mapping component for
use in strategic planning of agency emergency response activities.
    6. Develops and updates agency emergency operations plans and
incident specific annexes, ensuring their alignment and compliance with
the National Response Framework and its Emergency Support Functions and
the National Incident Management System.
    7. Plans and conducts agency exercises to test emergency operations
plans. Plans and coordinates FDA's participation in emergency exercises
sponsored by other Departments and agencies, including national and
international level exercises.
    8. Oversees the FDA Emergency Call Center which provides after
normal-hours service for responding to public inquiries and reports
related to FDA-regulated products as well as surge capacity service for
managing increased volumes of inquiries due to an event involving an
FDA-regulated product.
    9. Manages FDA's Emergency Operations Center (EOC), activating the
EOC with augmented staffing from relevant Centers and Offices to
monitor emergency situations, triage complaints and alerts, issue
mission assignments to organizational components, coordinate overall
agency response operations, and communicate with external partners
requesting technical and material support. FDA's EOC serves as the
central point of contact with the Department of Homeland Security's
National Operations Center, DHHS Secretary's Operation Center, CDC
Emergency Operations Center, USDA/FSIS Situation Room, and other
Federal EOCs as appropriate.
    10. Coordinates agency evaluation of emergency responses and crisis
situations to determine appropriate internal and external referral for
further action and recommended changes in agency procedures.
    11. Oversees the work of the Office of Emergency Operations.
    Office of Emergency Operations:
    1. Serves as the agency focal point for emergency preparedness and
response operating the 24-hour, 7-day-a-week emergency response system.
    2. Provides support and assistance to Food and Drug Administration
(FDA) offices in managing the agency's response to emergency incidents
and situations involving FDA regulated products and disasters.
    3. Assists in the development and coordination of the agency's
emergency preparedness and response activities.
    4. Serves as the agency focal point for the review and analysis of
preliminary information about threats and hazards, and assists in the
early recognition of emergencies, outbreaks, natural disasters, and
terrorism or other criminal acts, in direct coordination with
individual headquarters and field emergency coordination units.
    5. Coordinates FDA emergency activities with other Federal
agencies, State, local and foreign government officials and industry
associations.
    6. Identifies and advocates emergency training needs for FDA
personnel and participates in the design, implementation, and
presentation of the training programs.
    7. Provides guidance to agency emergency response staff in the use
of the Incident Command System to manage single or multi-agency
response activities.
    8. Represents the agency at interagency, intra-agency, State, local
and foreign government and industry association meetings and
conferences on emergency preparedness and response.
    9. Manages the National Consumer Complaint System which monitors
reports of problems with FDA-regulated products for potential
emergencies.
    10. Participates in daily National Biosurveillance Integration
Center conference calls sponsored by Department of Homeland Security to
provide a secure forum for interagency information sharing for early
recognition of biological events of national concern, both natural and
man-made, to make a timely response possible.
    11. Oversees and tests the agency's ability to communicate through
the Government Electronic Telecommunications Service (GETS) which
provides global telecommunications (secure voice, facsimile and data
communications) capability for organizations that perform national
security and emergency preparedness functions.
    Office of Women's Health:
    1. Serves as the principal advisor to the Commissioner and other
key
    agency officials on scientific, ethical and policy issues relating
to women's
    health.
    2. Provides leadership and policy direction for the agency
regarding issues of women's health and coordinates efforts to establish
and advance a women's health agenda for the agency.
    3. Monitors the inclusion of women in clinical trials and the
implementation of guidelines concerning the representation of women in
clinical trials and the completion of gender analysis.
    4. Identifies and monitors the progress of crosscutting and
multidisciplinary women's health initiatives including changing needs,
areas that require study and new challenges to the health of women as
they relate to FDA's mission.
    5. Serves as the agency's liaison with other agencies, industry,
and professional associations with regard to the health of women.
    Office of Special Medical Programs:
    1. Serves as the agency focal point for special programs that are
cross-cutting and medical in nature.
    2. Manages the activities of the agency's effort to ensure that
medical products used in pediatric applications are properly overseen.
    3. Oversees the implementation of the orphan products provisions of
the Federal Food, Drug and Cosmetic Act.
    4. Administers and manages the Office Good Clinical Practice.
    5. Provides executive leadership to the Office of Combination
Products to ensure that appropriate jurisdictional decisions are made
for the regulation of those products.

    Office of Good Clinical Practice:
    1. Advises and assists the Commissioner, and other key officials on
Good Clinical Practice (including human subject protection) issues
arising in clinical trials regulated by the FDA that have an impact on
policy, direction, and long-range goals.
    2. Supports and administers FDA's Human Subject Protection (HSP)/
Bioresearch Monitoring (BIMO) Council that manages and sets agency
policy on Good Laboratory Practices, Bioresearch Monitoring, and Good
Clinical Practices.
    3. Represents the agency to other government agencies, State and
local governments, industry, academia, consumer organizations,
Congress, national and international organizations, and the scientific
community on Good Clinical Practice policy issues.
    4. Provides leadership and direction on human subject protection
and Good Clinical Practice matters and stimulates the application of
these principles in the FDA.
    5. Evaluates the adequacy of Good Clinical Practice resources
available to the agency and initiates action as appropriate.
    6. Coordinates agency policies related to the protection of human
subjects in research, including institutional review and ethical
considerations.
    7. Plans training programs for external use and for FDA staff on
the agency's Good Clinical Practice policies.
    8. Coordinates and provides oversight of Good Clinical Practice
policy working groups developed on the recommendation of the agency
HSP/BIMO Council.
    9. Fosters the science of bioresearch monitoring within the Centers
and the Office of Regulatory Affairs and coordinates for the Office of
the Commissioner.
    10. Serves as the agency coordinating point for Good Clinical
Practice regulation, harmonization, and outreach activities.
    11. Serves as liaison between the agency's HSP/BIMO Council and the
agency's Management Council.
    12. Coordinates and assists in implementation of regulations,
policies, operational initiatives, and program priorities related to
clinical bioresearch monitoring as developed by the HSP/BIMO Council.
    13. Monitors agency activities and leads the development of a
quality assurance and quality improvement program to ensure uniform
application of clinical bioresearch monitoring policies across the
agency.
    14. Serves as a liaison with other Federal agencies and outside
organizations, the regulated industry, and public interest groups on
clinical bioresearch monitoring policy and regulatory matters.
    Office of Combination Products:
    1. Serves as the agency focal point for combination products (i.e.,
drug-device, drug-biologic, device-biologic or drug-biologic-device
products).
    2. Serves as the agency Product Jurisdiction Office and administers
21 CFR Part 3. (Assigns agency centers with primary jurisdiction for
combination products.)
    3. Advises the Commissioner and other key agency officials on
policy formulation, execution, cross-cutting and precedent setting
issues involving combination products.
    4. Develops regulations, guidances, policies, procedures, and
processes to facilitate the agency's regulation, review, and oversight
of combination products.
    5. Reviews and updates agreements, guidance or practices specific
to assignment of combination products. Prepares reports to Congress on
the activities and impact of the Office.
    6. Serves as the focal point for employees and stakeholders to
resolve issues arising during assignment, premarket review or
postmarket regulation of combination products.
    7. Ensures timely and effective premarket review by overseeing the
timeliness of and coordinating reviews involving more than one agency
center.
    8. Ensures consistency and appropriateness of postmarket regulation
of combination products.
    9. Resolves disputes presented regarding the timeliness of the
premarket review of a combination product.
    10. Advises the Chief Scientist on disputes presented regarding the
substance of the premarket review of a combination product.
    11. Makes determinations as to whether an individual component
product will be regulated as a human drug, human biologic, or human
medical device.
    Office of Orphan Products Development
    1. Manages the implementation of the provisions of the Orphan Drug
Act and its amendments and manages a program to encourage the
development of drugs of limited commercial value for use in rare or
common diseases and conditions.
    2. Develops and communicates agency policy and makes decisions on
approval of sponsor requests and incentives under the Federal Food,
Drug, and Cosmetic Act, including orphan drug protocol assistance per
section 525, orphan drug designation per section 526, orphan drug
exclusivity per section 527, orphan drug grants and contracts to
support clinical research and other areas of agency policy related to
the development of products for rare disorders.
    3. Represents the Commissioner or serves as the agency's principal
authority and spokesperson to the PHS Orphan Products Board, other
governmental committees and industry, professional, and consumer
associations, requesting agency participation in orphan product
development activities.
    4. Reviews investigational new drug and biologics applications and
investigational device exemptions to locate the existence of products
under investigational study that show evidence of effectiveness for
rare or common diseases but lack commercial sponsorship. Assists
sponsors, researchers, and investigators in communicating with agency
regulatory officials and expediting solutions to problems in obtaining
investigational or market approval status.
    5. Manages an extramural program of clinical research to evaluate
safety and effectiveness of orphan products by funding grants and
contracts, requesting applications for funding, organizing peer review
of applications, monitoring and guiding investigators, and evaluating
study results.
    Office of Pediatric Therapeutics:
    1. Coordinates and facilitates all activities of the Food and Drug
Administration that may have any effect on the population, the practice
of pediatrics, or may in any way involve pediatric issues.
    2. Coordinates the review of and communicates internally and
externally any report of an adverse event of a drug which received
pediatric exclusivity.
    3. Provides for the review of adverse event reports and other new
safety information and obtains recommendations whether FDA should take
action.
    4. Coordinates with all Department of Health and Human Service and
FDA employees who exercise responsibilities relating to pediatric
therapeutics.
    5. Serves as the FDA focal point for all issues involving ethics
with respect to the pediatric populations.
    6. Coordinates with the Office of International Programs while
serving as the agency focal point for international pediatric
activities.
    Office of External Affairs:
    1. Advises the Commissioner, Deputy Commissioners and other key
agency

officials on FDA's communications to the media, Congress, and the
general public on issues that affect agency-wide programs, projects,
strategies, partnerships and initiatives.
    2. Advises and assists the Commissioner and other key officials on
all public information programs; acts as the focal point for
disseminating news on FDA activities and as a liaison with the Public
Health Service and the Department on public information programs.
    3. Advises the Commissioner, Deputy Commissioners and other senior
staff throughout FDA on sensitive and controversial programs and
initiatives that impact external stakeholder groups.
    4. Serves as an information resource to FDA and provides advice to
the Commissioner and other key agency officials on matters related to
serious and life-threatening diseases; patient advocacy, and health
professional organizations; minority health and other special health
issues.
    Office of External Relations:
    1. Advises the Commissioner, Deputy Commissioners and other key
agency officials on agency-level activities and issues that affect
agency wide programs, projects, strategies, partnerships, and
initiatives.
    2. Advises the Commissioner, Deputy Commissioners and senior staff
throughout FDA on sensitive and controversial programs and initiatives
that impact external stakeholder groups.
    3. Coordinates activities involving emergency or crises situations
and resolves complex problems and issues related to agency programs
that are sensitive and controversial which impact upon agency relations
with other Federal agencies and foreign governments.
    4. Oversees and directs the agency's ombudsman and editorial
functions to ensure coherence in decision making and the efficient
operation of these functions internally and across agency
jurisdictions.
    5. Provides leadership and direction to assure the efficient and
effective planning, performance and evaluation of oversight activities.
    6. Provides direction, coordination and oversight of the agency's
consumer activities and serves as the agency's focal point for national
consumer groups.
    7. Advises the Commissioner, Deputy Commissioners and senior staff
throughout FDA on sensitive and controversial programs and initiatives
that impact external stakeholder groups.
    8. Serves as the agency's focal point to provide direction,
coordination and oversight of the agency's stakeholder relations with
national consumer groups, patient advocacy organizations, health
professionals, academia, trade associations, ethnic and minority
groups, and Tribes.
    9. Coordinates speaker requests for industry programs that cover
multi-center issues; identifies potential conflict of interest speaker
requests.
    10. Assists in the programmatic design, development and planning
with internal and external organizations regarding educational and
informational activities intended to educate regulated industry.
    Communications Staff:
    1. Identifies consumer communication and educational requirements
for the agency and creates, implements, and coordinates appropriate
programs conducted through the media, agency public affairs
specialists, and other communication sources.
    2. Plans, designs, produces, publishes, and disseminates
audiovisual materials, exhibits, posters, publications, and
periodicals, including FDA Consumer; participates in the planning and
development of all publications and audiovisual aspects of
communications programs directed at mass audiences.
    3. Provides centralized agency graphic arts and editorial services
for public information materials.
    4. Acts as the agency's public information liaison with the
Department for all publications and audiovisual needs; provides
prepublication clearance of publications, exhibits, and audiovisual
materials in accordance with procedures established by the agency, PHS,
the Department, OMB, and the White House.
    Office of Public Affairs:
    1. Advises and assists the Commissioner and other key officials on
all public information programs; acts as the focal point for
disseminating news on FDA activities and as a liaison with the Public
Health Service and the Department on public information programs.
    2. Plans, develops, implements, and monitors policy and programs on
agency media relations, and consumer information and education programs
conducted through the media, FDA's public affairs specialists, and
other communications sources.
    3. Plans, develops, produces, and publishes agency publications and
graphic arts materials.
    4. Executes Freedom of Information denial authority for the agency.
    5. Directs the effective utilization of all management resources by
coordinating the management, facilities, budget, and equipment
resources for the Office of Public Affairs.
    6. Reviews organizational, management, and administrative policies
of the Office to appraise the efficiency and effectiveness of
operations.
    7. Identifies potential management problems and/or needs and plans,
develops and conducts management studies.
    8. Coordinates speaker requests for industry programs that cover
multi-center issues; identifies potential conflict of interest speaker
requests.
    9. Assists in the programmatic design, development, and planning
with internal and external organizations regarding educational and
informational activities intended to educate regulated industry.
    10. Advises and assists top level agency officials on electronic
media matters involving mass media communications.
    11. Plans, develops, and implements agency wide broadcast media
strategies for disseminating regulatory and educational materials to
the public through the mass media.
    12. Serves as the agency focal point for preparing, clearing and
disseminating electronic media requests representing agency policy and
responding to electronic media inquiries; maintains liaison with
broadcast media contacts.
    13. Establishes policy for and coordinates all broadcast media
information activities, including on-camera interviews and responses to
media inquiries; prepares position and policy statements for use by
agency employees in responding to broadcast media questions; tracks
issues of potential interest to the media.
    14. Plans and coordinates all broadcast media training for the
agency.
    Print Media Staff:
    1. Advises and assists top level agency officials on printed press
matters involving mass media communications.
    2. Plans, develops, and implements agency wide print media
strategies for disseminating regulatory and educational material to the
public through the mass media.
    3. Serves as the agency focal point for preparing, clearing, and
disseminating press releases and other print media statements
representing agency policy and responding to media inquiries; maintains
liaison with news media and pertinent publications.
    4. Establishes policy for and coordinates all print media
information activities, including news interviews and responses to
inquiries; prepares position and policy statements for use

by agency employees in responding to print media questions; tracks
issues of potential interest to the media.
    5. Coordinates the research and drafting of major public statements
by the Commissioner including transmittal documents and supportive
statements for use in transactions with the Department, other agencies,
and the White House; provides editorial consultation and review for
manuscripts, articles, and speeches written by the staff offices
serving the Commissioner to ensure consistency of information and
policy interpretation.
    6. Compiles, publishes, and distributes the weekly FDA Enforcement
Report and the FDA Public Calendar; maintains the FDA Daily Clipping
Service; and coordinates the Daily Media Report.
    Web Site Management Staff:
    1. Responsible for the content and design of the FDA Web site
(www.fda.gov). Develops and interprets the agency's Web policies, and
serves as advocates for FDA's Web presence and catalysts for creative
use of the Web by the agency.
    2. Works closely, as partners, with the FDA Office of Information
Resources Management (OIRM), which is responsible for the technical
operations of FDA's Web site.
    3. Works closely with the Web site contacts in each of the Centers
and principal offices within the Office of the Commissioner (OC) to
plan, coordinate, execute and evaluate the agency's Web site
operations.
    4. Serves as the focal point and contact with the agency,
Department, and other Federal Government Web site programs and
operations.
    5. Provides direction, strategic planning assistance, and
management coordination on agency Web site programs.
    6. Establishes, manages, and monitors the implementation of agency
standards and policies for information published on agency Web sites.
    7. Provides Web-related information management strategy input
through a collaborative effort with OIRM and the Web site operations
staffs in the centers and OC.
    8. Designs, develops, implements, monitors, and manages information
published on the agency's Web site.
    9. Delivers the agency's messages to the public through the
agency's Web site.
    10. Provides Web-related electronic information dissemination
services to the agency and the public.
    Office of Special Health Issues:
    1. Serves as an information resource to FDA and provides advice to
the Commissioner and other key agency officials on matters related to
serious and life-threatening diseases; patient advocacy, and health
professional organizations; minority health and other special health
issues.
    2. Coordinates interactions between FDA and health professional
organizations and patient advocacy groups dealing with serious and
life-threatening diseases and other special health issues.
    3. Serves as a focal point to coordinate contacts between FDA and
other Federal agencies to ensure effective coordination and
communication on serious and life-threatening diseases and other
special health issues.
    4. Provides internal coordination on FDA activities related to
serious and life-threatening diseases, patient advocacy and health
professional organizations, and other special health issues.
    5. Assists in the planning, administration, development, and
evaluation of FDA policies related to serious and life-threatening
diseases, patient advocacy and health professional organizations, and
other special health issues.
    Medwatch Staff:
    1. Coordinates and implements policies and initiatives relating to
human medical product adverse events, including the MedWatch Partners
Program, the MedWatch Web site, and the MedWatch e-list.
    2. Conducts outreach and education to health professionals,
patients and the public to facilitate the reporting of serious harm and
injury associated with the use of human medical products.
    3. Reviews, updates, and disseminates medical product safety alerts
and safety labeling changes.
    Office of Foods:
    1. Provides executive leadership and management to all FDA food-
related programs.
    2. Exercises, on behalf of the Commissioner, direct line authority
over the Center for Food Safety and Applied Nutrition and the Center
for Veterinary Medicine.
    3. Exercises, on behalf of the Commissioner, all food-related legal
authorities that the Commissioner is empowered to exercise under the
Federal Food, Drug, and Cosmetic Act, as amended, the Public Health
Service Act, and other applicable laws.
    4. Directs efforts to integrate the programs of CFSAN, CVM, and the
Office of Regulatory Affairs (ORA) and thereby ensure the optimal use
of all available FDA resources and tools to improve the safety,
nutritional quality and proper labeling of the food supply.
    5. Directs the development of integrated strategies, plans,
policies, and budgets to build FDA's food-related scientific and
regulatory capacities and programs, including recruitment and training
of key personnel and development of information systems.
    6. Represents FDA on food-related matters in dealings with the
Office of the Secretary of HHS, the Centers for Disease Control and
Prevention, the U.S. Department of Agriculture, the White House and
other elements of the executive branch.
    7. Represents FDA on food-related matters in dealings with
Congress.
    8. Represents FDA on food-related matters in dealings with foreign
governments and international organizations.
    9. Directs FDA efforts to build an integrated national food safety
system in collaboration with other Federal agencies and State and local
governments.
    10. Directs a program of public outreach and communications on food
safety, nutrition, and other food-related issues to advance FDA's
public health and consumer protection goals.
    Office of the Chief Scientist:
    1. Provides strategic leadership, innovation and expertise to
enhance and support scientific excellence, integrity and capacity to
achieve the Food and Drug Administration's public heath mission. Key
activities include:
    Fostering development and use of innovative technologies to meet
public health needs, including through its Office of Science and
Innovation, the Critical Path Initiative and cross-Center working
groups.
    Supporting scientific excellence and the professional development
of FDA scientists in all areas (i.e. population/statistical, review,
laboratory and manufacturing sciences), including through the
Commissioner's Fellowship Program, continuing education, and through
relationships and staff exchanges with Universities and others.
    Providing strategic leadership and support for high quality,
collaborative, peer-reviewed scientific activities at FDA that advance
regulatory science and address important public health and regulatory
issues concerning FDA regulated products, including their evaluation,
quality, safety and effectiveness. This includes support for the
National Center for Toxicological Research to serve as a national FDA
resource for mission driven regulatory science.
    Supporting scientific outreach, training, collaboration in
research, development and Critical Path activities that advance FDA's
mission, with other

Federal agencies, global regulatory partners, academia (e.g., through
planned Centers of Excellence in Regulatory Science), innovators, and
consumers.
    Supporting science and public health activities to effectively
anticipate and respond to emerging deliberate and natural threats to
U.S. and global health and security including through the Office of
Counterterrorism and Emerging Threats and a planned Center for
Innovation in Medicine and Public Health.
    Providing core scientific leadership and technical expertise, and
ensuring agency capacity, for advanced bioinformatics activities needed
to support FDA programs (e.g. scientific computing to allow analysis of
large health care and safety datasets, genomic and other complex
laboratory data, and simulation and modeling) . Serve as an agency and
government resource for excellence, methods development, outreach and
partnerships in advanced bioinformatics science.
    Leading agency efforts to protect and enhance scientific integrity,
and, where substantive scientific differences of opinion arise and
require review at the FDA level, addressing them through appropriate
processes intended to protect both FDA's mission and the integrity of
its science.
    Office of Counter-Terrorism and Emerging Threats:
    1. Develops and implements a comprehensive counterterrorism
strategy for FDA to identify and address gaps in current efforts to
safeguard food and medical products from adulteration or disruption of
supplies due to terrorist activities.
    2. Develops and coordinates the implementation of crosscutting
policies to facilitate the availability of safe and effective medical
countermeasures against chemical, biological, radiological, and nuclear
agents of concern.
    3. Provides policy leadership for FDA's Emergency Use Authorization
(EUA) activities for terrorism and public health emergencies, including
emerging threats.
    4. Develops and implements, in collaboration with the Centers and
Offices and with external partners, comprehensive FDA plans and
strategies for pandemic influenza preparedness and other emerging
threats.
    5. Provides policy leadership by promoting the goals and needs for
counterterrorism and other emerging threats in the agency budgeting and
priority-setting processes.
    6. Coordinates the portfolio of FDA counterterrorism and pandemic
influenza policy and planning initiatives and serves as the point of
entry to the agency on counter-terrorism and emerging threats policy
and planning matters.
    7. On behalf of the Office of the Commissioner, facilitates intra-
and inter-agency communications on counterterrorism policy and pandemic
influenza preparedness.
    Office of Critical Path Programs:
    1. Serves as the focus for cross-center scientific and medical
initiatives and policy development related to the Critical Path (CP)
initiative and related activities in the Office of the Commissioner.
    2. Assists the Chief Scientist in planning, executing, and
monitoring projects, including, CP-related cross-center and interagency
projects and collaborations with other agencies, academia, and industry
as identified by the Office of the Commissioner and the Department of
Health and Human Services.
    3. Serves as the focus for cross center bioinformatics activities,
including data management and analysis. Supports agency Bioinformatics
Board and Data Councils.
    4. Performs project development, project management, policy and
document development and clearance, and related tasks as directed by
the Chief Scientist.
    5. Coordinates related administrative activities (e.g., personnel,
communication, staffing, purchasing, and CP-related travel).
    Office of Scientific Integrity:
    1. Helps ensure consistent understanding, application and
implementation of regulatory standards throughout FDA to ensure
integrity and accountability of FDA functions and processes.
    2. Provides advice and guidance to the Commissioner, Chief
Scientist, and other key officials regarding premarket approval
processes for all FDA-regulated products including requirements
pertaining to applications, petitions, amendments and supplements; and
product, processing, packaging and emerging product technologies.
    3. Advises and assists senior FDA leadership in coordinating
responses to allegations of patterns of deviations by FDA or its
components from appropriate standards of conduct and performance. Also
advises and assists senior FDA leadership in preventing such
deviations.
    4. Investigates and resolves informal complaints and disagreements,
whether generated internally or externally, with respect to the
administrative processing of various applications for products
regulated by the agency as well as regarding the fair and even-handed
application of agency policy and procedures in this process.
    5. Processes all formal appeals, or requests for review, that are
submitted to the Office of the Commissioner, whether generated
internally or externally, including requests for hearings, appeals from
administrative actions, and requests to review decisions at a lower
level of the agency. Examples include, but are not limited to, requests
for hearings in debarment and disqualification proceedings, requests to
review decisions by the Centers, the Office of Regulatory Affairs, and
elsewhere in the Office of the Commissioner under 21 CFR 10.75, appeals
of formal or informal hearings, and agency-level scientific dispute
resolution matters.
    6. Advises and assists the Chief Scientist and senior leadership in
evaluating and resolving all formal appeals, requests for review, and
requests for hearings submitted to the Office of the Commissioner and
coordinates responses to such appeals and requests.
    7. Develops regulations and procedures to promote an efficient and
effective process for addressing and resolving formal appeals, requests
for review, and requests for hearings, as well as any other types of
disputes suitable for formal resolution in the Office of the
Commissioner.
    8. Leads Advisory Committee Oversight and Management Staff, working
in close collaboration with all FDA Centers to provide consistency in
and continuously improve the operations of agency advisory committees.
    9. Serves as the liaison between the Office of the Secretary, the
Department Committee Management Office, all of FDA's Center advisory
committee support staff, and other organizations/offices within FDA.
    10. Ensures that all FDA committee management activities are
consistent with the provisions of Federal Advisory Committee Act,
departmental policies, and related regulations and statutes.
    11. Coordinates with the Office of Appeals, within the Office of
Scientific Integrity, to determine whether an informal complaint should
be construed and treated as a request for formal review by the Office
of the Commissioner under established regulations or procedures.
    Office of Science and Innovation:

    1. Provides strategic leadership, coordination, infrastructure and
support for excellence and innovation in FDA science that will advance
the agency's ability to protect and promote the health of the public.
Key activities include:
    Providing support for high quality, collaborative, peer-reviewed
scientific activities throughout FDA that address important public
health and regulatory issues concerning FDA regulated products,
including their evaluation, quality, safety and effectiveness.
    Fostering development and use of innovative technologies to meet
public health needs, including through a planned Center for Innovation
in Medicine and Public Health and through core scientific capacity to
support FDA's regulatory functions and decision making.
    Supporting excellence and the professional development of FDA
scientists in all areas (i.e. population/statistical, review,
laboratory and manufacturing sciences), including through the
Commissioner's Fellowship Program, continuing education and
professional activities (including clinical activities, cross agency
working groups, and through relationships and staff exchanges with
Universities and others.
    Addressing scientific and public health priorities through support
of high quality, peer reviewed scientific research, programs and
related activities, both within and outside FDA and collaboratively,
and through dissemination of new scientific information, methods and
approaches.
    Supporting scientific outreach, training, and collaboration in
research and development activities that advance FDA's mission,
including with sister agencies, global regulatory partners, academia
(e.g., through planned Centers of Excellence in Regulatory Science),
innovators, and consumers.
    Seeking input from both FDA programs, stakeholders and outside
advisors, including the FDA Science Board, to help define, review and
meet FDA scientific needs and priorities to support our public health
mission.
    Office of International Programs:
    1. Serves as the agency focal point for all international matters.
    2. Serves as the primary agency liaison with other U.S. Government
components, international and foreign governments (including
Washington, DC embassies) for policy formulation and execution
impacting FDA and FDA regulated products.
    3. Provides leadership to agency program areas for international
activities.
    4. Serves as the focal point for the agency and the authority for
policies and procedures pertaining to international travel.
    5. Serves as the focal point and final clearing authority for all
international technical cooperation and assistance activities.
    6. Serves as the agency focal point and final clearing authority
for all international programs and interactions with foreign
counterpart regulatory agencies, international organizations, foreign
embassies, all foreign officials, and with agency and all other United
States Government components when international issues are involved.
    7. Directs, manages, and leads agency strategic planning, priority-
setting and resource allocation processes for agency international
programs.
    8. Serves as the agency focal point and final clearing authority
for trade issues involving e.g., North American Free Trade Agreement
(NAFTA), World Trade Organization (WTO), Free Trade Area of the
Americas (FTAA), Asia Pacific Economic Cooperation (APEC), and United
States Trade Representative (USTR).
    9. Serves as the agency focal point and final clearing authority
for formal arrangements with foreign governments e.g., memoranda of
understanding (MOU), mutual recognition agreements (MRAs), exchange of
letters, partnerships, equivalence issues, country assessments, and
confidentiality commitments.
    10. Serves as the agency focal point on policies and procedures for
sharing public and non-public information and, in conjunction with the
Office of Regulatory Affairs, import/export policy issues.
    11. Manages the agency's foreign offices, including FDA staff
deployed in foreign locations and all related budgeting, strategic
planning, priority setting and resource allocation.
    Office of Administration:
    1. The Office of Administration (OA) will focus on enhancing agency
wide administrative operations and overseeing a variety of agency-wide
management programs, information management, financial and shared
services operations, as well as the Office of the Commissioner's
executive operations.
    2. Provides executive direction, leadership, coordination, and
guidance for the overall day-to-day administrative operations of the
agency assuring the timely and effective implementation and high
quality delivery of services across the agency and centers.
    3. Advises and assists the Commissioner, Deputy Commissioners,
Chief of Staff, and other key agency officials on various
administrative management and business activities of the agency. Chairs
the Prescription Drug User Fee Act (PDUFA) Review Board, which oversees
financial management of the PDUFA program.
    4. Assures that the conduct of agency administrative and financial
management activities, including budget, finance, personnel,
organization, methods, and similar support activities, effectively
support program operations.
    5. Utilizes a call center to address all administrative and
information technology management issues, and monitors and analyzes
operational performance and customer satisfaction.
    6. Plans, directs and coordinates a comprehensive financial
management program for FDA encompassing the areas of automated
financial systems, fiscal accounting, voucher audit, and financial
reporting. Issues periodic reports regarding the status of FDA's
financial management and develops financial inputs for the agency's
programs and financial plans.
    7. Provides leadership and direction regarding all aspects of a
variety of agency management programs including organization
management, delegations of authority, freedom of information, Privacy
Act, and regulatory dockets management as well as programs related to
ethics and conflict of interest matters.
    8. Advises the Commissioner and other key agency officials on
administrative management and budget matters for components within the
Office of the Commissioner. Provides advice and guidance with regard to
formulation and development of administrative management policies,
procedures, and controls.
    9. Provides advice and assistance to the Commissioner and senior
management officials on information management resources and programs.
Establishes and oversees implementation of the FDA information
management policy and governance, procedures and processes to ensure
the agency is in conformance with the Clinger/Cohen Act. Establishes,
directs and leads agency level programs and all strategic aspects of
information management including: information technology (IT) shared
services, telecommunications, security, strategic planning, capital
planning and investment control, and enterprise architecture.
    Office of Equal Employment Opportunity and Diversity Management:
    1. Advises and assists the Commissioner and other key officials on

equal employment opportunity (EEO), Diversity, and Civil Rights
activities which impact on policy development and execution of program
goals.
    2. Serves as the agency focal point and liaison to the Department,
other Federal agencies, State and local governments, and other
organizations regarding EEO, Diversity, and Civil Rights matters.
    3. Develops and recommends policies and priorities designed to
implement the intent of the Office of Personnel Management, Equal
Employment Opportunity Commission, and Office of Civil Rights,
Department of Health and Human Services requirements under Executive
Orders, regulations, EEO and Civil Rights legislation.
    4. Provides leadership, direction, and technical guidance to the
agency on EEO, Diversity, and Civil Rights matters.
    5. Examines the use and impact of administrative mechanisms on work
assignments, pay systems, award systems, performance appraisal systems,
promotion patterns, reorganization impacts, delegations of authority,
management controls, information and documentation systems, and similar
functions of management as they impact upon equal employment
opportunities for all employees within the agency.
    6. Issues policies, publications and information dissemination
services to agency employees including Commissioner Policy Statements,
brochures, the EEO Counselors Manual, etc.
    Compliance Staff:
    1. Develops plans, programs, and procedures designed to assure the
prompt adjudication of complaints of alleged discrimination based on
race, color, sex, age, religion, national origin, handicap, and sexual
orientation.
    2. Provides sign language interpreting services and manages the
interpreting services contracts.
    Conflict Prevention and Resolution Staff:
    1. Provides confidential, informal assistance to employees and
managers in resolving work-related concerns.
    2. Develops and coordinates effective resolution processes and
procedures.
    3. Offers a variety of services and programs to address likely
sources of conflict such as performance appraisals, harassment,
mentoring relationships, and scientific collaboration.
    4. Operates as a neutral, independent, and confidential resource
providing informal assistance to FDA scientists, administrators, and
support staff in addressing work-related issues. Assists in resolving
conflicts and addressing concerns prior to and within established
grievances processes.
    5. Provides a neutral and impartial resource where employees can
candidly discuss issues and explore options informally.
    6. Provides alternative dispute resolution and mediation services
as needed.
    7. Develops and maintains training and technical assistance for
agency EEO specialists, counselors, special emphasis/program
representatives, employees, supervisory personnel, and other key
officials.
    Diversity Staff:
    1. Develops and oversees agency diversity initiatives and the
diversity databank.
    2. Develops, implements, and monitors the agency's Affirmative
Employment Plan and directs the agency's Affirmative Employment
programs to achieve specific objectives.
    3. Develops labor-management partnerships on EEO and Diversity
matters. Provides sign language interpreting services and manages the
interpreting services contracts.
    Office of Acquisitions and Grants Services:
    1. Serves as the agency focal point for developing, coordinating,
and implementing FDA policies and procedures pertaining to
acquisitions, interagency agreements, technology transfer and grants
management; coordinates all administrative matters related to
acquisitions, grants, cooperative agreements, interagency agreements,
memoranda of understanding and technology transfer.
    2. Provides acquisition management information and overall policy
and technical support to all levels of the Office, agency, Department,
and the Federal government in the areas of technology transfer, patents
and acquisition and assistance matters.
    3. Maintains liaison with the Department on contracts and grants/
assistance management policy and procedural and operating matters;
serves as the FDA focal point for the processing of audit reports and
for liaison with the agency Office of Inspector General.
    4. Provides the oversight function to all levels of the agency in
the Small Business contracting program.
    5. Provides technical and legal guidance in all areas of the agency
printing management program.
    6. Develops policy for printing to insure timely and cost effective
implementation of the agency printing program.
    Division of Acquisition Operations:
    1. Responsible for mission specific contracts and simplified
acquisitions, including research and development requirements and lab
supply and equipment requirements.
    2. Responsible for acquisition of service contracts and simplified
acquisitions, including but not limited to, furniture, security, events
management, temporary services, moving, library support, custodial,
etc.
    Division of Acquisition Support And Grants:
    1. Develops acquisition policy. Provides customer relation support,
responding to contract related FOIA requests, and ratifying
unauthorized procurements.
    2. Provides current policies and procedures to assist the FDA
community to develop and transfer Federal technology to the commercial
marketplace.
    3. Negotiates, awards and monitors Federal funds awarded through
various grant mechanisms.
    4. Awards and administers Inter-agency Agreements (IAGs). Assigns
Memorandum of Understanding (MOU) tracking number and maintains MOU
files.
    5. Provides managerial oversight of the agency's purchase card
program. Serves as liaison with the bank, processing administrative
functions, providing training and other assistance to ensure that
participants understand their responsibilities under the program.
    Division of Acquisition Programs:
    1. Responsible for all information technology related contracts and
simplified acquisitions related requirements.
    2. Provides facility support, construction and renovation,
architect/engineering services contracts and simplified acquisitions
for all headquarter locations, Irvine, San Juan, and Dauphin Island.
    3. Provides contracts to support the MQSA, Food, Tissue and
Medicated Feed/BSE Programs. These contracts commission the States to
conduct inspections to ensure the quality and safety of the nations'
food, animal feed and medical devices.
    4. Responsible for simplified acquisitions for ORA Headquarters and
the Office of Criminal Investigations.
    Division of Information Technology:
    1. Responsible for all information technology related contracts and
simplified acquisitions related requirements.
    Office of Executive Operations:
    1. Develops policy and provides guidance, advice and oversight to
Office of the Commissioner (OC) staff with regard to programmatic FDA
and OC administrative management policies, procedures, and controls.
    2. Advises the Commissioner and other key agency officials on

administrative, financial and information management matters for
components within the Office of the Commissioner (OC).
    3. Manages the OC budget formulation and execution activities.
Provides advice, guidance and direction on the administration of the OC
budget.
    4. Manages a variety of program administrative services including
but not limited to travel, space, time and attendance, property, etc.
for OC offices with appropriate officials. Establishes and maintains
liaison with administrative staff throughout the OC to keep abreast of
current policies and procedures.
    5. Serves as OC liaison for acquisitions and grants activities
ensuring compliance with agency and Federal contracting policies.
    6. Coordinates and provides guidance and oversight concerning OC
information management activities including those related to activities
of FDA Bioinformatics Board.
    7. Advises the Commissioner and Deputy Commissioners and other
senior staff concerning all OC human capital programs and activities.
    Office of Financial Operations:
    1. Plans, directs, and coordinates a comprehensive financial
management operations program for FDA encompassing the areas of budget
analysis, execution, automated financial systems, fiscal accounting,
voucher audit, financial services related to accounts payable, travel
support and payroll liaison, and financial reporting. Provides staff
assistance in justifying budgets through executive and congressional
echelons. After appropriation, develops an orderly expenditure plan.
    Office of Financial Management:
    1. Plans, directs, and coordinates a comprehensive financial
management program for FDA encompassing the areas of budget analysis,
formulation and execution, automated financial systems, fiscal
accounting, voucher audit, and financial reporting. Provides staff
assistance in justifying budgets through executive and congressional
echelons. After appropriation, develops an orderly expenditure plan.
    2. Develops apportionment plans and issues allotments for
expenditures.
    3. Makes periodic reports regarding the status of FDA's financial
management.
    4. Develops financial inputs for the agency's programs and
financial plans.
    Division of Accounting:
    1. Plan, evaluate and coordinate activities to ensure Food and Drug
Administration (FDA) is in compliance with Federal government
accounting policy and procedures.
    2. Principal contact to ensure FDA compliance with Chief Financial
Officers Act (CFO) audit activities.
    3. Devise and implement new and creative mechanisms to streamline
administrative procedures; for example, implementation or electronic
certification for treasury schedules expansion of lock box techniques.
    4. Operates the Prompt Pay System for FDA, which pays over 50,000
invoices annually, providing integrity checks throughout the system
from receipt of the invoice to payment.
    5. Maintains over 400 headquarters and field users of automated
financial systems as they request assistance with problems and special
requests using various systems and special reports.
    6. Operates and maintains the FDA District Electronic Certification
System, which processes payments for vendors and travelers for all FDA
districts while complying with Treasury's directive on EFT payments.
    7. Produces daily, biweekly, monthly and yearly budgetary reports
for field and headquarters components.
    8. Liaison with Shared Services Organization.
    User Fee Staff:
    1. Manages and oversees the receipt, deposit, and allocation of
user fees paid by industry.
    2. Prepares annual revenue reports for submission to Congress.
    3. Reports on FDA's compliance with Congressional mandates.
    4. Develops, manages user fee systems.
    Division of Budget Execution and Control:
    1. Provides guidance and advice on the management and development
of the budgets for FDA's Office of the Commissioner and Headquarters.
Conducts analysis about agency-level and cross-component accounts,
trends, and projects. Interpret agency requirements and establish FDA
policy/procedures on all phases of budget execution.
    2. Apportions funds appropriated by Congress among components and
oversees transfers of funds between components.
    3. Completes detailed reviews and analyses of components' financial
operating plans at the end of each quarter. Ensures budgetary resources
are used in a manner consistent with the agency's mission and are not
over spent or obligated beyond appropriate limits.
    4. Manages key agency-level accounts and shared costs, such as FDA
rent and central accounts.
    5. Assists in the preparation of historical budget-related data,
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.
    Division of Payment Services:
    1. Performs billing and collecting services for headquarters
accounts. Maintains internal control over processing of transactions to
accounts, including application of batch controls to ensure accurate
coding and making of necessary accounting transaction adjustments and
corrections.
    2. Maintains liaison with the Department of Central Payroll on
headquarters payroll operations. Reconciles payroll data with accounts.
Maintains tax withholding files. Issues withholding statements.
    3. Processes employee time records; resolves payroll errors and
assists employees with pay problems; issues new procedures as needed.
    4. Participates in reengineering the payroll process to streamline
correction of errors and reduce first time errors; and participates in
timekeeper training.
    5. Processes all purchase orders, receiving reports, and invoices
for commercial payments made by the Food and Drug Administration (FDA)
headquarters, assuring compliance with accounts and the Prompt Pay Act.
    6. Coordinates with vendor and center personnel in researching
payment information.

    7. Responds to all vendor inquiries as well as inquiries from
center personnel.
    8. Prepares various reconciliations to ensure that schedules are
properly accounted for and entered into the accounting system.
    9. Reviews and distributes monthly accounting reports and processes
corrections, as necessary.
    10. Liaison with the Department of Treasury to initiate check
traces.
    Division of Travel Services:
    1. Oversees processing of vouchers, including audit, matching with
obligations, and scheduling for direct deposit using Travel Manager
Software.
    2. Oversees post audit of travel vouchers.
    3. Provides travel advice/guidance throughout the agency, including
significant research on Comptroller General Decisions; participates in
training on travel procedures.
    4. Oversees contractor processing of all headquarters and field
Permanent Change of Station travel vouchers, including complex tax
calculations.
    5. Coordinates with the General Services Administration (GSA)
contractual travel agent to ensure the Food and Drug Administration
(FDA) travel and transportation requirement are met.
    6. Field activities perform travel services directly for ORA and
NCTR to include NCTR travel, ORA international travel, FATA
responsibilities, data calls, travel audits, 348 travel and conference
reporting.
    Office of Information Management:
    1. Develops the architecture, standards, policies, governance, best
practices and technology road map that support the business priorities
of the agency, including managing information technology
infrastructure, telecommunications, security, strategic planning,
capital planning and investment control, enterprise architecture, and
applications development and; management. Provides advice and
assistance to the Commissioner and senior management officials on
information technology resources and programs.
    2. Establishes and oversees implementation of the Food and Drug
Administration (FDA) information technology policy and governance,
procedures and processes to bring the agency in conformance with the
Clinger/Cohen Act and the Paperwork Reduction Act. Provides leadership
and direction regarding all aspects of the agency records management
program.
    3. Works in full partnership with FDA business areas, develops and
communicates the overall vision for the agency's IT program.
    4. Provides expert technical evaluation and recommendations for the
new and emerging technologies to ensure the agency's IT program can
proactively adjust to changing business needs and technology drivers.
    5. Represents the agency IT program on internal and external
meetings and workgroups on agency information technology programs and
issues (e.g., Health and Human Services (HHS) Chief Information Officer
(CIO) Council, FDA Leadership council, FDA level Review boards, etc.).
    6. Establishes policies and procedures for system risk assessments
and system business continuity and contingency planning.
    Division of Business Partnership Support:
    1. Advocates, communicates, provides, and manages liaison services
and provides management and technical consultation resources regarding
information technology to FDA offices, centers and other FDA
stakeholders, including parties external to FDA (non-govt, e.g., PHRMA,
BIO, DIA, ICH, etc) and PHS, Department, and other Federal government
IRM and ADP operations.
    2. Collaborates with BIB and the BRBs to prioritize new business
requirements and establish projects which will require PM's and
designs, develops and maintains the communication plan for all
Enterprise agency projects the BIB, BRBs, and OIM.
    3. Collaborates with other divisions within OIM to review request
for each system; providing estimates for implementation and to assist
in the establishment of priorities and schedules (overarching timeline
of all projects/independencies), as well as ensure project/investment
formulation, execution and actual information is reported.
    4. Oversees and manages IT program and project management
activities of major IT initiatives following project management best
practices (Project Management, System Development, and Enterprise
Program life cycles), in collaboration with the Division of CIO
Support/Governance Branch, develops policies and procedures on all
aspects of project planning, and interacts with and coordinates
responses to the Department and OMB on all project management related
activities.
    5. Coordinates development of Center/Offices IT budget and provides
support for budget execution and contract monitoring of information
resources.
    6. Oversees day-to-day operations of FDA web development, redesign,
and web hosting environment.
    7. Manages FDA Forms programs and is the lead for agency Section
508 implementation.
    8. Receives user requests, orders, and issues desktop-related tools
and equipment.
    9. Manages and oversees help desk services and user support for
infrastructure Center and/or FDA-wide applications (excludes field help
desk which is part of the Division for Infrastructure Operations).
    Division of Chief Information Officer Support:
    1. Establishes and maintains an agency Enterprise Architecture (EA)
governance structure that includes processes for systems, business,
data, applications, technology, and security architectures.
    2. Serves as a focal point within FDA and as a liaison between FDA
and external public and private sector organizations regarding
enterprise standards, IT architecture, investment management practices
and related methodologies, data sharing and support services, and
regarding all aspects of IT planning, development and management.
    3. Develops, tracks and maintains the IT budget, operating plan,
and acquisition plan. Manages and maintains an acquisition strategy
policy and implements all aspects of contract administration and
management for the Office of Information Management.
    4. Plans, organizes and manages FDA's IT investment management
process (CPIC) to ensure that IT resources are acquired and managed
effectively, and to ensure effective ongoing control of IT investments.
Additionally, architectural reviews of IT investments are conducted to
ensure alignment with business functions, avoid duplication of effort,
reduce costs, and improve the efficiency and effectiveness of IT
initiatives and to ensure that the FDA IT enterprise employs
appropriate standards.
    5. Coordinates the agency IT risk management program, including
identification, analysis, and mitigation and reporting of program and
system level weaknesses. The division also maintains and audits
compliance for system risk assessments and system business continuity
and contingency planning.
    6. Establishes administrative policies for OIM consistent with
agency policies and manages all administrative activities including
Administrative Support, Travel and Timekeeping.
    7. Develops, maintains and manages the electronic records (e-
records) policy within the Office of Information Management and
coordinates as

necessary with other business entities within the FDA on records
management activities.
    8. Provides management of all aspects of human capital in the
recruitment, hiring, deployment, development, management, training and
evaluation of the OIM workforce to ensure that human capital programs
are aligned with organizational goals and agency Human Resource
requirements.
    9. Develops and disseminates administrative internal communications
and operational procedures for the OIM in coordination with the
Communications Team. Keeps abreast of agency and office rules,
regulations, procedures, policies and decisions
    Division of Systems Management:
    1. Designs, develops, implements, and maintains all agency software
applications, IT systems, systems support and maintenance, and their
integration with other Federal agencies, State and foreign governments
and public and private entities.
    2. Establishes and implements an Enterprise IT Common Component
Framework containing modules/services to be shared across FDA
information systems and maintains FDA enterprise applications through
effective evaluation, streamlined application development, monitoring,
testing, and control of agency-wide systems utilizing e-platform
initiatives and interchangeable common components in order to support
FDA business process needs and objectives efficiently and effectively.
    3. Validates requirements for and directs the design, development
and implementation of new system requirements, system enhancements and
system maintenance changes for the agency, performs systems analyses to
develop and implement testing strategies, procedures and methodologies,
especially automated varieties, and develops and implements system
specifications, requirements, procedures and guidelines.
    4. Designs, develops, implements, and maintains standards-based
electronic IT data systems and repositories that provide the FDA with
an integrated and interoperable information environment to receive,
track, analyze, and disseminate knowledge on FDA business/program
activities and directs the development and implementation of FDA Data
Administration policies standards and procedures to ensure design
consistency, including review of work products for compliance with
standards.
    5. Assists in the development and implementation of technical
specifications and plans for 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.
    Division of Technology:
    1. Reviews and evaluates the appropriateness of new and emerging
information technologies, including those with potential science and
laboratory benefits and enterprise architecture, for incorporation into
existing systems and applications and for use in future agency
supported initiatives.
    2. Oversees the establishment and implementation of technology
through an enterprise approach of common IT frameworks, connectivity
and consistent practices, standards and policies to enable and support
interoperability and consistency throughout the agency.
    3. Establishes and manages, through an enterprise approach, the
development of standards, including governance for reusable templates,
services and common functions for application development.
    4. Interacts with HHS, and other interagency groups to guide and
align FDA to Government-wide initiatives regarding information
technology.
    5. Regularly attends industry and other technology meetings to stay
abreast of emerging trends and technologies.
    6. Directs and implements the FDA information security program to
ensure that security controls for hardware, software and
telecommunications solutions are: effective, facilitate the continuity
of operations for FDA information systems, protect privacy,
confidentiality and availability of FDA data; that they manage system
security policies and standards for FDA information systems enterprise-
wide in accordance with the agency, HHS, GSA, OMB and other Federal
government security requirements.
    7. Directs and responds to security audits and collaborates with
assessment teams and other agency groups to develop and implement
corrective action plans.
    8. Establishes and communicates policies and procedures for system
risk assessments and system business continuity and contingency
planning.
    9. Oversees disaster recovery planning for data center operations
and coordinates with other divisions within OIM to plan, monitor, and
test recovery plans for all applications throughout FDA.
    10. Develops and monitors scientific workstation standards. Designs
and implements new IT methods and applications for scientific computing
for Bioinformatics Board activities.
    Office of Management:

    1. Advises and assists the Commissioner, Deputy Commissioner,
Associate Commissioners and other key agency officials on various
management and systems activities.
    2. Assures that the conduct of agency administrative, personnel,
organization, and similar support activities effectively support
program operations.
    3. Provides leadership and direction regarding all aspects of a
variety of agency management programs, including ethics, dockets
management, organization management, delegations of authority and
special studies and projects for the Office of the Commissioner.
Establishes agency-wide policy and provides overall direction and
leadership for the Freedom of Information (FOI) program and Privacy Act
program.
    4. Integrates the agency's technical, programmatic and facilities
requirements into the overall budgetary and development plan for the
agency's consolidation. Implements relocation planning needed to
successfully transition the agency into its new location.
    5. Provides Food and Drug Administration's administrative services
and facilities. Utilizes a call center to address all administrative
and information technology management issues, and monitors and analyzes
operational and customer satisfaction.
    6. Provides leadership and direction regarding all aspects of
agency-wide human resources management including employment,
recruitment, training, career development, partnership activities,
quality of work life issues, and executive services.
    7. Provides program, technical and resources management for the FDA
White Oak consolidation, logistics and facilities operations and
maintenance services.
    8. Provides leadership and guidance to the agency for all aspects
of physical and personnel security including the suitability and
National Security Information Program. Develops and implements agency
wide security policy.
    9. Manages and administers the suitability and security program as
required by the Office of Personnel Management as set forth in
``Suitability'' (5 CFR, Part 731), and ``National Security Positions''
(5 CFR, Part 732). Monitors the appropriate security clearance levels
for agency positions, employees, and contract employees.
    10. Processes clearance requests, reviews investigative reports/
findings and makes suitability determinations based on investigative
findings.
    11. Develops and directs the agency wide physical security programs
and provides professional leadership and authoritative guidance.
    12. Formulates policy and procedures necessary to maintain the
integrity of privileged and trade secret information submitted by
industry.
    13. Develops and manages the agency's contractor security program
when Automated Data Processing services or non-public information is
released under contract agreement.
    14. Serves as the single point of contact and focus for the
Operating Division's management of more than 800 PHS commissioned
officers assigned to approximately 150 duty stations in 47 states.
    15. Provides coordination between FDA management and the Assistant
Secretary for Health's Commissioned Corps programs. Serves the FDA
Centers, special assignments and details to other organizations and
initiatives.
    16. Develops and implements all policies for utilization of all PHS
Commissioned Officers in FDA. Coordinates all orders, billets,
Commissioned Officer Effectiveness Reports, promotions, and awards for
commissioned officers.
    Ethics and Integrity Staff:
    1. Develops agency policy and procedures implementing the
``Standards of Ethical Conduct for Employees of the Executive Branch''
(5 CFR, Part 2635) including the Department of Health and Human
Services (DHHS) supplemental regulations (5 CFR, Part 5501).
    2. Monitors employee compliance with Federal regulations by
reviewing employees' financial disclosure reports and outside activity
requests. Reviews, prepares, evaluates and secures appropriate
approvals for waivers and other determinations regarding financial
interest, conflict of interest and other ethical issues. Counsels
employees and provides authoritative advice on the statutory,
regulatory, policy and procedural requirements regarding ethics and
conflict-of-Interest issues. Develops and conducts training for
supervisors, managers, administrative staff, special government
employees and other agency employees. Provides oversight and direction
to the agency's Advisory Committee program as it relates to special
government employees. Assures that conflicts of interest waivers are
consistent, legally supportable, well-documented and timely. Evaluates
cooperative agreements developed by agency components under the Federal
Technology Transfer Act and provides technical advice on any related
conflict of interest matters.
    3. Provides advice to employees to ensure their compliance with
applicable regulations and statutes on the following: (1) ``Standards
of Ethical Conduct for Employees of the Executive Branch'' (5 CFR, Part
2635); (2) ``Supplemental Standards of Conduct for Employees of the
Department of Health and Human Services'' (5 CFR, Part 5501); (3)
``Executive Branch Financial Disclosure, Qualified Trusts, Certificates
of Divestiture'' (5 CFR, Part 2634); and (4) Criminal Conflict of
Interest Statutes--Chapter 11--Bribery, Graft, and Conflicts of
Interest (Chapter 11 of Title 18 U.S.C.)
    4. Serves as liaison with other FDA components and the agency
Office of General Counsel/Ethics Division to develop co-sponsorship
agreements.
    5. Provides executive and administrative support to the Conflict of
Interest Review Board.
    6. Coordinates Board activities, prepares background materials,
analyzes recommendations and other correspondence for Board members and
participates in Board decisions. Implements decisions including
advising affected employees of Board determinations.
    Office of Business Operations and Human Capital Programs:
    1. The Office of Business Operations and Human Capital Programs is
responsible for planning and directing agency management programs to
include administering the FDA administrative policy programs. The
following are specific functions within the Office:
    Provides leadership and direction regarding all aspects of a
variety of agency management programs, including strategic human
capital, organization management, delegations of authority, competitive
sourcing, executive resources management, performance management,
rewards and recognition, workforce development and succession planning.
    Provides executive leadership and direction to coordinate and
operationalize the agency's business process improvement initiatives to
increase quality, productivity, and transparency.
    Oversees the development, prioritization and implementation of
business process improvement recommendations to provide predictable,
consistent and efficient application of decision-making standards,
increase internal and external process transparency resulting in
process clarity for internal and external stakeholders and improve the
overall

operation and effectiveness of FDA resulting in productivity and
efficiency gains.
    Provides agency-wide leadership and guidance for all aspects of
physical and personnel security including the Suitability and National
Security Information program.
    Develops and implements agency wide security policy.
    Office of Management Programs:
    1. Provides leadership and direction regarding all aspects of a
variety of agency management programs, including strategic human
capital, organization management, delegations of authority, competitive
sourcing, executive resources management, performance management,
rewards and recognition, workforce development and succession planning,
and special studies and projects for the Office of the Commissioner.
The following are specific functions within the Office:
    Provides management analysis support and advisory services to the
Office of the Commissioner and other agency components.
    Serves as the agency focal point for FDA's organizational
management and delegations of authority program, including monitoring
of the establishment, abolishment, modification, transfer or
consolidation of agency organizational components and their functional
statements, and administering the Standard Administrative Code (SAC)
system.
    Provides direction and oversight for the agency's Competitive
Sourcing Program, including the development of the FAIR Act Inventory,
evaluating the efficiencies of the Most Efficient Organization,
establishing policies, and advising senior leadership.
    Manages the agency's human capital program, ensuring that human
capital management programs are merit-based, effective, efficient and
supportive of mission goals; alignment of human capital strategies with
agency mission/goals; assessing workforce staffing needs; ensuring
continuity of effective leadership to manage programs and achieve
goals; and identification of mission-critical competency gaps and
strategies to close the gaps and hire/retain necessary talent.
    Provides leadership, direction, policy development, and oversees
the performance management programs covering the Senior Executive
Performance Management Program and the Performance Management Appraisal
Program.
    Provides leadership, direction, policy development and program
management for agency workforce and succession planning activities.
    Provides leadership, direction, policy development and program
management for a variety of incentive programs, including recruitment,
retention and relocation incentives, annual leave service credit,
student loan program, Telework, etc.
    Provides leadership, direction, policy development, program
management, and training for special appointment authorities, including
the Intergovernmental Personnel Act (IPA), Senior Executive Service
(SES), Title 38, and Title 42, (including Service Fellowship, Senior
Science Managers, and Senior Biomedical Research Service (SBRS)).
    Provides leadership, direction, policy development and program
management for compensation programs including the hiring and
advancement within the Senior Executive Service (SES), SBRS, Title 38,
Title 42, Service Fellowships, as well as waiver of overpayments, etc.
    Assists the Office of the Chief Scientist in the management of peer
review processes for scientific positions by: (1) Providing
classification services for peer reviewed positions, and (2) providing
staff support and advisory services for the SBRS.
    Manages the agency reward and recognition programs, including the
agency Honor Awards Program.
    Provides leadership and direction to the agency for meeting the
government's competitive sourcing program outlined by OMB Circular A-
76, Performance of Commercial Activities.
    Provides strategic management of human capital in the recruitment,
deployment, development and evaluation of the FDA workforce to ensure
human capital programs and policies are aligned with organizational
goals.
    Provides leadership and direction on agency workforce planning and
succession planning activities.
    Develops and coordinates the implementation of policies,
procedures, and review activities for the agency's peer review program.
Provides classification services for research scientists, medical
officers, consumer safety officers, and related positions. Provides
leadership and direction in the effective and efficient use of
resources by conducting management and policy studies and providing
management consulting services to the Office of the Commissioner.
Employs a variety of data gathering and quantitative analytical
techniques to determine the merit of current and proposed management
policies and procedures and to assess the impact of new policies and
legislation.
    Provides management analysis services to the Office of the
Commissioner to assess program and management concerns, which may
include management studies, option papers, reports, and working group
facilitation.
    Provides organizational expertise and policy advice, consultation,
and support to agency components and monitors the establishment,
abolishment, modification, transfer, and/or consolidation of the agency
organizational components and their functional statements; controls the
assignment of standard administrative codes for implementation of
approved organization proposals in the agency and serves as the agency
liaison with the Department on SAC activities.
    Plans, develops, modifies, and coordinates the delegations of
authority program for the agency. Provides advice and consultation on
matters related to delegations of authority.
     Office of Security Operations:
    1. Provides leadership and guidance to Food and Drug Administration
(FDA) for all aspects of physical and personnel security including the
suitability and National Security Information program.
    2. Develops and implements agency wide security policy.
    3. Manages and administers the Suitability and Security Program as
required by the Office of Personnel Management as set forth in
``Suitability'' (5 CFR, Part 731), and ``National Security Positions''
(5 CFR, Part 732). Monitors the appropriate security clearance levels
for agency positions, employees, and contract employees.
    4. Processes clearance requests, reviews investigative reports/
findings and makes suitability determinations based on investigative
findings.
    5. Serves as liaison with the Department's drug testing officials
and coordinates the agency's drug testing program.
    6. Carries out duties as outlined in the Department of Health and
Human Services and the National Security Information Manual. Serves as
liaison and coordinates with the Department regarding the classified
document program.
    7. Coordinates other agency checks for all non-citizen personnel
who work in the agency's facilities.
    8. Develops and directs the 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
Food and Drug Administration (FDA) White Oak consolidation, logistics
and facilities operations and maintenance services.
    2. Provides leadership and guidance to FDA Headquarters' staff
offices and Headquarters operating activities for White Oak services.
    3. Directs building operations functions for all FDA facilities at
the White Oak Campus.
    4. Provides direct interface with the General Services
Administration (GSA) for White Oak services.
    5. Serves as liaison with the Department of Health and Human
Services (DHHS) and GSA for the efficient management and operation of
facilities occupied by FDA programs at White Oak.
    6. Directs and manages over a $70 million appropriation for the
operation, construction, relocation, and maintenance for the White Oak
Campus.
    7. Provides leadership and direction to assure the efficient and
effective utilization of FDA's resources dedicated to engineering
design, facility improvements, and new construction of FDA facilities
at White Oak.
    8. Furnishes project management services including project
planning, cost estimating and design, and oversight of construction
until completion.
    9. Ensures meaningful and continuous communication with community
leaders and associations, other Federal officials, State and local
governments, and business leaders and customers at White Oak.
    10. Develops multiple strategies for addressing FDA's long and
short-range facility plans at White Oak.
    11. Develops agency plans, policy and procedures consistent with
new regulatory requirements and agency needs for White Oak.
    Division of Logistics Services and Facilities Operations:
    1. Manages shared use conference and training facilities at the
White Oak Campus.
    2. Oversees transportation management programs and services, serves
as the inter-governmental liaison on transportation issues, manages
parking, ridesharing program, shuttle services, fleet management and
motor pool management.
    3. Oversees and directs a variety of commercial contracts to ensure
smooth and efficient delivery of services.
    4. Participates in the development of agency policy involving
logistics programs and services.
    5. Provides guidance and assistance to the agency operating
activities on a variety of logistics management issues.
    6. Manages the warehousing program for the White Oak facility to
include material receiving and distribution, loading dock management,
storage, collection and processing excess personal property, and labor
services for movement of personal property.
    7. Manages the Food and Drug Administration (FDA) mail room program
for FDA headquarters and field organizations including mail room
management, locator services, courier services, off-site mail screening
and the nationwide meter contract.
    8. Actively participates in and supports the continued development
of the White Oak Campus.
    Division of White Oak Consolidation:
    1. Evaluates and implements strategies that enable the agency to
maximize efficiency through the consolidation of specific and shared
functions.
    2. Coordinates budget and schedule in order to successfully
implement project phases.
    3. Establishes management structure and dialog with GSA,
architectural and engineering design and construction contractors to
ensure the FDA needs and concerns are fully addressed.
    4. Monitors construction progress as individual projects proceed
and coordinates necessary changes.
    5. Provides technical direction interaction with design architects
that ensure engineering, architectural and programmatic requirements
are met in new facilities.
    6. Coordinates the various activities required to successfully
relocate the agency to its new location including the move, Information
Technology (IT), security, safety and building operations.
    7. Participates in the development of agency policy involving the
consolidation program.
    Office of Shared Services:
    1. Provides FDA's administrative services including communications,
facilities, library services, FDA historical activities, Freedom of
Information (FOI) and Privacy Act programs, and dockets management.
Utilizes a call center to address all administrative and information
technology management issues, and monitors and analyzes operational and
customer satisfaction.
    Employee Resource and Information Center:
    1. Provides information and services through a call center
environment to all Food and Drug Administration (FDA) employees for
administrative and information technology management issues. Maintains
and populates key technology tools and monitors and analyzes
operational and customer satisfaction.
    2. Provides call center support to the general public via the FDA
Employee Locator phone line.
    3. Provides leadership policy development, and coordination for
programs with a financial impact on FDA employees including transit
subsidy and childcare subsidy programs, fleet management and motor pool
management, Presidential Management Fellows Program, Emerging Leaders
Program and new employee orientation.
    Office of Public Information and Library Services:
    1. The Office of Public Information and Library Services (OPILS) is
responsible for planning and directing agency information programs to
set the direction, coordinate, determine policy, and provide oversight
for the provision of information services and information, in a variety
of formats and for a variety of purposes, to FDA and the public. OPILS
includes the following divisions and sections: Division of Dockets
Management (DDM), Division of Freedom of Information (DFOI), FDA
Biosciences Library (FBSL), and the FDA History Office. The following
are specific functions within the Office:
    Provides leadership and direction for the operations of all of the
agency information centers, including the FDA Biosciences Library and
the DFOI and DDM public reading rooms.
    Provides executive perspective on current policy objectives and
increases public understanding of the agency's purpose and function.
    Establishes agency-wide policy and provides overall direction and
leadership for the Freedom of information (FOI) and Privacy Act
programs.
    Provides information, information services and research support to
FDA through access to information in various formats, via information
consulting and advisory services.
    Provides leadership and direction regarding all aspects of the
agency's regulated dockets program.
    Division of Dockets Management and Freedom of Information:
    1. The Division of Dockets Management and Freedom of Information is
responsible for planning and directing agency information programs to
set the direction,

coordinate, determine policy, and provide oversight for the provision
of services and information, in a variety of formats and for a variety
of purposes, to FDA and the public for the services provided by the
Dockets Management Branch (DMB) and the Freedom of Information Branch
(FOIB).
    The following are specific functions within the Office:
    Provides leadership and direction for the operations of the agency
information centers, including the FOIB and DMB public reading rooms.
    Provides executive perspective on current policy objectives and
increases public understanding of the agency's purpose and function.
    Establishes agency-wide policy and provides overall direction and
leadership for the Freedom of information (FOI) and Privacy Act
programs.
    Provides information and support to FDA through access to various
documents via consulting and advisory services, and through proactive
posting to the FDA internet.
    Provides leadership and direction regarding all aspects of the
agency's regulated dockets program.
    Dockets Management Branch:
    1. Receives, examines and processes submissions required or
permitted in agency administrative proceedings; establishes and
maintains docket files containing agency official records relating to
an administrative proceeding. Disseminates submissions to appropriate
offices for action. Routinely coordinates activities of the branch with
other appropriate components.
    2. Serves as the agency expert on requirements for submissions
required or permitted in agency administrative proceedings.
Participates in the development of regulations and policy impacting on
agency administrative proceedings and the release of information under
the Freedom of Information Act (FOIA).
    3. Provides staff support for agency rulemaking activities.
Determines compliance of petitions, comments, request for hearings,
motions, briefs, and objections with agency regulations.
    4. Establishes agency-wide policy and provides overall direction
and leadership for the Freedom of information (FOI) and Privacy Act
programs.
    5. Maintains and operates a public reading room to make agency
official records available to any interested party, and provides copies
upon request, under the provisions of the FOIA.
    6. Provides electronic access to these records, via the Internet,
and other means, as required by the EFOIA.
    7. Provides information access via the Intranet and other means to
FDA personnel for Dockets Management Branch materials and to
copyrighted documents.
    8. Plans and conducts agency-wide analytical reviews and studies to
assess and management information and address concerns. Makes
recommendations and assists in the implementation of the
recommendations.
    Freedom of Information Branch:
    1. Serves as the agency expert and focal point for headquarters and
field personnel in the development and implementation of effective
policies and procedures in accordance with the FOIA, the Privacy Act,
FDA regulations, and other relevant statues.
    2. Receives, reviews, controls, coordinates and routes all FOI
requests to the proper action office; designs and implements control
mechanisms to assure FOI and Privacy Act inquiries are processed and
responded to within established timeframes.
    3. Establishes agency-wide policy and provides overall direction
and leadership for the Freedom of information (FOI) and Privacy Act
programs.
    4. Reviews all recommendations for denials submitted by
headquarters and field FOI officers. 5. Determines the need for
supplemental information and/or changes in the denial recommendation
and coordinates required action with the submitting office.
    6. Analyzes, compiles, and prepares reports on privacy and FOI
activities in the agency for the annual reports to the Department and
for other reporting requirements.
    7. Maintains copies of agency manuals, indexes, and other records
required to be on public display in the public reading room.
    Division of FDA Biosciences Library:
    1. The Division of the FDA Biosciences Library is responsible for
planning and directing agency library programs to set the direction,
coordinate, determine policy, and provide oversight for the provision
of library services and information, in a variety of formats and for a
variety of purposes to FDA and the public. The following are specific
functions within the Office:
    Provides research support to FDA through delivery of information
consulting and advisory services, literature searches, and document
delivery services in order for FDA to carry out its public health
mission.
    Collaborates with FDA researchers on research projects,
bibliographies, internal publication databases, copyright issues,
digitization and more, so FDA has the information it needs to meet its
scientific and regulatory mission.
    Plans, develops and conducts training sessions to teach customers
how to access and best utilize the online resources available to them
to enhance their research efforts.
    Stewards of a unique, valuable, extensive and specialized
collection of materials essential to FDA's scientific, legal,
administrative and regulatory staff. Collects, organizes, maintains and
preserves information resources, in multiple formats, in all areas of
FDA's research and products FDA regulates, including: biologics, blood
products, cosmetics, devices, drugs, food processing and safety,
nutrition, pharmacy, pharmacology, radiology, tobacco, toxicology, and
veterinary medicine.
    Promotes and markets services and resources to customers. Leverages
FDA's resources and increases awareness of the library services, staff
expertise, and its valuable research collection. Provides services and
resources to agency customers, other Federal employees and the public
on a limited basis.
    Selects, evaluates, acquires and/or develops, and provides
electronic access to scientific and technical databases, publications
and other media mechanisms in support of agency-wide research needs.
    Partners with libraries and information centers, publishers,
consortia across the Federal government, health related associations,
and other organizations, to enhance resource sharing opportunities that
provide for cost savings, resource sharing, sharing of skills and
knowledge, benchmarking best practices, and collaboration on projects
that have a beneficial impact on the library and FDA's work.
    Public Services Branch:
    1. Maintains library operations and staffs the public information
desk, responding to requests for information from FDA and members of
the public.
    2. Provides information, information services and research support
to FDA through access to information in various formats.
    3. Provides training to FDA on the library's subscribed electronic
research resources and tools.
    4. Provides consulting and advisory services to FDA staff, through
briefings and participation in scientific and regulatory meetings.
    5. Provides research support through preparation of extensive
literature

searches and delivery of customized information packages.
    6. Provides articles and documents to researchers via document
delivery and inter-library loan services.
    7. Monitors and administers the document delivery system, ILLiad,
and the customer relationship management system, Ask a Librarian.
    8. Interprets library and information policy and copyright guidance
for FDA customers.
    9. Manages and coordinates access to bibliographic citation
management systems, Reference Manager and EndNote, and consultants with
researchers to assist with preparation of bibliographies and citations.
    10. Delivers presentations and briefings at New Employee
Orientations, Awareness Days, Open Houses, and FDA center events to
promote the library resources and services.
    Technical Services Branch:
    1. Ensures the library collections, both online and in print
formats, are responsive to customer research and information needs.
    2. Manages portfolio of the library's research resources.
    3. Develops and implements the library's collection development
policy and interprets policy to customers to justify purchase
decisions, collection scope and other criteria.
    4. Collects usage data, customer recommendations and feedback to
determine information resources to maintain and to cancel; administers
acquisition of print and online resources.
    5. Establishes site licenses beneficial to FDA research for all
library subscribed electronic resources.
    6. Establishes pilot tests to evaluate new electronic information
resources; analyzes feedback and makes determinations for purchase
decisions.
    7. Administers the integrated library system and its modules,
including the online public access catalog, the federated search
engine, and the electronic resource management system.
    8. Provides news pushes including the Federal Register, and manages
listservs to provide daily email updates to online newsletters of
interest.
    FDA History Office:
    1. Provides expertise on the history of FDA and its predecessors;
is a key resource for historical records and resources used for agency
commemoratives, anniversaries and milestones.
    2. Responds to information requests from FDA centers, scholars, the
press, consumers, government agencies, industry, trade organizations,
health professionals, associations, and foreign sources. Presents
information in workshops, briefings, and seminars.
    3. Conducts research and produces publications, briefing reports,
and presentations interpretive of FDA. Maintains an extensive office
research file.
    4. Provides expertise and assesses the historical value of agency
resources, i.e., records, photographs, films, audio-visual records, and
rare or out-of-print monographs. Leverages FDA resources through
consultative partnerships with FDA offices. Collaborates on
preservation of historical materials with experts at the National
Archives and Records Administration, the National Library of Medicine,